The Pharma Closeout | Daily Pharmaceutical & Biotech News in 15 minus

FDA approves Ionis Tryngolza as first treatment to reduce pancreatitis risk in severe hypertriglyceridemia — a potential blockbuster expansion. Merck KGaA acquires Bio-Techne for $11.3B in largest deal in a decade. SCOTUS limits Bayer Roundup state-level claims; Gilead-Pfizer ADC divergence deepens.pharma, pharmaceutical, FDA, clinical trials, biotech, drug approvals, healthcare, pharma podcast, The Pharma Closeout, Ionis, Tryngolza, olezarsen, hypertriglyceridemia, pancreatitis, FDA approval, Merck KGaA, Bio-Techne, Bayer, Roundup, SCOTUS, Gilead, Trodelvy, Pfizer, Seagen, ADC, AbbVie, Apogee, Ollin, Vabysmo, Novartis, Antares, pelacarsen, RQ Bio, Oblenio Bio, Remix, Passage Bio, Eli Lilly, orforglipron, Recordati, Lilly, Roche, Merck

Gilead's Trodelvy wins front-line triple-negative breast cancer approval — and the stock barely moves. Lilly expands its Abbisko partnership to $1.9B, Novartis pays $105M upfront to Antares for undruggable cancer targets, and three ADC stories in two days force a class-level reckoning.pharma, pharmaceutical, FDA, clinical trials, biotech, drug approvals, healthcare, pharma podcast, The Pharma Closeout, Trodelvy, sacituzumab govitecan, Gilead, TNBC, triple-negative breast cancer, FDA approval, Eli Lilly, Abbisko Therapeutics, Novartis, Antares Therapeutics, ADC, antibody-drug conjugate, Pfizer, Ibrance, Ionis, triglycerides, Ollin, Vabysmo, ADC Therapeutics, Zynlonta, HHS, pelacarsen, BioNTech, Lilly, Roche

Pfizer's sigvotatug vedotin disappoints in Phase 3 NSCLC — another blow to the $43B Seagen deal. Plus CMS settles with Incyte on Opzelura classification, Sangamo Therapeutics closes after 30 years, and Moderna's flu vaccine wins unanimous FDA panel support.Visit us at www.thepharmacloseout.compharma, pharmaceutical, FDA, clinical trials, biotech, drug approvals, healthcare, pharma podcast, The Pharma Closeout, Pfizer, Seagen, sigvotatug vedotin, ADC, antibody-drug conjugate, non-small cell lung cancer, NSCLC, Incyte, Opzelura, Jakafi, ruxolitinib, CMS, Medicare Part D, Sangamo Therapeutics, zinc-finger nuclease, gene editing, Eli Lilly, Astellas, Moderna, mFlusiva, flu vaccine, Regenxbio, UniQure, gene therapy, Makary, Genentech, Novartis, Xolair, Braftovi, encorafenib, 340B, Sanofi, Houman Ashrafian, Bionyra, Osanni Bio, Lilly, AstraZeneca, Merck 

AbbVie bets $10.9B on Apogee Therapeutics to challenge Dupixent — its biggest deal since Allergan. Plus: the first CAR-T approved for a solid tumor clears in China, Merck's $10.8B Prometheus IBD bet pays off with a Phase 3 win, and HHS clinical trial reforms target China. Visit www.thepharmacloseout.compharma, pharmaceutical, FDA, clinical trials, biotech, drug approvals, healthcare, pharma podcast, The Pharma Closeout, AbbVie, Apogee Therapeutics, zumilokibart, Dupixent, Regeneron, Sanofi, CARsgen, CAR-T, Claudin 18.2, solid tumor, gastric cancer, Merck, Prometheus Biosciences, IBD, Keytruda, HHS, RFK Jr, clinical trial reform, Moderna, mFlusiva, Alnylam, Pfizer, Kardigan, MacroGenics, TZIELD, Bionyra, cAMPfield, WuXi Biologics, Novartis, pelacarsen, UniQure, AMT-130, Novo Nordisk, ransomware, BMS 

US government opens formal probe into Germany's drug pricing reforms, escalating transatlantic pharma trade tensions. Kardigan IPO raises $400M and pops 31%. Moderna flu vaccine gets unanimous FDA advisory panel support ahead of Aug 5 PDUFA. Jazz and AbCellera strike $4.1B T cell engager collaboration.Visit us at www.thepharmacloseout.compharma, pharmaceutical, FDA, clinical trials, biotech, drug approvals, healthcare, pharma podcast, The Pharma Closeout, Germany drug pricing, US trade probe, Moderna flu vaccine, mFlusiva, Kardigan IPO, Jazz Pharmaceuticals, AbCellera, T cell engagers, Pfizer CFO Dave Denton, Eli Lilly, 4E Therapeutics, Edgewise Biosciences, HCM, Biogen, RayThera, Traws Pharma, tivoxavir marboxil, Merck Capvaxive, Treasury China biotech, cAMPfield, Vedana Therapeutics, Spot Bio, Innoviva, Lyndra, Sanofi, Aurobindo, Lannett, Pfizer, Lilly, Merck, Moderna 

Moderna's mRNA flu vaccine gets unanimous FDA panel backing — PDUFA August 5. NovoCure's TRIDENT trial misses overall survival in glioblastoma; stock drops ~18%. Biogen acquires immunology startup RayThera for up to $1B; Kardigan IPO raises $400M.Visit us at www.thepharmacloseput.compharma, pharmaceutical, FDA, clinical trials, biotech, drug approvals, healthcare, pharma podcast, The Pharma Closeout, Moderna, mFlusiva, MRNA, VRBPAC, mRNA flu vaccine, NovoCure, NVCR, TRIDENT, glioblastoma, TTFields, Biogen, BIIB, RayThera, immunology, Pfizer, PFE, CFO, Kardigan, IPO, cAMPfield, Legend Biotech, LEGN, Carvykti, Eli Lilly, 4E Therapeutics, Merck, Capvaxive, pneumococcal vaccine, Innoviva, Lyndra, Aurobindo, Lannett, FTC, Treasury, China biotech, Lilly, GSK, Sanofi 

UniQure surges 70% as FDA reverses course on Huntington's gene therapy AMT-130 filing path. Jazz and AbCellera strike $4.1B T cell engager deal for GI cancers. Novo Nordisk faces $25M ransom demand after hackers claim drug formulations and AI models. Visit www.thepharmacloseout.compharma, pharmaceutical, FDA, clinical trials, biotech, drug approvals, healthcare, pharma podcast, The Pharma Closeout, UniQure, QURE, AMT-130, Huntington's disease, gene therapy, FDA accelerated approval, Jazz Pharmaceuticals, AbCellera, T cell engagers, Novo Nordisk, cyberattack, data breach, Biogen, RayThera, immunology, Moderna, mFlusiva, VRBPAC, mRNA flu vaccine, GSK, Spero Therapeutics, complicated UTI, compounded GLP-1, Vedana Biosciences, Spot Bio, Triveni Bio, Colorado drug importation 

