After 118 years as a private company, dermatology specialist Leo Pharma A/S is poised to complete an IPO after reporting a full-year net profit for the first time since 2018.
Though it’s largely viewed by analysts as a simple delay rather than a setback, Disc Medicine Inc.’s unexpected complete response letter (CRL) for bitopertin in the rare genetic disorder erythropoietic protoporphyria (EPP) raises more questions regarding consistency and stability at the U.S. FDA.
Ocular Therapeutix Inc.’s wet age-macular degeneration candidate, Axpaxli, beat anti-VEGF therapy Eylea (aflibercept) from Regeneron Pharmaceuticals Inc. in the phase III head-to-head trial called Sol-1, but not by enough of a margin for Wall Street. Shares of the firm (NASDAQ:OCUL) closed Feb. 17 at $6.99, down $1.89, or 21%, as investors mulled the top-line findings.
More than a decade after it was first proposed, the U.S. Precision Medicine Initiative that grew into the NIH’s All of Us dataset has reached its target of collecting genetic and health-related data from 1 million Americans representative of the diversity across the country.
Agios Pharmaceuticals Inc. is preparing to present a mixed bag of phase III Rise Up data to the U.S. FDA in hopes of “full approval” for mitapivat in sickle cell disease (SCD), which would make it its third indication in rare hematology.
After closing an oversubscribed $85 million series B round, Quantx Biosciences Inc. is gearing up to begin clinical trials of its two lead immunology compounds, a STAT6 oral small-molecule inhibitor and an IL-17 oral small-molecule inhibitor.
After closing an oversubscribed $85 million series B round, Quantx Biosciences Inc. is gearing up to begin clinical trials of its two lead immunology compounds, a STAT6 oral small-molecule inhibitor and an IL-17 oral small-molecule inhibitor.
Bridgebio Pharma Inc. kept the phase III wins coming, this time with positive top-line results from Propel 3, the global phase III pivotal study of oral infigratinib, designed to inhibit FGFR3 signaling in children with achondroplasia.
Citing an increase in safety events and evidence of futility, the U.S. NIH stopped an investigational low-dose rivaroxaban arm of its Comparison of Anticoagulation and Antiplatelet Therapies for Intracranial Vascular Atherostenosis (CAPTIVA) trial.
The U.S. FDA accepted, with priority review, Takeda Pharmaceutical Co. Ltd.’s NDA submission for oveporexton (TAK-681), bringing the oral orexin receptor 2 agonist closer to clearance in narcolepsy type 1.
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.webp?height=488&t=1770931675&width=650 "Interleukin 17 (IL-17)")
