Five-year follow-up data from the Phase 3 ARCHES trial shows XTANDI (enzalutamide) plus androgen deprivation therapy (ADT) reduces risk of death by 30% After a median follow-up of 61.4 months, treatment with XTANDI (enzalutamide) plus ADT was associated with a 66% probability of survival at five years compared to 53% probability of survival with placebo plus ADT XTANDI (enzalutamide) is the first and only androgen receptor...Read more
First results to be presented in two ASCO oral presentations Data in both combinations demonstrate high response rates TARRYTOWN, N.Y., May 22, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced initial results from two cohorts of the Phase 1b LINKER-MM2 trial evaluating linvoseltamab in combination with two different proteasome inhibitors (PI) – carfilzomib or bortezomib – in patients with...Read more
Nucala is the only approved biologic studied in a wide COPD population with an eosinophilic phenotype characterized by blood eosinophil count (BEC) starting at 150 cells/μL Approval based on the positive MATINEE and METREX phase III trials MATINEE data included reduction of exacerbations leading to hospitalization and/or emergency department visits Nearly 70% of patients in the US who are inadequately controlled on inhaled triple...Read more
With all doses of FDA-approved Wegovy® fully available nationwide, it is illegal under US compounding laws to make or sell knockoff "semaglutide" drugs, with rare exceptions New, one-time $199 first-month offer for Wegovy® available through June 30, 2025; offer designed to help new self-paying patients previously prescribed unapproved "semaglutide" start on FDA-approved Wegovy® "Choose the Real Thing" campaign launching to raise...Read more
The authorization in Australia is for adult patients who are Apolipoprotein E-ε4 heterozygotes or non-carriers INDIANAPOLIS, May 21, 2025 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced today that the Australian Therapeutic Goods Administration (TGA) has granted marketing authorization for Kisunla (donanemab), an injection for intravenous infusion every four weeks to treat mild cognitive impairment and mild dementia...Read more
Insmed Presented 11 Abstracts at ATS 2025 from Across Its Respiratory Portfolio, Including Data on ARIKAYCE®, TPIP and Health Economics and Outcomes Research BRIDGEWATER, N.J., May 21, 2025 /PRNewswire/ -- Insmed Incorporated (Nasdaq: INSM), a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing serious diseases, presented 11 new...Read more
CAMBRIDGE, Mass. / May 21, 2025 / Business Wire / Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, shared the following update related to ELEVIDYS (delandistrogene moxeparvovec-rokl), the only approved gene therapy for patients with Duchenne muscular dystrophy. We have received feedback from the Medicines & Healthcare products Regulatory Agency (MHRA) in the United Kingdom (U.K.)...Read more
CAMBRIDGE, MA / ACCESS Newswire / May 21, 2025 / Moderna, Inc. (Nasdaq:MRNA), today announced that in consultation with the U.S. Food and Drug Administration (FDA), the Company has voluntarily withdrawn the pending Biologics License Application (BLA) for mRNA-1083, its flu/COVID combination vaccine candidate for adults aged 50 years and older. The Company plans to resubmit the BLA later this year, after vaccine efficacy data from the...Read more
ODAC recommendation based on the positive progression-free survival and clinical benefit in the Phase 3 AQUILA study If approved, DARZALEX FASPRO® would be the first treatment to potentially delay or prevent progression to multiple myeloma RARITAN, N.J., May 20, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ) announced today the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted (6-2) in...Read more
Columvi is the first bispecific antibody to show a statistically significant and clinically meaningful 41% survival benefit in R/R DLBCL in the Phase III STARGLO study There is an urgent need for effective, immediately available therapies that are broadly accessible to people with transplant-ineligible R/R DLBCL This first-of-its-kind Columvi combination could provide a much-needed, off-the-shelf and fixed-duration treatment option for...Read more
NEW YORK / May 19, 2025 / Business Wire / Pfizer Inc. (NYSE: PFE) today announced it has entered into an exclusive global, ex-China, licensing agreement with 3SBio, Inc. (01530.HK), a leading Chinese biopharmaceutical company, for the development, manufacturing and commercialization of SSGJ-707, a bispecific antibody targeting PD-1 and VEGF, currently undergoing several clinical trials in China for non-small cell lung cancer, metastatic...Read more
AIRSUPRA demonstrated a 47% reduction in the risk of severe exacerbations in mild asthma compared with albuterol alone Full results published in the New England Journal of Medicine and presented at ATS 2025 International Conference WILMINGTON, Del. / May 19, 2025 / Business Wire / Positive full results from the BATURA Phase IIIb trial showed AstraZeneca’s anti-inflammatory reliever rescue therapy, AIRSUPRA (albuterol/budesonide),...Read more
