Pharma and biotech news, week of Oct 26 – Nov 1, 2026
82 stories: 5 FDA and regulatory, 35 trial, 9 deal stories and more. Every headline opens the original press release, FDA letter or SEC filing. For today's news, see TheraRadar News.
Top stories (5)
- Enhertu approved in the EU as adjuvant treatment for patients with residual disease after neoadjuvant treatment for HER2-positive early breast cancer ↗
The European Commission approved Enhertu (trastuzumab deruxtecan) as monotherapy for adjuvant treatment of adult patients with resected HER2-positive breast cancer who have residual invasive disease after neoadjuvant treatment. Based on the DESTINY-Breast05 Phase III trial, Enhertu reduced the risk of invasive disease recurrence or death by 53% versus T-DM1 (HR 0.47). A milestone payment of $75 million is due from AstraZeneca to Daiichi Sankyo.AI summary
- Adults Living with Familial Chylomicronaemia Syndrome (FCS) in England and Wales Have REDEMPLO® (Plozasiran) as a New Treatment Option to Reduce Triglycerides ↗
The UK MHRA has granted Marketing Authorisation for REDEMPLO (plozasiran) to reduce triglyceride levels in adults with Familial Chylomicronaemia Syndrome (FCS). Additionally, NICE issued guidance recommending NHS funding for the drug in England and Wales. Arrowhead Pharmaceuticals plans to continue work to make plozasiran available across several European countries.AI summary
- Oct 28, 2026 Trials Win Phase 3 Press release · GenmabGenmab Announces Statistically Significant, Clinically Meaningful Improvement in Overall Survival and Objective Response with Petosemtamab Combination at First Interim Analysis in First-Line R/M Patients with PD-L1+ Head and Neck Cancer ↗
Genmab announced positive topline results from the Phase 3 LiGeR-HN1 trial evaluating petosemtamab in combination with pembrolizumab in patients with first-line PD-L1 positive recurrent/metastatic head and neck squamous cell carcinoma. At the first interim analysis, the combination met its dual primary endpoints, reducing the risk of death by 50% versus pembrolizumab alone. Genmab plans to engage global regulatory authorities and submit full trial results for presentation at a future medical meeting.AI summary
- Lilly's retatrutide delivered greater A1C reduction and more than double the weight loss of Ozempic's highest approved dose in head-to-head trial ↗
Eli Lilly announced positive topline results from the Phase 3 TRANSCEND-T2D-2 trial evaluating retatrutide against Ozempic 2 mg in adults with type 2 diabetes. Retatrutide met its primary and all key secondary endpoints at 80 weeks, demonstrating an average A1C reduction of 2.2% and weight loss up to 20.9% (47.4 lbs). Detailed results will be presented at a future medical meeting and published in a peer-reviewed journal.AI summary
- AMGEN TO PRESENT NEW DATA ACROSS RARE AND OTHER SERIOUS AUTOIMMUNE DISEASES AT ACR CONVERGENCE 2026 ↗
Amgen announced plans to present data across its autoimmune portfolio at ACR Convergence 2026, highlighted by late-breaking Phase 3 OASIZ-301 trial results for dazodalibep in Sjögren's disease. At Week 48, dazodalibep dosing regimens demonstrated statistically significant reductions in systemic disease activity versus placebo. Amgen will also present data for UPLIZNA, KRYSTEXXA, and TAVNEOS.AI summary
FDA and regulatory decisions (3)
- AbbVie Submits Biologics License Application (BLA) for Etentamig to U.S. FDA for Adults Living With Relapsed/Refractory Multiple Myeloma ↗
AbbVie has submitted a Biologics License Application to the FDA for etentamig to treat adults with relapsed or refractory multiple myeloma. The submission is supported by Phase 3 CERVINO trial data, where etentamig demonstrated a 74.0% overall response rate and a 60% reduction in progression-free survival risk compared to standard therapies. AbbVie aims to deliver this monthly option across diverse care environments.AI summary
- Oct 27, 2026 Regulatory Phase 1/2 Press release · Cullinan TherapeuticsCullinan Therapeutics Advances Velinotamig into Global Clinical Development for Autoimmune Cytopenias Following IND Clearance by the U.S. FDA ↗
Cullinan Therapeutics received IND clearance from the U.S. FDA and clearance from the Australian TGA to initiate a global Phase 1b/2a trial of velinotamig. The open-label study will evaluate the BCMAxCD3 T cell engager in adults with relapsing and refractory immune thrombocytopenia and warm autoimmune hemolytic anemia. Clinical data for velinotamig in autoimmune diseases will be presented on November 8, 2026.AI summary
- Agios Announces New PDUFA Goal Date of February 1, 2027, for Mitapivat Sickle Cell Disease sNDA; Company Is Launch-Ready and in Labeling Discussions with FDA ↗
The FDA extended the PDUFA goal date for Agios Pharmaceuticals' supplemental New Drug Application for mitapivat in sickle cell disease to February 1, 2027. The three-month extension occurred after the FDA classified updated safety data submitted by Agios as a major amendment. Agios remains launch-ready and is continuing labeling and potential REMS discussions with the FDA.AI summary
Trial readouts and trial news (32)
- Oct 29, 2026 Trials Phase 3 Press release · aTyr PharmaaTyr Pharma Announces Publication of Results from the Phase 3 EFZO-FIT™ Study of Efzofitimod in Pulmonary Sarcoidosis in The Lancet Respiratory Medicine ↗
