Biotech Clubhouse

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.

On this week's episode, Chris Garabedian, Brad Loncar, Eric Schmidt, Paul Matteis, and Tess Cameron begin by recapping the markets, highlighting the rise in bond yields. The discussion then transitions to the efficiency of the FDA, noting its current overextension. Next, the group addresses an open letter from biotech executives and investors to Senator Bill Cassidy, highlighting the dismissal of key employees important to FDA review processes. Park Marks' dismissal is also revisited, along with the impending threat of pharmaceutical tariffs. Wrapping up the discussion on the FDA, its initiative to replace animal testing is overviewed. The conversation shifts to “zombie” biotechs and ongoing private investment, as evidenced by recent Series A announcements. On the data front, Lexeo's plans to initiate a registrational trial for its gene therapy for Friedreich ataxia, Rhythm's Phase 3 data, and its stock price increase are discussed. The group also reviews the strategies early companies can adopt now that the IPO window has closed. The episode concludes with a review of notable updates from AAN 2025 and ADPD 2025. *This episode aired on April 11, 2025.

On this week's episode, Eric Schmidt, Brad Loncar, Yaron Werber, Paul Matteis, and Nina Kjellson discuss impact of tariffs on biopharma relative to other sectors, FDA updates and bright spots, data, and fundraising. The episode opens with a conversation on tariffs and the upheaval and shifts at the FDA, including the departure of Peter Marks, former director of the FDA's Center for Biologics Evaluation and Research, which has the group concerned over loss of institutional memory, history, and the ability to meet deadlines. The conversation shifts to the measles outbreak, noting concerns about public health and future regulation due to HHS reorganization plans and perceived industry inaction. The group then discusses data, including Vaxcyte's underwhelming Phase 2b data, and hopes to avoid negative vaccine sentiment. Additionally, Eli Lilly's Phase 2 data for its siRNA-based therapeutic to lower lipoprotein(a) showed promising results and Amgen and Novartis are conducting their own Phase 3 trials for Lp(a). The episode concludes with a discussion on Isomorphic Labs, which raised over $600 million, with the group praising the investment in early-stage discovery science and expressed hope that it will facilitate the company's transformation of technology into drugs. *This episode aired on April 4, 2025.

On this week's episode, Chris Garabedian, Tim Opler, Bruce Booth, and Sam Fazeli discuss the current investor mood, a PIPEs retrospective, and the contraction of new startups. The episode opens with a conversation on the biotech market updates, which have been driven by economic uncertainty and shifting investor sentiment, noting that macroeconomic factors continue to weigh on performance of biotech stocks in the market. Regulatory discussion centers on recent HHS personnel cuts, and the confirmations of FDA and NIH leaders. The conversation shifts to data with Soleno Therapeutics' Prader-Willi drug approval, oncology readouts, and presentations at the European Lung Cancer Congress 2025. Tim Opler also discussed findings from a recent aging report. On the global front, China's role in biotech continues to expand, with an increasing share of large pharma molecules originating from the country. The episode concludes with a look at obesity drug deals, including a major partnership with a China-based biotech and a preclinical asset with a novel mechanism targeting satiety and energy expenditure. *This episode aired on March 28, 2025.

On this week's episode, Sam Fazeli, Eric Schmidt, and Brian Skorney are joined by Roivant's Matthew Gline to discuss data, deals and the latest policy updates. The episode kicks off with concerns over potential U.S. Department of Health and Human Services (HHS) funding cuts for domestic HIV programs, with the group analyzing the impact on companies like Gilead and GSK, whose HIV prevention drugs have driven significant investor enthusiasm. They then discuss the uncertainty surrounding the new administration's commitment to public health initiates, considering Robert F. Kennedy Jr.'s appointment as HHS Secretary and his past controversial views on vaccines and HIV prevention. The conversation then shifts to data, including positive results from Immunovant and Roivant's Phase 3 study of batoclimab for myasthenia gravis. The group also examines the surprising absence of short sellers engaging with Roivant post-data release, highlighting shifts in biotech trading strategies. In the muscular dystrophy space, new exon-skipping therapies from Avidity and Dyne show unprecedented dystrophin restoration, suggesting potential functional benefits. However, the tragic death of a patient treated with Sarepta's gene therapy, Elevidys, reignites concerns about accelerated approvals and the FDA's risk-benefit calculus in rare disease research. On the deal-making front, AstraZeneca's $425M acquisition of stealth-mode cell therapy startup EsoBiotec and Sanofi's $600M deal with Dren Bio underscore biotech's valuation disconnect, where early-stage private assets command premium prices while public biotechs struggle. The episode closes with insights into Alnylam's broad label win for Amvuttra in ATTR cardiomyopathy and AstraZeneca's $2.5B investment in biotech agreements and manufacturing in China, reflecting its long-term strategic vision despite ongoing geopolitical tensions. *This episode aired on March 21, 2025

On this week's episode, Eric Schmidt, Sam Fazeli and Yaron Werber are joined by Biotechnology Innovation Organization's (BIO) John Crowley where they discuss biotech policy shifts, regulatory updates, obesity clinical trials and deal flow. The conversation begins with a focus on the obesity landscape including Novo Nordisk's CagriSema data, Roche's partnership with Zealand Pharma and Viking Therapeutics manufacturing agreements, signaling continued investment in the field. John Crowley then leads a conversation on policy and regulatory developments, sharing optimism about a more favorable U.S. policy environment for biotech. He highlights key priorities such as FDA modernization, PBM reforms and domestic manufacturing incentives. Crowley also notes bipartisan recognition of biotech as a strategic asset, though concerns persist around anti-science rhetoric, vaccine skepticism and regulatory challenges. Despite ongoing uncertainty, he sees more opportunities than threats for the industry. On the deal-making front, small-cap oncology acquisitions continue, with Sun Pharma acquiring Checkpoint Therapeutics and BMS consolidating its stake in 2seventy Bio. The discussion also covers biotech pipeline updates, including BioNTech's disappointing revenue guidance and Legend Bio's expansion of its CAR-T therapy manufacturing capacity. The episode concludes with insights into the broader biotech market, highlighting the impact of regulatory shifts, M&A activity and clinical trial data. While challenges remain, companies prioritizing innovation and execution continue to be well-positioned for long-term success. This episode aired on March 14, 2025.

