Browsing Tag
FDA
320 posts
Trevi Therapeutics (NASDAQ: TRVI) bets everything on two Phase 3 chronic cough trials
Trevi Therapeutics (NASDAQ: TRVI) has no revenue and is up 71%, yet its future rides on two Phase 3 cough trials that do not read out until 2027.
Why NCEL-101’s FDA pathway could influence the future of stem-cell-derived islet therapies
Why NewcelX Ltd.’s FDA pre-IND process for NCEL-101 could shape the future of regenerative diabetes medicine. Read the full analysis.
Corcept Therapeutics (NASDAQ: CORT) climbs 7% as Lifyorli launch and analyst upgrades drive cortisol re-rating
Corcept turned a stress hormone into an ovarian cancer drug. Lifyorli is launching fast and analysts are chasing, but a premium multiple prices in a lot.
ImmuPharma at 4p is a P140 licensing bet: What IMM retail investors should know
ImmuPharma targets a P140 licensing deal in 2026 with cash to H2 2028. Here is what IMM retail investors need to weigh before chasing the small-cap biotech.
AstraZeneca, Daiichi Sankyo secure FDA approval for Enhertu in two early breast cancer indications
Enhertu is moving from late-stage control to early-stage cure. AstraZeneca and Daiichi Sankyo now face the bigger test: adoption.
Anteris Technologies (ASX: AVR) stock up 9.6% as PARADIGM trial reaches first US patient enrolments
Edwards and Medtronic own TAVR. Anteris (ASX: AVR) wants in with DurAVR. First US PARADIGM patients enrolled, US$320m raised, and Medtronic is now a shareholder.
4DMedical (ASX: 4DX) stock up 7.3% as Mayo Clinic adoption and GSK contract reset lung imaging story
Nuclear medicine VQ scans are a US$1 billion market. 4DMedical (ASX: 4DX) just landed Mayo Clinic, GSK, and Medicare. The question is now scan volume scaling speed.
What the Acclaim cochlear implant’s pivotal data could mean for the broader hearing device market
Could Envoy Medical, Inc.’s Acclaim implant reshape the hearing-device market? Explore the regulatory, commercial, and industry implications.
Image Analysis Group and HeartcoR Solutions target clinical trial bottlenecks with integrated core lab model
Clinical trials have too many data silos. IAG and HeartcoR Solutions are betting integrated core labs can cut friction for sponsors.
Mirum Pharmaceuticals (NASDAQ: MIRM) jumps 13% after VISTAS Phase 2b PSC win
Two Phase 2b wins in seven days. A pre-NDA meeting this summer. Mirum is starting to look less like a single-product rare disease story.