Purchase is subject to bankruptcy court and regulatory approvals Regeneron will prioritize the privacy, security and ethical use of 23andMe’s customer data; stands ready to work with independent, court-appointed Customer Privacy Ombudsman Planned purchase to strengthen Regeneron’s ongoing leadership in genetics-guided research and drug development to help people with serious diseases TARRYTOWN, N.Y., May 19, 2025 (GLOBE NEWSWIRE)...Read more
BASKING RIDGE, N.J. & RAHWAY, N.J. / May 19, 2025 / Business Wire / The first patient has been dosed in the IDeate-Esophageal01 phase 3 trial evaluating the efficacy and safety of investigational ifinatamab deruxtecan (I-DXd) versus investigator’s choice of chemotherapy in patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC) with disease progression following treatment with a platinum-containing...Read more
Treatment with ELEVIDYS for Duchenne muscular dystrophy resulted in mean protein expression of 93.87% as measured by western blot in study participants (n=6) Safety profile consistent with prior studies of ELEVIDYS and real-world experience CAMBRIDGE, Mass. / May 16, 2025 / Business Wire / Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today reported new results from Study...Read more
Bagsværd, Denmark, 16 May 2025 – Novo Nordisk today announced changes to its executive leadership and Board of Directors. As per mutual agreement with the Novo Nordisk Board, Lars Fruergaard Jørgensen will step down from his role as CEO of Novo Nordisk. He will continue as CEO for a period to support a smooth transition to new leadership. A search for Lars Fruergaard Jørgensen’s successor is ongoing, and an announcement will be made...Read more
Acquisition is Strong Strategic Fit for BioMarin, Adding INZ-701, a Phase 3 Enzyme Replacement Therapy Being Developed for Treatment of ENPP1 Deficiency First Pivotal Data Readout in Children Expected in Early 2026 with Potential Launch in 2027; Additional Clinical Programs to Expand to Patients of all Ages Potential First-in-Disease Treatment for ENPP1 Deficiency Conference Call and Webcast Scheduled Today at 8:45 a.m....Read more
Approval based on results from the CheckMate-77T trial which showed perioperative Opdivo improved event-free survival compared to neoadjuvant chemotherapy and placebo followed by surgery and adjuvant placebo Opdivo is now the only PD-(L)1 inhibitor approved for both perioperative and neoadjuvant-only treatment of resectable non-small cell lung cancer in the European Union PRINCETON, N.J. / May 16, 2025 / Business Wire / Bristol Myers...Read more
Zynyz® (retifanlimab-dlwr), a PD-1 inhibitor, is now approved for the treatment of advanced squamous cell carcinoma of the anal canal (SCAC) in combination with chemotherapy and as a monotherapy Patients with SCAC treated with Zynyz achieved a statistically significant improvement in progression-free survival and improvement in overall survival WILMINGTON, Del. / May 15, 2025 / Business Wire / Incyte (Nasdaq:INCY) today announced that...Read more
Study also met secondary endpoint of overall survival (OS) for patients whose tumors express PD-L1 KEYTRUDA® (pembrolizumab) plus chemotherapy (paclitaxel) with or without bevacizumab is the first immune checkpoint inhibitor-based regimen to show a statistically significant improvement in OS for ovarian cancer RAHWAY, N.J. / May 15, 2025 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today...Read more
EMRELIS is the first and only treatment approved for previously treated advanced NSCLC patients with high c-Met protein overexpression who often face poor prognosis and have limited treatment options Lung cancer remains the leading cause of cancer-related deaths throughout the world1 NORTH CHICAGO, Ill., May 14, 2025 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that EMRELIS™ (telisotuzumab vedotin-tllv) has been granted...Read more
MORRISTOWN, N.J. and CAMBRIDGE, Mass., May 14, 2025 /PRNewswire/ -- Sanofi today announces its intention to invest at least $20 billion in the United States through 2030. The expected investment includes a significant increase in research and development spending and the allocation of billions of dollars to US manufacturing. The announcement comes as Sanofi prepares for the potential launch of numerous new first- or best-in-class...Read more
WELIREG becomes the only approved and available treatment in the U.S. for eligible patients with advanced PPGL RAHWAY, N.J. / May 14, 2025 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) has approved WELIREG® (belzutifan), Merck’s oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, for the treatment of adult and pediatric...Read more