aTyr Pharma announced the journal publication of Phase 3 EFZO-FIT study results for efzofitimod in pulmonary sarcoidosis in The Lancet Respiratory Medicine. The trial missed its primary endpoint of statistically significant daily oral corticosteroid reduction compared to placebo. However, efzofitimod improved multiple patient-reported outcomes, maintained lung function, and aTyr recently initiated activities for a new global Phase 3 study in pulmonary sarcoidosis.AI summary
- Ris-Rez reduced risk of disease progression or death by 67% versus chemotherapy in patients with relapsed osteosarcoma in China ↗
Hansoh Pharmaceutical Group announced positive results from its pivotal phase III ARTEMIS-011 trial evaluating risvutatug rezetecan (Ris-Rez) in relapsed osteosarcoma in China. Ris-Rez reduced the risk of disease progression or death by 67% compared to chemotherapy, with a median progression-free survival of 5.5 months versus 1.4 months. The findings will support a regulatory submission by Hansoh in China.AI summary
- Oct 26, 2026 Trials Phase 3 Press release · BioNTechBioNTech and DualityBio Announce Topline Results of the DYNASTY-Breast02 Global Phase 3 Clinical Trial Evaluating Trastuzumab Pamirtecan in HR+/HER2-low Metastatic Breast Cancer ↗
BioNTech and DualityBio announced that the global Phase 3 DYNASTY-Breast02 trial of trastuzumab pamirtecan met its primary endpoint, showing a statistically significant but modest improvement in progression-free survival versus investigator's choice chemotherapy in HR+/HER2-low metastatic breast cancer. Overall survival data were not mature at this interim analysis, and a higher rate of interstitial lung disease was reported, mostly Grade 1 and 2. The companies will discuss the data and determine next steps.AI summary
- Sacituzumab Tirumotecan (Sac-TMT) Reduced the Risk of Death by 32% and the Risk of Disease Progression or Death by 41% Compared to Chemotherapy in Certain Patients With Advanced or Recurrent Endometrial Cancer ↗
Merck announced Phase 3 TroFuse-005 trial results showing sacituzumab tirumotecan reduced the risk of death by 32% and disease progression or death by 41% compared to chemotherapy in certain advanced or recurrent endometrial cancer patients. The U.S. FDA has accepted a Biologics License Application for priority review based on these data. The FDA set a target action date of June 15, 2027.AI summary
- Oct 26, 2026 Trials Phase 3 Press release · Ascendis PharmaTransCon® PTH (Palopegteriparatide) Demonstrates Sustained, Clinically Meaningful Improvements in Kidney Function in Adults with Hypoparathyroidism Treated Up to 5 Years ↗
Ascendis Pharma announced pooled data from the Phase 2 PaTH Forward and Phase 3 PaTHway trials evaluating TransCon PTH in adults with hypoparathyroidism. Treatment for up to 5 years demonstrated sustained, statistically significant improvements in kidney function, including eGFR increases and normalized urine calcium excretion. TransCon PTH was generally well tolerated with no new safety signals.AI summary
- KEYTRUDA® (pembrolizumab) as Monotherapy Reduced the Risk of Disease Progression or Death by 43% for Certain Patients With Advanced or Recurrent Endometrial Cancer With Mismatch Repair Deficient (dMMR) Tumors Compared to Chemotherapy ↗
Merck announced Phase 3 KEYNOTE-C93 trial results evaluating KEYTRUDA monotherapy in dMMR advanced or recurrent endometrial cancer. KEYTRUDA significantly improved progression-free survival compared to chemotherapy, reducing the risk of disease progression or death by 43% with a median PFS of 38.2 months versus 8.4 months. Results will be shared with global regulatory authorities.AI summary
- Oct 26, 2026 Trials Phase 2/3 Press release · Eikon TherapeuticsA Phase 2/3 Study of EIK1001 in Combination with Pembrolizumab and Chemotherapyin Participants with Stage 4 Non-Small Cell Lung Cancer (NSCLC) [TeLuRide-008]-ESMO-Poster ↗
- Alkermes Expands ALKS 7290 Development Program With Initiation of Phase 2 Study for the Adjunctive Treatment of Major Depressive Disorder (MDD) ↗
Alkermes has initiated a Phase 2 study evaluating ALKS 7290 as an adjunctive treatment to standard antidepressants in adults with major depressive disorder (MDD). The randomized, double-blind, placebo-controlled proof-of-concept trial aims to evaluate the safety, tolerability, and efficacy of the oral orexin 2 receptor agonist. The study is expected to enroll approximately 180 adult participants.AI summary
- Biogen to Present New Data Across Alzheimer's Disease Portfolio at CTAD 2026 ↗
Biogen announced it will present new data across its Alzheimer's disease portfolio at the CTAD conference from November 16–19, 2026. Presentations will feature 96-week long-term extension data from the Phase 2 CELIA study of diranersen and initial 60-month open-label extension data from the Clarity AD study of lecanemab. The company will also highlight real-world evidence from the LEADER study and additional portfolio analyses.AI summary
- Oct 29, 2026 Trials Phase 2 Press release · IovanceIovance Reports Updated IOV-LUN-202 Results and Adds Precision TIL Strategy for Second-Line Metastatic Non-Small-Cell Lung Cancer (mNSCLC) ↗
