Pharma and biotech news, week of Nov 2 – Nov 8, 2026

The U.K. MHRA approved an extension of Joenja (leniolisib)'s marketing authorization to children aged 4 to 11 weighing at least 27 kg with activated PI3K delta syndrome (APDS). The approval includes 40 mg and 50 mg twice-daily dosing and makes Joenja the first treatment approved in the U.K. specifically for children with APDS. Joenja is expected to become available under the expanded indication in February 2027.AI summary

Bristol Myers Squibb presented 56-week results from the Phase 3 SCOUT-HCM trial of Camzyos (mavacamten) in pediatric patients with symptomatic obstructive hypertrophic cardiomyopathy. Patients on mavacamten had a mean Valsalva LVOT gradient change of -48.1 mmHg from baseline at 56 weeks; no patient had LVEF below 50%, and no new safety signals were reported. Additional presentations are planned at the American Heart Association's Scientific Sessions 2026.AI summary

Arcutis Biotherapeutics has enrolled the first participant in its Phase 3 INTEGUMENT-3 study. The double-blind, vehicle-controlled trial is evaluating the efficacy, safety, and tolerability of once-daily ZORYVE (roflumilast) cream 0.3% in approximately 415 participants aged 6 and older with moderate to severe atopic dermatitis. Participants completing the 4-week treatment period can join a 48-week open-label extension.AI summary

Eli Lilly will present clinical and real-world research evaluating retatrutide, Taltz, and Zepbound at ACR Convergence 2026. Phase 3 results from TRIUMPH-1 and TRIUMPH-4 showed retatrutide significantly reduced knee osteoarthritis pain and weight in patients with knee osteoarthritis and obesity. Additionally, Phase 3b TOGETHER-PsA trial data demonstrated improved disease activity and metabolic outcomes when combining Taltz and Zepbound compared to Taltz alone in psoriatic arthritis.AI summary

The U.S. FDA has acknowledged receipt of Elevar Therapeutics' NDA resubmission for rivoceranib in combination with Hengrui Pharma's camrelizumab for first-line treatment of unresectable or metastatic hepatocellular carcinoma. The agency assigned a PDUFA target action date of April 9, 2027. The resubmission addresses concerns from a July 2026 Complete Response Letter and is supported by Phase 3 trial data.AI summary

The EMA's Committee for Orphan Medicinal Products (COMP) adopted a positive opinion recommending maintenance of orphan medicinal product designation for once-weekly TransCon CNP (navepegritide) as a treatment for achondroplasia in children, which would provide 10 years of orphan market exclusivity upon final European Commission adoption. The CHMP has also given a positive opinion recommending marketing authorization in the EU. The final EC decision is expected during Q4 2026, and if authorized, Ascendis expects its first EU launch under the brand name YUVIWEL in Germany during Q1 2027.AI summary

Lantheus welcomed CMS' Calendar Year 2027 OPPS final rule, which maintains separate payment for qualifying diagnostic radiopharmaceuticals. CMS confirmed PYLARIFY TruVu received Transitional Pass-Through payment status through September 30, 2029, and assigned it permanent HCPCS code A9613 effective October 1, 2026. The company continues to support policies enabling reimbursement for diagnostic radiopharmaceuticals in clinical practice.AI summary

Elevar Therapeutics announced that the FDA acknowledged receipt of the resubmitted NDA for rivoceranib in combination with camrelizumab as a first-line treatment for unresectable or metastatic hepatocellular carcinoma. The FDA assigned a PDUFA target action date of April 9, 2027. The resubmitted NDA addresses concerns previously raised in a Complete Response Letter.AI summary

Rhythm Pharmaceuticals announced that the UK's National Institute for Health and Care Excellence (NICE) has issued updated positive guidance for IMCIVREE (setmelanotide). The expanded guidance broadens reimbursement eligibility to include adults living with genetically confirmed Bardet-Biedl syndrome (BBS). This update builds on NICE's previous recommendation from May 2024, enabling adults with BBS in England, Wales, and Northern Ireland to access NHS-funded treatment.AI summary

ImmunityBio announced that the first European patients have been treated with ANKTIVA in combination with BCG for BCG-unresponsive non-muscle invasive bladder cancer. The initial treatments took place in Germany and Austria following conditional marketing authorization from the European Commission in February 2026. Commercialization and distribution across Europe are being supported through partnerships with Accord Healthcare and Uniphar.AI summary

Elevar Therapeutics announced that lirafugratinib (Lyrfigtu) has been added to the NCCN Clinical Practice Guidelines in Oncology as a Category 2A preferred subsequent-line therapy for cholangiocarcinoma with FGFR2 fusion or rearrangement. The inclusion follows FDA approval based on Phase 1/2 ReFocus trial data demonstrating a 46% objective response rate. Lyrfigtu is expected to be available to U.S. patients by Q4 2026.AI summary

Genmab announced that 22 abstracts evaluating epcoritamab across multiple B-cell malignancies will be presented at the 2026 ASH Annual Meeting. Highlights include the first disclosure of primary results from the Phase 3 EPCORE DLBCL-4 study evaluating epcoritamab plus lenalidomide in relapsed or refractory diffuse large B-cell lymphoma. Genmab will host a virtual R&D Update and ASH Data Review on December 16, 2026.AI summary

Merck has initiated the Phase 3 ENHANCE-3 trial evaluating Ohtuvayre (ensifentrine) for preventing COPD exacerbations in adult patients receiving standard of care with an exacerbation history. The study plans to enroll approximately 2,136 patients across 28 countries, with enrollment currently underway in the United States. Merck looks forward to sharing the study results with global regulatory authorities.AI summary

Lantheus Holdings announced data to be featured at the 2026 Clinical Trials on Alzheimer’s Disease Annual Meeting in Boston. The presentations include a poster on the diagnostic performance of florquinitau F 18 PET in pivotal Phase 3 studies for detecting tau pathology in early Alzheimer's disease. A second poster will present data on 18F-FDED PET imaging in the Alzheimer's disease spectrum.AI summary

Jazz Pharmaceuticals announced it will present neuro-oncology research at the SNO 2026 Annual Meeting. Key highlights include progress on the confirmatory Phase 3 ACTION trial evaluating Modeyso (dordaviprone) in newly diagnosed H3 K27M-mutant diffuse glioma. An interim analysis for the Phase 3 trial is planned for the first half of 2027.AI summary

Milestone Pharmaceuticals announced subgroup analysis data from the Phase 3 RAPID trial evaluating CARDAMYST (etripamil) nasal spray. Results showed 66.7% of patients with recurrent PSVT following a prior catheter ablation converted to normal heart rhythm within 30 minutes, compared to 20.0% on placebo. The findings will be presented at the AHA Scientific Sessions 2026.AI summary

