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Astria Therapeutics

Gilead Sciences’ Twice-Yearly Lenacapavir Demonstrated 100% Efficacy and Superiority to Daily Truvada® for HIV Prevention

June 20
Last Trade: 69.75 1.26 1.84

First Phase 3 HIV Prevention Trial Ever to Show Zero Infections  Independent Data Monitoring Committee Recommended That Gilead Stop the Blinded Phase of the PURPOSE 1 Trial at Interim Analysis and Offer Open-Label Lenacapavir to All Participants  FOSTER CITY, Calif. / Jun 20, 2024 / Business Wire / Gilead Sciences, Inc. (Nasdaq: GILD) today announced topline results from an interim analysis of its pivotal, Phase 3 PURPOSE 1...Read more


Roche launches new highly-sensitive test to more easily diagnose patients who may have B-cell lymphoma

June 20
Last Trade: 35.47 0.24 0.68

The VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail assay is the first clinically approved in-situ hybridisation (ISH) test with the sensitivity to assess the full spectrum of B-cell lymphoma subtypes.1,2 The test helps differentiate a B-cell cancer from a normal, reactive immune response, providing diagnostic certainty for healthcare providers and their patients. B-cell lymphoma accounts for approximately 85 percent of...Read more


Johnson & Johnson: TREMFYA® (guselkumab) studies underscore its potential to be the only IL-23 inhibitor to offer both subcutaneous and intravenous induction

June 20
Last Trade: 148.14 0.36 0.24

TREMFYA® Phase 3 Crohn's disease study achieves all primary and secondary endpoints SPRING HOUSE, Pa., June 20, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced positive topline results from the pivotal Phase 3 GRAVITI investigational study of TREMFYA® (guselkumab) subcutaneous (SC) induction therapy in adult patients with moderately to severely active Crohn's disease.1 The study met both co-primary endpoints,...Read more


AbbVie Appoints Roxanne S. Austin as Lead Independent Director of the Board of Directors

June 20
Last Trade: 170.36 -1.77 -1.03

Ms. Austin assumes role from Glenn F. Tilton, who will continue to serve as an independent director NORTH CHICAGO, Ill., June 20, 2024 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that the independent directors of the board have selected Roxanne S. Austin as lead independent director, effective July 1, 2024. Ms. Austin succeeds Glenn F. Tilton, who has served as lead independent director since 2013. Mr. Tilton will...Read more


U.S. FDA Approves SKYRIZI® (risankizumab-rzaa) for Ulcerative Colitis, Expanding AbbVie's Portfolio Across Inflammatory Bowel Disease

June 18
Last Trade: 170.36 -1.77 -1.03

Approval supported by two Phase 3 clinical trials that evaluated SKYRIZI® for the treatment of moderate to severe ulcerative colitis: a 12-week induction study, INSPIRE,1 and a 52-week maintenance study, COMMAND2 Data showed that clinical remission, the primary endpoint in both the induction and maintenance studies, was achieved along with endoscopic improvement, a key secondary endpoint1,2 SKYRIZI is the first IL-23...Read more


Takeda Presents Long-Term Data from Phase 3 ADVANCE-CIDP 3 Clinical Trial of HYQVIA® in Patients with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) at PNS Annual Meeting

June 18
Last Trade: 12.66 0.05 0.40

Favorable Findings from the Longest Public Clinical Study in CIDP Support HYQVIA as an Effective Long-Term Treatment Option for Maintaining Stable Disease Course in CIDP ADVANCE Clinical Program Reflects Takeda’s Commitment to Continued Research on the Role of Immunoglobulin (IG) Therapy for Patients with Rare Neuroimmunological Disorders OSAKA, Japan & CAMBRIDGE, Mass. / Jun 18, 2024 / Business Wire / Takeda (TSE:4502/NYSE:TAK)...Read more


Roche receives FDA clearance on its digital pathology solution for diagnostic use

June 18
Last Trade: 35.47 0.24 0.68

The solution, which includes the VENTANA DP 200 slide scanner, Roche's digital pathology workflow software and a display, is now cleared to aid in clinical diagnosis, enabling pathologists to diagnose patients using digital images. Primary diagnosis for digital pathology enhances healthcare efficiency and helps ensure effective and timely patient care, especially in areas where access to pathologists is limited. This clearance is a...Read more


Merck: U.S. FDA Approves CAPVAXIVE™ (Pneumococcal 21-valent Conjugate Vaccine) for Prevention of Invasive Pneumococcal Disease and Pneumococcal Pneumonia in Adults

June 17
Last Trade: 129.54 -0.13 -0.10

CAPVAXIVE (V116) is specifically designed for adults and covers serotypes responsible for approximately 84% of invasive pneumococcal disease in adults 50 years of age and older Across four Phase 3 studies, CAPVAXIVE demonstrated robust immune responses in both vaccine-naïve and vaccine-experienced adult populations RAHWAY, N.J. / Jun 17, 2024 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada,...Read more


FDA Approves Merck’s KEYTRUDA® (pembrolizumab) Plus Carboplatin and Paclitaxel as Treatment for Adult Patients With Primary Advanced or Recurrent Endometrial Carcinoma

June 17
Last Trade: 129.54 -0.13 -0.10

KEYTRUDA is now the first and only anti-PD-1 therapy FDA-approved in combination with chemotherapy for adult patients with primary advanced or recurrent endometrial carcinoma regardless of mismatch repair status Approval marks the third FDA-approved indication for KEYTRUDA in endometrial carcinoma and the 40th indication for KEYTRUDA in the US RAHWAY, N.J. / Jun 17, 2024 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the...Read more


Takeda Announces Phase 3 Topline Results for Soticlestat (TAK-935) in Patients with Dravet Syndrome and Lennox-Gastaut Syndrome

June 17
Last Trade: 12.66 0.05 0.40

SKYLINE Study in Dravet Syndrome Narrowly Missed its Primary Endpoint of Reduction in Convulsive Seizure Frequency and Showed Clinically Meaningful and Nominally Significant Effects in Multiple Key Secondary Efficacy Endpoints SKYWAY Study in Lennox-Gastaut Syndrome Missed its Primary Endpoint of Reduction in Major Motor Drop Seizures Soticlestat Showed a Consistent and Favorable Safety and Tolerability Profile in Both Studies Takeda...Read more


AstraZeneca: IMFINZI® (durvalumab) plus chemotherapy approved in the US for mismatch repair deficient advanced or recurrent endometrial cancer

June 17
Last Trade: 78.81 0.25 0.32

Approval based on DUO-E trial results, which showed IMFINZI reduced the risk of disease progression or death by 58% vs. chemotherapy WILMINGTON, Del. / Jun 17, 2024 / Business Wire / AstraZeneca’s IMFINZI® (durvalumab) in combination with carboplatin and paclitaxel followed by IMFINZI monotherapy has been approved in the US as treatment for adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair...Read more


Johnson & Johnson: Subcutaneous amivantamab Biologics License Application submitted to U.S. FDA for patients with EGFR-mutated non-small cell lung cancer

June 17
Last Trade: 148.14 0.36 0.24

Application based on Phase 3 PALOMA-3 results showing five-fold reduction in infusion-related reactions with five-minute administration of subcutaneous amivantamab Longer overall survival, progression-free survival and duration of response also observed with subcutaneous amivantamab RARATIN, N.J., June 17, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) announced today the submission of a Biologics License Application...Read more


