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The FDA Is About to Lose Its Boss. Wall Street Is Throwing a Party.
Biotech stocks rallied on reports that Trump plans to fire FDA Commissioner Marty Makary after just 14 months. The twist: an industry that normally dreads regulatory shakeups is relieved, after Makary's inconsistent drug rejections, staff exodus, and political clashes left companies unable to predict whether their therapies would get a fair review. Several major approval decisions now face a leadership vacuum.
Why it matters: When the regulated industry actively roots for the regulator's removal, it signals a broken relationship that will take months to repair, with billions in pipeline value hanging on pending decisions during the transition.
Read more →Clinical and Regulatory
The Gene Therapy That Killed Four Boys Gets a Second Chance
Five years after four boys died of liver failure in Astellas' XLMTM gene therapy trial, the first patient has been dosed in a new study called VALOR. The redesigned therapy uses a muscle-targeted vector at 100-fold lower doses, essentially rerouting the delivery truck away from the liver. Nine patients will decide if that's enough to tip the risk calculus for a disease with zero approved treatments and near-certain early death.
Read more →Vyvgart Becomes the First Drug Approved for Every Type of Myasthenia Gravis
About 10% of generalized myasthenia gravis patients had no targeted therapy because their antibody subtype didn't match existing labels. The FDA just fixed that, approving argenx's Vyvgart for all serotypes. The $4.2 billion franchise (up 90% year-over-year) keeps widening its moat as the first-in-class FcRn inhibitor pulls further ahead of UCB and Janssen.
Read more →Funding and Deals
CellCentric Raises Europe's Largest Private Biotech Round of 2026
A $220 million Series D (with Pfizer on the cap table) funds a first-in-class oral pill for myeloma patients who've failed everything else. Phase 2 data showed 69% response rates in heavily pretreated patients, roughly triple what existing options deliver. The target market: patients who relapse after CAR-T and bispecific antibodies, a population that grows every time those therapies succeed earlier in treatment.
Read more →Amgen-Backed Quantum Computing Firm Files for Landmark IPO
Quantinuum, valued at $10 billion and backed by Amgen, JPMorgan, and NVIDIA, filed for what could be the largest quantum computing IPO ever. The biotech angle: Amgen is an investor in the company, betting quantum simulation can eventually shave years off drug development timelines.
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