Lipocine Announces LPCN 1154 Meets Bioequivalence with IV Brexanolone in Pivotal Study
- Met standard bioequivalence (BE) criteria Cmax, AUC0-t, and AUC 0- ∞ Ctrough criterion was met LPCN 1154 was well tolerated with no sedation or somnolence events observed On track for NDA filing, targeted by end of Q4 2024 SALT LAKE CITY , June 25, 2024 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to augment therapeutics through effective oral delivery, today announced positive topline study results demonstrating bioequivalence of LPCN 1154 to IV brexanolone in an NDA enabling pivotal pharmacokinetic (PK) study. Lipocine is developing LPCN 1154, oral brexanolone, for the treatment of postpartum depression (PPD).
- 06/25/2024
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Lipocine Presents 52 Week Results from LPCN 1148 Phase 2 Study in Late Breaking Session at EASL Congress 2024
- SALT LAKE CITY , June 10, 2024 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company, today announced that Phase 2 results on LPCN 1148 in cirrhosis were featured in a late breaking oral presentation at the European Association for the Study of Liver (EASL) Congress on Saturday, June 8, in Milan, Italy. The presentation "Intervention with oral LPCN 1148 improves sarcopenia and hepatic encephalopathy (HE) in patients with cirrhosis: a 52-week phase 2 randomized clinical trial" was presented by Arun J.
- 06/10/2024
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Lipocine (LPCN) Is a Great Choice for 'Trend' Investors, Here's Why
- Lipocine (LPCN) made it through our "Recent Price Strength" screen and could be a great choice for investors looking to make a profit from stocks that are currently on the move.
- 06/06/2024
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7 Penny Biotech Stocks to Triple Your Investment
- One of the oldest maxims in investing is that higher risk produces greater returns. That maxim holds particularly true across penny biotech stocks.
- 05/28/2024
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Here's Why Momentum in Lipocine (LPCN) Should Keep going
- Lipocine (LPCN) could be a solid choice for shorter-term investors looking to capitalize on the recent price trend in fundamentally sound stocks. It is one of the many stocks that passed through our shorter-term trading strategy-based screen.
- 05/21/2024
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Lipocine Announces Financial Results for the First Quarter Ended March 31, 2024
- SALT LAKE CITY , May 9, 2024 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company, today announced financial results for the first quarter ended March 31, 2024 and provided a corporate update. LPCN 1154 for Postpartum Depression In May 2024, dosing of subjects was completed in the pivotal pharmacokinetic (PK) study designed to support a New Drug Application (NDA) for LPCN 1154.
- 05/09/2024
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Lipocine Announces Late Breaking Oral Presentation of Data from the Phase 2 Study of LPCN 1148 at EASL Congress 2024
- SALT LAKE CITY , May 8, 2024 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company, today announced that data from the Phase 2 study of LPCN 1148 has been selected for a late breaking oral presentation at the European Association for the Study of Liver ("EASL") Congress, to take place June 5 to 8, 2024 in Milan, Italy. Presentation Details Title Intervention with oral LPCN 1148 improves sarcopenia and hepatic encephalopathy ("HE") in patients with cirrhosis: a 52-week phase 2 randomized clinical trial Presenter: Dr. Arun J.
- 05/08/2024
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Lipocine Announces Completion of Dosing in Pivotal Study of Postpartum Depression Candidate, LPCN 1154
- Pivotal study design aligned with FDA on streamlined pathway to NDA submission goal in 2024 Topline results anticipated late in 2Q 2024 SALT LAKE CITY , May 1, 2024 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company, today announced that dosing of subjects has been completed in the pivotal pharmacokinetic (PK) study designed to support a New Drug Application (NDA) for LPCN 1154. LPCN 1154, oral brexanolone, is being developed as a treatment of postpartum depression (PPD).
- 05/01/2024
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Lipocine Announces Positive LPCN 2401 Clinical Results Showing Improved Body Composition in Participants with Obesity
- LPCN 2401 treatment resulted in statistically significant body composition improvement in men Increased lean mass (LM) by 4.4% and decreased fat mass (FM) by 6.7% Reduced android fat (AF) by 4.1% and increased bone mineral content (BMC) by 2.8% Well-tolerated, adverse events (AEs) similar to placebo Potential for use in combination with incretin mimetics (GLP-1/GIP agonists and/or post GLP-1/GIP agonist) or as a monotherapy post discontinuation Conference call and webcast at 8.30 a.m. ET today SALT LAKE CITY , April 11, 2024 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company, today announced results from a Phase 2 clinical trial (NCT04134091) which includes LPCN 2401, an oral proprietary combination of anabolic androgen receptor agonist and α-tocopherol, an antioxidant.
- 04/11/2024
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Lipocine Announces Positive Week 52 Results from LPCN 1148 Phase 2 Study in Patients with Cirrhosis
- Met primary and Hepatic Encephalopathy (HE) endpoints in Phase 2 study Increase in Skeletal Muscle Index (SMI) observed at Week 24 was maintained through 52 weeks Participants on placebo increased SMI when switched to LPCN 1148 Fewer Overt Hepatic Encephalopathy (OHE) events and time to first recurrent OHE event was longer while on LPCN 1148 therapy LPCN 1148 was well-tolerated, with AE rates and severities similar to placebo. Participants on LPCN 1148 were hospitalized for fewer days SALT LAKE CITY , March 28, 2024 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company today announced positive topline results from a Phase 2 clinical study of LPCN 1148.
- 03/28/2024
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Lipocine Announces First Cohort Dosed in Pivotal Study of LPCN 1154
- Company anticipates topline results from this crossover pivotal study late in the second quarter of 2024 SALT LAKE CITY , March 25, 2024 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company focused on treating Central Nervous System (CNS) disorders by leveraging its proprietary platform, today announced that study enrollment is complete and the first cohort of subjects has been dosed in pivotal pharmacokinetic (PK) study designed to support a New Drug Application (NDA) for LPCN 1154. LPCN 1154, oral brexanolone, is being developed by Lipocine for the treatment of postpartum depression (PPD).
- 03/25/2024
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Lipocine Announces Financial Results for the Full Year Ended December 31, 2023
- SALT LAKE CITY , March 7, 2024 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company focused on treating Central Nervous System ("CNS") disorders, today announced financial results for the year ended December 31, 2023 and provided a corporate update. Neuroactive Steroids Lipocine announced positive topline results from a pharmacokinetics ("PK") pilot bridge study of LPCN 1154 (oral brexanolone).
- 03/07/2024
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Lipocine to Present at 36th Annual Roth Conference
- SALT LAKE CITY , March 6, 2024 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company focused on treating Central Nervous System (CNS) disorders, today announced that Dr. Mahesh V. Patel, President and Chief Executive Officer, will participate in a fireside chat and meet with investors at the 36th Annual Roth Conference, to take place in Laguna Niguel, CA, on March 18.
- 03/06/2024
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Lipocine Announces Confirmation of Dosing Regimen for Pivotal Study of LPCN 1154
- Positive clinical study results confirm 48-hour dosing regimen for the pivotal PK study On track for Q2-24 pivotal study topline results and planned Q4-24 NDA filing SALT LAKE CITY , Feb. 6, 2024 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company focused on treating Central Nervous System (CNS) disorders by leveraging its proprietary platform, today announced that results from a multi-dose clinical study have confirmed the LPCN 1154 48-hour dosing regimen for the upcoming NDA enabling pivotal pharmacokinetic (PK) study. LPCN 1154 is an oral neurosteroid being developed by Lipocine for the treatment of postpartum depression (PPD).