BridgeBio's BBP-418 sweeps Phase 3 in limb-girdle muscular dystrophy — stock up 15%, no approved competition. FDA briefing docs challenge Moderna mFlusiva efficacy ahead of Thursday's VRBPAC vote. Plus Lilly acquires non-opioid pain startup 4E Therapeutics, Edgewise advances EDG-7500 toward Phase 3 in HCM, and Neumora abandons navacaprant after two Phase 3 failures.Visit www.thepharmacloseput.compharma, pharmaceutical, FDA, clinical trials, biotech, drug approvals, healthcare, pharma podcast, The Pharma Closeout, BridgeBio, BBP-418, LGMD, limb-girdle muscular dystrophy, Moderna, mFlusiva, VRBPAC, flu vaccine, Eli Lilly, 4E Therapeutics, non-opioid pain, MNK inhibitor, Edgewise, EDG-7500, HCM, hypertrophic cardiomyopathy, Adaptive Biotechnologies, MRD, Neumora, navacaprant, myelofibrosis, Jakafi, Be Biopharma, enGene, Parabilis, biotech IPO, Colorado drug import, Lilly, Novartis 

CMS proposes closing Medicare negotiation loophole threatening Keytruda and Opdivo subcutaneous strategies — billions at stake. Plus Takeda's zasocitinib tops Sotyktu, Novartis validates $12B Avidity deal, Elicio's KRAS vaccine crashes, and FDA approves Truqap in prostate cancer and Tzield for pediatric T1D.Visit us at www.thepharmacloseout.compharma, pharmaceutical, FDA, clinical trials, biotech, drug approvals, healthcare, pharma podcast, The Pharma Closeout, CMS, Medicare drug price negotiation, IRA, Keytruda, pembrolizumab, Opdivo, nivolumab, subcutaneous, Merck, Bristol Myers Squibb, Takeda, zasocitinib, Sotyktu, deucravacitinib, TYK2, Novartis, Avidity Biosciences, del-brax, RNA therapeutics, Elicio Therapeutics, KRAS, cancer vaccine, ELI-002, pancreatic cancer, AstraZeneca, Truqap, capivasertib, prostate cancer, PTEN, Sanofi, Tzield, teplizumab, type 1 diabetes, Welireg, belzutifan, kidney cancer, J&J, Talvey, Darzalex Faspro, multiple myeloma, Summit Therapeutics, ivonescimab, oveporexton, narcolepsy, SLEEP 2026, Gan & Lee, bofanglutide, obesity, GLP-1, Eisai, Leqembi, Lilly, BMS

The Pharma Closeout's comprehensive recap of EHA 2026(Stockholm, June 11-14). HEADLINE: J&J's MonumenTAL-3 (talquetamab +daratumumab) in earlier-line R/R myeloma — PFS HR 0.28/0.33, complete-response 71% vs 34.5%, NEJM-published; ~73% dysgeusia the caveat.AML: the menin inhibitor frontline class war — ziftomenib KOMET-007 (CRc 96% NPM1m / 90%KMT2Ar) vs revumenib (frontline CRc 97%; SAVE ORR 88%) — and the gilteritinib-vs-midostaurin FLT3 survival miss (HR 1.02). CLL: BRUIN CLL-322 — pirtobrutinib + venetoclax-rituximab, PFS HR 0.55, first Phase 3 to beat a venetoclax control. LYMPHOMA: frontMIND (tafasitamab+len+R-CHOP, 1L DLBCL, PFS HR 0.75) and EPCORE DLBCL-1 (epcoritamab wins PFS, misses OS). MYELOFIBROSIS: SENTRY (selinexor+rux, SVR35 49.8% vs 28%, symptom co-primary missed). BENIGNHEME: warm AIHA gets two drugs (sovleplenib, nipocalimab) in a disease with no approved therapy; CASGEVY first pediatric gene-editing data. Lightning round, discipline corner (why three 'EHA' myeloma headlines were actually ASCO), and what to watch. Three throughlines: immunotherapy moving earlier andoff-the-shelf, a frontline standard-of-care reset, and the survival misses that set the discipline. Stock reactions qualitative only.pharma, pharmaceutical, hematology, blood cancer, clinicaltrials, biotech, EHA 2026, pharma podcast, The Pharma Closeout

FDA approves Merck's Welireg-Keytruda combo for adjuvant kidney cancer — 28% risk reduction vs. active Keytruda monotherapy in LITESPARK-022. Jazz's Zepzelca misses OS endpoint in Phase 3 LAGOON, Incyte acquires Vega Therapeutics for $1.25B, and Amgen files independent Duke review to fight FDA's proposed Tavneos withdrawal.pharma, pharmaceutical, FDA, clinical trials, biotech, drug approvals, healthcare, pharma podcast, The Pharma Closeout, Merck, Keytruda, Welireg, belzutifan, pembrolizumab, kidney cancer, renal cell carcinoma, LITESPARK-022, Jazz Pharmaceuticals, Zepzelca, lurbinectedin, small cell lung cancer, LAGOON, Incyte, Vega Therapeutics, Star Therapeutics, Amgen, Tavneos, avacopan, AstraZeneca, Truqap, capivasertib, prostate cancer, Sanofi, Tzield, type 1 diabetes, Enliven Therapeutics, WuXi AppTec, CMS, Medicare, IRA, Novo Nordisk, oral semaglutide, M&A, GSK

Zasocitinib hits 35% complete skin clearance at week 16,topping Sotyktu by more than 2.5x in Takeda's head-to-head Phase 3. Plus: Novartis validates its $12B Avidity AOC platform in FSHD, Summit withdraws $500M offering, and Genentech reshapes its research organization.Visit us at www.thepharmacloseout.compharma, pharmaceutical, FDA, clinical trials, biotech, drugapprovals, healthcare, pharma podcast, The Pharma Closeout, zasocitinib, Takeda, Sotyktu, deucravacitinib, Bristol Myers Squibb, TYK2, plaque psoriasis, PASI 100, Novartis, Avidity Biosciences, AOC, muscular dystrophy, FSHD, SummitTherapeutics, ivonescimab, Kardigan, IPO, J&J, nipocalimab, Imaavy, wAIHA, Genentech, Roche, Vishva Dixit, Camurus, Oclaiz, acromegaly, CRL, Sensorion, Regeneron, hearing loss, Ethyreal, thyroid eye disease, Teva, Astellas, Xtandi, BMS

Parabilis Medicines prices the largest-ever venture-backed biotech IPO at $670M as 12 startups top $4.1B in 2026. Sanofi stops MOBILIZE Phase 3 for riliprubart in CIDP. TG Therapeutics surges on Briumvi myasthenia gravis data. AstraZeneca's oral GLP-1 elecoglipron hits 11.8% weight loss.Visit us at www.thepharmacloseout.compharma, pharmaceutical, FDA, clinical trials, biotech, drug approvals, healthcare, pharma podcast, The Pharma Closeout, Parabilis Medicines, biotech IPO, zolucatetide, TG Therapeutics, Briumvi, ublituximab, myasthenia gravis, Sanofi, riliprubart, CIDP, complement inhibitor, AstraZeneca, elecoglipron, GLP-1, oral obesity, Novartis, Orionis Biosciences, molecular glue, Beren Therapeutics, adrabetadex, Niemann-Pick disease, SonoThera, Ethyreal, City Therapeutics, Shattuck Labs, Treeline Biosciences, COINS Act, Pfizer, Lilly, Moderna

