On this week's episode, Josh Schimmer, Paul Matteis, Eric Schmidt and Yaron Werber kick off with an optimistic view of the current biotech state of affairs, citing the FDA is open for business, we’re seeing companies successfully launch and M&A is happening, though the Trump Administration’s Most Favored Nation plan still looms. In regulatory news, UroGen’s FDA approval of Zusduri for tumor ablation in recurrent low-grade, intermediate-risk non–muscle-invasive bladder cancer was seen as a sign the FDA is continuing to be flexible and business as usual. Where it’s not business as usual, concerns were raised about RFK Jr.’s dismantling of the ACIP and worry for the future of vaccine practices. With a continued amount of investor activism against boards, the group opined on ADAR1’s letter to Keros’ board and Deep Track’s battle with Dynavax. The group shared some excitement around the emerging field of psychedelics, including a bullish perspective on Compass Pathways' upcoming data readout. The conversation shifts to questions about biotech’s current focus on M&A versus building large companies. The episode concludes with EULAR and EHA conference updates and the favorable data sets coming out of those meetings, leading to a discussion on what’s holding CAR-T valuations back in the I&I space. *This episode aired on June 13, 2025.
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Episode 144 - June 6, 2025
On this week’s episode, Brad Loncar, Eric Schmidt, and Sam Fazeli kick off with a look at Sanofi’s $9 billion acquisition of Blueprint Medicines, highlighting the move as a mature, strategic bet for Sanofi and a positive sign for investment in biotech. On the data front, the group highlights the Phase 3 HARMONi trial from Summit and Akeso in non-small cell lung cancer, which is the first to include both U.S. and Chinese patients in a head-to-head comparison with Keytruda. Vera Therapeutics’ positive Phase 3 data in IgA nephropathy was also discussed. The conversation shifts to ASCO 2025, spotlighting early-stage data in targeted protein degraders and novel therapies in breast cancer and myeloma. Despite some volatility in share prices and lack of bold headlines coming out of ASCO, overall sentiment remains optimistic about the pace of innovation in oncology. Next, they dive into TIGIT developments from Roche and AstraZeneca, noting AstraZeneca’s ambitious 10 Phase 3 trials. The episode wraps with Bicara Therapeutics’ updated data in HPV-negative head and neck cancer, targeting a subgroup identified through translational research. *This episode aired on June 6, 2025.
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Episode 143 - May 30, 2025
On this week's episode, Chris Garabedian, Josh Schimmer, Nina Kjellson, Mike Yee, and Tim Opler kick off with breaking data from Summit and Akeso's lung cancer therapy, exploring the results and potential next steps for the treatment. The current state of biotech M&A is the next topic of conversation, with continued macroeconomic uncertainty and investor preferencefor commercial-stage companies over clinical-stage deals highlighted. The hosts note that industry challenges preceded recent government agency upheavals, with the industry seeing a wave of shutdowns, noting iTeos as one of those companies most recently impacted. The conversation touches on Bruce Booth's "Biotech Wisdom of the Crowds" blog for additional market perspective. On the policy front NIH funding adjustments for early research and the Trump administration'scancellation of Moderna's $600M bird flu vaccine contract are overviewed. The FDA's upcoming listening tour is also noted, where industry leaders will provide feedback to regulators. Next, the group analyzes Prothena's Phase 3 data in AL amyloidosis. Looking ahead, the hosts preview ASCO 2025 andthe Jefferies Healthcare Conference, where attendees look forward to hearing from Marty Makary. The episode concludes with Regeneron's acquisition of 23andMe, examining implications for genetic data privacy and congressional legislation. *This episode aired on May 30, 2025.
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Episode 142 - May 16, 2025
On this week’s episode, Sam Fazeli, John Maraganore, Nina Kjellson and Matt Gline dig into an in-depth discussion on the Trump Administration’s recent executive order aimed at lowering drug prices as part of a broader “Most Favored Nation.” The group discusses the 30-day ultimatum, the 180- days for negotiations and concerns that biotechs may not be adequately represented at the table. The conversation shifts to PBMs, noting that there’s growing support for banning spread pricing and requiring more reporting from PBMs. The group also touches on orphan drugs, sharing that there’s bipartisan support to exempt orphan drugs from IRA negotiations. Pharma’s talk of investment in AI is also overviewed. Next, the group discusses Recursion Pharmaceuticals’ Q1 pipeline reorganization and Galapagos reversing its decision to split in two. CMS guidance on IRA Part B negatively impacted Halozyme Therapeutics and J&J, raising questions about the classifications of subQ formulations as different drugs despite sharing the same active ingredient. The episode ends with a discussion on CytomX Therapeutics’ resurrection, including its stock price jump. *This episode aired on May 16, 2025.
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Episode 141 - May 9, 2025
On this week’s episode, Grace Colón, Josh Schimmer, Sam Fazeli, Tess Cameron, Eric Schmidt, and Yaron Werber kick off with a discussion on recent policy moves including the appointment of Vinay Prasad as the director of the FDA’s CBER division and nomination of Casey Means for U.S. Surgeon General, noting the impact on the XBI and uncertainty around vaccine gene therapy approvals. The group pondered what kind of regulator Prasad may be, predicting a stricter approach than his predecessor, Peter Marks. The conversation covered the shifting dynamics in vaccine approvals under the new FDA leadership, highlighting that delays like Novavax’s flu combo signal heightened scrutiny, with mRNA follow-ons likely to pass under stricter labels, while new vaccines face raised efficacy bars. On the policy front, Trump’s proposed “Most Favored Nation” drug pricing strategy raises alarms over a potential trillion-dollar hit to innovation and unintended consequences for U.S. drug prices. The conversation shifts to early data on Genocury’s in vivo CAR-T, PTC’s mixed Huntington’s disease results, and Krystal’s gene therapy for neuropathic keratitis. The episode concludes with a roundup of Q1 earnings results. *This episode aired on May 9, 2025.
A weekly discussion of all things biotech – breaking news, data, deals, and FDA actions – with a community of biotech industry leaders and experts. Join the live streams hosted by @BiotechCH, @daphnezohar, @bradloncar and @biotech1 on Twitter Spaces every Friday at 12pm ET.
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