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Daily Roundup | Jaypirca Adds a First-Line CLL Choice & Novartis Signs $575M Abogen License

Season 1

Saturday, October 3, 2026 • Duration 08:47

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.

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Survodutide Phase 3 Comes With GI Tolerability Cost & Trevogrumab Trims Lean-Tissue Loss on Scans

Season 1

Friday, October 2, 2026 • Duration 08:35

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.

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Daily Roundup | Lilly's amylin add-on brings more weight loss and more dropouts & Rafael plans NDA after NPC miss

Season 1

Thursday, October 1, 2026 • Duration 11:34

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.

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Daily Roundup | uniQure's Mixed Huntington's Readout & AstraZeneca's $2B Summit Deal

Season 1

Wednesday, September 30, 2026 • Duration 14:21

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.

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Daily Roundup| Mirum's Brelovitug Wins Phase 3 on Two Schedules & Kodiak's Zenkuda: 54% Reach Six-Month Dosing

Season 1

Tuesday, September 29, 2026 • Duration 15:47

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.

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Full Week in Review | Gilead's Anito-cel, Genentech's Gazyva & Myeloma's New Cure Standard

Season 1

Monday, September 28, 2026 • Duration 48:32

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.

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Daily Roundup | Mirum Wins FOP Approval Despite Primary Endpoint Miss & Carvykti's Five-Year Data

Season 1

Saturday, September 26, 2026 • Duration 12:08

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.

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Daily Roundup| Merck–Eisai Win Kidney Cancer Approval & Lilly Joins Weekly Insulin Race

Friday, September 25, 2026 • Duration 11:12

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.

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Daily Roundup| GRAIL's Galleri Vote Puts Label and Coverage in Focus & Roche Posts Phase 3 Kidney Win

Season 1

Thursday, September 24, 2026 • Duration 13:11

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.

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Celldex Safety Clouds Pivotal Wins & Otsuka–Ionis ALS Trial Hits Joint Endpoint

Season 1

Wednesday, September 23, 2026 • Duration 12:35

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.

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The Pharma Closeout | Daily Pharmaceutical and Biotech News in 15 Minutes – Details, episodes & analysis

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The Pharma Closeout | Daily Pharmaceutical and Biotech News in 15 Minutes – Details, episodes & analysis

Podcast details

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Spotify

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Other5

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Publication history

Latest published episodes

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Other5

Substack2

LinkedIn1

Apple Podcasts

Spotify