The Pharma Closeout | Daily Pharmaceutical and Biotech News in 15 Minutes

Friday, October 16 edition.

Roche’s Enspryng wins FDA approval for thyroid eye disease as a home injection, while Omeros faces another negative European opinion for narsoplimab and plans to end compassionate use there. Alex Mercer and Maya Patel unpack the patient, evidence and commercial implications.

Also covered: Talvey’s proposed earlier-line use in Europe; Arrowhead’s early ARO-MAPT tau data in healthy volunteers; Foundayo’s European committee recommendations; RYZUMVI’s presbyopia approval; China’s draft drug-technology export controls; and Labcorp’s agreement to acquire select BioReference assets.

Reco...

FDA expanded ImmunityBio's Anktiva (nogapendekin alfa inbakicept-pmln) to papillary-only bladder cancer by extrapolating earlier evidence. Vanda paused VQW-765 after its Phase 3 social-anxiety trial missed, while Vir and Gilead agreed a solid-tumor T-cell engager collaboration. The roundup covers a European recommendation for Revolution Medicines' daraxonrasib in pancreatic cancer, Osivax's OVX836 influenza-vaccine miss, and Alvotech/Advanz's AVT29 high-dose Eylea (aflibercept) biosimilar filing. Galderma's planned ZO Skin Health acquisition and OrbiMed's $3 billion in fund commitments round out the day.

Alex Mercer and Maya Patel host. Get the daily rundown in your inbox — subscribe at https://thepharmacloseout.com.

October 14, 2026 edition, released October 15, 2026. BioNTech's BNT113 missed progression-free survival in its pivotal head and neck cancer trial, leaving overall survival as the remaining path to a positive result. Roche licensed Rona Therapeutics' undisclosed ALK7-targeting RNAi obesity candidate—a fat-cell approach with most potential deal value contingent on milestones. Johnson & Johnson raised full-year guidance as newer medicines offset Stelara erosion; the roundup also covers FDA review of FYB206, a proposed Keytruda (pembrolizumab) biosimilar, Syndax ending axatilimab in IPF, 84-week Pasatru (garetosmab) data in FOP, and Tremfya (guselkumab) analyses in Crohn's perianal fistulas.

Alex Mercer an...

Monday, October 12, 2026 edition, released Tuesday, October 13, 2026. News checked through October 13, 2026; no material updates to the stories below were found.

Bristol's admilparant met its Phase 3 lung-function endpoint at the lower dose, while the higher dose missed significance in idiopathic pulmonary fibrosis. Its acquired RYZ101 program also delivered a Phase 3 win in neuroendocrine tumors after lutetium therapy, with benefit size still undisclosed. Mirum's LIVMARLI (maralixibat) reduced childhood itch in EXPAND, while the roundup covers First Tracks' ANB033 in celiac disease, Sebela's tegoprazan in reflux, Zenas' obexelimab in IgG4-related disease, Claris' eye-drop data and Ascelia's Orviglance...

Merck's remigromig met BRUNELLO's noninferiority bar in diabetic macular edema, but showed no superiority and a notable safety imbalance. AstraZeneca completed its $2 billion Summit Therapeutics investment around ivonescimab combinations, while Roche's vamikibart entered FDA review with mixed Phase 3 evidence behind the filing. The Sunday, October 11 Week in Review—released Monday, October 12—also spans oncology, cardiometabolic and rare disease, respiratory and neuroscience, immunology, vaccines, infectious disease, access and medicine safety. Across 45 news stories and three forward watches, Alex and Maya separate completed events and clinical results from filings, plans and pending catalysts.

Alex Mercer and Maya...

The Pharma Closeout's MDS 2026 Debrief covers the readouts from the International Parkinson and Movement Disorder Society congress in Seoul that matter for drug, diagnostic and payer strategy. Biogen and Denali'sLUMA and Bial's ACTIVATE showed full data on two genetic bets in Parkinson's disease that missed, and we look at what still stands: Arvinas's LRRK2 degrader, a spinal-fluid marker that could help pick patients, and Roche's prasinezumab Phase 3. AbbVie's newly approved Juvmo meets ICER's numbers, and we put Cerevance's solengepras result against the approved add-ons. Plus Syntara's trial in REM sleep behaviour disorder, a skin test for alpha-synuclein, Praxis's essential...