AstraZeneca: CALQUENCE® (acalabrutinib) plus chemoimmunotherapy reduced the risk of disease progression or death by 27% vs. standard of care in patients with untreated mantle cell lymphoma in ECHO Phase III trial

June 16
Last Trade: 78.81 0.25 0.32

First and only BTK inhibitor to demonstrate favorable overall survival trend vs. standard-of-care chemoimmunotherapy in this setting WILMINGTON, Del. / Jun 16, 2024 / Business Wire / Positive results from the ECHO Phase III trial showed AstraZeneca’s CALQUENCE® (acalabrutinib) in combination with bendamustine and rituximab demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS)...Read more


Regeneron Pharmaceuticals: Updated Linvoseltamab Data Showcase Continued Deepening of Responses in Patients with Heavily Pre-Treated Multiple Myeloma

June 16
Last Trade: 1,049.31 4.92 0.47

At 14-months median follow-up in the pivotal trial, 50% of patients achieved a complete response or better and a 71% overall response rate, as presented in an EHA oral presentation and simultaneously published in the Journal of Clinical Oncology Also presented at EHA, a retrospective study of patient outcomes that compared investigational linvoseltamab to real-world standard-of-care treatment in clinical practice TARRYTOWN, N.Y.,...Read more


Genentech’s Phase III STARGLO Study Demonstrates Columvi Significantly Extends Survival in People With Relapsed or Refractory Diffuse Large B-cell Lymphoma

June 15
Last Trade: 35.47 0.24 0.68

The study met its primary endpoint of overall survival with a 41% reduction in the risk of death in people with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) treated with Columvi plus chemotherapy This Columvi combination could provide a much-needed off-the-shelf treatment option for people with transplant-ineligible R/R DLBCL Data were featured in the congress Press Briefing and presented today in the Plenary...Read more


Johnson & Johnson: Late-breaking results show nipocalimab significantly improves Sjögren's disease activity in a Phase 2 study

June 15
Last Trade: 148.14 0.36 0.24

Patients who received nipocalimab 15 mg/kg demonstrated a greater than 70 percent relative average improvement on the primary endpoint compared to patients who received placebo Sjögren's disease is a chronic, debilitating, and prevalent autoantibody disease with no approved advanced treatments VIENNA, June 15, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) announces patients treated with nipocalimab demonstrated...Read more


Amgen: FDA Approves BLINCYTO® (blinatumomab) In CD19-Positive Philadelphia Chromosome-Negative B-Cell Precursor Acute Lymphoblastic Leukemia (B-ALL) in the Consolidation Phase

June 14
Last Trade: 309.25 -0.64 -0.21

BLINCYTO® Added to Multiphase Consolidation Chemotherapy Reduced Risk of Death by 58% Showing Superior Overall Survival Versus Chemotherapy Alone First and Only Bispecific T-cell Engager (BiTE®) Therapy for Consolidation Treatment Regardless of Measurable Residual Disease (MRD) Status THOUSAND OAKS, Calif., June 14, 2024 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced the U.S. Food and Drug Administration (FDA) has...Read more


Pfizer: ELREXFIO™ Shows Median Overall Survival of More Than Two Years in People with Relapsed or Refractory Multiple Myeloma

June 14
Last Trade: 27.64 -0.10 -0.36

Patients in MagnetisMM-3 demonstrated a median overall survival (OS) of 24.6 months, with median progression-free survival (PFS) of 17.2 months NEW YORK / Jun 14, 2024 / Business Wire / Pfizer Inc. (NYSE: PFE) today announced detailed overall survival (OS) results from the Phase 2 MagnetisMM-3 study of ELREXFIO™ (elranatamab-bcmm) in patients with heavily pretreated relapsed or refractory multiple myeloma (RRMM). The study demonstrated...Read more


Takeda Signs Option Agreement with Ascentage Pharma to Enter into Exclusive Global License for Olverembatinib, a Third-Generation BCR-ABL Tyrosine Kinase Inhibitor (TKI)

June 14
Last Trade: 12.66 0.05 0.40

Takeda to Receive Exclusive Option to License Global Rights to Olverembatinib in All Territories Outside of Mainland China, Hong Kong, Macau, Taiwan and Russia Olverembatinib Has the Potential to Address Significant Unmet Need for Patients with Chronic Myeloid Leukemia Following Treatment with Currently Approved TKIs Ascentage Pharma to Advance Late-Stage Clinical Development of Olverembatinib Prior to Potential Exercise of the Option...Read more


Johnson & Johnson: TALVEY® (talquetamab-tgvs) demonstrates highly durable, longer-term responses in patients with relapsed or refractory multiple myeloma

June 14
Last Trade: 148.14 0.36 0.24

24-month overall survival rate of 67 percent achieved with TALVEY® 0.8 mg/kg biweekly dosing in the Phase 1/2 MonumenTAL-1 study MADRID, June 14, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) announced today that long-term data from the Phase 1/2 MonumenTAL-1 study showed that with 20 to 30 months of median follow-up, triple-class-exposed patients with relapsed or refractory multiple myeloma (RRMM) who were treated with...Read more


Vertex Pharmaceuticals Presents Positive Long-Term Data On CASGEVY™ (exagamglogene autotemcel) at the 2024 Annual European Hematology Association (EHA) Congress

June 14
Last Trade: 466.08 -5.30 -1.12

Results from CLIMB-111, -121 and -131 accepted for oral presentation Data from these trials, with the longest follow-up of more than five years, demonstrate transformative, consistent and durable benefit of CASGEVY™ Safety profile consistent with busulfan conditioning and autologous hematopoietic stem cell transplant BOSTON / Jun 14, 2024 / Business Wire / Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced longer-term...Read more


Bristol-Myers Squibb: U.S. Food and Drug Administration Approves Augtyro™ (repotrectinib), a Next-Generation Tyrosine Kinase Inhibitor (TKI), for the Treatment of Patients with NTRK-Positive Locally Advanced or Metastatic Solid Tumors

June 13
Last Trade: 41.19 0.15 0.37

Augtyro is the only FDA-approved treatment option for NTRK-positive tumors studied in both TKI-naïve and TKI-pretreated patients across solid tumors, demonstrating clinically meaningful response rates in the TRIDENT-1 trial1 This accelerated approval marks the second indication for Augtyro in the U.S.1 PRINCETON, N.J. / Jun 13, 2024 / Business Wire / Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug...Read more


AbbVie and FutureGen Announce License Agreement to Develop Next-Generation Therapy for Inflammatory Bowel Disease

June 13
Last Trade: 170.36 -1.77 -1.03

Global license agreement to focus on the development of FG-M701, a TL1A antibody, for the treatment of inflammatory bowel disease (IBD) NORTH CHICAGO, Ill. and BEIJING, June 13, 2024 /PRNewswire/ -- AbbVie (NYSE: ABBV) and FutureGen Biopharmaceutical (Beijing) Co., Ltd. today announced a license agreement to develop FG-M701, a next generation TL1A antibody for the treatment of IBD currently in preclinical development. FG-M701 is a...Read more


Moderna Announces Positive Phase 3 Efficacy Data for mRNA-1283, the Company’s Next Generation COVID-19 Vaccine