Kardigan Inc. announced it completed enrollment in the Phase 2b KATALYST-AV trial of ataciguat in aortic stenosis, with 156 participants enrolled. The primary endpoint, aortic valve calcium, will now be assessed at Week 48 alongside aortic valve area and other measures, following a blinded protocol amendment that was not prompted by any safety finding. Kardigan expects to update its Phase 3 plans in the first half of 2027 and to report Week 48 topline data in the second half of 2027.AI summary

Recursion presented updated Phase 2 data from the ongoing TUPELO trial evaluating REC-4881 in patients with familial adenomatous polyposis. After 12 weeks of treatment, patients achieved a 47% median reduction in total polyp burden, with 85% remaining below baseline 12 weeks after stopping treatment. Pending ongoing FDA discussions, the company plans to initiate a registrational trial in the second half of 2027.AI summary

Cabaletta Bio presented new Phase 1/2 data on rese-cel at ACR Convergence 2026. In dermatomyositis, 100% (6/6) of patients maintained immunomodulator-free, moderate-to-major TIS responses through one year. Across 71 patients, 94% (67/71) had no or Grade 1 cytokine release syndrome. Topline results from the registrational DM/ASyS cohort are expected in the second half of 2027, with a BLA submission planned for the first quarter of 2028.AI summary

Cullinan Therapeutics announced interim data from the Genrix Bio Phase 1b/2a study of velinotamig (GR1803) in refractory systemic lupus erythematosus, presented at ACR Convergence 2026. As of September 8, 2026, eight of nine evaluable patients achieved a reduction of at least four points in SLEDAI-2K. Four of seven evaluable patients with proteinuria above 500 mg/24 hours at baseline achieved a complete renal response within 24 weeks.AI summary

Regeneron reported first-in-human Phase 1/2 trial results for CIDEB siRNA, a single subcutaneous dose given to adults with MASLD, published in The New England Journal of Medicine and presented at AASLD. At week 36, liver fat fell 58-80% in a dose-dependent manner, versus a mean decrease of 2.9% with placebo, and 62% of recipients normalized liver fat. Phase 2a, Phase 2b and Phase 3 trials are ongoing and now recruiting.AI summary

Immunocore presented Phase 1/2 data at the 2026 SITC Annual Meeting on brenetafusp alone and with KIMMTRAK in HLA-A*02:01-positive metastatic uveal melanoma. In 17 evaluable first-line patients on the combination, overall response rate was 29%, median duration of response 24.1 months, and estimated two-year overall survival 70%. The company plans a randomized Phase 2/3 trial, DUET-UVEAL, to further evaluate the combination.AI summary

Precision BioSciences announced that an independent Data Safety Monitoring Board completed a safety review of the first patient treated with PBGENE-DMD in the Phase 1/2 FUNCTION-DMD study. No serious adverse events were reported through week eight. The DSMB endorsed proceeding with dosing additional patients, and Precision expects to provide safety and efficacy updates throughout 2027.AI summary

Opus Genetics has completed dosing in the higher-dose Cohort 2 of its Phase 1/2 BIRD-1 clinical trial evaluating OPGx-BEST1 for BEST1-related retinal diseases. The cohort enrolled 11 participants at a dose of 4.5 × 10⁹ vg/eye. Topline three-month data from Cohort 2 are expected in Q1 2027, with dosing in a potential pivotal Phase 3 trial anticipated to begin in H2 2027.AI summary

FORE Biotherapeutics announced two upcoming presentations of clinical and preclinical data for plixorafenib at oncology meetings in November 2026. Updated Phase 1/2a data in BRAF V600 primary CNS tumors demonstrate sustained efficacy and safety, with treatment durations exceeding four years. The company will also present new preclinical data evaluating plixorafenib in BRAF-altered colorectal cancer models.AI summary

Lexeo Therapeutics announced it will present data at the AHA and ICAR scientific conferences in November 2026. Phase I/II interim clinical data for LX2006 in Friedreich ataxia demonstrated sustained improvements in mFARS scores, LVMI, and troponin over 36 months compared to controls. Lexeo will also present preclinical data for LX2021 and TNNI3 gene therapy programs.AI summary

Precision BioSciences announced updated Phase 1 ELIMINATE-B trial data for PBGENE-HBV in chronic hepatitis B. The therapy achieved durable pgRNA loss to undetectable in 100% of evaluable patients at the 0.4 mg/kg dose with a manageable safety profile and no dose-limiting toxicities. Based on these results, the company selected 0.4 mg/kg for a global Phase 2 study expected to begin dosing in Q1 2027.AI summary

Attovia Therapeutics announced positive topline 12-week Phase 1b results for ATTO-1310 in patients with chronic pruritus and high-itch atopic dermatitis. A single subcutaneous dose demonstrated itch relief, skin lesion improvements, and sustained IL-31 suppression of approximately 95% through Week 12. Attovia plans to initiate two Phase 2 trials of ATTO-1310 in the first half of 2027.AI summary

Arvinas announced that preliminary clinical data from the Phase 1 study of ARV-393 (zaloblideg) in patients with relapsed/refractory non-Hodgkin lymphoma will be presented at the 2026 ASH Annual Meeting. The data presentation will cover safety, pharmacokinetics, and pharmacodynamics across all patients, alongside preliminary efficacy in T-cell lymphoma patients. ARV-393 is being evaluated as both a monotherapy and in combination with glofitamab.AI summary

Cullinan Therapeutics announced four poster presentations featuring CLN-049 and velinotamig at the 68th ASH Annual Meeting. Updated Phase 1 dose escalation data for CLN-049 reported anti-leukemic activity at target doses of 6 µg/kg and 12 µg/kg alongside a favorable safety profile. The company will also present Trials in Progress posters for both T cell engager programs.AI summary

Allergan Aesthetics reported results from two Phase 4 studies, HARMONY IN DIVERSITY and HALO, of aesthetic treatment in adults on GLP-1 medications. In HARMONY IN DIVERSITY Cohort 2 (30 adults), mean FACE-Q Satisfaction With Facial Appearance improved by a statistically significant 42.4 points. HALO's interim analysis of 25 adults showed a 39.6-point mean improvement, and 95.7% were satisfied or very satisfied that they still looked like themselves.AI summary

Neurocrine Biosciences announced new survey and post-hoc trial data for INGREZZA (valbenazine) capsules in adults with tardive dyskinesia. The survey showed work or school disruptions dropped from 57% before treatment to 21% after starting INGREZZA. Additionally, a post-hoc analysis of the KINECT-PRO study demonstrated patient-reported improvements across all six physical and socio-emotional areas evaluated by the Tardive Dyskinesia Impact Scale.AI summary

