Biohaven reports third quarter 2023 financial results and recent business developments
Cash, cash equivalents, marketable securities and restricted cash totaled approximately $495 million on october 5, 2023, which included net proceeds of $242 million from completed public offering on october 5, 2023 completed public offering of 11,761,363 biohaven ltd. common shares, which included the exercise in full of the underwriters' option to purchase additional shares, at a price to the public of $22.00 per share announced important updates on the company's immunology and extracellular protein degradation platform: immunoglobulin g (igg) degrader bhv-1300 demonstrated igg reductions of greater than 90% from baseline with repeat dosing in non-human primates bhv-1300 offers a mechanism of action that is differentiated from neonatal fc receptor (fcrn) targeting agents with the potential for a faster onset of action, deeper reductions in igg, no mechanistic effects on albumin or cholesterol, self-administered subcutaneous dosing, and ability to dose in conjunction with fc-containing biologic therapeutic agents data support biohaven's strategy of advancing bhv-1300 in combination with standard-of-care treatments for rheumatoid arthritis investigational new drug (ind) submission for bhv-1300 remains on track for 2023 with phase 1 initiation anticipated shortly thereafter bhv-1300 provides roadmap for accelerated development of future assets from biohaven's targeted extracellular protein degradation platform; several targets using second and third generation technologies expected to yield sustainable pipeline with potential to add significant value across rare and common diseases ind submission for iga degrader bhv-1400 for iga nephropathy and a third undisclosed extracellular protein degrader target ind submission expected in 2024 announced positive data from electroencephalogram (eeg) biomarker study of bhv-7000 confirming central nervous system (cns) activity, and other important updates including: dose-dependent and time-dependent effects on eeg across all brain regions and spectral frequencies successfully completed development of extended-release (er) formulation of bhv-7000 to enable once-daily dosing in clinical trials; established relative bioavailability of the er to standard release formulation differentiated safety profile from phase 1 sad/mad study showing favorable cns adverse event profile compared to other asms phase 3 study in focal epilepsy on track to commence in 2023 and mood disorder study to begin shortly thereafter announced continued progress with taldefgrobep alfa, the company's anti-myostatin adnectin program presented preclinical data demonstrating taldefgrobep alfa reduces fat and improves lean mass at obesityweek® completed enrollment in pivotal phase 3 study of taldefgrobep alfa for the treatment of spinal muscular atrophy (sma) taldefgrobep granted orphan drug designation (odd) for sma by the european commission; taldefgrobep previously received fda fast-track and odd announced successful completion of the sad portion of the phase 1 trial for bhv-8000, a brain penetrant tyk2/jak1 inhibitor, and initiation of the mad cohort to enable a phase 2/3 clinical trial in 2024 european medicines agency (ema) informed the company that its marketing authorization application (maa) for troriluzole (dazluma) in the treatment of spinocerebellar ataxia has been validated and is now under review by ema's committee for medicinal products for human use (chmp) new haven, conn.
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