On this week's episode, Daphne Zohar, Eric Schmidt, Tess Cameron, Brian Skorney, and Yaron Werber discuss the state of the biotech market, emphasizing the resilience of the sector despite current downtowns. The IPO market also remains stagnant, with many companies trading below IPO prices.  The conversation shifts to notable deals, including Jazz Pharmaceuticals acquiring Chimerix for $935 million and AbbVie's move into the obesity space with its $350 million acquisition of Gubra. The group also discusses Pliant Therapeutics' discontinuation of its Phase 2b trial in idiopathic pulmonary fibrosis and Biohaven's promising results from its Phase 1 study of BHV-1300, a potential IgG degrader for autoimmune diseases. The conversation then covers BMS' decision to terminate MRTX1133, a G12D inhibitor from its $4.8bn acquisition of Mirati Therapeutics, and the challenges independent biotech companies face post-launch, including investor skepticism and long-term value pressure. In regulatory news, the group touches on FDA and NIH Senate hearings, vaccine policy debates, and concerns over the revolving door between industry and regulatory agencies, particularly with Pfizer's hire of former FDA director, Patrizia Cavazzoni. They also discuss the broader implications of scientific credibility and public trust in healthcare institutions. The episode concludes with insights on professional networking best practices, emphasizing clear and specific outreach strategies. *This episode aired on March 7, 2025.

On this episode of Biotech Hangout hosts Brad Loncar, Eric Schmidt, Tess Cameron, Luba Greenwood, and Tim Opler, along with special guest Adam Feuerstein, kick off with a discussion on ‘zombie' biotech companies – those trading below their cash value – and whether they can be revived or should return capital to investors. The conversation then turns to Stoke's collaboration agreement with Biogen, Solid Biosciences' promising gene therapy data for Duchenne muscular dystrophy, and industry concerns over biotech fundraising practices. Other key topics include Bluebird Bios take-private acquisition, SpringWorks' potential buyout by Merck KGaA, and updates in the obesity space, including the FDA removing semaglutide from the shortage list. The group also covers BridgeBio's strong launch of Attruby, biotech M&A sentiment, and rumors of a potential Viking Therapeutics acquisition. *This episode aired on February 21, 2025.

On this week's episode, Chris Garabedian, Yaron Werber and Sam Fazeli discuss the challenges facing the biotech sector, including high interest rates and the overabundance of public biotech companies. The hosts take a look at recent IPOs, noting that Metsra and Sionna have performed well, while others like Septerna and Upstream struggled. Reasons for the market's reaction to IPOs was also discussed, including concerns about valuation, competition and future funding needs. The hosts also discuss the potential acquisition of SpringWorks by Merck. BioCentury's Steve Usdin also joins the show to discuss the policy and regulatory environment. He outlines the opportunities and risks for the biotech sector, including potential reforms to onshore manufacturing, IRA Medicare drug negotiation, PBM reforms, FDA and NIH staffing cuts, and much more. This episode aired on February 14, 2025.

On this week's episode, Daphne Zohar, Paul Matteis, Brian Skorney, Tim Opler and Abe Ceesay kick off with a more optimistic yet cautious perspective that investor sentiment may be improving. The group notes positive market trends post-JPM with the XBI index rising from 86.5 to around 92 since early January. The discussion also touches on on the re-emergence of wall cross pipes and the impact on generalist investor interest. The hosts discuss the positive M&A outlook for 2025, noting Intra-Cellular's recent acquisition by J&J. Staying on the neuro theme, GH Research announced impressive data from its Phase 2b trial for a short-acting psychedelic drug for treatment-resistant depression. This extended into a discussion on the broader implications of neuropsych drug development, including the need for experienced management and the challenges of patient selection and managing high placebo responses. Other topics discussed include FDA's approval of Axsome's migraine drug, the anti-VEGF therapy competitive dynamics, Trump's tariffs, and more. This episode aired on February 7, 2025.

On this week's episode, Brad Loncar, Chris Garabedian, Eric Schmidt, Paul Matteis and Sam Fazeli kick off with an open mic session on the potential impact of the RFK Jr. hearings and the Trump administration's policies on the biotech industry. The conversation turns to a “unicorn day” with IPOs for Metsara, Maze, Odyssey and Sionna Therapeutics. The group also discusses the approval of Vertex's journavx and the potential for it to be a blockbuster drug. Akero, Sarepta and Cargo also announced data this week and the hosts summarized the market reactions. Other topics covered include Merck's buyback announcement and potential impact on M&A activity, Takeda's CEO, Christophe Weber, steps down, Curie Bio's new fund, and more. This episode aired on January 31, 2025.

On this week's episode, Chris Garabedian, Tim Opler, Sam Fazeli, Brian Skorney and Luba Greenwood begin with breaking news on the obesity front with Novo Nordisk's next-gen program, amycretin. The conversation transitions to post-JPM public market sentiment and a reluctance in capital markets. On the flip side, the hosts suggest a positive outlook for venture capital investments despite the public market challenges. The group also highlights the active M&A and licensing deal market, including the significant role of Chinese biotechs in licensing deals. The hosts also discusses the impact of Trump's administration's actions on the biotech sector, including the freeze on NIH activities and the potential withdrawal from the WHO. Other topics include potential of AI in healthcare, Biogen's strategic shifts, Nature Medicine paper on GLP-1 drugs effects, and more. This episode aired on January 24, 2025.