- 02/06/2024
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Lipocine Announces Continued Commercialization of TLANDO® through Verity Pharmaceuticals
- SALT LAKE CITY , Feb. 2, 2024 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company focused on treating Central Nervous System (CNS) disorders, today announced that commercialization of TLANDO® in the U.S. has been transitioned to its licensee Verity Pharma, effective February 1, 2024, enabling the continuity of patient access to TLANDO. TLANDO is the first and only oral testosterone replacement therapy (TRT) option approved by the US Food and Drug Administration (FDA) that does not require dose titration.
- 02/02/2024
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Lipocine and Verity Pharma Enter into License Agreement for TLANDO® Franchise in the U.S. and Canada
- Lipocine to receive $11 million license fee Up to $259 million in development and commercial sales milestones Tiered royalties on net sales of licensed products up to 18% Commercialization of TLANDO transitions to Verity Pharma effective Feb.1 2024 Lipocine retains all rights for territories outside the United States and Canada, and all non-TRT rights globally SALT LAKE CITY , Jan. 18, 2024 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company focused on treating Central Nervous System (CNS) disorders, Gordon Silver Limited and Verity Pharmaceuticals, Inc. (Verity Pharma) today announced that they have entered into an exclusive licensing agreement under which Verity Pharma will market TLANDO® in the United States and, if approved, in Canada. TLANDO is the first and only oral testosterone replacement therapy (TRT) option approved by the US Food and Drug Administration (FDA) that does not require dose titration.
- 01/18/2024
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Lipocine to Present at Biotech Showcase 2024
- Company Management Will Also Host Meetings at LifeSci Partners Corporate Access Event SALT LAKE CITY , Dec. 19, 2023 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company focused on treating Central Nervous System (CNS) disorders, today announced that it will present at the Biotech Showcase and host institutional investor and partnering meetings at this event and at a Corporate Access Event organized by LifeSci Partners. Both in-person events will take place January 8 - 10, 2024, in San Francisco, California.
- 12/19/2023
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Lipocine Releases Late Breaking Presentation on LPCN 1148 Phase 2 Results at The Liver Meeting® 2023
- Results demonstrate improvements in sarcopenia and other clinically meaningful outcomes Patients converting from placebo to LPCN 1148 in the ongoing open label extension also showed improvement in sarcopenia SALT LAKE CITY , Nov. 13, 2023 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company focused on treating Central Nervous System (CNS) disorders, today announced that results of its Phase 2 study evaluating LPCN 1148 are being presented at The American Association for the Study of Liver Diseases (AASLD) – The Liver Meeting® 2023, taking place in Boston MA. The results are featured in a late-breaking oral presentation and e-poster by Dr. Arun Sanyal, MD, Director, Stravitz-Sanyal Institute for Liver Disease and Metabolic Health, Virginia Commonwealth University, advisor to Lipocine.
- 11/13/2023
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Lipocine Announces Financial Results for the Third Quarter Ended September 30, 2023
- SALT LAKE CITY , Nov. 8, 2023 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company focused on treating Central Nervous System (CNS) disorders by leveraging its proprietary platform to develop differentiated products, today announced financial results for the third quarter and nine months ended September 30, 2023, and provided a corporate update. Clinical Program Highlights Neuroactive Steroids On October 18, Lipocine completed a successful meeting with the FDA on LPCN 1154, which is in development for postpartum depression (PPD).
- 11/08/2023
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Lipocine to Present Clinical Data on LPCN 1148 at The Liver Meeting® 2023
- "Late Breaking" abstract scheduled for oral presentation on November 13 SALT LAKE CITY , Nov. 1, 2023 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company focused on treating Central Nervous System (CNS) disorders, today announced that an abstract on LPCN 1148 has been selected for a late breaking oral presentation at The American Association for the Study of Liver Diseases (AASLD) – The Liver Meeting® 2023, to take place in Boston MA, November 10 to 14, 2023. Presentation Details Title Oral LPCN 1148 improves sarcopenia and hepatic encephalopathy in patients with cirrhosis Presenter: Dr. Arun J.
- 11/01/2023
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Lipocine Completes Successful Meeting with FDA on LPCN 1154 in Postpartum Depression
- Lipocine and FDA agreed on the acceptance criteria for the pivotal study which enables advancement of LPCN 1154 for postpartum depression (PPD) Company on track to initiate dosing in the pivotal study Q1'24 SALT LAKE CITY , Oct. 26, 2023 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company focused on treating Central Nervous System (CNS) disorders by leveraging its proprietary platform, today announced the completion of a meeting with the FDA and guidance for the appropriate acceptance criteria for the upcoming LPCN 1154 pivotal study. PPD is a major depressive disorder with onset either during pregnancy or within four weeks of delivery, with symptoms persisting up to 12 months after childbirth.
- 10/26/2023
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Lipocine to Present at the H.C. Wainwright Annual NASH Investor Conference
- SALT LAKE CITY , Oct. 23, 2023 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company focused on treating Central Nervous System (CNS) disorders, today announced that it will present and meet with investors at the H.C. Wainwright 7th Annual NASH Investor Conference, taking place virtually October 24, 2023.
- 10/23/2023
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Lipocine to Present at the Cantor Fitzgerald Global Healthcare Conference
- SALT LAKE CITY , Sept. 19, 2023 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company focused on treating Central Nervous System (CNS) disorders, today announced that Dr. Mahesh Patel, President and Chief Executive Officer, will present and meet with investors at the 2023 Cantor Fitzgerald Global Healthcare Conference to take place September 26th to September 28th in New York City.
- 09/19/2023
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Lipocine Announces Financial Results for the Second Quarter Ended June 30, 2023
- SALT LAKE CITY , Aug. 10, 2023 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company focused on treating Central Nervous System (CNS) disorders, today announced financial results for the second quarter and six months ended June 30, 2023, and provided a corporate update. Clinical Program Highlights Neuroactive Steroids Lipocine announced positive topline results from a pilot pharmacokinetics ("PK") bridge study of LPCN 1154 (oral brexanolone).
- 08/10/2023
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Why Is Lipocine (LPCN) Stock Up 32% Today?
- Lipocine (NASDAQ: LPCN ) stock is rising higher on Thursday after the company released positive results from a Phase 2 clinical trial. That trail covers the use of LPCN 1148 as a treatment for patients suffering from cirrhosis.
- 07/27/2023
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Lipocine to Present LPCN 1148 and LPCN 1144 at the EASL Congress 2023
- Phase 2 proof-of-concept study of LPCN 1148 in male cirrhotic patients with sarcopenia is fully enrolled with topline 24-week results expected mid-2023 SALT LAKE CITY , June 7, 2023 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company focused on treating Central Nervous System (CNS) disorders by leveraging its proprietary technology platform to develop differentiated products, today announced that it will present posters on LPCN 1148 and LPCN 1144 at the forthcoming European Association for the Study of the Liver (EASL) Congress 2023, to take place in Vienna, Austria, June 21 – 24, 2023. A multimodal treatment candidate for sarcopenia in men with decompensated cirrhosis: a randomized, placebo-controlled trial evaluating LPCN 1148 Lead author and presenter: Dr. Benjamin J.
- 06/07/2023
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Lipocine to Present at Biotech Showcase
- Company Management Will Also Host Meetings at LifeSci Partners Corporate Access Event SALT LAKE CITY , Jan. 5, 2023 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company focused on treating Central Nervous System ("CNS") disorders by leveraging its proprietary platform to develop differentiated products, today announced that its management will present at the Biotech Showcase and host institutional investor and partnering meetings at this event and a Corporate Access Event organized by LifeSci Partners. Both in-person events will take place January 9-11, 2023, in San Francisco, California.
- 01/05/2023
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Lipocine to Present at Ladenburg Thalmann 2022 Healthcare Conference
- SALT LAKE CITY , Sept. 22, 2022 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company focused on leveraging its proprietary Lip'ral platform to augment therapeutics through effective oral delivery by developing differentiated products relative to standard of care, announced today that it will present at the Ladenburg Thalmann 2022 Healthcare Conference on September 29 in New York.
