Biotech & Life Sciences
BriaCell’s FDA Clearance for Bria-PROS+ Adds a Fourth Active Immunotherapy
BriaCell just added a fourth active immunotherapy program to a pipeline that already has one candidate in Phase 3. The FDA didn’t blink. Two names covered here last week did get their answers this week, and the answers landed nothing alike, one company watched its stock double, the other is now talking about suing its…
Capricor’s Deramiocel Voted Down 9-3 by FDA Advisory Panel
Nine advisory committee members looked at the same trial data Capricor called a win and voted against it. The 9-3 result on July 29 didn’t kill Capricor’s Duchenne muscular dystrophy program, but it added a real question mark to a therapy the company insists already cleared its bar. INmune Bio spent the same stretch doing…
FDA Panel Votes Down Capricor’s Deramiocel 9-3 for Duchenne Cardiomyopathy
Nine advisory committee members voted against Capricor’s Duchenne muscular dystrophy therapy on Tuesday. Three voted for it. The FDA’s own briefing document had called the primary evidence unconvincing before a single panelist spoke, and a nearly identical scene is playing out for a different company on the same regulatory stage today. Altimmune, meanwhile, needed no…
Capricor Plunges 67% on FDA Panel News Ahead of DMD Vote
Capricor Therapeutics lost roughly two-thirds of its market value on Monday. Not from a failed trial. From a document explaining what a panel might discuss on Wednesday. Curis and Autonomix Medical had smaller, quieter reactions of their own to their own news this week, one up, one down, each worth understanding on its own terms.…
Tempus AI’s $1.5 Billion Personalis Deal and Celldex’s Phase 2 Miss This Week
BridgeBio’s rare disease drug cleared its first FDA hurdle on July 22. Celldex’s itch drug cleared every hurdle except the one that mattered, on July 21, one day earlier. One is a step closer to patients. The other proved its mechanism worked in a lab sense and got shelved anyway. In between, Tempus AI put…
CareDx Jumps on Medicare Win, OKYO Pharma Funds Phase 3 Trial
A federal coverage policy that took a year to finalize added more than $200 million to CareDx’s market value in a single trading session. Nothing about the underlying science changed. The paperwork did. Two much smaller names had quieter weeks of their own: one locked in the cash to finish its pivotal trial, the other…
Orca Bio’s Tregzi Is the First Regulatory T Cell Therapy Ever Approved
The FDA approved Orca Bio’s Tregzi on June 30, making it the first regulatory T cell-based immunotherapy to receive clearance in the agency’s history. The next morning it expanded Casgevy’s label to children as young as two, placing a potentially curative CRISPR gene therapy within reach of approximately 5,500 additional American children with sickle cell…
Satellos Bioscience Earns Third FDA Designation for Duchenne Drug SAT-3247
The FDA approved 44 novel therapies in the first half of 2026, including 26 in the final six months alone. BioPharma Dive described it as an acceleration, driven partly by a White House-directed overhaul aimed at restoring more traditional leadership to the agency. The pace matters for small companies whose entire business model rests on…
Ionis Tryngolza Wins FDA Approval, Expands to 3.6 Million Patients
Ionis Pharmaceuticals submitted a label expansion and the FDA said yes. Replimune has now been rejected twice on the same melanoma drug and just got the FDA to accept a third attempt, this time with an advisory committee meeting attached. One company is celebrating a smooth approval. The other is celebrating an agency that will…
Boundless Bio Stock Up 87% on Failed Drug and Reverse Merger Deal
Boundless Bio’s cancer drug did not work. The company is cutting three-quarters of its staff. Its stock went up 87%. Boundless Bio Hands Control to a Private Gene-Editing Startup After Its Lead Drug Fails On June 22, Boundless Bio (Nasdaq: BOLD) signed a definitive merger agreement with Serapha Bio, a privately held company developing a…
