Apazunersen (GTX-102) missed its primary cognition endpoint and the key secondary MDRI endpoint in Angelman syndrome, wiping out nearly half of Ultragenyx's market value and triggering a strategic review.
September 3, 2026 · Rare Disease · $RAREAkeso's China-only HARMONi-2 trial met its key secondary endpoint of overall survival at an interim analysis, making ivonescimab dual-positive on PFS and OS versus Keytruda. Summit shares surged.
September 3, 2026 · Oncology · $SMMTAbbVie reported Phase 3 CERVINO topline results: etentamig delivered a 74% objective response rate and a 60% reduction in progression risk (HR 0.40) versus standard therapy in triple-class exposed relapsed/refractory multiple myeloma, with a low-grade CRS and monthly dosing profile.
September 3, 2026 · Oncology · $ABBVThe FDA approved Zanvastro (zilganersen) for Alexander disease, the first treatment for the ultra-rare and often fatal GFAP-driven neurological disorder. Ionis earned a Rare Pediatric Disease Priority Review Voucher and will launch the drug in the US while Recordati handles ex-US rights.
September 3, 2026 · Neurology · $IONSPfizer licenses its shelved Seagen ADC PF-08046031 to Medicus Pharma for $12M upfront plus up to $1B in milestones; MDCX fell 34% on the dilution risk.
September 3, 2026Tagrisso plus Orpathys beat Tagrisso alone on progression-free survival in China's 326-patient SANOVO trial for MET-overexpressing EGFR-mutant lung cancer.
September 2, 2026Roche licensed preclinical tri-specific SIM0660 from Simcere Zaiming for $75 million upfront and up to $1.53 billion in milestones, plus tiered royalties.
September 2, 2026Stoke and Biogen reported 4-year durability for zorevunersen in Dravet syndrome, with new sub-analyses on the severe seizures that drive SUDEP deaths.
September 2, 2026uniQure submitted its AMT-130 BLA for Huntington's disease, the first gene therapy filing for the disorder. QURE fell 4.7% to $46.23; priority review requested.
September 2, 2026Teva's anti-IL-15 antibody TEV-408 met its Phase 2a primary endpoint in celiac disease, cutting gluten-induced gut damage at week 8. TEVA rose to $37.49.
September 2, 2026The FDA accepted United Therapeutics' sNDA for inhaled Tyvaso in IPF, a fatal lung disease. UTHR closed at $492.02, decision expected in late April 2027.
September 2, 2026Novartis halted eight clinical trials of rap-cel, its CAR-T therapy for lupus, multiple sclerosis, and other autoimmune and neurological disorders, after three patients died from a severe immune response. Bristol Myers Squibb paused its own CAR-T autoimmune trials as a precaution.
September 1, 2026 · Cell Therapy · $NVSBridgeBio 42-month CMR data shows acoramidis may reverse cardiac damage in ATTR-CM, with 54% improving LV function vs 20% on placebo. Published in EJHF.
September 1, 2026Novartis reported positive topline results from the identical REMODEL-1 and REMODEL-2 Phase 3 trials of oral BTK inhibitor remibrutinib in relapsing multiple sclerosis, beating teriflunomide on annualized relapse rate with no liver safety signal. Remibrutinib is the first BTK inhibitor to pair Phase 3 MS efficacy with a clean liver profile.
September 1, 2026 · neuroscience · $NVSBeOne Medicines and Jazz Pharmaceuticals reported the Phase 3 HERIZON-GEA-01 second interim analysis met the overall survival co-primary endpoint for Ziihera plus chemo in first-line HER2+ gastroesophageal adenocarcinoma, six days after FDA approval.
August 31, 2026 · oncology · $JAZZEli Lilly will acquire privately held Merida Biosciences for up to $2.875 billion in cash, adding MER511, a Phase 1 autoantibody-degradation therapy for Graves' disease and thyroid eye disease, plus a precision immunology platform.
August 31, 2026 · Immunology · $LLYThe FDA approved J&J's Stelara (ustekinumab) for pediatric ulcerative colitis Aug 28, making it the first non-TNF biologic across both pediatric IBD forms.
August 31, 2026Plozasiran cut pancreatitis 78% and triglycerides 79-81% in full SHASTA-3/4 data, pressing Tryngolza on safety and quarterly dosing before a year-end sNDA.
August 31, 2026 · $ARWRThe FDA approved PharmaEssentia's BESREMi for essential thrombocythemia, first new ET drug in nearly three decades. SURPASS-ET: 42.9% vs 6.0% anagrelide.
August 31, 2026Karyopharm submitted an sNDA for selinexor plus ruxolitinib in myelofibrosis, requesting Priority Review under accelerated approval. FDA decision in Q4.
August 31, 2026 · $KPTIThe FDA accepted Nicox's NCX 470, a nitric oxide-donating bimatoprost eye drop for glaucoma, and set an April 30, 2027 PDUFA date. Kowa is the U.S. licensee.
August 30, 2026Teva is the stalking-horse bidder for BioXcel's BXCL501, an at-home agitation film with a Nov. 14 PDUFA date. The $57.5M upfront rides on timing milestones.
August 30, 2026BioXcel Therapeutics filed Chapter 11 and named Teva stalking-horse bidder at $57.5M upfront plus $67.5M in milestones for BXCL501, ahead of the Nov 14 PDUFA.
August 29, 2026The FDA cleared Mounjaro to lower heart attack, stroke, and cardiovascular death risk in adults with type 2 diabetes, a first for any GIP/GLP-1 drug ever.
