Browsing Tag
U.S. Food and Drug Administration
165 posts
Aspen Neuroscience (ASPE) prices $140.6m IPO at $15 as Parkinson’s therapy enters pivotal development phase
Aspen Neuroscience has priced its Nasdaq initial public offering at $15 per share, the bottom of its proposed range, as it prepares to advance the investigational Parkinson's disease cell therapy sasineprocel into Phase 3 testing. The financing extends the company's expected operating runway into the second half of 2028, but its clinical programme remains expensive, and the company expects to require additional capital before development is complete.
60 Degrees Pharmaceuticals eyes FDA approval pathway for tafenoquine in babesiosis treatment
60 Degrees Pharmaceuticals targets FDA approval for tafenoquine in babesiosis as January 2027 trial results approach. Explore the risks.
Regeneron earnings surge as Dupixent sales hit $6.5bn and Sanofi expands partnership
Regeneron revenue jumps 36% to $5.1 billion as Dupixent sales surge and Sanofi expands its partnership. Explore the earnings outlook.
Serapha Bio’s gene-editing breakthrough raises stakes for $200m Boundless Bio merger
Serapha Bio's SERP-01 gene-editing results strengthen its Boundless Bio merger outlook. Explore the $200M financing and clinical risks.
Octant’s OCT-980 gains FDA orphan status, but can an oral molecule slow inherited vision loss?
Octant has received FDA orphan drug designation for OCT-980, an investigational oral therapy targeting protein misfolding associated with inherited retinal degeneration. The regulatory milestone follows the first patient dosing in September and supports development of a potentially disease-modifying treatment for rhodopsin-associated autosomal dominant retinitis pigmentosa.
Tango Therapeutics targets pancreatic cancer market with Revolution Medicines combination as investors turn cautious
Tango Therapeutics stock drops 16% despite an 82% pancreatic cancer response rate. Explore its $1B cash position and Phase 3 outlook.
Genmab targets new oncology growth as Rina-S delivers major survival gains over chemotherapy
Genmab stock jumps 9.5% after Rina-S delivers major ovarian cancer survival gains. Explore its FDA prospects, competition and growth outlook.
F2G and Shionogi move closer to commercializing novel oral antifungal after pivotal trial results
Shionogi shares gain as olorofim's Phase 3 success advances its F2G partnership. Explore the $480M deal, FDA plans and market potential.
Roivant Sciences targets new uveitis market as brepocitinib delivers major clinical breakthrough
Roivant Sciences stock rises after brepocitinib's double Phase 3 uveitis success. Explore its FDA plans, cash strength and growth potential.
Fractyl Health just hit a pivotal endpoint. Why is it cutting 45% of its workforce?
Fractyl Health is eliminating roughly 45% of its workforce and ending internal Rejuva development despite positive pivotal Revita data, concentrating a shrinking cash runway around one obesity programme and a late-2026 FDA filing.