On this week's episode, Daphne Zohar, John Maraganore, Mike Yee and Sam Fazeli begin the show recapping JPM '25, noting investor sentiment was muted and concerns on interest rates have contributed to mixed market sentiment. In terms of deals,  three M&A transactions were announced this week including J&J's plans to buy Intra-Cellular Therapies for $14B, Gilead's $250M preclinical asset acquisition and GSK's $1.2B deal with IDRx. Commenting on a challenging IPO market, the group discusses that more private companies are being acquired due to market difficulties and the overvaluation of public companies. The hosts are joined by BIO CEO John Crowley to discuss China's role in biotech and policy initiatives, FDA reforms and the impact on the biotech industry, and more.  This episode aired on January 17, 2025.

On this week's episode, hosts Chris Garabedian, Brad Loncar,Sam Fazeli and Yaron Werber cover a busy news week ahead of the J.P. Morgan Healthcare Conference as well as a preview of what to expect next week at the event. Thegroup highlights some of the mega private deals announced, including three that involved the licensing of China assets. The hosts zoom out with a recap of end-of-year reports, the current state of the market and XBI outlook. On the data front, Jasper reports positive Phase 1/2 data for chronic urticaria, Vir shares data for masked T-cell engagers and Stoke moves into Phase 3 with their antisense oligonucleotide for Dravet syndrome. The group also discusses Novo's deal with Valo Health, Galapagos' interesting move with new spin out company, whether we've reached ‘peak obesity' and much more. This episode aired on January 10, 2025.

On this week's episode, Brad Loncar, Daphne Zohar, Josh Schimmer, Yaron Werber and Michael Preminger kick off the show with Vertex's much anticipated Phase 2 study results, highlighting the modest treatment effect and high placebo response. The group also comments on overly positive spin on data and the importance of credibility in interpreting data. The conversation turns to Novo Nordisk's weight loss data and the market's negative reaction with stock down 20%. The group also discusses Roche's termination of its hemophilia gene therapy program, and Teva's TL1A data showing promise in inflammatory bowel disease. Turning to market sentiment, the group comments on Wall Street's high expectations for new data and the resulting volatility in the market. The hosts also touch on the impact of Chinese biotech investments, potential PBM reforms, Regeneron's high-dose ILEA trials, upcoming auction of Mitsubishi pharma unit, and more. This episode aired on December 20, 2024.

On this week's episode, Josh Schimmer,  Yaron Werber, Brian Skorney, Tess Cameron, and Eric Schmidt kick off the show covering the macro news of the week including the new FTC head and what it means for M&A in the industry. The group also discusses how the biopharma industry is not challenging RFK Jr., the BioSecure Act missing from the Defense Bill and Luigi Mangione's arrest. In ASH Conference highlights, the hosts recap the CAR-T battle of Arcellx/Gilead vs Ligand/J&J, as well as updates from Agios and other SCD cell therapies. Other topics discussed include Blenrep's return, BTK degraders from Beigene and Nurix, the Revance/Crown deal as well the big stock movers off the week. This episode aired on December 13, 2024.

On this episode of Biotech Hangout, Eric Schmidt, Bruce Booth, Yaron Werber, Tim Opler and Mike Yee begin the show discussing the highlights from the Jefferies Healthcare Conference before taking a look at public investor sentiment this week. The discussion turns to Atlas Venture's 2024 Year in Review and transitions into the emerging themes for 2025. The hosts also recap ACR Convergence including Amgen's Phase 3 data as well as data from cell therapies for SLE, SSC, IMNM. The group also discuss lipid readouts from Eli Lilly, Silence Therapeutics and NewAmsterdam Pharma. Other topics covered include the Incyte and Escient deal collapse, Kura Oncology's pact with Kyowa Kirin, and perspectives on Trump's nomination of Dr. Mehmet Oz to lead the CMS. This episode aired on November 22, 2024.

On this episode, Brad Loncar, Sam Fazeli, Tess Cameron, Nina Kjellson and Michal Preminger kick off the show sharing perspectives on Trump's selection of Robert F. Kennedy Jr as secretary of the U.S. Department of Health and Human Services. The hosts shift to Abbvie's disappointing Phase 2 trials and a broader discussion on why M&A can be tough. The group also discussed the recent flood of licensing and new companies based on China assets, including some of the players and approaches. The hosts also discuss Halozyme's takeover proposal of Evotec, the VEGF/PD-1 frenzy, J&J hits back with 340b lawsuit, the GOP tax bill and impact on biopharma priorities, and more. This episode aired on November 15, 2024.

On this episode, Daphne Zohar, John Maraganore, Josh Schimmer, Eric Schmidt and Sam Fazeli are joined by Endpoints' Zach Brennan for a discussion on the election results and what we can expect with a Trump administration, including the negatives/risks for the biotech industry as well as the positives and potential opportunities. The hosts also cover other news from the week including Moderna's Q3 earnings and the company's CEO Bancel stepping down as sales chief, as well as BioNTech's Q3 earnings and the potential softening of vaccine pricing. The group recapped the ASH conference and readouts including Arcellx's early data and related stock movement. The discussion turns to ObesityWeek highlights including data from AstraZeneca, Vertex, Zealand and Novo Nordisk. Other topics covered this week include Sarepta's SRP-5051 discontinuation, the death of gene editing and the impact to the fledgling field. This episode aired on November 8, 2024. 

