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Latest Phase 3 Clinical Trial News

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Pfizer: XTANDI® Plus Leuprolide Significantly Improves Survival Outcomes in Men with Non-Metastatic Hormone-Sensitive Prostate Cancer with High-Risk Biochemical Recurrence

July 10
Last Trade: 25.51 -0.11 -0.43

XTANDI: the first and only androgen receptor inhibitor-based regimen to demonstrate overall survival benefit in non-metastatic hormone-sensitive prostate cancer (nmHSPC) with high-risk biochemical recurrence (BCR) NEW YORK & TOKYO / Jul 10, 2025 / Business Wire / Pfizer Inc. (NYSE: PFE) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced positive topline results from the overall...Read more


Ultragenyx Pharmaceutical and Mereo BioPharma Announce UX143 Phase 3 Orbit Study for Osteogenesis Imperfecta Progressing to Final Analysis

July 9
Last Trade: 41.44 2.02 5.12

Data from Orbit and Cosmic studies expected around the end of the year NOVATO, Calif., July 09, 2025 (GLOBE NEWSWIRE) -- Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE) and Mereo BioPharma Group plc (NASDAQ: MREO), today announced that the randomized, placebo-controlled Phase 3 portion of the Orbit study evaluating UX143 (setrusumab) in pediatric and young adult patients with osteogenesis imperfecta (OI) is progressing toward a final...Read more


Moleculin Biotech Expands Phase 3 MIRACLE Clinical Trial into the Country of Georgia, Enrollment Update and Future Plans

July 9
Last Trade: 0.57 0.05 9.70

Secured approval from the Regulation Agency for Medical and Pharmaceutical Activities (RAMPA) in Georgia for Phase 2B/3 MIRACLE trial  Recent EU approval from the European Medicines Agency (EMA) boosts trial profile Enrollment in Part A of MIRACLE reaches seven subjects treated and one additional subject in screening 16 additional clinical sites in Europe and the US expected to begin recruitment by the end of August; building to...Read more


Arrowhead Pharmaceuticals Initiates Phase 3 YOSEMITE Study of Investigational Zodasiran for the Treatment of Homozygous Familial Hypercholesterolemia

July 8
Last Trade: 18.88 1.34 7.64

Zodasiran targets ANGPLT3, an emerging therapeutic target to treat HoFH and other dyslipidemias YOSEMITE Phase 3 study further enhances Arrowhead’s late-stage pipeline of RNAi-based cardiometabolic candidates PASADENA, Calif. / Jul 08, 2025 / Business Wire / Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced that it has dosed the first subject in the YOSEMITE Phase 3 clinical trial of zodasiran, the company’s...Read more


UroGen Pharma Announces Completion of Enrollment in the Phase 3 UTOPIA Clinical Trial of UGN-103 for the Treatment of Recurrent Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer

July 7
Last Trade: 13.81 0.10 0.73

PRINCETON, N.J., July 07, 2025 (GLOBE NEWSWIRE) -- UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced that it has completed patient enrollment in its Phase 3 UTOPIA clinical trial of UGN-103 (mitomycin) for intravesical solution, a next-generation formulation in development for the treatment of recurrent...Read more


Novartis provides update on Phase III GCAptAIN study of Cosentyx® in giant cell arteritis (GCA)

July 3
Last Trade: 122.94 1.26 1.04

The GCAptAIN study did not meet its primary endpoint of sustained remission at Week 52 in adults with newly diagnosed or relapsing GCA1 Safety in GCA patients was consistent with known safety profile of Cosentyx® (secukinumab)1 EAST HANOVER, N.J., July 3, 2025 /PRNewswire/ -- Novartis today announced top-line results from the Phase III GCAptAIN study evaluating Cosentyx® (secukinumab) in adults with newly diagnosed or relapsing...Read more


4D Molecular Therapeutics Announces Accelerated 4D-150 Phase 3 Development in Wet AMD and Streamlined Organization to Drive Late-Stage Execution

July 2
Last Trade: 4.42 0.20 4.74

4FRONT-1 Phase 3 expected data readout accelerated from H2 2027 to H1 2027 4FRONT-2 Phase 3 trial initiated ahead of schedule Streamlined late-stage clinical and pre-commercial organization aligns with focused pipeline shift, as announced in January 2025 EMERYVILLE, Calif., July 02, 2025 (GLOBE NEWSWIRE) -- 4D Molecular Therapeutics (Nasdaq: FDMT, 4DMT or the Company), a leading late-stage biotechnology company advancing...Read more


BriaCell Therapeutics Highlights Additional Phase 3 Clinical Sites Including Los Angeles Cancer Network and Smilow Cancer Hospital at Yale New Haven

July 2
Last Trade: 2.12 -0.79 -27.15

Together, Los Angeles Cancer Network and Smilow Cancer Hospital at Yale New Haven add 30 satellite locations to enroll patients in BriaCell’s pivotal Phase 3 study BriaCell’s Phase 3 study currently has 58 active clinical sites across 15 states, including Smilow Cancer Hospital, Los Angeles Cancer Network, University of Arizona, DHR Health Oncology Institute, Sylvester Comprehensive Cancer Center, Cancer Care Northwest, Hematology...Read more


Belite Bio Announces Completion of Enrollment in the Pivotal Global Phase 3 PHOENIX Trial Evaluating Oral Tinlarebant in Geographic Atrophy

July 2
Last Trade: 64.18 4.06 6.75

500 subjects enrolled across the United States, the United Kingdom, France, Czech Republic, Switzerland, China, Taiwan, and Australia SAN DIEGO, July 02, 2025 (GLOBE NEWSWIRE) -- Belite Bio, Inc. (NASDAQ: BLTE), a clinical-stage drug development company focused on advancing novel therapeutics targeting degenerative retinal diseases that have significant unmet medical needs, today announced the completion of enrollment in the...Read more


BioXcel Therapeutics Receives Second Positive Recommendation from Data Safety Monitoring Board (DSMB) to Continue SERENITY At-Home Pivotal Phase 3 Safety Trial for Acute Treatment of Agitation Associated with Bipolar Disorders or Schizophrenia

July 1
Last Trade: 2.00 -0.02 -0.75

DSMB recommended the continuation of trial as planned Topline data expected in Q3 2025 NEW HAVEN, Conn., July 01, 2025 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience, today announced the second positive recommendation by an independent Data Safety Monitoring Board (DSMB) to continue, without...Read more


Zai Lab Announces Positive Topline Phase 3 Results for Bemarituzumab in Fibroblast Growth Factor Receptor 2b (FGFR2b) Positive First-Line Gastric Cancer

June 30
Last Trade: 35.66 0.74 2.12

At an Interim Analysis, Bemarituzumab Plus Chemotherapy Significantly Improved Overall Survival in People With FGFR2b Overexpression Compared to Chemotherapy Alone SHANGHAI & CAMBRIDGE, Mass. / Jun 30, 2025 / Business Wire / Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced the Phase 3 FORTITUDE-101 clinical trial evaluating first-line bemarituzumab plus chemotherapy (mFOLFOX6) met its primary endpoint of overall survival...Read more


Amgen Announces Positive Topline Phase 3 Results For Bemarituzumab In Fibroblast Growth Factor Receptor 2b (FGFR2b) Positive First-Line Gastric Cancer