Collaboration to leverage AbbVie's expertise in biotherapeutic drug development and commercialization together with ADARx's proprietary RNA technology to advance next-generation siRNA therapies across neuroscience, immunology and oncology NORTH CHICAGO, Ill. and SAN DIEGO, May 14, 2025 /PRNewswire/ -- AbbVie (NYSE: ABBV) and ADARx Pharmaceuticals, a late clinical-stage biotechnology company developing next-generation RNA...Read more
Approval based on efficacy and safety results from clinical studies, including longer-term functional outcomes from EMBARK global phase 3 study Company is eligible to receive up to $103.5M in near-term regulatory and commercial milestone payments CAMBRIDGE, Mass. / May 13, 2025 / Business Wire / Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today announced that the Japanese...Read more
Long term follow-up in this curative setting demonstrated clinically meaningful survival benefit when adding adjuvant Perjeta® (pertuzumab) to Herceptin® (trastuzumab) and chemotherapy 21% reduction in the risk of death was seen in the pre-specified subgroup of people with lymph node-positive disease Data to be presented as a late-breaking abstract at the 2025 European Society for Medical Oncology (ESMO) Breast Cancer...Read more
An investment of up to $550 million by 2030 will establish the Indianapolis site as a hub for manufacturing of Roche's continuous glucose monitoring solution. Expansion will create hundreds of jobs while also enhancing U.S. production capabilities. Increased access to diabetes management tools will help improve health outcomes for patients in the U.S. and globally. INDIANAPOLIS, May 12, 2025 /PRNewswire/ -- Roche (SIX: RO, ROG;...Read more
Participants achieved an average weight loss of 20.2% with Zepbound vs. 13.7% with Wegovy In key secondary endpoints, Zepbound was superior to Wegovy across all weight reduction targets and waist circumference reduction INDIANAPOLIS, May 11, 2025 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced detailed results from SURMOUNT-5, a Phase 3b open-label clinical trial, evaluating the safety and efficacy of Zepbound...Read more
Patients lived significantly longer without high-risk disease recurrence or progression after one year of IMFINZI treatment plus Bacillus Calmette-Guérin (BCG) induction and maintenance therapy vs. BCG alone WILMINGTON, Del. / May 09, 2025 / Business Wire / Positive high-level results from the POTOMAC Phase III trial showed one year of treatment with AstraZeneca’s IMFINZI® (durvalumab) plus standard-of-care BCG induction and...Read more
Data Consistent Across All Patient Subgroups, Including Demographic Subgroups, by Baseline Androstenedione Levels and by Baseline Glucocorticoid Dose Findings to be Presented at the 2025 Joint Congress of the European Society for Paediatric Endocrinology and the European Society of Endocrinology SAN DIEGO, May 8, 2025 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced new results from subgroup...Read more
Portfolio Receipts growth of 17% to $839 million; Royalty Receipts growth of 12% Net cash provided by operating activities of $596 million Raised full year 2025 guidance: Portfolio Receipts expected to be $2,975 to $3,125 million NEW YORK, May 08, 2025 (GLOBE NEWSWIRE) -- Royalty Pharma plc (Nasdaq: RPRX) today reported financial results for the first quarter of 2025 and raised full year 2025 guidance for Portfolio Receipts. “Our...Read more
ARIKAYCE® (amikacin liposome inhalation suspension) Total Revenue of $92.8 Million for the First Quarter of 2025, Reflecting 23% Growth Over the First Quarter of 2024 NDA for Brensocatib in Patients with Bronchiectasis Remains on Track, with a PDUFA Target Action Date of August 12, 2025 Phase 2b Study of TPIP in Patients with PAH Completed; Topline Data Expected in June 2025 Enrollment Completed for Phase 2b BiRCh Study of...Read more
Delivers Total Revenues in Line With Expectations Demonstrating Strength of the Base Business Makes Significant Pipeline Progress With Three Positive Phase 3 Data Readouts Returns More Than $450 Million in Capital to Shareholders Year-to-Date and Reaffirms 2025 Capital Allocation Priorities PITTSBURGH, May 8, 2025 /PRNewswire/ -- Viatris Inc. (Nasdaq: VTRS) today reported first quarter 2025 financial results and...Read more
Treatment With XULANE LO Low Estrogen Dose Achieved Primary and All Secondary Efficacy and Safety Endpoints Results Demonstrated Potential Best-In-Class Patch Performance New Drug Application Submission to U.S. FDA Anticipated in the Second Half of 2025 PITTSBURGH, May 8, 2025 /PRNewswire/ -- Viatris Inc. (Nasdaq: VTRS), a global healthcare company, today announced positive results of its Phase 3 study (NCT05139121)...Read more
Merck Animal Health unveils its largest economic development project in recent history RAHWAY, N.J. / May 08, 2025 / Business Wire / Merck Animal Health, known as MSD Animal Health outside of the United States and Canada, a division of Merck & Co., Inc., Rahway, N.J., USA (NYSE: MRK), and Kansas Governor Laura Kelly jointly announced today the $895 million expansion of Merck Animal Health’s manufacturing facility in De Soto,...Read more