The Pharma Closeout's full recap of the American Diabetes Association's 86th Scientific Sessions (New Orleans,June 5-8, 2026) - the meeting that ended the A1C-only era and reset what obesity medicine can do. Hosts Alex Mercer and Maya Patel walk every major readout, with the commercial read on each.Visit us at www.thepharmacloseout.comADA 2026, American DiabetesAssociation, diabetes, obesity, GLP-1, retatrutide, orforglipron, tirzepatide, semaglutide, CagriSema, survodutide, MASH, type 1 diabetes, tegoprubart,teplizumab, Dexcom, CGM, automated insulin delivery, Eli Lilly, Novo Nordisk, Boehringer Ingelheim, AstraZeneca, Roche, Standards of Care, weight loss drugs,endocrinology, pharma, biotech, clinical trials

In about six weeks this spring, four of the biggest names in pharma each picked an AI partner — Bristol Myers Squibb chose Anthropic's Claude for 30,000+ employees, Merck signed with Google Cloud for up to $1B, Novo Nordisk went with OpenAI, and Eli Lilly built what NVIDIA calls the industry's most powerful AI supercomputer. A Pharma Closeout Special Report, fact-checked against the primary company and FDA releases, on what they actually bought — and who's likely to be proven right.Visit us at www.thepharmacloseout.com pharma, pharmaceutical, AI, agentic AI, artificialintelligence, drug development, biotech, FDA, healthcare, pharma podcast, ThePharma Closeout, Anthropic, Claude, OpenAI, Google Cloud, Gemini, NVIDIA,Bristol Myers Squibb, Merck, Novo Nordisk, Eli Lilly, AstraZeneca, Sanofi,Pfizer, digital health

Alnylam commits up to $2B to Inceptive Nucleics forAI-driven RNAi drug discovery — $30M upfront, milestone-heavy structure. Lundbeck's bocunebart hits Phase IIb primary endpoint with 1.38-day treatmentdifference in refractory migraine. Plus Otsuka Voyxact IgAN data, Replimune's third RP1 submission, the Supreme Court's skinny label ruling, and Biogen's salanersen Breakthrough Therapy Designation.

SCOTUS unanimously backs Hikma's skinny-label Vascepa generic, reshaping patent defense for branded pharma. ADC Therapeutics drops 50%+ on LOTIS-5 death rate (13.2% vs 4.6%), biotech M&A crosses $106B in 2026, and Legend Biotech surges on in vivo CAR-T data.Visit us at www.thepharmacloseout.compharma, pharmaceutical, FDA, clinical trials, biotech, drug approvals, healthcare, pharma podcast, The Pharma Closeout, Hikma, Amarin, Vascepa, skinny label, Supreme Court, generics, ADC Therapeutics, Zynlonta, loncastuximab tesirine, DLBCL, LOTIS-5, Legend Biotech, CAR-T, in vivo, Novo Nordisk, manufacturing, Kyle Diamantas, Merck, WELIREG, KEYTRUDA, Alnylam, Inceptive, Parabilis, Fulcrum, Celcuity, Axsome, Sunosi, biotech M&A, COINS Act, Otsuka, Voyxact, IgA nephropathy, Pfizer, Novartis, GSK

Part 2 of The Pharma Closeout's ASCO 2026 special covers the closing days, MondayJune 1 and Tuesday June 2 — net-new readouts plus resolution of Part 1's June 1-2 watch-list. HEADLINE: izalontamab brengitecan (iza-bren), an EGFR-directed bispecificADC, hits dual PFS+OS endpoints in pretreated TNBC (OS HR 0.60, PFS HR 0.29, ORR 52% vs 21%) and again in 2L esophageal squamous cancer (OS HR 0.64).BREAST: persevERA misses (giredestrant+palbociclib, HR 0.89, p=0.16); SERENA-6 final PFS2 (camizestrant, HR 0.63); I-SPY 2.2. GI: HERIZON-GEA-01 (zanidatamab+tislelizumab >2-yr OS, HR 0.72); EMERALD-3 (STRIDE+lenvatinib+TACE liver, PFS HR 0.70); ivonescimab 1L MSS CRC (ORR 71%);FIGHT-302; ATTRACTION-6 miss. GU/GYNE/OCULAR: OptimUM-02 (darovasertib+crizotinib, first Phase 3 win in HLA-A*02:01-neg uveal melanoma, PFS HR0.42 — covered neutrally, Servier co-developer); RUBY (dostarlimab dMMR endometrial cure modeling, 4-yr OS HR 0.34); NRG-GY018 (HR 0.56); Bluestar (B7-H4 ADC);MIROVA miss. HEME: SENTRY (selinexor+rux MF, SVR35 49.8% vs 28%, OS HR 0.43, symptom co-primary missed); eganelisib; CLOVER-WaM. LUNG: ALCHEMIST adjuvantnivolumab negative (HR 0.97); MARIPOSA non-event (mature OS was a 2025 readout). MELANOMA: KEYNOTE-942 5-yr (intismeran autogene, 49% RFS reduction). H&N:FID-007. Themes: bispecifics/ADCs come of age, China-origin assets, and a wave of instructive negatives. Stock moves described qualitatively only.

ASCO 2026 comprehensive opening-weekend recap (28 readouts through Sunday, May 31). Headline: Revolution Medicines' RASolute 302 doubles overall survival in second-line pancreatic cancer (daraxonrasib, 13.2 vs 6.7months, HR 0.40). LUNG: CROWN 7-year (lorlatinib 55% vs 3% PFS), LIBRETTO-432 adjuvant selpercatinib (83% reduction), WU-KONG28 sunvozertinib, HARMONi-6ivonescimab (34% OS, soft reaction), OptiTROP-Lung05 sac-TMT (PFS HR 0.35), plus ROSETTA Lung-02, CHRYSALIS-2, Krascendo-170, elisrasib. BREAST: KEYNOTE-522 7-yr OS (85.1% vs 77.2%), lidERA. GI: RASolute 302, CIRCULATE ctDNA-guidedcolon, EPISODE-III aspirin miss. PROSTATE: PROTEUS, TALAPRO-3 (PARP into mHSPC rPFS HR 0.481). KIDNEY: RAMPART split. HEAD & NECK: TMC-I (~$225/moregimen, 43% death-risk reduction). GLIOMA: INDIGO vorasidenib (PFS 44.1mo). SARCOMA: SARC041 abemaciclib. HEME: MajesTEC-9 teclistamab, SUCCESSOR-2 mezigdomide, frontMIND tafasitamab, golcadomide, PRIMAVERA. MELANOMA: IGNYTE/RP1. SCREENING: NHS-Galleri miss. Plus the June 1-2 forward look.pharma, pharmaceutical, FDA, clinical trials, biotech, drugapprovals, healthcare, pharma podcast, The Pharma Closeout, ASCO 2026,Revolution Medicines, daraxonrasib, RASolute 302, RAS, KRAS, pancreatic cancer,lorlatinib, CROWN, Pfizer, selpercatinib, LIBRETTO-432, RET fusion, lungcancer, NSCLC, sunvozertinib, WU-KONG28, Dizal, ivonescimab, HARMONi-6, Akeso,Summit Therapeutics, bispecific, sacituzumab tirumotecan, OptiTROP-Lung05,Kelun, Merck, ADC, pumitamig, BioNTech, amivantamab, lazertinib, CHRYSALIS-2,divarasib, Krascendo-170, elisrasib, pembrolizumab, KEYNOTE-522,triple-negative breast cancer, giredestrant, lidERA, Roche, CIRCULATE, ctDNA,colorectal cancer, EPISODE-III, aspirin, PROTEUS, apalutamide, Erleada,prostate cancer, Johnson & Johnson, talazoparib, enzalutamide, TALAPRO-3,PARP, RAMPART, durvalumab, kidney cancer, AstraZeneca, TMC-I, nivolumab, headand neck cancer, Tata Memorial, vorasidenib, INDIGO, glioma, Servier, SARC041,abemaciclib, liposarcoma, sarcoma, teclistamab, MajesTEC-9, mezigdomide,SUCCESSOR-2, multiple myeloma, BMS, tafasitamab, frontMIND, Incyte, DLBCL,golcadomide, PRIMAVERA, AZD3470, Hodgkin lymphoma, RP1, IGNYTE, Replimune,melanoma, NHS-Galleri, GRAIL, MCED, early detection, MARIPOSA, oncology, Lilly,J&J 