June 30
Last Trade: 296.52 -0.48 -0.16

At an Interim Analysis, Bemarituzumab Plus Chemotherapy Significantly Improved Overall Survival in People With FGFR2b Overexpression Compared to Chemotherapy Alone THOUSAND OAKS, Calif., June 30, 2025 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced the Phase 3 FORTITUDE-101 clinical trial evaluating first-line bemarituzumab plus chemotherapy (mFOLFOX6) met its primary endpoint of overall survival (OS) at a pre-specified interim...Read more


Biogen Initiates Phase 3 Study of Felzartamab for the Treatment of Primary Membranous Nephropathy

June 30
Last Trade: 133.02 -1.44 -1.07

Global Phase 3 PROMINENT study will evaluate the efficacy and safety of felzartamab, as compared to tacrolimus, in adults with primary membranous nephropathy (PMN) There are currently no therapies specifically approved for PMN, a rare immune-mediated disease affecting the kidneys with an estimated prevalence of ~36k patients in the U.S.1 Felzartamab, an investigational anti-CD38 monoclonal antibody, is a potentially differentiated...Read more


Moderna Announces Positive Phase 3 Results for Seasonal Influenza Vaccine

June 30
Last Trade: 32.69 0.15 0.46

mRNA-1010 demonstrated superior relative vaccine efficacy that was 26.6% (95% CI; 16.7%, 35.4%) higher than a licensed standard-dose seasonal influenza vaccine in adults aged 50 years and older CAMBRIDGE, MA / ACCESS Newswire / June 30, 2025 / Moderna, Inc. (NASDAQ:MRNA) today announced positive results from a Phase 3 efficacy study (P304) evaluating the relative vaccine efficacy (rVE) against influenza illness of mRNA-1010, the...Read more


Pfizer Announces Positive Topline Phase 3 Results for HYMPAVZI™ in Hemophilia A or B with Inhibitors

June 26
Last Trade: 25.51 -0.11 -0.43

Study demonstrates superiority, showing both statistically significant and clinically meaningful reduction in annualized bleeding rate with a generally well-tolerated safety profile compared to on-demand treatment in patients 12 years and older HYMPAVZI was administered with a straightforward, once-weekly subcutaneous injection that required minimal preparation NEW YORK / Jun 26, 2025 / Business Wire / Pfizer Inc. (NYSE: PFE) today...Read more


Lipocine Announces First Patient Dosed in Phase 3 Clinical Trial for LPCN 1154 in Postpartum Depression

June 26
Last Trade: 3.20 0.06 1.91

Phase 3 Top Line Results Expected Q2 2026 SALT LAKE CITY, June 26, 2025 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to develop innovative products with effective oral delivery, today announced that the first patient has been dosed in its pivotal Phase 3 clinical trial of LPCN 1154 (oral brexanolone), its investigational oral treatment for postpartum...Read more


Viatris Announces Positive Top-Line Results from Second Pivotal Phase 3 VEGA-3 Trial of MR-141 in Presbyopia

June 26
Last Trade: 9.23 -0.03 -0.32

MR-141 Met Primary And All Secondary Endpoints, Demonstrating Rapid And Sustained Improvement In Near Visual Acuity Without Compromising Distance Vision Safety Profile Consistent With Previous Clinical Trials And No Treatment-Related Serious Adverse Events Reported In This Study Targeting Application To U.S. FDA In Second Half of 2025 PITTSBURGH, June 26, 2025 /PRNewswire/ -- Viatris Inc. (Nasdaq: VTRS), a global...Read more


Biodexa Pharmaceuticals Announces Activation of First Clinical Study Site for Phase 3 Serenta Trial in Familial Adenomatous Polyposis (FAP)

June 25
Last Trade: 0.88 0.006 0.69

June 25, 2025 - Biodexa Pharmaceuticals PLC (“Biodexa” or “the Company”), (Nasdaq: BDRX), a clinical stage biopharmaceutical company developing a pipeline of innovative products for the treatment of diseases with unmet medical needs, is pleased to announce the activation of the first clinical study site for its Serenta trial in patients with familial adenomatous polyposis (FAP). The trial, which is now enrolling, represents a significant...Read more


Amneal Pharmaceuticals Highlights Positive Topline Results from Confirmatory Clinical Study of Biosimilar Candidate to XOLAIR(R) (omalizumab), Developed by Kashiv BioSciences

June 25
Last Trade: 8.33 0.08 0.97

Amneal holds exclusive U.S. commercialization rights; BLA filing expected in Q4 2025 Poised to be among the first wave of biosimilars in the $3.9 billion U.S. omalizumab market and an important growth driver for Amneal BRIDGEWATER, N.J., June 25, 2025 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”) today highlighted positive topline results from a confirmatory clinical efficacy and safety...Read more


Viking Therapeutics Announces Initiation of Phase 3 Obesity Clinical Program with GLP-1/GIP Agonist VK2735

June 25
Last Trade: 30.32 0.13 0.43

VANQUISH-1 and VANQUISH-2 Studies to Evaluate Subcutaneous VK2735 in Obese Adults with and without Type 2 Diabetes SAN DIEGO, June 25, 2025 /PRNewswire/ -- Viking Therapeutics, Inc. (Viking) (NASDAQ: VKTX), a clinical-stage biopharmaceutical company focused on the development of novel therapies for metabolic and endocrine disorders, today announced the initiation of the VANQUISH Phase 3 clinical program for VK2735, the company's dual...Read more


Atea Pharmaceuticals Announces Continued Advancement of Global Phase 3 HCV Program with Dosing of First Patient in C-FORWARD Outside North America

June 24
Last Trade: 3.76 0.10 2.73

C-FORWARD is the Second Phase 3 Trial in the Global HCV Development Program; the First Phase 3 Trial, C-BEYOND, is Currently Enrolling Patients in the US and Canada Regimen has Potential Best-in-Class Profile with Short Treatment Duration, Low Risk for Drug-Drug Interactions and Convenience with No Food Effect HCV Infection Remains a Significant Global Health Burden, with Approximately 50 Million People...Read more


Krystal Biotech Announces First Patient Dosed in Phase 3 Clinical Trial of KB803 for the Treatment and Prevention of Corneal Abrasions in Patients with Dystrophic Epidermolysis Bullosa

June 24
Last Trade: 148.90 5.56 3.88

Intra-patient, double-blind, multicenter, placebo-controlled study with crossover design Repeat administration under compassionate use was previously shown to be well tolerated and associated with full corneal healing by 3 months as well as significant visual acuity improvement from hand motion to 20/25 at 8 months PITTSBURGH, June 24, 2025 (GLOBE NEWSWIRE) --  Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS) announced...Read more


Arrowhead Pharmaceuticals Completes Enrollment in SHASTA-3, SHASTA-4, and MUIR-3 Phase 3 Studies of Plozasiran

June 23
Last Trade: 18.88 1.34 7.64

Study completion anticipated in mid-2026 with subsequent data readout and regulatory submissions for treatment of severe hypertriglyceridemia PASADENA, Calif. / Jun 23, 2025 / Business Wire / Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced that it has completed enrollment in SHASTA-3, SHASTA-4, and MUIR-3, the company’s global Phase 3 clinical studies designed to support regulatory submissions for marketing approval of...Read more


