Biotech Hangout

On this week’s episode, Sam Fazeli, Josh Schimmer, Paul Matteis, and Graig Suvannavejh kick off with a discussion on the impact of current geopolitics on biotech investor sentiment, noting that biotech is fundamentally insulated from oil prices and emphasizing that the sector is becoming cash‑flow positive at a pace not previously seen. Shifting to regulatory news, the group discusses Vinay Prasad’s departure from the FDA and highlights that upcoming rare disease readouts will serve as a test of the FDA’s flexibility. They also cover the FDA’s new Adverse Event Monitoring System, which consolidates multiple adverse event reporting databases into a single platform. Next, the co-hosts highlight John Crowley’s opinion piece in STAT News on Biotech’s 50th anniversary (marked by the founding of Genentech), emphasizing the importance of protecting U.S. biotech and pharmaceutical pricing to sustain innovation. On the deal front, the group discusses Servier’s $2.5B cash acquisition of Day One Biopharmaceuticals’ oncology asset, as well as the recurring rumor of an Abivax takeover. The episode closes with a review of recent clinical data and company updates from IDEAYA Biosciences, Roche, Benitec Biopharma, RenovoRx, Vertex, Xenon, and Dianthus, along with broader commentary on FDA decision‑making following the approval of leucovorin. *This episode aired on March 13, 2025.

On this week’s episode, Mike Yee, Eric Schmidt, Matt Gline, and Yaron Werber kick off with a discussion on the sector's resilience amid market volatility, highlighting positive capital markets developments. The fourth quarter of 2025 saw approximately $10 billion in follow-on financing, with the first quarter of 2026 approaching about a $2.5 billion IPO run rate, which would be the highest single quarter in the past few years. The co-hosts express cautious optimism, notingthat after a long period where companies were struggling to capitalize themselves, the overall mood has improved. The discussion then shifts to the big news from this week and intellectual property dynamics including the $2.25B Roivant/Moderna settlement and its impacts on Moderna’s cash position, alongside IP implications for mRNA/LNP platforms. Regulatory updates are mentioned through UniQure’s rejection and FDA decision-making, emphasizing the complexity of FDA reviews. The group also explores the GLP-1 obesity market potential and its impact on consumer sectors, particularly with the emergence of oral GLP-1 therapies; payer dynamics are also discussed. Next, the co-hosts discuss financial guidance and “sandbagging” using the Harrow case as an example in transparency in financial guidance and its impact on investor expectations. The episode concludes with the group highlighting Miami as an emerging hub for biotech and finance conferences, offering efficient scheduling for deal-making. *This episode aired on March 6, 2026.

On this week’s episode, Tess Cameron, Josh Schimmer, Brian Skorney, and special guest Adam Feuerstein kick off with regulatory updates, including the FDA’s rejection of Atara Biotherapeutics and Pierre Fabre Pharmaceuticals’ cell therapy, Ebvallo -- a therapy that should have been approvable. The co-hosts then highlight ongoing inconsistencies at the agency and the challenge it creates for investors and companies as the regulatory goal posts continue to shift. Next, they discuss a New York Post editorial from the Alliance for Regenerative Medicine CEO Tim Hunt, who outlined how last‑minute reversals on rare disease and CGT approvals are leaving patients and biotech companies in limbo. The conversation then shifts to deals, including Gilead’s $7.8B acquisition of Arcellx for full control of anito-cel for relapsed/refractory multiple myeloma, and Vir’s pivot to oncology through a $1.7B collaboration with Astellas. In data news, the co-hosts cover CagriSema’s head-to-head trial results against Lilly’s Zepbound, Gossamer Bio’s lung disease drug, seralutinib, which did not meet the primary endpoint in its Phase 3 pulmonary arterial hypertension study, and Palvella Therapeutics’ positive topline results from the Phase 3 study of QTORIN rapamycin in microcystic lymphatic malformations. The episode closes with company updates, including Sarepta CEO Doug Ingram’s retirement and Xenon Pharmaceuticals’ upcoming seizure drug readout. *This episode aired on February 27, 2026.

On this week’s episode, Eric Schmidt, Paul Matteis, Sam Fazeli, Graig Suvannavejh, and Luba Greenwood kick off with a discussion on the surge in out licensing deals and growing drug development momentum in China -- a trend they expect will continue. The conversation then shifts to market sentiment, touching on biotech outlook and M&A. in policy news, the group highlights that the FDA reversed its refusal to file a letter for Moderna’s flu vaccine after President Trump met with Dr. Marty Makary. They also discuss the FDA’s recent regulatory unpredictability, particularly in vaccines and rare diseases. Next, the co-hosts highlight Denali Therapeutics’ upcoming PDUFA date for its Hunter syndrome therapy as another test of the FDA’s flexibility. The group notes the agency’s paper published in NEJM announcing approval of certain drugs based on a single clinical trial, with some viewing it positively for biotech innovation while others caution it may be meaningless, especially with leadership changes. The co-hosts close the discussion on regulatory news by reflecting on positives that have emerged during the Dr. Makary/Dr. Prasad era. In company news, the co-hosts discuss an analysis on the Keytruda patent landscape J&J’s investment in a new cell therapy manufacturing plant and data updates from Roche in kidney disease and Compass Pathways’ latest psilocybin results. *This episode aired on February 20, 2026.

On this week’s episode, Graig Suvannavejh, Chris Garabedian, Eric Schmidt, and Yaron Werber kick off with a look at a big week for biotech IPOs, led by Veradermics and Eikon Therapeutics. The co-hosts note that this could mark the start of a healthy year for high‑quality IPOs, with many companies entering the market with mature assets Generate Biomedicines’ S‑1 filing was highlighted as another positive signal for the industry. The conversation moves to policy, including Amgen’s decision not to withdraw Tavneos after the FDA flagged data from a 2021 trial conducted by ChemoCentryx before it was acquired by Amgen. The group also discusses the narrowly passed spending bill that reauthorizes the FDA’s rare pediatric disease priority review voucher program and the White House’s rejection of fast‑track review for Compass Pathways’ psychedelic. In obesity news, the group discusses Dr. Makary’s signaling FDA will take action against compound pharmacies following HIMS’ announcement that they will provide compounded semaglutide pills. The co-hosts also highlight promising clinical data from Pfizer and Metsera’s GLP‑1 program and Amgen’s investigational MariTide, which seem to reaffirm each other’s data and the competition between Novo and Lilly. There's also discussion on the broader obesity landscape. In company updates, the group covers GSK returning rights to Wave for its lead rare disease asset. The episode concludes with discussion of GSK’s decision to hold on a Phase 3 trials for its long‑acting TSLP program and upcoming Ocular Therapeutix wet AMD data. *This episode aired on February 6, 2026.