RevMed's ASCO pancreatic cancer data earn 'unprecedented' from three major outlets — potential paradigm shift in a historically intractable tumor. Plus ivonescimab's 34% OS improvement with caveats,Pfizer-Innovent's $10.5B deal for 12 cancer programs, and GSK/Ionis's buried hepatitis B 'functional cure.'Visit us at www.thepharmacloseout.compharma, pharmaceutical, FDA, clinical trials, biotech, drugapprovals, healthcare, pharma podcast, The Pharma Closeout, RevolutionMedicines, ivonescimab, Akeso, Summit Therapeutics, Pfizer, Innovent Biologics,Eli Lilly, ASCO 2026, pancreatic cancer, KRAS, RAS, lung cancer, bepirovirsen,GSK, Ionis, hepatitis B, Braftovi, Lorbrena, Talzenna, Erleada, Zepbound,Foundayo, MannKind, Afrezza, Incyte, Monjuvi, DLBCL, BMS, Retevmo, Allogene,Lilly, Novo Nordisk, Merck, J&J

Pfizer and Innovent strike a deal worth up to $10.5B for 12 cancer programs — the sixth mega-licensing deal out of China since last July. BMS wins Phase 3 for Pomalyst successor mezigdomide at ASCO 2026. Merck, Agios, MannKind, and PDUFA reauthorization round out a packed Friday.Visit us at www.thepharmacloseout.compharma, pharmaceutical, FDA, clinical trials, biotech, drug approvals, healthcare, pharma podcast, The Pharma Closeout, Pfizer, Innovent Biologics, Bristol Myers Squibb, mezigdomide, Pomalyst, CELMoD, ASCO 2026, Merck, China licensing, Biosecure Act, oncology, Agios, tebapivat, MDS, MannKind, Afrezza, AstraZeneca, Imfinzi, Tremfya, Venclyxto, Dizal Pharma, EGFR, Replimune, melanoma, Allogene, PDUFA reauthorization, drug pricing, most-favored-nation, Roche, J&J, AbbVie, BMS 

Bepirovirsen hits 19% functional cure rate in Phase 3 chronic HBV trials — a first for a disease affecting 300 million. Plus Spero's 245% surge on tebipenem, AstraZeneca's Imfinzi NMIBC approval, CVS restoring Lilly obesity drug coverage, BridgeBio LGMD data, Kardigan IPO plans, and ASCO 2026 abstracts drop.Visit us at www.thepharmacloseout.compharma, pharmaceutical, FDA, clinical trials, biotech, drug approvals, healthcare, pharma podcast, The Pharma Closeout, bepirovirsen, GSK, Ionis, hepatitis B, functional cure, Spero Therapeutics, tebipenem, oral carbapenem, cUTI, CVS, Eli Lilly, Zepbound, Foundayo, obesity drugs, AstraZeneca, Imfinzi, durvalumab, bladder cancer, NMIBC, BridgeBio, BBP-418, LGMD, muscular dystrophy, Kardigan Therapeutics, MyoKardia, Secretome Therapeutics, Duchenne, ASCO 2026, Trump drug pricing, MFN, Akeso, Novo Nordisk, Merck, BioNTech, Moderna, Lilly, Sanofi, BMS 

Pfizer's 25-valent pneumococcal shot shows 8.8x–15x higher antibody levels vs. Prevnar 20 in Phase 2, advancing to Phase 3. BMS deploys Claude across 30,000+ employees in landmark pharma-AI deal. Lilly acquires Engage Bio for $202M. Tavneos linked to 20 deaths in Japan.Visit us at www.thepharmacloseout.compharma, pharmaceutical, FDA, clinical trials, biotech, drug approvals, healthcare, pharma podcast, The Pharma Closeout, Pfizer, Prevnar 20, 25vPnC, pneumococcal vaccine, Bristol Myers Squibb, BMS, Anthropic, Claude, artificial intelligence, enterprise AI, Eli Lilly, Engage Biologics, Gilead Sciences, Yuhan, Amgen, Tavneos, avacopan, ImmunityBio, Anktiva, NMIBC, Parabilis, Relay Therapeutics, GHO Capital, CBC Group, PDUFA, Lilly, Novartis, Roche, Merck, Gilead, Regeneron

Takeda hit with $885M pay-for-delay verdict over generic Amitiza delay. UCB's Bimzelx beats AbbVie's Skyrizi 49% vs 38% on ACR50 in PsA head-to-head. Trump bought up to $680K in Eli Lilly stock while admin promoted obesity drugs. Maryland caps Ozempic payments. Amgen Tavneos linked to 20 deaths in Japan. Relay zovegalisib Phase 2 data beats expectations. Visit us at www.thepharmacloseout.compharma, pharmaceutical, FDA, clinical trials, biotech, drug approvals, healthcare, pharma podcast, The Pharma Closeout, Takeda, Amitiza, pay-for-delay, antitrust, UCB, Bimzelx, bimekizumab, AbbVie, Skyrizi, risankizumab, psoriatic arthritis, Trump, Eli Lilly, Zepbound, Mounjaro, obesity drugs, Maryland, Ozempic, Novo Nordisk, semaglutide, Amgen, Tavneos, avacopan, Relay Therapeutics, zovegalisib, BioMarin, ENPP1, Roche, Xofluza, Regeneron, Parabilis, Novartis, Porton, CDMO, Tarsier Pharma, drug pricing, Lilly, AstraZeneca

Regeneron's fianlimab misses PFS endpoint in melanoma, erasing ~$8B in market cap. Supreme Court rejects IRA pricing challenges from six pharma companies. FDA approves AstraZeneca's first-in-class Baxfendy for hypertension. Merck's sac-TMT scores Phase 3 dual-endpoint win.Visit us at www.thepharmacloseput.com pharma, pharmaceutical, FDA, clinical trials, biotech, drug approvals, healthcare, pharma podcast, The Pharma Closeout, Regeneron, fianlimab, LAG-3, melanoma, REGN, Keytruda, pembrolizumab, Merck, sac-TMT, sacituzumab tirumotecan, endometrial cancer, Kelun-Biotech, AstraZeneca, Baxfendy, baxdrostat, hypertension, Supreme Court, IRA, drug pricing, Medicare, Amgen, Tavneos, avacopan, CDER, Sara Høeg, Bristol Myers Squibb, Enhertu, Parabilis Medicines, Novo Nordisk, Novartis, Bristol-Myers, BMS

