Advertise on podcast: The Pharma Closeout | Daily Pharmaceutical and Biotech News in 15 Minutes

Delayed Friday edition, recorded October 2. Lilly's Jaypirca (pirtobrutinib) gains first-line approval for adults with CLL/SLL without a known 17p deletion—but how does a trial against older chemotherapy guide today's treatment choice? Novartis agrees to $575 million upfront for Abogen's early-stage RNA medicine ABO2203, with closing still pending and autoimmune benefit unproven. Also: Pfizer's Litfulo (ritlecitinib) advances toward vitiligo filings; Biogen reports longer-term litifilimab results in cutaneous lupus without a continuing placebo comparison; and Bayer plans a $2.2 billion Ohio manufacturing site. Alex Mercer and Maya Patel host. Get the daily rundown in your inbox — subscribe at https://thepharmacloseout.com.

Boehringer's survodutide reached up to 13.1% weight loss in Phase 3 assuming patients stayed on treatment, but GI-related dropouts complicate its place in obesity and Type 2 diabetes. CMS's final GLOBE rule tests international prices in Medicare Part B rebates: what changes for patients and doctors? Regeneron's trevogrumab reduced lean-mass loss on scans with semaglutide, without proving greater strength. Also: Sanofi and Regeneron expand their Dupixent alliance with four long-acting antibodies; Foghorn and Lilly stop FHD-909 expansion after insufficient efficacy; and Wave's WVE-006 gets a potential registration path in alpha-1 antitrypsin deficiency. Alex Mercer and Maya Patel host. Get the daily rundown in your inbox — subscribe at https://thepharmacloseout.com.

September 30 edition, released October 1. Date references in the audio are anchored to September 30. Lilly's EloraTZP (eloralintide plus tirzepatide) reached 23.3% weight loss vs 14.8% for tirzepatide in a secondary Phase 2b comparison, while more patients stopped over adverse events. Rafael Holdings' Trappsol Cyclo missed its Phase 3 TRANSPORT-NPC goal in Niemann-Pick disease type C, yet a fourth-quarter filing is still planned. The daily roundup covers Roche's fenebrutinib Priority Review in MS, Merck's tulisokibart in hidradenitis suppurativa, Pierre Fabre's Ebvallo (tabelecleucel) resubmission and NorthStar's actinium-225 financing. Plus Connect Biopharma's rademikibart in COPD flares, with its safety caveats. Alex Mercer and Maya Patel host. Get the daily rundown in your inbox — subscribe at https://thepharmacloseout.com.

September 29 edition: uniQure's four-year Huntington's readout is mixed, while its filing rests on earlier data. AstraZeneca agrees to invest $2 billion in Summit alongside a cancer-combination program, without acquiring Summit's drug rights. In the roundup: Veracyte's retrospective Decipher analysis in prostate cancer; FDA approval of Teva's Xgeva biosimilar; and Novo's license to Hengrui's early oral GLP-1/GIP program. Invivyd reports tolerability, not protection, results for VYD2311, and we examine the September 29 implementation of Section 232 drug tariffs. Alex Mercer and Maya Patel host. Get the daily rundown in your inbox — subscribe at https://thepharmacloseout.com.

Mirum's brelovitug met Phase 3 AZURE-1's virus-plus-ALT endpoint on weekly and every-four-week dosing in chronic hepatitis delta; durable liver outcomes were not shown. Kodiak's Zenkuda and tabirafusp were noninferior to aflibercept 2 mg on vision in wet AMD, and 54% of Zenkuda patients reached a 24-week interval; neither was compared with newer alternatives. 4DMT started Phase 3 testing of 4D-150 in diabetic macular edema, while Roche will return emugrobart rights to Chugai after an obesity trial's interim efficacy stop. Also: Egetis won FDA approval for Emcitate (tiratricol) for peripheral thyrotoxicosis in MCT8 deficiency, Adicet reported early prula-cel lupus data, Merck licensed preclinical SPR2015, and BARDA backed SCYNEXIS's SCY-247. Alex Mercer and Maya Patel host. Get the daily rundown in your inbox — subscribe at https://thepharmacloseout.com.

This full Week in Review is a comprehensive review of the week's covered stories across oncology, kidney and immune disease, respiratory disease, metabolic disease, neuroscience, rare disease and ophthalmology, plus financings, deals and five events ahead. Gilead's anito-cel gets its full peer-reviewed Phase 1 record before a December FDA target; myeloma groups define cure; and Genentech's Gazyva wins approval to reduce relapse risk in childhood-onset nephrotic syndrome. Also in the review: Lilly's once-weekly Onswik approval, Otsuka and Ionis's Phase 3 ulefnersen result in FUS-ALS, Beacon's pivotal laru-zova win, and regulatory, safety and evidence updates across the covered therapeutic areas, followed by the week ahead. Alex Mercer and Maya Patel host. Get the daily rundown in your inbox — subscribe at https://thepharmacloseout.com.

Mirum's Atebrioz (zilurgisertib) wins FDA approval for FOP despite a primary-endpoint miss; Carvykti (ciltacabtagene autoleucel) shows five-year disease control without maintenance in half of 20 myeloma patients. aTyr plans another efzofitimod trial in sarcoidosis. The roundup covers Pharming's Joenja (leniolisib), ADARx's IPO, Canada's Epkinly (epcoritamab) expansion, Novo–Nanexa's long-acting peptide deal, FDA nominee Heidi Overton's hearing, and Medicaid's GENEROUS pricing plan. September 25 edition, published September 26: relative dates and pending events reflect the original reporting cutoff. Alex Mercer and Maya Patel host. Get the daily rundown in your inbox — subscribe at https://thepharmacloseout.com.