Iovance Biotherapeutics reported updated Phase 2 IOV-LUN-202 trial data for lifileucel in non-squamous mNSCLC, showing a 24.6% objective response rate in 69 patients. A retrospective biomarker analysis demonstrated a 59.1% response rate in a novel enriched subgroup. Iovance plans to enroll a prospective, biomarker-enriched cohort with registrational intent in November 2026 and submit an sBLA in 2027.AI summary
- Oct 28, 2026 Trials Phase 2 Press release · IovanceIovance Biotherapeutics to Host Webcast on Positive Data for TIL Therapy in Metastatic Non-Small Cell Lung Cancer (mNSCLC) and Broader Precision Medicine Strategy ↗
Iovance Biotherapeutics announced it will host a conference call and webcast on October 29, 2026. The event will highlight positive results for one-time lifileucel TIL therapy from the IOV-LUN-202 Phase 2 registrational cohorts in previously treated nonsquamous mNSCLC. Additionally, the company will present an update on precision-based medicine opportunities for the TIL platform in mNSCLC.AI summary
- Oct 28, 2026 Trials Phase 2 Press release · Mineralys TherapeuticsMineralys Therapeutics Announces Publication of Phase 2 Explore-CKD Trial Results for Lorundrostat in Kidney International ↗
Mineralys Therapeutics announced the publication of full Phase 2 Explore-CKD trial results for lorundrostat in Kidney International. In the study, once-daily lorundrostat 25 mg achieved a statistically significant placebo-adjusted reduction of 7.5 mmHg in systolic blood pressure at four weeks. Longer-term evaluation of lorundrostat will continue in the Transform-HTN open-label extension study.AI summary
- Oct 26, 2026 Trials Win Phase 2 Press release · OrukaOruka Therapeutics Announces Positive Week 16 Results for ORKA-001 from the Ongoing EVERLAST-B Trial in Moderate-to-Severe Psoriasis ↗
Oruka Therapeutics announced positive Week 16 results from its EVERLAST-B Phase 2b trial of ORKA-001 in moderate-to-severe plaque psoriasis. In the high-dose 600 mg group, 61% of patients achieved complete skin clearance (PASI 100) compared to 0% on placebo, with a favorable safety profile. The company plans to initiate Phase 3 trials in the first half of 2027.AI summary
- Oct 26, 2026 Trials Phase 2 Press release · GenmabGenmab Announces Updated Phase 2 Data Demonstrating More Than Two-Year Median Overall Survival with Petosemtamab Plus Pembrolizumab in First-Line Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma ↗
Genmab announced updated Phase 2 results evaluating petosemtamab combined with pembrolizumab in first-line recurrent/metastatic head and neck squamous cell carcinoma. The combination achieved a median overall survival of 28.2 months, an overall response rate of 63%, and a median progression-free survival of 9.0 months. Genmab is ongoing with a Phase 3 program for the drug.AI summary
- Oct 26, 2026 Trials Phase 2 Press release · Eikon TherapeuticsTeLuRide-005: Phase 2 Study of EIK1001 (TLR 7/8 Dual Agonist) Plus Pembrolizumab and Chemotherapy in Patients with Stage IV NSCLC: Results from the Squamous Cohort and Updated Pooled Results-ESMO Poster ↗
Eikon Therapeutics presented an ESMO poster featuring results from the Phase 2 TeLuRide-005 study. The trial evaluated EIK1001, a TLR 7/8 dual agonist, combined with pembrolizumab and chemotherapy in patients with Stage IV NSCLC. The presentation included data from the squamous cohort alongside updated pooled results.AI summary
- Oct 26, 2026 Trials Win Phase 2 Press release · CorceptCorcept Reports Positive Results from Phase 2 BELLA Trial of Lifyorli® Combined with Nab-Paclitaxel and Bevacizumab in Patients with Platinum-Resistant Ovarian Cancer ↗
Corcept Therapeutics announced positive results from Part A of the Phase 2 BELLA trial evaluating Lifyorli (relacorilant) combined with nab-paclitaxel and bevacizumab in 95 patients with platinum-resistant ovarian cancer. The triplet regimen demonstrated a median progression-free survival of 7.2 months and an objective response rate of 59%. Complete results will be presented at a medical conference next year.AI summary
- Oct 29, 2026 Trials Phase 1/2 Press release · ImmunocoreImmunocore will present Phase 1 data for brenetafusp plus KIMMTRAK® (tebentafusp-tebn) in metastatic uveal melanoma, during a late-breaking oral session at the 2026 SITC meeting ↗
Immunocore announced it will present Phase 1/2 data for brenetafusp alone and in combination with KIMMTRAK at the 2026 SITC Annual Meeting. The presentations will evaluate the combination in HLA-A*02:01-positive patients with metastatic uveal melanoma, including additional safety and efficacy data. The company will issue a release on November 6, 2026, when the poster session begins.AI summary
- Oct 28, 2026 Trials Phase 1/2 Press release · Remix TherapeuticsRemix Therapeutics™ Selected for Late-Breaking Oral Presentation at the 38th EORTC-NCI-AACR Symposium ↗
Remix Therapeutics announced an abstract featuring updated interim results from the Phase 1/2 ARIA study of REM-422 in Adenoid Cystic Carcinoma has been selected for a late-breaking oral presentation. The presentation will take place at the 38th EORTC-NCI-AACR Symposium on November 19, 2026. The company continues to advance REM-422 as an oral MYB mRNA degrader for the disease.AI summary