June 13
Last Trade: 135.28 0.88 0.65

mRNA-1283 met its primary vaccine efficacy endpoint in a Phase 3 trial, demonstrating non-inferior vaccine efficacy against COVID-19 compared to Spikevax® in participants 12 years of age and older Higher efficacy was observed in mRNA-1283 compared to Spikevax in adults 18 years of age and older CAMBRIDGE, MA / ACCESSWIRE / June 13, 2024 / Moderna, Inc. (NASDAQ:MRNA) today announced that its Phase 3 trial of mRNA-1283, an...Read more


AstraZeneca: FARXIGA approved in the US for the treatment of pediatric type-2 diabetes

June 12
Last Trade: 78.81 0.25 0.32

US patients aged 10 years and older can now benefit from FARXIGA for type-2 diabetes Approval based on results from T2NOW, one of the largest pediatric type-2 diabetes Phase III trials to date WILMINGTON, Del. / Jun 12, 2024 / Business Wire / AstraZeneca’s FARXIGA® (dapagliflozin) has been approved by the US Food and Drug Administration (FDA) to improve glycemic control in pediatric patients with type-2 diabetes (T2D) aged 10 years...Read more


Pfizer Provides Update on Phase 3 Study of Investigational Gene Therapy for Ambulatory Boys with Duchenne Muscular Dystrophy

June 12
Last Trade: 27.64 -0.10 -0.36

NEW YORK / Jun 12, 2024 / Business Wire / Pfizer Inc. (NYSE: PFE) today announced that CIFFREO, a Phase 3 global, multicenter, randomized, double-blind, placebo-controlled study evaluating the investigational mini-dystrophin gene therapy, fordadistrogene movaparvovec, in ambulatory patients with Duchenne muscular dystrophy (DMD) did not meet its primary endpoint of improvement in motor function among boys 4 to 7 years of age treated with...Read more


Regeneron Pharmaceuticals: Kevzara® (sarilumab) Approved by FDA for the Treatment of Active Polyarticular Juvenile Idiopathic Arthritis (pJIA)

June 11
Last Trade: 1,049.31 4.92 0.47

Approval in patients with pJIA weighing 63kg or greater adds to Kevzara’s position in treating adult chronic inflammatory conditions of moderately to severely active rheumatoid arthritis and polymyalgia rheumatica TARRYTOWN, N.Y. and CAMBRIDGE, MA, June 11, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the U.S. Food and Drug Administration has approved Kevzara® (sarilumab) for...Read more


AstraZeneca: TAGRISSO® (osimertinib) granted Priority Review in the US for patients with unresectable, Stage III EGFR-mutated lung cancer

June 10
Last Trade: 78.81 0.25 0.32

Decision based on LAURA Phase III trial results which extended median progression-free survival by more than three years TAGRISSO also granted Breakthrough Therapy Designation in US in this setting WILMINGTON, Del. / Jun 10, 2024 / Business Wire / AstraZeneca’s supplemental New Drug Application (sNDA) for TAGRISSO® (osimertinib) has been accepted and granted Priority Review in the US for the treatment of adult patients with...Read more


Moderna Announces Positive Phase 3 Data for Combination Vaccine Against Influenza and COVID-19

June 10
Last Trade: 135.28 0.88 0.65

mRNA-1083 met its primary endpoints, eliciting higher immune responses against influenza virus and SARS-CoV-2 than licensed flu and COVID vaccines in adults 50 years and older, including an enhanced influenza vaccine in adults 65 years and older CAMBRIDGE, MA / ACCESSWIRE / June 10, 2024 / Moderna, Inc. (NASDAQ:MRNA) today announced that its Phase 3 trial of mRNA-1083, an investigational combination vaccine against influenza and...Read more


FDA Accepts Eisai's Filing of LEQEMBI® (lecanemab-irmb) Supplemental Biologics License Application for IV Maintenance Dosing for the Treatment of Early Alzheimer's Disease

June 9
Last Trade: 222.31 -3.27 -1.45

TOKYO and CAMBRIDGE, Mass., June 9, 2024 /PRNewswire/ -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, "Biogen") announced today that the U.S. Food and Drug Administration (FDA) has accepted Eisai's Supplemental Biologics License Application (sBLA) for monthly lecanemab-irmb (U.S. brand name: LEQEMBI®)...Read more


Eli Lilly's tirzepatide was superior to placebo for MASH resolution, and more than half of patients achieved improvement in fibrosis at 52 weeks

June 8
Last Trade: 885.29 -0.70 -0.08

SYNERGY-NASH results were presented at the European Association for the Study of the Liver Congress 2024 and simultaneously published in The New England Journal of Medicine INDIANAPOLIS, June 8, 2024 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced detailed results from SYNERGY-NASH, a phase 2 study of 190 patients, with or without type 2 diabetes, to evaluate the investigational use of tirzepatide in adults with...Read more


US FDA Approves Expanded Age Indication for GSK’s AREXVY, the First Respiratory Syncytial Virus (RSV) Vaccine for Adults Aged 50-59 at Increased Risk

June 7
Last Trade: 40.38 -0.38 -0.93

Over 13 million US adults aged 50-59 years have a medical condition that increases their risk of severe RSV outcomes1 Clinical development program continues to evaluate safety and immunogenicity in adults 18+ with data read-outs expected H2 2024 PHILADELPHIA / Jun 07, 2024 / Business Wire / GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved AREXVY (Respiratory Syncytial Virus (RSV)...Read more


Vertex Pharmaceuticals Presents New Data at the European Cystic Fibrosis Conference Demonstrating Significant Benefits of Treatment with TRIKAFTA®

June 7
Last Trade: 466.08 -5.30 -1.12

Results from a randomized, placebo-controlled study of TRIKAFTA® in people with cystic fibrosis with rare, non-F508del CFTR mutations showed statistically significant and clinically meaningful improvements in the primary and all secondary endpoints Interim results of largest real-world study of TRIKAFTA® showed sustained improvement in lung function at three years as well as lower rates of lung transplant and death in people with cystic...Read more


Moderna Files FDA Application for the JN.1 Targeting COVID-19 Vaccine

June 7
Last Trade: 135.28 0.88 0.65

Manufacturing is underway and doses of Moderna's Spikevax 2024-2025 formula will be ready to ship as early as August, pending regulatory approval CAMBRIDGE, MA / ACCESSWIRE / June 7, 2024 / Moderna, Inc. (NASDAQ:MRNA) today announced that it has submitted an application to the U.S. Food and Drug Administration (FDA) for review of its Spikevax 2024-2025 formula, targeting the SARS-CoV-2 variant JN.1. "For four years, Moderna has...Read more


AbbVie Announces Positive Topline Results from Phase 2 PICCOLO Trial Evaluating Mirvetuximab Soravtansine (ELAHERE®) for High Folate Receptor-Alpha (FRα) Expressing Platinum-Sensitive Ovarian Cancer

June 6
Last Trade: 170.36 -1.77 -1.03

PICCOLO trial met its primary endpoint of objective response rate (ORR) Data from the study will be presented at a future medical meeting NORTH CHICAGO, Ill., June 6, 2024 /PRNewswire/ -- AbbVie (NYSE: ABBV) announced today positive topline results from the Phase 2 PICCOLO trial evaluating investigational mirvetuximab soravtansine (ELAHERE®) monotherapy in heavily pre-treated patients with folate receptor-alpha (FRα) positive,...Read more