August 28, 2026 · Cardiometabolic · $LLYThe FDA approved MIMRYLO (rusfertide) for erythrocytosis in polycythemia vera, the first and only hepcidin mimetic. VERIFY hit 76.9% vs 32.9% response; PTGX closed at $144.33.
August 28, 2026 · Hematology · $PTGXBioNTech is ending its Phase 2 autogene cevumeran trial in resected colorectal cancer after a data board flagged a survival imbalance between the two arms.
August 28, 2026Cytokinetics presented full ACACIA-HCM data at ESC 2026, the first positive Phase 3 result in non-obstructive HCM, with an sNDA filing planned for Q4.
August 28, 2026Amgen and AstraZeneca's Tezspire met both co-primary endpoints in the Phase 3 CROSSING trial for eosinophilic esophagitis, positioning the TSLP antibody for a third epithelial-driven indication.
August 27, 2026 · immunology · $AMGNRoivant's once-daily LISRAYA (brepocitinib) is the first targeted therapy approved for dermatomyositis, clearing the FDA about five weeks ahead of its Sept 30 PDUFA date. ROIV closed up 2.3%.
August 27, 2026 · Immunology · $ROIVGilead's Bixlenvo (bictegravir/lenacapavir) won FDA approval August 27 as the first single-tablet regimen for virologically suppressed adults on complex HIV regimens. GILD closed at $148.86.
August 27, 2026 · Infectious disease / HIV · $GILDThe FDA approved ViiV Healthcare's Tivicay PD (dolutegravir) tablets for oral suspension to treat HIV infection in newborns from birth to four weeks weighing at least 2 kg. Dolutegravir becomes the first integrase inhibitor cleared for this youngest patient population.
August 26, 2026 · Infectious Disease · $GSKRoche's Genentech licensed Hanmi's HM17321, a urocortin-2 analog that preserves lean muscle mass, for $190M upfront and up to $2.3B in milestone payments.
August 26, 2026Ivonescimab beat Imfinzi on overall survival in first-line biliary tract cancer in the China-only HARMONi-GI1 trial, its fifth positive Phase 3 readout.
August 26, 2026Revolution Medicines' daraxonrasib won FDA approval for previously treated metastatic pancreatic cancer after nearly doubling median overall survival to 13.2 months in RASolute 302.
August 26, 2026Celcuity filed an sNDA to extend REVTORPYK (gedatolisib) to PIK3CA-mutant breast cancer after beating Novartis' Piqray in the VIKTORIA-1 mutant cohort.
August 26, 2026Spyre's anti-TL1A antibody SPY072 hit its RA primary endpoint but missed the efficacy bar, so the company is pivoting to psoriasis and ulcerative colitis.
August 26, 2026Biohaven licenses its Kv7 epilepsy platform and lead drug opakalim to SK Biopharmaceuticals, which funds development toward a 2029 launch, for up to $795M.
August 26, 2026Fulcrum reverse-merges with migraine biotech Slate Medicines in an all-stock deal backed by a $245M PIPE, with the combined company set to trade as SLTE.
August 26, 2026FDA accepted GSK's sBLA for Jemperli in stage II/III dMMR rectal cancer with Priority Review on August 24, 2026 — the regulatory step toward the first organ-preservation label in rectal cancer. Here is the data and the competitive stakes.
August 25, 2026Merck and Moderna's intismeran autogene met RFS and DMFS endpoints in the Phase 3 INTerpath-001 melanoma trial — the first Phase 3 win for a personalized mRNA cancer vaccine. MRNA doubled. Here is what the data means.
August 25, 2026The FDA approved Johnson & Johnson's IMAAVY (nipocalimab-aahu) as the first-ever therapy for warm autoimmune hemolytic anemia, a rare autoantibody disease with no prior approved treatment. In the Phase 2/3 ENERGY trial, about three times as many patients achieved a durable hemoglobin response versus placebo.
August 25, 2026 · Immunology · $JNJThe FDA placed a clinical hold on REGENXBIO's RGX-121 after asymptomatic spine MRI findings in five CAMPSIITE participants. The biotech no longer plans to resubmit the Hunter syndrome gene therapy rejected in February. RGNX fell about 25%.
August 25, 2026 · Gene Therapy · $RGNXTwo Ziihera-containing regimens cleared for first-line HER2+ gastroesophageal adenocarcinoma on the Aug 25 PDUFA date, with median overall survival of 26.4 months, the longest reported in the setting. JAZZ up about 3.5% intraday.
August 25, 2026 · oncology · $JAZZSkye Bioscience reverse-merges with Redx Pharma to form Fibrx Therapeutics, a $125M-backed fibrosis company led by RXC008 in fibrostenotic Crohn's disease.
August 25, 2026The FDA accepted United Therapeutics' ralinepag NDA for PAH, setting a June 24, 2027 decision. It would be the first once-daily oral prostacyclin for adults.
August 25, 2026The FDA issued a CRL for ITM 177Lu-edotreotide in GEP-NETs on Aug 7, citing only manufacturing and facility items. The Phase 3 COMPETE win still stands.
August 22, 2026Activist Kaos Capital seeks Capricor (CAPR) board changes and an M&A review days before the deramiocel PDUFA. Shares have lost two-thirds since late July.
August 22, 2026Seven deaths and 100+ serious adverse events for Neurocrine Vykat XR in Prader-Willi have surfaced in FDA post-marketing data. NBIX stands by the drug.
