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.
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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.
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Episode 161 - October 31, 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.
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Episode 160 - October 24, 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.
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Episode 159 - October 17, 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.
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