- 09/22/2022
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7 Undervalued Penny Stocks With Major Upside
- Each of these penny stocks has proven momentum throughout 2022 and major upside on top of the returns through the the first quarter. The post 7 Undervalued Penny Stocks With Major Upside appeared first on InvestorPlace.
- 03/29/2022
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Lipocine Is One To Watch Based On Possible FDA Approval Of TLANDO And NASH Data
- Lipocine has obtained positive results in a phase 2 study using its drug LPCN1144 for the treatment of patients with NASH.
- 11/11/2021
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Penny Stocks to Buy Now? 5 Reddit Stocks To Watch This Week
- Looking for penny stocks on Reddit? Check these 5 out The post Penny Stocks to Buy Now?
- 11/07/2021
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Lipocine, Antares Ink Licensing Pact For Testosterone Replacement Therapy In US
- Lipocine Inc (NASDAQ: LPCN) has entered into an exclusive licensing agreement with Antares Pharma Inc (NASDAQ: ATRS) to commercialize Tlando in the U.S. Tlando is an oral testosterone product for testosterone replacement therapy in adult males indicated for conditions associated with a deficiency or absence of endogenous testosterone.
- 10/18/2021
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Penny Stocks To Watch Today As Buying Drives ADMP, IO, LPCN & Others
- A jump in penny stock prices has retail traders cashing out on big gains. The post Penny Stocks To Watch Today As Buying Drives ADMP, IO, LPCN & Others appeared first on Penny Stocks to Buy, Picks, News and Information | PennyStocks.com.
- 10/18/2021
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Lipocine And Antares Pharma Enter Into U.S. Licensing Agreement To Commercialize TLANDO®
- SALT LAKE CITY, Oct. 18, 2021 /PRNewswire/ -- Under the terms of Agreement Lipocine to receive: Up to $21.0 million in licensing fees, including $11.0 million payable immediately and $10.0 million to be paid in the future subject to certain conditions Commercial sales milestone payments of up to $160.0 million Tiered royalties on net sales of TLANDO from mid-teens up to 20% Antares Pharma to undertake all commercialization, post-marketing study obligations, and sourcing of TLANDO in the U.S. Lipocine grants Antares Pharma an option to license TLANDO XR for development and commercialization in the U.S. Upon exercise of the option, Lipocine to receive: An additional $4.0 million in license fees, clinical and regulatory milestone payments of up to $35.0 million, and tiered royalties on net sales from mid-teens up to 20% Antares Pharma to be responsible for all clinical development costs, regulatory filings, commercialization, and post-marketing commitments Lipocine retains all rights for ex-U.S. territories, and non TRT indications for TLANDO and TLANDO XR Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced it has entered into an exclusive licensing agreement with Antares Pharma, Inc. to commercialize TLANDO in the United States. TLANDO is an oral testosterone product for testosterone replacement therapy ("TRT") in adult males indicated for conditions associated with a deficiency or absence of endogenous testosterone: primary hypogonadism (congenital or acquired) and hypogonadotropic hypogonadism (congenital or acquired).
- 10/18/2021
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Lipocine to Present at The H.C. Wainwright 5th Annual NASH Investor Conference
- SALT LAKE CITY, Oct. 5, 2021 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced that the Company will present at the H.C. Wainwright 5th Annual NASH Investor Conference being held virtually on October 12, 2021.
- 10/05/2021
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Top Reddit Penny Stocks to Watch in September 2021
- Are these 3 Reddit penny stocks on your watchlist right now? The post Top Reddit Penny Stocks to Watch in September 2021 appeared first on Penny Stocks to Buy, Picks, News and Information | PennyStocks.com.
- 08/27/2021
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Top Penny Stocks Analysts Say To Buy, Targets Up To 200% Right Now
- Penny stocks with high marks from analysts right now. The post Top Penny Stocks Analysts Say To Buy, Targets Up To 200% Right Now appeared first on Penny Stocks to Buy, Picks, News and Information | PennyStocks.com.
- 08/26/2021
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Lipocine Meets Resolution Regulatory Endpoint In Mid-Stage NASH Trial
- Lipocine Inc (NASDAQ: LPCN) has announced topline 36-week results from its Phase 2 proof of concept LiFT study investigating LPCN 1144 in Non-Alcoholic Steatohepatitis (NASH). LPCN 1144 comprises an orally delivered prodrug of endogenous testosterone (T).
- 08/25/2021
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Lipocine's LPCN 1144 Met Non-Alcoholic Steatohepatitis ("NASH") Resolution Regulatory Endpoint in Phase 2 LiFT Study
- SALT LAKE CITY, Aug. 25, 2021 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced positive topline 36-week results from its Phase 2 proof of concept LiFT (" Liver F at intervention with oral T estosterone") clinical study, NCT04134091, investigating LPCN 1144 in men with biopsy-confirmed NASH. Currently, there are no approved treatments for NASH, a leading cause of liver failure and liver transplantation globally.
- 08/25/2021
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Lipocine Stock Jumps On Litigation Settlement With Clarus Therapeutics
- Lipocine Inc (NASDAQ: LPCN) has entered into a settlement and license agreement with Clarus Therapeutics to resolve claims in the ongoing intellectual property litigation and interference proceeding. Under the terms of the settlement, both the companies have agreed to dismiss the litigation presently pending in the District Court for the District of Delaware.
- 07/15/2021
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Lipocine Announces Settlement With Clarus Therapeutics
- SALT LAKE CITY, July 14, 2021 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced that it has entered into a global settlement and license agreement with Clarus Therapeutics Inc. ("Clarus") to resolve all outstanding claims in the on-going intellectual property litigation between the two companies as well as the on-going interference proceeding between the two companies. Under the terms of the settlement announced today, Lipocine and Clarus have agreed to dismiss the Lipocine Inc. v Clarus Therapeutics, Inc., No 19-cv-622 (WCB) litigation presently pending in the U.S. District Court for the District of Delaware.
- 07/14/2021
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Lipocine To Present At The Ladenburg Thalmann Healthcare Conference
- SALT LAKE CITY, July 6, 2021 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced that the Company will present at the Ladenburg Thalmann Healthcare Conference. The conference will be held virtually.
- 07/06/2021
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Lipocine To Present At The Raymond James Human Health Innovation Conference
- SALT LAKE CITY, June 16, 2021 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced that the Company will present at the Raymond James Human Health Innovation Conference. The conference will be held virtually.
- 06/16/2021
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Lipocine To Start Testing Neuro-Steroid Candidate In Postpartum Depression Patients
- The FDA has signed off Lipocine Inc's (NASDAQ: LPCN) Investigational New Drug Application (IND) to initiate a Phase 2 study to evaluate LPCN 1154 for the treatment of postpartum depression (PPD) in adults. A pharmacokinetic (PK) study to assess dose proportionality is planned to start in July 2021, with top-line results expected in the third quarter of 2021.
- 06/14/2021
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FDA Clears LPCN 1154 IND Application for a Phase 2 Postpartum Depression Study
- SALT LAKE CITY, June 14, 2021 /PRNewswire/ -- Lipocine Inc. (Nasdaq: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced that the U.S. Food and Drug Administration ("FDA") has cleared the Company's Investigational New Drug Application ("IND") to initiate a Phase 2 study to evaluate the therapeutic potential of LPCN 1154, an oral neuro-steroid product candidate, for the treatment of postpartum depression ("PPD") in adults. A pharmacokinetic ("PK") study to assess dose proportionality is planned to start in July 2021 with top-line results expected in the third quarter of 2021.