On this week's episode, hosts Chris Garabedian, Brad Loncar,Sam Fazeli and Yaron Werber cover a busy news week ahead of the J.P. Morgan Healthcare Conference as well as a preview of what to expect next week at the event. Thegroup highlights some of the mega private deals announced, including three that involved the licensing of China assets. The hosts zoom out with a recap of end-of-year reports, the current state of the market and XBI outlook. On the data front, Jasper reports positive Phase 1/2 data for chronic urticaria, Vir shares data for masked T-cell engagers and Stoke moves into Phase 3 with their antisense oligonucleotide for Dravet syndrome. The group also discusses Novo's deal with Valo Health, Galapagos' interesting move with new spin out company, whether we'vereached ‘peak obesity' and much more. This episode aired on January 10, 2025.

On this episode of Biotech Hangout, hosts Chris Garabedian, Daphne Zohar, Josh Schimmer, Tim Opler, Paul Matteis and special guest Allison DeAngelis kick off the show with a look at the renewed interest and recent funding in the neuropsychiatric disease space, including Seaport Therapeutics' $225 million Series B financing. This progresses into a comparison of diversified versus focused pipelines as Roivant CEO Matt Gline joins the stage as an impromptu guest to share his perspective on the benefits and challenges of the hub-and-spoke model. The group also discusses recent biotech market performance and how the statistics show that biotech is actually having a really good year. Turning to data, the hosts cover Alto Neurosciences' Phase 2 results and discuss the idea of precision psych and the use of biomarkers in clinical trials. The group also discusses Vertex's Phase 2 pain data and how Intellia's positive Phase 2 data in hereditary angioedema moved the stock in the surprisingly wrong direction. Other topics discussed include Sangamo's accelerated path for its Fabry gene therapy, Starboard takes on Pfizer, Alkermes and Roche earnings highlights, and more. *This episode aired on October 25, 2024.

On this week's episode of Biotech Hangout, hosts Daphne Zohar, Josh Schimmer, Brad Loncar, John Maraganore, Paul Matteis, Mike Yee and Tess Cameron open up with market commentary and how derivatives, debates and dynamics are impacting stocks including Scholar Rock, Biohaven, Roche and Regeneron. The group also highlights CeriBell, which is the first medtech IPO in years. The hosts turn to neuro sentiment with a look at Lundbeck's acquisition of Longboard at an approximate value of $2.5 billion net of cash. The conversation turns to the idea of competitors benefiting from M&A and data, with this week's example of Bright Minds Bioscience's market cap going from $4 million to $172 million. The group also discusses the FDA's approval of Novocure's Optune device for the treatment of metastatic non-small cell lung cancer before turning to a conversation on vaccines, including Moderna's upcoming Phase 3 CMV data. Wave Life Sciences first-ever therapeutic RNA was also covered, which led to a discussion on how important milestones open new doors. Other topics discussed include the launch of City Therapeutics, Benitec's gene therapy update, and more. *This episode aired on October 18, 2024.

On this week's episode of Biotech Hangout, hosts Chris Garabedian, Bruce Booth, Josh Schimmer, Eric Schmidt and Sam Fazeli start the show on the topic of M&A and ponder “where are the deals?” as they consider potential reasons such as the U.S. election, too few assets or too few buyers. The conversation turns to the venture funding environment with a preview of the third quarter venture funding numbers. On the theme of stock price reactions, the group digs into why Sarepta's has dropped despite its gene therapy now fully approved and discusses Soleno's stock jump on the news from regulators to not hold an advisory meeting over its new drug application. In other news, the group highlights another China deal, this time between AstraZeneca and CSPS Pharma for a pre-clinical novel lipid-lowering therapy. The hosts also discuss the move by Lily to go after the compounding pharmacies, GSK agrees to settle Zantac lawsuits and the latest on Pfizer and Starboard which leads to a broader discussion on activism in biopharma. Regarding data, the hosts cover GSK's RSV data, Scholar Rock's spinal muscular atrophy data, among other topics. *This episode aired on October 11, 2024.

On this week's Biotech Hangout, hosts Josh Schimmer, Brad Loncar, Sam Fazeli and Tess Cameron kick off the show digging into some macro trends and the potential of an incoming M&A wave. The conversation then turns to a range of topics related to China, including the impact of the stimulus, recent innovation, and the latest obesity assets & China-sourced drugs. The hosts also discuss the updates coming out of Roche's business day, including the company's acquisition of a CDK inhibitor from China's Regor. On the data front, the hosts discuss Poseida and Roche's myeloma data and J&J / Legend's Carvytki data, then turn to other news of the week including J&J's battle to implement a 340B rebate model, BioNTech & Instadeep AI Day updates, IGM Biosciences pivots to immunology, Harrow relaunches Triesence, and more. *This episode aired on October 4, 2024.

On this week's Biotech Hangout, hosts Daphne Zohar, Brad Loncar, Josh Schimmer, Chris Garabedian, John Maraganore and Sam Fazeli kick off the show sharing perspectives on the markets and its effects on the growing queue of biotech IPOs, particularly following the influx of large private deals over the past few months. As the founding CEO of Alnylam, John provides his thoughts on the Helios-B full study data presentation at the ESC Congress while the broader group weighs in on the competitive implications of the data. The hosts also discuss Recursion, which shared some mixed data this week on its lead AI-derived drug candidate. In other data news, the group discussed the battle of the BTK inhibitors with both Sanofi and Roche announcing multiple sclerosis clinical trial readouts. The management theme was prominently featured in this week's discussion as the hosts talk about some rules of engagement for biotech executives, ‘founder mode versus manager mode' leadership styles, and ponder the sweep of management changes announced by Dyne Therapeutics. The hosts also set the stage for anticipated data announcements at the upcoming World Conference on Lung Cancer (WCLC) and European Society for Medical Oncology (ESMO), and much more. *This episode aired on September 6, 2024.

