Biotech Hangout

On this week’s episode, Grace Colón, Josh Schimmer, Eric Schmidt, and Brian Skorney open with a look at the macro backdrop. With market volatility and interest rate uncertainty, the hosts agree the macro is still “driving the bus,” tempering what might otherwise be stronger bullish sentiment. Even so, biotech continues to demonstrate relative resilience – XBI holding up better than the broader market – reinforcing the view that investors still want to own biotech. In deals, the co-hosts discuss Gilead’s more than $2 billion purchase of Ouro Medicines for its autoimmune disease drug, Merck’s $6.7 billion takeover of Terns to bolster its oncology pipeline, and Novartis’ deal for Exellergy to strengthen its allergy portfolio. The conversation shifts to regulatory news, including the approval of Denali’s Hunter syndrome drug, Avlayah, which comes shortly after the FDA rejected Regenxbio’s gene therapy for the same condition. Other recent rare disease approvals are noted, with the group interpreting them as signs of slightly increased regulatory flexibility following leadership changes, though uncertainty remains across the health agencies.  The episode concludes with recent data news and market reactions from Sarepta and Arrowhead, Maze versus Vertex in kidney disease, Beam’s data in AATD, Lyme disease vaccine data from Pfizer and Valneva, and a preview of data to be presented at AAD. *This episode aired on March 27, 2026.

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.