Top Story Today
The FDA Just Created an Entire Treatment Category for a Leaky Heart Valve
For millions of Americans with aortic regurgitation (a valve that lets blood slosh backward with every heartbeat), there has never been a dedicated transcatheter device to fix it. Doctors either cracked open the chest or jury-rigged tools designed for a completely different problem. JenaValve's Trilogy system just changed that, earning the first-ever FDA approval for this condition with a greater than 95% technical success rate across 500 patients, blowing past the 82-93% seen with off-label alternatives. The company launches independently after the FTC blocked Edwards Lifesciences' acquisition earlier this year.
Why it matters: This isn't just a new device; it's a new category. Opening a dedicated transcatheter pathway for aortic regurgitation could meaningfully expand the $7 billion TAVR market and reshape how cardiologists treat one of the most underserved conditions in structural heart medicine.
Read more →Approvals and Regulatory Moves
The First Drug for the Itch That Keeps 100,000 Americans Awake
Up to 89% of patients with primary biliary cholangitis suffer relentless itching caused by bile acids pooling in their blood, and no FDA-approved drug has existed for it. Lynavoy (linerixibat) blocks intestinal bile acid recycling to attack the itch at its source and faces an FDA decision date of March 24, 2026. GSK developed it but handed the rights to Alfasigma for up to $690 million twelve days before that decision date.
Read more →A Once-Daily Pill That Matches Biologic Injections for Psoriasis
The FDA approved ICOTYDE (icotrokinra), the first oral peptide targeting the IL-23 pathway, for moderate-to-severe plaque psoriasis. In Phase 3 trials, approximately 70% of patients achieved clear or near-clear skin at 16 weeks. J&J's pill beat BMS's oral competitor head-to-head and showed adverse event rates within 1.1% of placebo.
Read more →The FDA's Most Polarizing Leader Just Walked Out
Vinay Prasad's ten-month run atop the FDA's biologics division ended with drug rejections, staff retaliation probes, and a brief firing-then-rehiring saga. His exit could accelerate the agency's push toward faster approvals and single-study standards. The choice of his replacement, expected by late April, is being called make-or-break for agency stability.
Read more →Trial Failures and Fallout
Immutep's 15-Year Immunotherapy Bet Evaporated in One Morning
An independent data committee killed Immutep's flagship Phase 3 lung cancer trial after a futility analysis showed its novel LAG-3 drug, combined with Keytruda, wasn't going to work. The stock lost roughly 88-89% on the ASX in a single session. Analysts slashed price targets from $7 to $1, and the CEO called the result "very disappointing and surprising."
Read more →Gossamer Bio's PAH Drug Missed by a Hair; 77 Jobs Gone
Gossamer's inhaled PAH drug seralutinib posted a p-value of 0.0320 against a prespecified threshold of 0.025, the biotech equivalent of losing on a missed field goal. The company cut 48% of its workforce and is now burning through $137 million in cash while exploring "strategic options" (read: a lifeline).
Read more →Bicycle Therapeutics Shelves Its Star Program, Cuts 30% of Staff
After the FDA rejected its Phase 2 trial as a viable approval path, Bicycle Therapeutics shelved internal work on its lead bladder cancer drug and cut 86 employees. The pivot: radioconjugates, one of oncology's hottest areas. The restructuring extends cash runway to 2030.
Read more →Funding and Financings
$77.5M to Replace the Chalky Pills Dialysis Patients Hate
R1 Therapeutics emerged from stealth with an oversubscribed Series A to develop AP306, a drug that blocks phosphate absorption at the source instead of trying to sponge it up in the gut. DaVita (one of the world's largest dialysis providers) co-led the round, signaling that the people closest to this problem believe the science works.
Read more →Crossbow Nabs $77M to Build Antibodies That See Inside Cancer Cells
Crossbow's T-Bolt platform creates antibodies that mimic T-cell receptors, letting them read peptide targets hidden inside tumor cells rather than just surface proteins. Taiho Ventures and Arkin Bio Capital co-led the Series B, with Pfizer and Lilly returning. Lead candidate CBX-250 is already in a Phase 1 trial, with initial data expected by year's end.
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