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Biotech Hangout

Daphne Zohar, Josh Schimmer, Brad Loncar, Tim Opler and more

A weekly discussion of all things biotech – breaking news, data, deals, and FDA actions – with a community of biotech industry leaders and experts. Join the live streams hosted by @BiotechCH, @daphnezohar, @bradloncar and @biotech1 on Twitter Spaces every Friday at 12pm ET.

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Tuesday · 1 hr
Episode 195 - September 11, 2026
On this week's episode, Tess Cameron, Brian Skorney, Paul Matteis, and Yaron Werber open with a look at markets, noting the XBI slipped just over 3% amid concerns about energy prices, inflation, and long-term U.S. fiscal health weighing on the rate-sensitive sector. The conversation then turns to policy, discussing new FDA leadership appointments including Karim Mikhail as CBER director, with hosts noting the industry's hope for a calmer, less chaotic regulatory tone. They highlight the FDA's apparent openness to psychedelics, pointing to stock reactions across the space. On the data front, Novartis's pelacarsen missed expectations reducing Lp(a) relative to rival programs from Amgen and Eli Lilly, while its DM1 program also fell short, shifting attention to Dyne Therapeutics' upcoming expansion cohort data. The hosts debate whether Novartis's setbacks make early-commercial, post-Phase 3 companies more attractive acquisition targets given looming loss-of-exclusivity pressure across large pharma. In other data news, Roivant's mosliciguat hit its Phase 2 primary endpoints in interstitial lung disease, with the company already advancing to Phase 3. The episode closes with Biohaven's epilepsy trial hold pending further metabolite data, and questions over whether the hold could affect its recent SK Pharma deal. This episode aired on September 11, 2026.
August 28 · 1 hr 1 min
Episode 194 - August 28, 2026
On this week's episode, Daphne Zohar, Eric Schmidt, Sam Fazeli, and Graig Suvannavejh open with a strong week for biotech, partially driven by M&A, noting it's already past 2025's full-year total. The group turns to Moderna, whose melanoma cancer vaccine data sent shares up nearly 200% and stirred some mixed feelings from investors. Contrastly, BioNTech's decision to halt its colorectal cancer vaccine trial was also noted. In data news, Revolution Medicines' FDA approval of daraxonrasib (RASONQUE) for pancreatic cancer drew attention for its potential first-line use and implications for trials behind it, while Akeso/Summit's ivonescimab was approved in China for NSCLC and also reported positive Phase 3 data in biliary tract cancer, reinforcing the case for VEGF/PD-1 bispecifics. Also in data news, AstraZeneca's full dataset of eplontersen for ATTR-CM raised doubts about the class of RNA-targeted silencers over currently marketed drugs that “silence” TTR proteins, while EyePoint's Phase 3 miss in wet AMD sent shares down about 70%. The conversation shifts to policy, where the group discusses pros and cons of FDA commissioner nominee Heidi Overton, the HHS plans for two new deputy roles, alongside concerns over declining U.S. IND filings versus China's rising trial volume. The episode concludes with Amylyx raising over $500 million on strong avexitide data in post-bariatric hypoglycemia, and J&J's Imaavy earning a second indication, expanding the anti-FcRn class. *This episode aired on August 28, 2026.