United Therapeutics Concludes Enrollment of the ADVANCE OUTCOMES Study of Ralinepag for the Treatment of Pulmonary Arterial Hypertension

June 23
Last Trade: 300.56 6.05 2.05

Ralinepag has the potential to be the first once-a-day oral prostacyclin agonist for patients with pulmonary arterial hypertension ADVANCE OUTCOMES will continue to accrue clinical worsening events through the end of 2025 and top-line data is expected in the first half of 2026 SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C. / Jun 23, 2025 / Business Wire / United Therapeutics Corporation (Nasdaq: UTHR), a public benefit...Read more


Merck Announces Phase 3 HYPERION Study of WINREVAIR™ (sotatercept-csrk) Met Primary Endpoint in Recently Diagnosed Adults with Pulmonary Arterial Hypertension (PAH)

June 23
Last Trade: 83.72 2.35 2.89

WINREVAIR significantly reduced the risk of clinical worsening events in recently diagnosed PAH patients over 70 percent of whom were on double background therapy HYPERION, third Phase 3 study to demonstrate significant efficacy in adults with PAH, was previously stopped early based on review of available data from clinical program RAHWAY, N.J. / Jun 23, 2025 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United...Read more


Compass Pathways Successfully Achieves Primary Endpoint in First Phase 3 Trial Evaluating COMP360 Psilocybin for Treatment-Resistant Depression

June 23
Last Trade: 3.53 0.07 2.02

A single administration of COMP360 demonstrated a highly statistically significant and clinically meaningful reduction in symptom severity as measured by MADRS1 with a mean difference of -3.6 comparing 25 mg to placebo (p<0.001)2 Independent Data Safety Monitoring Board (DSMB) reviewed safety data for COMP360 and found no unexpected safety findings and no clinically meaningful imbalance in suicidal ideation between treatment and...Read more


Exelixis Announces Zanzalintinib in Combination with an Immune Checkpoint Inhibitor Improved Overall Survival in STELLAR-303 Phase 3 Pivotal Trial in Patients with Metastatic Colorectal Cancer

June 22
Last Trade: 44.07 0.56 1.29

Zanzalintinib in combination with atezolizumab demonstrated a statistically significant reduction in risk of death versus regorafenib in intent-to-treat population ALAMEDA, Calif. / Jun 22, 2025 / Business Wire / Exelixis, Inc. (Nasdaq: EXEL) today announced positive topline results from the STELLAR-303 phase 3 pivotal trial in which zanzalintinib in combination with atezolizumab (Tecentriq®) demonstrated a statistically significant...Read more


Novo Nordisk: Mim8 prophylaxis treatment shown to be well-tolerated when switching from emicizumab in people with haemophilia A in new phase 3 data presented at the ISTH 2025 Congress

June 22
Last Trade: 69.67 0.03 0.04

New FRONTIER5 data show that a direct switch to investigational Mim8 (denecimig) prophylaxis treatment from emicizumab, without the need for a washout period, was well-tolerated with no safety concerns in adults and adolescents with haemophilia A, with or without inhibitors1. Switching to Mim8 led to a sustained increase in thrombin generation into the normal range, but without causing thrombin levels that might pose a thrombotic...Read more


Eli Lilly's once-weekly insulin efsitora alfa demonstrated A1C reduction and a safety profile consistent with daily insulin in multiple Phase 3 trials

June 22
Last Trade: 786.92 9.26 1.19

Results from the fixed-dose QWINT-1 study, along with the QWINT-3 and QWINT-4 studies, reinforce efsitora's potential to simplify insulin management with weekly dosing Lilly plans to submit efsitora for the treatment of adults with type 2 diabetes to global regulatory agencies by the end of this year INDIANAPOLIS, June 22, 2025 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced detailed results from QWINT-1,...Read more


Eli Lilly's oral GLP-1, orforglipron, showed compelling efficacy and a safety profile consistent with injectable GLP-1 medicines, in complete Phase 3 results published in The New England Journal of Medicine

June 21
Last Trade: 786.92 9.26 1.19

The investigational once-daily pill lowered A1C by an average of 1.3% to 1.6% across doses, with improvements seen as early as four weeks, in adults with type 2 diabetes  In ACHIEVE-1, orforglipron also led to an average weight loss of 16.0 lbs (7.9%) at the highest dose by week 40 in a key secondary endpoint The safety profile of orforglipron was consistent with the established GLP-1 class INDIANAPOLIS, June 21, 2025...Read more


Novo Nordisk: Higher dose of Wegovy® provided average weight loss of 21% in people with obesity – with a third achieving 25% or more – according to data presented at ADA

June 20
Last Trade: 69.67 0.03 0.04

Higher dose of Wegovy® provided average weight loss of 21% in people with obesity – with a third achieving 25% or more – according to data presented at ADA Results from the phase 3b STEP UP trial showed that a higher dose of Wegovy® (semaglutide 7.2 mg) delivered 21% weight loss in people with obesity, with a third of participants losing 25% or more of their weight, compared to placebo1 Safety and tolerability of the higher...Read more


Genentech’s Lunsumio and Polivy Combination Significantly Prolongs Remission for People With Relapsed or Refractory Large B-cell Lymphoma

June 20
Last Trade: 40.87 0.76 1.89

Pivotal Phase III SUNMO study demonstrated an 11.5 month median progression-free survival – three times longer than R-GemOx This well-tolerated investigational combination therapy avoids traditional chemotherapy and may be suitable for outpatient community care Results will be submitted to global health authorities including the U.S. Food and Drug Administration SOUTH SAN FRANCISCO, Calif. / Jun 20, 2025 / Business Wire / Genentech,...Read more


Biogen Initiates Phase 3 Pediatric Study of Omaveloxolone for the Treatment of Friedreich Ataxia

June 18
Last Trade: 133.02 -1.44 -1.07

Global Phase 3 BRAVE study will evaluate the efficacy and safety of omaveloxolone in children 2 to <16 years old with Friedreich ataxia, a rare neurodegenerative disorder BRAVE study will explore the potential of omaveloxolone to address the critical unmet need of the pediatric FA population Omaveloxolone is currently marketed under the brand name SKYCLARYS® for the treatment of adults and adolescents aged 16 years and older...Read more


AbbVie Announces New Data Demonstrating Atogepant (QULIPTA® / AQUIPTA®) Achieves Superiority Across All Endpoints in Phase 3 Head-to-Head Study Compared to Topiramate for Migraine Prevention

June 18
Last Trade: 190.62 0.85 0.45

TEMPLE, a Phase 3 multicenter, randomized, double-blind, head-to-head study, evaluated the tolerability, safety and efficacy of atogepant compared to topiramate for the preventive treatment of migraine in adult patients with a history of four or more migraine days per month1 Atogepant met the primary endpoint of fewer treatment discontinuations attributed to adverse events versus topiramate, and all six secondary endpoints achieved...Read more


Merck: IDeate-Prostate01 Phase 3 Trial of Ifinatamab Deruxtecan Initiated in Patients with Pretreated Metastatic Castration-Resistant Prostate Cancer