- 06/14/2021
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Lipocine to Present at the Lytham Partners Summer 2021 Investor Conference
- SALT LAKE CITY, June 7, 2021 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced that the Company will present at the Lytham Partners Summer 2021 Investor Conference. The conference will be held virtually.
- 06/07/2021
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Summary Judgment Ruling in Patent Infringement Lawsuit
- SALT LAKE CITY, May 26, 2021 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced that the United States District Court for the District of Delaware ("Court") has granted Clarus Therapeutics, Inc.'s ("Clarus") motion for Summary Judgment, finding the asserted claims of Lipocine's U.S. patents 9,034,858; 9,205,057; 9,480,690; and 9,757,390 invalid for failure to satisfy the written description requirement of 35 U.S.C. § 112. Clarus still has remaining claims before the Court.
- 05/26/2021
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Clarus Therapeutics Defeats Lipocine's Patent Infringement Lawsuit On Summary Judgment
- NORTHBROOK, Ill., May 25, 2021 /PRNewswire/ -- Today, Federal Circuit Judge William C.
- 05/25/2021
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Lipocine Announces Financial Results for the First Quarter Ended March 31, 2021
- SALT LAKE CITY, May 6, 2021 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced financial results for the first quarter ended March 31, 2021 and provided a corporate update. First Quarter Recent Corporate Highlights Announced positive topline results from the Phase 2 LiFT ("Liver Fat intervention with oral Testosterone") clinical study, investigating LPCN 1144 in biopsy-confirmed NASH male subjects Both LPCN 1144 treatment arms met the primary endpoint, change in hepatic fat fraction via magnetic resonance imaging proton density fat fraction ("MRI-PDFF"), with statistical significance 36-week biopsy data from the LiFT study are expected in August 2021 Continued enrolling patients into an open label extension to the LiFT clinical study in which all patients will have access to LPCN 1144 Announced the publication of results supporting the therapeutic potential of LPCN 1144 in the treatment of non-alcoholic steatohepatitis ("NASH") and hepatic fibrosis The results were featured in a paper entitled "Treatment Potential of LPCN 1144 on Liver Health and Metabolic Regulation in a Non–Genomic, High Fat Diet Induced NASH Rabbit Model" (Comeglio et al), published in the Journal of Endocrinological Investigation Continued to evaluate commercial options for TLANDO, our oral testosterone product for testosterone replacement therapy ("TRT") in adult males with hypogonadism Posters featuring clinical data on TLANDO™ were presented at the ENDO 2021 Conference Raised gross proceeds of approximately $28.7 million in a public offering of approximately 16.4 million shares of common stock First Quarter Ended March 31, 2021 Financial Results Lipocine reported a net loss of $3.4million, or ($0.04) per diluted share, for the first quarter ended March 31, 2021, compared with a net loss of $5.8 million, or ($0.14) per diluted share, for the first quarter ended March 31, 2020.
- 05/06/2021
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7 Reddit Penny Stocks to Keep Your Eye on for Big Movement
- Reddit stocks -- and in particular Reddit penny stocks -- are some of the riskiest shares out there. Yet, investors could make out big with some of the names on this list.
- 03/24/2021
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Top Penny Stocks News Today: TNXP, ONTX, AREC, LPCN and ZCMD
- Amid risk-on sentiment, penny stocks are surging higher today as investors seek to grab the higher upside these small-cap stocks provide. The post Top Penny Stocks News Today: TNXP, ONTX, AREC, LPCN and ZCMD appeared first on InvestorPlace.
- 03/17/2021
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Lipocine Announces Financial Results For The Year Ended December 31, 2020
- SALT LAKE CITY, March 11, 2021 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced financial results for the fourth quarter and year ended December 31, 2020, and provided a corporate update. "Lipocine had a number of important accomplishments in 2020, most notably the U.S. Food and Drug Administration ("FDA") decision to grant tentative approval to TLANDO, the Company's oral testosterone product for testosterone replacement therapy ("TRT") in adult males with hypogonadism.
- 03/11/2021
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Lipocine Announces Update on Jury Trial in Patent Infringement Lawsuit Against Clarus Therapeutics
- SALT LAKE CITY, Dec. 29, 2020 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced that Judge William C. Bryson of the United States District Court of Delaware has postponed the February 8,...
- 12/29/2020
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Lipocine: Imminent Catalysts In NASH And Oral Testosterone Replacement Therapy Make For A Strong Buy
- LPCN's long road to market for its oral testosterone pill has been bumpy; however, the FDA just gave TLANDO tentative approval.
- 12/14/2020
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Lipocine Announces Tentative Approval of TLANDO™
- SALT LAKE CITY, Dec. 8, 2020 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced that the U.S. Food and Drug Administration ("FDA") has granted tentative approval to TLANDO, its oral...
- 12/08/2020
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Lipocine Announces Deletion of Unauthorized Changes to Company's Website
- SALT LAKE CITY, Dec. 8, 2020 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced that an independent contractor posted on Lipocine's website (www.lipocine.com), without authorization from...
- 12/08/2020
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Lipocine Provides New Regulatory Update on TLANDO™
- SALT LAKE CITY, Dec. 4, 2020 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced that the U.S. Food and Drug Administration ("FDA") has informed the Company that it is continuing to work...
- 12/04/2020
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Here is What Hedge Funds Think About Lipocine Inc (LPCN)
- Most investors tend to think that hedge funds and other asset managers are worthless, as they cannot beat even simple index fund portfolios. In fact, most people expect hedge funds to compete with and outperform the bull market that we have witnessed in recent years. However, hedge funds are generally partially hedged and aim at delivering attractive risk-adjusted returns rather than following the ups and downs of equity markets hoping that they will outperform the broader market. Our research shows that certain hedge funds do have great stock picking skills (and we can identify these hedge funds in advance pretty accurately), so let's take a glance at the smart money sentiment towards Lipocine Inc (NASDAQ:LPCN).
- 11/26/2020
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Lipocine: TLANDO Might Become A Potential TRT Option In Patients With COVID-19 Infection
- Lipocine is about to report data from its clinical study on whether TLANDO can restore testosterone levels in hypogonadal men without the dose titration requirement on November 9, 2020. Low baseline testosterone levels result in a higher risk of serious complications or even death in patients with COVID-19 infection.
- 11/06/2020
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Fortress Reports Positive Data And Other News: The Good, Bad And Ugly Of Biopharma
- Fortress Biotech reports positive data from CUTX-101. Lipocine suffers setback on Tlando front.
- 08/31/2020
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Stocks To Watch: Spotlight On Palo Alto Networks, Best Buy And Xpeng Motors
- Welcome to Seeking Alpha's Stocks to Watch - a preview of key events scheduled for the next week. Follow this account and turn the e-mail alert on to receive this article in your inbox every Saturday morning.
