Episode 176
On this week’s episode, Sam Fazeli, Josh Schimmer, Paul Matteis, and Graig Suvannavejh kick off with a discussion on the impact of current geopolitics on biotech investor sentiment, noting that biotech is fundamentally insulated from oil prices and emphasizing that the sector is becoming cash‑flow positive at a pace not previously seen. Shifting to regulatory news, the group discusses Vinay Prasad’s departure from the FDA and highlights that upcoming rare disease readouts will serve as a test of the FDA’s flexibility. They also cover the FDA’s new Adverse Event Monitoring System, which consolidates multiple adverse event reporting databases into a single platform. Next, the co-hosts highlight John Crowley’s opinion piece in STAT News on Biotech’s 50th anniversary (marked by the founding of Genentech), emphasizing the importance of protecting U.S. biotech and pharmaceutical pricing to sustain innovation. On the deal front, the group discusses Servier’s $2.5B cash acquisition of Day One Biopharmaceuticals’ oncology asset, as well as the recurring rumor of an Abivax takeover. The episode closes with a review of recent clinical data and company updates from IDEAYA Biosciences, Roche, Benitec Biopharma, RenovoRx, Vertex, Xenon, and Dianthus, along with broader commentary on FDA decision‑making following the approval of leucovorin. *This episode aired on March 13, 2025.
Episode 173
On this week’s episode, Eric Schmidt, Paul Matteis, Sam Fazeli, Graig Suvannavejh, and Luba Greenwood kick off with a discussion on the surge in out licensing deals and growing drug development momentum in China -- a trend they expect will continue. The conversation then shifts to market sentiment, touching on biotech outlook and M&A. in policy news, the group highlights that the FDA reversed its refusal to file a letter for Moderna’s flu vaccine after President Trump met with Dr. Marty Makary. They also discuss the FDA’s recent regulatory unpredictability, particularly in vaccines and rare diseases. Next, the co-hosts highlight Denali Therapeutics’ upcoming PDUFA date for its Hunter syndrome therapy as another test of the FDA’s flexibility. The group notes the agency’s paper published in NEJM announcing approval of certain drugs based on a single clinical trial, with some viewing it positively for biotech innovation while others caution it may be meaningless, especially with leadership changes. The co-hosts close the discussion on regulatory news by reflecting on positives that have emerged during the Dr. Makary/Dr. Prasad era. In company news, the co-hosts discuss an analysis on the Keytruda patent landscape J&J’s investment in a new cell therapy manufacturing plant and data updates from Roche in kidney disease and Compass Pathways’ latest psilocybin results. *This episode aired on February 20, 2026.
Episode 170
On this week’s episode, Grace Colon, Tim Opler, Graig Suvannavejh, and Eric Schmidt kick off with an overview of Tim’s “The Case for Optimism” report, highlighting that macroeconomic conditions will need to stabilize and that M&A is likely to be significant in the coming year. The group also notes how quickly things can shift in biotech, citing recent inconsistencies at the FDA. Next, the co-hosts discuss the reopening of the IPO market after a quiet period, and how this could reshape M&A dynamics and company valuations compared to when acquisitions were the primary exit route. The conversation then turns to recent deals, including GSK’s $2.2B acquisition of RAPT Therapeutics for its next‑generation food allergy drug and Janux Therapeutics’ up to $850M cancer collaboration with BMS. On the policy front, the co-hosts cover the United States’ official withdrawal from the WHO and the FDA’s new draft guidance outlining how minimal residual disease and complete response could support accelerated approvals in multiple myeloma. They also highlight Corvus Pharmaceuticals’ positive Phase 1 results in atopic dermatitis and the company’s stock jump. Tim closes the episode by discussing his recent women’s health report and the growing interest and investment in the space. *This episode aired on January 23, 2026.
Episode 168
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.
2026 Episodes
Episode 175
On this week’s episode, Mike Yee, Eric Schmidt, Matt Gline, and Yaron Werber kick off with a discussion on the sector's resilience amid market volatility, highlighting positive capital markets developments. The fourth quarter of 2025 saw approximately $10 billion in follow-on financing, with the first quarter of 2026 approaching about a $2.5 billion IPO run rate, which would be the highest single quarter in the past few years. The co-hosts express cautious optimism, noting that after a long period where companies were struggling to capitalize themselves, the overall mood has improved. The discussion then shifts to the big news from this week and intellectual property dynamics including the $2.25B Roivant/Moderna settlement and its impacts on Moderna’s cash position, alongside IP implications for mRNA/LNP platforms. Regulatory updates are mentioned through UniQure’s rejection and FDA decision-making, emphasizing the complexity of FDA reviews. The group also explores the GLP-1 obesity market potential and its impact on consumer sectors, particularly with the emergence of oral GLP-1 therapies; payer dynamics are also discussed. Next, the co-hosts discuss financial guidance and “sandbagging” using the Harrow case as an example in transparency in financial guidance and its impact on investor expectations. The episode concludes with the group highlighting Miami as an emerging hub for biotech and finance conferences, offering efficient scheduling for deal-making. *This episode aired on March 6, 2026.