June 18
Last Trade: 83.72 2.35 2.89

BASKING RIDGE, N.J. & RAHWAY, N.J. / Jun 18, 2025 / Business Wire / The first patient has been dosed in the IDeate-Prostate01 phase 3 trial evaluating the efficacy and safety of investigational ifinatamab deruxtecan (I-DXd) versus docetaxel in patients with metastatic castration-resistant prostate cancer (mCRPC) with disease progression during or after treatment with an androgen receptor pathway inhibitor. Ifinatamab deruxtecan is a...Read more


AbbVie Provides Update on VERONA Trial for Newly Diagnosed Higher-Risk Myelodysplastic Syndromes

June 16
Last Trade: 190.62 0.85 0.45

NORTH CHICAGO, Ill., June 16, 2025 /PRNewswire/ -- AbbVie (NYSE: ABBV) announced the global Phase 3 VERONA trial evaluating venetoclax in combination with azacitidine in the treatment of newly diagnosed higher-risk myelodysplastic syndrome (HR-MDS) did not meet the primary endpoint of overall survival (OS) with a hazard ratio (HR) of 0.908; stratified log-rank, p=0.3772. No new safety signals were observed.1 Results from the VERONA trial...Read more


Brainstorm Cell Therapeutics Announces New Survival Data from Expanded Access Program Cohort: Remarkably 90% of ALS Patients Survived Over 5 Years with NurOwn®

June 16
Last Trade: 1.24 -0.07 -5.34

NEW YORK, June 16, 2025 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapies for neurodegenerative diseases, today announced new survival data from 10 participants in its Expanded Access Program (EAP) for NurOwn® (autologous MSC-NTF cells) in amyotrophic lateral sclerosis (ALS). The EAP enrolled 10 participants who had previously completed the Phase 3 clinical trial. The...Read more


Gossamer Bio Announces Completion of Enrollment in Registrational Phase 3 PROSERA Study for the Treatment of PAH

June 16
Last Trade: 1.36 0.09 7.09

Enrollment Completed in Ongoing Registrational PROSERA Phase 3 Study in PAH  Topline Results Announcement from PROSERA Phase 3 Expected in February 2026  Blinded Preliminary Baseline Characteristics Align with Intended Study Population  SAN DIEGO / Jun 16, 2025 / Business Wire / Gossamer Bio, Inc. (Nasdaq: GOSS), a late-stage, clinical biopharmaceutical company focused on the development and commercialization of...Read more


Novo Nordisk to advance subcutaneous and oral amycretin for weight management into phase 3 clinical development

June 12
Last Trade: 69.67 0.03 0.04

Bagsværd, Denmark, 12 June 2025 – Novo Nordisk today announced that it will advance subcutaneous and oral amycretin into phase 3 development in weight management based on completed clinical studies. The decision to advance subcutaneous and oral amycretin into phase 3 is based on feedback received from regulatory authorities following end-of-phase 2 interactions for subcutaneous and oral amycretin in weight management. “We are very...Read more


Merck Initiates Phase 3 Study Evaluating Dengue Vaccine Candidate

June 12
Last Trade: 83.72 2.35 2.89

MOBILIZE-1 is the first Phase 3 study being initiated for V181 as part of a planned robust clinical development program Study will evaluate a single dose of V181 for the prevention of dengue disease caused by any of the four serotypes of the dengue virus regardless of previous exposure RAHWAY, N.J. / Jun 12, 2025 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the initiation...Read more


Johnson & Johnson: New data show TREMFYA® (guselkumab) is the only IL-23 inhibitor proven to significantly inhibit progression of joint structural damage in active psoriatic arthritis

June 11
Last Trade: 156.28 0.49 0.31

TREMFYA ® demonstrated two and a half times greater ability to inhibit joint structural damage versus placebo in the Phase 3b APEX study More than 40% of TREMFYA®-treated patients across both dose groups achieved ACR50 at Week 24 Improvement in both joint and skin symptoms reinforce TREMFYA® as a first-line treatment option with a proven safety profile for adults with active psoriatic arthritis BARCELONA, June 11,...Read more


Ionis Pharmaceuticals: First patient dosed in pivotal Phase 3 REVEAL clinical study of ION582 in Angelman syndrome

June 11
Last Trade: 42.83 1.49 3.60

Completion of enrollment anticipated in 2026  CARLSBAD, Calif. / Jun 11, 2025 / Business Wire / Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) today announced that the first participant has been dosed in the global Phase 3 REVEAL study, which is designed to evaluate the efficacy and safety of ION582, an investigational medicine for the treatment of people living with Angelman syndrome (AS), a serious and rare neurodevelopmental...Read more


Novavax's COVID-19-Influenza Combination and Stand-alone Influenza Vaccine Candidates Showed Robust Immune Responses and Were Well Tolerated in Initial Cohort of a Phase 3 Trial

June 11
Last Trade: 7.03 -0.01 -0.14

Both vaccine candidates induced robust immune responses across all antigens tested No new safety signals were observed and both vaccine candidates were well tolerated consistent with past trials Novavax continues to pursue partnering opportunities to advance further development of these programs GAITHERSBURG, Md., June 11, 2025 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX) today announced results of the initial cohort of its...Read more


PolyPid Announces Positive Topline Results from Phase 3 SHIELD II Trial: D-PLEX₁₀₀ Demonstrated Significant Reduction in Surgical Site Infections and Successfully Met Primary and All Key Secondary Endpoints

June 9
Last Trade: 3.50 0.07 2.04

D-PLEX100 successfully met the primary efficacy endpoint, with statistically significant results (p<0.005) in 798 patients with large abdominal surgery incisions. The trial successfully met all key secondary efficacy endpoints, including a 58% reduction in the rate of surgical site infections (“SSI”) in patients treated with D-PLEX100 arm versus standard of care (“SoC”) arm (p<0.005). The Company expects to submit a New Drug...Read more


NewAmsterdam Pharma Announces Positive Topline Alzheimer’s Disease Data from BROADWAY Clinical Trial

June 9
Last Trade: 21.64 1.61 8.04

Pre-specified analyses show that obicetrapib treatment leads to statistically significant and clinically meaningful reductions in the primary outcome measure of Alzheimer’s disease biomarker in both the full ITT population (p<0.002) and in ApoE4 carriers (p=0.0215), supporting the emerging link between CETP-inhibition and prevention of AD pathology  NewAmsterdam to present results during the AAIC conference in...Read more


Merck Announces Positive Topline Results From the First Two Phase 3 CORALreef Trials Evaluating Enlicitide Decanoate for the Treatment of Adults With Hyperlipidemia

June 9
Last Trade: 83.72 2.35 2.89

Enlicitide demonstrated statistically significant and clinically meaningful reductions in LDL-C in both Phase 3 CORALreef HeFH and CORALreef AddOn trials Enlicitide, a novel macrocyclic peptide, has the potential to be the first approved oral PCSK9 inhibitor RAHWAY, N.J. / Jun 09, 2025 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced positive topline results from the first two...Read more


Apellis Pharmaceuticals and Sobi Announce EMPAVELI® (pegcetacoplan) Showed Sustained Efficacy at One Year in Phase 3 Study for C3G and Primary IC-MPGN

