Key Points InspireMD expects potential FDA decisions in Q4 2026 for the CGuard Prime 80 cmsystem for transcarotid artery revascularization, or TCAR, and its original CGuard carotid artery…
August 17, 2026
Faeth Therapeutics Gains FDA Fast Track Status Ahead of Phase 2 Endometrial Cancer Readout
PIKTOR is designed to inhibit multiple points in a cancer-driving pathway, with topline data expected by year-end. Faeth Therapeutics (Nasdaq: FTH) has received FDA Fast…
Key Points The companies expect the transaction to close in Q4 2026, subject to shareholder, regulatory, court, Nasdaq, and other approvals. Fibrx will be led…
August 17, 2026
Ocular Therapeutix Rises After EyePoint’s Wet AMD Trial Miss Reshapes Competitive Landscape
Key Points EyePoint’s DURAVYU did not meet LUGANO’s primary endpoint of change from baseline in best-corrected visual acuity compared with aflibercept in the full patient…
Capricor Therapeutics (NASDAQ: CAPR) is sharply higher today, up 51.31% to 6.37 from Thursday’s 4.21 close, although it has pulled back from an intraday high…
August 14, 2026
Capricor Stock Rallies as FDA Opens Path for Revised Deramiocel Filing in Duchenne Muscular Dystrophy
Key Points Capricor Therapeutics, Inc. plans to amend its biologics license application, or BLA, for deramiocel after an FDA advisory committee voted 9–3 against the…
August 14, 2026
Allogene’s ALPHA3 Data and FDA Designations Sharpen the Case for Cema-Cel in Lymphoma
Key Points Allogene Therapeutics reported Q2 2026 results and a business update, highlighted by an interim futility analysis in the pivotal ALPHA3 trial of cema-cel…
The planned 800-patient U.S. study will test an oral FASN inhibitor in moderate to severe acne, including approximately 450 adolescents. Sagimet Biosciences (Nasdaq: SGMT) is…
August 13, 2026
Biomea Fusion Advances Icovamenib Into Obesity as First Patient Is Dosed in Semaglutide Combination Study
Key Points Biomea Fusion dosed the first participant in a new arm of the OPAL platform trial evaluating its oral small molecule icovamenib alongside low-dose…
Key Points Clearmind Medicine Inc. received unanimous approval from an independent Data and Safety Monitoring Board to advance its CMND-100 Phase I/II trial. The decision…
Key Points Alterity Therapeutics received a new U.S. composition-of-matter patent covering a crystalline mesylate form of ATH434, its lead treatment candidate for multiple system atrophy….
Key Points Annexon added a Month 24 dual-primary endpoint to the ongoing ARCHER II Phase 3 trial of vonapramide in geographic atrophy. The original Month…