On this week's episode, Josh Schimmer, Chris Garabedian, Sam Fazeli, Yaron Werber and guest Adam Feuerstein dive into breaking news, including Sarepta's recent updates -- layoffs, a black box warning, and pipeline reorganization -- and the juxtaposition of Amylyx's post-bariatric hypoglycemia and GLP-1 inhibitor following a webinar update at ENDO 2025. In regulatory news, the group discusses the evolving FDA under Makary's leadership, examining agency morale, rapid review processes for favorable drug pricing, and recent CRLs including Ultragenyx. The discussion then explores what these changes mean for CBER and Peter Marks' accelerated approval pathway for orphan disorders, alongside the ODAC panel for GSK's belantamab for multiple myeloma and the broader space. Market sentiment analysis reveals encouraging signs with the second quarter and first half reports on VC investment showing a clear uptick, along with additional positive feedback from a CEO forum on the FDA’s listening tour. The group shares some interesting stats around M&A so far this year, demonstrating strong momentum and a possible trajectory to possibly beat, or at least meet, the 2020 numbers. Data updates include, lung cancer survey insights, DiaMedica’s preeclampsia results, obesity updates from Hengrui/Kailera and Chinese biotech. The episode wraps with an overview of Novartis and J&J earnings reports. *This episode aired on July 18, 2025.

On this week’s episode, Eric Schmidt, Brad Loncar, Tim Opler and Tess Cameron kick off with a discussion on the surgein biotech M&A, with 2025 almost matching 2024’s deal count and surpassing it in value ($40B YTD vs $30B), highlighting recent deals like Merck’s acquisition of Verona and AbbVie’s purchase of Capstan. The group debateswhether this signals a true “M&A wave,” noting pharma’s $150 billion of LOE approaching and reduced macro uncertainty could be driving deal flow. They alsonote a current competitive dynamic around commercial-stage assets. Shifting to policy, Trump’s “Big Beautiful Bill” introduces key IRA exemptions for rare diseases and on tariffs, the co-hosts note the market’s quiet reaction andwonder if investors are becoming desensitized to D.C. headlines. As M&A steadies and drug launches hold strong despite pricing pressure, some stability seems to be on the way. On the regulatory front, the group praises the FDA’simproved communication under new leadership, citing their strong online presence and experience with media. Despite the FDA’s recent rejection of Capricor’s cell therapy for DMD, optimism remains about the therapy’s potential. Despite the improved communication discussed earlier, questionsabout the FDA’s transparency arise following the agency’s issuance of CRLs to be more transparent; it remains uncertain if this trend will continue. Conversation shifts to data, overviewing KalVista’s approval of Ekterly, thefirst oral calcineurin inhibitor approved for hereditary angioedema attacks and ProKidney’s cell therapy that showed improved eGFR slope in CKD patients in aPhase 2 trial, skyrocketing shares. The episode closes with a conversation on obesity trends. *This episode aired on July 11, 2025. 

On this week’s episode, Chris Garabedian, Daphne Zohar, Sam Fazeli, Tess Cameron, Paul Matteis and Tim Opler share cautious optimism about the biotech market as IPOs and follow-ons gain momentum. Continuing on market sentiment, competitive pressure looms for small and mid-sized U.S. biotechs as the Chinese biotech market grows and big pharma continues to invest in these assets. Next, the group recapped #BIO2025, where sentiment was mixed due to sector uncertainty. In regulatory news, Daphne reflects on her time with Makary and Prasad at the FDA’s listening tour, highlighting positive opportunities for biotech as the new administration takes shape. However, a report linking Makary to KalVista’s rejection request stirred concerns. At ADA 2025, Lilly dominated the with positive results across its weight loss portfolio; Novo’s data was also discussed. The group then covered Novo’s cancellation of its partnership with HIMS due to concerns about the compounded versionof Wegovy. The conversation shifts to data, with Cidara’s positive flu vaccine results, Compass’ psilocybin data and Nektar’s atopic dermatitis win. Additionally, Sarepta’s Elevidys faces further safety questions and Capricor’scancelled AdCom raises worries of the FDA’s flexibility.  The first ACIP meeting was also mentioned. On deals, Revolution Medicines’ $2B deal with Royalty Pharma, Illumina’s acquisition of SomaLogic and BlueRock’s shutdown were overviewed. The episode concluded with a summary of the Royalty Pharma conference. *This episode aired on June 27, 2025.

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.

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.

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.

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.

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.

On this week’s episode, Eric Schmidt and Sam Fazeli are joined by special guests Adam Feuerstein and Peter Kolchinsky to discuss the upward movement of the biotech market along with strong drug launches, deals, and net-positive Q1 earnings, all signaling things may be improving. Next, the group notes the FDA is unlikely to undergo significant reorganization and while this stability is reassuring, complacency should be avoided as headwinds persist. Despite the turmoil, the pharmaceutical industry remains resilient, as people prioritize their health and the need for medicine. The conversation shifts back to the new FDA leadership, highlighting Makary and RFK Jr.’s relationship, anti-vaccine rhetoric and the impacts this may have on vaccine trials. The group notes that at conversations at AACR suggest that large pharma is not worried about the FDA changes, while smaller companies have concerns. BridgeBio’s successful launch of Attruby was also discussed, highlighted as a positive trend for the industry. The conversation shifts back to vaccine uncertainty and the future of mRNA given the skepticism from healthcare professionals, illustrated by Moderna’s potential delays fortheir flu vaccine combo. The episode ends with Adam’s optimistic take on biotech’s recent turn toward stabilization. *This episode aired on May 2, 2025.

On this week’s episode, Daphne Zohar, Josh Schimmer, Tim Opler, John Maraganore, and Paul Matteis discuss the biotech market’s recent resurgence, and new FDA commissioner Marty Makary’s comments during his interview with former Fox News journalist Megyn Kelly. The discussion then shifts to the FDA’s reorganization, confusing return-to-work policies, and low morale at the agency, which resulted in slower review times. The conversation moves to BMS’ Cobenfy Phase 3 ARISE trial results and uniQure’s breakthrough therapy designation for its Huntington’s disease gene therapy. The group then revisits a discussion about biotech market updates and short selling. They also shared perspectives on Harvard University’s lawsuit against the Trump Administration, the broader issue of academic freedoms, and antisemitism on college campuses. The episode concludes with a discussion on the challenging microenvironments, CEO survival tips, and an overview of how investors are evaluating data. *This episode aired on April 25, 2025.