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The Twice-Yearly HIV Prevention Shot Gets Its First Generic Nod From the FDA, at $40 a Year
The FDA gave tentative approval to Dr. Reddy's Laboratories' generic of lenacapavir, Gilead's HIV prevention injection given twice a year. Tentative is the label the FDA uses for generics while the original drug is still under patent; it lets the U.S. government buy the product. Dr. Reddy's will sell it for $40 per person per year in the 120 low- and middle-income countries covered by Gilead's voluntary license. That comes 16 months after the FDA approved Gilead's version for prevention. First doses should reach countries by the end of 2026, with wider supply in 2027. Unitaid, Wits RHI and CHAI backed the effort, and more than 125,000 people in 10 African countries already use Gilead's version.
Why it matters: Getting a generic out 16 months after the original, rather than a decade later, is the point, and it sets a new bar for how fast a cheap version can follow a breakthrough. Supply is only half the job, though; a Wits RHI leader warned that an affordable drug alone is not enough.
Unitaid →Clinical & Regulatory
uniQure's Huntington's Gene Therapy Gets a May 1 FDA Date After a Year of Back-and-Forth
The FDA accepted uniQure's application for ifezuntirgene inilparvovec (formerly AMT-130), a one-time Huntington's gene therapy delivered by brain surgery, with priority review and a May 1 decision date. It tentatively plans an advisory panel too. At three years the high dose slowed progression by 75% against an outside comparison group; the four-year figure, 44%, wasn't statistically significant. Shares slipped 3%.
GEN →A Chinese Psoriasis Pill Wins Phase 3 as the TYK2 Race Gets Crowded
Shanghai's InventisBio said its oral TYK2 inhibitor nomelcitinib won a Phase 3 trial in 391 people in China with moderate-to-severe plaque psoriasis. Over 70% of patients on either dose saw at least 90% improvement at week 16, the trial's main goal. A head-to-head trial against Bristol Myers' Sotyktu is still running, and Takeda and Alumis recently posted their own positive late-stage TYK2 data.
Clinical Trials Arena →Deals & Money
Karyopharm Files for Bankruptcy and Puts Itself Up for Auction
Karyopharm, maker of the blood cancer drug Xpovio, filed for Chapter 11 and will sell itself in a court-run auction, with Gamida Cell's parent Ayrmid as lead bidder. Its lenders are putting up a $55 million loan to keep the lights on. The company hasn't been able to turn a profit, and Xpovio failed a trial in endometrial cancer. Shares fell 83%, to 11 cents.
BioPharma Dive →Lonza More Than Doubles Its U.S. Plants by Buying Merck KGaA's Contract Manufacturing Sites
Lonza is buying five U.S. contract manufacturing sites and about 1,100 staff from Merck KGaA, taking its American network from four sites to nine. The price is in the low- to mid-hundreds of millions of Swiss francs. The sites serve customers making antibody-drug conjugates (antibodies that carry a toxic payload to cancer cells) and viral vectors for gene therapy. The deal should close around mid-2027.
Pharmaceutical Technology →Rhythm Nearly Triples Its Deal for LG Chem's Rare-Obesity Pill
Rhythm Pharmaceuticals reworked its 2024 license for bivamelagon, LG Chem's oral pill for rare forms of obesity such as hypothalamic obesity, lifting the deal's total value to $855 million, nearly three times the original. LG Chem gets $350 million more upfront, paid in installments through 2029, while its royalty drops to a flat 1%. A global Phase 3 trial is expected to start by year-end.
The Herald Business →Science
Five Labs Gave Mice Psilocybin. The Lasting Benefits Didn't Show Up.
Five labs at UC Berkeley, UCSF and Stanford ran the same psilocybin experiment in mice and pooled the results in Nature Neuroscience. The short-term effects held up: head twitches, more anxiety and less fear soon after dosing. But a day later, no lasting change in anxiety, depression-like behavior, fear or social interaction remained. It's a sobering read for a field selling lasting change; one author warned hype could outrun the science.
UC Berkeley →