All Primary and Secondary Endpoints Were Met in Both Phase 3 Studies In Both Acute Pain Models, MR-107A-02 Demonstrated Statistically Significant and Clinically Meaningful Improvement in Pain Compared to Placebo, Significant Reduction in Opioid Usage and Superior Pain Control Versus the Opioid Arm Targeting New Drug Application Submission to U.S. FDA by End of 2025 PITTSBURGH, May 8, 2025 /PRNewswire/ -- Viatris Inc. (Nasdaq:...Read more
Core Revenue Growth of 7.4% at Actual Exchange Rates (AER), + 2.8% at Constant Exchange Rate (CER) in FY2024 Core Operating Profit Growth of 4.9% at CER with Efficiency Program Driving Cost Savings Up to Six New Molecular Entities in Phase 3 Development in FY2025 with Three Phase 3 Data Readouts Recently Completed or Anticipated FY2025 Outlook for Broadly Flat Revenue and Core Profit Reflecting Product Momentum and Increasing...Read more
$790 million in first quarter global product net sales First patients treated with VYVGART Hytrulo pre-filled syringe for self-injection in US and Germany CIDP global expansion with positive CHMP opinion for VYVGART-SC (vial and pre-filled syringe) in EU Management to host conference call today at 2:30 PM CET (8:30 AM ET) May 8, 2025, 7:00 AM CET - Amsterdam, the Netherlands – argenx SE (Euronext & Nasdaq: ARGX), a...Read more
AstraZeneca and Daiichi Sankyo’s ENHERTU followed by THP showed an improved safety profile vs. standard of care First Phase III trial to demonstrate benefit of ENHERTU in early breast cancer WILMINGTON, Del. / May 07, 2025 / Business Wire / Positive high-level results from the DESTINY-Breast11 Phase III trial showed ENHERTU® (fam-trastuzumab deruxtecan-nxki) followed by paclitaxel, trastuzumab and pertuzumab (THP) demonstrated a...Read more
On track for 30% operating profit margin by 2027 in line with our Pivot to Growth Strategy; Q1 2025 shows ninth consecutive quarter of revenue growth, excluding revenues recorded for Sanofi collaboration. Q1 2025 revenues of $3.9 billion, an increase of 5%; net of $100 million foreign exchange impact, reported revenues growth of 2%. AUSTEDO® – shows continued strong growth, with worldwide revenues of $411 million in Q1 2025, an...Read more
MINNEAPOLIS, May 7, 2025 /PRNewswire/ -- Bio-Techne Corporation (NASDAQ: TECH) today reported its financial results for the third quarter ending March 31, 2025. Third Quarter FY2025 Highlights Third quarter organic revenue increased by 6% (4% reported) to $316.2 million. GAAP earnings per share (EPS) was $0.14 versus $0.31 one year ago. Delivered adjusted EPS of $0.56 compared to $0.48 one year ago. Improved pharma end market...Read more
90% of Adults with Chronic Hepatitis Delta Virus (HDV) who Achieved Undetectable HDV RNA at 96 Weeks of Treatment with Bulevirtide Remained Undetectable for Almost 2 Years After Stopping Treatment FOSTER CITY, Calif. / May 07, 2025 / Business Wire / Gilead Sciences Inc. (Nasdaq: GILD) today announced final results from the pivotal Phase 3 MYR301 study revealing that 36% (23 out of 64) of adults living with chronic hepatitis delta...Read more
Net product revenues for the first quarter 2025 totaled $611.5 million, a 70% increase over the same quarter of the prior year ELEVIDYS net product revenue for the first quarter totaled $375.0 million; Royalty revenue from the sales of ELEVIDYS by Roche for the quarter totaled $4.0 million Revised 2025 total net product revenues guidance to $2.3 to $2.6 billion Meaningfully advanced multiple clinical candidates in limb-girdle muscular...Read more
INGREZZA® (valbenazine) First-Quarter 2025 Net Product Sales of $545 Million and Reaffirms 2025 Net Product Sales Guidance of $2.5 - $2.6 Billion CRENESSITYTM (crinecerfont) First-Quarter 2025 Net Product Sales of $14.5 Million with 413 Total Patient Enrollment Start Forms Initiated Phase 3 Registrational Programs for Osavampator in Major Depressive Disorder and NBI-'568 in Schizophrenia to Position for Next Phase of Growth SAN...Read more
Total revenue of $2.77 billion, a 3% increase compared to Q1 2024; raised the low end of total revenue guidance by $100 million to a new range of $11.85 to $12 billion Strong progress with CASGEVY®, ALYFTREK™ and JOURNAVX™ launches Povetacicept (pove) IgAN Phase 3 interim analysis (IA) cohort fully enrolled and zimislecel Phase 3 program to complete dosing this quarter, setting up potential filings in 2026; inaxaplin Phase 3...Read more
TREMFYA® subcutaneous induction demonstrates significant rates of clinical remission and endoscopic improvement at Week 24 in ulcerative colitis Findings build on recent FDA-approval of both routes of administration for induction therapy with TREMFYA® in Crohn's disease SAN DIEGO, May 5, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced new data from the Phase 3 ASTRO study evaluating TREMFYA®...Read more