August 22, 2026Vogenx (VOGX) priced an $81M IPO at $13 and ran to $29.52 as mizagliflozin, an oral SGLT1 inhibitor for post-bariatric hypoglycemia, rode the Amylyx wave.
August 22, 2026Moderna and Merck's personalized mRNA cancer vaccine met its primary endpoint in the Phase 3 INTerpath-001 trial, cutting melanoma recurrence risk. Moderna stock closed up 177%. Here is what the data says and what happens next.
August 21, 2026 · Oncology · $MRNAAmylyx's first-in-class GLP-1 receptor antagonist avexitide cut Level 2/3 hypoglycemic events 55% versus placebo in the Phase 3 LUCIDITY trial for post-bariatric hypoglycemia, a condition with no approved therapy. AMLX has climbed about 85% since the readout.
August 21, 2026 · Metabolic · $AMLXargenx's ALKIVIA Phase 3 trial met its primary endpoint, showing efgartigimod improved Total Improvement Score by 15.4 points over placebo in autoimmune myositis. ARGX has climbed about 22% since the readout.
August 21, 2026 · Immunology · $ARGXAstraZeneca and Daiichi Sankyo's Enhertu met its primary endpoint in the DESTINY-Lung04 Phase 3 trial, becoming the first HER2-directed drug to improve progression-free survival over standard of care in first-line HER2-mutant NSCLC.
August 21, 2026 · Oncology · $AZNThe FDA approved Bristol Myers Squibb's Zenbexus (iberdomide) for relapsed multiple myeloma, the first CELMoD. MRD-negative response hit 41% versus 21%.
August 21, 2026 · Oncology · $BMYThe FDA approved Ultragenyx's Genglycos (DTX401), the first gene therapy for GSDIa. It cuts daily cornstarch needs and earned a priority review voucher.
August 21, 2026 · Rare Disease · $RAREThe FDA approved Regeneron's Pasatru (garetosmab) for FOP, a disorder where bone grows in muscle. It cut new bone lesions 90% in OPTIMA and reduced flare-ups.
August 21, 2026 · Rare Disease · $REGNBioMarin (BMRN) buys Alesta for $275M upfront, adding ALE1, a Phase 1/2a oral drug for hypophosphatasia that could rival AstraZeneca's injectable Strensiq.
August 21, 2026Capricor (CAPR) will amend its deramiocel BLA to an upper-limb-only claim after the 9-3 AdCom vote, pushing the Aug 22 PDUFA back. The FDA may still reject it.
August 21, 2026Werewolf (HOWL) reverse-merges with Ambros, which gets 71.7% plus a $150M PIPE to fund neridronate for CRPS-1. It will re-trade on Nasdaq as AMBX next year.
August 21, 2026Sionna's SION-719 missed its sweat chloride target in a 15-patient Phase 2a CF trial with -1.0 mmol/L, far below the 5-7 mmol/L bar. VRTX rose 6% to $524.
August 11, 2026Jazz will withdraw Zepzelca's second-line SCLC approval after LAGOON failed. Two confirmatory misses in six years close the accelerated approval chapter.
August 10, 2026Sonelokimab achieved 42.1% ACR50 response at Week 16 in biologic-naïve psoriatic arthritis, with strong skin and functional outcomes. The IL-17A/F Nanobody now has positive Phase 3 data in two multi-billion-dollar indications.
August 10, 2026 · rheumatology · $MLTXJazz Pharmaceuticals will acquire Actio Biosciences for $820 million upfront plus up to $500 million in milestones, gaining ABS-1230, a first-in-class KCNT1 inhibitor for a rare epilepsy with no approved therapies.
August 10, 2026 · CNS · $JAZZTenax's TNX-103 missed the 6-minute walk endpoint in the Phase 3 LEVEL trial for PH-HFpEF, a non-significant 3.5m gap vs placebo. TENX fell roughly 90% intraday.
August 10, 2026 · cardiovascular · $TENXAbCellera's NK3R antibody cut moderate-to-severe hot flashes by 83% at week 4 with a single 600 mg dose. At $9.34, the stock added roughly $550M in market cap.
August 10, 2026Sobi pays Innate $75M upfront for lacutamab, a first-in-class antibody for Sézary syndrome. The deal funds the Phase 3 trial toward accelerated approval.
August 10, 2026Revolution Medicines licensed Asian rights to four RAS(ON) inhibitors to BeOne, which funds a global Phase 3 trial. RVMD retains US, Europe, Japan, Korea.
August 10, 2026Silence Therapeutics' divesiran produced an 88% response rate vs 19% placebo in the Phase 2 SANRECO trial of phlebotomy-dependent PV. SLN jumped 42% intraday.
August 10, 2026Iovance posted Q2 revenue of $99.3M, up 66%, on record Amtagvi sales. The TIL therapy for melanoma hit 56% gross margin and the stock surged 43% on the beat.
August 9, 2026Otsuka VOYXACT delivered the largest eGFR treatment effect ever in an IgAN Phase 3 trial. The APRIL inhibitor showed +0.3 slope vs -4.2 for placebo at GlomCon.
August 9, 2026BioVie stock dropped 50% after the bezisterim Phase 2 SUNRISE-PD readout in early PD. The primary endpoint was buried behind a self-constructed composite scale.