Moderna's Investigational Therapeutic for Methylmalonic Acidemia (mRNA-3705) Selected by U.S. Food & Drug Administration for START Pilot Program

June 6
Last Trade: 135.28 0.88 0.65

Center for Biologics Evaluation and Research has chosen mRNA-3705 as one of four investigational medicines for accelerated development to address unmet medical needs for rare diseases CAMBRIDGE, MA / ACCESSWIRE / June 6, 2024 / Moderna, Inc. (NASDAQ:MRNA) today announced that the U.S. Food and Drug Administration (FDA) has selected mRNA-3705 for the Support for Clinical Trials Advancing Rare Disease Therapeutics (START) pilot...Read more


Gilead Sciences Announces New England Journal of Medicine Publication of Data that Demonstrate Bulevirtide with PegIFN Achieved Post-Treatment Undetectable HDV RNA

June 6
Last Trade: 69.75 1.26 1.84

Phase 2b Data Presented at EASL and Published in NEJM Show Potential for Bulevirtide 10 mg in Combination with Pegylated Interferon Alfa-2a as Finite Therapy for People with Chronic Hepatitis Delta  Data Published in NEJM Demonstrate 46% of Patients Taking Bulevirtide 10 mg with PegIFN Achieved Post-Treatment Undetectable HDV RNA at Week 24  Data Presented at EASL Demonstrate Consistent Study Findings of Undetectable HDV RNA...Read more


AbbVie Advances Oncology Pipeline With Start of Multiple Myeloma Phase 3 Clinical Trial for Investigational Asset ABBV-383

June 5
Last Trade: 170.36 -1.77 -1.03

ABBV-383 is a B-cell maturation antigen (BCMA) bispecific antibody T-cell engager being evaluated in relapsed/refractory multiple myeloma (r/r MM) The CERVINO Phase 3 trial will evaluate the efficacy, safety, and tolerability of ABBV-383 monotherapy compared with standard available therapies (SATs) in patients with r/r MM who have received at least two lines of prior therapy NORTH CHICAGO, Ill., June 5, 2024 /PRNewswire/ --...Read more


Amgen Announces Positive Results For Phase 3 Registrational Trial Evaluating Uplizna® (inebilizumab-cdon) For Treatment Of Immunoglobulin G4-related Disease (IgG4-RD)

June 5
Last Trade: 309.25 -0.64 -0.21

Data Show a Statistically Significant 87% Reduction in IgG4-RD Flares, With Primary and All Key Secondary Endpoints Met First Randomized, Placebo-Controlled Trial to Demonstrate Benefit in IgG4-RD THOUSAND OAKS, Calif., June 5, 2024 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced positive topline results from its randomized, double-blind, multicenter, placebo-controlled Phase 3 clinical trial (NCT04540497) evaluating the...Read more


Gilead Sciences’ Seladelpar Demonstrated a Sustained and Consistent Long-Term Efficacy and Safety Profile in Primary Biliary Cholangitis

June 5
Last Trade: 69.75 1.26 1.84

Positive Results from Two-year Interim Analysis Includes Participants from Phase 3 RESPONSE Study and are Highly Consistent with One-year Interim Analysis  Reduction in Patient-Reported Pruritus (Itching) was Rapid and Durable in Participants with Moderate to Severe Symptoms  Subset Analysis of Participants with Compensated Cirrhosis Demonstrated Clinically Meaningful Improvements in Markers of Cholestasis and Liver...Read more


AbbVie: RINVOQ® (upadacitinib) Now Available for Pediatric Patients Two Years and Older with Polyarticular Juvenile Idiopathic Arthritis and Psoriatic Arthritis

June 4
Last Trade: 170.36 -1.77 -1.03

First indications of RINVOQ (upadacitinib) for pediatric patients two years of age and older1 RINVOQ is now approved for eight indications across immune-mediated inflammatory diseases1 NORTH CHICAGO, Ill., June 4, 2024 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that RINVOQ® (upadacitinib) is indicated in the U.S. for the treatment of pediatric patients two years of age and older with active polyarticular juvenile idiopathic...Read more


Bristol Myers Squibb Announces Opdivo (nivolumab) Plus Yervoy (ipilimumab) Significantly Improved Overall Survival Compared to Lenvatinib or Sorafenib as First-Line Treatment for Patients with Advanced Hepatocellular Carcinoma in CheckMate -9DW Trial

June 4
Last Trade: 41.19 0.15 0.37

Late-breaking data to be presented at the 2024 American Society of Clinical Oncology (ASCO®) Annual Meeting Dual immunotherapy combination of Opdivo plus Yervoy demonstrated improved survival benefit compared to lenvatinib or sorafenib in this patient population Objective response rate (ORR) for Opdivo plus Yervoy was more than double that for lenvatinib or sorafenib, with median duration of response of 30 months PRINCETON, N.J. /...Read more


Melissa Seymour to join Eli Lilly as executive vice president of Global Quality

June 4
Last Trade: 885.29 -0.70 -0.08

INDIANAPOLIS, June 4, 2024 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced today that Melissa Seymour will join the company as executive vice president of Global Quality and member of the company's Executive Committee, effective July 22, 2024. Seymour currently serves as the chief quality officer for Bristol Myers Squibb and succeeds Johna Norton, whose retirement after 34 years of service was announced earlier this year. "As...Read more


Bristol Myers Squibb’s Breyanzi Demonstrates Clinically Meaningful Outcomes Across Broad Range of B-Cell Malignancies in New Data Presented at 2024 ASCO® Annual Meeting

June 3
Last Trade: 41.19 0.15 0.37

Three-year follow-up results from TRANSFORM show ongoing event-free survival and durable responses with Breyanzi compared to standard of care Results from a subgroup analysis from mantle cell lymphoma cohort of TRANSCEND NHL 001 show Breyanzi demonstrated consistent clinical benefit regardless of number of prior lines of therapy, supporting use of Breyanzi in earlier lines of treatment Data from bridging therapy subgroup analysis of...Read more


Kite’s Tecartus® Demonstrates Sustained Overall Survival in Adult Patients With Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia

June 3
Last Trade: 69.75 1.26 1.84

 After More Than Four Years of Follow-up in the Pivotal ZUMA-3 Study, Median Overall Survival (OS) was 26 Months and the OS Rate was 40% at 48 Months   Survival Benefit was Seen Regardless of Age, Prior Treatment or Subsequent Allogeneic Stem Cell Transplant Status   Data Being Presented at the 2024 American Society of Clinical Oncology Annual Meeting  SANTA MONICA, Calif. / Jun 03, 2024 / Business Wire...Read more


Novo Nordisk launches national Wegovy® campaign, Power of Wegovy®

June 3
Last Trade: 142.02 1.03 0.73

Designed to celebrate diverse, unique portrayals of individuals who partner with their healthcare professional to change the course of their weight-management journey, while educating on the clinical data of Wegovy® Reflects the power of personal journeys to address stigma, and the importance of us all working together to address excess weight and treat obesity PLAINSBORO, N.J., June 3, 2024 /PRNewswire/ -- Novo Nordisk today...Read more


Genmab: Investigational Tisotumab Vedotin Phase 2 Data Demonstrates Encouraging Antitumor Activity in Patients with Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)