Data from the QUASAR long-term extension study demonstrate more than 70% of patients were in clinical remission and more than 40% of patients were in endoscopic remission at Week 92 SAN DIEGO, Calif., May 5, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced new data from the TREMFYA® (guselkumab) Phase 3 QUASAR long-term extension (LTE) study in adults with moderately-to-severely active ulcerative colitis...Read more
Continued oncology pipeline advancement with a strategic focus on two priority pan-tumor programs: next-generation immunomodulator BNT327, a bispecific antibody targeting PD-L1 and VEGF-A1, and mRNA cancer immunotherapies Presented multiple clinical updates across oncology pipeline underlining BioNTech’s combination strategy in oncology with first data presented for the novel combination of BNT327 plus antibody-drug conjugates...Read more
WILMINGTON, Del. / May 02, 2025 / Business Wire / Positive high-level results from the Phase III KALOS and LOGOS trials in patients with uncontrolled asthma showed that AstraZeneca’s fixed-dose triple-combination therapy BREZTRI AEROSPHERE (budesonide/glycopyrronium/formoterol fumarate or BGF (320/28.8/9.6μg)) met all primary endpoints, demonstrating a statistically significant and clinically meaningful improvement in lung function compared...Read more
Revenue in Q1 2025 increased 45% to $12.73 billion driven by volume growth from Mounjaro and Zepbound. Pipeline progress included positive Phase 3 trial results for orforglipron (small molecule oral GLP-1 agonist) in Type 2 diabetes in the first of seven obesity and diabetes Phase 3 trials. Q1 2025 EPS increased 23% to $3.06 on a reported basis and increased 29% to $3.34 on a non-GAAP basis, both inclusive of $1.72 of acquired...Read more
Reports first quarter revenues of $0.1 billion, GAAP net loss of $(1.0) billion and GAAP EPS of $(2.52) Reiterates 2025 expected revenue range of $1.5 to $2.5 billion and 2025 year-end cash balance of approximately $6 billion Announces reduction of $1.4 to $1.7 billion in estimated GAAP operating costs by 2027 Advancing up to 10 products toward approval, including multiple oncology candidates CAMBRIDGE, MA / ACCESS Newswire / May...Read more
Decision to submit based on a positive overall response rate (ORR) (p-value < 0.0001), one of the dual primary endpoints in the Phase 3 EPCORE® FL-1 trial Full results from the trial will be submitted for presentation at an upcoming medical conference in 2025 COPENHAGEN, Denmark / May 01, 2025 / Business Wire / Genmab A/S (Nasdaq: GMAB) announced today its intention to submit in the first half of 2025 a supplemental Biologics...Read more
THOUSAND OAKS, Calif., May 1, 2025 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced financial results for the first quarter of 2025. "Demand for our products was strong globally in the first quarter. Ongoing new product launches and successful Phase 3 trial results for several products make us feel confident in our long-term growth prospects," said Robert A. Bradway, chairman and chief executive officer. Key results include: For...Read more
Achieved First Quarter 2025 Global Net Product Revenues of $469 Million, Representing 28% Year-Over-Year Growth Compared to Q1 2024 Driven by Continued Strong Growth of 36% from hATTR-PN Franchise Received U.S. Food and Drug Administration (FDA) Approval of AMVUTTRA® (vutrisiran) to Reduce Cardiovascular Death, Cardiovascular Hospitalizations and Urgent Heart Failure Visits in Adults with ATTR Amyloidosis with Cardiomyopathy...Read more
First Quarter 2025 Total Revenues of $745 million (+15% Y/Y and +17% at Constant Currency Y/Y) First Quarter 2025 GAAP Diluted Earnings Per Share (EPS) of $0.95 (+107% Y/Y) First Quarter 2025 Non-GAAP Diluted EPS of $1.13 (+59% Y/Y) Conference Call and Webcast Scheduled Today at 4:30 p.m. ET SAN RAFAEL, Calif., May 1, 2025 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) today announced financial results for the...Read more
First and only FcRn blocker approved in anti-AChR and anti-MuSK antibody positive adults and pediatric gMG patients aged 12 and older IMAAVY delivered rapid and substantial reduction in immunoglobulin G (IgG) levels, one of the root causes of gMG, in both the adult and pediatric pivotal studies gMG patients taking IMAAVY demonstrated 20 months of lasting disease...Read more
SAN DIEGO, April 30, 2025 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced the initiation of a Phase 3 registrational program to evaluate the efficacy, safety and tolerability of NBI-1117568, the company's investigational oral muscarinic M4 selective orthosteric agonist, as a potential treatment for schizophrenia. Positive top-line data for the Phase 2 clinical study in adults with schizophrenia were reported in...Read more
SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C. / Apr 30, 2025 / Business Wire / United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, today announced its financial results for the quarter ended March 31, 2025. Total revenues in the first quarter of 2025 grew 17 percent year-over-year to $794.4 million, compared to $677.7 million in the first quarter of 2024. “2025 is off to a tremendous start as we reported...Read more
