Ep. 340 - Obesity Data, Kymera & FDA Survey Results

Obesity readouts continue to be hot for biotech with new top-line data from both injectable and oral therapies pushing the boundaries on efficacy. On the latest BioCentury This Week podcast, BioCentury’s analysts break down last week’s readouts from Eli Lilly, Structure  and Wave Life Sciences, and discuss a deal in the space by Pfizer.Lilly reported the latest for its triple agonist contender retatrutide for best-in-class weight loss, while strong Phase IIb data put Structure back in the oral GLP-1 race. Meanwhile, Pfizer added an oral GLP-1R agonist via a deal). Structure and Wave parlayed their data into follow-on cash, as did Kymera after posting data for its STAT6 program KT-621 that hints at a new era for degraders in immunology.The analysts then detailed the results of BioCentury’s industry sentiment survey on FDA, which found that politicization of the agency’s leadership, volatility and uncertainty are casting a long shadow over investor and drug developer sentiment. Finally, they discuss the impact of the congressional stalemate over the U.S. Small Business Innovation Research (SBIR) program.View full story: https://www.biocentury.com/article/657880#ObesityDrugDevelopment #TargetedProteinDegradation #STAT6 #FDARegulation #SBIRFunding00:00 - Introduction01:45 - Obesity Data12:17 - Kymera's Breakthrough21:45 - FDA Survey Results29:41 - SBIR Funding StalemateTo submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected] us by sending a text

Fueled by cancer, obesity and cardiovascular deals, $1 billion-plus takeouts in biotech are at their highest level in a decade with three weeks to go in the year. On the latest BioCentury This Week, BioCentury’s analysts discuss the rise in large M&A deals and what the trends among the 37 acquisitions say about biopharma dealmaking.The analysts assess first-in-human in vivo CAR T data at the American Society of Hematology meeting from Kelonia Therapeutics, which showcase the promise of the modality and justify the growing pipeline. They also break down readouts from Praxis in developmental and epileptic encephalopathy from the American Epilepsy Society Annual Meeting and from Novo Nordisk, which presented full data at the Clinical Trials on Alzheimer’s Disease meeting on semaglutide’s failure to treat Alzheimer’s disease.Washington Editor Steve Usdin analyzes a roller-coaster week at FDA in which Richard Pazdur resigned as director of FDA’s Center for Drug Evaluation and Research and Tracy Beth Høeg became acting CDER director, a move that Usdin says will prompt staff departures, ease restraints on FDA leadersView full story: https://www.biocentury.com/article/657781#BiotechMA #CARTTherapy #EpilepsyResearch #AlzheimersDisease #FDA02:37 - Biotech M&A06:39 - In vivo CAR T10:08 - Semaglutide for Alzheimer's16:17 - Praxis22:11 - FDATo submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected] us by sending a text

Novo Nordisk’s highly anticipated data for semaglutide in Alzheimer’s dashed hopes that the GLP-1 therapy could become a game changer in the disease. On the latest BioCentury This Week podcast, Executive Editor Selina Koch discusses the Phase III readout including what it says about the mechanism’s use in the neurodegenerative disease, Novo’s decision to skip Phase II and enroll a large patient group in a later stage trial, and what other datasets for GLP-1s in the indication have shown.Washington Editor Steve Usdin explains why FDA’s new vaccine policies, driven by CBER Director Vinay Prasad, could have impacts more far-reaching than expected, including making it more difficult to develop or modify vaccines. And Lauren Martz, Executive Director of Biopharma Intelligence, analyzes the bleak investment outlook for cell and gene therapy companies in the U.S. and why China’s biotech ecosystem offers a glimmer of hope for sponsors of these assets.View full story: https://www.biocentury.com/article/657721#Semaglutide #GLP1Therapies #VaccinePolicy #CellAndGeneTherapy #AlzheimersResearch00:00 - Introduction01:53 - Novo's Alzheimer’s Miss13:19 - FDA's New Vaccine Policy19:53 - Funding C&GT BiotechsTo submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected] us by sending a text