On this week's Biotech Hangout, hosts Brad Loncar, Tim Opler, Josh Schimmer and Sam Fazeli assess the recent macro trends, including the current state of the US economy and some good news for biotech. The group also discussed the big reveal this week on Medicare drug pricing issues and industry perspectives on whether it was more of a whimper versus a bang. In M&A, the Revance and Crown Laboratories merger was discussed as well as broader M&A trends including how a potential change in the White House could impact the FTC and scrutiny on pharma deals. In other news, the hosts shared differing perspectives on Genentech shutting down its cancer immunology group and the company's wider R&D prioritization. The group also discussed the World Health Organization declaring MPOX a global health emergency and the vaccines in development from Bavarian Nordic, Moderna and BioNTech. Other topics covered on this episode include Zealand's earnings, positive data from Rivus and Denali, a look ahead at The World Conference on Lung Cancer (WCLC) and European Society for Medical Oncology (ESMO) and more. *This episode aired on August 16, 2024.

On this week's Biotech Hangout, hosts Eric Schmidt, Brad Loncar, Brad Skorney, Luba Greenwood and Josh Schimmer kick off the episode summarizing the wild week for biotech stocks. The group also recaps some of the big earning announcements from the week, including a larger discussion on overall learnings from the Q2 earnings season. The hosts discuss Charles River Laboratories as a harbinger of pharma cost cutting and share general perspectives on the IRA impact on pharma. The FDA's approval of Agios/Servier's vorasidenib (Voranigo) for glioma was also discussed, with a look back at Servier's earlier acquisition of Agios' oncology business. The group also engages in a discussion on muscle disease as a growing area with potential to address large unmet medical needs and highlights some innovative companies in the space. Other topics covered include the Recursion and Exscientia merger, the biotech bubble, the potential impact of the election on the pharma industry and more. *This episode aired on August 9, 2024.

On this week's episode, hosts Josh Schimmer, Sam Fazeli, Brian Skorney, Michal Preminger and Eric Schmidt kick off the show by discussing the recent growth in XBI performance. The group weighs in on IPO dynamics, hypothesizing on the influence of investors and the power of FOMO. They go on to note the success of Viking Therapeutics as they're moving into Phase 3 for their GLP-1 agonist, and what the future may hold for the weight-loss drug market. Shifting gears, the hosts raise concerns on CHMP issuing a negative opinion of Leqembi for Alzheimer's disease, signaling a shift in the relation of CHMP and FDA standards. The group also discusses PBM execs facing heat from the House Oversight Committee as well as recent rare disease news including the FDA's launch of a Rare Disease Innovation Hub. The hosts also highlight the growing success of gene therapy and close the show by discussing one of the top ten rules of engagement for biotech executives. *This episode aired on July 26, 2024.

On this week's episode, hosts Daphne Zohar, Josh Schimmer, Sam Fazeli, Luba Greenwood, Brian Skorney and Paul Matteis begin the show with commentary on the Republican National Convention, including former President Trump's pick of former biotech entrepreneur and Senator J.D. Vance as his running mate and the potential impact of this administration on the biotech sector, if elected. The discussion transitions to the week's theme of biotech catalysts, including stock reactions in the current environment and some key catalysts that the hosts are watching closely. The group begins with a roundup of catalysts from the last five days, including Revolution Medicines pancreatic cancer drug data, Lexeo's positive interim Phase 1/2 data for the treatment of Friedreich Ataxia Cardiomyopathy, 4D Molecular's Phase 2 interim results in Broad Wet AMD, Pathom Pharma's approval of VOQUENZA for relief of heartburn associated with Non-Erosive GERD, and Roche's early data from its Phase 1 obesity drug trial. The discussion then shifts to upcoming catalysts with the hosts sharing the companies and catalysts on their watchlists. Some of the key catalysts highlighted include Amgen's MariTide Phase 2 readout in obesity, Biogen's Phase 3 readout for its lupus program, three big data events in depression including from Neumora, J&J and Alto Neuroscience, plus an expected FDA decision for AutoImmune, Alnylam's Phase 3 full study results of vutrisiran and more. *This episode aired on July 19, 2024.

On this week's episode, hosts Chris Garabedian, Brad Loncar, Tim Opler, Dawn Bell, John Maraganore and Eric Schmidt provide a deep dive into the obesity, diabetes and cardiometabolic space, beginning with an overview of the key findings in Stifel's latest obesity report. The hosts also provide a recap of ADA and EASD abstract highlights and take a look at the next wave of injectable therapies and the trends in consumerization and access. They also discuss Pfizer's update on its once daily oral GLP-1 pill as well as recent reports on patients discontinuing GLP-1 drugs in two years and GLP-1s for obesity-related cancers. Shifting gears, the hosts spotlight a report on the evolving pharma landscape and the future landscape of the blockbuster drug category. In deals of the week, the group discusses Eli Lilly agreeing to buy Morphic for $3.2 billion and Flagship's new $3.6 billion fund. In data news, the hosts cover Roche's setback with its pivotal TIGIT trial, uniQure's positive data for its Huntington's gene therapy and IDEAYA's positive interim phase 2 MAT2a data. *This episode aired on July 12, 2024.

On this week's Biotech Hangout, hosts Daphne Zohar, Brad Loncar, Josh Schimmer, Tim Opler and Chris Garabedian open up with a conversation on recent trends in M&A for private biotechs versus public companies and the potential impact of the election year. The hosts also cover the important data readouts from the week, including Alnylam's positive Phase 3 results for its ATTR drug and Lyell's report of a patient death in its early-stage CAR T trial. Additional data covered includes Wave's Huntington data readout, Intellia's redosing of CRISPR gene editing therapy and Savara's Phase 3 readout in rare lung disease. In financing news, the hosts recap Curie.bio's $380M Pro Rata Series A Fund, Formation's $372M Series D and Recursion's $200M offering. This leads into a conversation on AI in drug development and how this is an area full of both promise and hype. On the management theme, the group discusses Gingko's recent layoffs, business model & revenues. Rounding out the show on the management theme, Amylyx's pivot to license GLP-1 was mentioned as an example of a management team earning credibility for following through on their word. *This episode aired on June 28, 2024.