August 8, 2026Arcturus (ARCT) terminated its $4.3B CSL vaccine deal, regaining KOSTAIVE rights. ARCT-032 inhaled mRNA for cystic fibrosis is now the investment thesis.
August 8, 2026BlossomHill Therapeutics priced an upsized $150M IPO at $16 for two oncology programs: BH-30643 in EGFR NSCLC and BH-30236 in AML. Shares trade as BLSM.
August 7, 2026Latigo Biotherapeutics priced a $345.6M IPO at $18 for LTG-001, an oral Nav1.8 inhibitor with positive Phase 2 data. Shares trade today as LTGO on Nasdaq.
August 7, 2026Merck and Gilead ended the KEYNOTE-D46/EVOKE-03 trial after the E-DMC said Trodelvy plus Keytruda would not beat Keytruda alone on OS in first-line PD-L1+ NSCLC.
August 7, 2026BioMarin discontinued BMN 401 across all indications on August 6, writing off the $270M Inozyme deal. VOXZOGO raised 2026 guidance to at least $1 billion.
August 7, 2026Sanofi suspended SAR445399 in NCFB, the fourth pipeline program cut under new CEO Belén Garijo. The trial was halted July 29 for strategic reasons, not safety.
August 7, 2026A senior source denied any AstraZeneca-Bristol merger talks on Aug 5, three days after the FT reported preliminary discussions. AZN shares recovered 6%.
August 6, 2026 · Pharma · $AZN, BMYThe FDA approved Moderna mFLUVISA on Aug 5, the first mRNA seasonal flu vaccine in the US. Phase 3 showed 26.6% higher efficacy vs standard-dose flu shots.
August 6, 2026 · Vaccines · $MRNAFDA grants accelerated approval to Replimune's Tudriqev (RP1) plus nivolumab for advanced melanoma patients who progressed on anti-PD-1 therapy, marking the first oncolytic viral immunotherapy approval in melanoma.
August 6, 2026 · Oncology · $REPLBraveheart Bio (BRVE) surged 66% to $29.80 on Nasdaq debut after a $382.5M IPO to fund Phase 3 trials of BHB-1893, a Hengrui-licensed cardiac myosin inhibitor.
August 6, 2026 · Cardiometabolic · $BRVETarsus (TARS) will acquire Alkeus for $450M upfront, adding Phase 3 gildeuretinol for Stargardt disease, a rare retinal disorder with no FDA-approved treatment.
August 6, 2026 · Ophthalmology · $TARSThe FDA accepted Merck ENFLONSIA sBLA to expand RSV protection to high-risk children under 2. SMART trial showed antibody levels comparable to healthy infants.
August 6, 2026Summit (SMMT) launched HARMONi-GU1, a Phase 2/3 trial of ivonescimab-Padcev in bladder cancer, its 16th registrational study ahead of the Nov 14 NSCLC PDUFA.
August 6, 2026Gilead Q2 revenue grew 10% to $7.8B driven by HIV, but GAAP EPS swung to $(8.45) on $9.08/share in acquisition charges. Base business is healthy. Here is what matters.
August 5, 2026 · Infectious Disease · $GILDEli Lilly Q2 revenue jumped 48% to $23B on Mounjaro and Zepbound. Retatrutide Phase 3 is complete with a BLA filing planned for Q1 2027. Here is what matters.
August 5, 2026 · Cardiometabolic · $LLYMerck Q2 revenue hit $16.6B but a $5.7B Terns acquisition charge produced a $(0.54) GAAP loss. Full-year EPS guidance was cut to $2.66-$2.76 from $5.04-$5.16.
August 5, 2026Novo Nordisk Q2 sales hit DKK78.5B on semaglutide strength, but a DKK4B monlunabant write-down clouds the post-Wegovy pipeline. Here is what matters now.
August 5, 2026Novo Nordisk took DKK 6.3B in pipeline impairments including DKK 4B for monlunabant. Core GLP-1 franchise strong but beyond-GLP-1 pipeline is thinning fast.
August 5, 2026 · Cardiometabolic · $NVOPfizer beat Q2 estimates (EPS $0.77 vs $0.68) and raised guidance, but axed two obesity programs from its $10B Metsera pipeline. Only berobenatide remains.
August 5, 2026Pfizer beat Q2 estimates (EPS $0.77 vs $0.68) but axed MET-224o and a GIPR candidate from its $10B Metsera acquisition. Only berobenatide remains as the obesity bet.
August 5, 2026 · Cardiometabolic · $PFEThe IL-31-focused biotech raised 45% more than originally planned, pricing 17 million shares at $17.00 ahead of its Nasdaq debut under ticker ATTO.
August 4, 2026 · Immunology · $ATTORhythm RM-718 showed -11.6% BMI in hypothalamic obesity across 7 patients at 16 weeks. The MC1R-sparing agonist targets better tolerability than setmelanotide.
August 4, 2026Supernus Pharmaceuticals (SUPN) and Indivior Pharmaceuticals (INDV) announced an all-stock merger of equals on August 3, 2026. The combined company will have $2.2 billion in revenue, 11 approved CNS drugs, and $125 million in targeted cost synergies. SUPN holders get 1.5401 INDV shares per share.
August 3, 2026 · CNS / M&A · $SUPNCurium agreed to buy Lantheus Holdings (LNTH) for up to $114.50 per share in cash, a deal worth up to $8 billion and the largest radiopharmaceutical acquisition to date. Lantheus holders get $102.50 upfront plus up to $12 in CVR payments tied to commercial milestones through 2030.