A baffling decision by FDA to issue a complete response letter for a pediatric medicine the medical community stood behind is just the latest example raising concerns that the agency is shifting the regulatory goalposts amid a lack of transparency. On the latest BioCentury This Week podcast, Washington Editor Steve Usdin explains how the absence of advisory committee meetings at FDA is in part to blame for a lack of consistency in decision-making and divergence from decisions taken by other global regulatory agencies. VP and Editor-in-Chief Simone Fishburn then discusses the takeaways from Franck Le Deu’s guest commentary on how China’s biotech ecosystem is evolving, and whether government support for the sector is helping or hindering its overall health. BioCentury’s analysts also discuss whether conventional CRISPR therapies will ever be commercially successful, and what’s next for NLRP3 inhibitors to treat obesity following the first set of Phase II data for the class.We'd also like to invite our listeners to participate in our important survey about their experiences interacting with FDA. To take the survey, please go to BioCentury's FDA Sentiment Survey. This episode of the BioCentury This Week podcast is brought to you by Voyager Therapeutics.View full story: https://www.biocentury.com/article/657698#FDARegulation #CRISPRTherapies #NLRP3Inhibitors #ChinaBiotech #DrugApproval00:01 - Sponsor Message: Voyager Therapeutics01:31 - FDA Sydnexis CRL07:36 - CDC Vaccine Claims09:55 - China’s Innovation Arc16:49 - CRISPR Commercial Viability 26:39 - NLRP3 for ObesityTo submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected] us by sending a text

There is cautious optimism around continued M&A momentum and the public equities markets as biotech heads into the New Year. On a special edition of the BioCentury This Week podcast recorded in London during London Life Sciences Week, BioCentury’s Simone Fishburn and Stephen Hansen were joined by a trio of guests to discuss their key takeaways from the week and expectations for next year, including trends in M&A and creative deal structures for business development.The group also discussed the potential for biotech venture investing to make a comeback as a key asset class for LPs, especially in the U.K., as the government continues to encourage pension funds to invest more broadly.The three guests joining BioCentury included Luciana Griebel from law firm Morgan Lewis, James Critchley from PJT Partners, and Carmine Circelli from the British Business Bank.The podcast was recorded Nov. 19 on stage at the Victoria House in London as part of the 3rd Biotech CEO & Investor Reception.BioCentury’s next recording “on the road” will take place on the sidelines of the annual J.P. Morgan Healthcare Conference in San Francisco in January at the 11th East West Healthcare Reception hosted by BioCentury, Panacea Venture and Maytech Global Investments.View full story: https://www.biocentury.com/article/657686#BiotechMandA #DrugDevelopment #VentureCapital #LifeSciences #LondonLifeSciencesWeek00:00 - Introduction02:24 - Market Recovery08:02 - Growth and Influence16:24 - Creative Dealmaking21:40 - Role of CVRs25:52 - Pension Funds and Venture Capital30:09 - AI Bubble34:17 - Accelerating Clinical TrialsMorgan Lewis has prepared its materials for this podcast for general informational purposes only. They do not and are not intended to constitute legal advice. This podcast was recorded on Nov. 19. Morgan Lewis does not guarantee the accuracy or timeliness of the information contained in these materials and disclaims any obligation to advise you of any changes in the law. You should always refer to original source documents for complete information and consult directly with an attorney for advice, including on the latest developments in this rapidly changing area of the law.To submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected] us by sending a text

Voyager CEO and former head of R&D at Biogen Al Sandrock is more optimistic than ever about the prospect of bringing clinically meaningful solutions to patients with Alzheimer’s disease and other neurodegenerative disorders. The threads of progress are finally coming together, he said in a special episode of the BioCentury This Week podcast. From the first disease-modifying therapies for Alzheimer’s disease, to a growing biomarker toolkit, to an expanding set of genetically validated targets in other neurodegenerative conditions — and, crucially, to delivery vehicles capable of broadly and deeply penetrating the brain — neurology drug development may be poised to accelerate. This episode of the BioCentury This Week podcast is brought to you by Voyager Therapeutics.View full story: https://www.biocentury.com/article/657678#AlzheimersDisease #AAVGeneTherapy #BloodBrainBarrier #TauTargeting #Neurodegeneration00:01 - Sponsor Message: Voyager Therapeutics 03:41 - Voyager's Approach to Gene Therapy15:07 - Alzheimer's Disease25:25 - Big Biotech to Small Biotech29:21 - Neurodegenerative Diseases31:19 - FDA FlexibilityTo submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected] us by sending a text