Allergan Aesthetics announced it will present nine abstracts at the 2026 ASDS Annual Meeting in November. The presentations include new Phase 4 data on aesthetic treatments following medical weight loss, focusing on patient satisfaction and psychosocial outcomes. Additionally, the company will share a digital image analysis comparing investigational trenibotulinumtoxinE with BOTOX Cosmetic for glabellar lines.AI summary

Mineralys Therapeutics presented long-term results from the Transform-HTN open-label extension trial of lorundrostat at AHA Scientific Sessions 2026. Lorundrostat reduced automated office systolic blood pressure by 17.8 mmHg from the Launch-HTN baseline through Week 48 (n=504), and 56% of participants reached AOSBP below 130 mmHg. Lorundrostat was well tolerated, with no new clinically relevant safety findings compared with Launch-HTN. The FDA review is underway, with a PDUFA target date of December 22, 2026.AI summary

Arrowhead Pharmaceuticals presented American Heart Association Scientific Sessions 2026 data on plozasiran and investigational ARO-DIMER-PA. A pooled SHASTA-3 and SHASTA-4 analysis showed plozasiran reduced acute pancreatitis event rates by 78% versus placebo and by 91% in patients with recent pancreatitis history. Interim Phase 1/2a ARO-DIMER-PA results showed mean LDL-C reductions of 26% to 65%, and longer-term studies are needed.AI summary

Orca Bio announced that new clinical data will be presented in four poster sessions at the American Society of Hematology Annual Meeting, December 12-15 in New Orleans, LA. The presentations include two-year follow-up of TREGZI® from the pivotal Phase 3 Precision-T trial, along with data on Orca-T® and the next-generation candidate Orca-Q®. The ASH abstracts are available at www.hematology.org.AI summary

Compass Therapeutics will present data at the SITC 2026 Annual Meeting showing a novel mechanism for CTX-10726, a PD-1 x VEGF-A bispecific antibody, in which PD-1 is cleaved from T cells in a VEGF-A-dependent manner. Adding VEGF-A increased the potency of CTX-10726 approximately ten-fold in a human immune-cell assay, reducing the EC50 from 2.0 to 0.2 nM. CTX-10726 is in a Phase 1 dose-escalation study, and the poster presentation is scheduled for November 7, 2026.AI summary

Madrigal Pharmaceuticals announced new real-world data presented at AASLD 2026 for Rezdiffra (resmetirom) in patients with MASH. In real-world studies, up to 93% of patients experienced improvement or stabilization in liver stiffness after one year, with up to 72% remaining persistent on therapy. Safety findings were consistent with established clinical trial data.AI summary

Aquestive Therapeutics announced it will present data at the 2026 ACAAI Annual Meeting in Phoenix, Arizona. The presentations will feature research on the pharmacokinetic and pharmacodynamic profiles of Anaphylm (dibutepinephrine) sublingual film and AQST-109. Abstracts will become available online on November 12, 2026.AI summary

Alkermes announced plans to present data across its psychiatry and sleep medicine portfolios at the Neuroscience Education Institute (NEI) Fall Congress. Highlights include real-world assessments of acute care events following LYBALVI initiation and data on alixorexton in patients with narcolepsy and idiopathic hypersomnia. The presentations aim to support clinical decision-making and expand the body of evidence in neuroscience.AI summary

Amgen announced real-world study results showing that Repatha (evolocumab) reduced the risk of fatal or nonfatal heart attacks by 20% compared with ezetimibe in adults with atherosclerotic cardiovascular disease and prior statin use. The four-year cumulative risk of heart attack was lower with Repatha than with ezetimibe (5.88% vs. 7.76%) among patients with baseline LDL-C measurements. The findings were published in The American Journal of Preventive Cardiology.AI summary

GSK announced it will present data across 21 abstracts for its liver portfolio at AASLD 2026. Findings include long-term Phase 3 B-Well data for Hibsago (bepirovirsen) in chronic hepatitis B and Phase 2 data for efimosfermin in MASH. The presentations support the continued evaluation and advancement of GSK's pipeline.AI summary

Eton Pharmaceuticals announced preliminary results from a pilot study evaluating ET-700 in healthy participants. ET-700 demonstrated a lower rate of drug-related adverse events than GALZIN, but showed a more modest 12% decrease in hepatic copper uptake compared to 46% for GALZIN. The company plans to evaluate faster-release formulations in additional study arms in 2027.AI summary

Lyell Immunopharma announced two accepted abstracts for presentation at ASH 2026 featuring positive updated clinical data for rondecabtagene autoleucel (ronde-cel) in relapsed/refractory large B-cell lymphoma. Response-evaluable patients achieved an overall response rate of 91% in the pivotal PiNACLE 3L+ trial and 95% in the Phase 1/2 2L cohort. Lyell plans to present updated results with longer follow-up at the meeting.AI summary

Incyte announced that it will present data from more than 30 abstracts across its hematology portfolio at the 2026 ASH Annual Meeting. Key presentations will highlight clinical progress for INCA033989 in myelofibrosis and essential thrombocythemia, as well as Phase 1/2 data for latarcibart in von Willebrand disease. Incyte will also host an investor event and webcast on December 12, 2026.AI summary

Agios announced that clinical data for its rare hematology portfolio will be featured at ASH 2026. New Phase 3 RISE UP data for mitapivat showed long-term hemoglobin improvements and potential renal and cardiac benefits in sickle cell disease. Additionally, Phase 1 data for AG-236 demonstrated favorable safety and biomarker reductions through Month 6, supporting plans to advance into a Phase 2/3 polycythemia vera program.AI summary

Kura Oncology and Kyowa Kirin announced that eight abstracts featuring ziftomenib will be presented at the 2026 ASH Annual Meeting. The presentations will showcase preliminary safety and clinical activity for ziftomenib in combination with quizartinib, gilteritinib, venetoclax, azacitidine, and chemotherapy in acute myeloid leukemia settings. Additionally, Kura will host an investor webcast on December 15, 2026.AI summary

Caribou Biosciences announced that clinical abstracts for vispa-cel and CB-011 were accepted for presentations at the 2026 ASH Annual Meeting. Investigators will present data from the ANTLER and CaMMouflage trials. The abstracts were submitted prior to Caribou's plans to explore strategic alternatives and discontinue further development of both programs.AI summary

Legend Biotech announced multiple abstracts accepted for the 2026 ASH Annual Meeting (December 12–15, New Orleans), covering CARVYKTI clinical and real-world analyses and next-generation cell therapy programs. CITADEL showed an IEC-parkinsonism rate of 1.6% with a preemptive steroid strategy versus 2.9% in historical data, and updated LB2501 data showed overall and complete response rates of 100% among eight patients at dose level 2.AI summary