RINVOQ (upadacitinib) is now the first and only oral Janus Kinase (JAK) inhibitor approved for the treatment of GCA in adults Also known as temporal arteritis, GCA is the most common vasculitis affecting adults in Western countries2 This marks the ninth approved indication for RINVOQ in the U.S., across rheumatology, gastroenterology, and dermatology1 NORTH CHICAGO, Ill., April 29, 2025 /PRNewswire/ -- AbbVie (NYSE: ABBV) today...Read more
Total revenues of $1,053 million in the first quarter (Q1'25) (+20% Y/Y); total product revenues of $922 million in Q1'25 (+26%Y/Y) Jakafi® (ruxolitinib) net product revenues of $709 million in Q1'25 (+24% Y/Y); increasing full year 2025 Jakafi guidance to a new range of $2,950 - $3,000 million from $2,925 - $2,975 million Opzelura® (ruxolitinib) cream net product revenues of $119 million in Q1'25 (+38% Y/Y) Niktimvo™ (axatilimab-csfr)...Read more
Delivers Robust Earnings Performance, Successfully Navigating a Dynamic Environment Made Significant Progress Strengthening the R&D Organization On Track to Exceed Net Cost Savings Targets NEW YORK / Apr 29, 2025 / Business Wire / Pfizer Inc. (NYSE: PFE) reported financial results for the first quarter of 2025 and reaffirmed its 2025 financial guidance(1). EXECUTIVE COMMENTARY Dr. Albert Bourla, Chairman and CEO of Pfizer: “We...Read more
First quarter 2025 revenues of $3.0 billion; GAAP diluted EPS of $7.27 and non-GAAP diluted EPS(a) of $8.22 First quarter 2025 Dupixent® global net sales (recorded by Sanofi) increased 19% to $3.67 billion versus first quarter 2024 First quarter 2025 EYLEA HD® U.S. net sales increased 54% to $307 million versus first quarter 2024; total EYLEA HD and EYLEA® U.S. net sales decreased 26% to $1.04 billion Dupixent approved for...Read more
Growth momentum and pipeline delivery set AstraZeneca on a strong trajectory towards 2030 ambition CAMBRIDGE, England / Apr 29, 2025 / Business Wire / AstraZeneca: Revenue and EPS summary Q1 2025 % Change $m Actual CER1 - Product Sales 12,875 6 9 -...Read more
Purchase price of $47 per share in cash represents an equity value of approximately $3.9 billion, or an enterprise value of $3.4 billion (€3.0 billion) Planned acquisition will immediately add revenue and accelerate mid- to long-term growth for Merck KGaA, Darmstadt, Germany’s Healthcare business SpringWorks Therapeutics is a U.S. biopharmaceutical company with a first-in-class, systemic standard-of-care therapy in adults...Read more
Recommended Approval Based on the Pivotal HELIOS-B Phase 3 Study in which Vutrisiran Demonstrated Significant Reductions in Mortality and Cardiovascular Events, While Preserving Functional Status and Quality of Life Offers a Clinically Differentiated Approach with Rapid and Sustained Transthyretin (TTR) Knockdown and Quarterly Subcutaneous Dosing Follows Recent Approvals in the U.S. and Brazil European Commission...Read more
Approval of Lynozyfic is based on data showing deep and durable responses in relapsed/refractory multiple myeloma Lynozyfic will provide a new option with convenient dosing and administration to patients who face cycles of relapse and remission TARRYTOWN, N.Y., April 28, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the European Commission (EC) has granted conditional marketing...Read more
VYVGART® is first-and-only targeted IgG Fc-antibody fragment for CIDP First novel mechanism of action for CIDP treatment in more than 30 years CHMP positive opinion based on ADHERE data, the largest ever CIDP clinical trial European Commission (EC) decision on marketing authorization application (MAA) expected within approximately two months April 28, 2025, 07:00 AM CET - Amsterdam, the Netherlands – argenx SE (Euronext...Read more
KEYNOTE-689 marks the first positive trial in more than two decades for patients with resected locally advanced head and neck squamous cell carcinoma (LA-HNSCC) Results to be presented at American Association for Cancer Research (AACR) Annual Meeting 2025 during a Plenary Session and included in official meeting press program RAHWAY, N.J. / Apr 27, 2025 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and...Read more
Pivotal Phase 3 CREST trial results show a 32% reduction in the risk of disease-related events, including high-grade disease recurrence or progression, with sasanlimab in combination with standard of care (SOC) Bacillus Calmette-Guérin (BCG) regimen compared to SOC alone Sasanlimab, a subcutaneously administered PD-1 inhibitor, in combination with BCG represents the first potential treatment advancement for BCG-naïve, high-risk...Read more
Reports First-Quarter Diluted EPS of $0.72 on a GAAP Basis, a Decrease of 6.5 Percent; Adjusted Diluted EPS of $2.46, an Increase of 6.5 Percent; These Results Include an Unfavorable Impact of $0.13 Per Share Related to Acquired IPR&D and Milestones Expense Delivers First-Quarter Net Revenues of $13.343 Billion, an Increase of 8.4 Percent on a Reported Basis or 9.8 Percent on an Operational Basis First-Quarter Global...Read more