Friday, October 9 edition, released late Saturday, October 10.

FDA approved Hovilpri (pritelivir) for immunocompromised adults with stubborn herpes simplex lesions, but the oral drug is not yet available and is expected in the U.S. before the end of 2026. Biohaven agreed to license rights for parts of Asia to Phase 3 Graves' disease candidate BHV-1300 to Ono for $80 million at closing, plus a separate conditional $20 million; the deal is not evidence of efficacy. Also: J&J reports two-year Icotyde PASI 90 results without a long-term Sotyktu comparison, and Pennsylvania details GSK's $800 million-plus Upper Merion manufacturing expansion.

Thursday, October 8 edition, published after midnight Pacific.

FDA approves Roche's Tecentriq (atezolizumab) with chemotherapy after stage III dMMR colon cancer surgery: fewer recurrence-or-death events, more frequent grade 3–4 adverse events. Bristol Myers Squibb reports a topline median progression-free survival of 42 vs 20 months for Zenbexus (iberdomide) in multiple myeloma; the result is not peer-reviewed, reports no overall survival result, and whether it verifies clinical benefit is the FDA's call. argenx stops its Phase 3 UNITY study of Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase) in Sjögren's disease and says FB102 met its Phase 2 celiac primary endpoint. Plus Via...

Pfizer's Tukysa (tucatinib) wins a breast cancer maintenance approval after delaying progression, while MimiVax's SurVaxM misses its overall glioblastoma survival goal despite a younger-patient signal. Halozyme reports an injunction against subcutaneous Keytruda (pembrolizumab) in eight European markets; Caribou said yesterday it plans to halt its two donor CAR-T programs amid financing pressure. Cerevance's investigational solengepras cuts Parkinson's off time by 37 minutes a day beyond placebo. Novartis reports FDA approval of Rhapsido (remibrutinib) for adults with symptomatic dermographism inadequately controlled by H1 antihistamines.

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ArriVent's firmonertinib missed its Phase 3 primary progression-free-survival endpoint in lung cancer, with its next step still undecided; this delayed Tuesday edition was recorded October 6. Alector grants Genentech worldwide rights to preclinical Parkinson's program AL050 for $100 million committed upfront and up to $1.17 billion in milestones, with brain delivery untested in people. FDA seeks public input on early ibogaine trials—not an approval—and ViiV reports investigational Cabenuva (cabotegravir/rilpivirine) results in people with detectable HIV, without rates, confidence intervals or detailed safety. Forbion raises €2.3 billion in fund commitments, with first investments already made.

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The Pharma Closeout's EASD 2026 Debrief covers the readouts from the European Association for the Study of Diabetes meeting in Milan that matter for drug, device and payer strategy. The new ADA/EASD consensus reportmoves GLP-1 and SGLT2 drugs earlier in type 2 diabetes care, potentially from diagnosis, and prefers weight-lowering drugs for people with overweight orobesity. Lilly's ACHIEVE-4 put its oral GLP-1 pill Foundayo against insulin and met a heart-safety bar. Real-world data arrived from Novo on stepping up semaglutide versus switching, from Abbott on continuous glucose monitors, and from a Nordic study on semaglutide and pancreatic cancer. Plus the...

Genmab and AbbVie's investigational frontline Epkinly (epcoritamab) combination cut progression-or-death hazard 51% versus R-CHOP in lymphoma patients with IPI scores of 3–5; it did not face Polivy's approved regimen. Vaxcyte's VAX-31 met its pivotal immune-response framework, with two serotypes clearing only a looser threshold against Merck's CAPVAXIVE—not proof of disease prevention. Deals span GE HealthCare–SOFIE and PET tracer FAPI-74, Shionogi–IntraBio and AQNEURSA in rare neurology, and CSL–Alentis for kidney-disease antibody lixudebart. CMS finalized rules for future prescription-drug files that could improve market-access pricing visibility if the schedule holds.

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Lilly's retatrutide detail reveals that adverse-event discontinuations peaked below the top dose, while Jaypirca gains first-line CLL and SLL approval for adults without a known 17p deletion. Novartis agrees to $575 million upfront for Abogen's autoimmune RNA program, and Sanofi-Regeneron expands its long-acting antibody partnership. Ovarian-cancer datasets, Mirum's hepatitis D results and uniQure's Huntington's filing show why patient populations and control groups matter. CMS rebates and medicine tariffs reach manufacturer economics, alongside retina, respiratory and rare-disease updates.