- 08/22/2020
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Lipocine’s Tlando Drug Could Push Shares Higher, Says Analyst
- When it comes to biotechs, all it takes is a single spark to ignite the flame. For Lipocine (LPCN), which is focused on metabolic and endocrine disorders, this spark could be a fast-approach regulatory decision. The company is gearing up for Tlando’s PDUFA date, currently scheduled for August 28.Writing for H.C. Wainwright, analyst Oren Livnat tells clients that Tlando, the company's oral testosterone replacement therapy (TRT), has had a “long regulatory saga” that features two complete response letters (CRLs).That being said, based on multiple factors, Livnat is cautiously optimistic that the FDA will give the therapy its final stamp of approval. First and foremost, the analyst believes LPCN might be able to satisfy the PK excursion thresholds if it can convince the FDA “to accept a comparable PK analysis to that used by Clarus (private) for approved oral TRT Jatenzo, adjusting PK for different collection methods and ex-vivo testosterone conversion.” Additionally, in April, the FDA denied Clarus’ Citizens Petition which wanted to block Tlando approval and limit the agency’s flexibility around approval criteria. “We believe Tlando has demonstrated a likely better blood pressure profile than approved Jatenzo, with a simpler dosing regimen to achieve efficacy, and that the FDA would likely rather avoid the headache of a Formal Dispute Resolution and just allow both products be approved with appropriate labeling,” Livnat explained. Therefore, he assumes the therapy will be approved on August 28, with commercial partnering and the launch coming in Q4 2020 and 2021, respectively.Comparing Tlando to Jatenzo, Livnat argues that LPCN’s candidate is “favorably positioned” in the ongoing patent dispute with Clarus, with a jury trial slated for February 2021. He added, “While that could present some risk to getting a partnership done, we believe Lipocine is already favorably positioned there given its success in its USPTO interference case, already affirmed by the Court of Appeals. We believe Lipocine should be a more successful product than Jatenzo, in an enormous TRT market with plenty of room for both.”As a result, Livnat thinks Tlando peak partner sales could clock in at over $275 million, with peak Lipocine royalties landing at around $50 million. If that wasn’t enough, oral-TRT data from the ongoing LiFT Phase 2 in NASH is set to read out by year-end. This data will be related to preliminary week-12 liver fat reduction, with 36-week biopsy data expected in Q2 2021.“Clearly the NASH angle is so speculative at this point, in a crowded field and uncertain pathway, but we give a bit of credit given the 40% liver-fat reduction seen in prior proof-of-concept, and the differentiated mechanism vs. other candidates,” Livnat commented.Everything that LPCN has going for it convinced Livnat to stay with the bulls. To this end, he reiterated a Buy rating and left the $3 price target as is. This target conveys his confidence in the stock’s ability to climb 47% higher in the next twelve months. (To watch Livnat’s track record, click here) To find good ideas for healthcare stocks trading at attractive valuations, visit TipRanks’ Best Stocks to Buy, a newly launched tool that unites all of TipRanks’ equity insights.Disclaimer: The opinions expressed in this article are solely those of the featured analyst. The content is intended to be used for informational purposes only. It is very important to do your own analysis before making any investment.
- 08/19/2020
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Attention Biotech Investors: Mark Your Calendar For August PDUFA Dates
- July turned out to be a mixed month for FDA approvals. Endo International PLC's (NASDAQ: ENDP) cellulite treatment, Osmotica Pharmaceuticals PLC's (NASDAQ: OSMT) eye...
- 07/31/2020
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Lipocine (NASDAQ:LPCN) Trading Down 2%
- Lipocine Inc (NASDAQ:LPCN)’s share price traded down 2% during mid-day trading on Tuesday . The company traded as low as $1.21 and last traded at $1.23, 22,086 shares were traded during trading. A decline of 99% from the average session volume of 2,173,750 shares. The stock had previously closed at $1.25. A number of research […]
- 07/16/2020
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Lipocine Regains Complinace With Nasdaq Minimum Bid Price Requirement
- Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced that it has received a letter from The Nasdaq Stock Market LLC ("Nasdaq") on July 9, 2020 indicating that Lipocine has regained compliance with Nasdaq's minimum bid price for continued listing on the Nasdaq Capital Market set forth in Nasdaq Listing Rule 5550(a)(2) ("Min Bid Price Listing Rule").
- 07/13/2020
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Lipocine Target of Unusually High Options Trading (NASDAQ:LPCN)
- Lipocine Inc (NASDAQ:LPCN) saw unusually large options trading on Tuesday. Stock investors acquired 2,469 call options on the company. This is an increase of 772% compared to the average volume of 283 call options. A number of brokerages have recently weighed in on LPCN. HC Wainwright upped their target price on Lipocine from $2.00 to […]
- 06/24/2020
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Last Minute Father's Day magazine sale from $5/yr. - 9to5Toys
- DiscountMags has now kicked off a Last Minute Father's Day magazine sale including Wired, Men’s and Women’s Health, GQ, Esquire, and more.
- 06/18/2020
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Hedge Funds Cashing Out Of Lipocine Inc (LPCN)
- In this article we will check out the progression of hedge fund sentiment towards Lipocine Inc (NASDAQ:LPCN) and determine whether it is a good investment right now. We at Insider Monkey like to examine what billionaires and hedge funds think of a company before spending days of research on it. Given their 2 and 20 […]
- 05/28/2020
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LPCN: Cirrhosis IND Cleared
- By John Vandermosten NASDAQ:LPCN READ THE FULL LPCN RESEARCH REPORT First Quarter 2020 Operational and Financial Results On May 7, 2020 Lipocine (NASDAQ:LPCN) filed its first quarter 2020 10-Q and posted its earnings release for the three month period ending March 31, 2020. The company reported zero revenues and a net loss per share of ($0.14) compared to prior year revenues of zero and loss of
- 05/28/2020
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Lipocine Inc. (NASDAQ:LPCN): When Will It Breakeven?
- Lipocine Inc.'s (NASDAQ:LPCN): Lipocine Inc., a specialty pharmaceutical company, focuses on the development of...
- 05/28/2020
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HC Wainwright & Co. Maintains Buy on Lipocine, Raises Price Target to $3
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Shares of several healthcare companies are trading higher in sympathy with the overall market as optimism around a coronavirus vaccine increased following news from Moderna.
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Lipocine Announces Presentations On TLANDO At AUA Virtual Experience 2020 May 15-17
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Lipocine Announces Presentations on TLANDO™ at AUA Virtual Experience 2020
- Lipocine Inc. (Nasdaq: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced that clinical data for lead candidate TLANDO™ will be presented at the American Urological Association ("AUA") Virtual Experience, to take place May 15-17, 2020. TLANDO is an oral testosterone replacement therapy ("TRT") product candidate being developed for adult males with conditions associated with a deficiency or absence of endogenous testosterone, also known as hypogonadism.
- 05/15/2020
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Lipocine Highlights Results Of Pre-Clinical Study Of LPCN 1144
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Treatment Potential of LPCN 1144 Demonstrated in a Pre-Clinical NASH and Hepatic Fibrosis Model
- Lipocine Inc. (LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced the results of a pre-clinical study of LPCN 1144. LPCN 1144 is an oral prodrug of bioidentical testosterone ("testosterone undecanoate" or "TU"). The pharmacological effect of LPCN 1144 was investigated in a non-genomic, five arm, 12-week high fat diet ("HFD")-induced, rabbit animal model of NASH and hepatic fibrosis.
- 05/13/2020
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Shares of several healthcare companies are trading higher amid continued economic optimism as some US states ease lockdown restrictions. While jobless claims came in worse than estimates, figures were lower than in prior weeks.
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Lipocine Q1 EPS $(0.140), Same YoY
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Lipocine Announces First Quarter 2020 Financial and Operational Results
- Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced financial results for the first quarter ended March 31, 2020, and provided a corporate update.
- 05/07/2020
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Lipocine Reports FDA Clears LPCN 1148 Investigational New Drug Application For Phase 2 Cirrhosis Trial
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FDA Clears LPCN 1148 IND Application for Phase 2 Cirrhosis Trial
- Lipocine Inc. (Nasdaq: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced that the U.S. Food & Drug Administration ("FDA") has accepted the Company's Investigational New Drug application ("IND") to initiate a Phase 2 proof-of-concept study to evaluate the therapeutic potential of LPCN 1148, an oral prodrug of bioidentical testosterone, for the treatment of liver cirrhosis in adult male cirrhotic patients. The planned Phase 2 clinical study is a prospective, multi-center, randomized, placebo-controlled 52-week study in male cirrhotic patients that are on the liver transplant list. Contingent upon available funding, Lipocine projects study initiation in the fourth quarter of 2020 or the first quarter of 2021.