August 14 · 59 min
Episode 193 - August 14, 2026
On this week's episode, Chris Garabedian, Graig Suvannavejh, Paul Matteis, and Tess Cameron open with the biotech market. They describe 2026 as strong but discerning, with 19 Nasdaq IPOs this year and generalist investors still not fully back. The co-hosts also cover recent launches and raises, including Boulevard Bio's launch with Deerfield backing and Epicrispr's $90 million Series C raise for FSHD. In data news, Tenax's HFpEF candidate missed its primary and secondary endpoints, while Sionno's cystic fibrosis drug missed its biomarker target, sending shares down 90%. On the dealmaking front, Jazz acquired epilepsy biotech Actio for $820 million upfront to deepen its rare epilepsy pipeline, and Revolution Medicines struck a RAS-inhibitor partnership covering China development alongside a PRMT5 clinical collaboration. Elsewhere, AbCellera raised $200 million on positive Phase 2 vasomotor data, and Silence Therapeutics raised $175 million on positive polycythemia vera data, while Definium posted positive Phase 3 data for its psychedelic GAD candidate, and Cullinan/Taiho did the same for their lung cancer drug zipalertinib. In regulatory news, Neurocrine's Prader-Willi drug faced new safety scrutiny after reports of seven deaths, and Amgen's Tavneos was pulled by the EMA over misleading trial data. Belite Bio's tinlarebant earned FDA priority review for Stargardt disease, while rival Tarsus acquired Alkeus for about $800 million. The episode closed with a debate on expanding the COINS Act into biosecurity. This episode aired on August 14, 2026.
August 7 · 1 hr 3 min
Episode 192 - August 7, 2026
On this week’s episode, Sam Fazeli, Brian Skorney, Yaron Werber, and Strand Therapeutics CEO Jake Becraft open with the wave of dealmaking and a solid Q2 earnings season, then turn to the reports of the potential AstraZeneca/Bristol Myers merger, which the group called “more smoke than fire.” Next, as the trend of reverse mergers continues, the co-hosts note they’re increasingly well-received as a faster path to going public. Meanwhile, the IPO window has remained open and strong. The conversation moved to the ongoing China biotech debate, discussing the challenges and opportunities facing US biotech. In regulatory news, the FDA granted breakthrough therapy and orphan drug designations for Mirum’s volixibat, while Replimune received approval for Tudriqev (RP1) in melanoma after its third submission. The group also compared Moderna and BioNTech heading into a data-heavy second, noting BioNTech’s CEO change, and covered Ascendis’s strong launch against BioMarin in achondroplasia, now complicated by ITC patent litigation. The episode closed on a high note with Otsuka’s atrasentan, showing unprecedented two-year eGFR stabilization in IgA nephropathy. *This episode aired on August 7, 2026.
August 3 · 1 hr
Episode 191 - July 31, 2026
On this week's episode, Graig Suvannavejh, Tim Opler, Yaron Werber, Paul Matteis, and Brian Skorney kicked off with a review of the market, noting pressure in the XBI despite a longer-term bounce-back from trough levels, though they see biotech fundamentals as largely intact. The group also discussed the trend of reverse mergers as an alternative to traditional IPOs, along with AI's expansion and uncertain role in accelerating drug discovery. In regulatory news, the co-hosts welcomed the return of FDA advisory committee meetings, including those for Capricor and Replimune, and highlighted Anthony Fauci's recent Senate testimony on the handling of the COVID-19 pandemic. In deals, J&J struck an in vivo CAR-T partnership with Sail Biomedicines, with potential readthroughs for Legend Biotech, and Argenx is set to acquire Forte Biosciences to bolster its immunology pipeline. The group also highlighted Lilly's recent acquisition of psychedelics company AtaiBeckley, opening a broader discussion on deals in the psychedelics space. The episode concluded with company news including Alnylam shares dropping 30% following disappointing updated guidance, Novo Nordisk’s Phase 3 study for its anti-IL-6 ligand antibody, and MapLight’s Phase 2 schizophrenia readout. *This episode aired on July 31, 2026.
July 24 · 58 min
Episode 190 - July 24, 2026
On this week's episode, Josh Schimmer, Brian Skorney, Eric Schmidt, and Brad Loncar kick off with IPOs and raises, including Scribe's IPO, the first preclinical biotech IPO since the COVID era, which priced in a modest but upsized deal. The group also covers Mentari's additional $200 million raise ahead of its reverse merger with InMed, leading the co-hosts to question if reverse mergers are a positive for biotech or a worrisome trend. Next, the group turns to Colossal Biosciences' talks to raise at a $20–30 billion valuation, prompting a broader question of what counts as biotech and where the industry's roots lie. The conversation turns to a recap of BiotechTV's inaugural U.S. Science Summit, where a central theme was the need to better explain biotech's work to the general public. The co-hosts then cover the fallout at Immix, whose CMO (hired in March 2025) turned out to be a fugitive on the run; the company disclosed the news in an 8-K, as they believed it not to be a material event. In data news, Dyne's Z-rostudirsen received FDA acceptance and priority review for DMD. The episode concludes with a discussion on policy, debating whether upcoming FDA adcomms for Replimune and Capricor signal a shift under new leadership. *This episode aired on July 24, 2026.