June 6
Last Trade: 19.21 1.32 7.38

Robust proteinuria reduction and stable kidney function were maintained across a broad population of patients No new safety signals were observed New data presented at late-breaking session at the European Renal Association Congress Marketing applications for EMPAVELI are under review with the FDA and EMA WALTHAM, Mass. and STOCKHOLM, June 06, 2025 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) and Sobi®...Read more


Immunic Announces Completion of Enrollment for Both Phase 3 ENSURE Trials in Relapsing MS and Presents Additional Data Underlining Positive Outcome of Phase 2 CALLIPER Trial in Progressive MS

June 5
Last Trade: 0.81 -0.02 -2.80

Enrollment Completed for Both Phase 3 ENSURE Trials of Vidofludimus Calcium in Relapsing Multiple Sclerosis; Top-Line Data Expected End of 2026  Additional Data from Phase 2 CALLIPER Trial in Progressive Multiple Sclerosis Further Supports the Recently Released Positive Top-Line Results and Further Underlines Vidofludimus Calcium's Neuroprotective Potential  New CALLIPER Data Regarding Time to 24-Week Confirmed Disability...Read more


Sagimet Biosciences Announces Positive Phase 3 Results for Denifanstat for the Treatment of Moderate-to-Severe Acne from Partner Ascletis

June 4
Last Trade: 9.50 0.35 3.83

Denifanstat met all primary and secondary endpoints versus placebo Denifanstat was well tolerated Oral FASN inhibitors offer a novel mechanism of action for the potential treatment of moderate to severe acne Sagimet initiated first-in-human Phase 1 clinical trial of a second FASN inhibitor, TVB-3567, that is planned to be developed for acne in the U.S. SAN MATEO, Calif., June 04, 2025 (GLOBE NEWSWIRE) -- Sagimet Biosciences Inc....Read more


Quince Therapeutics Exceeds 75% Enrollment in Pivotal Phase 3 NEAT Clinical Trial in Ataxia-Telangiectasia

June 3
Last Trade: 1.71 0.10 6.21

SOUTH SAN FRANCISCO, Calif. / Jun 03, 2025 / Business Wire / Quince Therapeutics, Inc. (Nasdaq: QNCX), a late-stage biotechnology company dedicated to unlocking the power of a patient’s own biology for the treatment of rare diseases, today announced that its pivotal Phase 3 NEAT (Neurological Effects of eDSP on Subjects with A-T; NCT06193200/IEDAT-04-2022) clinical trial in the rare neurodegenerative disease Ataxia-Telangiectasia (A-T) has...Read more


Johnson & Johnson leads with first PARP inhibitor combo to improve efficacy in patients with HRR-altered mCSPC

June 3
Last Trade: 156.28 0.49 0.31

Results from the Phase 3 AMPLITUDE study show the potential of AKEEGA® (niraparib and abiraterone acetate dual-action tablet) to delay cancer progression and worsening of symptoms Data show a nearly 50 percent reduction in disease progression in BRCA-altered mCSPC vs. current standard of care CHICAGO, June 3, 2025 /PRNewswire/ -- Johnson & Johnson announced today first results from the Phase 3, randomized, double-blind,...Read more


Johnson & Johnson: DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj)-based regimen shows 95 percent progression-free survival at four years in transplant-eligible, newly diagnosed patients with multiple myeloma who achieved sustained MRD negativity...

June 3
Last Trade: 156.28 0.49 0.31

More than half of patients maintained minimal residual disease (MRD) negativity (10-5) with DARZALEX FASPRO® for 24 months or longer in the Phase 3 PERSEUS study Data from Phase 3 CEPHEUS study show 60 percent overall MRD negativity (10−5) and improved PFS with DARZALEX FASPRO® in transplant-ineligible newly diagnosed patients CHICAGO, June 3, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced data from two...Read more


Jazz Pharmaceuticals Announces Zepzelca® (lurbinectedin) and Atezolizumab (Tecentriq®) Combination Significantly Improves Survival as First-Line Maintenance Therapy for Extensive-Stage Small Cell Lung Cancer

June 2
Last Trade: 111.60 2.47 2.26

First-line maintenance combination therapy reduced the risk of disease progression or death by 46%, with a median overall survival of 13.2 months vs 10.6 months for atezolizumab alone from the point of randomization First Phase 3 study to demonstrate statistically significant and clinically meaningful improvements in both progression-free and overall survival in ES-SCLC first-line maintenance Results presented at the ASCO 2025...Read more


Corcept Therapeutics Presents Pivotal Clinical Data in ASCO Late-Breaker with Simultaneous Publication in The Lancet: Relacorilant Improves Progression-Free and Overall Survival in Patients with Platinum-Resistant Ovarian Cancer

June 2
Last Trade: 70.89 2.72 3.99

Relacorilant plus nab-paclitaxel improves progression-free and overall survival in patients with platinum-resistant ovarian cancer, with no need for biomarker selection Addition of relacorilant did not increase side-effects, compared to nab-paclitaxel monotherapy Results presented in late-breaking podium presentation at ASCO 2025 with simultaneous publication in The Lancet REDWOOD CITY, Calif. / Jun 02, 2025 / Business Wire / Corcept...Read more


Viatris Announces Positive Top-Line Results from Phase 3 LYNX-2 Trial of MR-142 in Keratorefractive Patients With Visual Disturbances Under Mesopic, Low-Contrast Conditions

June 2
Last Trade: 9.23 -0.03 -0.32

MR-142 Achieved Primary Endpoint of ≥15-letter (≥3-line) Gain in Mesopic Low Contrast Distance Visual Acuity in Comparison to Placebo Results Showed Patient-Reported Functional Benefit in Treating Significant Chronic Night Driving Impairment in Keratorefractive Patients With Reduced Mesopic Vision, a Condition With No Current FDA-Approved Therapies No Evidence of Tachyphylaxis Was Observed In This Study Over The 6-Week Period Study...Read more


AstraZeneca: ENHERTU® (fam-trastuzumab deruxtecan-nxki) plus pertuzumab reduced the risk of disease progression or death by 44% vs. THP as 1st-line therapy in patients with HER2-positive metastatic breast cancer in DESTINY-Breast09 Phase III trial

June 2
Last Trade: 70.73 0.71 1.01

AstraZeneca and Daiichi Sankyo’s ENHERTU plus pertuzumab showed a median progression-free survival greater than three years First trial in more than a decade to demonstrate an improvement in outcomes in the 1st-line setting for a broad population of patients with HER2-positive metastatic breast cancer WILMINGTON, Del. / Jun 02, 2025 / Business Wire / Positive results from the DESTINY-Breast09 Phase III trial showed ENHERTU®...Read more


Guardant Health: SERENA-6 Phase III Trial Demonstrates Clinical Value of Guardant360 CDx Test to Detect Emergence of Endocrine Resistance and Inform a Switch in Therapy Before Radiological Disease Progression in Advanced Breast Cancer

June 2
Last Trade: 51.04 0.22 0.43

First pivotal trial to use a circulating tumor DNA (ctDNA)-guided approach to detect and treat emerging resistance in 1st-line therapy ahead of disease progression in breast cancer Trial showed AstraZeneca’s camizestrant reduced risk of disease progression or death by 56% in patients with advanced HR-positive breast cancer with an emergent ESR1 tumor mutation as detected by Guardant360 CDx PALO ALTO, Calif. / Jun 02, 2025 / Business...Read more