Merck announced it will present new data across its oral HIV treatment and prevention portfolio at HIV Glasgow 2026. Presentations will cover Phase 3 subgroup analyses and patient-reported outcomes for daily IDVYNSO, as well as the investigational once-weekly oral combination of islatravir/lenacapavir. Additionally, Merck will highlight data on once-weekly islatravir/ulonivirine and participant demographics from Phase 3 trials evaluating once-monthly oral alimatravir for PrEP.AI summary

Arrowhead Pharmaceuticals announced it will present clinical data on ARO-DIMER-PA and plozasiran at the American Heart Association Scientific Sessions 2026. Presentations include Phase 1/2a results for ARO-DIMER-PA in mixed hyperlipidemia and pooled Phase 3 data for plozasiran in severe hypertriglyceridemia. Three-year efficacy and safety data for plozasiran in familial chylomicronemia syndrome will also be presented.AI summary

Arrowhead Pharmaceuticals has completed a refinancing transaction with funds managed by Sixth Street. The deal retires an existing $400 million facility at a $68 million discount and establishes a new $400 million senior secured term loan facility bearing interest at SOFR plus 5.50%. The new facility extends debt maturity to November 2, 2031, with no scheduled amortization payments or required revenue sweeps.AI summary

Rhythm Pharmaceuticals and LG Chem have amended their exclusive global license agreement for bivamelagon. Under the amended terms, Rhythm will pay LG Chem $350 million in additional fixed payments over four years and revise royalties to 1% on global net sales of its MC4R portfolio. To fund the agreement and support commercialization, Rhythm secured a $750 million term-loan facility.AI summary

Precision BioSciences announced the pricing of an underwritten offering of common stock and pre-funded warrants. The gross proceeds to Precision are expected to be approximately $125 million before deducting expenses. The company intends to use the net proceeds to fund the continued research and development of PBGENE-HBV and PBGENE-DMD, as well as for general corporate purposes.AI summary

Nxera Pharma has entered into an exclusive global license agreement with AbbVie for its inflammatory bowel disease candidate, NXE0033744. Under the terms, Nxera will receive $100 million upfront and is eligible for up to $1.37 billion in development and commercial milestone payments, plus tiered royalties. AbbVie will receive exclusive global rights to develop and commercialize the novel EP4 receptor agonist.AI summary

Lyell Immunopharma has entered into a securities purchase agreement for a private placement of approximately $80 million. The gross proceeds are expected to extend Lyell's cash runway into 2028. This capital will support the clinical development of ronde-cel toward its planned BLA submission in the second half of 2027, as well as the ongoing development of LYL273.AI summary

Pharmaceuticals company. Total offering $30M; first sale 2026-10-28. Form D is filed up to 15 days after the first sale.

Acrivon Therapeutics acquired ACR-525 (formerly AQ280), a Phase 2-ready, oral, highly selective JAK1 inhibitor, and a PKCθ inhibitor preclinical program from Aqilion AB for an undisclosed cash consideration with no future royalties or milestone obligations. Concurrently, the royalty and milestone obligations on ACR-525 previously agreed between Aqilion and LEO Pharma were terminated. Eosinophilic esophagitis is the first targeted potential indication, and Acrivon will host a KOL webcast on November 10, 2026.AI summary

Eli Lilly and Hims & Hers Health announced an agreement to help expand access to Zepbound (tirzepatide) and Foundayo (orforglipron). Eligible patients with a prescription from a licensed provider on the Hims & Hers platform can access self-pay prices starting at $149 per month for Foundayo and $299 per month for Zepbound. Patients can have an FDA-approved Lilly medicine shipped directly to their home.AI summary

Eton Pharmaceuticals has licensed patent rights from Baylor College of Medicine to develop ET-900 (mecasermin/IGF-1) for infantile and epileptic spasms. An Investigational New Drug application has been submitted for an investigator-sponsored Phase 2 trial in children with refractory epileptic spasms. The study expects to begin patient enrollment and dosing in the first quarter of 2027.AI summary

Moderna reported third-quarter 2026 revenue of $1.3 billion, up 29%, and net income of $162 million, with GAAP diluted EPS of $0.38. The company raised its 2026 revenue growth outlook to 15%–25%, from up to 10%, and expects year-end cash and investments of $8.1–$8.3 billion. The release also cites U.S. FDA approval of mFLUSIVA and positive Phase 3 intismeran results in melanoma, with further intismeran readouts and regulatory approvals anticipated.AI summary

Elanco Animal Health reported third quarter 2026 revenue of $1.265 billion, up 11% year-over-year and 9% on an organic constant currency basis. Reported net income was $18 million and adjusted net income was $136 million, with adjusted EBITDA of $243 million and a net leverage ratio of 2.9x. The company raised its full year 2026 guidance, with revenue now $5.155 billion to $5.18 billion and adjusted EBITDA $1.05 billion to $1.065 billion, and provided an early 2027 outlook.AI summary

Immunocore reported KIMMTRAK net sales of $102.2 million for the third quarter of 2026 and $324.8 million for the first nine months, representing 10% year-over-year growth year to date. The Phase 3 TEBE-AM trial completed enrollment of 540 patients, with topline overall survival data expected in the second quarter of 2027. The first person with type 1 diabetes was dosed in the Phase 1 trial of IMC-S118AI, and cash, cash equivalents and marketable securities were $901 million as of September 30, 2026.AI summary

Amylyx Pharmaceuticals reported its third quarter 2026 financial results, including positive topline results from the Phase 3 LUCIDITY trial of avexitide in post-bariatric hypoglycemia. The study met its primary endpoint with a 55% reduction in Level 2 and Level 3 hypoglycemic events versus placebo. Amylyx remains on track to submit a New Drug Application by the end of 2026.AI summary

Korro Bio has initiated dosing in healthy volunteers for its Phase 1/2 ANCHOR trial evaluating KRRO-121 for hyperammonemia. The company plans to dose participants with urea cycle disorders in the first half of 2027 and report interim data in the second half of 2027. Additionally, Korro expects to submit a regulatory filing for KRRO-111 in the first half of 2027.AI summary

Adicet Bio reported its third quarter 2026 financial results and provided pipeline updates. Phase 1 data for prulacabtagene leucel (prula-cel) demonstrated durable responses in systemic lupus erythematosus, and startup activities for a pivotal lupus nephritis study are underway. The FDA also cleared the IND for ADI-212 in metastatic castration-resistant prostate cancer.AI summary

Monte Rosa Therapeutics reported positive Phase 1 GFORCE-1 trial results for MRT-8102, showing reductions in key ASCVD drivers with safety comparable to placebo. The company plans to initiate Phase 2 studies of MRT-8102 in gout, coronary artery disease, and hidradenitis suppurativa. Additionally, Novartis triggered $87.5 million in Phase 2 milestone payments by initiating studies for MRT-6160.AI summary

