Ep. 350 - Oral SERD Spotlight. Plus: Setbacks at FDA

Biotechs have been pricing follow-ons at a steady pace, with some companies parlaying data into upsized deals, and others even beginning to debut on NASDAQ — but will geopolitical tensions and war in the Middle East scuttle the forward momentum? On the latest BioCentury This Week podcast, BioCentury’s analysts take the temperature of the markets for biotech."They also discuss last week’s late-stage epilepsy data from Xenon Pharmaceuticals, which revived the biotech’s stock and the Kv7 target.And, in a Rare Disease Spotlight, BioCentury’s analysts discuss how Friedreich ataxia is moving into a mechanistic second act, with biotechs pivoting from stabilizing the mitochondrial damage caused by frataxin loss to developing therapies designed to fix the gene itself.View full story: https://www.biocentury.com/article/658810#BiotechMarkets #EpilepsyResearch #Kv7 #RareDisease #GeneTherapy00:00 - Introduction03:23 - Market Sentiment09:58 - Xenon Phase III Win18:03 - Friedreich Ataxia PipelineTo submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected] us by sending a text

Biotechs in South Korea and other regions of Asia outside of China need to lean into innovation to distinguish themselves from their Chinese counterparts. On a special edition of the BioCentury This Week podcast, BioCentury’s analysts are joined by industry guests Ya-Ting Lei and Luther (Ruizhe) Zhao to discuss why the best path for biotechs in Korea and Japan is to lean into target, biology and modality risk, as well as other takeaways from the fifth BioCentury-BayHelix Biopharma Summit, which ran March 9-12 in Seoul and Daejeon, South Korea.Lei is director of BD Asia at Merck KGaA, and Zhao is VP, China clinical analytics at Caidya.View full story: https://www.biocentury.com/article/658776#AsiaBiotech #SouthKoreaBiotech #BiopharmaSummit #BiotechInnovation #DrugDevelopmentStrategy00:00 - Introduction02:32 - Key Takeaways05:46 - Faster Trials, Better Data08:19 - Global Diligence, Local Success15:13 - Cross Border Synergies17:34 - Korean BiotechTo submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected] us by sending a text

The second ousting of Vinay Prasad from FDA in the past eight months won’t lead to major changes at the agency, other than selecting a successor tasked with keeping FDA out of the news ahead of the coming midterm elections. On the latest BioCentury This Week podcast, Washington editor Steve Usdin lays out why the former CBER director was pushed out at FDA and what’s next for the agency following his departure.BioCentury’s editors also discuss the next wave of therapies for idiopathic pulmonary fibrosis, including whether new candidates might go beyond slowing disease to halt or even reverse progression, the biological complexity that makes fibrosis so challenging, and what the 20-plus Phase II programs could teach the field about fibrosis biology.Also up for discussion were recent clinical wins — as well as more complicated readouts — from psychedelic therapies; plus the latest data updates from obesity treatments, with a focus on amylin agonists.View full story: https://www.biocentury.com/article/658698#FDA #IdiopathicPulmonaryFibrosis #PsychedelicTherapies #ObesityDrugs #AmylinAgonists00:00 - Introduction01:56 - Prasad's Departure15:27 - Fibrosis Therapies23:35 - Psychedelics Clinical Catalysts28:24 - Obesity UpdatesTo submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected] us by sending a text

Can a strong U.S. biopharma industry be reconciled with the successful emergence of China? And can China be a catalyst of positive change across the global industry, even if this implies some level of rebalancing away from the U.S.? On the latest BioCentury This Week podcast, BioCentury’s analysts discuss a Guest Commentary by McKinsey Senior Partner Emeritus Franck Le Deu, who argues that a multipolar biopharma world in which the U.S. continues to thrive even as China becomes meaningfully stronger can emerge.The analysts also discuss BioCentury’s latest Rare Disease Spotlight, which focuses on a wave of therapies aiming to activate retinal function in Stargardt disease patients.Turning to FDA, BioCentury Washington Editor Steve Usdin discusses recent public statements by FDA Commissioner Marty Makary, questions about Vinay Prasad’s future, and the plausible mechanism pathway.View full story: https://www.biocentury.com/article/658606 #GlobalBiopharma #ChinaBiotech #RareDisease #StargardtDisease #FDAPolicy 00:00 - Introduction02:47 - Multipolar Biopharma World13:39 - Rare Disease Spotlight25:15 - Makary Remarks31:14 - Plausible Mechanism FrameworkTo submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected] us by sending a text

Gilead is acquiring Arcellx for $7.8 billion up front three years after forging a partnership with the biotech around a cell therapy for multiple myeloma. On the latest BioCentury This Week podcast, BioCentury’s analysts assess what the deal does for the Foster City, Calif.-based biotech’s pipeline.The analysts also discuss the case for using ctDNA as a surrogate endpoint for early cancer trials. Turning to Washington, Steve Usdin offers his takeaways from last week’s PhRMA Forum, which focused on China and the Trump administration’s most favored nation (MFN) drug pricing policy, and on the lessons that can be drawn from FDA’s about-face on the recent vaccine application from Moderna.View full story: https://www.biocentury.com/article/658516#BiotechMA #MultipleMyeloma #ctDNA #DrugPricingPolicy #FDA00:00 - Introduction02:34 - Gilead's Arcellx Buy11:14 - ctDNA Surrogate Endpoints21:59 - PhRMA Forum Takeaways29:19 - FDA Moderna U-turnTo submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected] us by sending a text

