On this week’s episode, Paul Matteis, John Maraganore, Eric Schmidt, and Graig Suvannavejh open with a look at biotech market sentiment, which has notably strengthened amid steady M&A and successful drug launches. The XBI is also up over 40% in six months, signaling optimism that the long “biotech winter” may be ending. While cautious, the co-hosts agree the recovery feels sustainable. The group then discussed the IPO and private financing landscape, noting a more mature crop of companies could drive strong IPOs in 2026. On the regulatory front, the co-hosts discussed the FDA’s announcement of nine voucher recipients under the new Commissioner’s National Priority Voucher (CNPV) pilot program. President Trump’s comments on reducing GLP-1 pricing were also noted. In M&A, BioCryst’s ~$700B acquisition of Astria Therapeutics was seen as a healthy sign of industry consolidation. The FDA’s OAI letter to Novo Nordiskalso has implications for Scholar Rock and Regeneron. In data news, Praxis’ positive essential tremor results were highlighted as a win in the CNS space, showing strong data can drive meaningful raises. Next, John recapped his STAT Summit panel with Chris Viehbacher and Emma Walmsley on the hurdles the pharma industry has faced and the next decade ahead. Bicara Therapeutics’ breakthrough therapy designation in head and neck cancer was another sentiment boost. The group also previewed Alector’s upcoming Phase 3 readout in frontotemporal dementia. The episode closed with excitement heading into ESMO this weekend. *This episode aired on October 17, 2025.

On this week’s episode, Tess Cameron, Brian Skorney, Sam Fazeli, Yaron Werber, and Luba Greenwood, kick off with a pop quiz on the last time the $XBI hit 105 (spoiler, it was 2021) driven by recent positive news. The co-hosts highlight a steady rate of M&A activity, including Novo Nordisk’s acquisition of Akero Therapeutics highlighting continued interest in metabolic conditions and BMS’ acquisition of Orbital Therapeutics reflecting growing momentum around in vivo CAR-T delivery platforms. The LB Pharma and MapLight IPOs are also mentioned. The conversation shifts to AI pharma deals, spotlighting AstraZeneca’s partnership with Algen Biotechnologies and Sanofi’s collaboration with BenchSci, both designed to accelerate discovery and target identification. In other financing news, the co-hosts cover Nilo Therapeutics’ $101 million Series A financing and the debut of Ascenta’s $325 million biotech fund. In data news, the group covers Arcus’ HIF-2a monotherapy data in kidney cancer, Dyne Therapeutics’ encouraging results in DM1, and Ionis’ pipeline and platform updates presented at its Innovation Day. The episode concludes with Lexeo Therapeutics’ regulatory updates for its Freidreich’s ataxis gene therapy and discussion on Peter Marks’ transition from the head of CBER to Eli Lilly, noting the pharma-agency “revolving door.” *This episode aired on October 10, 2025.

On this week’s episode, Eric Schimidt, Sam Fazeli, Brian Skorney, Yaron Werber, and Brad Loncar open withmacro news including Pfizer’s deal with the White House on U.S. drug manufacturing and pricing, which helped shelve the Most Favored Nation pricing and looming tariffs. The co-hosts agreed it was a savvy move that secured goodwillfor the industry and gave investors confidence, leading to new XBI highs. Discussion then moved to regulatory updates with the new CDER head, George Tidmarsh, stirring controversy with now-deleted LinkedIn posts criticizing surrogate endpoints. Combined with recent CRLs on CMC grounds, the group debates inconsistency at the agency and top-down decision-making that adds uncertainty for companies and investors. In M&A, Genmab’s $8 billionacquisition of Merus and competitive dynamics with Bicara are mentioned, along with whether the streak of weekly biotech deals marks a broader industry trend. In data, the co-hosts discussed MoonLake’s hidradenitis suppurativa data and stock moves, Larimar’s Friedreich’s ataxia data and stock fall, along with Enanta’s RSV data and big stock reversal. The episode concludes with a look ahead as the group discusses Q4 conferences, including ESMO, and Q3 earnings risks forcertain companies. *This episode aired on October 3, 2025.