July 17 · 58 min
Episode 189 - July 17, 2026
On today’s episode, Yaron Werber, John Maraganore, Sam Fazeli, and Matt Gline open with a discussion of biotech market volatility, with Matt noting that it often seems driven more by opaque factor dynamics than company-specific fundamentals. The group then turns to Eli Lilly’s continued “Amazonification” and reinventing the pharma business as it acquires a variety of different companies, including this week’s $2.8B upfront acquisition of Atai Beckley, a psychedelic-focused company. The conversation turns to BioCentury’s reporting on Asia-to-West NewCos, prompting a debate about whether China is uniquely changing the market or simply reflects broader shifts in cheaper, faster development. On policy, the group covers BIO’s response to the OMB proposal that could inject political review into federal grant decisions. The co-hosts also debate Kalshi’s move to create prediction markets around clinical trial and regulatory outcomes. On pipeline updates, the group discusses Merck’s approval of Lipfendra, the first oral PCSK9 drug, and the broader class implications. In CNS, Biogen and Ionis’ diranersen tau ASO data spark a discussion of aconfusing dose response, ASO tolerability, tau as a target in Alzheimer’s disease, and the promise of alternative modalities from Arrowhead and Alnylam. The episode closes with M&A and financing, including AstraZeneca’s licensing deal with Dizal for the EGFR exon 20 inhibitor sunvozertinib andErasca’s RAF data plus its $500M financing, which Sam views as a strong market signal despite a volatile biotech backdrop. This episode aired on July 17, 2026.
July 10 · 1 hr
Episode 188 - July 10, 2026
On this week's episode, Sam Fazeli, Josh Schimmer, Eric Schmidt, Paul Matteis, and special guest STAT's Matt Herper open on the market, noting that despite a wobbly day for biotech, the XBI holds strong gains year-to-date. The conversation turns to FDA transparency, where the co-hosts flag that CRLs haven't been released since April and that the agency may be walking back that practice. The co-hosts debate whether the FDA is swinging too far toward leniency after Agios' mitapivat won priority review in sickle cell disease despite missing its primary endpoint last year. On AI in drug discovery, Matt Herper recaps an interview with Anthropic's CEO about a new research tool, noting that it's plausible the tool helps industry pick better targets and lower the failure rate. In M&A, Vertex's largest-ever deal takes Crinetics for $10 billion net of cash, staking a claim in the specialty rare endocrine space, while Novartis expands its ADC portfolio with Myricx for $1.1 billion upfront plus $400 million in milestones — the second European ADC deal in recent months. On data, AstraZeneca and Ionis' eplontersen trial in ATTR-CM missed its endpoint, showing no benefit or biomarker signal on top of background tafamidis; the group then discusses the readthroughs for BridgeBio, Alnylam, and Pfizer's ATTR therapies. This episode aired on July 10, 2026.