As targeted protein degradation gains momentum, oral selective estrogen receptor degraders are emerging as one of its most advanced proving grounds. On the latest BioCentury This Week podcast, BioCentury’s Lauren Martz assesses how the oral SERD landscape is evolving.Washington Editor Steve Usdin then discusses setbacks at FDA for an orphan therapy from Disc Medicine and a vaccine from Moderna, and why he is calling on life sciences industry leaders to publicly demand the dismissal of Vinay Prasad, FDA’s CSO, CMO, and director of CBER.View full story: https://www.biocentury.com/article/658455#TargetedProteinDegradation #OralSERDs #OncologyDrugDevelopment #FDASetbacks #CBER00:00 - Introduction03:12 - Oral SERD Spotlight11:40 - Setbacks at FDA15:12 - Disc Medicine CRLTo submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected] us by sending a text

2025 marked the end of a four-year slide in series A financings for biotechs, with 144 biotechs raising an aggregate of $8 billion, up $1 billion from the prior two years. On the latest BioCentury This Week podcast, BioCentury’s Danielle Golovin assesses which companies VCs backed last year and what their investments say about where technology is headed.Washington Editor Steve Usdin offers a perspective on why compounded Wegovy is an assault on the biopharma industry and also explains how the spending bill signed into law last week is a rebuke to proposed White House biomedical cuts.And Executive Editor Selina Koch unpacks her interview on The BioCentury Show podcast with neuroscientist and Seaport Chair Steven Paul, noting that while serendipity drives drug discovery in psychiatry, it’s engineering that gets it across the finish line.View full story: https://www.biocentury.com/article/658367#BiotechFinancing #SeriesAFunding #VentureCapital #DrugDiscovery #BiopharmaPolicy00:00 - Introduction02:15 - Start-up Spotlight11:03 - Compounded Wegovy18:10 - Congress Rebuffs Trump Cuts23:50 - Steve Paul on NeuropsychiatryTo submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected] us by sending a text

RNAi and exon-skipping therapies headline the list of regulatory and pivotal data catalysts in 2026, while new lipid-lowering mechanisms, modalities, and precision medicines define cardiovascular disease catalysts this year. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss the most important milestones of the year in new modalities, CV and renal diseases.The analysts also discuss a new regulation in China introducing orphan drug exclusivity that could incentivize development of rare disease therapies.Dig into the BioCentury’s catalyst picks and the new China policy below• 2026 Catalysts: The rise of RNAi• 2026 Cardiovascular Catalysts: Lp(a) on the Horizon• 2026 Obesity Catalysts: Launches, readouts and challengers• 2026 Catalysts: Breakthrough progress in renal disease• AZ signals all-in on obesity via CSPC deal for $1.2B up front• China’s orphan drug exclusivity could bolster market, incentivize developmentView full story: https://www.biocentury.com/article/65828600:00 - Introduction02:28 - RNAi and Antisense Therapies06:37 - Neuromuscular and Musculoskeletal10:33 - Renal Disease Catalysts22:26 - China's New Orphan RulesTo submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected] us by sending a text

New rules in China will accelerate the country’s cell and gene therapy sector by reshaping how investigator-initiated trials are conducted and commercialized. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss the new framework and why it will create a powerful incentive for deploying new gene and cell therapies.Executive Editor Selina Koch discusses which milestones she is watching in neurology in the year ahead, from psychedelics to Alzheimer's disease. Finally, Senior Biopharma Analyst Danielle Golovin discusses a pair of stories from BioCentury’s Emerging Company Profile series: one focused on Yale spinout Bexorg Inc., which is rethinking CNS drug discovery with a whole-human-brain model, and another on Elkedonia S.A.S., a French start-up aiming at ELK1 to reboot neuroplasticity in depression.View full story: https://www.biocentury.com/article/65818900:00 - Introduction03:14 - Speeding China's Innovation10:36 - Neuro Catalysts22:01 - NewcosTo submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected] us by sending a text

The biotech bull is back, and buysiders believe this market has staying power for the first time in nearly five years. On a special episode of the BioCentury This Week podcast, Director of Biopharma Intelligence Stephen Hansen and colleagues discuss Hansen’s 2026 Public Markets Preview, which found interest rates, policy in Washington and fundamentals finally aligning and a wave of launches and M&A that could keep capital flowing into the sector.View full story: https://www.biocentury.com/article/658154#BiotechBullMarket #PublicMarkets #BiotechMA #IPOOutlook #FDApolicy00:00 - Introduction00:41 - Market Sentiment07:55 - Biotech's Next Wave14:47 - Lingering Concerns23:29 - IPOs26:47 - M&ATo submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected] us by sending a text