Biotech Hangout

Episode 166 - December 12, 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 tone-down 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.

Episode 165 - December 5, 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.

Episode 164 - November 21, 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.

Episode 163 - November 14, 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.

Episode 162 - November 7, 2025

On this week’s episode, Graig Suvannavejh, Paul Matteis, Brian Skorney, Yaron Werber, Chris Garabedian, and guest Adam Feuerstein open with a discussion on George Tidmarsh’s departure from the FDA and the uncertainty it has caused in the markets. Next, the co-hosts discuss the shifting policies of the FDA and Sarepta’s Phase 3 ESSENCE trial of casimersen for DMD with the group debating if the drug actually works. Biohaven’s complete response letter for its new drug application for its spinocerebellar ataxia drug is also mentioned. The co-hosts also overviewed the FDA’s decision deeming Uniqure’s Huntington’s disease therapy data inadequate, and the read through for other companies like Stoke Therapeutics. The conversation shifts to company news where Novo Nordisk and Pfizer’s bidding war for Metsera is noted as a positive for biotech investors. Next the co-hosts discuss Soleno Therapeutic’s stock moves amid questions about its growth trajectory. The episode concludes with a look ahead to ASH 2025 with a preview of Terns Pharmaceuticals CML data. *This episode aired on November 7, 2025.