Biotech Hangout

On this week's episode, Chris Garabedian, Josh Schimmer, Nina Kjellson, Mike Yee, and Tim Opler kick off with breaking data from Summit and Akeso's lung cancer therapy, exploring the results and potential next steps for the treatment. The current state of biotech M&A is the next topic of conversation, with continued macroeconomic uncertainty and investor preferencefor commercial-stage companies over clinical-stage deals highlighted. The hosts note that industry challenges preceded recent government agency upheavals, with the industry seeing a wave of shutdowns, noting iTeos as one of those companies most recently impacted. The conversation touches on Bruce Booth's "Biotech Wisdom of the Crowds" blog for additional market perspective. On the policy front NIH funding adjustments for early research and the Trump administration'scancellation of Moderna's $600M bird flu vaccine contract are overviewed. The FDA's upcoming listening tour is also noted, where industry leaders will provide feedback to regulators. Next, the group analyzes Prothena's Phase 3 data in AL amyloidosis. Looking ahead, the hosts preview ASCO 2025 andthe Jefferies Healthcare Conference, where attendees look forward to hearing from Marty Makary. The episode concludes with Regeneron's acquisition of 23andMe, examining implications for genetic data privacy and congressional legislation. *This episode aired on May 30, 2025.

On this week’s episode, Sam Fazeli, John Maraganore, Nina Kjellson and Matt Gline dig into an in-depth discussion on the Trump Administration’s recent executive order aimed at lowering drug prices as part of a broader “Most Favored Nation.” The group discusses the 30-day ultimatum, the 180- days for negotiations and concerns that biotechs may not be adequately represented at the table. The conversation shifts to PBMs, noting that there’s growing support for banning spread pricing and requiring more reporting from PBMs. The group also touches on orphan drugs, sharing that there’s bipartisan support to exempt orphan drugs from IRA negotiations. Pharma’s talk of investment in AI is also overviewed. Next, the group discusses Recursion Pharmaceuticals’ Q1 pipeline reorganization and Galapagos reversing its decision to split in two. CMS guidance on IRA Part B negatively impacted Halozyme Therapeutics and J&J, raising questions about the classifications of subQ formulations as different drugs despite sharing the same active ingredient. The episode ends with a discussion on CytomX Therapeutics’ resurrection, including its stock price jump. *This episode aired on May 16, 2025.

On this week’s episode, Grace Colón, Josh Schimmer, Sam Fazeli, Tess Cameron, Eric Schmidt, and Yaron Werber kick off with a discussion on recent policy moves including the appointment of Vinay Prasad as the director of the FDA’s CBER division and nomination of Casey Means for U.S. Surgeon General, noting the impact on the XBI and uncertainty around vaccine gene therapy approvals. The group pondered what kind of regulator Prasad may be, predicting a stricter approach than his predecessor, Peter Marks. The conversation covered the shifting dynamics in vaccine approvals under the new FDA leadership, highlighting that delays like Novavax’s flu combo signal heightened scrutiny, with mRNA follow-ons likely to pass under stricter labels, while new vaccines face raised efficacy bars. On the policy front, Trump’s proposed “Most Favored Nation” drug pricing strategy raises alarms over a potential trillion-dollar hit to innovation and unintended consequences for U.S. drug prices. The conversation shifts to early data on Genocury’s in vivo CAR-T, PTC’s mixed Huntington’s disease results, and Krystal’s gene therapy for neuropathic keratitis. The episode concludes with a roundup of Q1 earnings results. *This episode aired on May 9, 2025.

On this week’s episode, Eric Schmidt and Sam Fazeli are joined by special guests Adam Feuerstein and Peter Kolchinsky to discuss the upward movement of the biotech market along with strong drug launches, deals, and net-positive Q1 earnings, all signaling things may be improving. Next, the group notes the FDA is unlikely to undergo significant reorganization and while this stability is reassuring, complacency should be avoided as headwinds persist. Despite the turmoil, the pharmaceutical industry remains resilient, as people prioritize their health and the need for medicine. The conversation shifts back to the new FDA leadership, highlighting Makary and RFK Jr.’s relationship, anti-vaccine rhetoric and the impacts this may have on vaccine trials. The group notes that at conversations at AACR suggest that large pharma is not worried about the FDA changes, while smaller companies have concerns. BridgeBio’s successful launch of Attruby was also discussed, highlighted as a positive trend for the industry. The conversation shifts back to vaccine uncertainty and the future of mRNA given the skepticism from healthcare professionals, illustrated by Moderna’s potential delays fortheir flu vaccine combo. The episode ends with Adam’s optimistic take on biotech’s recent turn toward stabilization. *This episode aired on May 2, 2025.

The podcast dives into the biotech market's recent revival and the implications of the new FDA commissioner’s remarks. It highlights the FDA's reorganization and its impact on review times due to low morale. The discussion also covers innovative therapies like BMS’ Cobenfy trial and uniQure’s gene therapy for Huntington’s disease. A critical look at anti-Semitism at Harvard calls for action, while strategies for navigating the biotech landscape reveal the challenges CEOs face in a turbulent market. The conversation wraps up with insights on investor evaluations.

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.

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.

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.

Matthew Gline from Roivant joins the discussion, bringing insights into the current biotech landscape. The conversation kicks off with concerns over potential funding cuts impacting HIV programs and major biotech firms like Gilead. They delve into promising clinical data from Roivant's batoclimab study for myasthenia gravis and the surprising lack of short sellers. The group also tackles advancements in Duchenne Muscular Dystrophy therapies and ethical dilemmas surrounding accelerated drug approvals, especially after recent patient safety incidents.

On this week’s episode, Eric Schmidt, Sam Fazeli and Yaron Werber are joined by Biotechnology Innovation Organization's (BIO) John Crowley where they discuss biotech policy shifts, regulatory updates, obesity clinical trials and deal flow. The conversation begins with a focus on the obesity landscape including Novo Nordisk’s CagriSema data, Roche’s partnership with Zealand Pharma and Viking Therapeutics manufacturing agreements, signaling continued investment in the field. John Crowley then leads a conversation on policy and regulatory developments, sharing optimism about a more favorable U.S. policy environment for biotech. He highlights key priorities such as FDA modernization, PBM reforms and domestic manufacturing incentives. Crowley also notes bipartisan recognition of biotech as a strategic asset, though concerns persist around anti-science rhetoric, vaccine skepticism and regulatory challenges. Despite ongoing uncertainty, he sees more opportunities than threats for the industry. On the deal-making front, small-cap oncology acquisitions continue, with Sun Pharma acquiring Checkpoint Therapeutics and BMS consolidating its stake in 2seventy Bio. The discussion also covers biotech pipeline updates, including BioNTech’s disappointing revenue guidance and Legend Bio’s expansion of its CAR-T therapy manufacturing capacity. The episode concludes with insights into the broader biotech market, highlighting the impact of regulatory shifts, M&A activity and clinical trial data. While challenges remain, companies prioritizing innovation and execution continue to be well-positioned for long-term success. This episode aired on March 14, 2025.