On this week’s episode, Sam Fazeli, Eric Schmidt, PaulMatteis, Brian Skorney, and Brad Loncar dive into what was a positive week for biotech, marked by M&A, offerings, and compelling clinical data, spotlighting Pfizer’s acquisition of Metsera. The conversation shifts to data, starting with UniQure’s three-year Huntington’s disease gene therapy results and Acadia’s Phase 3 results in Prader-Willi syndrome, and the implications for Soleno and Rhythm Therapeutics. Next, the co-hosts overview Stealth Bio’s approval in Barth syndrome and signs of the FDA’s flexibility. Cidara Therapeutics’ influenza prophylaxis antibody and enthusiasm around the Phase 3 results are also discussed. Additionally, positive data from MBX in chronic hypoparathyroidism and PepGen in DM1 further showcase biotech’s rebound, with positive stock reactions. The episode closes with a look at what’s happening at the FDA (some flexibility in rare diseases, CRLs), the latest MAHA press conference – discussion around Tylenol & autism specifically -- and public trust in science. *This episode aired on September 26, 2025. 

On this week’s episode, Daphne Zohar, Josh Schimmer, Luba Greenwood and Matt Gline open with a look at overall market sentiment, spotlighting Stifel’s bullish report on the biotech sector’s nice recovery since April’s “liberation day” with the XBI up over 40%, the recent wave of M&A activity, and the Biotech Winter. The co-hosts then highlight recent deals, including Roche’s $3.5 billion acquisition of 89Bio and Novartis’s $5.7 billion licensing agreement with Monte Rosa Therapeutics. In data news, the group overviews aTyr Pharma’s Phase 3 results in pulmonary sarcoidosis, with Matt Gline sharing perspective on the therapeutic area after Roivant’s similar fate. Next, long-versus-short dynamics around biotech data readouts are highlighted, along with positive data sets from Areteia and Apollo. Matt also details Roivant’s positive Phase 3 results in dermatomyositis. The conversation then turns to big pharma’s exodus from the UK, as several companies including Merck, AstraZeneca, and Eli Lilly scale back large investments. The co-hosts explore possible causes for the pullback, such as heavy regulation and tax incentives holding back innovation. Michal Preminger joins the discussion to share her unique insights on UK and US biotech hubs and draws attention to the Massachusetts paradox and the impact on the biopharma industry. *This episode aired on September 19, 2025

On this week’s episode, Chris Garabedian, Tess Cameron, EricSchmidt, Sam Fazeli, and Brad Loncar open with a look at the market environment as biotech sees its first IPO since February -- LB Pharma -- and financings, including Maze’s $150M PIPE and Rapport’s $250M follow-on. The co-hosts discuss improving sentiment around rates, the $XBI, and insights from conversations at the HC Wainwright conference. Novartis’ $1.4B acquisition of Tourmaline Bio and broader deal-making dynamics are also highlighted. On thepolicy front, the group examines the latest China biotech news, including a draft executive order from the Trump Administration. The co-hosts debate access, geopolitical concerns, and the FDA’s slower trial-startup process. Indata news, the co-hosts examine Revolution Medicines’ pancreatic cancer therapy, emerging small-cell lung cancer data from the World Conference on Lung Cancer, Summit’s mixed readout and market reaction, and promising newnarcolepsy data from Takeda and Alkermes. Dianthus’ positive generalized myasthenia gravis results are also highlighted. Regulatory and safety updates cover the FDA’s withdrawal of Intercept’s liver drug, a patient death in Capsida’s gene therapy trial, Soleno’s FAERS-related stock drop, SEC action on Fibrogen data manipulation, and cancellations of several FDA ad comms raising transparency questions. The episode concludes with a discussion on BridgeBio accusing Alnylam and Pfizer of aggressive tactics in the ATTR-CM market, Arena Bioworks appointing veteran Harvey Berger as CEO, and Novo Nordisk’s 11% workforce reduction. *This episode aired on September 12, 2025.

On this week’s episode, hosts Paul Matteis, Sam Fazeli, John Maraganore, and Graig Suvannaveijh kick off the discussion with a more positive look at the sector and some of the fundamental factors at play. The group then shares an overview of Sanofi’s 10% stock fall on the back of positive Phase 3 eczema data with worries about the Dupixent patent expiry. The discussion then turns to Insmed, a company that has had a monster year with the stock up 100% and a market cap of over $30 billion market. On the data front, the group highlights ApoC3 data from Ionis and Arrowhead at the European Society of Cardiology Congress 2025, which leads into a discussion around ASO versus RNAi. With multiple obesity readouts in recent weeks, the group theorizes on whether obesity is a zero sum game. It’s a big year ahead for AD readouts and the hosts summarizes some important catalysts on the horizon. Other discussion topics include the launch of Corsera Health for cardiovascular prevention, Trump’s Truth Social post on vaccine data, RFK Jr in front of congress, and public concern around access to vaccines. This episode aired on September 5, 2025.

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.

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.