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.

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. 

On this week’s episode, Daphne Zohar, Bruce Booth, Sam Fazeli, Brian Skorney, Yaron Werber, and Eric Schmidt kick off with market updates, noting that the XBI is showing signs of a sustainable recovery after years of underperformance and highlighting that the IPO market is likely closed for the remainder of the year, but note optimism for early 2026. In deal news, Novartis’ $12B acquisition of Avidity is spotlighted as an unprecedented move for a company yet to read out Phase 3 data. The co-hosts also speculate on what this acquisition could mean for Dyne Therapeutics, has a similar RNA-based pipeline in rare muscle disease. Next, Daphne highlights that some of the biggest M&A deals of the year have come from women-led companies - including Avidity. The conversation then shifts to Novo Nordisk’s surprise $9Bbid for Metsera, which challenges Pfizer’s existing $7.3B deal and raises questions about Novo’s intentions. In policy news, manufacturing issues at Novo's Catalent Indiana facility and the impact on the sector are mentioned. The episode concludes with a group discussion around Bruce’s lessons from his 20 years in early-stage biotech. *This episode aired on October 31, 2025.

On this week’s episode, Chris Garabedian, Brian Skorney, and Sam Fazeli open with optimism about the biotech market, predicting an upcoming acceleration in IPO activity. In deals and financing news, the co-hosts discussed Summit Therapeutics’ $500 million raise, with more than half coming from insiders, and continued momentum in M&A, including Alkermes’ $2.1 billion acquisition of Avadel for its narcolepsy drug. The group also highlighted Takeda’s $1.2 billion oncology deal with Innovent. European biotech funding showed positive signs, evidenced by Tubulis’ $360 million Series C. Next, the co-hosts recapped ESMO, spotlighting Summit and Akeso’s NSCLC data, Incyte’s KRAS G12D inhibitor, and Arcus and AstraZeneca’s TIGIT data. The episode concluded with additional data readouts, including mixed results from Alector and GSK’s dementia drug, and Moderna’s CMV mRNA vaccine results. *This episode aired on October 24, 2025.

On this week’s episode, Paul Matteis, John Maraganore, Eric Schmidt, and Graig Suvannavejh open with a look at biotech market sentiment, which has notably strengthened amid steady M&A and successful drug launches. The XBI is also up over 40% in six months, signaling optimism that the long “biotech winter” may be ending. While cautious, the co-hosts agree the recovery feels sustainable. The group then discussed the IPO and private financing landscape, noting a more mature crop of companies could drive strong IPOs in 2026. On the regulatory front, the co-hosts discussed the FDA’s announcement of nine voucher recipients under the new Commissioner’s National Priority Voucher (CNPV) pilot program. President Trump’s comments on reducing GLP-1 pricing were also noted. In M&A, BioCryst’s ~$700B acquisition of Astria Therapeutics was seen as a healthy sign of industry consolidation. The FDA’s OAI letter to Novo Nordiskalso has implications for Scholar Rock and Regeneron. In data news, Praxis’ positive essential tremor results were highlighted as a win in the CNS space, showing strong data can drive meaningful raises. Next, John recapped his STAT Summit panel with Chris Viehbacher and Emma Walmsley on the hurdles the pharma industry has faced and the next decade ahead. Bicara Therapeutics’ breakthrough therapy designation in head and neck cancer was another sentiment boost. The group also previewed Alector’s upcoming Phase 3 readout in frontotemporal dementia. The episode closed with excitement heading into ESMO this weekend. *This episode aired on October 17, 2025.

On this week’s episode, Tess Cameron, Brian Skorney, Sam Fazeli, Yaron Werber, and Luba Greenwood, kick off with a pop quiz on the last time the $XBI hit 105 (spoiler, it was 2021) driven by recent positive news. The co-hosts highlight a steady rate of M&A activity, including Novo Nordisk’s acquisition of Akero Therapeutics highlighting continued interest in metabolic conditions and BMS’ acquisition of Orbital Therapeutics reflecting growing momentum around in vivo CAR-T delivery platforms. The LB Pharma and MapLight IPOs are also mentioned. The conversation shifts to AI pharma deals, spotlighting AstraZeneca’s partnership with Algen Biotechnologies and Sanofi’s collaboration with BenchSci, both designed to accelerate discovery and target identification. In other financing news, the co-hosts cover Nilo Therapeutics’ $101 million Series A financing and the debut of Ascenta’s $325 million biotech fund. In data news, the group covers Arcus’ HIF-2a monotherapy data in kidney cancer, Dyne Therapeutics’ encouraging results in DM1, and Ionis’ pipeline and platform updates presented at its Innovation Day. The episode concludes with Lexeo Therapeutics’ regulatory updates for its Freidreich’s ataxis gene therapy and discussion on Peter Marks’ transition from the head of CBER to Eli Lilly, noting the pharma-agency “revolving door.” *This episode aired on October 10, 2025.

On this week’s episode, Eric Schimidt, Sam Fazeli, Brian Skorney, Yaron Werber, and Brad Loncar open withmacro news including Pfizer’s deal with the White House on U.S. drug manufacturing and pricing, which helped shelve the Most Favored Nation pricing and looming tariffs. The co-hosts agreed it was a savvy move that secured goodwillfor the industry and gave investors confidence, leading to new XBI highs. Discussion then moved to regulatory updates with the new CDER head, George Tidmarsh, stirring controversy with now-deleted LinkedIn posts criticizing surrogate endpoints. Combined with recent CRLs on CMC grounds, the group debates inconsistency at the agency and top-down decision-making that adds uncertainty for companies and investors. In M&A, Genmab’s $8 billionacquisition of Merus and competitive dynamics with Bicara are mentioned, along with whether the streak of weekly biotech deals marks a broader industry trend. In data, the co-hosts discussed MoonLake’s hidradenitis suppurativa data and stock moves, Larimar’s Friedreich’s ataxia data and stock fall, along with Enanta’s RSV data and big stock reversal. The episode concludes with a look ahead as the group discusses Q4 conferences, including ESMO, and Q3 earnings risks forcertain companies. *This episode aired on October 3, 2025.

On this week’s episode, Sam Fazeli, Eric Schmidt, PaulMatteis, Brian Skorney, and Brad Loncar dive into what was a positive week for biotech, marked by M&A, offerings, and compelling clinical data, spotlighting Pfizer’s acquisition of Metsera. The conversation shifts to data, starting with UniQure’s three-year Huntington’s disease gene therapy results and Acadia’s Phase 3 results in Prader-Willi syndrome, and the implications for Soleno and Rhythm Therapeutics. Next, the co-hosts overview Stealth Bio’s approval in Barth syndrome and signs of the FDA’s flexibility. Cidara Therapeutics’ influenza prophylaxis antibody and enthusiasm around the Phase 3 results are also discussed. Additionally, positive data from MBX in chronic hypoparathyroidism and PepGen in DM1 further showcase biotech’s rebound, with positive stock reactions. The episode closes with a look at what’s happening at the FDA (some flexibility in rare diseases, CRLs), the latest MAHA press conference – discussion around Tylenol & autism specifically -- and public trust in science. *This episode aired on September 26, 2025.