Ironwood Pharmaceuticals reported its third quarter 2026 financial results, generating $133 million in total revenue and $59.8 million in GAAP net income. Driven by continued growth in U.S. LINZESS net sales, the company raised its full-year 2026 guidance for LINZESS U.S. net sales to $1.20–$1.25 billion and total revenue to $485–$510 million. Additionally, site expansion remains on track for its ongoing STARS-2 Phase 3 trial of apraglutide.AI summary

Allogene Therapeutics reported its third quarter 2026 financial results, ending the period with $388.9 million in cash, cash equivalents, and investments. The company continues to progress its pivotal Phase 2 ALPHA3 trial evaluating cema-cel in first-line large B-cell lymphoma, with the next clinical update expected in mid-2027 and trial enrollment completion planned by year-end 2027. Additionally, Allogene will present updated Phase 1 RESOLUTION data for ALLO-329 in autoimmune disease at ACR Convergence.AI summary

Intellia Therapeutics reported its third quarter 2026 financial results and business updates. The company completed enrollment in its MAGNITUDE-2 Phase 3 trial of nex-z in ATTRv-PN and advanced enrollment in the MAGNITUDE Phase 3 trial in ATTR-CM. Intellia holds $614.8 million in cash, which is expected to fund operations into 2028.AI summary

Evotec reported Q3 2026 Group revenue of €164.9 million and nine-month revenue of €465.0 million, with Q3 adjusted EBITDA improving to -€1.6 million. The company reaffirmed its full-year 2026 revenue guidance of €570 million to €610 million. Additionally, Evotec detailed a framework targeting around €1 billion in Group revenue by 2030.AI summary

Celcuity Inc. announced its third quarter 2026 financial results, reporting a net loss of $73.3 million and $642.7 million in cash reserves. Its drug REVTORPYK became commercially available on September 30, 2026, following FDA approval in July, though no product revenue was recognized in Q3 due to delivery timing. Celcuity also submitted an sNDA for a PIK3CA mutant breast cancer cohort during the quarter and expects its cash to fund operations through 2029.AI summary

Sarepta Therapeutics reported third-quarter 2026 total revenues of $381.4 million, including $323.8 million in net product revenues. The company updated its full-year guidance, raising the lower end of total net product revenue by $50.0 million to $1.25 billion–$1.3 billion. Sarepta expects multiple ascending dose data from SRP-1003 and SRP-1001 by the end of 2026 and is preparing for Phase 3 development in both programs.AI summary

Agios reported third quarter 2026 results, with worldwide net revenues of $55.4 million from mitapivat (PYRUKYND and AQVESME), more than four times the $12.9 million reported in the third quarter of 2025. The FDA extended the review of the mitapivat sickle cell disease sNDA by three months, with a new PDUFA goal date of February 1, 2027. Cash, cash equivalents and marketable securities were $907.0 million as of September 30, 2026, and the company targets non-GAAP profitability in 2028.AI summary

Zoetis reported third-quarter 2026 revenue of $2.4 billion, a 1% decrease, with net income falling 18% to $591 million. The company narrowed its full-year 2026 revenue guidance to $9.220 billion to $9.320 billion while raising its adjusted diluted EPS guidance to $6.25 to $6.35. Zoetis also announced several product updates, including U.S. FDA approval for Convenia RTU for Dogs.AI summary

Korsana Biosciences reported its third quarter 2026 financial results, highlighting the completion of its merger with Cyclerion Therapeutics and a concurrent $380 million private placement. The company ended the quarter with $456.2 million in cash and cash equivalents, which is expected to fund operations into 2029. Next, Korsana expects Phase 1 healthy volunteer data for lead asset KRSA-028 in mid-2027.AI summary

aTyr Pharma reported third quarter 2026 financial results, ending the period with $50.3 million in cash and investments. The company reached alignment with the FDA on a Phase 3 study protocol for efzofitimod in pulmonary sarcoidosis and initiated study-related activities. aTyr is prioritizing strategic partnerships or licensing arrangements to further advance the trial.AI summary

Verastem Oncology reported third-quarter 2026 financial results, generating $24.0 million in net product revenue from AVMAPKI FAKZYNJA CO-PACK. The FDA accepted the NDA for the product's blister pack presentation under Priority Review with a decision expected by February 7, 2027. Additionally, Verastem completed a $250.0 million public offering and plans to initiate the Phase 3 TARGET-D 301 trial for VS-7375 by year-end 2026.AI summary

REGENXBIO reported its third quarter 2026 financial results, posting a net loss of $40.7 million and revenue of $9.2 million. The company remains on track to submit a Biologics License Application for RGX-202 in Duchenne muscular dystrophy in Q1 2027. Additionally, topline data from pivotal trials evaluating sura-vec in wet AMD are expected in Q4 2026.AI summary

Celldex reported its third-quarter 2026 financial results and provided a business update. The company highlighted Phase 3 data for barzolvolimab in chronic spontaneous urticaria and announced plans for a BLA submission in 2027. Celldex ended the quarter with $650.3 million in cash, cash equivalents, and marketable securities, which is expected to fund operations through 2028.AI summary

MannKind reported third quarter 2026 total revenues of $101.9 million, up 24% from Q3 2025, with commercial product revenue of $45.0 million, up 102%. Furoscix ReadyFlow was approved and shipments commenced in mid-September, and approximately 75% of Furoscix shipments had transitioned to ReadyFlow by late October. The company reported positive Phase 1b INFLO-1 results for nintedanib DPI, and a global Phase 2 trial is underway.AI summary

Cabaletta Bio reported third quarter 2026 financial results and a business update. Cash and cash equivalents were approximately $299.4 million as of September 30, 2026, including approximately $115.0 million from warrant exercises, and are expected to fund the operating plan into the first quarter of 2028. Registrational RESET-Myositis topline results are expected in 2H27, with a BLA submission planned for 1Q28.AI summary

Caribou Biosciences reported third quarter 2026 financial results, including a GAAP net loss of $26.6 million and cash, cash equivalents, and marketable securities of $94.8 million as of September 30, 2026. The report follows an October 2026 operational restructuring to explore strategic alternatives such as a merger, acquisition, or liquidation. Caribou plans to discontinue clinical trials and development for vispa-cel and CB-011 while executing workforce reductions.AI summary

Tectonic Therapeutic reported third-quarter 2026 financial results and business highlights, including positive Phase 1a safety and pharmacokinetic data for TX2100 in healthy volunteers. The company dosed the first patient in the Phase 2a ALPINE trial of TX45 in PH-ILD, with interim results expected in H2 2027. Tectonic expects its $234.7 million in cash as of September 30, 2026, to fund operations into Q1 2029.AI summary

BeOne Medicines reported third quarter 2026 total revenues of $1.9 billion, a 34% increase from the prior year, driven by $1.4 billion in global sales for BRUKINSA. GAAP net income for the quarter reached $385 million, and diluted GAAP earnings per ADS was $3.28. Consequently, the company raised its full-year 2026 total revenue guidance to between $6.9 billion and $7.0 billion.AI summary