- 05/05/2020
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Lipocine Announces FDA Has Denied Oral Testosterone Ester Citizen Petition Filed By Clarus Therapeutics
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U.S. FDA Denies Clarus's Oral Testosterone Ester Citizen Petition
- Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced that the United States Food and Drug Administration ("FDA") denied the Citizen Petition filed by Clarus Therapeutics Inc. ("Clarus") on October 2, 2019. Specifically, the FDA declined to issue product-specific guidance on oral T-ester drug products and denied without comment Clarus' request regarding how the FDA should review and make approval decisions on any pending or future oral T-ester products.
- 04/17/2020
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Investors Who Bought Lipocine (NASDAQ:LPCN) Shares Five Years Ago Are Now Down 94%
- It's nice to see the Lipocine Inc. (NASDAQ:LPCN) share price up 13% in a week. But spare a thought for the long term...
- 04/10/2020
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Lipocine Reports US Appeals Court Affirmed Decision By Patent Trial, Appeal Board
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Lipocine Announces US Court of Appeals for the Federal Circuit Affirms Decision of USPTO
- Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, announced today that the U.S. Court of Appeals for the Federal Circuit affirmed the decision of the Patent Trial and Appeal Board ("PTAB") of the United States Patent and Trademark Office ("USPTO") under Rule 36. Previously the PTAB granted Lipocine's Priority Motion in the interference case, Patent Interference No. 106,045, between Clarus Therapeutics, Inc. ("Clarus") U.S. Patent No. 8,828,428 (the "Clarus '428 Patent") and Lipocine Inc. ("Lipocine"), U.S. Patent Application No. 14/713,692 (the "Lipocine '692 Application"), and entered adverse judgment against Clarus.
- 04/09/2020
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LPCN: Target Date: August!
- By John Vandermosten, CFA NASDAQ:LPCN READ THE FULL LPCN RESEARCH REPORT 2019 Operational and Financial Results On March 13, 2020 Lipocine (NASDAQ:LPCN) filed its fiscal year 2019 10-K and posted its earnings release for the twelve-month period ending December 31, 2019. The company reported $165,000 in revenues and a net loss per share of ($0.50) compared to prior year revenues of $428,000 and
- 04/06/2020
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Lipocine Says 'No ultimate determination of infringement or validity of the patents has been determined at this point.' In Patent Infringement Suit Against Clarus
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Lipocine Announces Outcome of Markman Hearing in Patent Infringement Suit Against Clarus
- Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced that Judge William C. Bryson of the United States District Court of Delaware has issued a Claim Construction Order post the claim construction hearing (commonly referred to as a "Markman Hearing") related to Lipocine's patent infringement lawsuit against Clarus Therapeutics, Inc. ("Clarus"). The purpose of a Markman Hearing is to determine the precise meaning of words from patent claims that are in dispute in a patent infringement lawsuit. No ultimate determination of infringement or validity of the patents has been determined at this point.
- 03/26/2020
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The Daily Biotech Pulse: Pfizer's Eczema Drug Aces Latestage Study, Orphan Drug Designation For Dicerna, Dyadic's COVID-19 Connection
- Here's a roundup of top developments in the biotech space over the last 24 hours. Scaling The Peaks (Biotech Stocks Hitting 52-week highs on March 18) Biomerica, Inc. (NASDAQ: BMRA )( announced commencement of international shipment of rapid COVID-19 test) BioNTech SE – ADR (NASDAQ: BNTX ) Imara Inc (NASDAQ: IMRA ) Down In The Dumps (Biotech Stocks Hitting 52-week lows on March 18) 89bio Inc (NASDAQ: ETNB ) AC Immune SA (NASDAQ: ACIU ) Acasti Pharma Inc (NASDAQ: ACST ) Accelerate Diagnostics Inc (NASDAQ: AXDX ) Aclaris Therapeutics Inc (NASDAQ: ACRS ) Adamas Pharmaceuticals Inc (NASDAQ: ADMS ) Adamis Pharmaceuticals Corp (NASDAQ: ADM ) Adial Pharmaceuticals Inc (NASDAQ: ADIL ) ADMA Biologics Inc (NASDAQ: ADMA ) Aerie Pharmaceuticals Inc (NASDAQ: AERI ) Aerpio Pharmaceuticals Inc (NASDAQ: ARPO ) AEterna Zentaris Inc. (NASDAQ: AEZS ) Agenus Inc (NASDAQ: AGEN ) Agios Pharmaceuticals Inc (NASDAQ: AGIO ) Aikido Pharma Inc (NASDAQ: AIKI ) Akorn, Inc. (NASDAQ: AKRX ) Alkermes Plc (NASDAQ: ALKS ) Allogene Therapeutics Inc (NASDAQ: ALLO ) Alterity Therapeutics Ltd (NASDAQ: ATHE ) AMAG Pharmaceuticals, Inc.
- 03/19/2020
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The Daily Biotech Pulse: Pfizer's Eczema Drug Aces Latestage Study, Orphan Drug Designation For Dicerna, Dyadic's COVID-19 Connection
- Here's a roundup of top developments in the biotech space over the last 24 hours.
Scaling The Peaks
(Biotech Stocks Hitting 52-week highs on March 18)
Biomerica, Inc. (NASDAQ...
- 03/19/2020
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Lipocine Announces 2019 Year End Financial and Operational Results
- Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company, today announced financial results for the year ended December 31, 2019, and provided a corporate update.
- 03/13/2020
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Lipocine Q4 EPS $(0.5) Up From $(0.55) YoY
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Lipocine Announces TLANDO™ PDUFA Date of August 28, 2020
- Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company, announced today that the U.S. Food and Drug Administration ("FDA") acknowledged receipt of the resubmission of TLANDO New Drug Application ("NDA"), the Company's oral testosterone product candidate for testosterone replacement therapy ("TRT") in adult males for conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism. TLANDO is part of Lipocine's TRT franchise of development candidates. The FDA has assigned a Prescription Drug User Fee Act ("PDUFA") goal date of August 28, 2020. The NDA incorporates the reanalysis of existing data based on written feedback to address the single remaining deficiency discussed in the Post Action Meeting with the FDA.
- 03/04/2020
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Lipocine Announces TLANDO PDUFA Date Of August 28, 2020
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24 Healthcare Stocks Moving In Wednesday's Pre-Market Session
- Gainers
Tonix Pharmaceuticals, Inc. (NASDAQ: TNXP) stock moved upwards by 65.7% to $0.67 during Wednesday's pre-market session.
InflaRx, Inc. (NASDAQ: IFRX) stock...
- 02/26/2020
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Why Lipocine Inc.'s (NASDAQ:LPCN) CEO Pay Matters To You
- In 1997 Mahesh Patel was appointed CEO of Lipocine Inc. (NASDAQ:LPCN). First, this article will compare CEO...
- 02/25/2020
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Lipocine Announces $6 Million Registered Direct Offering Priced At-The-Market
- Lipocine Inc. (NASDAQ:LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced that it has entered into securities purchase agreements with certain institutional investors providing for the purchase and sale of 10,084,034 Class A Units at an offering price of $0.595 per unit, with each Class A Unit consisting of one share of its common stock and one-half of a common warrant to purchase one share of common stock at an exercise price of $0.53 per share of common stock, in a registered direct offering priced at-the-market. Gross proceeds to the Company are expected to be approximately $6 million, before deducting placement agent fees and other estimated offering expenses. The closing of the sale of the securities is expected to take place on or about February 27, 2020, subject to the satisfaction of customary closing conditions. The Company intends to use the net proceeds from this offering for working capital and general corporate purposes.