Three top FDA positions now in temporary hands as CDER's Høeg follows Makary out the door. Roche's Tecentriq wins ctDNA-guided bladder cancer approval with 36% DFS and 41% OS risk reductions paired with Natera's Signatera diagnostic. Plus Enhertu's early breast cancer expansion, Rigel's $85M Veppanu deal, Biogen's tau gamble, and oral Wegovy's first prescription decline.Visit is at www.thephamacloseout.compharma, pharmaceutical, FDA, clinical trials, biotech, drug approvals, healthcare, pharma podcast, The Pharma Closeout, CDER, Tracy Beth Høeg, Marty Makary, Richard Pazdur, Roche, Tecentriq, atezolizumab, Natera, Signatera, ctDNA, bladder cancer, Enhertu, trastuzumab deruxtecan, Daiichi Sankyo, AstraZeneca, breast cancer, HER2, Novo Nordisk, Wegovy, oral semaglutide, GLP-1, Aardvark Therapeutics, ARD-101, Prader-Willi syndrome, Rigel Pharmaceuticals, Veppanu, vepdegestrant, Arvinas, Pfizer, United Therapeutics, UHeart, xenotransplantation, Biogen, BIIB080, tau, Alzheimer's, Takeda, Create Medicines, mifepristone, SCOTUS, Lilly, Merck 

AstraZeneca's VOLGA trial hits EFS and OS incisplatin-ineligible bladder cancer, putting Imfinzi squarely in Keytruda's lane. Plus: Regenxbio's Duchenne gene therapy heads for FDA filing amid safetysignals, a brain tumor linked to a viral vector raises AAV concerns, and biopharma rallies behind Richard Pazdur for FDA commissioner. Also: BMS-Hengrui$15.2B alliance, BeOne's Beqalzi challenges Venclexta, and Taiho's Inqovi expands into AML.visit us at www.thepharmacloseout.compharma, pharmaceutical, FDA, clinical trials, biotech, drugapprovals, healthcare, pharma podcast, The Pharma Closeout, AstraZeneca, Imfinzi, durvalumab, bladder cancer, VOLGA, Merck, Keytruda, Padcev, Pfizer,Regenxbio, RGX-202, Duchenne muscular dystrophy, gene therapy, BeOne, Beqalzi, sonrotoclax, Venclexta, Taiho, Inqovi, AML, FDA commissioner, Richard Pazdur,Encoded Therapeutics, Dravet syndrome, ETX101, BMS, Hengrui, Takeda, MacroGenics, BioAge, Isomorphic Labs, Kyverna, Biogen, diranersen, Alzheimer's, ASGCT, Roche, AbbVie

FDA approves Beqalzi (sonrotoclax) for mantle cell lymphoma — the first new BCL-2 inhibitor in a decade, directly challenging AbbVie's Venclexta franchise. Takeda slashes 4,500 jobs in a $1.26B restructuring; Lilly and Novo duel with new obesity maintenance data on the same day.Visit us a www.thepharmcloseout.compharma, pharmaceutical, FDA, clinical trials, biotech, drug approvals, healthcare, pharma podcast, The Pharma Closeout, BeOne, Beqalzi, sonrotoclax, BCL-2 inhibitor, mantle cell lymphoma, AbbVie, Venclexta, Takeda, restructuring, layoffs, Eli Lilly, Novo Nordisk, obesity, GLP-1, Zepbound, Foundayo, Tessera Therapeutics, sickle cell disease, gene editing, FDA leadership, Makary, Assertio, Zydus, Pfizer, Hympavzi, hemophilia, Valneva, Galapagos, Lakefront Biotherapeutics, Merck KGaA, hantavirus, Replimune, Lilly, Merck, BMS, Gilead, Moderna 

FDA Commissioner Makary resigns; Kyle Diamantas steps in as acting chief amid regulatory upheaval. BMS and Hengrui ink $15.2B alliance across 13 programs in oncology, hematology, and immunology. Lilly's Foundayo maintains 82% of weight loss vs. Wegovy switch in ATTAIN-MAINTAIN Phase 3 data.Visit us at www.thepharmacloseout.compharma, pharmaceutical, FDA, clinical trials, biotech, drug approvals, healthcare, pharma podcast, The Pharma Closeout, Marty Makary, Kyle Diamantas, Bristol Myers Squibb, BMS, Hengrui Pharma, Eli Lilly, Foundayo, orforglipron, Zepbound, tirzepatide, Wegovy, Novo Nordisk, Rigel Pharmaceuticals, Veppanu, vepdegestrant, Pfizer, Arvinas, PROTAC, Alkermes, Lumryz, Avadel, idiopathic hypersomnia, obesity, weight loss, breast cancer, BioMarin, Amicus, GSK, Sino Biopharmaceutical, bepirovirsen, Isomorphic Labs, Bayer, Leqembi, Critical Medicines Act, hantavirus, Lilly, AstraZeneca

CSL's $5B write-down from the Vifor Pharma acquisition sends shares to a nine-year low — the largest single-day drop on record. Inhibrx's INBRX-106 posts 44% ORR vs Keytruda's 21% in head and neck cancer. PlusRezdiffra clears $311M in Q1, Fractyl's GLP-1 gene therapy gets European clinical trial greenlight, and Daiichi Sankyo targets global top-5 oncology by 2035.visit us at www.thepharmacloseout.com pharma, pharmaceutical, FDA, clinical trials, biotech, drugapprovals, healthcare, pharma podcast, The Pharma Closeout, CSL, Vifor Pharma,INBRX-106, Inhibrx Biosciences, Keytruda, pembrolizumab, Merck, HNSCC, head andneck cancer, Rezdiffra, resmetirom, Madrigal Pharmaceuticals, MASH, FractylHealth, GLP-1 gene therapy, Eli Lilly, Mounjaro, Zepbound, Daiichi Sankyo,Enhertu, ADC, antibody-drug conjugate, Bizengri, zenocutuzumab, NRG1, CNPV,GSK, Sino Biopharmaceutical, bepirovirsen, hepatitis B, Braveheart Bio, Hengrui, hypertrophic cardiomyopathy, Lilly

FDA approves Vyvgart for all adult gMG serotypes two daysbefore PDUFA — argenx locks in broadest MG label with no FcRn rival in seronegative disease. Plus Merck's $6.7B Terns completion, Avalo's Phase 2 HS win, and Gilead's billion-dollar PrEP forecast.www.thepharmacloseout.compharma, pharmaceutical, FDA, clinical trials, biotech, drugapprovals, healthcare, pharma podcast, The Pharma Closeout, Vyvgart,efgartigimod, argenx, myasthenia gravis, seronegative gMG, ADAPT SERON, Merck,Terns Pharmaceuticals, TERN-701, CML, chronic myeloid leukemia, Gilead,Yeztugo, PrEP, Biktarvy, Avalo Therapeutics, abdakibart, hidradenitissuppurativa, Viridian, elegrobart, thyroid eye disease, Celcuity, gedatolisib,breast cancer, Enhertu, Daiichi Sankyo, AstraZeneca, Odyssey Therapeutics, CellCentric,Bayer, Perfuse, Roche, PathAI, BioNTech, Leqembi, Entrada, FDA approval,M&A, IPO, J&Jpharma, pharmaceutical, FDA, clinical trials, biotech, drugapprovals, healthcare, pharma podcast, The Pharma Closeout, Vyvgart,efgartigimod, argenx, myasthenia gravis, seronegative gMG, ADAPT SERON, Merck,Terns Pharmaceuticals, TERN-701, CML, chronic myeloid leukemia, Gilead,Yeztugo, PrEP, Biktarvy, Avalo Therapeutics, abdakibart, hidradenitissuppurativa, Viridian, elegrobart, thyroid eye disease, Celcuity, gedatolisib,breast cancer, Enhertu, Daiichi Sankyo, AstraZeneca, Odyssey Therapeutics, CellCentric,Bayer, Perfuse, Roche, PathAI, BioNTech, Leqembi, Entrada, FDA approval,M&A, IPO, J&Jpharma, pharmaceutical, FDA, clinical trials, biotech, drugapprovals, healthcare, pharma podcast, The Pharma Closeout, Vyvgart,efgartigimod, argenx, myasthenia gravis, seronegative gMG, ADAPT SERON, Merck,Terns Pharmaceuticals, TERN-701, CML, chronic myeloid leukemia, Gilead,Yeztugo, PrEP, Biktarvy, Avalo Therapeutics, abdakibart, hidradenitissuppurativa, Viridian, elegrobart, thyroid eye disease, Celcuity, gedatolisib,breast cancer, Enhertu, Daiichi Sankyo, AstraZeneca, Odyssey Therapeutics, CellCentric,Bayer, Perfuse, Roche, PathAI, BioNTech, Leqembi, Entrada, FDA approval,M&A, IPO, J&J