June 26 · 1 hr
Episode 187 - June 26, 2026
On this week’s episode, Josh Schimmer, Eric Schmidt, Tess Cameron, and Sam Fazeli open by noting the XBI’s continued rise, debating whether biotech is getting ahead of itself. The co-hosts call this a “new era” in which biotech can be profitable rather than sold off to pharma. The conversation shifts to deals, with AbbVie’s $10.9 billion acquisition of Apogee, which raised questions about China-sourced drugs given their volume, pace of innovation, and cheaper price. The group also covers Boundless Bio and Serapha’s merger, alongside a $230M private raise. Ollin Bio -- whose pipeline is built entirely on Chinese assets -- raised $330M Series B to advance Phase 3 trials of a bispecific antibody for diabetic macular edema and wet AMD, which led to a debate on the COINS Act and the distinction between physical and innovation supply chains. The group then overviews potential FDA Commissioner candidates, with BIO CEO John Crowley and physician Heidi Overton as front-runners alongside acting leader Kyle Diamantas. In company news, CVS Caremark deferred adding $SPRY’s epinephrine nasal spray Neffy to its formulary, pushing the review to January 2027. The episode concludes with data updates from Moonlake in HS, Merck’s ulcerative colitis drug, Definium’s Phase 3 LSD data in MDD, and Absci’s Lilly-backed prolactin antibody raise. *This episode aired on June 26, 2026.
June 12 · 1 hr 1 min
Episode 186 - June 12, 2026
On this week’s episode, Graig Suvannavejh, Eric Schmidt, Paul Matteis and Financial Times’ Oliver Barnes kicked off with the biotech market, with the XBI in positive territory and 12 biotech IPOs completed so far this year. They expected the IPO window to remain open for high-quality private companies. The group also overviewed recent financings, including SonoThera’s $125 million Series B, City Therapeutics’ $100 million Series B, Ethyreal’s $101 million Series A, and Summit’s decision to cancel a $500 million secondary offering. In data news, the co-hosts covered Tango’s combination data with Revolution Medicines’ RAS inhibitor. They also discussed Incyte’s acquisition of Vega Therapeutics as a pipeline-building move ahead of Jakafi’s 2028 patent expiration and J&J’s acquisition of Firefly, with the RAS inhibitor space expected to remain hot. The group also discussed GSK’s acquisition of Nuvalent -- its largest deal to date -- for two late-stage lung cancer assets. Oliver added perspective on biotech deal leaks, following the Incyte/Vega deal and GSK/Nuvalent deals this week. In partnership updates, Novartis expanded its molecular glue work with Orionis, Lilly licensed an Alzheimer’s candidate from AlzeCure, and Corvus supported China partner Angel Pharmaceuticals. The episode concluded with the latest in rare disease and gene therapy, covering Novartis’ FSHD program, FDA flexibility, Rett syndrome programs, and Sensorion’s exit from hearing loss development. *This episode aired on June 12, 2026.
June 9 · 1 hr
Episode 185 -June 5, 2026
On this week’s episode, Yaron Werber, Tess Cameron, SamFazeli, and Brian Skorney kick off with a look at markets, noting that while AI remains hot, biotech may be cooling amid anticipated tech IPOs. The co-hosts note that biotech saw a significant recovery over the past year driven by M&A and improving sentiment, highlighting that the XBI has remained remarkably stable. The discussion then turns to policy, where momentum to expand the COINS Act into biotech raises concerns. The group highlights the need to distinguish between manufacturing supply chains, where national security risks are real, and innovation ecosystems, where restricting capital flows could slow drug development and shift advantage outside of the US. Recapping the highlights from ASCO 2026, Akeso/Summit’s ivonescimab showed meaningful survival benefits, while Revolution Medicines’ KRAS program in pancreatic cancer stood out as a breakthrough, receiving a standing ovation at the conference. In breast cancer, the focus was centered on emerging CDK4 selective inhibitors from Pfizer and others. Grail’s multi-cancer early detection readout was also discussed, along with in vivo CAR-T data from Kelonia that showed strong early responses but raised durability questions. *This episode aired on June 5, 2026.