June 3
Last Trade: 25.82 -0.06 -0.23

Results from innovaTV207 evaluating tisotumab vedotin, showing 32.5% confirmed objective response rate in patients with recurrent or metastatic HNSCC, presented in a rapid oral session at 2024 ASCO® Annual Meeting HNSCC is the sixth most common cancer worldwide, with incidence rates expected to increase 30% by 2030i COPENHAGEN, Denmark / Jun 03, 2024 / Business Wire / Genmab A/S (Nasdaq: GMAB) announced today that data from the Phase...Read more


GSK: Jemperli (dostarlimab-gxly) trial continues to show unprecedented results with no evidence of disease in 100% of patients with locally advanced mismatch repair deficient (dMMR) rectal cancer

June 3
Last Trade: 40.38 -0.38 -0.93

Updated analysis from Memorial Sloan Kettering Cancer Center presented at ASCO 2024 has expanded to 42 patients with clinical complete response New treatment options are needed for patients facing negative impacts to quality-of-life with current standard of care Additional registrational studies of dostarlimab-gxly in dMMR/microsatellite instability-high rectal (MSI-H) and colorectal cancer are recruiting PHILADELPHIA / Jun 03, 2024...Read more


AstraZeneca: TAGRISSO® (osimertinib) reduced the risk of disease progression or death by 84% in patients with unresectable, Stage III EGFR-mutated lung cancer vs. placebo in LAURA Phase III trial

June 2
Last Trade: 78.81 0.25 0.32

​​​First and only EGFR inhibitor and targeted treatment to show benefit in Stage III setting, extending progression-free survival by more than three years WILMINGTON, Del. / Jun 02, 2024 / Business Wire / Positive results from the LAURA Phase III trial showed AstraZeneca’s TAGRISSO® (osimertinib) demonstrated a statistically significant and highly clinically meaningful improvement in progression-free survival (PFS) for patients with...Read more


Belantamab Mafodotin combination reduced the risk of disease progression or death by nearly 50% versus standard of care combination in relapsed/refractory multiple myeloma

June 2
Last Trade: 40.38 -0.38 -0.93

DREAMM-8 phase III trial showed statistically significant and clinically meaningful improvement in primary endpoint of progression-free survival (PFS) Median PFS not yet reached at 21.8 months median follow-up versus 12.7 months in bortezomib combination Second trial to show robust efficacy for a belantamab mafodotin combination versus a standard of care in second line and later relapsed/refractory multiple myeloma Results...Read more


Genmab: Preliminary Analysis of Data Evaluating Investigational Epcoritamab (DuoBody® CD3xCD20) Combination Demonstrates 95% Overall Response Rate in Patients with Previously Untreated Follicular Lymphoma

June 2
Last Trade: 25.82 -0.06 -0.23

Preliminary analysis of data from the EPCORE™ NHL-2 study demonstrates patients with previously untreated follicular lymphoma (FL) who received epcoritamab in combination with rituximab-lenalidomide (R2) experienced a 95% overall response rate (ORR) Results from the optimization cohort of the EPCORE™ NHL- 1 study show that mitigation strategies led to a clinically significant reduction in rate of cytokine release syndrome (CRS) and...Read more


AstraZeneca: IMFINZI® (durvalumab) is the first and only immunotherapy to show survival benefit in limited-stage small cell lung cancer in global Phase III trial, reducing the risk of death by 27% vs. placebo

June 2
Last Trade: 78.81 0.25 0.32

57% of patients treated with IMFINZI were alive at three years in ADRIATIC Phase III trial WILMINGTON, Del. / Jun 02, 2024 / Business Wire / Positive results from the ADRIATIC Phase III trial showed AstraZeneca’s IMFINZI® (durvalumab) ​demonstrated statistically significant and clinically meaningful improvements in the dual primary endpoints of overall survival (OS) and progression-free survival (PFS) compared to placebo for patients...Read more


Takeda and Pfizer Announce Four-Year Results from Positive Phase 3 HD21 Trial of Additional ADCETRIS® (brentuximab vedotin) Combination in Frontline Hodgkin Lymphoma

June 1
Last Trade: 12.66 0.05 0.40

Four-year Analysis Conducted by GHSG Reported ADCETRIS + ECADD Combination Improved Progression-Free Survival, Showing Superior Efficacy and Tolerable Safety Profile in Patients with Newly Diagnosed Stage IIb/III/IV Classical Hodgkin Lymphoma vs eBEACOPP, a Current Standard of Care in This Setting in Europe The HD21 Study Adds to the Body of Evidence Supporting ADCETRIS as a Backbone Agent in the Treatment of Specific Lymphomas Results...Read more


Pfizer’s ADCETRIS® Regimen Produces Clinically Meaningful Improvement in Overall Survival in Patients with Relapsed/​Refractory Diffuse Large B-cell Lymphoma (DLBCL)

June 1
Last Trade: 27.64 -0.10 -0.36

Detailed data from Phase 3 ECHELON-3 study demonstrate investigational ADCETRIS regimen reduced risk of death by 37 percent compared to chemotherapy alone, resulting in median overall survival of 13.8 months versus 8.5 months Third Phase 3 trial in third type of lymphoma to show improvement in overall survival with an ADCETRIS-containing regimen NEW YORK / Jun 01, 2024 / Business Wire / Pfizer Inc. (NYSE: PFE) today announced detailed...Read more


Eli Lilly: Updated Data from the Phase 1/2 Study of Olomorasib in KRAS G12C-Mutant Advanced Solid Tumors Presented at the 2024 ASCO® Annual Meeting

June 1
Last Trade: 885.29 -0.70 -0.08

Data demonstrated promising monotherapy activity with olomorasib across a range of KRAS G12C-mutant solid tumors, including non-small cell lung cancer, and a tolerability profile in combination with pembrolizumab that is well-suited to first-line lung cancer development INDIANAPOLIS, June 1, 2024 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced updated data from the Phase 1/2 clinical trial evaluating olomorasib as...Read more


Bristol-Myers Squibb: KRAZATI (adagrasib) Demonstrated Statistically Significant Improvement in Progression-Free Survival in Patients with Pretreated Locally Advanced or Metastatic KRASG12C-Mutated Non-Small Cell Lung Cancer

June 1
Last Trade: 41.19 0.15 0.37

First presentation of data from Phase 3 KRYSTAL-12 study showed statistically significant and clinically meaningful improvement in progression-free survival with KRAZATI compared to standard of care chemotherapy Late-breaking data featured in an oral presentation at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting PRINCETON, N.J. / Jun 01, 2024 / Business Wire / Bristol Myers Squibb (NYSE: BMY) today announced...Read more


Gilead Sciences and Arcus Biosciences Announce Anti-TIGIT Domvanalimab Plus Zimberelimab and Chemotherapy Exceeded One Year of Median Progression-Free Survival as a First-Line Treatment for Upper GI Cancers

June 1
Last Trade: 69.75 1.26 1.84

Data Support the Ongoing Phase 3 STAR-221 Study of Domvanalimab Plus Zimberelimab and Chemotherapy, Potentially the First Anti-TIGIT Combination to Market for These Cancers Results will be Presented Today During an Oral Session at the ASCO Annual Meeting FOSTER CITY, Calif. & HAYWARD, Calif. / Jun 01, 2024 / Business Wire / Gilead Sciences, Inc. (Nasdaq: GILD) and Arcus Biosciences, Inc. (NYSE: RCUS) today announced longer-term...Read more