- 02/25/2020
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LPCN: Reanalysis Elicits Resubmission
- By John Vandermosten, CFA NASDAQ:LPCN READ THE LATEST LPCN RESEARCH REPORT Lipocine (NASDAQ:LPCN) held its post action meeting with the FDA’s Division of Bone, Reproductive and Urologic Products in mid-January and recently received the minutes of the meeting. On February 24th the company announced that, according to FDA feedback, it will be able to address the remaining outstanding deficiency
- 02/25/2020
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LPCN: Reanalysis Elicits Resubmission
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Lipocine Announces Regulatory Path Forward for TLANDO™ Resubmission
- Lipocine Inc. (LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced the results of its Post Action meeting with the U.S. Food and Drug Administration ("FDA') regarding its New Drug Application ("NDA") for TLANDO™, the Company's oral testosterone product candidate for testosterone replacement therapy ("TRT") in adult males for conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism. Based on the Post Action meeting and written feedback, the FDA indicated Lipocine's approach to addressing the single remaining deficiency through the reanalysis of existing data in accordance with FDA feedback appears to be a reasonable path forward. The FDA requested that the information generated by the reanalysis be submitted as part of an NDA resubmission with a six-month Prescription Drug User Fee Act ("PDUFA") clock.
- 02/24/2020
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Lipcine Says the FDA is Satisfied with its Approach to Collect Data for the Resubmission of TLANDO
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Lipocine Receives Patent Titled 'Testosterone undecanoate compositions'
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Lipocine Streamlines Its Infringement Lawsuit Against Clarus Therapeutics
- Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company, announced today that in an effort to streamline the issues and associated costs for dispute in its infringement lawsuit against Clarus Therapeutics, Inc. ("Clarus") in the United States District Court ("Delaware") related to the infringement of six Lipocine U.S. Patents by Clarus's JATENZO® product, Lipocine has voluntarily dismissed its allegations of patent infringement for expired U.S. Patent Nos. 6,569,463 and 6,923,988. Lipocine continues to vigorously defend its patent rights and maintains its allegations for patent infringement of four U.S. patents – U.S. patent nos. 9,034,858; 9,205,057; 9,480,690; and 9,757,390 – by Clarus's JATENZO® product, which has yet to launch.
- 02/11/2020
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Lipocine Reports Voluntary Dismissal Of Allegations Of Patent Infringement for Expired US Patents '463, '988 Related To Clarus Therapeutics
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Lipocine 13G Filing From Hudson Bay Capital Shows 9.99% Stake
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20 Specialty & Generic Drug Manufacturer Stocks Moving In Monday's Session
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14 Drug Manufacturers—Specialty & Generic Stocks Moving In Thursday's Session
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18 Drug Manufacturers—Specialty & Generic Stocks Moving In Wednesday's Session
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TUESDAY DEADLINE REMINDER: The Schall Law Firm Announces it is Investigating Claims Against Lipocine Inc. and Encourages Investors with Losses to Contact the Firm
- TUESDAY DEADLINE REMINDER: The Schall Law Firm Announces it is Investigating Claims Against Lipocine Inc.
- 01/14/2020
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DEADLINE TODAY: The Schall Law Firm Announces the Filing of a Class Action Lawsuit Against Lipocine Inc. and Encourages Investors with Losses in Excess of $100,000 to Contact the Firm
- LOS ANGELES, CA / ACCESSWIRE / January 14, 2020 / The Schall Law Firm , a national shareholder rights litigation firm, announces the filing of a class action lawsuit against Lipocine Inc. ("Lipocine" ...
- 01/14/2020
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LPCN FINAL DEADLINE TODAY: Rosen, a Leading Law Firm, Reminds Lipocine Inc. Investors of Important January 14th Deadline in Securities Class Action – LPCN
- NEW YORK, Jan. 14, 2020 -- Rosen Law Firm, a global investor rights law firm, reminds purchasers of the securities of Lipocine Inc. (NASDAQ: LPCN) between March 27, 2019 and.
- 01/14/2020
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TUESDAY DEADLINE ALERT: Bragar Eagel & Squire, P.C. Reminds Investors That a Class Action Lawsuit Has Been Filed Against Lipocine, Inc. and Encourages Investors to Contact the Firm
- Bragar Eagel & Squire, P.C., a nationally recognized shareholder law firm, reminds investors that a class action lawsuit has been filed in the United States District Court for the District of Utah on behalf of investors that purchased Lipocine, Inc. (LPCN) securities between March 27, 2019 and November 8, 2019 (the “Class Period”). Lipocine’s lead product candidate is TLANDO (LPCN 1021), an oral testosterone replacement therapy. The Company has previously submitted New Drug Applications (“NDA”) for TLANDO twice and, both times, received Complete Response Letters (“CRL”) from the U.S. Food and Drug Administration (“FDA”) rejecting the NDAs.
- 01/14/2020
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20 Healthcare Stocks Moving In Tuesday's Pre-Market Session
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20 Healthcare Stocks Moving In Monday's Pre-Market Session
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Lipocine Chairman Patel Buys 40,000 @$0.38
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Lipocine Received Notice From Nasdaq Stating Bid Price Of Common Stock For Last 30 Trading Days Closed Below Requirement
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The Daily Biotech Pulse: Roche Gets US Antitrust Clearance For Spark Purchase, An Orphan Drug Designation For Prevail, Dynavax Names CEO
- The following is a roundup of top developments in the biotech space over the last 24 hours. Scaling The Peaks (Biotech stocks that hit 52-week …
- 12/17/2019
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Stocks That Hit 52-Week Lows On Monday
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LPCN LOSS NOTICE: TOP RANKED ROSEN LAW FIRM Reminds Lipocine Inc. ...
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Stocks That Hit 52-Week Lows On Friday
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The Daily Biotech Pulse: Second Time's The Charm For Sarepta, Pfizer's Xeljanz Snags Third Approval, NewLink Genetics Rejects Competing Offer
- The following is a roundup of top developments in the biotech space over the last 24 hours. Scaling The Peaks (Biotech stocks that hit 52-week highs on Dec. 12.) Allergan plc (NYSE: AGN ) Amgen, Inc. (NASDAQ: AMGN ) (received approval for its bone-building osteoporosis drug in the U.S.) Aprea Therapeutics Inc (NASDAQ: APRE ) Aptose Biosciences Inc (NASDAQ: APTO ) Aurinia Pharmaceuticals Inc (NASDAQ: AUPH ) Avenue Therapeutics Inc (NASDAQ: ATXI ) (submitted the NDA for intravenous tramadol for the management of moderate to moderately severe pain in adults in a medically supervised health care setting) Bausch Health Companies Inc (NYSE: BHC ) (reacted to upgrade to Overweight rating by JPMorgan) BioNTech SE – ADR (NASDAQ: BNTX ) Bio-Rad Laboratories, Inc. Class A (NYSE: BIO ) Boston Scientific Corporation (NYSE: BSX ) Bristol-Myers Squibb Co (NYSE: BMY ) Deciphera Pharmaceuticals Inc (NASDAQ: DCPH ) Eidos Therapeutics Inc (NASDAQ: EIDX ) ESSA Pharma Inc (NASDAQ: EPIX ) Flexion Therapeutics Inc (NASDAQ: FLXN ) Forty Seven Inc (NASDAQ: FTSV ) Globus Medical Inc (NYSE: GMED ) (reacted to upgrade to Overweight by Wells Fargo Securities) Gossamer Bio Inc (NASDAQ: GOSS ) Hologic, Inc.
- 12/13/2019
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Bronstein, Gewirtz & Grossman, LLC Reminds Investors of Class Action Against Lipocine Inc. ...
