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

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 Thera...

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.com pharma, pharmaceutical, FDA, clinical trials, biotech, drug approvals, healthcare, pharma podcast, The...

Part 2 of The Pharma Closeout's ASCO 2026 special covers the closing days, Monday June 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 bispecific ADC, 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 cance...

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 react...

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.com pharma, pharmaceutical,...

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.com pharma, pharmaceutical, FDA, clinical trials, biotech, drug approvals, healthcare...

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.com pharma, pharmaceutical, FDA, clinical trials, biotec...

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.com pharma, pharmaceutical, FDA, clinical trials, biotech, drug approvals, healthcare, pharma p...

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.com pha...

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, pharm...

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.thephamacl...

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 c...

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.com pharma, pharmaceutical, FDA, clinical trials, biotech, drug approvals, healthcare, p...

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.com pharma, pharmaceutical, FDA, clinical trials, biotech, drug approvals,...

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.t...

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.com pharma, pharmaceutical, FDA, clinical trials, biotech, drugapprovals, healthcare, pharma podcast, The Pharma...

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.com pharma, pharmaceutical, FDA, clinical trials, biotech, drug approvals, he...

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.com pharma, pharmaceutical, FDA, clinical trials, biotech, drugapprovals, healthcare, p...

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.com p...

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.com pharma, pharmaceutical, FDA, clinical trials, biotech, drugappr...

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.com pharma, pharmaceutical,...

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 degrader Visit us at www.thepharmacloseout.com pharma, pharmaceutical, FDA, clinical trials, biotech, drugapprovals, hea...

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.com pharma, pharmaceutical, FDA, clinic...

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.com pharma, pharmaceutical, FDA, clinical trials, biotech, drugapprovals, healthcare, phar...

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.com pharma, pharmaceutical, FDA, clinical trials...