FDA leadership in crisis — multiple outlets report Trump will fire Commissioner Makary after 14 turbulent months. Leqembi SC review extended three months to August 24. Bayer acquires Perfuse for $2.45B; Daiichi Sankyo takes $610M ADC manufacturing hit; Gilead targets $1B in Yeztugo sales.Visit us at www.thepharmcloseout.compharma, pharmaceutical, FDA, clinical trials, biotech, drug approvals, healthcare, pharma podcast, The Pharma Closeout, Marty Makary, Trump, Leqembi, lecanemab, Eisai, Biogen, Bayer, Perfuse Therapeutics, glaucoma, Daiichi Sankyo, ADC, Enhertu, Gilead, Yeztugo, lenacapavir, PrEP, HIV, Bizengri, zenocutuzumab, CNPV, Partner Therapeutics, Artiva, rheumatoid arthritis, Odyssey Therapeutics, IPO, Entrada, Capricor, Duchenne, DMD, Angelini, Catalyst, Argenx, Vyvgart, Novo Nordisk, Wegovy, Sarepta, Lilly, Sanofi

Angelini Pharma pays $4.1B cash for Catalyst Pharmaceuticals — the fourth biotech buyout this month. Atara surges 40%+ on FDA path to resubmit tab-cel BLA. Roche acquires PathAI in $1B+ AI diagnostics deal. Duchenne takes two hits as Entrada data disappoint and Sarepta slides.Visit us at www. thepharmacloseout.compharma, pharmaceutical, FDA, clinical trials, biotech, drugapprovals, healthcare, pharma podcast, The Pharma Closeout, Angelini Pharma,Catalyst Pharmaceuticals, Firdapse, amifampridine, Lambert-Eaton myasthenicsyndrome, Atara Biotherapeutics, tabelecleucel, tab-cel, Pierre Fabre, Roche,PathAI, digital pathology, Entrada Therapeutics, ENTR-601-44, Duchenne musculardystrophy, Sarepta, Elevidys, EnGene, bladder cancer, Alnylam, Amvuttra,vutrisiran, Blackstone, Anagram Therapeutics, cystic fibrosis, Eli Lilly,manufacturing, Amazon, Ozempic, oral semaglutide, Novo Nordisk, MirumPharmaceuticals, volixibat, PSC, Argenx, Vyvgart, Leqembi, MannKind, Afrezza,M&A, rare disease, Lilly, Merck, AbbVie, Gilead, Bayer

Bayer bets up to $2.45B on glaucoma drug maker PerfuseTherapeutics — its biggest pharma deal in years. Novo's oral Wegovy hits $355M in Q1, the strongest GLP-1 launch by volume in the US. Plus UCB's $2.2B Candid deal, GSK's $1B SiranBio siRNA licensing, Lilly's $4.5B manufacturing pledge, and Sanofi walks away from the FDA's CNPV program.Visit us at www.thepharmacloseout.compharma, pharmaceutical, FDA, clinical trials, biotech, drugapprovals, healthcare, pharma podcast, The Pharma Closeout, Bayer, PerfuseTherapeutics, PER-001, glaucoma, diabetic retinopathy, ophthalmology, NovoNordisk, Wegovy, oral semaglutide, obesity, GLP-1, UCB, Candid Therapeutics,bispecific antibodies, autoimmune, GSK, SiranBio, siRNA, ALK7, cardiometabolic,Eli Lilly, manufacturing, Sanofi, Tzield, teplizumab, CNPV, VYVGART, Argenx,myasthenia gravis, Viridian, thyroid eye disease, Celcuity, ASCO, IRA, drugpricing, MFN, Avalo Therapeutics, CellCentric, Latus Bio, Cytokinetics,Madrigal, MASH, BioNTech, Novartis, Lilly, AbbVie, Amgen

Myqorzo hits both endpoints in ACACIA-HCM, opening amultibillion-dollar HCM market Camzyos can't reach. Plus: Pfizer scraps its last CD47 program from the $2.3B Trillium acquisition, Madrigal licenses Arrowhead's PNPLA3 siRNA for up to $1B, and the Supreme Court keeps mifepristone in play.Visit us at www.thepharamcloseout.compharma, pharmaceutical, FDA, clinical trials, biotech, drugapprovals, healthcare, pharma podcast, The Pharma Closeout, Cytokinetics,Myqorzo, aficamten, hypertrophic cardiomyopathy, HCM, ACACIA-HCM, Pfizer,Trillium Therapeutics, CD47, Madrigal, Arrowhead, MASH, PNPLA3, Rezdiffra,mifepristone, Supreme Court, Auvelity, Axsome, Viridian, Tepezza, Intercept,BioNTech, Jakafi XR, Incyte, Leqembi, Sanofi, Passage Bio, Gilead, Arcellx,Novartis, J&J, Amgen

Supreme Court grants emergency stay restoring mifepristone access — and the ruling's implications hit every drugmaker's risk model. Plus: Arvinas/Pfizer's vepdegestrant becomes the first PROTAC approved by the FDA, UCB acquires Candid Therapeutics for $2.2B in autoimmune bispecifics, and Cytokinetics' pivotal HCM readout lands tomorrow.Visit us at www.thepharmacloseout.compharma, pharmaceutical, FDA, clinical trials, biotech, drug approvals, healthcare, pharma podcast, The Pharma Closeout, mifepristone, Supreme Court, PROTAC, vepdegestrant, Veppanu, Arvinas, Pfizer, UCB, Candid Therapeutics, bispecific antibodies, autoimmune, Teva, Emalex, ecopipam, Tourette syndrome, Ligand, XOMA, royalty, Incyte, Jakafi XR, ruxolitinib, Axsome, Auvelity, Alzheimer's agitation, Celcuity, gedatolisib, breast cancer, Cytokinetics, aficamten, HCM, Samsung Biologics, Windward Bio, Amgen, Novartis, oral GLP-1, Foundayo, Wegovy, AbbVie, Regeneron 