- Oct 29, 2026 Trials Win Phase 1 Press release · Kymera TherapeuticsKymera Therapeutics Announces Third Quarter 2026 Financial Results and Reports Positive Results from the KT-579 Phase 1 Healthy Volunteer Trial ↗
Kymera Therapeutics reported positive results from its KT-579 Phase 1 healthy volunteer trial, demonstrating deep IRF5 degradation and robust biomarker modulation with a favorable safety profile. The company plans to initiate the LUMORA Phase 1b trial in lupus patients by early 2027. Additionally, topline data from the KT-621 Phase 2b trial in atopic dermatitis are expected by year-end 2026.AI summary
- Oct 28, 2026 Trials Phase 1 Press release · Kymera TherapeuticsKymera Therapeutics to Announce KT-579 Phase 1 Healthy Volunteer Trial Results on October 29, 2026 ↗
Kymera Therapeutics announced it will report results from its Phase 1 clinical trial of KT-579 in healthy volunteers on October 29, 2026. The readout will occur alongside its third quarter 2026 financial results. The company will also host a video conference call and webcast to present the findings.AI summary
- Incyte Highlights New Data Advancing its Gastrointestinal Cancer Portfolio at ESMO 2026 ↗
Incyte presented new Phase 1 data at ESMO 2026 for its KRAS G12D inhibitor INCB161734 and TGFβR2×PD-1 bispecific antibody INCA33890 in gastrointestinal cancers. INCB161734 combinations showed high response rates in pancreatic ductal adenocarcinoma and colorectal cancer, while INCA33890 combined with FOLFOX and bevacizumab yielded a 71% response rate in microsatellite stable colorectal cancer. Incyte plans to initiate a Phase 3 CRC trial for INCB161734 in 2027.AI summary
- Neurocrine Biosciences Presents New Analysis Establishing Benchmark for Clinically Meaningful Change in Overall Health Reported by Patients with Tardive Dyskinesia ↗
Neurocrine Biosciences presented a new analysis establishing a 6-point increase on the EQ Visual Analogue Scale as a benchmark for clinically meaningful change in overall health for tardive dyskinesia patients. This threshold helps contextualize findings from the Phase 4 KINECT-PRO study, which demonstrated a mean 13.1-point score improvement following treatment with INGREZZA. Findings are being presented at the AMCP Nexus 2026 conference.AI summary
- Oct 30, 2026 Trials SEC filing · MoleculinMoleculin reports a trial milestone (Form 8-K) ↗
- Oct 29, 2026 Trials SEC filing · Iovance BiotherapeuticsIovance Biotherapeutics reports trial results (Form 8-K) ↗
- BioCryst to Present New Data for ORLADEYO® (berotralstat) and Navenibart at the 2026 American College of Allergy, Asthma & Immunology Annual Scientific Meeting ↗
BioCryst Pharmaceuticals announced that four abstracts from its hereditary angioedema portfolio have been accepted for presentation at the ACAAI 2026 Annual Scientific Meeting. The presentations will feature new clinical data and real-world outcomes for ORLADEYO, as well as interim results for navenibart. The conference will take place November 12-16 in Phoenix, Arizona.AI summary
- Oct 29, 2026 Trials SEC filing · CoherusCoherus reports trial results (Form 8-K) ↗
- Madrigal to Present Multiple Abstracts at AASLD's The Liver Meeting 2026, Including New Real-World Evidence Reinforcing Rezdiffra as a Foundational Therapy for MASH ↗
Madrigal Pharmaceuticals announced that new clinical and real-world evidence evaluating Rezdiffra will be presented at AASLD's The Liver Meeting 2026. Data from the company's RESONANCE program and clinical studies demonstrate real-world effectiveness, treatment persistence, and positive effects on MASH noninvasive response measures up to 12 months. The presentations feature datasets spanning more than 12,000 patients.AI summary
- Oct 26, 2026 Trials SEC filing · XencorXencor reports trial results (Form 8-K) ↗
- Oct 26, 2026 Trials Press release · IovanceIovance Announces Data Showing Durable Responses with Lifileucel TIL Cell Therapy in Advanced Soft Tissue Sarcomas at ESMO 2026 ↗
Iovance Biotherapeutics presented pilot trial data for lifileucel in refractory soft tissue sarcomas at ESMO 2026. One-time lifileucel monotherapy achieved a 50% confirmed objective response rate among eight evaluable patients, with all responses ongoing. Following these results, Iovance is enrolling patients in the SARATOGA Phase 2 registrational trial to support new regulatory approvals.AI summary
- Oct 26, 2026 Trials Press release · Eikon TherapeuticsEikon Therapeutics Presents Updated EIK1001 Data from TeLuRide-005 at the European Society for Medical Oncology Congress ↗
Eikon Therapeutics presented updated data from the open-label TeLuRide-005 trial evaluating EIK1001 combined with pembrolizumab and chemotherapy in advanced non-small cell lung cancer (NSCLC). In pooled efficacy data, the combination achieved a 63.1% objective response rate and an 89.2% disease control rate. Eikon is currently enrolling the Phase 2/3 TeLuRide-008 trial, with a dose-selection interim analysis expected in the second half of 2027.AI summary
- Oct 26, 2026 Trials SEC filing · EikonEikon reports trial results (Form 8-K) ↗
- Oct 26, 2026 Trials SEC filing · Can-FiteCan-Fite reports trial results (Form 6-K) ↗
Deals and financings (9)
- Oct 27, 2026 Deals Press release · Ferring PharmaceuticalsFerring Pharmaceuticals and Gameto sign agreement for proposed acquisition ↗