On this week's Biotech Hangout, hosts Daphne Zohar, Brad Loncar, Josh Schimmer, Eric Schmidt, Sam Fazeli, Bruce Booth and Grace Colon discuss the big news of the week including the FDA granting a landmark expanded approval for Sarepta's Elevidys for patients with Duchenne Muscular Dystrophy. The hosts share their varying opinions on whether the expanded approval was the right decision. The group also engages in a few discussion topics around management, including the “everything is awesome CEO” and the best and worst practices for managing a board. With multiple companies dealing with a stock drop this week (Cabaletta Bio, Kyverna Therapeutics, Taysha Gene Therapies, Aerovate Therapeutics, Ovid Therapeutics), the hosts discuss the different issues these pose for management teams and how to deal with market reactions. The group also shares thoughts on the 2024 class of IPOs, EHA 2024 highlights, BioNTech's clinical hold on its early-stage cancer drug study, and much more. This episode aired on June 21, 2024.

On this week's Biotech Hangout, hosts Eric Schmidt, Josh Schimmer, Dawn Bell, Brad Loncar, Tim Opler, Sam Fazeli and Paul Matteis kick off the show by discussing CPI data and how inflation is impacting the $XBI, with analysts hopeful that stability will bring lower interest rates soon. The hosts cover the obesity market, providing updates on new datasets, such as findings from $LLY and $NVO, which indicate promising results in liver fat reduction and potential fibrosis reversal with GLP1+ agents. They also discuss competitive dynamics and investor sentiment of the obesity market and highlight the involvement of various players, including new startups and established pharma companies. In addition, the hosts share updates on Alzheimer's treatments, including takeaways from the EULAR meeting and $LLY's lecanemab panel, alongside the competitive landscape between $LLY, $ESAIY and $BIIB. The hosts also explore the role of patient advocacy within the biotech industry, focusing on $PFE's DMD study and $SRPTA's upcoming PDFUA, the role that patient advocacy groups have on regulatory decisions,  and the impact these groups have on influencing industry standards and guidelines. *This episode aired on June 14, 2024.

On this week's Biotech Hangout, hosts Josh Schimmer, Brad Loncar, Tim Opler, Eric Schmidt and Sam Fazeli are joined by special guests Jacob Plieth and Madeleine Armstrong for a deep dive into ASCO 2024, including the highs and lows on the data front. The hosts also discuss the shifting interests from pharma companies as some suggest T-cell engagers may have overtaken ADCs and radios in the oncology space. In non-ASCO news, the group covers NASH data from Lilly and Viking and Structure's data in obesity. The hosts also discuss the latest on BioSecure Act, improving inflation numbers and pickup in the XBI, Moderna's first vaccine approval outside of COVID, and more. This episode aired on June 7, 2024.

On this week's Biotech Hangout, hosts Daphne Zohar, Josh Schimmer, Yaron Werber, Luba Greenwood and Dawn Bell start the show with a look at the XBI and M&A activity from the week, including multiple deals topping over $1 billion. The hosts highlight a few of these big transactions, including Biogen acquiring Hi-Bio for $1.15 billion, Merck acquiring Eyebio for $1.3 billion, J&J buying Yellow Jersey for $1.25 billion, and Novartis buying out Mariana for $1 billion, among others. With private acquisitions in the spotlight, the group digs into some of the high caliber private companies emerging in biotech. The group also covers data updates and related stock price reactions from Summit (the company's shares tripled after cancer treatment data), Insmed (shares rocketed following Phase 3 trial results for the company's experimental airway disease drug), Biohaven (its protein-degrader drug falls short of investor expectations), and Roivant's update on FcRn development plans. In a lively discussion, the hosts share varying viewpoints on whether a CEO should respond or comment to criticism on social media, plus they look ahead to ASCO, and more. This episode aired on May 31, 2024.

On this week's Biotech Hangout, hosts Chris Garabedian, Josh Schimmer, Brad Loncar, Eric Schmidt and Tim Opler kick off the episode with a spotlight on women's health, which was sparked by Bayer's Phase 3 data readouts for menopause symptoms. The group also cover Incyte's $2B share repurchase which leads into a discussion on stock buybacks and the ‘broken' R&D model. The group also recaps ASGCT 2024 and new gene editing technologies. In deals of the week, the hosts discuss deals and financings from the week, including Takeda and AC Immune's $100M license agreement, Uniquity Bio's $300M launch and J&J;s $850M purchase of Proteologix. In other data news, hosts discuss Merck's TIGIT/PD-1 Phase 2 safety concerns, Ionis/Biogen discontinue ALS treatment, COVID-19 data from Shionogi and AstraZeneca, and a look at obesity ‘limited data' versus Vertex's data transparency. Other topics include Bolt Therapeutics discontinuing its oncology asset, Dynavax denied expanded use by FDA, Recursion's stock surges with fastest supercomputer claim, and short selling and meme stocks in biotech. *This episode aired on May 17, 2024.

On this week's Biotech Hangout, hosts Eric Schmidt, Daphne Zohar, Josh Schimmer and Paul Matteis kick off the show with a look at M&A in the sector and debate whether we're in a “good market” for biotech, if the sector is overly dependent on M&A as an investment thesis and the therapeutic areas that are most attractive for M&A. The hosts also discuss “hot” targeted oncology modalities including radiopharm, ADCs and bispecifics, and predict which of these technologies will likely continue to benefit from M&A interest. Following earnings this week, the hosts cover Janux Therapeutics' stock price dropping 11.5% while CytomX stock moves +120% to -40% in a matter of minutes. Acelyrin's founder stepped down as CEO, which opens up a discussion amongst the hosts on how disruptive change at the top can be for an organization and when investors should and shouldn't care about CEO transitions. The group also discusses Bluebird and Vertex prepping for the first commercial use of sickle cell gene therapies. The episode wraps up with a review of other news from the week including Maze's deal with Shionogi for Pompe disease, Walking Fish shuts down, Denali's regulatory update, and FDA sets June date for Eli Lilly's Alzheimer's drug donanemab adcomm. *This episode aired on May 10, 2024.

