Biotech Hangout

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.

On this week’s episode, Daphne Zohar, Eric Schmidt, Tess Cameron, Brian Skorney, and Yaron Werber discuss the state of the biotech market, emphasizing the resilience of the sector despite current downtowns. The IPO market also remains stagnant, with many companies trading below IPO prices.  The conversation shifts to notable deals, including Jazz Pharmaceuticals acquiring Chimerix for $935 million and AbbVie’s move into the obesity space with its $350 million acquisition of Gubra. The group also discusses Pliant Therapeutics' discontinuation of its Phase 2b trial in idiopathic pulmonary fibrosis and Biohaven's promising results from its Phase 1 study of BHV-1300, a potential IgG degrader for autoimmune diseases. The conversation then covers BMS’ decision to terminate MRTX1133, a G12D inhibitor from its $4.8bn acquisition of Mirati Therapeutics, and the challenges independent biotech companies face post-launch, including investor skepticism and long-term value pressure. In regulatory news, the group touches on FDA and NIH Senate hearings, vaccine policy debates, and concerns over the revolving door between industry and regulatory agencies, particularly with Pfizer’s hire of former FDA director, Patrizia Cavazzoni. They also discuss the broader implications of scientific credibility and public trust in healthcare institutions. The episode concludes with insights on professional networking best practices, emphasizing clear and specific outreach strategies. *This episode aired on March 7, 2025.

Adam Feuerstein, an insightful author at Stat News, joins the discussion to explore the intriguing world of 'zombie' biotech companies, assessing whether they can be revived or should return capital to investors. He delves into Stoke's collaboration with Biogen and highlights promising gene therapy data for Duchenne muscular dystrophy. The conversation also touches on ethical concerns in biotech fundraising, the challenges faced by Bluebird Bios, and potential mergers like SpringWorks with Merck KGaA, revealing shifting landscapes in the industry.

On this week’s episode, Chris Garabedian, Yaron Werber and Sam Fazeli discuss the challenges facing the biotech sector, including high interest rates and the overabundance of public biotech companies. The hosts take a look at recent IPOs, noting that Metsra and Sionna have performed well, while others like Septerna and Upstream struggled. Reasons for the market’s reaction to IPOs was also discussed, including concerns about valuation, competition and future funding needs. The hosts also discuss the potential acquisition of SpringWorks by Merck. BioCentury’s Steve Usdin also joins the show to discuss the policy and regulatory environment. He outlines the opportunities and risks for the biotech sector, including potential reforms to onshore manufacturing, IRA Medicare drug negotiation, PBM reforms, FDA and NIH staffing cuts, and much more. This episode aired on February 14, 2025.

On this week’s episode, Daphne Zohar, Paul Matteis, Brian Skorney, Tim Opler and Abe Ceesay kick off with a more optimistic yet cautious perspective that investor sentiment may be improving. The group notes positive market trends post-JPM with the XBI index rising from 86.5 to around 92 since early January. The discussion also touches on on the re-emergence of wall cross pipes and the impact on generalist investor interest. The hosts discuss the positive M&A outlook for 2025, noting Intra-Cellular’s recent acquisition by J&J. Staying on the neuro theme, GH Research announced impressive data from its Phase 2b trial for a short-acting psychedelic drug for treatment-resistant depression. This extended into a discussion on the broader implications of neuropsych drug development, including the need for experienced management and the challenges of patient selection and managing high placebo responses. Other topics discussed include FDA’s approval of Axsome’s migraine drug, the anti-VEGF therapy competitive dynamics, Trump’s tariffs, and more. This episode aired on February 7, 2025.

On this week’s episode, Brad Loncar, Chris Garabedian, Eric Schmidt, Paul Matteis and Sam Fazeli kick off with an open mic session on the potential impact of the RFK Jr. hearings and the Trump administration's policies on the biotech industry. The conversation turns to a “unicorn day” with IPOs for Metsara, Maze, Odyssey and Sionna Therapeutics. The group also discusses the approval of Vertex’s journavx and the potential for it to be a blockbuster drug. Akero, Sarepta and Cargo also announced data this week and the hosts summarized the market reactions. Other topics covered include Merck’s buyback announcement and potential impact on M&A activity, Takeda’s CEO, Christophe Weber, steps down, Curie Bio’s new fund, and more. This episode aired on January 31, 2025.