Biotech Hangout

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.

On this week’s episode, Josh Schimmer, Sam Fazeli, Brian Skorney, and Yaron Werber kick off with a discussion on policy with special guest BIO’s CEO John Crowley, overviewing what it means for the U.S. to “win” the biotech race against China, emphasizing the need for innovation and ensuring access to medicines. The conversation shifts to the latest at the FDA, where John acknowledges concerns around consistency at the agency and expresses optimism following conversations with FDA leadership at the JP Morgan Healthcare conference earlier this month. Next, the co-hosts discuss major investments in China, including AstraZeneca’s $15B commitment to China through 2030, focusing on R&D, manufacturing, and partnerships. Shifting back to U.S. policy, the group addresses the growing measles outbreak, highlighting the belief that science, data, and policy pressure will win out over anti-science rhetoric. Next, John notes that codifying MFN would be devastating for the industry. The conversation turns to deals, with Merck’s decision not to acquire Revolution Medicines, noting that the company’s current strong cash position and recent deals will likely make them attractive to Big Pharma in the future. Next, Eikon Therapeutics’ planned $273.5M IPO is also highlighted. The episode concludes with an overview of the FDA’s clinical hold on a Regenxbio gene therapy and discussion on Amgen stepping away from its OX40 partnership. *This episode aired on January 30, 2026.

On this week’s episode, Grace Colon, Tim Opler, Graig Suvannavejh, and Eric Schmidt kick off with an overview of Tim’s “The Case for Optimism” report, highlighting that macroeconomic conditions will need to stabilize and that M&A is likely to be significant in the coming year. The group also notes how quickly things can shift in biotech, citing recent inconsistencies at the FDA. Next, the co-hosts discuss the reopening of the IPO market after a quiet period, and how this could reshape M&A dynamics and company valuations compared to when acquisitions were the primary exit route. The conversation then turns to recent deals, including GSK’s $2.2B acquisition of RAPT Therapeutics for its next‑generation food allergy drug and Janux Therapeutics’ up to $850M cancer collaboration with BMS. On the policy front, the co-hosts cover the United States’ official withdrawal from the WHO and the FDA’s new draft guidance outlining how minimal residual disease and complete response could support accelerated approvals in multiple myeloma. They also highlight Corvus Pharmaceuticals’ positive Phase 1 results in atopic dermatitis and the company’s stock jump. Tim closes the episode by discussing his recent women’s health report and the growing interest and investment in the space. *This episode aired on January 23, 2026.