August 3, 2026 · Radiopharma / M&A · $LNTHVertex (VRTX) posted $3.33B in Q2 2026 revenue, raised guidance, and got a Nov. 30 PDUFA for povetacicept in IgA nephropathy. The first non-CF pillar is near.
August 3, 2026Otsuka's VOYXACT became the first APRIL inhibitor to show 2-year eGFR stabilization in IgAN. The data supports its rolling sBLA for traditional FDA approval.
August 2, 2026AstraZeneca has held months of talks with Bristol Myers Squibb about a potential merger valued at nearly $400 billion, the Financial Times reported. The deal would be the largest pharma merger in history and reshape the global oncology market.
August 2, 2026 · M&A · $AZNSelinexor missed PFS in XPORT-EC-042 endometrial cancer with HR 0.76 and CI crossing 1.0. Karyopharm now hinges on its August myelofibrosis sNDA filing.
August 1, 2026Karyopharm submitted its sNDA for selinexor plus ruxolitinib in myelofibrosis on August 31, seeking accelerated approval and Priority Review. FDA decision possible in H1 2027.
August 1, 2026Novo Nordisk's ziltivekimab missed the ZEUS Phase 3 primary endpoint with a MACE hazard ratio of 0.99. The IL-6 cardiovascular hypothesis needs HERMES and ARTEMIS to survive. NVO at $51.61.
July 31, 2026 · biotech · $NVOThe FDA accepted Saol SL1009 resubmission for PDCD with a Dec. 30 PDUFA. No approved therapies exist. A Priority Review Voucher worth $100M+ is on the table.
July 31, 2026BMY pushed Cobenfy ADEPT and milvexian LIBREXIA-AF readouts to 2027. Slower enrollment resets the catalyst calendar. The iberdomide PDUFA on August 17 is next.
July 31, 2026The FDA approved Pluvicto for PSMA-positive metastatic hormone-sensitive prostate cancer on July 31, 2026, 13 days ahead of the August 13 PDUFA date. The first radioligand therapy in mHSPC expands the addressable population roughly fourfold.
July 31, 2026 · Oncology / Radiopharmaceuticals · $NVSModerna's mRNA-1403 norovirus vaccine did not meet statistical criteria for early success in a Phase 3 interim analysis. The stock fell 5.4% as the company prepares to enroll an additional cohort.
July 31, 2026 · mRNA · $MRNAIonis posted Q2 revenue of $268M with a $115M net loss. Salanersen earned FDA Breakthrough Therapy for annual-dose SMA. Two FDA decisions are due by October.
July 30, 2026Johnson & Johnson will pay $785M upfront and secure a $2.58B acquisition option for Sail Biomedicines, a Flagship Pioneering company developing in vivo CAR-T therapies for autoimmune diseases using its eRNA nanoparticle platform.
July 30, 2026 · Cell Therapy · $JNJPfizer's LITFULO met co-primary endpoints in two Phase 3 vitiligo trials on July 30, one day after the European Commission approved AbbVie's Rinvoq as the first systemic vitiligo therapy. Pfizer arrives second to a market AbbVie just opened.
July 30, 2026 · dermatology · $PFEAn FDA advisory committee voted 10-3 that RP1 plus nivolumab has a favorable benefit-risk profile in anti-PD-1-resistant melanoma, reversing the agency's own briefing-docs stance two days earlier. REPL jumped 39% in after-hours trading. The FDA approved Tudriqev on August 6, 2026.
July 30, 2026 · oncology · $REPLAgios Q2: FDA granted Priority Review for the mitapivat sickle cell sNDA with a Nov 1 PDUFA. Cevidoplenib licensed and AG-236 siRNA advances to Phase 2/3.
July 30, 2026Alnylam Q2: Net product revenue hit $1.17B as AMVUTTRA crossed $1B for the first time. A TTR guidance cut to $4.2-$4.5B sent shares down 29% on July 30.
July 30, 2026JNJ Rybrevant Faspro sBLA for head and neck cancer got FDA Priority Review. OrigAMI-4 showed 42% ORR with 15% complete responses. PDUFA expected in Q1 2027.
July 30, 2026Apnimed (APMD) upsized its IPO 20% to 12 million shares at $16.00, raising $192 million for AD109 (Oxnimbi), the first oral pill targeting obstructive sleep apnea. Shares begin trading July 31 on Nasdaq ahead of a February 28, 2027 PDUFA date.
July 30, 2026 · Sleep medicine / neuroscience · $APMDViiV 2-drug Dovato matched Gilead 3-drug Biktarvy in VOGUE at 89% vs 92% suppression. First head-to-head HIV data could shift first-line prescribing patterns.
July 29, 2026 · infectious-disease · $GSKOak Hill Bio raises $175M via RA Capital SPAC to advance rugonersen toward Phase 3 for Angelman syndrome. No FDA-approved treatments exist for the disorder.
July 29, 2026 · rare-disease · $OAKHAstraZeneca's Ultomiris missed its primary endpoint in a Phase 3 trial for HSCT-TMA. It's the second Alexion Phase 3 failure in July 2026, following eplontersen's ATTR-CM miss. AZN closed at $172.48.
July 29, 2026 · Rare Disease / Hematology · $AZNBiogen Q2 2026: Growth Portfolio hit $1.06B, overtaking Legacy MS revenue for the first time. Leqembi reached $184M. Five registrational readouts ahead.