Dyne Therapeutics announced its third-quarter 2026 financial results, reporting a net loss of $193.6 million and cash resources of $1.134 billion. The FDA is reviewing its BLA for z-rostudirsen in exon 51 DMD with a PDUFA target date of January 21, 2027. Additionally, Dyne plans to report topline data from the ACHIEVE trial expansion cohort for z-basivarsen in Q1 2027.AI summary

Eton Pharmaceuticals reported record third quarter 2026 revenue of $57.9 million, representing 158% year-over-year growth. Driven by strong sales and portfolio performance, the company raised its full-year 2026 revenue guidance to more than $175 million. Eton also advanced several clinical programs and expects multiple product launches and regulatory submissions in 2027.AI summary

Vera Therapeutics reported Q3 2026 financial results, including $10.3 million in net product revenue following the July accelerated approval of TRUTAKNA. The company completed its supplemental Biologics License Application submission to the FDA on November 3, 2026, seeking full approval for TRUTAKNA in primary IgAN. Potential full FDA approval is expected in mid-2027.AI summary

Lantheus reported third-quarter 2026 worldwide revenue of $389.9 million and GAAP fully diluted EPS of $0.33. During the period, the company secured FDA approvals for TAUKLARIFY and BRAVNETSA. Additionally, Lantheus announced a definitive agreement to merge with Curium in an all-cash deal valued at up to approximately $8.0 billion.AI summary

Sana Biotechnology reported third quarter 2026 financial results, ending the quarter with $121.7 million in cash and marketable securities. The company remains on track to file an IND and initiate a Phase 1/2 trial for SC451 in type 1 diabetes as early as this year. Clinical studies for SG293 in non-Hodgkin lymphoma are expected to start in the first quarter of 2027.AI summary

Genmab reported financial results for the first nine months of 2026, with revenue increasing 22% year-over-year to $3,238 million. Operating profit reached $986 million, driven by higher royalty revenues and sales of EPKINLY. The company maintained its 2026 financial guidance published in August 2026.AI summary

Cogent Biosciences reported third quarter 2026 financial results with $791.1 million in cash, expected to fund operations into late 2028. The company is preparing for commercial launch and pending FDA PDUFA action dates for bezuclastinib in GIST on November 30, 2026, NonAdvSM on December 30, 2026, and AdvSM on June 29, 2027. Cogent also plans to submit INDs for its JAK2 and KRAS programs in Q4 2026.AI summary

Viatris reported third-quarter 2026 total revenues of $3.75 billion, a U.S. GAAP net loss of $325 million, and adjusted EBITDA of $1.20 billion. The company received FDA approval for RYZUMVI for presbyopia and Japanese approval for WAKIX, and it plans to acquire Pacira BioSciences, expected to close by the end of November. Viatris raised the midpoints of its 2026 financial guidance ranges for all metrics.AI summary

Iovance Biotherapeutics reported third quarter 2026 total product revenue of about $122 million, up about 80% from about $67 million in 3Q25 and about 22% from about $99 million in 2Q26. U.S. Amtagvi revenue was about $102 million, and gross margin was about 60%. The company remains on track for its full-year 2026 total product revenue guidance of $410 to $420 million.AI summary

Lyell Immunopharma reported third quarter 2026 business highlights and clinical updates, including Phase 1/2 and pivotal trial data for rondecabtagene autoleucel (ronde-cel) accepted for presentation at ASH 2026. Among 44 efficacy-evaluable patients in the 3L+ PiNACLE trial, ronde-cel achieved a 91% overall response rate and a 77% complete response rate. The company also announced an $80.0 million private placement financing, extending its expected cash runway into 2028.AI summary

Vaxcyte announced positive topline results from the pivotal Phase 3 OPUS-1 trial evaluating VAX-31 in adults, meeting all prespecified primary endpoints with a safety profile similar to PCV20 and PCV21. The company plans to report results from the OPUS-2 and OPUS-3 Phase 3 trials in the first half of 2027 to support a BLA submission in the first half of 2028. Additionally, Vaxcyte raised approximately $1.1 billion in net proceeds from recent financing, extending its pro forma cash position to $3.4 billion.AI summary

BioCryst Pharmaceuticals reported third-quarter 2026 total net revenue of $180.3 million and ORLADEYO net revenue of $174.8 million. The company raised its full-year total revenue guidance to $715 million–$730 million and reported receiving FDA approval for ORLADEYO 150 mg oral pellets for patients aged 12 and older. BioCryst expects initial Phase 1 data for BCX17725 by the end of 2026.AI summary

Septerna announced the selection of SEP-204, an oral small molecule TSHR negative allosteric modulator, as its potential first-in-class development candidate for Graves' disease and thyroid eye disease. In Graves' disease animal models, SEP-204 inhibited TSHR activation, with findings including restoration of normal T4 levels and reductions in thyroid enlargement and orbital proptosis. A Phase 1 trial in healthy volunteers is anticipated to initiate in the first quarter of 2027.AI summary

Innoviva reported third quarter 2026 financial results, generating $106.1 million in total revenue and $43.3 million in U.S. net product sales. The company reported a net loss of $73.9 million, driven by a decrease in the fair value of equity and long-term investments. Additionally, Innoviva announced that NUZOLVENCE is now commercially available in the U.S.AI summary

Arcutis Biotherapeutics reported third quarter 2026 ZORYVE net product sales of $143.9 million, a 45% increase year-over-year. Driven by strong product demand, the company raised its full-year 2026 net product sales guidance to $535 million–$545 million. Topline results from a Phase 2 trial of ZORYVE foam 0.3% in vitiligo remain on track for Q4 2026.AI summary

Edgewise Therapeutics reported third quarter 2026 results, with cash, cash equivalents and marketable securities of approximately $1,743.9 million as of September 30, 2026. Net income was $1,166.2 million, primarily reflecting a $1.348 billion gain on the sevasemten sale to Servier. The company expects to start a Phase 3 trial of EDG-7500 in HCM by year-end 2026.AI summary

Novo Nordisk raised its full-year 2026 outlook for adjusted sales and adjusted operating profit to between -2% and +2% growth at CER, following third-quarter results. Q3 2026 adjusted sales rose 4% at CER, while adjusted operating profit reached DKK 31,720 million, a 27% increase at CER driven by GLP-1 volume growth. Moving forward, the company is preparing for potential market launches, including CagriSema in the US in early 2027 subject to approval.AI summary

Relay Therapeutics reported third quarter 2026 results, with cash, cash equivalents and investments of $848.6 million as of September 30, 2026, and a net loss of $81.7 million, or $0.37 per share. The company expects its cash to fund operations into 2029. Enrollment in the Phase 3 ReDiscover-2 trial is estimated to complete in mid-2027, and updated ReInspire data for vascular anomalies will be presented at ASH on December 14, 2026.AI summary