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The Daily Biotech Pulse: European Nod For Amgen, miRagen Overhauls Clinical Pipeline, Tonix Snags Patent Win
- Here's a roundup of top developments in the biotech space over the last 24 hours. Scaling The Peaks (Biotech stocks hitting 52-week highs on Dec. 11) Acceleron Pharma Inc (NASDAQ: XLRN ) Aimmune Therapeutics Inc (NASDAQ: AIMT ) Aprea Therapeutics Inc (NASDAQ: APRE ) Aptose Biosciences Inc (NASDAQ: APTO ) argenx SE – ADR (NASDAQ: ARGX ) ArQule, Inc. (NASDAQ: ARQL ) Arvinas Inc (NASDAQ: ARVN ) Audentes Therapeutics Inc (NASDAQ: BOLD ) Axsome Therapeutics Inc (NASDAQ: AXSM ) Avadel Pharmaceuticals PLC (NASDAQ: AVDL ) Bausch Health Companies Inc (NYSE: BHC ) BioNTech SE – ADR (NASDAQ: BNTX ) Bio-Rad Laboratories, Inc. (NYSE: BIO ) Bristol-Myers Squibb Co (NYSE: BMY ) Cue Biopharma Inc (NASDAQ: CUE ) Deciphera Pharmaceuticals Inc (NASDAQ: DCPH ) Eidos Therapeutics Inc (NASDAQ: EIDX ) Flexion Therapeutics Inc (NASDAQ: FLXN ) Forty Seven Inc (NASDAQ: FTSV ) GlaxoSmithKline plc (NYSE: GSK ) Gossamer Bio Inc (NASDAQ: GOSS ) Immunomedics, Inc. (NASDAQ: IMMU ) Incyte Corporation (NASDAQ: INCY ) IVERIC bio Inc (NASDAQ: ISEE ) Kadmon Holdings Inc (NYSE: KDMN ) Ra Pharmaceuticals Inc (NASDAQ: RARX ) Repro-Med Systems, Inc.
- 12/12/2019
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Stocks That Hit 52-Week Lows On Thursday
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13 Healthcare Stocks Moving In Wednesday's Pre-Market Session
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INVESTOR CLASS ACTION DEADLINES: Bernstein Liebhard LLP Reminds Investors in Lipocine, Inc. ...
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Bronstein, Gewirtz & Grossman, LLC Reminds of Class Action Against Lipocine Inc. ...
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ROSEN, A GLOBALLY RECOGNIZED LAW FIRM, Reminds Lipocine Inc. ...
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Bragar Eagel & Squire, P.C. Reminds Investors That Class Action Lawsuits Have Been Filed ...
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INVESTOR ALERT - Lipocine Inc. (LPCN) - Bronstein, Gewirtz & Grossman, LLC Notifies ...
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SHAREHOLDER ALERT: Pomerantz Law Firm Reminds Shareholders with Losses on their Investment in ...
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Lipocine 13G Filing From Sabby Shows New 8.74% Stake
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LPCN LOSS NOTICE: ROSEN, A GLOBAL LAW FIRM, Announces Filing of Securities Class Action Lawsuit ...
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The Week Ahead In Biotech: Clinical Readouts In Focus As Earnings Wind Down
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70 Biggest Movers From Yesterday
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Lipocine Prices Offering Of 10.45M Class A Units And 1.55M Class B Units At $0.50/Class A Unit And $0.4999/Class B Unit
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Lipocine shares are trading lower after the company reported a common stock offering of no disclosed size.
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Lipocine Q3 EPS $(0.12), Same YoY
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Mid-Afternoon Market Update: Qurate Retail Gains On Upbeat Earnings; ASLAN Pharmaceuticals Shares Slide
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38 Stocks Moving In Monday's Mid-Day Session
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Mid-Day Market Update: Carbonite Jumps Following Acquisition News; Lipocine Shares Plummet
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Mid-Morning Market Update: Markets Open Lower; SunPower To Receive $298 Million Equity In Company Split
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Lipocine's Male Hormone Therapy Stumbles With FDA For The Third Time
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The Week Ahead In Biotech: Smid-Cap Earnings Deluge, SITC Conference In The Spotlight
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17 Healthcare Stocks Moving In Friday's Pre-Market Session
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51 Biggest Movers From Friday
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54 Biggest Movers From Yesterday
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44 Stocks Moving In Wednesday's Mid-Day Session
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71 Biggest Movers From Yesterday
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Stocks That Hit 52-Week Highs On Monday
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Stocks That Hit 52-Week Highs On Thursday
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The Daily Biotech Pulse: Puma Leaps, Aerie Borrows, Hepion Back In Nasdaq's Good Books
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Lipocine Announces Patent Infringement Trial With Clarus Will Begin Aug. 4 2020
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Lipocine Withdraws Preliminary Injunction Threat Against Marketing Of Clarus Therapeutics' Jatenzo Product, Trial Date Set For August 2020
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Stocks That Hit 52-Week Highs On Friday
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Stocks That Hit 52-Week Highs On Thursday
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Lipocine Q2 EPS $(0.14) Beats $(0.16) Estimate
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Lipocine Receives FDA Clearance For Clinical Testing Of Its NASH Candidate, LPCN 1144, In Expanded Target Population
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18 Stocks Joining The Russell Indices
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Lipocine Set To Join Russell Microcap Index , Effective Jul. 1
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Lipocine Announces TLANDO NDA PDUFA Action Date Of November 9, 2019
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Lipocine Q1 EPS $(0.14), Inline
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48 Biggest Movers From Friday
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Clarus Therapeutics Has Refuted Patent Infringement Complaint By Lipocine
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Lipocine Shares Tick Lower As Traders Circulate FDA Access Data Doc Showing Approval For Competitor Clarus Therapeutics' Jatenzo
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Lipocine Reports Acceptance Of Abstract Of Late-Breaker Presentation On LPCN 1144 Results As Part Of EASL
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Lipocine Reports Has Been Selected To Present LPCN 1144 Results at ENDO 2019
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48 Stocks Moving In Wednesday's Mid-Day Session
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Lipocine Surges On Positive 16-Week Liver Imaging Study For Its NASH Candidate
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Lipocine Q4 EPS $(0.55) Misses $(0.13) Estimate, Sales $428.031K
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Lipocine Inc. Rpoerts FDA Clearance Of IND to Commence Phase 2 Study Of LPCN 1144 In Biopsy Confirmed NASH Subjects
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Lipocine: A Micro-Cap Stock That Can Compete In The NASH/NAFLD Race
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Lipocine shares are trading higher after the company filed an Investigational New Drug Application to initiate a Phase 2 2 study of LPCN 1144 in NASH subjects.
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Lipocine completes round trip from LPCN 1144-stoked spike; shares down 7%
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48 Biggest Movers From Yesterday
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'Lipocine fatty liver drug study results don't hold up to scrutiny' -STAT News
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USPTO Grants Priority Motion To Lipocine And Enters Judgment Against Clarus
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Lipocine Reports Successful Ex Vivo Conversion Assessment Of TLANDO
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Lipocine Q3 EPS $(0.12) Beats $(0.24) Estimate
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Lipocine Announces Completion Of Enrollment In LPCN 1144 Liver Imaging Study In Subjects At-Risk For NASH
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Lipocine Announces Completion of Enrollment in Ambulatory Blood Pressure Study for TLANDO
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Lipocine Q2 EPS $(0.15) Beats $(0.25) Estimate
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Lipocine Announces Dosing Of First Subject In Ambulatory Blood Pressure Study For TLANDO Testosterone Replacement Therapy
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Benzinga's Daily Biotech Pulse: ARMO Skyrockets On Eli Lilly Deal, Akcea Meets FDA Panel, vTv Alzheimer's Trial Results
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Lipocine's Regulatory Hiccups Continue: Testosterone Drug Issued Complete Response Letter, Stock Tanks
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REMINDER: Lipocine Has FDA PDUFA Date for LPCN 1021 NDA
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The Week Ahead: Nvidia And Dropbox Earnings, April Retail Sales, Trump Drug Pricing Speech Expected
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