Biotech Hangout

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.

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 On the policy front, the co-hosts cover the United States’ official withdrawal from the WHO and the FDA’s new draft guidance outlining how minimal residual disease and complete response could support accelerated approvals in multiple myeloma.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.

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.

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. 

On the final episode of 2025, Daphne Zohar, Bruce Booth, and Eric Schmidt kick off with a general market overview, including a look back at 2025 and some predictions for 2026. The co-hosts discuss biotech rebounding in the last few months of 2025 after years of underperformance, driven by macro rotations and biopharma as an AI-trade hedge. They also discuss some recent follow-on activity from Immunome and Kyverna coming off positive data, before transitioning the conversation to the pros and cons of staying private versus going public. The recent FDA turmoil is also discussed, including reaction to the New York Times article on a potential coup attempt against Dr. Marty Makary led by RFK Jr., as well as an increase in seemingly random CNPV decisions, including J&J’s Tecvayli. The co-hosts then dive into STAT’s best and worst CEOs of 2025, suggesting leadership success can sometimes come down to luck. In data news, Kyverna reported positive results for its CAR‑T miv‑cel in stiff person syndrome, which — if approved — could represent one of the smallest datasets for a cell therapy approval and the first cell therapy for an autoimmune disease. The episode concludes with the breaking news of BioMarin’s $4.8B acquisition of Amicus Therapeutics. *This episode aired December 19, 2025.

On this week’s episode, Grace Colón, Chris Garabedian, Sam Fazeli, Paul Matteis, Yaron Werber, and special guest John Stanford kick off with a policy discussion on the National Defense Authorization Act (NDAA), outlining both the opportunities and constraints it presents for biotech. The bill includes major biotech provisions such as a scaled back version of the BIOSECURE Act and the creation of a DoD Biotech Office, which suggests that biotech is now viewed as a national security asset. The conversation then shifts to positive signs in the biotech sector, including rising valuations, a decrease in companies with negative enterprise value, and predictions for the number of IPOs expected in the first half of 2026. Next, the group discusses conference highlights, including data from ASH presented by Lilly, BeOne Medicines, Gilead, and Arcellx versus J&J and Legend, as well as Genmab’s Epkinly. In other data news, the discussion turns to Dyne Therapeutics’ plans to seek FDA approval for DYNE-251 for DMD, following promising Phase 1/2 trial results. Despite some investor concerns about the FDA’s regulatory stance on rare diseases, sentiment remains optimistic that it will be approved. The episode closes with a round robin where each co-host shares their optimism levels for biotech in 2026, rating it on a scale from 1 to 10. *This episode aired on December 12, 2025.

On this week’s episode, Josh Schimmer, Brian Skorney, Paul Matteis, and Graig Suvannavejh share their outlook for the biotech industry in 2026, including a lively discussion on IPO market and predictions for what to expect next year. The discussion then shifts to Washington, where Tracy Beth Høeg has been appointed acting CDER director -- the fifth person to lead CDER this year -- following Richard Pazdur’s sudden retirement and ongoing staffing volatility at the agency. Next the co-hosts mention the FDA’s moves to speed up drug approvals, the plausible mechanism pathway, and latest with vaccine policies. The FDA’s final minutes from a pre-BLA meeting with UniQure and the implications for the broader gene therapy landscape are also discussed. Capricor’s positive DMD cell therapy results are also highlighted, reviving hopes for FDA approval. The conversation shifts to data news, including BMS’ update on the ADEPT-2 study readout for Cobenfy in Alzheimer’s disease psychosis, which the co-hosts read as a net positive. Praxis Medicine’s positive Phase 2 results for its seizure drug and ongoing FDA discussions, and Janux Therapeutics in prostate cancer. Otsuka pricing Voyxact at $390K a year is briefly mentioned. The episode concludes with excitement for upcoming conferences including ASH and JPM. *This episode aired on December 5, 2025. 

On week’s episode, Eric Schmidt, Yaron Werber, Tess Cameron, and Sam Fazeli kick off with biotech M&A news, including Alkermes’ $2.37 billion offer for Avadel, following Lundbeck’s surprise bid. Next, the co-hosts discuss J&J’s $3.05 billion cash acquisition of Halda - the highest-priced deal for a company at this stage. The group also covers Merck’s acquisition of Cidara Therapeutics to strengthen its antiviral pipeline. They debate whether biotech M&A is becoming more competitive, what big pharma is prioritizing, and the role M&A is playing in the current biotech rally. The conversation then shifts to Washington policy news, including the CDC website updates suggesting vaccines haven’t been proven not to cause autism, alleged tensions between RFK Jr. and Dr. Marty Makary over FDA leadership authority and management-style concerns Next, in regulatory news, the co-hosts overview the FDA’s approval of Arrowhead’s Redemplo for FCAS, priced at $60K, and its competition with Ionis’ Tryngolza. Novo Nordisk’s semaglutide price cut and conversations on drug pricing trends and the impact on competition are also mentioned. The episode concludes with an overview of Zymeworks positive data and shifting in business model, Nuvalent’s positive data and $500 million raise, and Olema’s stock price increase and raise on the back of Roche’s breast cancer data. *This episode aired on November 21, 2025.