May 29 · 58 min
Episode 184 - May 29, 2026
On this week’s episode, Chris Garabedian, Brian Skorney, Graig Suvannavejh, and special guest Ginkgo Bioworks CEO, Jason Kelly, kick off with a market update, highlighting a continued positive sentiment, citing Endpoints’ recent Biopharma Sentiment Index survey results, which showed improvements in biopharma conditions. The co-hosts also note the continued IPO activity, including Kardigan’s recent filing. The conversation shifts to China, with Jason suggesting that genetic engineering is a strategic technology extending beyond therapeutics, warning that the U.S. is offshoring critical innovation to China. This sparks a debate with others noting that global collaboration is embedded in drug development and questioning whether restricting partnerships would ultimately harm U.S. competitiveness. In deals, the group highlights Lilly’s acquisition of three vaccine companies for up to $3.8 billion and Apogee’s $1.3 billion strategic collaboration with Blackstone to advance their eczema drug. The conversation shifts to data, with GSK’s Phase 3 data for chronic hepatitis B drug, and an overview of datasets at ASCO 2026, including Revolution Medicines Phase 3 trial results for pancreatic cancer, which are expected to be the headline of the conference. The episode concludes with an overview of Biohaven’s R&D Day, BMS in multiple myeloma, Dyne’s DMD, and updates on the FDA following the recent leadership changes. after the departure of Dr. Marty Makary. *This episode aired on May 29, 2026.
May 15 · 1 hr 1 min
Episode 183 - May 15, 2026
On this week’s episode, Sam Fazeli, Josh Schimmer, Eric Schmidt, and Tess Cameron kickoff with deals, highlighting the up to $15.2B Hengrui–BMS partnership and the broader trend of outsourcing early-stage drug development to China. The discussion continues with the co-hosts noting China’s edge in speed, quality, and cost-efficiency, while underscoring that the strength of U.S. capital markets remains a key advantage. This week also saw a significant raise, with Isomorphic Labs announcing a $2.1B Series B. In regulatory news, the group described the departure of FDA Commissioner Dr. Marty Makary as creating fresh uncertainty around FDA leadership and direction as they speculated on his exit and who will replace him. On the data front, Regenxbio met the primary endpoint inits Phase 3 trial for Duchenne, though the hosts flagged potential investor skepticism around the side effects, limited data, and FDA uncertainty. Next, they discuss that Biogen and Ionis are advancing their Alzheimer’s tau program despite mixed results. The co-hosts also mention Inhibrx’s Phase 2 data in head and neck squamous cell carcinoma, as well as Moderna’s Hantavirus vaccine research following the recent cruise ship outbreak. The episode concludes with a look ahead to upcoming conferences, including ASCO, ADA, and ATS. *This episode aired on May 15, 2026.
May 8 · 1 hr
Episode 182 - May 8, 2026
On this week’s episode, Josh Schimmer, Paul Matteis, Eric Schmidt, Yaron Werber, and special guest STAT’s Allison DeAngelis open with what they describe as “a bananas week for biotech,” highlighting strong substantial secondary offerings, including Cytokinetics and Avalo Therapeutics. The conversation then turns to M&A, with multiple new deals announced in Q1 and continued activity this week, including UCB’s acquisition of Candid Therapeutics for up to $2.2B, Angelini’s $4.1B purchase of Catalyst Pharmaceuticals, and Bayer’s acquisition of Perfuse for up to $2.45B. The group also reflects on what feels like the year of developmental-stage biotech, highlighting investor focus on companies with pipeline events such as Vertex and Biogen, while commercial-stage companies have lagged. In regulatory news, the co-hosts discuss Sanofi’s decision to withdraw diabetes drug, teplizumab, from the Commissioner’s National Priority Review program, broader concerns about shifting goalposts and political influence, and contradicting outcomes including Replimune’s rejection versus Atara’s reversal. On the data front, the hosts discuss Cytokinetics’ Phase 3 results and subsequent $650M raise, as well as encouraging autoimmune data from Artiva Biotherapeutics. They also overview neurofilament as a biomarker following Clene’s data, and J&J’s decision to advance its DUET program despite failing to meet its primary endpoint in IBD. *This episode aired on May 8, 2026.