Genmab: Investigational Acasunlimab (DuoBody® -PD-L1x4-1BB) in Combination with Pembrolizumab Demonstrates Meaningful Clinical Activity in Phase 2 Trial in Patients with Previously Treated Metastatic Non-small Cell Lung Cancer (mNSCLC)

June 1
Last Trade: 25.82 -0.06 -0.23

Initial data from the ongoing Phase 2 trial showed a 12-month overall survival (OS) rate of 69% and median overall survival (mOS) of 17.5 months in patients with previously treated PD-L1-positive mNSCLC treated with combination of acasunlimab with pembrolizumab every six weeks Data from this ongoing Phase 2 study to inform the planned pivotal Phase 3 trial, which is expected to start before the end of 2024 COPENHAGEN, Denmark &...Read more


Pfizer’s LORBRENA® CROWN Study Shows Majority of Patients with ALK-Positive Advanced Lung Cancer Living Beyond Five Years Without Disease Progression

May 31
Last Trade: 27.64 -0.10 -0.36

An unprecedented 60% of patients remain alive without disease progression after five years Updated results show continued 81% reduction in risk of progression or death and 94% reduction in progression of brain metastases compared to XALKORI® NEW YORK / May 31, 2024 / Business Wire / Pfizer Inc. (NYSE: PFE) today announced longer-term follow-up results from the Phase 3 CROWN trial evaluating LORBRENA® (lorlatinib, a third-generation...Read more


Moderna Receives U.S. FDA Approval for RSV Vaccine mRESVIA(R)

May 31
Last Trade: 135.28 0.88 0.65

mRESVIA is Moderna's second approved product and the only RSV vaccine available in single-dose pre-filled syringes CAMBRIDGE, MA / ACCESSWIRE / May 31, 2024 / Moderna, Inc. (NASDAQ:MRNA) today announced that the U.S. Food and Drug Administration (FDA) has approved mRESVIA (mRNA-1345), an mRNA respiratory syncytial virus (RSV) vaccine, to protect adults aged 60 years and older from lower respiratory tract disease caused by RSV...Read more


Takeda Receives Positive CHMP Opinion for Recombinant ADAMTS13 (rADAMTS13) in Congenital Thrombotic Thrombocytopenic Purpura (cTTP)

May 31
Last Trade: 12.66 0.05 0.40

cTTP Is an Ultra-rare, Potentially Fatal Blood-Clotting Disorder with Limited Treatment Options; Untreated, Acute TTP Events Have a Mortality Rate of >90%1,2 If Approved in the European Union, rADAMTS13 Will Be the First and Only Recombinant ADAMTS13 Enzyme Replacement Therapy for cTTP Positive Opinion Based on Totality of Evidence, Including Results from the First Randomized, Controlled, Open-label, Crossover Phase...Read more


Johnson & Johnson Completes Acquisition of Shockwave Medical

May 31
Last Trade: 148.14 0.36 0.24

Strengthens Position in Highest-Growth, Innovation-Oriented Segments of Cardiovascular Intervention Creates Greater Opportunity to Transform the Treatment Landscape for Cardiovascular Disease NEW BRUNSWICK, N.J. / May 31, 2024 / Business Wire / Johnson & Johnson (NYSE: JNJ) today announced it has completed its acquisition of Shockwave Medical. Shockwave is now part of Johnson & Johnson and will operate as a business unit...Read more


AbbVie Receives Positive CHMP Opinion for Risankizumab (SKYRIZI®) for the Treatment of Adults with Moderately to Severely Active Ulcerative Colitis

May 31
Last Trade: 170.36 -1.77 -1.03

The positive opinion is based on results from two pivotal Phase 3 trials, INSPIRE and COMMAND, that evaluated the efficacy and safety of risankizumab in adults with moderately to severely active ulcerative colitis (UC)1,2 In both trials, the primary endpoint of clinical remission (per Adapted Mayo Score*) and key secondary endpoints, including endoscopic improvement** and histologic-endoscopic mucosal improvement,† were...Read more


Regeneron Pharmaceuticals: Dupixent® (dupilumab) Recommended for EU Approval by the CHMP to Treat Patients with COPD

May 31
Last Trade: 1,049.31 4.92 0.47

Recommendation for adults with uncontrolled COPD with raised blood eosinophils based on data from two landmark Phase 3 trials demonstrating Dupixent significantly reduced exacerbations and improved lung function If approved, Dupixent would be the first-ever targeted therapy for COPD in the EU and the first new treatment approach for this disease in more than a decade TARRYTOWN, N.Y. and PARIS, May 31, 2024 (GLOBE NEWSWIRE) --...Read more


Regeneron Pharmaceuticals: Update on FDA Priority Review of Dupixent® (dupilumab) for the Treatment of COPD Patients with Type 2 Inflammation

May 31
Last Trade: 1,049.31 4.92 0.47

TARRYTOWN, N.Y. and PARIS, May 31, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced the U.S. Food and Drug Administration (FDA) has extended by three months the target action date of its priority review of the supplemental Biologics License Application (sBLA) for Dupixent® (dupilumab) as an add-on maintenance treatment in certain adult patients with uncontrolled chronic obstructive...Read more


Biogen Receives European Commission Approval for QALSODY® (tofersen), the First Therapy to Treat a Rare, Genetic Form of ALS

May 30
Last Trade: 222.31 -3.27 -1.45

SOD1-ALS is a devastating, uniformly fatal, and ultra-rare genetic form of ALS estimated to affect less than 1,000 people in Europe1 QALSODY is Biogen’s third rare disease therapy to be approved in the EU, demonstrating the company’s commitment to addressing diseases with a high unmet need With QALSODY, Biogen has helped advance neurofilament as a tool to optimize clinical trial design in ALS, offering the potential to expedite...Read more


Gilead Sciences Provides Update on Phase 3 TROPiCS-04 Study

May 30
Last Trade: 69.75 1.26 1.84

FOSTER CITY, Calif. / May 30, 2024 / Business Wire / Gilead Sciences, Inc. (Nasdaq: GILD) today announced topline results from the confirmatory Phase 3 TROPiCS-04 study in locally advanced or metastatic urothelial cancer (mUC). The TROPiCS-04 study evaluated Trodelvy® (sacituzumab govitecan-hziy; SG) vs. single-agent chemotherapy (treatment of physicians’ choice, TPC) in patients with mUC who have previously received platinum-containing...Read more


U.S. Food and Drug Administration Approves Bristol Myers Squibb’s Breyanzi as a New CAR T Cell Therapy for Relapsed or Refractory Mantle Cell Lymphoma

May 30
Last Trade: 41.19 0.15 0.37

In the MCL cohort of TRANSCEND NHL 001, Breyanzi delivered responses in 85.3% of patients with a one-time infusion while demonstrating a consistent safety profile across clinical trials Breyanzi is the only CAR T cell therapy approved by the FDA for four distinct subtypes of non-Hodgkin lymphoma, bringing this personalized therapy to the broadest array of patients with B-cell malignancies PRINCETON, N.J. / May 30, 2024 / Business Wire...Read more


BioNTech and CEPI Expand Partnership to Strengthen Africa’s mRNA Vaccine Ecosystem