Welireg plus Lenvima gains FDA approval in advanced clear-cell kidney cancer, with better disease control but no demonstrated survival advantage. Lilly says FDA approved weekly insulin Onswik, entering a market where Novo’s Awiqli is already available. Merck’s remigromig meets its pivotal vision goal, but safety and dosing questions remain. Plus: Acadia advances after a Phase 2 miss; Kyverna reports autoimmune follow-up; Elevar gains bile-duct cancer approval; Takeda’s Adzynma gets a boxed warning; and Gossamer files despite PROSERA’s miss. Alex Mercer and Maya Patel host. Get the daily rundown in your inbox — subscribe at https://thepharmacloseout.com.

GRAIL’s Galleri won backing from FDA advisers, but the narrow effectiveness split and a missed late-stage-cancer endpoint keep the label and coverage case in focus. Roche and Ionis report that sefaxersen reduced proteinuria in Phase 3 IgA nephropathy, while longer-term kidney-function data remain blinded and Novartis’s Fabhalta (iptacopan) sets the benchmark. Vertex tests inaxaplin in additional APOL1 kidney disease groups, and Amgen’s dazodalibep succeeds in systemic Sjögren’s disease. Plus: Immunovant halts its cutaneous lupus program, Oruka extends psoriasis follow-up, Boehringer Ingelheim signs an Envisagenics cancer-target pact, and Enveda raises $311 million. Alex Mercer and Maya Patel host. Get the daily rundown in your inbox — subscribe at https://thepharmacloseout.com.

Celldex's pivotal barzolvolimab wins in chronic hives carry an anaphylaxis signal. Otsuka and Ionis report a joint-endpoint ALS result for ulefnersen, while Iambic's IPO filing puts its AI platform and early cancer data before investors. Johnson & Johnson's Caplyta (lumateperone) reports bipolar mania data, Compass faces a filing-path question, and Roche's enicepatide and Viking's VK2735 add metabolic results. We also cover NewAmsterdam and Menarini's European obicetrapib authorization and Merck's Winrevair (sotatercept-csrk) label update in pulmonary arterial hypertension. Alex Mercer and Maya Patel host. Get the daily rundown in your inbox — subscribe at https://thepharmacloseout.com.

Beacon’s pivotal VISTA trial met its endpoint in inherited vision loss, with low-light gains and surgical risks shaping the next questions. Telix’s $1.65 billion ITM deal combines isotope supply with an investigational cancer therapy facing manufacturing hurdles. Novo’s CagriSema result in diabetes, Cue’s chronic-hives data and Insmed’s ARIKAYCE (amikacin liposome inhalation suspension) review show different evidence and regulatory paths. FDA opens clearer routes for validated non-animal methods, while a Wednesday panel will examine GRAIL’s Galleri cancer-screening claims. Alex Mercer and Maya Patel host. Get the daily rundown in your inbox — subscribe at https://thepharmacloseout.com.

Novo adds obesity programs as its Ascendis collaboration ends, while ivonescimab's China survival results sharpen the test facing its global lung-cancer program. Europe moves Corcept's Lifyorli toward authorization and backs broader perioperative use of Padcev with Keytruda, while Bayer's Kerendia, Vera's Trutakna, Xenon's azetukalner and Vertex's pediatric cystic-fibrosis applications show different regulatory and evidence paths. Gilead's lenacapavir agreements separate preparation for an investigational annual formulation from procurement of the approved twice-yearly option, with Merck's Winrevair label review and Novo's investor day ahead. Alex Mercer and Maya Patel host. Get the daily rundown in your inbox — subscribe at https://thepharmacloseout.com.

FDA fully approved Lilly's Inluriyo (imlunestrant) plus Verzenio (abemaciclib) after progression in ESR1-mutated advanced breast cancer; evidence is exploratory in 159 patients versus Inluriyo alone, and overall survival remains immature. LEO says FDA accepted dersimelagon's filing with Priority Review—not approval—for light-sensitive EPP and XLP. Novo signed an asset purchase agreement for three Kallyope obesity programs and an Orbis cardiometabolic discovery pact; Electra priced an IPO, and BMS halted Orum's AML/MDS program. CHMP gave MaaT a negative Xervyteg opinion after re-examination in severe gut graft-versus-host disease, while backing Pebrilzo's pertuzumab-biosimilar path and earlier-line Tecvayli monotherapy for multiple myeloma. Alex Mercer and Maya Patel host. Get the daily rundown in your inbox — subscribe at https://thepharmacloseout.com.

Ultragenyx's Fayuvi approval opens a first treatment path for eligible children with Sanfilippo syndrome type A, with preserved function and center access defining the boundary. Alex and Maya examine Xenon's azetukalner epilepsy filing and separate pause in new psychiatry enrollment, plus Roche's Phase 3 CELESTIMO endpoint result for Lunsumio in follicular lymphoma. They also cover Lisata's Marea acquisition and financing; Roche's Dualitas deal; Longeveron's laromestrocel miss in hypoplastic left heart syndrome; Bayer's Kerendia expansion in type 1 diabetes kidney disease; NICE's Enhertu access recommendation in England; and Aquestive's Anaphylm resubmission. Alex Mercer and Maya Patel host. Get the daily rundown in your inbox — subscribe at https://thepharmacloseout.com.

Skyhawk's early SKY-0515 Huntington's signal faces randomized confirmation, while Sling's $123M financing advances oral linsitinib for thyroid eye disease. Alex and Maya examine Novartis's Sironax option and Cogent's bezuclastinib review timetable. They also cover FDA review patterns, Bausch + Lomb's warning letter, and Gilead and PAHO's lenacapavir access agreement. The briefing follows what these clinical, financial and regulatory developments mean, with the evidence limits that matter. Alex Mercer and Maya Patel host. Get the daily rundown in your inbox — subscribe at https://thepharmacloseout.com.