May 8 · 1 hr
Episode 181 - May 1, 2026
On this week’s episode, Eric Schmidt, Matt Gline, Chris Garabedian, Sam Fazeli, and Graig Suvannavejh open with a discussion on biotech public‑market dynamics, noting solid year‑to‑date performance for the XBI. Next, the group highlights the reopening of the IPO window, with multiple upsized offerings and strong aftermarket performance, supported by renewed generalist investor interest. The conversation then turns to large‑cap pharma earnings, with focus on Lilly’s continued outperformance driven by its obesity franchise and evolving commercialization strategies. Next, the co-hosts discuss robust deal flow across the sector, led by Lilly’s aggressive M&A activity. On the data front, the co-hosts cover Revolution Medicines’ practice‑changing Phase 3 pancreatic cancer data and the contrasting market reaction to competitor results, as well as key takeaways from Summit Therapeutics’ Harmony‑3 interim analysis in lung cancer. Also in data news, developments in Alzheimer’s disease, including recent trial setbacks, regulatory approvals, and encouraging early commercial traction for new therapies are also mentioned. The episode concludes with reflections on IPO cycles, valuation discipline, and cautious optimism for sustained momentum in biotech markets. *This episode aired on May 1, 2026.
April 17 · 53 min
Episode 180 - April 17, 2026
On today’s episode, Chris Garabedian, Paul Matteis, Tess Cameron, and special guest Adam Feuerstein kick off with a discussion of the public markets, highlighting the XBI’s post‑pandemic highs, Kailera’s IPO pricing and more than $625 million raised, the opening of the IPO window with multiple filings, and increasing generalist interest in the biotech sector. The group also discusses Obsidian Therapeutics going public following a reverse merger with Galera, alongside a $350 million PIPE. The conversation shifts to the rise of clinical trial prediction markets and the growing role of AI tools in the life sciences industry. Next, the co‑hosts highlight another acquisition by Lilly, with their $300 million purchase of Crossbridge Bio. In Regulatory news, the group overview the FDA approval of Travere Therapeutics’ kidney disease drug for FSGS and the broader implications for the renal space. On the data front, the group mentions Allogene’s CAR‑T data and the mixed stock reaction, along with Revolution Medicines’ positive Phase 3 data in pancreatic cancer. Spyre’s positive Phase 2 data in ulcerative colitis is also covered. The episode concludes with a discussion on how clinical data continues to drive market dynamics. *This episode aired on April 17, 2026.
April 10 · 59 min
Episode 179 - April 10, 2026
On this week’s episode, Graig Suvannavejh, Josh Schimmer, Yaron Werber, Sam Fazeli, and special guest Financial Times journalist Oliver Barnes kick off by highlighting the strength of the biotech sector from a public markets perspective, noting the XBI has outperformed the S&P 500 so far this year. The group agrees biotech is in a solid position overall. In policy news, the co‑hosts discuss the latest on the Trump administration’s proposed 100% pharma tariffs, Most Favored Nation drug pricing, and deals between big pharma and the administration. The conversation shifts to regulatory news, including changes to the CDC’s ACIP charter, vaccine oversight concerns, and FDA Commissioner Dr. Marty Makary’s press conference highlighting progress under his leadership. The group then highlights major deals, including Merck’s $6.7 billion acquisition of Terns and details of the SEC filings, Gilead’s $3.15 billion upfront deal for Tubulis, Neurocrine’s $2.9 billion purchase of Soleno, and Garda Therapeutics’ $125 million acquisition of Assertio. In breaking news, the co-hosts discuss Replimune’s second CRL for its melanoma therapy. In data, the group highlights Ascendis’ encouraging week‑52 achondroplasia data and Insmed’s Phase 2 hidradenitis suppurativa results. The episode concludes with an update on the obesity landscape, including Lilly’s newly approved oral GLP‑1, Novo’s high‑dose Wegovy, and a Nature paper on GLP‑1 response variability. *This episode aired on April 10.