Lyra Therapeutics Reports Positive Results from the ENLIGHTEN 2 Phase 3 Trial of LYR-210 Achieving Statistically Significant Results for Primary and Key Secondary Endpoints in the Treatment of Chronic Rhinosinusitis (CRS)

June 2
Last Trade: 9.30 0.05 0.54

ENLIGHTEN 2 trial met primary endpoint with LYR-210 demonstrating statistically significant improvement in the composite of the three cardinal symptoms (3CS) of CRS at 24 weeks (p=0.0078) ENLIGHTEN 2 trial also showed statistically significant improvement in key secondary endpoints in the full population of 3CS at 24 weeks (p=0.0209) and SNOT-22 score at 24 weeks (p=0.0101) Additionally, in pooled data from ENLIGHTEN 2 and ENLIGHTEN 1...Read more


Reviva Pharmaceuticals Announces Positive Full Dataset for 1-Year Phase 3 RECOVER Open Label Extension Study Evaluating Brilaroxazine in Schizophrenia

June 2
Last Trade: 0.39 0.01 3.56

Robust broad-spectrum efficacy sustained over 1-year across all symptom domains including negative symptoms  Generally well-tolerated with low rates of adverse events and discontinuation  Brilaroxazine improved multiple neuroinflammatory markers reported to enhance efficacy and mitigate side effects  Virtual investor webcast today at 8:00 a.m. EDT  CUPERTINO, Calif., June 02, 2025 (GLOBE NEWSWIRE) --...Read more


Vera Therapeutics Announces Atacicept Achieved 46% Proteinuria Reduction in ORIGIN Phase 3 Trial in Adults with IgA Nephropathy

June 2
Last Trade: 24.21 1.21 5.26

Atacicept ORIGIN Phase 3 trial met the primary endpoint of reduction in proteinuria (UPCR) at week 36; participants receiving atacicept achieved a 46% reduction from baseline and 42% reduction compared to placebo at week 36 (p<0.0001) Other prespecified endpoints achieved similar or better results compared to the ORIGIN Phase 2b clinical trial — per FDA guidance, Vera is not sharing eGFR results at this time while the ORIGIN 3...Read more


AstraZeneca: IMFINZI® (durvalumab) regimen reduced risk of progression, recurrence or death by 29% in early-stage gastric cancer vs. chemotherapy alone in MATTERHORN Phase III trial

June 1
Last Trade: 70.73 0.71 1.01

Two-thirds (67.4%) of patients treated with IMFINZI-based perioperative regimen remained event-free at two years First and only immunotherapy to demonstrate statistically significant event-free survival in a global Phase III trial in this setting WILMINGTON, Del. / Jun 01, 2025 / Business Wire / Positive results from the MATTERHORN Phase III trial showed perioperative treatment with AstraZeneca’s IMFINZI® (durvalumab) in combination...Read more


Protagonist and Takeda Announce ASCO Plenary Presentation Highlighting Full 32-Week Results from Phase 3 VERIFY Study of Rusfertide, Showing Reductions in Phlebotomy

June 1
Last Trade: 15.13 0.11 0.73

Rusfertide plus current standard of care more than doubled clinical response rates across high- and low-risk PV groups, significantly reducing phlebotomy eligibility compared to placebo plus current standard of care, which was the primary endpoint All key secondary endpoints met with statistical significance, including a nearly three-fold reduction in the proportion of patients requiring phlebotomy and a four-fold improvement in...Read more


AstraZeneca: Camizestrant reduced the risk of disease progression or death by 56% in patients with advanced HR-positive breast cancer with an emergent ESR1 tumor mutation in SERENA-6 Phase III trial

June 1
Last Trade: 70.73 0.71 1.01

First pivotal trial to demonstrate clinical value of monitoring circulating tumor DNA to detect and treat emerging resistance in 1st-line therapy ahead of disease progression in breast cancer First and only next-generation oral SERD and complete ER antagonist to demonstrate consistent progression-free survival benefit in combination with widely approved CDK4/6 inhibitors in 1st-line advanced breast cancer WILMINGTON, Del. / Jun 01,...Read more


Zai Lab and Novocure Announce Results From the Phase 3 PANOVA-3 Trial of Tumor Treating Fields (TTFields) Therapy for Pancreatic Cancer to be Presented at 2025 ASCO Annual Meeting

May 31
Last Trade: 35.66 0.74 2.12

TTFields therapy concomitant with gemcitabine and nab-paclitaxel is the first treatment to show a clinically meaningful and statistically significant improvement in overall survival (OS) for patients with unresectable, locally advanced pancreatic adenocarcinoma in a Phase 3 trial The OS benefit observed with TTFields therapy is supported by significantly improved quality of life and extended pain-free survival, a key outcome for patients...Read more


Arvinas and Pfizer's Vepdegestrant Significantly Improves Progression-Free Survival for Patients with ESR1-Mutant, ER+/HER2- Advanced Breast Cancer

May 31
Last Trade: 8.23 0.21 2.62

Pivotal Phase 3 VERITAC-2 clinical trial results presented at ASCO demonstrate 2.9-month improvement in median progression-free survival when compared to fulvestrant in second line-plus patients with an estrogen receptor 1 mutation Vepdegestrant was generally well tolerated, with few discontinuations and low rates of gastrointestinal-related adverse events Vepdegestrant is the first and only PROteolysis TArgeting Chimera (PROTAC)...Read more


Merck: KEYTRUDA® (pembrolizumab) Plus Trodelvy® (sacituzumab govitecan-hziy) Reduced Risk of Disease Progression or Death by 35% Versus KEYTRUDA Plus Chemotherapy in First-Line PD-L1+ Metastatic Triple-Negative Breast Cancer (TNBC)

May 31
Last Trade: 83.72 2.35 2.89

First pivotal Phase 3 trial to show superiority of KEYTRUDA plus a TROP2 antibody-drug conjugate, Trodelvy, versus standard of care in first-line metastatic TNBC RAHWAY, N.J. / May 31, 2025 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that KEYTRUDA® (pembrolizumab) plus Trodelvy® (sacituzumab govitecan-hziy) reduced the risk of disease progression or death by 35% (HR=0.65,...Read more


Gilead Sciences: Trodelvy® Plus Keytruda® Reduces Risk of Disease Progression or Death by 35% Versus Keytruda and Chemotherapy in First-Line PD-L1+ Metastatic Triple-Negative Breast Cancer

May 31
Last Trade: 113.24 2.18 1.96

First Pivotal Phase 3 Trial to Show Superiority of a TROP-2 Antibody-Drug Conjugate, Trodelvy, Plus Keytruda Versus Standard of Care in 1L Metastatic TNBC Early Trend in Improvement in Overall Survival Observed FOSTER CITY, Calif. / May 31, 2025 / Business Wire / Gilead Sciences, Inc. (Nasdaq: GILD) today announced Trodelvy® (sacituzumab govitecan-hziy) plus Keytruda® (pembrolizumab) reduced the risk of disease progression or death by...Read more