Ferring Pharmaceuticals and Gameto have signed a merger agreement under which Ferring would acquire Gameto. The proposed global transaction has a total deal value of up to $1.3825 billion, subject to development, regulatory, and commercial milestones. Completion of the deal remains subject to customary closing conditions.AI summary
- Oct 28, 2026 Deals Press release · Formation BioFormation Bio Announces $600 Million Debut Fund to Expand Drug Development Capacity ↗
Formation Bio announced the Formation Bio Drug Development Accelerator Fund with $600 million in capital commitments. The fund is designed to expand the company's clinical-stage portfolio by supporting its goal to acquire 10 to 15 drug programs over the next 3 to 5 years. Formation Bio plans to advance these programs through key clinical milestones before partnering them with pharmaceutical companies for commercialization.AI summary
- Regeneron Extends Agreement with BARDA to Provide Additional Supply of Ebola Treatment Inmazeb® for U.S. Preparedness ↗
Regeneron has extended its agreement with BARDA to provide additional supply of the Ebola treatment Inmazeb for U.S. preparedness against Ebola disease. Under the updated agreement, Regeneron expects to deliver doses through 2031 and receive a payment of approximately $270 million.AI summary
- Oct 26, 2026 Deals SEC Form D · BigHat Biosciences, Inc.BigHat Biosciences, Inc. reports $75M raised in a private offering (SEC Form D) ↗
Biotechnology company. Total offering $80M; first sale 2026-07-17. Form D is filed up to 15 days after the first sale.
- Viatris Announces Commencement of Tender Offer to Acquire Pacira BioSciences, Inc. ↗
Viatris subsidiary Peach Purchaser Sub Inc. has commenced a tender offer to acquire all outstanding shares of Pacira BioSciences for $36.50 per share in cash. Following the consummation of the offer, the subsidiary will merge into Pacira as a wholly owned Viatris subsidiary. The tender offer and withdrawal rights are scheduled to expire on November 16, 2026.AI summary
- Oct 29, 2026 Deals Press release · Nomic BioNomic and Parse Build a Multimodal, Time-Resolved Dataset for AI Models of Immune Response ↗
Nomic Bio and Parse Biosciences have partnered to generate Cascade, a multimodal, time-resolved dataset designed for AI models of human immune response. The dataset pairs single-cell transcriptomic and secretome proteomics measurements from healthy donors across multiple perturbations and timepoints. Data generation is currently underway, and the dataset will be made available for licensing.AI summary
- Oct 27, 2026 Deals Press release · AnthropicEarly progress on accelerating drug development with Claude ↗
Anthropic announced progress in scaling AI-assisted drug development through partnerships with six life sciences organizations, including Bristol Myers Squibb and Generate Biomedicines. The company also disclosed its acquisition of Mithril Medicine, a one-person startup developing treatments for rare forms of muscular dystrophy using Claude. Anthropic plans to scale these efforts and targets bringing a drug candidate to human clinical trials as soon as late 2028.AI summary
- Oct 27, 2026 Deals Press release · NVIDIA — healthcare & life sciencesHow AI Is Changing the Pace of Discovery for Millions Living With Dementia ↗
The Consortium for Biomedical Research and AI in Neurodegeneration (C-BRAIN) is collaborating with NVIDIA to advance Alzheimer's disease research using AI. The consortium has already built two open-source tools, OpenScientist and InsightEngine, to accelerate hypothesis generation and dataset analysis. Looking ahead, C-BRAIN aims to build a multimodal biological foundation model to discover new causal mechanisms of brain aging and Alzheimer's disease by year three.AI summary
- Oct 26, 2026 Deals Press release · RecordatiOn behalf of Respighi BidCo S.p.A – FINAL RESULTS OF THE OFFER APPROX 74.58% OF THE SHARE CAPITAL. 66.67% THRESHOLD CONFIRMED AND OTHER CONDITIONS FULFILLED. OFFER EFFECTIVE. REOPENING OF THE TERMS CONFIRMED ↗
Respighi BidCo S.p.A. announced the final results of its offer, with approximately 74.58% of the share capital tendered. The 66.67% threshold has been confirmed, other conditions have been fulfilled, and the offer is effective. The reopening of the terms is confirmed.AI summary
Pipeline, earnings and company news (33)
- Oct 30, 2026 Earnings Phase 3 Press release · Vor BioVor Bio Reports Third Quarter 2026 Financial Results and Provides Corporate Update ↗
Vor Bio reported its third-quarter 2026 financial results and provided corporate updates, finishing the quarter with $481.6 million in cash expected to fund operations into early 2029. The company completed enrollment in its Phase 3 UPSTREAM MG trial of telitacicept in generalized myasthenia gravis, with topline results expected in the first half of 2027. Additionally, Vor Bio plans to initiate first patient dosing for its Phase 3 UPSTREAM oMG trial in ocular myasthenia gravis in 1H 2027.AI summary
- AstraZeneca results: 9M and Q3 2026 Continued strong commercial performance and 12 positive Phase III programme readouts in the year to dat e ↗