On this week's Biotech Hangout, hosts Daphne Zohar, Eric Schmidt, Yaron Werber and Luba Greenwood are joined by special guest and STAT reporter, Adam Feuerstein. The episode kicks off with the hosts sharing their thoughts on industry sentiment and some of the revealing trends in the week's Stifel report before diving into Q1 earning reports from Ascendis, Amgen and SpringWorks. The hosts talk about ONO's acquisition of Deciphera for $2.4B, X4's FDA approval of XOLREMDI, and how COVID fatigue could be causing us to minimize the threat of the avian influenza H5N1.  The group also discusses Biden's Cancer Moonshot getting killed by Congress, a federal judge throws out two drugmaker IRA lawsuits and the FTC goes after drug company's “junk” patents in obesity and other device combos. Adam sparks a group discussion around his exclusive STAT article on how an emerging safety issue in MorphoSys' Phase 3 cancer study may complicate its acquisition by Novartis. Other topics covered this week include BridgeBio spinning out an oncology company as it focuses on the anticipated launch of its heart drug, US government moving to reclassify marijuana from schedule 1 to schedule 111 drug, and more. *This episode aired on May 3, 2024.

On this week's Biotech Hangout, hosts Daphne Zohar, Josh Schimmer, Sam Fazeli and Yaron Werber discuss macro updates from the week including President Biden's proposal to increase capital gains and apply a tax on unrealized capital gains and FTC's rule to ban non-competes nationwide. The group also covers the roller coaster ride of Q1 earnings including reports from AstraZeneca, BMS, Novartis and Biogen. In oncology news, the hosts review the underwhelming ASCO titles, Acrivon's positive data for ovarian and endometrial cancers, the FDA approval of ImmunityBio's Anktiva and Sam Blackman from Day One joins the panel to discuss the accelerated approval of OJEMDA. In financings and deals, the hosts cover Xaira Therapeutics $1B raise, Incyte's acquisition of Escient, Metsara's launch in obesity, Cellares/BMS collaboration and a joint venture between Takeda, Astellas and Sumitomo. The hosts also get into a stimulating discussion on liked versus unliked CEOs. *This episode aired on April 26, 2024.

On this week's Biotech Hangout, Chris Garabedian, Josh Schimmer, Tim Opler and John Maraganore discuss how it's been a big year for PIPEs and some of the controversy that has come along with it. The hosts also open up a discussion on supply and demand of venture capital and then pivots to Genentech ending its strategic collaboration with Adaptimmune. The group discusses other deals and financings of the week including Future Pak's proposal to acquire Vanda Pharmaceuticals, Sanofi's plans to divest Amuniz Pharmaceuticals and Regeneron enters venture investing with a $500 million fund. The hosts also discuss data readouts from Ultragenyx, Biohaven, Sage, Cerevel/Abbvie, Eli Lilly, Roche and Novartis. The show closes out with the latest on WuXi and the impact on biotech, Humira biosimilars grabbing huge market shares and Baker Brothers returns $10 billion to investors. *This episode aired on April 19, 2024.

On this week's episode of Biotech Hangout, hosts Brad Loncar, Daphne Zohar, Luba Greenwood and Eric Schmidt kick off the discussion with Vertex's plans to acquire Alpine Immune Sciences for almost $5 billion in cash, making it the largest deal for the sector in 2024. The hosts also discuss inflation effects on biotech stocks and M&A, macro takeaways from AACR and more fallout from the BioSecurity Act and implications for the industry. The group covers the US Department of Justice's complaint filed against Regeneron related to its eye drug, Eylea, and the unfortunate impact on the industry's reputation around drug pricing. The hosts also discuss Novartis' deal to pay $150 million for Arvinas's prostate cancer therapy and e-therapeutics CEO Ali Mortazavi joins the panel to discuss the London Stock Exchange challenges and his company's plans to delist from the LSE's junior market, AIM. *This episode aired on April 12, 2024.

On this week's Biotech Hangout, Chris Garabedian, Josh Schimmer, Dawn Bell, Paul Matteis and Yaron Werber discuss the white hot ADC space as Genmab pays $1.8 billion to acquire Profound Bio and its ADC portfolio, Ispen's $900 million pact with Sutro and Merck KGaA's $1.4 billion ‘BioBucks' AI deal with Caris Discovery. The hosts also cover the week's big private deals including Metsera $350 million funding, Oruka's $275 million PIPE, Obsidian's $175 million Series C, Alterome's $132 million Series B and Neurosterix $63m spinout from Addex. The group also discusses Amylyx's decision to withrawl ALS drug and Acorda and Eiger both file for bankruptcy. On the data and regulatory front, the hosts discuss Roivant's positive Phase 2 study results in eye disease, Gritstone's Phase 2 neoantigen cancer vaccine results, LENZ's Phase 3 data for Presbyopia and Vertex's Phase 3 kidney disease trial. *This episode aired on April 5, 2024.

On this week's episode of Biotech Hangout, hosts Brad Loncar, Josh Schimmer, Grace Colon, Chris Garabedian, and Eric Schmidt discuss the latest biotech industry news including M&A, regulatory news, pricing strategies, and progress within women's health and neurological disorders. The hosts cover data from Roche's IL-6 program, Biohaven's degrader program, followed by Crinetics' Phase 3 data in acromegaly. On the M&A front, the hosts discuss AstraZeneca's acquisition of Fusion Pharmaceuticals. The group also talks through Orchard Therapeutics' breakthrough $4.25 million drug, and the impact of high drug prices on the industry as a whole. They also weigh in on the BioSecure bill that caused WuXi to leave BIO, and the broader impact of this decision on the biotech sector. The group also discussed a new executive order and initiatives that serve to address disparities in research for women's health conditions. The hosts round out the show by discussing trends in early-stage investment, and the growing role of neurological conditions globally. *This episode aired on March 22, 2024.

