The vibe at BIO 2026 in San Diego last week was overwhelmingly positive, with attendees observing noticeable changes at the FDA and an uptick in dealmaking and IPOs. Plus, a top medical journal this week retracted a pivotal study for Amgen’s rare disease drug Tavneos, which has been in the FDA’s crosshairs since January.
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Amgen’s Tavneos continues to face serious challenges, with the FDA still pushing for its removal from the market. Early this year, the agency identified issues with an analysis from the drug’s original developer, ChemoCentryx, which Amgen acquired for $3.7 billion in August 2022 after the drug’s 2021 approval. The regulator in January asked Amgen to voluntarily pull Tavneos from the market, but the pharma refused. Since then, eight deaths have been tied to drug, and now, a top-tier medical journal has retracted its pivotal study.
Elsewhere, optimism prevailed at the BIO International Convention in San Diego last week. Celebrating the 50th anniversary of Genentech—and of biotech itself—the conference highlighted an uptick in deals and IPOs, while noting that these transactions have gotten more nuanced. Attendees also drew attention to continued threats from China and Trump’s Most Favored Nation drug pricing policy.
Meanwhile, the FDA seems to be turning a corner after a year and a half of turnover and controversial policymaking under former Commissioner Marty Makary. Acting leadership is now making an effort to support the staff they have left while also hiring 2,200 more, and the FDA’s new IND initiative was highlighted as a sign that normal procedures are returning to the agency. Still, the FDA lacks permanent leadership, and the industry is left to speculate who might serve as the next chief.
For now, though, the agency is taking another look at some controversial decisions made under Makary’s leadership. After the FDA’s reversal of course on uniQure’s gene therapy for Huntington’s disease, Replimune announced that the FDA had accepted a resubmission for its twice-rejected melanoma asset. REGENXBIO, meanwhile, announced that it will resubmit its Hunter syndrome gene therapy thanks to an FDA change of heart and seek accelerated approval for its Duchenne muscular dystrophy gene therapy. And Skyhawk Therapeutics pointed to uniQure’s situation as a positive sign for its own Huntington’s candidate, for which the company reported 12-month functional data from a midstage trial this week.
Capricor Therapeutics, another company that was blindsided by FDA decisions under Makary, was back on track with an accepted resubmission of its once-rejected Duchenne muscular dystrophy cardiomyopathy cell therapy, but last week, the company got another surprise when the FDA decided this decision required an advisory committee meeting.
Finally, with more than 50 deals in the first half of 2026—nine of them from Eli Lilly—the business environment also seems to be headed in the right direction.