AstraZeneca reported its 9M and Q3 2026 financial results, with total revenue up 7% to $46,881m and Core EPS up 14% to $8.00 for the nine-month period. The company reported 12 positive Phase III readouts year-to-date and completed a $2bn equity investment in Summit Therapeutics. AstraZeneca reconfirmed its FY 2026 guidance for mid-to-high single-digit percentage growth in total revenue.AI summary
- AbbVie Reports Third-Quarter 2026 Financial Results ↗
AbbVie reported third-quarter 2026 net revenues of $17.404 billion, a 10.3 percent increase, and diluted EPS of $2.37 on a GAAP basis. During the quarter, the company completed its acquisition of Apogee Therapeutics and secured key regulatory approvals. AbbVie raised its full-year 2026 adjusted diluted EPS guidance to $13.95-$13.99 and announced a 5.2 percent dividend increase for 2027.AI summary
- Regeneron Reports Third Quarter 2026 Financial and Operating Results ↗
Regeneron reported its third quarter 2026 financial results, with total revenues rising 36% to $5.1 billion. The growth was driven by net sales of EYLEA HD, Dupixent, and Libtayo, as well as an expanded collaboration with Sanofi that included $1.0 billion up-front. The company continues to advance its clinical pipeline, including upcoming FDA regulatory decisions and Phase 3 trial initiations.AI summary
- Q3 2026: double-digit growth in sales and business EPS FY 2026: guidance upgraded ↗
Sanofi reported Q3 2026 net sales of €14,444 million, reflecting a 14.3% increase at constant exchange rates driven by Dupixent and pharma launches. Business EPS grew 19.6% at CER to €3.55. Based on this commercial performance, Sanofi upgraded its full-year 2026 guidance, expecting sales growth in the low-teens and business EPS growth in the mid-teens percentage.AI summary
- PTC Therapeutics Provides Corporate Update and Reports Third Quarter 2026 Financial Results ↗
PTC Therapeutics reported third-quarter 2026 total revenue of $358 million, including $276 million of product revenue, and raised its full-year 2026 product revenue guidance to $960 to $990 million. Sephience generated $182 million in Q3 2026 revenue. The company acquired the ST-920 Fabry disease gene therapy for $111.0 million upfront and expects to complete its BLA submission in Q4 2026.AI summary
- Bristol Myers Squibb Reports Third Quarter Financial Results for 2026 and Raises Full-Year Revenue Outlook ↗
Bristol Myers Squibb reported third-quarter 2026 total revenues of $13.1 billion, a 7% increase, driven by a 12% rise in Growth Portfolio revenues to $7.7 billion. GAAP EPS was $1.05 and non-GAAP EPS was $1.35, both reflecting net charges from acquired IPRD and licensing income. Consequently, the company raised its full-year 2026 revenue guidance to between $49.75 billion and $50.25 billion.AI summary
- Oct 29, 2026 Corporate Press release · EtceleraFlagship Pioneering Forms Etcelera to Move Drug Discovery from Probability to Prediction ↗
Flagship Pioneering announced the formation of Etcelera through the merger of Cellarity, Etiome, and Empress Therapeutics platforms. Led by CEO Ad Rawcliffe, the new company combines proprietary AI capabilities and multi-omics data to advance small molecule drug discovery programs. Etcelera launches with programs in hematology, metabolism, and immunology, as well as high-impact partnerships and data services.AI summary
- BridgeBio Reports Third Quarter 2026 Financial Results and Corporate Updates ↗
BridgeBio reported third-quarter 2026 financial results, generating $353.2 million in total revenue, driven by $253.2 million in U.S. Attruby net product revenue. Cash, cash equivalents, and marketable securities totaled $1.5 billion as of September 30, 2026. The company is preparing for upcoming PDUFA action dates for BBP-418, oral infigratinib, and encaleret.AI summary
- Oct 29, 2026 Pipeline Press release · Element BiosciencesElement Biosciences Launches AVITI Dx™, Bringing CE-Marked IVD Sequencing to Ten EU Countries ↗
Element Biosciences has commercially launched AVITI Dx, its first CE-marked IVD sequencing platform under EU IVDR standards. The integrated system, reagents, and software have rolled out across ten EU countries, including Germany, France, and Italy. Element plans to expand access to additional European markets followed by select markets in the Asia-Pacific region.AI summary
- Oct 29, 2026 Earnings Press release · Bicycle TherapeuticsBicycle Therapeutics Reports Recent Business Progress and Third Quarter 2026 Financial Results ↗
Bicycle Therapeutics reported its third quarter 2026 financial results and business progress. The FDA granted Orphan Drug Designation to nuzefatide pevedotin for pancreatic cancer, with further updates expected in 2027. The company ended the quarter with $469.9 million in cash and cash equivalents, providing a cash runway into 2030.AI summary
- Merck & Co., Inc., Rahway, N.J., USA Announces Third-Quarter 2026 Financial Results; Highlights Multiple Milestones Advancing Broad, Diverse Pipeline ↗
Merck reported third-quarter 2026 sales of $18.1 billion, representing a 5% growth. Key achievements include the U.S. FDA accepting a Biologics License Application for Priority Review for sacituzumab tirumotecan based on Phase 3 TroFuse-005 data. Merck raised the midpoint of its full-year 2026 sales guidance to between $66.8 billion and $67.3 billion.AI summary