On this week's episode of Biotech Hangout, hosts Daphne Zohar, Brad Loncar, Tim Opler, Michal Preminger, Eric Schmidt and Yaron Werber discuss the latest biotech news, including commentary on the biotech sector performance in 2024 and a pharma R&D investment overview. The hosts cover the week's notable M&A, including AstraZeneca's acquisition of Amolyt plus Novartis' acquisition of IFM Due and a related discussion on option-to-buy deals. The group also discusses Ionis meeting the primary endpoint in its Phase 2 MASH trial and Madrigal's historic accelerated approval for NASH/MASH. Other topics include Eli Lilly's partnership with Amazon pharmacy to dispense prescription medicines and the impact of cutting out the middle man, as well as anticipated regulatory updates for Legend and 2Seventy Bio. The hosts weigh-in on the BioSecure Act that led BIO to cut ties with WuXi and the impact the bill may have on other Chinese CROs. The group also flagged recently reported Phase 2 data for Silence Therapeutics' Lp(a) therapy and Acadia's schizophrenia treatment pimavanserin fails Phase 3 study. *This episode aired on March 15, 2024.

On this week's episode of Biotech Hangout, hosts Brad Loncar, Daphne Zohar, Tim Opler, Brian Skorney, Luba Greenwood and Yaron Werber discuss the latest biotech news, including the delay of Eli Lilly's Alzheimer's drug donanemab as the FDA requires an AdComm and Amylyx's ALS Phase 3 trial failure that caused the stock to drop 80%. The hosts also weigh in on how the 2024 presidential election will impact biopharma and takeaways from the 2024 Cowen conference, including the number of generalist investors in attendance and how obesity has become a dominant narrative in the industry. The group also discusses the Boundless Bio IPO and how the ticker ($BOLD) was previously used by another company before being acquired, as well as how positive I&I data from Apogee caused the stock to double. Other topics covered include the impact of PBMs on drug pricing and big pharma companies pivoting to say that the IRA is not a bad thing for biopharma in order to preserve positive relationships with the government. The hosts close out with a discussion on Peter Thiel's “failure teaches you nothing” viral tweet and a conflict-of-interest debate regarding Harvard researcher David Sinclair who is under fire once again for promoting unproven benefits of longevity drugs. *This episode aired on March 8, 2024.

On this week's Biotech Hangout, hosts Daphne Zohar, Josh Schimmer, Eric Schmidt, Bruce Booth, Brian Skorney and Prakhar Agrawal discuss the latest biotech news, including the recent sector melt-up and what is driving the latest rally. When discussing the week's financing news, the hosts share different vantage points on wall-crossed PIPEs and the impact on stock performances. The group also discussed Viking Therapeutics soaring stock price on the heels of robust data for VK2735, its experimental weight loss drug. Other positive data discussed was from Akili and Shionogi announcing EndeavorRx met its primary endpoint and Shionogi has filed for approval with regulators in Japan, leading to a deeper discussion on digital therapeutics and issues around reimbursement. Additional topics covered include Chinese CROs back in the crosshairs and the implications for the sector, accelerated approvals for gene therapy and whether the FDA is getting too lenient on approvals, and a discussion on leadership in biotech. *This episode aired on March 1, 2024.

On this week's Biotech Hangout, hosts Daphne Zohar, Brad Loncar, Josh Schimmer, Eric Schmidt and Yaron Werber discuss the latest biotech news, including the IPO window creaking back open and aftermarket performance up 12-19% for secondary offerings and IPOs. The hosts also discuss the FTC challenges facing industry M&A and another roadblock for AbbVie's Cerevel deal. The retirement of AbbVie CEO Richard Gonzalez prompts a discussion amongst the hosts on important qualities of a CEO. A range of FDA-related news from the week is also covered including the approval of Iovance's Amtagvi as first T-cell therapy for a solid tumor; Ionis and AstraZeneca's fast track designation for Phase 3 ATTR-CM drug eplontersen; two drug trials at Rapt Therapeutics put on hold; the review of Sarepta's Elevidys for traditional approval; United Therapeutic's litigation and Alnylam's endpoint changes to Phase 3 study design for Amvuttra. Other topics include Bayer slashing its dividend by 95%, IQVIA's global R&D trends report, and a discussion on the biotech business model sparked by news that Regeneron and Vertex have crossed the $100B market cap threshold. *This episode aired on February 23, 2024.

On this week's Biotech Hangout, hosts Daphne Zohar, Josh Schimmer, Tim Opler, Chris Garabedian and Grace Colon discuss the latest in biotech news, including another strong week of IPOs, most notably with Kyverna Therapeutics' IPO upsizing by 49% to $300M. On the acquisition theme, the hosts discuss Novartis' plans to acquire MorphoSys for $2.9B and Gilead walking away from its acquisition of Tizona. The hosts also cover some obesity-related updates, including Lilly's tirzepatide Phase 2 trial for MASH and Amgen's Phase 1 data for weight-loss candidate, MariTide. Other data discussed this week includes Vertex's ‘vanza triple,' 4D Molecular Therapeutics' interim Phase 2 data in wet AMD and J&J's Phase 3 with Nipocalimab. Additional topics of discussion include plans by Novo Holdings (Novo Nordisk's parent company) to buy Catalent to boost Wegovy supply, the FDA modernizing the way it tracks post-market data by using AI, and Scion Life Sciences' debut with a new $310M fund. *This episode aired on February 9, 2024.