Total Worldwide Sales Were $15.5 Billion, a Decrease of 2% From First Quarter 2024; Excluding the Impact of Foreign Exchange, Sales Grew 1% KEYTRUDA Sales Grew 4% to $7.2 Billion; Excluding the Impact of Foreign Exchange, Sales Grew 6% WINREVAIR Sales Were $280 Million Animal Health Sales Grew 5% to $1.6 Billion; Excluding the Impact of Foreign Exchange, Sales Grew 10% GARDASIL/GARDASIL 9 Sales Declined 41% to $1.3 Billion;...Read more
Product Sales Excluding Veklury Increased 4% Year-Over-Year to $6.3 billion Biktarvy Sales Increased 7% Year-Over-Year to $3.1 billion FOSTER CITY, Calif. / Apr 24, 2025 / Business Wire / Gilead Sciences, Inc. (Nasdaq: GILD) announced today its first quarter 2025 results of operations. “Gilead had a strong start to the year driven by excellent commercial and clinical execution along with disciplined expense management,” said Daniel...Read more
Results Reflect Continued Growth Portfolio Momentum and Disciplined Execution First quarter revenues were $11.2 billion, -6% (-4% Ex-FX) Growth Portfolio revenues were $5.6 billion, +16% (+18% Ex-FX) GAAP EPS was $1.20 and non-GAAP EPS was $1.80 Raising 2025 revenue guidance to a range of ~$45.8 billion to $46.8 billion; Increasing non-GAAP EPS range to $6.70 to $7.00 PRINCETON, N.J. / Apr 24, 2025 / Business Wire...Read more
Post-hoc analysis of higher risk older adults showed substantial and sustained improvements in tardive dyskinesia symptoms with no new treatment-emergent adverse events of clinical concern SAN DIEGO, April 24, 2025 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced publication of a post-hoc analysis from two 48-week studies, the KINECT® 3 extension and KINECT® 4, demonstrating the long-term safety profile and...Read more
TrenibotE is a first-in-class botulinum neurotoxin serotype E characterized by a rapid onset of action as early as 8 hours after administration (earliest assessment time) and shorter duration of effect of 2-3 weeks. If approved, TrenibotE will be the first neurotoxin of its kind available to patients. Submission is supported by data from over 2,100 patients treated with TrenibotE throughout the clinical...Read more
New assay enables high-resolution spatial visualization of protein interactions, unlocking functional insights within complex tissues MINNEAPOLIS, April 24, 2025 /PRNewswire/ -- Bio-Techne Corporation (NASDAQ: TECH), a global provider of cutting-edge life science tools, today announced an Early Access Program for its latest advancement in spatial biology: a powerful new assay for in situ detection of protein proximity. Built upon...Read more
Largest Global Clinical Trial Ever Conducted in Bronchiectasis Demonstrates Statistically Significant and Clinically Meaningful Reduction in Frequency of Pulmonary Exacerbations Versus Placebo Brensocatib 25 mg is the First Investigational Therapy for Bronchiectasis to Show a Statistically Significant Reduction in the Rate of Lung Function Decline Brensocatib is Currently Under Priority Review with the U.S. Food and Drug...Read more
More than 60 abstracts, including 15 oral and rapid oral presentations, highlight advancements across Pfizer’s industry-leading Oncology portfolio ASCO press program to feature overall survival and progression-free survival data for BRAFTOVI® (encorafenib) combination regimen in first-line BRAF V600E-mutant metastatic colorectal cancer and progression-free survival data from VERITAC-2 study of vepdegestrant in metastatic breast...Read more
Cobenfy as an adjunctive treatment to atypical antipsychotics did not reach the threshold for a statistically significant difference compared to placebo with an atypical antipsychotic for the primary endpoint of the change from baseline to Week 6 in the Positive and Negative Syndrome Scale (PANSS) total score Treatment with Cobenfy and an atypical antipsychotic showed a numerical improvement compared to treatment with placebo and an...Read more
Approval is based on the results from the Phase 3 CCTG IND.227/KEYNOTE-483 trial KIRKLAND, QC, April 22, 2025 /CNW/ -- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that Health Canada has approved KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy, in combination with pemetrexed and platinum chemotherapy, for the first-line treatment of adult patients with unresectable advanced or...Read more
New manufacturing and supply agreement with FUJIFILM Diosynth Biotechnologies in North Carolina will enable additional production of Regeneron’s biologic medicines and support high-paying jobs in the region Regeneron’s ongoing and planned investments in New York and North Carolina infrastructure and manufacturing expected to total more than $7 billion TARRYTOWN, N.Y., April 22, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals,...Read more