Alex Mercer and Maya Patel host. Get the daily rundown in your inbox — subscribe at https://thepharmacloseout.com.

The Pharma Closeout's ASTRO 2026 Debrief covers the readouts from the American Society for Radiation Oncology meeting that matter for drug,diagnostic and payer strategy. Fourteen-year RTOG 0815 data re-open how much hormone therapy men need with prostate radiation, as Veracyte's Decipher andArtera compete to decide who can skip it. The NRG-GI003 plenary showed no survival improvement for protons over photons in liver cancer, Novocure's TRIDENT timing trial missed, and new data arrived on PSMA imaging, radioligands, SBRT versus surgery and lung immunotherapy after SABR. Plus what to watch: theLantheus shareholder vote on the Curium takeover.

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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.

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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...

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.

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...

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...

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.

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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 Merc...

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.

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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.co...

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 myel...

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...

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.

Vera reports a 76% reduction in composite kidney-disease progression risk and near-stable two-year kidney function for TRUTAKNA (atacicept-vymj) in sponsor topline data, addressing the clinical-benefit question behind its accelerated approval in IgA nephropathy. Curium's BEXLUTRY (lutetium Lu 177 dotatate) brings an adult neuroendocrine-tumor competitor to Lutathera, with delivery and access questions still open. GSK buys a preclinical myeloma development bet, while Lilly backs nervous-system genetic-medicine delivery. We also examine Connect's mixed asthma data, portfolio changes, longer-term lung-cancer evidence and the FDA's trial-startup pilot.

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Enhertu delayed lung cancer progression in a Phase 3 trial, but immature survival results and fatal lung toxicity complicate the first-line case. Definium reports a second Phase 3 anxiety-study win for DT120, while new ivonescimab results quantify a survival benefit previously announced. We also cover Sanofi's proposed Cheplapharm transaction, Cellectis's gene-editing pivot, Corbus's oral obesity candidate and regulatory updates from Amgen and Telix. This is the September 14 edition, released September 15.

Alex Mercer and Maya Patel host. Get the daily rundown in your inbox — subscribe at https://thepharmacloseout.com.

AstraZeneca's broader-use trial of Etcamah (camizestrant)missed its primary goal in advanced breast cancer, while the existing approval stands. Scholar Rock's ISEMBYLD (apitegromab) adds a muscle-directed option inspinal muscular atrophy, while Roivant's mosliciguat links vascular improvement with better walking distance in pulmonary hypertension associated with interstitial lung disease. Novartis faces pipeline and acquisition scrutiny asBiohaven pauses new BHV-7000 enrollment and Karyopharm confronts near-term financing pressure. Encoded's ETX101 results frame its Dravet syndromefinancing, and BioNTech's lung-cancer presentations lead the week ahead.

Alex Mercer and Maya Patel host. Get the daily rundown inyour inbox — subscribe at https://thepharmacloseout.com.

FDA extended its review of Exelixis's zanzalintinib-Tecentriq combination for metastatic colorectal cancer to March 3, 2027, after classifying updated data as a major amendment. Karyopharm missed a $15.8 million loan payment and secured a creditor standstill through October 15 tied partly to its selinexor-ruxolitinib myelofibrosis filing. Roche's Enspryng gained Priority Review in MOGAD; COSCIENS bought oral-film manufacturer Nualtis, and Frazier raised more than $1.1 billion for its Public Fund. Plus, Telix's Pixclara FDA decision remained unverified at our reporting cutoff.

Alex Mercer and Maya Patel host the Daily Roundup for September 11. Get the daily rundown in your inbox — subscribe at https://thepharmacloseout.co...

Biohaven's FDA partial hold pauses new epilepsy-trialenrollment; the company still expects RISE-3 results this year. AbbVie reports LUNA menstrual-migraine results for oral Qulipta (atogepant), while Shionogi misses a stroke endpoint and Disc Medicine reports fewer blood-removalprocedures in early polycythemia vera data. Novartis faces shareholder pressure, Solstice raises $225 million, and MannKind partners with Rose Pharma on inhaled weight management. NICE questions the value of Gilead's lenacapavir for HIV prevention, and new consensus guidance addresses type 1 diabetes screening.