July 29, 2026The FDA's CTGTAC voted 9-3 that Capricor's HOPE-3 trial did not provide substantial evidence of effectiveness for deramiocel in DMD cardiomyopathy, siding with FDA staff over the company's post-hoc analysis. The August 22 PDUFA now leans toward rejection.
July 29, 2026 · cell-therapy · $CAPRCabenuva cut viral rebound 7x vs daily pills in LATA adolescent HIV trial. GSK ViiV also showed OPERA real-world data and EXTEND 4M PrEP at AIDS 2026.
July 29, 2026 · infectious-disease · $GSKFDA cleared Viatris Gwyn Lo on July 29, a day before PDUFA. The low-estrogen weekly patch is restricted to women with BMI below 30 and launches later in 2026.
July 29, 2026FDA accepted Cullinan/Taiho's NDA for zipalertinib in EGFR exon 20 insertion NSCLC. PDUFA is Feb 27, 2027, with 40% ORR in chemo-pre-treated patients.
July 28, 2026Axsome AXS-12 (reboxetine) for cataplexy in narcolepsy gets a May 1 2027 PDUFA. Two Phase 3 trials met endpoints. First cataplexy-specific therapy if approved.
July 28, 2026LEGN CEO Ying Huang stepped down July 24 with no permanent successor. CARVYKTI hit $657M in Q2 as J&J bispecific combo poses a new threat to the franchise.
July 28, 2026Sarepta appointed Michael Severino, the former AbbVie R&D chief who built Rinvoq and Skyrizi, as CEO effective July 28. SRPT is down 91% from its 2024 high.
July 28, 2026FDA briefing documents released July 28 say Replimune's IGNYTE single-arm trial data for RP1 plus nivolumab in advanced melanoma are not interpretable. The 10-3 AdComm backed the drug, and the FDA approved Tudriqev on August 6.
July 28, 2026 · oncology · $REPLAtea HCV pill matched Epclusa in C-BEYOND Phase 3: 93.9% vs 94.8% SVR, shorter 8-week course in most patients. Market shrugged. AVIR at $4.82. Here is why.
July 28, 2026GSK beat Q2 with £8.41B revenue and launched a £1.9B cost-savings program to fund 20+ Phase III trial starts in 2026. Bepirovirsen PDUFA is October 26.
July 28, 2026FDA accepted Immunome NDA for varegacestat in desmoid tumors with April 28, 2027 PDUFA. RINGSIDE showed 84% risk reduction and 56% ORR. IMNM at $22.58.
July 28, 2026The FDA accepted Cogent bezuclastinib plus sunitinib NDA in GIST with PDUFA November 30. PEAK trial PFS was 16.5 vs 9.2 months, first win in 20 years.
July 28, 2026GSK licensor Hansoh reported positive ARTEMIS-011 Phase 3 in relapsed osteosarcoma on July 28. It is the second Phase 3 win for the B7-H3 ADC after SCLC.
July 28, 2026ALT pemvidutide reduced heavy drinking and cut blood alcohol biomarker 38% in RECLAIM Phase 2. The GLP-1 class just entered addiction medicine. Here is why.
July 28, 2026MapLight ML-007 met the primary PANSS endpoint in ZEPHYR but once-daily dosing failed. MPLT crashed 73% Monday, rebounded to $12.31 as the BID dose held.
July 28, 2026Argenx agreed to acquire Forte Biosciences for $77 per share in cash, a 2.2 billion deal adding first-in-class anti-CD122 antibody FB102 to its immunology pipeline. The 86% premium reflects clinical proof-of-concept in vitiligo and celiac disease.
July 27, 2026 · immunology · $ARGXFDA briefing documents released July 27 say Capricor's HOPE-3 trial did not meet its primary endpoint, citing post-hoc SAP changes and blinding concerns. CAPR stock fell 65% two days before the AdComm vote.
July 27, 2026 · cell-therapy · $CAPRAstraZeneca's sonesitatug vedotin hit overall survival in the CLARITY-Gastric01 Phase 3 trial for 2nd-line CLDN18.2-positive gastric cancer. The trial used a broader expression threshold than Astellas's approved Vyloy.
July 27, 2026 · oncology · $AZNArrowhead completed YOSEMITE enrollment for zodasiran in HoFH. 70 patients enrolled, topping the 60-patient target. Study completion expected mid-2027.
July 27, 2026The FDA accepted Organogenesis's BLA for ReNu in knee OA with an April 24, 2027 PDUFA. It would be the first biologic for 31 million knee OA patients.
July 27, 2026The FDA accepted Pharvaris's NDA for deucrictibant IR in hereditary angioedema with an April 23, 2027 PDUFA. It would be the first oral on-demand HAE therapy.
July 27, 2026The FDA extended Beren Therapeutics' PDUFA for adrabetadex in infantile-onset Niemann-Pick type C to November 17, 2026. A major amendment triggered the delay.
July 26, 2026Elevar Therapeutics, a majority-owned subsidiary of HLB Co. (KOSDAQ: 028300.KQ), faces a September 27 PDUFA for lirafugratinib in FGFR2-driven cholangiocarcinoma. The ReFocus trial showed a 46.5% ORR in patients.
July 26, 2026INOVIO's INO-3107 DNA medicine for recurrent respiratory papillomatosis faces an October 30 PDUFA. The FDA questioned the accelerated approval pathway.
