Biotech Hangout

On this week’s episode, Josh Schimmer, Eric Schmidt, and Tess Cameron kick off with policy, discussing Vinay Prasad’s return to the FDA and the implications for the biotech industry. The conversation turns to NIH’s Jay Bhattacharya, who attributed the decline in public trust in mRNA vaccines to perception rather than safety or efficacy, citing this as the reason to curtail funding. In market trends, the co-hosts discuss investor blind spots, specifically near-term product launches. Next, the group examines whether rising drug prices are sustainable and the six-month IPO drought. They also debate how non-commercial companies approach earnings calls, pointing to Summit Therapeutics’ choice to skip its Q2 call and whether most development-stage biotechs should follow suit. ARS Pharmaceuticals’ earnings/epinephrine nasal spray launch and RTW Investments deal with Aquestive Therapeutics are also overviewed. The episode concludes with data news, covering Insmed’s lung disease approval and Sarepta’s safety update. *This episode aired on August 15, 2025.

On this week’s episode, Grace Colón, John Maraganore, Paul Matteis and Eric Schmidt dive in with a discussion on policy news, including the pharma tariffs and latest on the Trump administration’s Most Favored Nations drug pricing plans. The co-hosts then question if Vinay Prasad has a path back to the FDA and express hope for someone more centrist if he does not return. They also mention the CRLs for Scholar Rock and Regeneron were due to manufacturing issues. Continuing with policy news, they cover RFK Jr.’s decision to cancel ~$500 million in Biomedical Advanced Research and Development Authority (BARDA) contracts related to mRNA vaccine development. In data news, the group discusses Vertex’s latest non-opioid pain data and the company’s future in this therapeutic area. Next, the co-hosts highlight Alnylam’s recently approved treatment for cardiomyopathy, noting it has surpassed consensus estimates and predicting mega-blockbuster status. A recent report on patient deaths among those who took Agios’ Pyrukynd for anemia - though determined to be unrelated to the drug - is also discussed. The co-hosts then review Biogen’s new “ventures” team, and the episode concludes with an overview of Novartis and Avidity deal rumors. *This episode aired on August 8, 2025.

On this week's episode, Daphne Zohar, Josh Schimmer, Brian Skorney, Paul Matteis, Sam Fazeli, Brad Loncar, and Matt Gline cover top news surrounding Trump's pricing letters to 17 major pharma companies demanding U.S. price cuts on new drugs, and the relevance to his MFN initiative. They also touch on Dr. Mehmet Oz’s meetings with biotech leaders in D.C. and looming tariff risks. The group discusses Vinay Prasad’s departure from CBER, opining on implications for biotech, and sharing insights from the CEO listening session with Marty Makary and George Tidmarsh. Next, they review the latest Sarepta news, including Vinay Prasad’s response to the patient deaths and broader credibility themes. To close out the regulatory discussion, RFK Jr.’s proposal to overhaul the Vaccine Injury Compensation Program (VICP) is discussed. In deals and restructuring news, the co-hosts unpack the GSK-Hengrui partnership amid China outlicensing trends, BMS/Bain’s new spinout company, Galapagos’s restructuring plans, and AbbVie’s reportedly targeting a $1B buyout of Gilgamesh. They also highlight drug launch momentum, with strong quarters from Alnylam, Argenx, and Neurocrine, challenging the “shorting the launch” thesis. The conversation shifts to data with Roche’s Alzheimer’s updates and expectations around Lilly’s abeta prevention study, touching on implications for the anti-amyloid class and Biogen’s outlook, including rising use of blood-based biomarkers and earnings commentary. They also discuss Compass’s regulatory strategy for psychedelics. The episode concludes with each co-host reflecting on market sentiment and the industry’s current state. *This episode aired on August 1, 2025.

On this week’s episode, Eric Schmidt, Paul Matteis, Sam Fazeli, and Brian Skorney begin with a recap of the week’s Sarepta news, covering their initial refusal then agreement to pause Elevidys shipments, if it can return to the market, the broader lessons for the biotech industry, and the communication breakdown between Sarepta and the FDA. Continuing with regulatory news, the group discusses the appointment of George Tidmarsh as the new CDER director and his role within FDA leadership. The conversation then turns to Replimune’s CRL for RP1 melanoma, Prasad’s likely influence in the rejection, and the impact on the investment community. In data news, the group overviews Alkermes’ positive Phase 1 data for its orexin 2 receptor agonist for type 1 narcolepsy, along with the safety controversy, and Abivax’s Phase 3 ulcerative colitis data and stock spike. Prime Medicine’s decision to reprice shares and strategies for better talent retention is also highlighted. The episode concludes with a brief overview of first-half 2025 licensing data, Roche earnings, and AstraZeneca’s $50 billion U.S. investment. *This episode aired on July 25, 2025.

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.