- Lilly reports third-quarter 2026 financial results, raises full-year guidance and highlights regulatory progress across the portfolio ↗
Lilly reported third-quarter 2026 revenue of $24.4 billion, up 39%, driven primarily by Mounjaro and Zepbound. Q3 reported EPS was $7.22 and non-GAAP EPS was $7.48, including $4.57 of acquired IPR&D charges. The company raised the midpoint of its 2026 full-year revenue guidance by $5.5 billion to a range of $91.0 to $92.0 billion, and updated its full-year EPS range to $35.00 to $36.00.AI summary
- Incyte Reports Third Quarter 2026 Financial Results and Provides Business Updates ↗
Incyte reported its third quarter 2026 financial results, achieving total revenue of $1.56 billion and total net sales of $1.32 billion, representing a 14% increase year-over-year. Driven by strong portfolio growth, the company raised its full-year 2026 total net sales guidance to $5,210 - $5,300 million. Incyte also highlighted key clinical updates, including upcoming Phase 3 data expected by year-end for povorcitinib and ruxolitinib cream.AI summary
- Takeda Announces FY2026 First-Half Results Highlighting Launch Momentum and Pipeline Milestones ↗
Takeda announced its FY2026 first-half financial results, reporting revenue of 2,407.0 billion JPY, an 8.4% increase at actual exchange rates. The period featured the approval of ORZEYFUL in the U.S., Japan, and China, the U.S. launch of MIMRYLO, and Priority Review acceptance for zasocitinib. Takeda upgraded its full-year FY2026 outlook due to foreign exchange benefits.AI summary
- GILEAD SCIENCES ANNOUNCES THIRD QUARTER 2026 FINANCIAL RESULTS ↗
Gilead Sciences reported its third quarter 2026 financial results, with total product sales rising 13% year-over-year to $8.3 billion. Strong sales were driven by an 18% increase in HIV product revenue, alongside growth from Trodelvy and Livdelzi. Consequently, the company raised its full-year 2026 base business revenue guidance.AI summary
- Oct 29, 2026 Pipeline Press release · BiohubSepsis is linked to 11 million deaths a year. A new machine-learning platform could help catch it within minutes ↗
Biohub scientists developed Remo-ID, a machine-learning model that runs on the Remoscope imaging cytometer to detect sepsis from blood cell images within 12 minutes. In an early study of 47 patients and controls, Remo-ID correctly classified 43 cases. Researchers plan to test the approach in a much larger group.AI summary
- Exelixis Announces Third Quarter 2026 Financial Results and Provides Corporate Update ↗
Exelixis reported third-quarter 2026 total revenues of $658.7 million, including cabozantinib franchise net product revenues of $604.9 million, and GAAP diluted EPS of $0.85. The FDA extended the NDA review for zanzalintinib with atezolizumab in metastatic CRC to a PDUFA target date of March 3, 2027. Exelixis expects topline Phase 3 STELLAR-304 results in early 2027.AI summary
- Insmed Reports Third-Quarter 2026 Financial Results and Provides Business Update ↗
Insmed reported third-quarter 2026 total revenues of $524.4 million, driven by $400.1 million from BRINSUPRI and $124.4 million from ARIKAYCE. Based on these results, the company raised its full-year 2026 revenue guidance for BRINSUPRI to $1.35 billion–$1.4 billion and ARIKAYCE to $460 million–$470 million. Insmed also launched BRINSUPRI Tablets 25 mg in Japan during October 2026.AI summary
- Oct 29, 2026 Earnings Press release · SEC copy · AlnylamAlnylam Pharmaceuticals Reports Third Quarter 2026 Financial Results and Highlights Recent Period Progress ↗
Alnylam Pharmaceuticals reported third-quarter 2026 financial results, achieving global net product revenues of $1,292 million, a 52% growth compared to Q3 2025. The company announced the expansion of target enrollment in its TRITON-CM study to 2,250 patients while maintaining an expected ATTR-CM launch by 2030. Additionally, Alnylam presented positive Phase 1 data for brezosiran in Huntington's disease and expects to initiate a pivotal study in 2027.AI summary
- Replimune Reports Fiscal Second Quarter 2027 Financial Results and Provides Corporate Update ↗
Replimune reported financial results for the fiscal second quarter ended September 30, 2026, and provided a business update. The company launched TUDRIQEV for advanced melanoma in October 2026 and holds $307.8 million in cash and cash equivalents. Replimune expects its existing cash to fund operations for greater than twelve months.AI summary
- Vanda Pharmaceuticals Reports Third Quarter 2026 Financial Results ↗
Vanda Pharmaceuticals reported third quarter 2026 financial results, with total revenues rising 24% year-over-year to $69.8 million. Third quarter operating expenses fell 18% sequentially to $93.3 million, and the company updated its full-year 2026 revenue guidance to greater than $240 million. Vanda plans to launch BYSANTI in the fourth quarter of 2026.AI summary
- Oct 28, 2026 Earnings Press release · Viking TherapeuticsViking Therapeutics Reports Third Quarter 2026 Financial Results and Provides Corporate Update ↗