July 26, 2026ONO's tirabrutinib NDA for relapsed CNS lymphoma has a December 18 PDUFA. PROSPECT showed 67% ORR and 44% CR. No approved therapy exists for R/R PCNSL.
July 26, 2026Vanda's imsidolimab BLA for GPP has a December 12 PDUFA. GEMINI showed 53% clear skin vs 13% placebo and zero flares. Spevigo owns the two-drug market.
July 26, 2026Zydus Lifesciences' saroglitazar for PBC has a November 27 PDUFA date. Phase 3 showed 56.7% response vs 9.8% placebo. No US ticker; trades on Indian NSE.
July 26, 2026The FDA approved LEQEMBI IQLIK as a subcutaneous initiation dose on July 13, 2026, more than a month ahead of its extended PDUFA date. It is the first anti-amyloid therapy with at-home dosing from day one.
July 25, 2026FDA issued a third CRL for Elevar's rivoceranib in liver cancer. The 23.8-month OS was never the problem. Manufacturing failures killed an approvable drug.
July 25, 2026FDA granted De Novo authorization for JNJ's OTTAVA robotic surgery system. First table-integrated robot challenges ISRG da Vinci monopoly. JNJ at $263.40.
July 25, 2026Lilly will acquire AtaiBeckley for $2.8B upfront plus $1B in CVRs, adding BPL-003 for treatment-resistant depression. Largest psychedelic deal to date.
July 25, 2026Roche discontinued acmopatide to prioritize enicepatide, which showed 22.5% weight loss with no plateau at 48 weeks. Carmot bet narrows to one obesity asset.
July 25, 2026CHMP backed Enhertu plus pertuzumab as first-line HER2 metastatic breast cancer. DESTINY-Breast09 showed 40.7 vs 26.9 months median PFS. AZN closed at $169.26.
July 25, 2026GSK discontinued camlipixant after CALM-2 failed, writing off the $2B Bellus Health buyout. The P2X3 class is now dead for chronic cough; Trevi rose 12%.
July 25, 2026Sanofi dropped amlitelimab in eczema on July 24, 2026 after Phase 3 data failed to clear the filing bar. Second OX40L drug shelved. SNY closed at $43.35.
July 25, 2026The FDA has a July 30 PDUFA date for Viatris Xulane LO, a weekly contraceptive patch cutting estrogen to 17.5 mcg from 35 mcg. VTRS closed at $17.24 on July 24.
July 25, 2026ACADIA won FDA Fast Track for remlifanserin in Alzheimer's disease psychosis, a condition with no approved therapies. RADIANT Phase 2 data is due in weeks.
July 25, 2026The EU approved AstraZeneca's Etcamah (camizestrant) for ESR1-mutated ER+ breast cancer after a SERENA-6 PFS win. The US FDA's ODAC voted 6-3 against in April.
July 25, 2026REGENXBIO dosed the first patient in the NAAVIGATE trial of sura-vec gene therapy for diabetic retinopathy, unlocking a $100M AbbVie milestone payment.
July 25, 2026Ipsen Phase 3 BOLD trial of Bylvay in biliary atresia missed its primary endpoint. The first global Phase 3 in the disease came up empty for IPSEY holders.
July 25, 2026Kelun sac-TMT plus Keytruda beat chemo plus Keytruda in first-line PD-L1-negative NSCLC. First Phase 3 win for an ADC-ICI combination gives Merck a blueprint.
July 25, 2026EMA CHMP rejected Zevra Miplyffa in Niemann-Pick disease type C. FDA approved the same drug in September 2024. Zevra seeks re-examination of the decision.
July 25, 2026The EMA's CHMP recommended GSK's Lynavoy (linerixibat), the first IBAT inhibitor for cholestatic pruritus in PBC, setting up EU approval within 67 days.
July 25, 2026The EMA's CHMP backed J&J's Icotyde (icotrokinra), the first oral IL-23 receptor antagonist, for moderate-to-severe plaque psoriasis in adults and teens 12+.
July 25, 2026The EMA's CHMP backed Shionogi's Zokovea (ensitrelvir), the first oral antiviral for COVID-19 post-exposure prophylaxis, with EU approval expected in 67 days.
July 25, 2026Merck announced access plans for alimatravir on July 24. The monthly oral HIV PrEP pill is in Phase 3. Seven generic licenses span 129 LMIC countries.
July 25, 2026Novo sued Eli Lilly on July 21 over ads claiming Zepbound beats Wegovy. The complaint cites outdated trial data comparing Lilly's top dose to Novo's lower dose.
July 25, 2026The EMA's CHMP recommended Roche's Susvimo for wet AMD on July 24. The refillable eye implant cuts injections to twice a year. Already FDA-approved in the US.
July 25, 2026Arrowhead Pharmaceuticals reported Phase 3 SHASTA-3/4 results for plozasiran, with 79-81% triglyceride reductions and a 100% reduction in acute pancreatitis events in the highest-risk subgroup. An sNDA filing is planned before year-end.
July 24, 2026 · Cardiometabolic · $ARWRJohnson & Johnson reported Phase 3 MonumenTAL-6 results showing TECVAYLI plus TALVEY reduced the risk of disease progression or death by 89% (HR 0.11) in relapsed/refractory multiple myeloma, the lowest hazard ratio in any bispecific myeloma study.
July 24, 2026 · Oncology · $JNJBridgeBio's encaleret NDA for ADH1, an ultra-rare calcium disorder with no approved treatments, was accepted by the FDA with a PDUFA date of May 8, 2027.