Episode 172
On this week’s episode, Graig Suvannavejh, Chris Garabedian, Eric Schmidt, and Yaron Werber kick off with a look at a big week for biotech IPOs, led by Veradermics and Eikon Therapeutics. The co-hosts note that this could mark the start of a healthy year for high‑quality IPOs, with many companies entering the market with mature assets Generate Biomedicines’ S‑1 filing was highlighted as another positive signal for the industry. The conversation moves to policy, including Amgen’s decision not to withdraw Tavneos after the FDA flagged data from a 2021 trial conducted by ChemoCentryx before it was acquired by Amgen. The group also discusses the narrowly passed spending bill that reauthorizes the FDA’s rare pediatric disease priority review voucher program and the White House’s rejection of fast‑track review for Compass Pathways’ psychedelic. In obesity news, the group discusses Dr. Makary’s signaling FDA will take action against compound pharmacies following HIMS’ announcement that they will provide compounded semaglutide pills. The co-hosts also highlight promising clinical data from Pfizer and Metsera’s GLP‑1 program and Amgen’s investigational MariTide, which seem to reaffirm each other’s data and the competition between Novo and Lilly. There's also discussion on the broader obesity landscape. In company updates, the group covers GSK returning rights to Wave for its lead rare disease asset. The episode concludes with discussion of GSK’s decision to hold on a Phase 3 trials for its long‑acting TSLP program and upcoming Ocular Therapeutix wet AMD data. *This episode aired on February 6, 2026.
Episode 169
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.
Episode 174
On this week’s episode, Tess Cameron, Josh Schimmer, Brian Skorney, and special guest Adam Feuerstein kick off with regulatory updates, including the FDA’s rejection of Atara Biotherapeutics and Pierre Fabre Pharmaceuticals’ cell therapy, Ebvallo -- a therapy that should have been approvable. The co-hosts then highlight ongoing inconsistencies at the agency and the challenge it creates for investors and companies as the regulatory goal posts continue to shift. Next, they discuss a New York Post editorial from the Alliance for Regenerative Medicine CEO Tim Hunt, who outlined how last‑minute reversals on rare disease and CGT approvals are leaving patients and biotech companies in limbo. The conversation then shifts to deals, including Gilead’s $7.8B acquisition of Arcellx for full control of anito-cel for relapsed/refractory multiple myeloma, and Vir’s pivot to oncology through a $1.7B collaboration with Astellas. In data news, the co-hosts cover CagriSema’s head-to-head trial results against Lilly’s Zepbound, Gossamer Bio’s lung disease drug, seralutinib, which did not meet the primary endpoint in its Phase 3 pulmonary arterial hypertension study, and Palvella Therapeutics’ positive topline results from the Phase 3 study of QTORIN rapamycin in microcystic lymphatic malformations. The episode closes with company updates, including Sarepta CEO Doug Ingram’s retirement and Xenon Pharmaceuticals’ upcoming seizure drug readout. *This episode aired on February 27, 2026.
Episode 171
On this week’s episode, Josh Schimmer, Sam Fazeli, Brian Skorney, and Yaron Werber kick off with a discussion on policy with special guest BIO’s CEO John Crowley, overviewing what it means for the U.S. to “win” the biotech race against China, emphasizing the need for innovation and ensuring access to medicines. The conversation shifts to the latest at the FDA, where John acknowledges concerns around consistency at the agency and expresses optimism following conversations with FDA leadership at the JP Morgan Healthcare conference earlier this month. Next, the co-hosts discuss major investments in China, including AstraZeneca’s $15B commitment to China through 2030, focusing on R&D, manufacturing, and partnerships. Shifting back to U.S. policy, the group addresses the growing measles outbreak, highlighting the belief that science, data, and policy pressure will win out over anti-science rhetoric. Next, John notes that codifying MFN would be devastating for the industry. The conversation turns to deals, with Merck’s decision not to acquire Revolution Medicines, noting that the company’s current strong cash position and recent deals will likely make them attractive to Big Pharma in the future. Next, Eikon Therapeutics’ planned $273.5M IPO is also highlighted. The episode concludes with an overview of the FDA’s clinical hold on a Regenxbio gene therapy and discussion on Amgen stepping away from its OX40 partnership. *This episode aired on January 30, 2026.