Odyssey Therapeutics reported third quarter 2026 financial results, ending the period with $387 million in cash expected to fund operations into the second half of 2028. The company presented additional Phase 2a results for OD-001 in ulcerative colitis and completed IND-enabling studies for OD-002. Odyssey expects to initiate a Phase 1/2a trial for OD-002 in the first half of 2027.AI summary

Summit Therapeutics reported its Q3 2026 financial results, ending the quarter with $629.8 million in cash and investments. The period was highlighted by receiving a $2.0 billion strategic equity investment from AstraZeneca. Summit continues to advance and expand its global clinical development program for ivonescimab across multiple tumor types.AI summary

Mineralys Therapeutics reported third quarter 2026 financial results and provided operational updates. The FDA is reviewing the New Drug Application for lorundrostat to treat hypertension, with a PDUFA target date of December 22, 2026. The company holds $624.7 million in cash, cash equivalents, and investments, which it expects will fund planned operations and commercial launch activities into 2028.AI summary

United Therapeutics Corporation reported financial results for the third quarter of 2026, with total revenues rising four percent year-over-year to $832.5 million. Net income for the quarter decreased to $258.6 million compared to $338.7 million in the third quarter of 2025. In October 2026, the company's Board of Directors approved a new share repurchase program authorizing up to $2.0 billion in repurchases through October 21, 2027.AI summary

Revolution Medicines reported third-quarter 2026 financial results, highlighting $198 million in net product revenue following the U.S. launch of RASONQUE (daraxonrasib) for metastatic pancreatic cancer. The drug also received a positive CHMP opinion recommending marketing authorization in the European Union. The company is advancing multiple Phase 3 trials across pancreatic cancer, non-small cell lung cancer, and colorectal cancer.AI summary

Viridian Therapeutics reported third quarter 2026 financial results, generating $24.7 million in Lumvoa net product revenue. The company expects to submit a Biologics License Application for elegrobart in the first quarter of 2027. Additionally, Viridian is on track to initiate a Phase 1 trial for VRDN-292 and disclose Phase 1 data for VRDN-008 in the fourth quarter of 2026.AI summary

Acadia Pharmaceuticals reported third-quarter 2026 GAAP total revenues of $342 million, representing a 22% year-over-year increase compared to non-GAAP adjusted total revenues. Driven by strong sales of DAYBUE and NUPLAZID, net income reached $54 million. The company raised its full-year 2026 DAYBUE global net product sales guidance to between $505 million and $520 million.AI summary

Cytokinetics reported its third quarter 2026 financial results, highlighting $44.5 million in net product revenue for MYQORZO (aficamten) and a cash position of approximately $1.6 billion as of September 30, 2026. Total revenue reached $47.6 million, while net loss was $190.1 million. The company expects to submit a Supplemental NDA for aficamten in non-obstructive hypertrophic cardiomyopathy in Q4 2026 and a Type II Variation in the European Union in early 2027.AI summary

Kailera Therapeutics reported its third quarter 2026 financial results and provided pipeline updates. The company expects to initiate a global Phase 3 program for oral ribupatide in the first half of 2027 following an End-of-Phase 2 meeting with the FDA. Kailera reported $1,037.6 million in cash, cash equivalents, and marketable securities, which is expected to fund operations into mid-2028.AI summary

Spyre Therapeutics reported positive topline induction data for SPY003 from Part A of the Phase 2 SKYLINE trial, completing proof-of-concept for all three monotherapies in inflammatory bowel disease. However, SPY072 failed to meet primary endpoints in psoriatic arthritis and axial spondyloarthritis sub-studies and will not be advanced in rheumatic disease. The company also initiated the Phase 2 SKYLIGHT trial of SPY072 in hidradenitis suppurativa.AI summary

Denali Therapeutics reported Q3 2026 financial results, generating $17.8 million in net product revenue for AVLAYAH and delivering $70.1 million in net income, aided by a $194.0 million voucher sale. The company remains on track for a 2027 BLA submission for zafinofusp alfa in Sanfilippo syndrome type A. Five TransportVehicle programs expect clinical data readouts in 2027.AI summary

Aquestive Therapeutics reported its third quarter 2026 financial results, recording total revenues of $7.6 million and a net loss of $16.5 million. The FDA accepted the NDA resubmission for Anaphylm with a PDUFA goal date of March 16, 2027. The company continues commercial preparation for a potential U.S. launch while advancing filings in Canada and the EU.AI summary

Allogene Therapeutics announced its participation in the SITC Annual Meeting to showcase clinical progress and next-generation innovations across its off-the-shelf CAR T platform. The company will deliver two invited presentations, including clinical experience from the TRAVERSE study in renal cell carcinoma. Preclinical poster data evaluating a novel DLL3/CD70 dual CAR T product candidate using Dagger technology for neuroendocrine tumors will also be presented.AI summary

Pfizer reported third-quarter 2026 revenues of $16.6 billion, which were relatively flat year-over-year. Non-COVID products delivered 7% operational revenue growth, while launched and acquired products grew 32% operationally. Following these strong results, the company raised its full-year 2026 revenue guidance to a range of $62.0 to $64.0 billion.AI summary

IDEAYA Biosciences reported third quarter 2026 financial results and provided pipeline updates. The company completed its NDA submission for darovasertib combined with crizotinib in metastatic uveal melanoma. Looking ahead, IDEAYA plans to initiate two Phase 3 registrational trials for IDE849 in ES-SCLC and NEC by year end.AI summary

Rhythm Pharmaceuticals reported third-quarter 2026 global IMCIVREE net product revenues of $92.1 million, a 29% increase from the prior quarter. The company secured a term loan facility for up to $750 million and amended its licensing agreement for bivamelagon with LG Chem. Rhythm plans to initiate a pivotal Phase 3 trial evaluating bivamelagon in acquired hypothalamic obesity by year-end 2026.AI summary

BioNTech reported third quarter 2026 revenues of €1,289.2 million, down from €1,518.9 million a year earlier, and IFRS net profit of €184.5 million versus a net loss of €28.7 million. The company raised the midpoint of its full-year 2026 revenue guidance to a range of €1.7–1.9 billion and reported cash, cash equivalents and security investments of €16.2 billion. BioNTech also said that, from January 1, 2027, future R&D costs for a collaboration program with Roche/Genentech will generally be assigned to Roche/Genentech, while BioNTech will be eligible for royalties.AI summary