Viking Therapeutics reported its third quarter 2026 financial results, ending with $960 million in cash. The company initiated its SUNRISE Phase 3 program for oral VK2735 and reported positive top-line results from Part 1 of a VK2735 maintenance dosing study. Additionally, Viking initiated Part 2 of the maintenance study and continues to advance its Phase 3 VANQUISH trials for subcutaneous VK2735.AI summary
- Axogen, Inc. Reports Third Quarter 2026 Financial Results ↗
Axogen reported third-quarter 2026 financial results with revenue reaching $75.8 million, up 26.2% compared to the prior-year period. The company completed the acquisition of BioCircuit Technologies and raised its full-year revenue guidance to at least $290 million. Moving forward, Axogen plans to initiate Prostate market development in 2027 based on positive clinical study outcomes.AI summary
- GSK delivers strong Q3 performance and continued momentum ↗
GSK reported total Q3 sales of £8.9 billion, up 4% AER and 5% CER, driven by Specialty Medicines sales of £3.9 billion. Total operating profit declined 16%, while core operating profit grew 5%. GSK reaffirmed its 2026 guidance and remains on track to start 22 phase III trials in 2026.AI summary
- Biogen Reports Third Quarter 2026 Results ↗
Biogen reported third quarter 2026 total revenue of $2.8 billion, representing an 11% year-over-year increase. Growth Portfolio revenue reached $1.26 billion, while Non-GAAP diluted EPS was $2.62. The company raised the lower end of its full year 2026 Non-GAAP diluted EPS guidance to a range of $12.20 to $13.00.AI summary
- Glaukos Announces Third Quarter 2026 Financial Results ↗
Glaukos reported record third quarter 2026 net sales of $211.0 million, representing a 58% year-over-year increase. The company achieved net income of $2.0 million and ended the quarter with $339.8 million in cash, cash equivalents, short-term investments, and restricted cash. Looking ahead, Glaukos raised its 2026 net sales guidance to between $775 million and $785 million.AI summary
- Oct 28, 2026 Pipeline Press release · PolyPidPolyPid Unveils Expanded Pipeline Strategy, Introducing PD01B, a New Kynatrix™ Based Product Candidate for the Treatment of Diabetic Foot Infections ↗
PolyPid Ltd. unveiled an expanded pipeline strategy introducing PD01B, a new Kynatrix-based product candidate targeting hyper-localized, controlled-release antibiotic treatment of diabetic foot infections. PD01B combines doxycycline with PolyPid's delivery technology and is planned for development as a new NDA. The company expects a pre-IND meeting with the FDA and a first-in-human study in the second half of 2027.AI summary
- Kiniksa Pharmaceuticals Reports Third Quarter 2026 Financial Results and Recent Portfolio Execution ↗
Kiniksa Pharmaceuticals reported third quarter 2026 ARCALYST net product revenue of $286.0 million and raised its full-year 2026 ARCALYST net sales guidance to between $1.045 billion and $1.050 billion. The company continues to enroll patients in the pivotal Phase 3 PASTORALE trial of KPL-387, expecting data in the second half of 2027. Additionally, Kiniksa expects to initiate a Phase 1 trial for KPL-1161 by the end of 2026.AI summary
- Pharming Group reports third quarter 2026 financial results; strong revenue growth, Joenja APDS expansion and CVID topline data in November ↗
Pharming Group reported third quarter 2026 total revenues of $117.6 million, an increase of 21% compared to Q3 2025. Joenja revenue rose 58% to $23.8 million, while RUCONEST revenue grew 14% to $93.8 million. Following positive Phase II topline data in genetically identifiable primary immunodeficiencies, the company expects Phase II topline results for leniolisib in CVID in November 2026.AI summary
- Oct 27, 2026 Corporate Press release · aTyr PharmaaTyr Pharma Announces One-for-40 Reverse Stock Split ↗
aTyr Pharma announced a 1-for-40 reverse stock split of its common stock, effective October 28, 2026. The split will reduce outstanding shares from approximately 100.5 million to 2.5 million to restore compliance with Nasdaq's minimum bid price requirement. The stock will begin trading on a split-adjusted basis on October 29, 2026.AI summary
- Novartis delivered sales growth and core margin expansion in Q3; raised FY core operating income guidance ↗
Novartis reported Q3 2026 net sales growth of 4% in constant currencies to $14.5 billion, with core operating income up 10% to $6.0 billion. Operating income fell 61% to $1.8 billion, primarily due to a $1.9 billion partial impairment charge for del-desiran. For full-year 2026, the company raised its core operating income guidance to expected growth of in line to low single-digit.AI summary
- Sanofi breaks ground on new state-of-the-art insulin manufacturing facility in Germany ↗
Sanofi has broken ground on a new state-of-the-art insulin manufacturing facility at its BioCampus in Frankfurt, Germany. The 36,000-square-meter facility will utilize advanced digital technologies, automation, and artificial intelligence for insulin active pharmaceutical ingredient production. Full production is scheduled to begin in 2032 following complete licensing.AI summary
Sources: FDA approval records and letters, human-confirmed PDUFA outcomes, SEC EDGAR filings, and companies' own press releases. Company headlines are shown as published. Summaries marked AI summary are written by an AI model from the release, and every number in them is checked against it.