On this week’s episode, John Maraganore, Yaron Werber, Ami Fadia, and special guests STAT’s Allison DeAngelis and Endpoints News’ Drew Armstrong kick things off with an overview of the latest FDA staffing changes, including long-time oncology chief Richard Pazdur’s appointment as the new CDER director, a move the co-hosts view as positive for the industry and a sign of potential stability. Next, the group breaks down the FDA’s new ‘Plausible Mechanism Pathway’, designed to accelerate certain personalized therapies to market when traditional trials aren’t feasible. Allison then shares insights from her reporting on the exclusive MAHA Summit held earlier this week -- an invite-only gathering of top HHS officials and leading biotech executives. In data news, the co-hosts discuss Alkermes’ Phase 2 narcolepsy trial, Cogent’s Phase 3 gastrointestinal stromal tumor results, and CRISPR’s cholesterol data. As one bidding war ends, another begins as Alkermes’ move to acquire Avadel faces competition from Lundbeck, who offered a $2.25 billion, rivaling Alkermes’ initial $2.1 billion offer. Drew Armstrong also overviewed his reporting on the Novo Nordisk-Pfizer bidding war, noting both companies’ obesity setbacks and their search for new directions. Deal-making conversations continues with Merck’s $9.2 billion acquisition of Cidara Therapeutics, and Day One Therapeutics’ $285 million acquisition of Mersana Therapeutics. The episode concludes with a discussion on the passing of genetic pioneer James Watson and Eli Lilly CEO David Ricks’ appearance on The Cheeky Pint podcast. *This episode aired on November 14, 2025.

On this week’s episode, Graig Suvannavejh, Paul Matteis, Brian Skorney, Yaron Werber, Chris Garabedian, and guest Adam Feuerstein open with a discussion on George Tidmarsh’s departure from the FDA and the uncertainty it has caused in the markets. Next, the co-hosts discuss the shifting policies of the FDA and Sarepta’s Phase 3 ESSENCE trial of casimersen for DMD with the group debating if the drug actually works. Biohaven’s complete response letter for its new drug application for its spinocerebellar ataxia drug is also mentioned. The co-hosts also overviewed the FDA’s decision deeming Uniqure’s Huntington’s disease therapy data inadequate, and the read through for other companies like Stoke Therapeutics. The conversation shifts to company news where Novo Nordisk and Pfizer’s bidding war for Metsera is noted as a positive for biotech investors. Next the co-hosts discuss Soleno Therapeutic’s stock moves amid questions about its growth trajectory. The episode concludes with a look ahead to ASH 2025 with a preview of Terns Pharmaceuticals CML data. *This episode aired on November 7, 2025. 

On this week’s episode, Daphne Zohar, Bruce Booth, Sam Fazeli, Brian Skorney, Yaron Werber, and Eric Schmidt kick off with market updates, noting that the XBI is showing signs of a sustainable recovery after years of underperformance and highlighting that the IPO market is likely closed for the remainder of the year, but note optimism for early 2026. In deal news, Novartis’ $12B acquisition of Avidity is spotlighted as an unprecedented move for a company yet to read out Phase 3 data. The co-hosts also speculate on what this acquisition could mean for Dyne Therapeutics, has a similar RNA-based pipeline in rare muscle disease. Next, Daphne highlights that some of the biggest M&A deals of the year have come from women-led companies - including Avidity. The conversation then shifts to Novo Nordisk’s surprise $9Bbid for Metsera, which challenges Pfizer’s existing $7.3B deal and raises questions about Novo’s intentions. In policy news, manufacturing issues at Novo's Catalent Indiana facility and the impact on the sector are mentioned. The episode concludes with a group discussion around Bruce’s lessons from his 20 years in early-stage biotech. *This episode aired on October 31, 2025.

On this week’s episode, Chris Garabedian, Brian Skorney, and Sam Fazeli open with optimism about the biotech market, predicting an upcoming acceleration in IPO activity. In deals and financing news, the co-hosts discussed Summit Therapeutics’ $500 million raise, with more than half coming from insiders, and continued momentum in M&A, including Alkermes’ $2.1 billion acquisition of Avadel for its narcolepsy drug. The group also highlighted Takeda’s $1.2 billion oncology deal with Innovent. European biotech funding showed positive signs, evidenced by Tubulis’ $360 million Series C. Next, the co-hosts recapped ESMO, spotlighting Summit and Akeso’s NSCLC data, Incyte’s KRAS G12D inhibitor, and Arcus and AstraZeneca’s TIGIT data. The episode concluded with additional data readouts, including mixed results from Alector and GSK’s dementia drug, and Moderna’s CMV mRNA vaccine results. *This episode aired on October 24, 2025.

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.