New Data Show Genentech’s Itovebi Significantly Extended Survival in a Certain Type of HR-positive Advanced Breast Cancer

May 31
Last Trade: 40.87 0.76 1.89

The Itovebi (inavolisib)-based regimen reduced the risk of death by more than 30% in people with PIK3CA-mutated HR-positive, HER2-negative advanced breast cancer, compared with palbociclib and fulvestrant alone The PIK3CA mutation is found in approximately 40% of HR-positive advanced breast cancers and is associated with a poor prognosis New data are being presented in an oral session at the 2025 American Society of Clinical Oncology...Read more


Regeneron Pharmaceuticals: Libtayo® (cemiplimab) Phase 3 Data in the Adjuvant Treatment of Post-Surgical High-Risk Cutaneous Squamous Cell Carcinoma (CSCC) Have Potential to Be Practice-Changing

May 31
Last Trade: 552.58 4.83 0.88

Libtayo demonstrated a 68% reduction in the risk of disease recurrence or death, the primary endpoint of the trial (p<0.0001) Libtayo also demonstrated 80% and 65% reductions in the risk of locoregional and distant recurrence, respectively, compared to placebo   Detailed results presented in an oral session at the 2025 American Society of Clinical Oncology Annual Meeting and simultaneously published in the New England...Read more


Teva Pharmaceutical Presents Latest Schizophrenia Portfolio Data Including Real-World Outcomes with UZEDY® (risperidone) Showing Lower Rates of and Longer Time to Relapse Compared to Oral Treatment Options and New Phase 3 SOLARIS Data

May 30
Last Trade: 16.71 0.08 0.48

Real-world claims studies evaluating UZEDY® (risperidone) also show improved adherence and persistence rates, fewer inpatient, outpatient and emergency department (ED) visits versus second-generation daily oral options Latest Phase 3 SOLARIS data show no suspected or confirmed PDSS events with TEV-'749 after more than 3,400 subcutaneous injections in study participants to date As a leader in neuroscience, Teva is committed to...Read more


Pfizer’s BRAFTOVI® Combination Regimen Cuts the Risk of Death in Half for Patients with BRAF V600E-Mutant Metastatic Colorectal Cancer

May 30
Last Trade: 25.51 -0.11 -0.43

Pivotal results from the Phase 3 BREAKWATER trial showed 51% risk reduction in death compared to standard-of-care treatment BRAFTOVI combination regimen also demonstrated 47% risk reduction in disease progression or death compared to standard-of-care treatment, meeting the trial’s dual primary endpoint of progression-free survival First and only combination regimen with targeted therapy to improve survival outcomes for treatment-naïve...Read more


Cartesian Therapeutics Announces First Participant Enrolled in the Phase 3 AURORA Trial of Descartes-08 in Patients with Myasthenia Gravis

May 30
Last Trade: 13.77 2.42 21.32

FREDERICK, Md., May 30, 2025 (GLOBE NEWSWIRE) -- Cartesian Therapeutics, Inc. (NASDAQ: RNAC) (“Cartesian” or the “Company”), a clinical-stage biotechnology company pioneering cell therapy for autoimmune diseases, today announced that the first participant has been enrolled in its Phase 3 AURORA trial of Descartes-08 in patients with myasthenia gravis (MG). Descartes-08, Cartesian’s lead cell therapy candidate, is an autologous engineered...Read more


Summit Therapeutics: Ivonescimab Plus Chemotherapy Demonstrates Statistically Significant and Clinically Meaningful Improvement in Progression-Free Survival in Patients with EGFR-Mutant Non-Small Cell Lung Cancer after EGFR TKI Therapy in Global Study...

May 30
Last Trade: 24.74 1.75 7.61

Consistent Results Noted between Single Region HARMONi-A and Multiregional HARMONi Studies; Favorable Trends in Sub-Populations from North America and China for Both Primary Endpoints Were Observed Ivonescimab in Combination with Chemotherapy Reduces the Risk of Disease Progression or Death by 48% Compared to Chemotherapy Alone; Positive Overall Survival Trend Observed with Hazard Ratio of 0.79 HARMONi Represents the First Phase III...Read more


Regeneron Pharmaceuticals: Itepekimab Met Primary Endpoint in One of Two Chronic Obstructive Pulmonary Disease (COPD) Phase 3 Trials

May 30
Last Trade: 552.58 4.83 0.88

AERIFY-1 trial met the primary endpoint of a statistically significant reduction in moderate or severe exacerbations in former smokers regardless of eosinophilic phenotype and provided a clinically meaningful benefit AERIFY-2, a second Phase 3 trial, did not meet the primary endpoint despite a benefit seen earlier in the trial Itepekimab was generally well tolerated in both AERIFY-1 and AERIFY-2, with safety consistent with prior...Read more


Alumis Completes Enrollment of Pivotal Phase 3 ONWARD Clinical Program of Lead Candidate ESK-001, a Highly Selective, Next-Generation Oral TYK2 Inhibitor for the Treatment of Moderate-to-Severe Plaque Psoriasis

May 29
Last Trade: 3.50 0.02 0.57

Topline readout expected in early Q1 2026 SOUTH SAN FRANCISCO, Calif., May 29, 2025 (GLOBE NEWSWIRE) -- Alumis Inc. (Nasdaq: ALMS), a late-stage biopharma company developing next-generation targeted therapies for patients with immune-mediated diseases, today announced the completion of patient enrollment in its pivotal Phase 3 ONWARD clinical program of ESK-001 for the treatment of moderate-to-severe plaque psoriasis. "We are...Read more


Incannex Healthcare Advances IHL-42X RePOSA Trial to Phase 3 Following FDA Protocol Clearance

May 29
Last Trade: 0.22 -0.0006 -0.27

Streamlined U.S.-only study design builds on Phase 2 momentum for IHL-42X in obstructive sleep apnea NEW YORK and MELBOURNE, Australia, May 29, 2025 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (Nasdaq: IXHL), a clinical-stage pharmaceutical company developing novel combination therapies, today announced that the Phase 3 component of the RePOSA clinical trial will proceed. The U.S. Food and Drug Administration (FDA) previously...Read more


Scynexis Resumes Patient Dosing in Phase 3 MARIO Study

May 28
Last Trade: 0.69 -0.02 -2.73

First new patient dosed in Phase 3 MARIO study following the lifting of the FDA clinical hold Resumption of dosing in this study triggers a $10M milestone payment from GSK plus an additional $20M milestone due in six months; as previously disclosed GSK disputes these milestone payments, and SCYNEXIS vigorously disagrees with their position JERSEY CITY, N.J., May 28, 2025 (GLOBE NEWSWIRE) -- SCYNEXIS, Inc. (NASDAQ: SCYX), a...Read more


Rezolute Announces Completion of Enrollment in the Phase 3 sunRIZE Study of Ersodetug in Patients with Congenital Hyperinsulinism

May 28
Last Trade: 5.28 0.31 6.24

Target enrollment exceeded with 62 participants enrolled, including approximately 15 percent from U.S. sites Topline data is anticipated in December of 2025 REDWOOD CITY, Calif., May 28, 2025 (GLOBE NEWSWIRE) -- Rezolute, Inc. (Nasdaq: RZLT) (“Rezolute” or the “Company”), a late-stage rare disease company focused on treating hypoglycemia caused by hyperinsulinism (HI), today announced that enrollment is complete in the sunRIZE...Read more