Alex Mercer and Maya Patel host the Daily Roundup forSeptember 10. Get the daily rundown in your inbox — subscribe at https://thepharmacloseout.co...

Bayer's Hyrnuo (sevabertinib) gains first-line accelerated approval in HER2-mutant lung cancer, joining an established rival. Permanent FDA center leaders follow repeated turnover, while Structure's experimental obesity pill aleniglipron adds 72-week follow-up without a concurrent placebo. Kura, EMD Serono and Encoded back new development efforts; Tyra reports early bladder cancer responses, Evommune changes its eczema program, and Beeline advances lupus studies. BioMarin's Voxzogo (vosoritide) filing targets hypochondroplasia, and Nanoscope reports application acceptance for severe retinitis pigmentosa.

Alex Mercer and Maya Patel host the Daily Roundup for September 9. Get the daily rundown in your inbox — subscribe at thepharmacloseout.co...

Novartis's del-desiran missed HARBOR's primary endpoint in myotonic dystrophy, adding pressure to a growth plan already facing setbacks. Roivant and Pulmovant's mosliciguat data advance Monday's PHocus preview, while AstraZeneca, Pharvaris, Amgen, Inhibrx and Bristol Myers add clinical updates across lung disease, hereditary angioedema and cancer. BrainChild Bio's financing, the proposed Sernova-Seraxis merger and Intellia's lonvo-z Priority Review round out the slate. Two resolved Rasonque access cases show why Revolution Medicines' pancreatic cancer launch requires more than approval: patients still need to navigate authorization, support and dispensing.

Alex Mercer and Maya Patel host the Daily Roundup for September 8...

Novo is ending the HERMES and ATHENA ziltivekimab trials after a monitoring committee judged them unlikely to succeed, leaving ARTEMIS as its remaining Phase 3 cardiovascular path. We examine ADARx's IPO filing, the Aptar-Aceso ACT-101 collaboration in cystic fibrosis, and STEP Young semaglutide results in children ages six to under twelve. SynAct's resomelagon reanalysis asks what another rheumatoid arthritis trial must prove after two primary-endpoint misses. This late Labor Day edition reflects information available through Monday and previews Roivant and Pulmovant's PHocus mosliciguat data in pulmonary hypertension associated with interstitial lung disease. Alex Mercer and Maya Patel host the Daily...

Bristol Myers Squibb told regulators in early June. The rest of us found out this week, after an analyst note. Three months sat between those two facts, and that gap is the story of the week. Also this week, a cardiovascular outcomes trial in more than eight thousand patients missed its endpoint and put a whole drug class in question. A mid-stage lupus readout took fifty five percent off a company in a day. And the FDA approved a cancer drug over its own advisers, while memos surfaced on a second approval it had granted over its own reviewers...

Novartis's pelacarsen missed its cardiovascular endpoint despite lowering Lp(a)—what should Amgen and Lilly rethink? FDA accelerated approval brings AstraZeneca's Etcamah (camizestrant) to ESR1-mutated, HR-positive, HER2-negative advanced breast cancer before progression, with confirmatory benefit still required. Following Monday's CAR-T coverage, new reporting traces Bristol Myers Squibb's notifications to early June, months before public confirmation. Also: Revolution Medicines' Rasonque (daraxonrasib) data in previously treated RAS-mutant lung cancer, and Superluminal's $60 million financing for rare genetic and hypothalamic obesity.

Alex Mercer and Maya Patel host the Daily Roundup for September 4. Get the daily rundown in...

AbbVie's BCMA x CD3 bispecific etentamig met both primary endpoints in the Phase 3 CERVINO myeloma study — a 74.0% response rate versus 45.7% for standard therapy and a 60% reduction in the risk of progression or death — with a safety profile AbbVie is positioning for outpatient and community care. GSK is paying HUTCHMED $110 million upfront — up to $1.295 billion in total — for HMPL-A830, a dual KRAS/EGFR antibody-targeted conjugate whose global Phase 1 hasn't started yet. Also: the FDA approved Ionis' Zanvastro (zilganersen), the first treatment for Alexander disease, two weeks ahead of its PDUFA date. Plus Gan & Lee licenses bofanglutide (GZR18) to Menarini across 39 European...