UCB drops $2B upfront for Candid Therapeutics' autoimmune T-cell engager cizutamig — their second billion-dollar deal in three weeks. FDA proposes withdrawing Amgen's Tavneos over data manipulation allegations. Pfizer/Arvinas' Veppanubecomes the first approved PROTAC degraderVisit us at www.thepharmacloseout.compharma, pharmaceutical, FDA, clinical trials, biotech, drugapprovals, healthcare, pharma podcast, The Pharma Closeout, UCB, Candid vTherapeutics, cizutamig, autoimmune, T-cell engager, BCMA, Amgen, Tavneos, avacopan, FDA withdrawal, Pfizer, Arvinas, Veppanu, vepdegestrant, PROTAC, Teva, Emalex, ecopipam, Tourette syndrome, Summit Therapeutics, ivonescimab, Harmoni-3, Axsome, Auvelity, Alzheimer's, argenx, Vyvgart, Enhertu, Leqembi, ASCO, Moderna, M&A, biotech IPO, Lilly, AstraZeneca, Gilead, Biogen

FDA clears Veppanu, the first protein degrader to reachmarket — but no commercial partner in sight. Q1 biopharma M&A hits $84B as patent cliff urgency drives a mega year. Plus: Truqap wins 7-1 ODAC vote in prostate cancer, Auvelity expands into Alzheimer's agitation, and Summit's ivonescimab stumbles before ASCO.Visit us at www.thepharmacloseout.compharma, pharmaceutical, FDA, clinical trials, biotech, drugapprovals, healthcare, pharma podcast, The Pharma Closeout, Veppanu,vepdegestrant, Arvinas, Pfizer, PROTAC, protein degrader, breast cancer, FDA approval, AstraZeneca, Truqap, capivasertib, ODAC, prostate cancer, SummitTherapeutics, ivonescimab, Esperion, ArchiMed, Teva, Emalex, ecopipam, Tourette syndrome, Axsome, Auvelity, Alzheimer's agitation, Moderna, Amgen, obesity,Tavneos, Chiesi, KalVista, Ligand, XOMA, Avalyn, Elrexfio, Lilly, Foundayo, Samsung Biologics, UniQure, Huntington's, pharma M&A, patent cliff, Merck, Gilead

Erasca loses half its market cap after a Phase 1 death —while AbbVie bets $1.45B on the same RAS target. Lilly acquires Ajax for $2.3B in its 5th deal of 2026; FDA alleges data manipulation behind Amgen's Tavneos; Boehringer survodutide hits 16.6% weight loss in Phase 3.Visit us at www.thepharmacloseout.compharma, pharmaceutical, FDA, clinical trials, biotech, drugapprovals, healthcare, pharma podcast, The Pharma Closeout, Erasca, ERAS-0015, pan-RAS, KRAS, AbbVie, Kestrel Therapeutics, Eli Lilly, Ajax Therapeutics, JAKinhibitor, myelofibrosis, Amgen, Tavneos, ChemoCentryx, data manipulation, Intellia Therapeutics, CRISPR, gene editing, BridgeBio, Vyndamax, Pfizer, Boehringer Ingelheim, survodutide, obesity, AstraZeneca, Breztri, asthma,Incyte, vitiligo, Oruka, psoriasis, Veradermics, Sanofi, tolebrutinib, Lilly

Sun Pharma just wrote an eleven-point-seven-five billiondollar check to acquire Organon — the largest outbound pharma acquisition in Indian history, according to Reuters. And Intellia's in vivo CRISPR therapyjust delivered the first Phase 3 win for gene editing inside the body. Big Monday. Let's get into it.Visit us at www.thepharmacloseout.compharma, pharmaceutical, FDA, clinical trials, biotech, drugapprovals, healthcare, pharma podcast, The Pharma Closeout, Pfizer, Eli Lilly, Lilly, AstraZeneca, Merck, AbbVie, Regeneron

Lilly's Foundayo logs just 3,707 prescriptions in week two vs. 18,410 for Novo's oral Wegovy — a 5:1 gap that sent Lilly stock tumbling. Inhibrx surges ~39% on Merck-led takeover interest at $53/share. EU backs Sanofi's tolebrutinib for MS despite FDA rejection. FDA issues psychedelics priority review vouchers.Visit us at www.thepharmacloseout.compharma, pharmaceutical, FDA, clinical trials, biotech, drug approvals, healthcare, pharma podcast, The Pharma Closeout, Foundayo, orforglipron, Eli Lilly, Novo Nordisk, Wegovy, oral GLP-1, obesity, Inhibrx, INBRX-106, Merck, Merck KGaA, Ono Pharmaceutical, oncology, tolebrutinib, Cenrifki, Sanofi, multiple sclerosis, SPMS, Regeneron, Otarmeni, gene therapy, hearing loss, Compass Pathways, Usona Institute, Transcend Therapeutics, psychedelics, psilocybin, AbbVie, CRL, Novartis, Pluvicto, Kelonia Therapeutics, Intellia, CRISPR, Roche, Moderna, Daiichi Sankyo, Avalyn Pharma, Pfizer, Lilly 

FDA approves Regeneron's Otarmeni — the first gene therapy for genetic hearing loss — as Regeneron closes the 17th and final White House MFN pricing deal. Roche calls giredestrant its potentially largest product ever, Novo Nordisk's 72% decline deepens, AbbVie commits $1.4B to North Carolina.Visit us at www.thepharmacloseout.compharma, pharmaceutical, FDA, clinical trials, biotech, drug approvals, healthcare, pharma podcast, The Pharma Closeout, Regeneron, Otarmeni, gene therapy, hearing loss, FDA approval, MFN pricing, White House, Roche, giredestrant, breast cancer, Novo Nordisk, oral semaglutide, Foundayo, orforglipron, AbbVie, Durham, manufacturing, Rigel, Eli Lilly, RIPK1, Grace Therapeutics, GTX-104, nimodipine, Sanofi, Dupixent, Novartis, radioligand therapy, GE HealthCare, LUMINA, Tempero, Amgen, Inovio, Lilly

Merck's Welireg misses in first-line RCC — Cantor challenges $2B+ peak sales. Lilly buys Kelonia for up to $7B in in vivo CAR-T push. Medicare indefinitely delays GLP-1 weight loss drug coverage pilot. Plus AstraZeneca IgAN data, Roche MOGAD results, Arrowhead upgrade.Visit us at www.thepharmacloseout.compharma, pharmaceutical, FDA, clinical trials, biotech, drug approvals, healthcare, pharma podcast, The Pharma Closeout, Merck, Welireg, belzutifan, kidney cancer, renal cell carcinoma, Keytruda, Lenvima, Eisai, Eli Lilly, Kelonia Therapeutics, CAR-T, cell therapy, in vivo, AstraZeneca, Ultomiris, IgA nephropathy, Roche, Enspryng, MOGAD, satralizumab, Medicare, GLP-1, weight loss, Foundayo, Wegovy, Novo Nordisk, Arrowhead Pharmaceuticals, Plozasiran, Pfizer, UCB, Neurona, Replimune, Idvynso, HIV, Kailera, Tortugas, Nektar, BioAge, Carvykti, Lilly, J&J 