May 29
Last Trade: 84.59 -1.29 -1.50

BioNTech and CEPI aim to enhance local R&D, clinical and commercial-scale manufacturing capacities to develop potential mRNA vaccines in Africa, for Africa CEPI to fund up to $145 million to support BioNTech in broadening the scope of the manufacturing facility in Kigali, Rwanda, aimed at addressing needs of African countries and in compliance with global standards Partnership intends to contribute to building a sustainable and...Read more


Roche: FDA Grants Priority Review to Genentech’s Inavolisib for Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer With a PIK3CA Mutation

May 29
Last Trade: 35.47 0.24 0.68

Priority Review recognizes the best-in-class potential of the inavolisib-based regimen for patients in urgent need of new treatment options  Additional analyses of INAVO120 will be presented in an oral abstract session at the 2024 American Society of Clinical Oncology Annual Meeting  The target action date for the FDA decision is November 27, 2024  SOUTH SAN FRANCISCO, Calif. / May 29, 2024 / Business Wire / Genentech,...Read more


FDA Grants Priority Review to Merck’s Application for KEYTRUDA® (pembrolizumab) Plus Chemotherapy as First-Line Treatment of Patients With Unresectable Advanced or Metastatic Malignant Pleural Mesothelioma

May 29
Last Trade: 129.54 -0.13 -0.10

Acceptance based on results from the pivotal Phase 3 CCTG IND.227/KEYNOTE-483 trial, which demonstrated a statistically significant improvement in overall survival versus chemotherapy alone in these patients RAHWAY, N.J. / May 29, 2024 / 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 accepted for priority review a new supplemental...Read more


Bristol Myers Squibb Receives European Commission Approval for Opdivo® (nivolumab) in Combination with Cisplatin and Gemcitabine for the First-Line Treatment of Adult Patients with Unresectable or Metastatic Urothelial Carcinoma

May 29
Last Trade: 41.19 0.15 0.37

Approval based on results from CheckMate -901, the first Phase 3 trial in this patient population with an immunotherapy-chemotherapy combination to demonstrate survival benefit versus standard-of-care chemotherapy alone First concurrent immunotherapy-chemotherapy combination approved for this patient population in the European Union PRINCETON, N.J. / May 29, 2024 / Business Wire / Bristol Myers Squibb (NYSE: BMY) today announced that...Read more


Merck to Acquire EyeBio

May 29
Last Trade: 129.54 -0.13 -0.10

Acquisition includes Restoret™, a novel late-phase candidate for diabetic macular edema and neovascular age-related macular degeneration, as well as a preclinical pipeline targeting retinal diseases Restoret anticipated to enter pivotal study for diabetic macular edema in the second half of 2024 Merck to acquire EyeBio for a $1.3 billion upfront payment and up to $1.7 billion in future milestone payments for a potential value of $3...Read more


Johnson & Johnson to Obtain Rights to a Clinical-Stage Bispecific Antibody to Address Distinct Patient Needs in Atopic Dermatitis

May 28
Last Trade: 148.14 0.36 0.24

The Company1 enters agreement with Numab Therapeutics to acquire its wholly owned subsidiary2 for the global rights to NM26, a Phase 2-ready investigational, first-in-class bispecific antibody targeting two clinically proven pathways in atopic dermatitis (AD) NM26 has the potential to offer distinctive benefits versus existing treatments and address key unmet needs for AD patients Johnson & Johnson is committed to developing...Read more


Merck Announces Phase 3 KEYNOTE-522 Trial Met its Overall Survival (OS) Endpoint in Patients With High-Risk Early-Stage Triple Negative Breast Cancer (TNBC)

May 28
Last Trade: 129.54 -0.13 -0.10

KEYTRUDA® (pembrolizumab) is the first and only immunotherapy-based regimen to show a statistically significant improvement in OS as pre-operative (neoadjuvant) treatment with chemotherapy and then as a single agent after surgery (adjuvant) compared to pre-operative chemotherapy in patients with high-risk early-stage TNBC New OS results build on the pathological complete response and event-free survival data previously reported from the...Read more


AstraZeneca: Datopotamab deruxtecan showed clinically meaningful overall survival improvement vs. chemotherapy in patients with advanced nonsquamous non-small cell lung cancer in TROPION-Lung01 Phase III trial

May 27
Last Trade: 78.81 0.25 0.32

In the overall trial population, survival results numerically favoured AstraZeneca and Daiichi Sankyo’s datopotamab deruxtecan but did not reach statistical significance TROPION-Lung01 previously met the dual primary endpoint of progression-free survival in the overall trial population Results support applications currently under review by regulatory authorities globally including in the US and EU This announcement contains inside...Read more


Roche and Hitachi High-Tech extend their 46-year partnership, paving the way for further breakthroughs in diagnostic testing

May 27
Last Trade: 35.47 0.24 0.68

Renewed partnership combines best in class engineering capabilities with cutting edge science to accelerate the availability of new solutions for customers and patients worldwide Upcoming launches of the new cobas® c703 & ISE neo units and cobas® Mass Spec solution are testament to the partnership's dedication to continued innovation The new 10-year contract will focus on strengthening the partnership for continued transformative...Read more


MediLink Therapeutics announces a multi-target TMALIN® ADC technology platform license agreement with BioNTech, expanding their global strategic partnership

May 26
Last Trade: 84.59 -1.29 -1.50

SUZHOU, China, May 26, 2024 /PRNewswire/ -- MediLink Therapeutics (Suzhou) Co., Ltd. ("MediLink"), a clinical-stage biotech company, today announces a new strategic collaboration with BioNTech SE (Nasdaq: BNTX, "BioNTech"), a next-generation immunotherapy company pioneering novel therapies for cancer and other serious diseases, under which BioNTech will receive an exclusive option to an exclusive global license to apply MediLink's TMALIN®...Read more


Novartis atrasentan Phase III data show clinically meaningful proteinuria reduction further advancing company's IgA nephropathy (IgAN) portfolio

May 25
Last Trade: 105.07 -0.67 -0.63

In the ALIGN study, atrasentan, in addition to supportive care with a renin-angiotensin system (RAS) inhibitor, demonstrated a statistically significant 36.1% proteinuria (protein in urine) reduction vs. placebo + supportive care at 36 weeks1 Endothelin A (ETA) receptor activation contributes to elevated proteinuria in IgAN2-5; atrasentan is a potent, selective ETA receptor antagonist with potential to reduce persistent proteinuria and...Read more


Novartis presents latest Phase III Fabhalta® (iptacopan) data in C3 glomerulopathy (C3G) showing clinically meaningful and statistically significant 35.1% proteinuria reduction vs. placebo

May 25
Last Trade: 105.07 -0.67 -0.63

Secondary endpoint data for estimated glomerular filtration rate (eGFR) showed numerical improvement over 6 months vs. placebo1; additional 6-month open-label data to be presented at a future medical meeting2,3 Fabhalta showed a favorable safety profile with no new safety signals1 C3G, an ultra-rare kidney disease caused by alternative complement pathway overactivation, progresses to kidney failure in ∼50% of patients within 10...Read more


Eli Lilly Increases Manufacturing Investment to $9 Billion at Newest Indiana Site to Boost API Production for Tirzepatide and Pipeline Medicines