July 24, 2026The FDA's CTGTAC meets July 29 to review Capricor's deramiocel for DMD cardiomyopathy. A rescinded CRL and $1.1B market cap make this a binary catalyst.
July 24, 2026The FDA has a July 29 PDUFA for Novo Nordisk's denecimig (Mim8) for subcutaneous prophylaxis in hemophilia A. Flexible dosing could challenge Roche's Hemlibra.
July 24, 2026Summit reported updated OS data showing a 24% death risk reduction in Western patients with EGFR-mutant lung cancer. The PDUFA date is November 14, 2026.
July 24, 2026Scribe Therapeutics (SCTX) priced its upsized IPO at $15/share, raising $128.7 million for its CRISPR-based cholesterol-lowering program. Co-founded by Nobel laureate Jennifer Doudna, Scribe is developing one-time genetic medicines for cardiovascular disease.
July 24, 2026 · Cardiometabolic · $SCTXAgios discontinued tebapivat in SCD after Phase 2 showed limited differentiation. Mitapivat sNDA has Nov 1 PDUFA. Novo Nordisk etavopivat gains ground.
July 24, 2026Celldex discontinued barzolvolimab in prurigo nodularis after a Phase 2 miss despite profound mast cell depletion, putting the Q4 AD readout in question.
July 24, 2026FDA granted accelerated approval to Replimune's Tudriqev (RP1) plus nivolumab on August 6, 2026 for advanced melanoma after two prior CRLs and a 10-3 AdComm vote. The first oncolytic virus approved for melanoma.
July 24, 2026 · Oncology · $REPLFDA approved Keytruda plus Padcev for muscle-invasive bladder cancer. KEYNOTE-B15 showed 47% EFS and 35% OS risk reductions versus chemotherapy in 808 patients.
July 24, 2026 · Oncology · $MRKEMA CHMP backed Trodelvy plus Keytruda in PD-L1+ first-line metastatic TNBC, based on a 35% risk reduction from ASCENT-04. GILD closed at $130.86 on July 23.
July 24, 2026The FDA proposed withdrawing approval of TAVNEOS after finding unblinded personnel manipulated ADVOCATE trial data to turn a failed endpoint into a statistically significant result. Amgen submitted new data on July 23 requesting a hearing.
July 24, 2026 · Immunology / Rare Disease · $AMGNThe FDA approved Otsuka's centanafadine (SIMTRIYO), the first norepinephrine-dopamine-serotonin reuptake inhibitor for ADHD, on July 24, 2026. First new non-stimulant mechanism in years.
July 24, 2026 · neuroscience · $OTSKYThe FDA granted Novartis traditional approval for Fabhalta in IgA nephropathy on July 17, 2026. That is a stronger regulatory position than the accelerated approvals held by Vera's Trutakna and Otsuka's Voyxact.
July 24, 2026 · Nephrology · $NVSAgios discontinued tebapivat in sickle cell after Phase 2 showed no differentiation. Mitapivat Phase 3 RISE UP is the remaining SCD catalyst. AGIO at $36.28.
July 24, 2026Ionis and AstraZeneca eplontersen missed Phase 3 in ATTR cardiomyopathy. The largest ATTR-CM trial failed on background TTR stabilizers. IONS closed at $56.55.
July 24, 2026FDA approved Lytenava for wet AMD on July 24, five days early. First approved ophthalmic bevacizumab after three prior CRLs. OTLK at $1.32, cap $247M.
July 24, 2026 · Ophthalmology · $OTLKFDA approved Sanofi Sarclisa Escena on-body injector for myeloma. First anticancer drug delivered via wearable device. Infusion reactions dropped 25% to 1.5%.
July 24, 2026FDA granted accelerated approval to Vera Trutakna for IgA nephropathy, first dual BAFF/APRIL inhibitor to reduce proteinuria. A 46% reduction supports approval.
July 24, 2026FDA approved MNKD FUROSCIX ReadyFlow on July 24, two days ahead of PDUFA. It delivers IV-equivalent furosemide in under 10 seconds for heart failure and CKD.
July 24, 2026 · Cardiovascular · $MNKDFDA expanded Vertex Casgevy to ages 2+ on July 1, 2026. First CRISPR therapy for pediatric sickle cell and beta thalassemia, approved in 53 days under CNPV.
July 24, 2026 · Gene therapy · $VRTXThe FDA approved GSK's Jideytro (zidesamtinib) for previously treated ROS1-positive non-small cell lung cancer, two months ahead of schedule and one week after GSK closed its Nuvalent acquisition.
July 23, 2026 · Oncology · $GSKEli Lilly's triple agonist retatrutide hit primary endpoints in TRIUMPH-2 and TRIUMPH-3, delivering up to 22.6% weight loss and meaningful cardiovascular biomarker improvements. A Q1 2027 FDA filing is planned.
July 23, 2026 · Metabolic · $LLYThe FDA approved Merck's LIPFENDRA (enlicitide), the first once-daily oral PCSK9 inhibitor for reducing LDL cholesterol. Two Phase 3 trials showed 56% and 59% LDL-C reductions. The pill format could finally unlock the PCSK9 market.
July 23, 2026 · Cardiometabolic · $MRKThe FDA approved Vertex's suzetrigine (Journavx) on January 30, 2025 for moderate-to-severe acute pain — the first new class of pain medicine in 25 years. Now Vertex is pushing into chronic pain.
July 21, 2026 · Rare Disease · $VRTX