The First Pivotal Phase 3 Trial to Demonstrate Superiority of a TROP-2 Antibody-Drug Conjugate, Trodelvy, Plus Keytruda Versus Standard of Care Keytruda plus Chemotherapy in 1L mTNBC Trodelvy Plus Keytruda Shows an Early Trend in Improvement for Overall Survival Versus Standard of Care in Patients with Previously Untreated PD-L1+ (CPS ≥10) mTNBC FOSTER CITY, Calif. / Apr 21, 2025 / Business Wire / Gilead Sciences, Inc....Read more
DESTINY-Breast09 Phase III trial of AstraZeneca and Daiichi Sankyo’s ENHERTU is the first trial in more than a decade to demonstrate superior efficacy across a broad HER2-positive metastatic patient population versus current 1st-line standard of care WILMINGTON, Del. / Apr 21, 2025 / Business Wire / Positive high-level results from a planned interim analysis of the DESTINY-Breast09 Phase III trial showed ENHERTU® (fam-trastuzumab...Read more
Aiming to address a significant unmet need for which no other approved treatment option is available for generalized anxiety disorder patients in Japan PITTSBURGH, April 21, 2025 /PRNewswire/ -- Viatris Inc. (Nasdaq: VTRS), a global healthcare company, today announced it has filed applications to the Ministry of Health, Labor and Welfare (MHLW) for approval of Effexor SR Capsules (venlafaxine hydrochloride), a...Read more
Approval based on Phase 3 trials demonstrating Dupixent significantly reduced itch and hives compared to placebo In the U.S., there are more than 300,000 adults and adolescents aged 12 years and older living with CSU who remain symptomatic despite antihistamine treatment CSU is the seventh disease with underlying type 2 inflammation in which Dupixent is approved TARRYTOWN, N.Y. and PARIS, April 18, 2025 (GLOBE NEWSWIRE) --...Read more
Orforglipron is the first small molecule GLP-1 to successfully complete a Phase 3 trial, lowering A1C by an average of 1.3% to 1.6% across doses The investigational once-daily oral pill reduced weight by an average 16.0 lbs (7.9%) at the highest dose in a key secondary endpoint The overall safety and tolerability profile of orforglipron in ACHIEVE-1 was consistent with injectable GLP-1 therapies INDIANAPOLIS, April 17,...Read more
Label updates include simplified twice-yearly echo monitoring for eligible CAMZYOS patients in the maintenance phase and expanded patient eligibility with reduced contraindications Updated U.S. label is supported by data including long-term clinical and real-world evidence which reinforce the strong safety profile of CAMZYOS PRINCETON, N.J. / Apr 17, 2025 / Business Wire / Bristol Myers Squibb (NYSE: BMY) today announced that the U.S....Read more
If approved, EYLEA HD would be the first and only treatment for RVO indicated for up to every 8-week dosing after an initial monthly dosing period – halving the number of injections that are indicated for all other anti-VEGF therapies Potential for as frequent as monthly dosing for all approved indications would provide greater dosing flexibility for physicians and patients TARRYTOWN, N.Y., April 17, 2025 (GLOBE NEWSWIRE) --...Read more
Vote expands existing recommendation, which was for all adults aged 75 and older and high-risk adults aged 60 to 74 NEW YORK / Apr 16, 2025 / Business Wire / Pfizer Inc. (NYSE: PFE) announced today that the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) voted to expand its recommendation for the use of respiratory syncytial virus (RSV) vaccines approved for adults 50-59 years...Read more
Vaccine recommended to help protect persons over 10 years old in the United States (US) against disease-causing serogroups of Neisseria meningitidis (A, B, C, W, and Y) Broad serogroup coverage in one vaccine reduces injections to help improve vaccination rates and help protect more US adolescents and young adults Vaccine doses will be ready for use in the US from Summer 2025 PHILADELPHIA / Apr 16, 2025 / Business Wire / GSK plc...Read more
| Company | Change | Last Trade |
|---|---|---|
| argenx | 6.17 1.06 | $587.61 |
| Vertex Pharmaceuticals | 1.97 0.45 | $436.00 |
| Insmed | 1.37 2.07 | $67.53 |
| Neurocrine Biosciences | 1.06 0.89 | $120.18 |
| Alnylam Pharmaceuticals | 0.96 0.33 | $289.96 |
| Gilead Sciences | 0.63 0.59 | $107.37 |
| AstraZeneca | 0.46 0.66 | $70.41 |
| Roche | 0.45 1.15 | $39.65 |
| Johnson & Johnson | 0.33 0.22 | $152.94 |
| Pfizer | 0.28 1.22 | $23.32 |
| Novartis | 0.25 0.22 | $112.75 |
| Takeda | 0.16 1.11 | $14.57 |
| Royalty Pharma | 0.14 0.43 | $32.45 |
| Bayer | 0.07 1.01 | $6.98 |
| Astellas Pharma | 0.03 0.31 | $9.67 |
Chimerix is on a mission to develop medicines that meaningfully improve and extend the lives of patients facing deadly diseases. The company is devoted to filling gaps in the treatment paradigm. Chimerix’s most advanced clinical-stage program is in development for H3 K27M-mutant glioma....
CLICK TO LEARN MORE
Astria Therapeutics is a biopharmaceutical company, and our mission is to bring life-changing therapies to patients and families affected by rare and niche allergic and immunological diseases. Our lead program, STAR-0215, is a monoclonal antibody inhibitor of plasma kallikrein in clinical development...
CLICK TO LEARN MORE