May 24
Last Trade: 885.29 -0.70 -0.08

Largest investment in active pharmaceutical ingredient manufacturing of synthetic medicines in U.S. history Since 2020, the company has committed more than $18 billion to build, upgrade and acquire facilities in the U.S. and Europe INDIANAPOLIS, May 24, 2024 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced today that it has more than doubled its investment in its Lebanon, Indiana, manufacturing site with a new...Read more


Biogen Bolsters Late-Stage Pipeline, Expands Immunology Portfolio with Agreement to Acquire Human Immunology Biosciences

May 22
Last Trade: 222.31 -3.27 -1.45

Transaction to include felzartamab, a potential first-in-class therapeutic candidate with promise as a pipeline-in-a-product across a range of immune-mediated diseases Felzartamab is an investigational anti-CD38 monoclonal antibody that, through its cell depletion approach, has demonstrated clinical proof of concept in rare immune-mediated indications, with plans to advance to Phase 3 Proposed acquisition builds on Biogen capabilities...Read more


More than one-half of patients with Crohn's disease treated with Eli Lilly's mirikizumab achieved clinical remission at one year, including patients with previous biologic failure

May 21
Last Trade: 885.29 -0.70 -0.08

Nearly one-half of patients on mirikizumab achieved endoscopic response at 52 weeks; most of these patients were also in clinical remission INDIANAPOLIS, May 21, 2024 /PRNewswire/ -- In Eli Lilly and Company's (NYSE: LLY) pivotal Phase 3 VIVID-1 study, patients with moderately to severely active Crohn's disease, with or without previous biologic failure, achieved statistically significant and clinically meaningful...Read more


Bristol Myers Squibb Announces Updated Action Date by the U.S. Food and Drug Administration for Subcutaneous Nivolumab (nivolumab and hyaluronidase)

May 21
Last Trade: 41.19 0.15 0.37

Updated Prescription Drug User Fee Act (PDUFA) goal date of December 29, 2024 PRINCETON, N.J. / May 21, 2024 / Business Wire / Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has reassigned the previously announced Prescription Drug User Fee Act (PDUFA) goal date of the Biologics License Application (BLA) for the subcutaneous formulation of Opdivo® (nivolumab) co-formulated with...Read more


Roche: FDA Grants Breakthrough Therapy Designation to Genentech’s Inavolisib for Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer with a PIK3CA Mutation

May 21
Last Trade: 35.47 0.24 0.68

The designation is based on Phase III INAVO120 results, showing the inavolisib-based regimen more than doubled progression-free survival compared with palbociclib and fulvestrant alone in the first-line setting  Approximately 40% of people with HR-positive breast cancer have a PIK3CA mutation and often face poorer prognosis and resistance to endocrine treatment  This is the 29th Breakthrough Therapy Designation for Genentech’s...Read more


Regeneron Pharmaceuticals: Dupixent® (dupilumab) Late-Breaking Data from NOTUS Confirmatory Phase 3 COPD Trial Presented at ATS and Published in The New England Journal of Medicine

May 20
Last Trade: 1,049.31 4.92 0.47

NOTUS results confirm landmark data from the Phase 3 BOREAS trial and show Dupixent significantly reduced exacerbations by 34% and improved lung function, compared to placebo, in uncontrolled chronic obstructive pulmonary disease (COPD) with evidence of type 2 inflammation Data support the potential of Dupixent as the first new treatment approach in more than a decade and first-ever targeted therapy for COPD TARRYTOWN, N.Y. and...Read more


AstraZeneca: New data presented at ATS 2024 show the potential of TEZSPIRE to play a role in the future treatment of chronic obstructive pulmonary disease

May 19
Last Trade: 78.81 0.25 0.32

Late-breaking results from the Phase IIa COURSE trial provide insight into TEZSPIRE’s impact on COPD exacerbations in patients with a broad range of eosinophil levels WILMINGTON, Del. / May 19, 2024 / Business Wire / The Phase IIa COURSE trial was a proof-of-concept study in people with moderate to very severe chronic obstructive pulmonary disease (COPD) with a broad range of blood eosinophil counts (BEC) and irrespective of emphysema,...Read more


Amgen: New Data Presented at ATS 2024 Show The Potential of Tezspire® to Help Patients Living with COPD

May 19
Last Trade: 309.25 -0.64 -0.21

Late-Breaking Results From the Phase 2a COURSE Trial Illustrate Tezspire's Impact on COPD Exacerbations in Patients With a Broad Range of Eosinophil Levels THOUSAND OAKS, Calif., May 19, 2024 /PRNewswire/ -- Amgen (NASDAQ:AMGN) and AstraZeneca today announced the results of the Phase 2a COURSE trial evaluating Tezspire® (tezepelumab-ekko) in people with moderate to very severe chronic obstructive pulmonary disease (COPD) with a...Read more


Gilead Sciences: Investigational Seladelpar Demonstrates Significant Improvements in Liver Disease Progression and Reduced Itching in Primary Biliary Cholangitis

May 18
Last Trade: 69.75 1.26 1.84

70% of Patients Receiving Seladelpar 10mg Achieved the Clinically Meaningful Composite Endpoint and 37% Achieved ALP Normalization at 12 Months Reduction in Patient-Reported Pruritus (Itching) was Rapid and Durable in Patients with Moderate to Severe Symptoms Positive Interim Results are Highly Consistent with Results from the Phase 3 RESPONSE Study of Seladelpar FOSTER CITY, Calif. / May 18, 2024 / Business Wire / Gilead Sciences,...Read more


Amgen: FDA Approves Imdelltra™ (Tarlatamab-dlle), The First And Only T-cell Engager Therapy For The Treatment of Extensive-stage Small Cell Lung Cancer

May 16
Last Trade: 309.25 -0.64 -0.21

Breakthrough DLL3-Targeting Therapy Regimen for a Major Solid Tumor IMDELLTRA Demonstrated Impressive 40% Objective Response Rate, 9.7 Month Median Duration of Response and 14.3 Month Median Overall Survival in Pivotal DeLLphi-301 Study Amgen to Host Webcast Investor Call on May 20, 2024 at 1:00 p.m. PT THOUSAND OAKS, Calif., May 16, 2024 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug...Read more


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Today's Big Pharma Gainers

 
CompanyChangeLast Trade
Regeneron Pharmaceuticals 4.92 0.47 $1,049.31
Alnylam Pharmaceuticals 4.44 2.82 $161.84
BeiGene 1.81 1.16 $157.35
Gilead Sciences 1.26 1.84 $69.75
Novo Nordisk 1.03 0.73 $142.02
Moderna 0.88 0.65 $135.28
Johnson & Johnson 0.36 0.24 $148.14
AstraZeneca 0.25 0.32 $78.81
Roche 0.24 0.68 $35.47
Bristol-Myers Squibb 0.15 0.37 $41.19
Sanofi 0.12 0.26 $46.97
Takeda 0.05 0.40 $12.66
Recursion

Recursion Pharmaceuticals is a clinical stage TechBio company leading the space by decoding biology to industrialize drug discovery. Enabling its mission is the Recursion OS, a platform built across diverse technologies that continuously expands one of the world’s largest....

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List of Big Pharma Stocks

List of Big Pharma Stocks

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ClearPoint Neuro

ClearPoint Neuro is a global therapy-enabling platform company providing stereotactic navigation and delivery to the brain. Applications of our ClearPoint Neuro Navigation System include electrode lead placement, placement of catheters, and biopsy. The platform has FDA clearance and is...

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