April 3 · 1 hr
Episode 178 - April 3, 2026
On this week’s episode, Graig Suvannavejh, Mike Yee, and Eric Schmidt kick off with a look back at biotech deal activity through the first quarter, highlighting a solid, but not overheated, M&A environment. The group discusses recent transactions, including large, commercially focused deals designed to drive near‑term revenue growth rather than pipeline speculation, particularly Biogen’s $5.6 billion acquisition of Apellis. While total Q1 deal value was roughly in line with historical averages, they note that meaningful capital continues to be recycled back into the sector. In other deals, Lilly’s $6.3 billion upfront acquisition of Contessa is also noted as an opportunity for Lilly diversify its pipeline beyond obesity. Next, the co-hosts highlight growing interest in blood–brain barrier drugs following Korsana’s merger with Cyclerion. The conversation shifts to regulatory news, including the FDA approval of Lilly’s oral GLP‑1, alongside signs of increasing regulatory flexibility in rare disease, such as Scholar Rock’s SMA BLA resubmission, and an upcoming decision for Replimune. The episode concludes with data updates, including Viridian’s Phase 3 thyroid eye disease results and discussion on NLRP3 inhibitors as a potential next wave cardiometabolic and obesity drugs beyond GLP 1s. *This episode aired on April 3, 2026.
March 27 · 55 min
Episode 177 - March 27, 2026
On this week’s episode, Grace Colón, Josh Schimmer, Eric Schmidt, and Brian Skorney open with a look at the macro backdrop. With market volatility and interest rate uncertainty, the hosts agree the macro is still “driving the bus,” tempering what might otherwise be stronger bullish sentiment. Even so, biotech continues to demonstrate relative resilience – XBI holding up better than the broader market – reinforcing the view that investors still want to own biotech. In deals, the co-hosts discuss Gilead’s more than $2 billion purchase of Ouro Medicines for its autoimmune disease drug, Merck’s $6.7 billion takeover of Terns to bolster its oncology pipeline, and Novartis’ deal for Exellergy to strengthen its allergy portfolio. The conversation shifts to regulatory news, including the approval of Denali’s Hunter syndrome drug, Avlayah, which comes shortly after the FDA rejected Regenxbio’s gene therapy for the same condition. Other recent rare disease approvals are noted, with the group interpreting them as signs of slightly increased regulatory flexibility following leadership changes, though uncertainty remains across the health agencies. The episode concludes with recent data news and market reactions from Sarepta and Arrowhead, Maze versus Vertex in kidney disease, Beam’s data in AATD, Lyme disease vaccine data from Pfizer and Valneva, and a preview of data to be presented at AAD. *This episode aired on March 27, 2026.
March 13 · 1 hr
Episode 176 - March 13, 2026
On this week’s episode, Sam Fazeli, Josh Schimmer, Paul Matteis, and Graig Suvannavejh kick off with a discussion on the impact of current geopolitics on biotech investor sentiment, noting that biotech is fundamentally insulated from oil prices and emphasizing that the sector is becoming cash‑flow positive at a pace not previously seen. Shifting to regulatory news, the group discusses Vinay Prasad’s departure from the FDA and highlights that upcoming rare disease readouts will serve as a test of the FDA’s flexibility. They also cover the FDA’s new Adverse Event Monitoring System, which consolidates multiple adverse event reporting databases into a single platform. Next, the co-hosts highlight John Crowley’s opinion piece in STAT News on Biotech’s 50th anniversary (marked by the founding of Genentech), emphasizing the importance of protecting U.S. biotech and pharmaceutical pricing to sustain innovation. On the deal front, the group discusses Servier’s $2.5B cash acquisition of Day One Biopharmaceuticals’ oncology asset, as well as the recurring rumor of an Abivax takeover. The episode closes with a review of recent clinical data and company updates from IDEAYA Biosciences, Roche, Benitec Biopharma, RenovoRx, Vertex, Xenon, and Dianthus, along with broader commentary on FDA decision‑making following the approval of leucovorin. *This episode aired on March 13, 2025.

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