Richard Pazdur took the top job at FDA’s Center for Drug Evaluation and Research after receiving vows that he would be leading CDER free from political interference. On the latest BioCentury This Week podcast, BioCentury's analysts discuss the issues that could prove to be flashpoints between Pazdur and the heads of FDA and HHS, including personnel, RSV mAbs, puberty blockers and SSRIs.BioCentury's analysts assess bispecific innovation at the annual meeting of the Society for Immunotherapy of Cancer (SITC) and the growing field of companies pursuing RNAi, many of which have multiple unpartnered assets. Also featured in this week's episode: new funds from European VCs Medicxi and Sofinnova Partners, FDA’s new plausible mechanism pathway and the Trump administration’s “most favored nation” drug-pricing plan, which is turning out to be much more less onerous to drug companies than its original description suggested. This episode of the BioCentury This Week podcast is brought to you by Voyager Therapeutics.View full story: https://www.biocentury.com/article/657631#RNAiTherapeutics #BispecificAntibodies #CD3TCellEngagers #MechanismOfAction #ImmunoOncology #PlausibleMechanismPathway #RegulatoryScience #ClinicalTranslation00:01 - Sponsor Message: Voyager Therapeutics 03:08 - FDA's Richard Pazdur13:08 - Plausible Mechanism Pathway19:30 - Most Favored Nation23:12 - Takeaways from SITC28:05 - RNAi in China33:21 - European VCsTo submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected] us by sending a text

Today’s South Korean biotechs have a risk-on mentality, a willingness to partner, and strategies focused on globalization. On a special edition of the BioCentury This Week podcast recorded at Venture Café Cambridge, BioCentury is joined by a quartet of investors and executives with deep knowledge of Korea’s life sciences ecosystem to discuss Korea biotech’s push to globalize and the opportunities in the country for Western companies. The four guests joining BioCentury were Aram Hong, CEO of Korean start-up Apollon; investors Spencer Nam and Debra Peattie; and Boehringer Ingelheim GmbH's Andy Whittle.The podcast was recorded Nov. 6 on stage at the Venture Café Cambridge during the K-Blockbuster Night hosted by KHIDI, the Korea Health Industry Development Institute. BioCentury analyses discussed during the podcast include one on Asian deals and another on the speed of clinical trials in China. BioCentury returns to Asia early next year for the 5th East-West Summit, March 9-11 in Seoul. This episode of the BioCentury This Week podcast is brought to you by KHIDI.View Full story: https://www.biocentury.com/article/657558#KoreaBiotech #Globalization #LifeSciences #BiotechEcosystem #PharmaDeals #ClinicalDevelopment #Innovation #BiotechLeadership00:01 - Sponsor Message: KHIDI05:08 - Asia Deals and Korea's Role09:12 - Boehringer's Perspective13:51 - Apollon's Journey17:24 - Building Relationships23:20 - Investors' View To submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected] us by sending a text

With ObesityWeek yielding eye-catching amylin data and a bidding war that ran to $10 billion for Metsera, weight loss companies were center stage in biotech last week. On the latest edition of the BioCentury This Week podcast, BioCentury’s analysts explained why Pfizer's victory for the start-up over European rival Novo Nordisk doesn’t necessarily mean a broader U.S. policy shift against foreign acquisitions of domestic biotechs.Turning to ObesityWeek readouts, they discuss Eli Lilly's data for amylin monotherapy eloralintide, arguing that just as Lilly did with GLP-1 agonists, the company is again setting the benchmark by which all other molecules in the class will be measured.BioCentury's analysts also discuss takeaways from Washington Editor Steve Usdin's Commentary, which finds FDA in a crisis of politicized decisions, plummeting morale, and a hollowed workforce, and highlights from BioCentury's interview with gene therapy pioneer Jim Wilson as he rethinks the funding model for ultrarare disease therapies to keep his mission on track. This episode of the BioCentury This Week podcast is brought to you by Voyager Therapeutics.View full story: https://www.biocentury.com/article/657545#ObesityWeek #Amylin #GLP1 #Eloralintide #DrugMechanism #FDA #RareDisease #GeneTherapy00:01 - Sponsor Message: Voyager Therapeutics 01:53 - Pfizer Wins Metsera08:48 - Lilly's Amylin Data13:06 - Funding Ultrarare Therapies20:51 - What's Next for FDATo submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected] us by sending a text

Novo Nordisk’s unsolicited $8.5 billion bid for Metsera has thrown a wrench into Pfizer’s plans to return to the obesity race via its acquisition of the New York-based start-up. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss the details of the competing bids and what’s at stake for the pair of suitors.The analysts also assess the reasons behind the abrupt departure of Center for Drug Evaluation and Research Director George Tidmarsh from FDA and a surge in activity on the Hong Kong stock exchange. This episode of the BioCentury This Week podcast is brought to you by Voyager Therapeutics.View full story: https://www.biocentury.com/article/657475#Biotech #PharmaDeals #ObesityDrugs #MergersAndAcquisitions #FDA #LifeSciences #GlobalBiotech #HongKongMarket00:01 - Sponsor Message: Voyager Therapeutics01:53 - Metsera M&A15:23 - Tidmarsh Ouster25:12 - Hong Kong IPOsTo submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected] us by sending a text