Biotech Hangout

• Episode 139 - April 25, 2025

  On this week’s episode, Daphne Zohar, Josh Schimmer, Tim Opler, John Maraganore, and Paul Matteis discuss the biotech market’s recent resurgence, and new FDA commissioner Marty Makary’s comments during his interview with former Fox News journalist Megyn Kelly. The discussion then shifts to the FDA’s reorganization, confusing return-to-work policies, and low morale at the agency, which resulted in slower review times. The conversation moves to BMS’ Cobenfy Phase 3 ARISE trial results and uniQure’s breakthrough therapy designation for its Huntington’s disease gene therapy. The group then revisits a discussion about biotech market updates and short selling. They also shared perspectives on Harvard University’s lawsuit against the Trump Administration, the broader issue of academic freedoms, and antisemitism on college campuses. The episode concludes with a discussion on the challenging microenvironments, CEO survival tips, and an overview of how investors are evaluating data. *This episode aired on April 25, 2025.

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• Episode 138 - April 11, 2025

  On this week’s episode, Chris Garabedian, Brad Loncar, Eric Schmidt, Paul Matteis, and Tess Cameron begin by recapping the markets, highlighting the rise in bond yields. The discussion then transitions to the efficiency of the FDA, noting its current overextension. Next, the group addresses an open letter from biotech executives and investors to Senator Bill Cassidy, highlighting the dismissal of key employees important to FDA review processes. Park Marks’ dismissal is also revisited, along with the impending threat of pharmaceutical tariffs. Wrapping up the discussion on the FDA, its initiative to replace animal testing is overviewed. The conversation shifts to “zombie” biotechs and ongoing private investment, as evidenced by recent Series A announcements. On the data front, Lexeo’s plans to initiate a registrational trial for its gene therapy for Friedreich ataxia, Rhythm’s Phase 3 data, and its stock price increase are discussed. The group also reviews the strategies early companies can adopt now that the IPO window has closed. The episode concludes with a review of notable updates from AAN 2025 and ADPD 2025. *This episode aired on April 11, 2025.

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• Episode 137 - April 4, 2025

  On this week’s episode, Eric Schmidt, Brad Loncar, Yaron Werber, Paul Matteis, and Nina Kjellson discuss impact of tariffs on biopharma relative to other sectors, FDA updates and bright spots, data, and fundraising. The episode opens with a conversation on tariffs and the upheaval and shifts at the FDA, including the departure of Peter Marks, former director of the FDA’s Center for Biologics Evaluation and Research, which has the group concerned over loss of institutional memory, history, and the ability to meet deadlines. The conversation shifts to the measles outbreak, noting concerns about public health and future regulation due to HHS reorganization plans and perceived industry inaction. The group then discusses data, including Vaxcyte’s underwhelming Phase 2b data, and hopes to avoid negative vaccine sentiment. Additionally, Eli Lilly’s Phase 2 data for its siRNA-based therapeutic to lower lipoprotein(a) showed promising results and Amgen and Novartis are conducting their own Phase 3 trials for Lp(a). The episode concludes with a discussion on Isomorphic Labs, which raised over $600 million, with the group praising the investment in early-stage discovery science and expressed hope that it will facilitate the company’s transformation of technology into drugs. *This episode aired on April 4, 2025.

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• Episode 136 - March 28, 2025

  On this week’s episode, Chris Garabedian, Tim Opler, Bruce Booth, and Sam Fazeli discuss the current investor mood, a PIPEs retrospective, and the contraction of new startups. The episode opens with a conversation on the biotech market updates, which have been driven by economic uncertainty and shifting investor sentiment, noting that macroeconomic factors continue to weigh on performance of biotech stocks in the market. Regulatory discussion centers on recent HHS personnel cuts, and the confirmations of FDA and NIH leaders. The conversation shifts to data with Soleno Therapeutics’ Prader-Willi drug approval, oncology readouts, and presentations at the European Lung Cancer Congress 2025. Tim Opler also discussed findings from a recent aging report. On the global front, China’s role in biotech continues to expand, with an increasing share of large pharma molecules originating from the country. The episode concludes with a look at obesity drug deals, including a major partnership with a China-based biotech and a preclinical asset with a novel mechanism targeting satiety and energy expenditure. *This episode aired on March 28, 2025.

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• Episode 135 - March 21, 2025

  On this week’s episode, Sam Fazeli, Eric Schmidt, and Brian Skorney are joined by Roivant’s Matthew Gline to discuss data, deals and the latest policy updates. The episode kicks off with concerns over potential U.S. Department of Health and Human Services (HHS) funding cuts for domestic HIV programs, with the group analyzing the impact on companies like Gilead and GSK, whose HIV prevention drugs have driven significant investor enthusiasm. They then discuss the uncertainty surrounding the new administration’s commitment to public health initiates, considering Robert F. Kennedy Jr.’s appointment as HHS Secretary and his past controversial views on vaccines and HIV prevention. The conversation then shifts to data, including positive results from Immunovant and Roivant’s Phase 3 study of batoclimab for myasthenia gravis. The group also examines the surprising absence of short sellers engaging with Roivant post-data release, highlighting shifts in biotech trading strategies. In the muscular dystrophy space, new exon-skipping therapies from Avidity and Dyne show unprecedented dystrophin restoration, suggesting potential functional benefits. However, the tragic death of a patient treated with Sarepta’s gene therapy, Elevidys, reignites concerns about accelerated approvals and the FDA’s risk-benefit calculus in rare disease research. On the deal-making front, AstraZeneca’s $425M acquisition of stealth-mode cell therapy startup EsoBiotec and Sanofi’s $600M deal with Dren Bio underscore biotech’s valuation disconnect, where early-stage private assets command premium prices while public biotechs struggle. The episode closes with insights into Alnylam’s broad label win for Amvuttra in ATTR cardiomyopathy and AstraZeneca’s $2.5B investment in biotech agreements and manufacturing in China, reflecting its long-term strategic vision despite ongoing geopolitical tensions. *This episode aired on March 21, 2025

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