Corcept Therapeutics reported third quarter 2026 revenue of $340.5 million, a 64 percent increase over the same period in 2025, and reiterated its 2026 revenue guidance of $1.1 to $1.2 billion. Net income reached $126.8 million, while cash and investments increased to $662.3 million. The company also announced Phase 2 trial results from its BELLA Part A study for platinum-resistant ovarian cancer and updated progress across its development pipeline.AI summary

Amgen reported its third quarter 2026 financial results, with total revenues increasing 8% year-over-year to $10.4 billion. GAAP earnings per share rose 19% to $7.08, while product sales increased 8% driven by volume growth. Non-GAAP EPS grew 14% to $6.45, and the company generated $3.7 billion in free cash flow.AI summary

Arvinas reported its third quarter 2026 financial results and provided a clinical pipeline update. The company initiated patient dosing in a Phase 1/2 trial of HPK1 degrader ARV-6723 and continued advancing ARV-393, ARV-027, and ARV-102. Arvinas ended the quarter with $558.9 million in cash, cash equivalents, restricted cash, and marketable securities, which is expected to fund operations into 2H 2028.AI summary

Mirum Pharmaceuticals reported third-quarter 2026 net product sales of $185.7 million and raised its full-year guidance to between $715 million and $720 million. The company launched FDA-approved ATEBRIOZ for FOP and announced positive readouts across its rare liver portfolio for LIVMARLI, ATEBRIOZ, and brelovitug. Regulatory submissions and several clinical trial readouts are planned for late 2026 and 2027.AI summary

Ultragenyx reported third-quarter 2026 total revenue of $173 million, including $109 million from Crysvita and $30 million from Dojolvi. The company initiated substantial expense reductions, cutting its headcount by 20% to achieve profitability in 2027. It also secured agreements to sell two Priority Review Vouchers for a combined $413 million.AI summary

Precision BioSciences reported its third quarter 2026 financial results, posting a net loss of $7.6 million and $108 million in cash. The company dosed the first patient in the Phase 1/2 FUNCTION-DMD study of PBGENE-DMD and continued enrolling patients in the ELIMINATE-B trial for PBGENE-HBV. Precision expects its cash runway to last through 2028 and plans to report clinical data updates for both programs by year-end.AI summary

Alkermes plc reported its financial results for the third quarter ended September 30, 2026. The company scheduled a conference call and webcast presentation to discuss these results and provide a corporate update. Detailed financial information and the earnings presentation were made available on Alkermes' investor relations website.AI summary

Beam Therapeutics reported third quarter 2026 financial results, ending the period with $1.0 billion in cash and runway into mid-2029. The company plans to submit a U.S. BLA for risto-cel in sickle cell disease as early as year-end 2026. Additionally, Beam expects to complete dosing in the BEAM-302 global pivotal cohort in the first half of 2027.AI summary

Madrigal Pharmaceuticals reported third-quarter 2026 net sales of $431.3 million for Rezdiffra (resmetirom), a 50% year-over-year increase, achieving its first profitable quarter with net income of $55.4 million. Year-to-date sales surpassed $1.1 billion. Madrigal also announced plans to initiate the Phase 3 MAESTRO-CSPH trial in compensated MASH cirrhosis in the first half of 2027.AI summary

Jazz Pharmaceuticals reported record third-quarter 2026 total revenues of $1.2 billion, representing a 10% year-over-year growth. Driven by strong execution and product sales, the company raised its full-year 2026 total revenue guidance to $4.775 billion–$4.85 billion. Recent operational highlights include the U.S. launch of Ziihera and the closing of the Actio acquisition.AI summary

CRISPR Therapeutics reported third quarter 2026 financial results, generating $99 million in CASGEVY revenue. The FDA granted RMAT designations to CTX310 for severe hypertriglyceridemia and elevated LDL-C, and enrollment was completed for a Phase 2 trial of CTX611. Incoming clinical data presentations for CTX310 and zugo-cel are scheduled for November 2026.AI summary

Neurocrine Biosciences reported third-quarter 2026 total revenues of $1.1 billion, representing a 41% year-over-year growth. Driven by strong demand, net product sales for INGREZZA reached $801 million, leading the company to raise its full-year 2026 net sales guidance for the drug to between $2.9 billion and $2.925 billion. Additionally, CRENESSITY and VYKAT XR generated third-quarter net product sales of $211 million and $107 million, respectively.AI summary

Syndax reported third-quarter 2026 total revenue of $83.3 million, driven by $60.7 million in Revuforj net revenue and $22.6 million in collaboration revenue from Niktimvo. The company anticipates presenting new revumenib data across acute leukemia trials in the fourth quarter of 2026. Additionally, Syndax announced executive leadership changes, including the appointment of Aaron A. Ondrey as Chief Financial Officer.AI summary

BioMarin Pharmaceutical reported third-quarter 2026 total revenues of $1.025 billion, a 32% increase year-over-year. The company updated its full-year 2026 financial guidance to reflect international order timing uncertainty and acquired IPR&D charges. Additionally, the FDA set a PDUFA action date of May 30, 2027, for the supplemental NDA of VOXZOGO in hypochondroplasia.AI summary

Atrium Therapeutics announced nonclinical data showing that a mouse surrogate of ATR 1072 reversed cardiac glycogen accumulation and improved features of PRKAG2 syndrome. The findings will be presented at the AHA Scientific Sessions 2026. Atrium expects initial proof of concept data from the ongoing Phase 1/2 Corventis trial in the second half of 2027.AI summary

Recursion reported its third quarter 2026 financial results, extending its cash runway into 2029 while highlighting positive clinical data for REC-4881 and REC-1245. Sanofi optioned the first immunology development candidate from their collaboration, triggering a $10 million milestone payment with Phase 1 trials expected in 2027. Additionally, the company appointed Fred Hassan as Chair of the Board and reiterated its 2026 cash operating expense guidance of less than $375 million.AI summary

Grifols reported its third-quarter 2026 financial results, with quarterly revenue rising 8.4% to EUR 2,040 million and net profit increasing 28% to EUR 162 million. Year-to-date revenue reached EUR 5,614 million, driven primarily by growth in its Biopharma business. The company confirmed it remains on track to meet its full-year 2026 guidance.AI summary

Axsome Therapeutics reported third quarter 2026 net product revenue of $259.7 million, representing 52% year-over-year growth. Driven by sales of Auvelity, Sunosi, and Symbravo, net loss decreased to $12.9 million. Axsome also initiated the Phase 3 SUMMIT study of AXS-05 for smoking cessation.AI summary

Vertex Pharmaceuticals reported third-quarter 2026 total revenue of $3.44 billion, representing a 12% increase compared to the third quarter of 2025. Following the results, the company raised its full-year 2026 revenue guidance to between $13.15 billion and $13.25 billion. Vertex also highlighted the recent closing of its Crinetics Pharmaceuticals acquisition and noted an upcoming FDA PDUFA date of November 30 for povetacicept in IgAN.AI summary