Eli Lilly pays $3.25B upfront for Kelonia Therapeutics' invivo CAR-T platform in a deal worth up to $7B — the sixth buyout in this space since March 2025. Plus Gilead-Arcus TIGIT Phase 3 failure, Nektar's 20%+ alopecia surge, Trump's psychedelic executive order, AACR KRAS data from Revolution Medicines, and Novo Nordisk sickle cell Phase 3 results.Visit us at www.thepharmacloseout.compharma, pharmaceutical, FDA, clinical trials, biotech, drugapprovals, healthcare, pharma podcast, The Pharma Closeout, Eli Lilly, KeloniaTherapeutics, in vivo CAR-T, cell therapy, TIGIT, Gilead, Arcus Biosciences,domvanalimab, Nektar Therapeutics, rezpegaldesleukin, alopecia areata,psychedelic drugs, ibogaine, Trump executive order, Revolution Medicines,zoldonrasib, KRAS, Merck, AACR 2026, Novo Nordisk, etavopivat, sickle celldisease, UCB, Neurona Therapeutics, Biogen, felzartamab, Kailera Therapeutics,IPO, Sanofi, Nuvaxovid, Novartis, Boehringer Ingelheim, PBM drug pricing,oncology, M&A, Lilly, Roche, BMS, Moderna

Allogene's cema-cel drives MRD negativity in 7 of 12lymphoma patients in Phase 3 Alpha3 — stock surges 50%+. Plus: Kailera's $625M biotech IPO, UCB's $1.2B Neurona acquisition for epilepsy cell therapy, Spyre'sbest-in-class UC data, Lilly Foundayo's launch metrics, and what to watch as AACR and Q1 earnings collide this week.Visit us at www.thepharmacloseout.compharma, pharmaceutical, FDA, clinical trials, biotech, drugapprovals, healthcare, pharma podcast, The Pharma Closeout, Allogene, cema-cel, CAR-T, allogeneic cell therapy, lymphoma, Kailera Therapeutics, IPO, UCB,Neurona Therapeutics, epilepsy, Spyre Therapeutics, SPY001, ulcerative colitis, Entyvio, Revolution Medicines, daraxonrasib, pancreatic cancer, Eli Lilly,Foundayo, orforglipron, AACR 2026, Novo Nordisk, GLP-1, zanidatamab, Obsidian Therapeutics, TIL therapy, Lilly, Moderna

Foundayo hits MACE-4 non-inferiority (HR 0.84) as Lillytargets diabetes filing by Q2 — but FDA requests liver risk data. Plus: Cochrane review dismisses anti-amyloid Alzheimer's drugs, Daiichi Sankyo divests $1.5B consumer health unit, and Kailera's $533M obesity IPO pricesahead of tomorrow's trading.visit us at www.thepharmacloseout.com pharma, pharmaceutical, FDA, clinical trials, biotech, drugapprovals, healthcare, pharma podcast, The Pharma Closeout, Foundayo,orforglipron, Eli Lilly, GLP-1, obesity, diabetes, ACHIEVE-4, MACE, Cochrane,Alzheimer's, lecanemab, donanemab, anti-amyloid, Kailera Therapeutics, IPO,Daiichi Sankyo, Suntory, Roche, Elevidys, Sarepta, Duchenne, RevolutionMedicines, Obsidian Therapeutics, CrossBridge Bio, ADC, UnitedHealth, Lilly,Novo Nordisk, AstraZeneca, Biogen

J&J's Tremfya hits $1.6B in Q1 sales with 74% growth,answering the Stelara biosimilar cliff. Plus: Revolution Medicines prices a $2B offering, Beeline launches with $300M and five BMS immunology assets, and Travere wins the first FDA approval for FSGS.Visit us at www.thepharmacloseout.compharma, pharmaceutical, FDA, clinical trials, biotech, drugapprovals, healthcare, pharma podcast, The Pharma Closeout, Johnson &Johnson, Tremfya, Stelara, Revolution Medicines, Beeline Medicines, BristolMyers Squibb, Bain Capital, Travere Therapeutics, Filspari, sparsentan, FSGS,Daiichi Sankyo, Suntory, Oric Pharmaceuticals, rinzimetostat, Foundayo,orforglipron, Eli Lilly, Allogene, CAR-T, peptides, GLP-1, Q1 earnings, Lilly,AstraZeneca, J&J, GSK, Sanofi, BMS

Daraxonrasib slashes death risk 60% in metastatic pancreaticcancer Phase 3 — Revolution Medicines leads a $1.5B offering wave. Neurocrine acquires Soleno for $2.9B, Regeneron enters radiopharma via Telix, and Travere nabs the first-ever FSGS approval with Filspari.Visit us at www.thepharmacloseout.compharma, pharmaceutical, FDA, clinical trials, biotech, drugapprovals, healthcare, pharma podcast, The Pharma Closeout, daraxonrasib, Revolution Medicines, RVMD, pancreatic cancer, RASolute 302, Neurocrine Biosciences, Soleno Therapeutics, VYKAT XR, Prader-Willi syndrome, Filspari,sparsentan, Travere Therapeutics, FSGS, Regeneron, Telix Pharmaceuticals, radiopharmaceuticals, Eli Lilly, CrossBridge Bio, ADC, antibody-drug conjugate, Jaypirca, pirtobrutinib, CLL, ORIC Pharmaceuticals, rinzimetostat, Zentalis,azenosertib, Allogene, cema-cel, CAR-T, Johnson & Johnson, Icotyde, Spyre Therapeutics, SPY001, ulcerative colitis, Pfizer, Adcetris, Lilly, Roche, AstraZeneca, J&J, Gilead

FDA issues second CRL for Replimune's melanoma therapy RP1 —stock drops 20%, single-arm trial debate sharpens. Sun Pharma's $12B all-cash bid for Organon, Amgen's 77% proptosis response in subcutaneous TEPEZZA Phase 3, Lilly launches Foundayo, and AACR 2026 preview.Visit us at www.thepharmacloseout.compharma, pharmaceutical, FDA, clinical trials, biotech, drugapprovals, healthcare, pharma podcast, The Pharma Closeout, Replimune, RP1,vusolimogene oderparepvec, melanoma, complete response letter, Sun Pharma,Organon, acquisition, Amgen, TEPEZZA, teprotumumab, thyroid eye disease, EliLilly, Foundayo, GLP-1, Novo Nordisk, Wegovy, Immunovant, batoclimab, Invivyd,VMS063, measles, AACR 2026, Gilead, Tubulis, ADC, Neurocrine, Soleno, Insmed,brensocatib, Travere, FILSPARI, sparsentan, FSGS, BioNTech, trastuzumabpamirtecan, Merck, Terns Pharmaceuticals, Roche, C4 Therapeutics, Lilly,AstraZeneca

Lilly launches Foundayo to challenge Novo Nordisk in oralGLP-1s with a GoodRx access play. Gilead acquires ADC specialist Tubulis for $3.15B upfront in its third deal since February. Plus FDA lifts MacroGenics hold, AbbVie sues over 340B, and Vanda targets GLP-1 side effects with theThetis trial.www.thepharmacloseout.compharma, pharmaceutical, FDA, clinical trials, biotech, drugapprovals, healthcare, pharma podcast, The Pharma Closeout, Eli Lilly, Foundayo, oral GLP-1, Novo Nordisk, Gilead Sciences, Tubulis, ADC, antibody-drug conjugate, MacroGenics, lorigerlimab, Vanda Pharmaceuticals, tradipitant, Nereus, AbbVie, 340B, PhRMA, Steven Ubl, Roche, C4 Therapeutics,DAC, Garda, Assertio, Rolvedon, Kyverna, KYSA-8, Invivyd, measles, Shionogi, BARDA, GoodRx, Lilly, GSK, BMS, Gilead