Biotech Hangout

On the final episode of 2025, Daphne Zohar, Bruce Booth, and Eric Schmidt kick off with a general market overview, including a look back at 2025 and some predictions for 2026. The co-hosts discuss biotech rebounding in the last few months of 2025 after years of underperformance, driven by macro rotations and biopharma as an AI-trade hedge. They also discuss some recent follow-on activity from Immunome and Kyverna coming off positive data, before transitioning the conversation to the pros and cons of staying private versus going public. The recent FDA turmoil is also discussed, including reaction to the New York Times article on a potential coup attempt against Dr. Marty Makary led by RFK Jr., as well as an increase in seemingly random CNPV decisions, including J&J’s Tecvayli. The co-hosts then dive into STAT’s best and worst CEOs of 2025, suggesting leadership success can sometimes come down to luck. In data news, Kyverna reported positive results for its CAR‑T miv‑cel in stiff person syndrome, which — if approved — could represent one of the smallest datasets for a cell therapy approval and the first cell therapy for an autoimmune disease. The episode concludes with the breaking news of BioMarin’s $4.8B acquisition of Amicus Therapeutics. *This episode aired December 19, 2025.

On this week’s episode, Grace Colón, Chris Garabedian, Sam Fazeli, Paul Matteis, Yaron Werber, and special guest John Stanford kick off with a policy discussion on the National Defense Authorization Act (NDAA), outlining both the opportunities and constraints it presents for biotech. The bill includes major biotech provisions such as a scaled back version of the BIOSECURE Act and the creation of a DoD Biotech Office, which suggests that biotech is now viewed as a national security asset. The conversation then shifts to positive signs in the biotech sector, including rising valuations, a decrease in companies with negative enterprise value, and predictions for the number of IPOs expected in the first half of 2026. Next, the group discusses conference highlights, including data from ASH presented by Lilly, BeOne Medicines, Gilead, and Arcellx versus J&J and Legend, as well as Genmab’s Epkinly. In other data news, the discussion turns to Dyne Therapeutics’ plans to seek FDA approval for DYNE-251 for DMD, following promising Phase 1/2 trial results. Despite some investor concerns about the FDA’s regulatory stance on rare diseases, sentiment remains optimistic that it will be approved. The episode closes with a round robin where each co-host shares their optimism levels for biotech in 2026, rating it on a scale from 1 to 10. *This episode aired on December 12, 2025.

On this week’s episode, Josh Schimmer, Brian Skorney, Paul Matteis, and Graig Suvannavejh share their outlook for the biotech industry in 2026, including a lively discussion on IPO market and predictions for what to expect next year. The discussion then shifts to Washington, where Tracy Beth Høeg has been appointed acting CDER director -- the fifth person to lead CDER this year -- following Richard Pazdur’s sudden retirement and ongoing staffing volatility at the agency. Next the co-hosts mention the FDA’s moves to speed up drug approvals, the plausible mechanism pathway, and latest with vaccine policies. The FDA’s final minutes from a pre-BLA meeting with UniQure and the implications for the broader gene therapy landscape are also discussed. Capricor’s positive DMD cell therapy results are also highlighted, reviving hopes for FDA approval. The conversation shifts to data news, including BMS’ update on the ADEPT-2 study readout for Cobenfy in Alzheimer’s disease psychosis, which the co-hosts read as a net positive. Praxis Medicine’s positive Phase 2 results for its seizure drug and ongoing FDA discussions, and Janux Therapeutics in prostate cancer. Otsuka pricing Voyxact at $390K a year is briefly mentioned. The episode concludes with excitement for upcoming conferences including ASH and JPM. *This episode aired on December 5, 2025. 

On week’s episode, Eric Schmidt, Yaron Werber, Tess Cameron, and Sam Fazeli kick off with biotech M&A news, including Alkermes’ $2.37 billion offer for Avadel, following Lundbeck’s surprise bid. Next, the co-hosts discuss J&J’s $3.05 billion cash acquisition of Halda - the highest-priced deal for a company at this stage. The group also covers Merck’s acquisition of Cidara Therapeutics to strengthen its antiviral pipeline. They debate whether biotech M&A is becoming more competitive, what big pharma is prioritizing, and the role M&A is playing in the current biotech rally. The conversation then shifts to Washington policy news, including the CDC website updates suggesting vaccines haven’t been proven not to cause autism, alleged tensions between RFK Jr. and Dr. Marty Makary over FDA leadership authority and management-style concerns Next, in regulatory news, the co-hosts overview the FDA’s approval of Arrowhead’s Redemplo for FCAS, priced at $60K, and its competition with Ionis’ Tryngolza. Novo Nordisk’s semaglutide price cut and conversations on drug pricing trends and the impact on competition are also mentioned. The episode concludes with an overview of Zymeworks positive data and shifting in business model, Nuvalent’s positive data and $500 million raise, and Olema’s stock price increase and raise on the back of Roche’s breast cancer data. *This episode aired on November 21, 2025.

On this week’s episode, John Maraganore, Yaron Werber, Ami Fadia, and special guests STAT’s Allison DeAngelis and Endpoints News’ Drew Armstrong kick things off with an overview of the latest FDA staffing changes, including long-time oncology chief Richard Pazdur’s appointment as the new CDER director, a move the co-hosts view as positive for the industry and a sign of potential stability. Next, the group breaks down the FDA’s new ‘Plausible Mechanism Pathway’, designed to accelerate certain personalized therapies to market when traditional trials aren’t feasible. Allison then shares insights from her reporting on the exclusive MAHA Summit held earlier this week -- an invite-only gathering of top HHS officials and leading biotech executives. In data news, the co-hosts discuss Alkermes’ Phase 2 narcolepsy trial, Cogent’s Phase 3 gastrointestinal stromal tumor results, and CRISPR’s cholesterol data. As one bidding war ends, another begins as Alkermes’ move to acquire Avadel faces competition from Lundbeck, who offered a $2.25 billion, rivaling Alkermes’ initial $2.1 billion offer. Drew Armstrong also overviewed his reporting on the Novo Nordisk-Pfizer bidding war, noting both companies’ obesity setbacks and their search for new directions. Deal-making conversations continues with Merck’s $9.2 billion acquisition of Cidara Therapeutics, and Day One Therapeutics’ $285 million acquisition of Mersana Therapeutics. The episode concludes with a discussion on the passing of genetic pioneer James Watson and Eli Lilly CEO David Ricks’ appearance on The Cheeky Pint podcast. *This episode aired on November 14, 2025.