Ocular Therapeutix To Close Enrollment This Week for SOL-R, its Second Registrational Trial Evaluating AXPAXLI™ in Wet Age-Related Macular Degeneration

May 28
Last Trade: 10.76 0.84 8.47

Enrollment for SOL-R, the largest retinal TKI trial to date, supports randomization of at least 555 subjects SOL-1, Ocular’s first registrational trial in wet AMD, completed randomization in December 2024 and retention remains exceptional as the trial continues on track for top-line readout in 1Q 2026 These two complementary trials are intended to form the basis of an NDA submission of AXPAXLI in wet AMD BEDFORD, Mass., May 28,...Read more


Spero Therapeutics and GSK Announce PIVOT-PO Phase 3 Study for Tebipenem HBr Stopped Early for Efficacy Following Review by Independent Data Monitoring Committee

May 28
Last Trade: 3.04 0.10 3.40

If approved, tebipenem HBr could be the first oral carbapenem antibiotic for US patients with complicated urinary tract infections (cUTIs) An estimated 2.9 million cases of cUTIs are treated annually in the US1 with many cases requiring hospitalization, contributing to over $6 billion per year in healthcare costs2 Data from the PIVOT-PO trial to be part of a planned US Food and Drug Administration (FDA) filing in 2H 2025 that Spero’s...Read more


InflaRx Announces Outcome of Interim Analysis for Vilobelimab Phase 3 Trial in Pyoderma Gangrenosum

May 28
Last Trade: 0.89 0.02 2.07

JENA, Germany, May 28, 2025 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX), a biopharmaceutical company pioneering anti-inflammatory therapeutics targeting the complement system, today announced that the Independent Data Monitoring Committee (IDMC) conducting the unblinded interim analysis for the Phase 3 trial for vilobelimab in pyoderma gangrenosum (PG), recommended that the trial be stopped due to futility. This...Read more


EyePoint Pharmaceuticals Completes Enrollment in Pivotal Phase 3 LUGANO Trial of DURAVYU™ for Treatment of Wet Age-Related Macular Degeneration

May 27
Last Trade: 10.96 1.01 10.15

Over 400 patients enrolled and randomized over a seven-month period, driven by strong physician and patient interest  LUCIA pivotal Phase 3 trial continues rapid enrollment pace with 60% of patients randomized; enrollment completion expected in 3Q 2025  Topline 56-week data for LUGANO expected in mid-2026 with LUCIA to follow  WATERTOWN, Mass., May 27, 2025 (GLOBE NEWSWIRE) -- EyePoint Pharmaceuticals, Inc. (Nasdaq:...Read more


Mineralys Therapeutics Announces Late-Breaking Presentation of Data from the Launch-HTN Pivotal Trial of Lorundrostat in Uncontrolled or Resistant Hypertension at 34th European Meeting on Hypertension and Cardiovascular Protection (ESH 2025)

May 24
Last Trade: 14.37 0.43 3.08

Largest hypertension trial of an aldosterone synthase inhibitor to date demonstrated the efficacy of lorundrostat in over 1,000 participants with uncontrolled or resistant hypertension in a real-world setting Lorundrostat 50 mg dosed once daily demonstrated clinically meaningful and sustained reductions in systolic blood pressure, with a 16.9 mmHg reduction at Week 6 (-9.1 mmHg placebo adjusted) and a 19.0 mmHg reduction at Week 12...Read more


Gilead Sciences ASCENT-03: Trodelvy® Demonstrates Highly Statistically Significant & Clinically Meaningful Improvement in Progression Free Survival in Patients With First-line Metastatic Triple-Negative Breast Cancer Who Are Not Candidates for Checkpoint ...

May 23
Last Trade: 113.24 2.18 1.96

Second Positive Phase 3 Trial in First-line Metastatic TNBC Where Trodelvy Has Demonstrated a Clinically Meaningful Benefit Versus Standard of Care Chemotherapy Trodelvy Has the Potential to Be the Backbone of Treatment and the First Antibody-Drug Conjugate for All Patients Across First-line Metastatic TNBC FOSTER CITY, Calif. / May 23, 2025 / Business Wire / Gilead Sciences, Inc. (Nasdaq: GILD) today announced positive topline...Read more


Prothena Announces Phase 3 AFFIRM-AL Clinical Trial for Birtamimab in Patients with AL Amyloidosis Did Not Meet Primary Endpoint

May 23
Last Trade: 6.58 0.06 0.92

Birtamimab did not meet the primary endpoint of time to all-cause mortality or the secondary endpoints Birtamimab development will be discontinued, including stopping the open label extension of the AFFIRM-AL clinical trial Company will decrease ongoing operating expenses, including an expected substantial reduction in organizational size, and plans to provide a further update in June DUBLIN / May 23, 2025 / Business Wire / Prothena...Read more


New Two-year Follow-up of Genentech’s Columvi Extends Overall Survival in Relapsed or Refractory Diffuse Large B-cell Lymphoma Patients

May 23
Last Trade: 40.87 0.76 1.89

Updated data from the pivotal Phase III STARGLO study continue to demonstrate a clinically meaningful improvement in overall survival with a 40% survival benefit for people with R/R DLBCL who are not candidates for transplant 89% of patients whose cancer had fully responded at the end of treatment with Columvi in combination with chemotherapy were still alive and 82% showed no signs of cancer one year post-treatment Timely initiation of...Read more


Astellas Pharma and Pfizer's XTANDI™ (enzalutamide) Shows Long-Term Overall Survival in Metastatic Hormone-Sensitive Prostate Cancer

May 22
Last Trade: 25.51 -0.11 -0.43

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


Gyre Therapeutics’ Hydronidone Met the Primary Endpoint and Demonstrated Statistically Significant Fibrosis Regression in Pivotal Phase 3 Trial for the Treatment of CHB-associated Liver Fibrosis in China

May 22
Last Trade: 8.00 -0.12 -1.48

Achieved statistically significant ≥1-stage fibrosis regression at Week 52 vs. placebo (52.85% vs. 29.84%, P=0.0002). Demonstrated favorable safety and tolerability profile: 4.88% serious adverse events vs. 6.45% for placebo; zero discontinuations due to adverse events. Breakthrough Therapy Designation granted by China’s National Medical Products Administration (“NMPA”) in 2021 supports potential first-in-class approval in...Read more


Insmed: Brensocatib Shows Consistent Efficacy and Safety Across Three Prespecified Subgroups in New Data from Landmark ASPEN Study

May 21
Last Trade: 96.47 0.33 0.34

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


Sarepta Therapeutics Provides Update on UK Dosing in ENVISION Study of ELEVIDYS for the treatment of Duchenne Muscular Dystrophy

May 21
Last Trade: 19.37 0.34 1.79

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


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Terns Pharmaceuticals is a clinical-stage biopharmaceutical company developing a portfolio of small-molecule product candidates to address serious diseases, including oncology and obesity. Terns’ pipeline contains three clinical stage development programs including GLP-1 receptor...

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