Episodi

  • Episode 169 - January 16, 2026
    Jan 16 2026

    On this week’s episode, Chris Garabedian, Paul Matteis, Mike Yee, and Sam Fazeli recap the 2026 J.P. Morgan Healthcare Conference, noting that the biotech outlook for 2026 is broadly positive. Investor sentiment is noted as healthy but not overheated, and from the specialist community, the outlook is similarly upbeat. On the venture side, the M&A landscape also looks strong, with one of the best pre‑JPM financing weeks in at least a decade. The conversation turns to company updates, with Alnylam’s 2030 strategy as well as Moderna’s cost-cutting initiatives and upcoming vaccine readouts. On the deal front, the group covers AbbVie’s $650M partnership with China-based RemeGen on a next‑gen PD‑1/VEGF bispecific antibody. AI developments were another key theme at JPM, including Pfizer’s claim that AI contributed to $5.6B in cost reductions. In regulatory news, FDA flexibility, new CMC guidance for cell and gene therapies, and updates on Dr. Makary’s CNPVs are overviewed. Next, the co-hosts cover the latest obesity news, including new oral GLP-1s and potential competition from Pfizer and Amgen in the monthly injectables market, as well as BMS and AbbVie’s interest in entering the space. The episode concludes with rapid‑fire round of data updates in DMD, gene therapy, myeloma, cystic fibrosis, and Alzheimer’s prevention. *This episode aired on January 16, 2026.

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    59 min
  • Episode 168 - January 9, 2026
    Jan 9 2026

    On this week’s episode, Sam Fazeli, Paul Matteis, Brian Skorney, and Tess Cameron discuss biotech market sentiment and the sector’s strong momentum heading into JPM and 2026, with expectations for increased M&A activity. They note that companies showing strong fundamentals have been rewarded, while policy uncertainty remains a risk. The group also overviews the HHS decision to revise pediatric vaccine recommendations -- removing 17 of the 11 previously recommended shots -- and its potential impact on public health and the sector. The conversation shifts to the first IPO of 2026: Lilly-backed Aktis Oncology, which raised $318M. The co-hosts then discuss rumors of AbbVie or Merck purchasing Revolution Medicines, with Merck potentially paying $32B -- a positive sign for industry deal-making. On the data front, Zenas Biopharma’s Phase 3 trial of obexelimab for IgG4-RD met its primary endpoint, while Ultragenyx shared updates on setrusumab for Osteogenesis Imperfecta. The group also highlighted Neumora’s Phase 1b Alzheimer’s agitation results, noting cautious optimism. The episode closes with discussion on late-stage success for Alumis’ envudeucitinib in plaque psoriasis and obesity updates, including Novo Nordisk’s oral GLP-1 pill and Arrowhead’s significant raise. *This episode aired January 9, 2026.

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    1 ora e 1 min
  • Episode 167 - December 19, 2025
    Dec 19 2025

    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.

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    59 min
  • Episode 166 - December 12, 2025
    Dec 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 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.

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    1 ora
  • Episode 165 - December 5, 2025
    Dec 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.

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    1 ora e 1 min
  • Episode 164 - November 21, 2025
    Nov 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.

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    1 ora
  • Episode 163 - November 14, 2025
    Nov 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.

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    58 min
  • Episode 162 - November 7, 2025
    Nov 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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    1 ora