Behind the Headlines Episode 28: Navigating FDA Shakeups and Obesity Drug Wars

Behind the Headlines bi-weekly episodes examine the ongoing trends, factors and fashions that cause pharmaceutical news to happen. Panelists are a mix of consultants, venture capitalists, scientists, patient advocates, journalists, and editors. Each episode talks about the current headlines of the preceding weeks that are on everyone’s lips but seeks to highlight the more enduring lessons that hide behind these headlines.

In Episode 28, Miroslav Gasparek, CEO and co-founder, Sensible Biotechnologies; Lizzy Lawrence, FDA reporter, STAT; and Joe Lewis, managing director, Deloitte Consulting, focus on an accelerating loss of expertise at FDA’s vaccine center. While Vinay Prasad is back in charge, the organizational structure is fractious at best (some say unstable), as George Tidmarsh is now out, officially as “resigned,” along with many others. This creates “uncertainty on top of uncertainty,” one of our panelists exclaimed. It is a highly charged moment for the organization but also for all industry stakeholders, including patients.

The same day as recording, as if to emphasize this point, the seemingly certain approval of UniQure’s Huntington disease (HD) candidate AMT-130 suddenly seems unlikely (1). UniQure described the feedback as a "key shift from prior communications," and said the timing of its plan to ask for approval of AMT-130 now looks bleak. Leerink Partners analyst Joseph Schwartz said the news is a "confusing" and "unexpected" twist (2). "QURE has been thoroughly aligned with the FDA over the past year, has breakthrough therapy designation and the data update QURE presented in September was very strong," he said in a note. So, while patients look likely to wait longer for improved therapies, the upshot for Uniqure is a plummeting share price, dropping nearly 50% at close of the stock market day. The HD community has been enthusiastically hopeful about what AMT-130 could mean for HD treatment, with key HD opinion leaders calling these results 'game-changing,'" Schwartz said. "So we expect there could be a rallying effort on that front to support QURE in the coming weeks."

As a discussion point, the panel noted a LinkedIn post from Amedo Vetere, senior group leader, Arena BioWorks, that reads “the obesity wars are getting spicy” (3). Pfizer isn’t just suing Novo Nordisk, they’re going after Metsera too. Breach of contract. Fiduciary duty. Interference. All because Metsera said “thanks, but no thanks” to Pfizer’s $7B and leaned toward Novo’s $9B counteroffer… The science is hot. The business is cutthroat. And in this arena, who gets to treat obesity may depend less on biology…and more on who survives the merger. All the while, Eli Lily raises guidance to $65Billion, on the back of a stronger-than-expected US revenue increase of 45% “driven by Zepbound and Mounjaro, despite a 15% price decline due to a one-time adjustment in Q3 2024. European revenue increased by over 100% in constant currency, bolstered by Mounjaro uptake and a $380 million milestone benefit (4). Revenue for Japan, China, and Rest of World grew 24%, 22%, and 51% respectively, with Mounjaro volume as the primary driver.”

References

1. Gatlin, A. UniQure Plummets 49% On A 'Confusing' And 'Unexpected' Twist For Its Gene Therapy. Investors.com. Nov 3, 2025.
2. Joseph, A. UniQure’s FDA submission for its Huntington’s disease therapy thrown into question. STATNews.com. Nov. 3, 2025.
3. Vetere, A. LinkedIn Post. Nov. 3, 2025.
4. Lilly Raises 2025 Revenue Guidance to $63–$63.5B with 54% Q3 Growth and Major Pipeline Advances. Seeking Alpha News. Oct, 30,2025.