LOGIN  |  REGISTER
Recursion

Latest Phase 3 Clinical Trial News

FILTER BY TOPIC:     Enrollment   Pre-Clinical   First Dose   Phase 1   Phase 1/2   Phase 2   Phase 2/3   Phase 3  

Neuphoria Therapeutics Completes Target Enrollment in Phase 3 AFFIRM-1 Trial of BNC-210 in Social Anxiety Disorder (SAD)

September 4
Last Trade: 11.89 -1.11 -8.54

Topline data anticipated in early Q4 2025 BURLINGTON, Mass., Sept. 04, 2025 (GLOBE NEWSWIRE) -- Neuphoria Therapeutics Inc. (Nasdaq: NEUP) (“Neuphoria” or the “Company”), a clinical-stage biotechnology company developing impactful treatments for neuropsychiatric disorders, today announced the achievement of target enrollment of 332 participants in the AFFIRM-1 Phase 3 trial evaluating lead candidate BNC-210 as a first-in-class,...Read more


Personalis Announces New Data from a Landmark Neoadjuvant Lung Cancer Trial Showing Superiority of Ultra-Sensitive, Tumor-Informed MRD Testing

September 3
Last Trade: 5.24 0.39 8.04

FREMONT, Calif. / Sep 03, 2025 / Business Wire / Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for precision oncology, announced new data from an AstraZeneca phase 3 clinical trial in lung cancer (NeoADAURA). The findings demonstrate that Personalis’ highly sensitive molecular residual disease (MRD) test, NeXT Personal®, is a strong predictor of outcomes in patients with stage II-IIIb, EGFR-mutated non-small cell lung...Read more


CG Oncology Completes Enrollment in PIVOT-006

September 3
Last Trade: 33.07 4.35 15.15

Rapid enrollment underscores high unmet need in intermediate-risk non-muscle invasive bladder cancer (NMIBC) One of the largest randomized phase 3 studies in this patient population will encompass broadest range of patient types per AUA/SUO Guidelines  IRVINE, Calif., Sept. 03, 2025 (GLOBE NEWSWIRE) -- CG Oncology, Inc. (NASDAQ: CGON), a late-stage clinical biopharmaceutical company focused on developing and commercializing a...Read more


Lyell Immunopharma Announces the Initiation of a Phase 3 Head-to-Head CAR T-Cell Therapy Clinical Trial in Aggressive Large B-Cell Lymphoma and Formation of Expert Steering Committee

September 3
Last Trade: 12.15 0.72 6.30

PiNACLE - H2H will evaluate rondecabtagene autoleucel (ronde-cel) versus investigator’s choice of approved CD19 CAR T-cell therapies in patients with aggressive large B-cell lymphoma receiving treatment in the second line (2L) setting Ronde-cel is Lyell’s next-generation, dual-targeting CD19/CD20 CAR T-cell therapy designed to deliver improved complete response rates and longer duration of responses over currently approved CD19 CAR...Read more


Ionis Pharmaceuticals: Olezarsen significantly reduces triglycerides and acute pancreatitis events in landmark pivotal studies for people with severe hypertriglyceridemia (sHTG)

September 2
Last Trade: 61.23 0.74 1.22

Up to 72% (p<0.0001) placebo-adjusted mean reduction in fasting triglycerides  85% (p=0.0002) reduction in acute pancreatitis events, the first and only time achieved for the treatment of sHTG  Favorable safety and tolerability profile  sNDA submission planned by end of year  Ionis to host webcast today at 8:30 a.m. ET  CARLSBAD, Calif. / Sep 02, 2025 / Business Wire / Ionis Pharmaceuticals, Inc....Read more


Merck’s Investigational Oral PCSK9 Inhibitor Enlicitide Decanoate Met All Primary and Key Secondary Endpoints in Adults with Hypercholesterolemia in Pivotal CORALreef Lipids Study

September 2
Last Trade: 84.71 0.53 0.63

Enlicitide is the first oral PCSK9 inhibitor to demonstrate statistically significant and clinically meaningful reductions in LDL-C compared to placebo in Phase 3 trials Enlicitide had a favorable safety profile, with comparable rates of discontinuation between treatment groups RAHWAY, N.J. / Sep 02, 2025 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced positive topline results...Read more


Alnylam Pharmaceuticals: New Data From Landmark HELIOS-B Phase 3 Study Presented at ESC Congress 2025 Demonstrate Vutrisiran’s Long-Term Cardiovascular Benefit in ATTR-CM

August 31
Last Trade: 452.00 4.57 1.02

Sustained Benefit of Vutrisiran Across Mortality, Cardiovascular Events, Quality of Life and Cardiac Biomarkers Observed Through Up to 48 Months, Including 12 Months from the Ongoing Open-Label Extension, Reinforce Potential as First-Line Treatment for ATTR-CM Vutrisiran, which Delivers Rapid Knockdown of Transthyretin, Reduced the Risk of Composite of All-Cause Mortality or First Cardiovascular Event by 37% in the Overall Population and...Read more


AstraZeneca: Baxdrostat demonstrated statistically significant and clinically meaningful reduction in systolic blood pressure in patients with hard-to-control hypertension in the BaxHTN Phase III ​trial

August 30
Last Trade: 81.70 -0.41 -0.50

Baxdrostat 2mg lowered systolic blood pressure by 15.7 mmHg (9.8 mmHg placebo-adjusted) from baseline, and was generally well tolerated with no unanticipated safety findings Full results presented at the European Society of Cardiology Congress 2025 and published in the New England Journal of Medicine WILMINGTON, Del. / Aug 30, 2025 / Business Wire / Positive full results from the ​BaxHTN Phase III trial showed ​baxdrostat demonstrated...Read more


Cytokinetics Announces Primary Results from MAPLE-HCM Presented at the European Society of Cardiology Congress 2025 and Published in The New England Journal Of Medicine

August 30
Last Trade: 53.01 3.02 6.04

Positive Trial Demonstrates Superiority of Aficamten to Standard-of-Care Beta-Blocker Metoprolol Primary Endpoint Result Consistent Across All Prespecified Subgroups Company to Host Investor Event and Webcast Tuesday September 2, 2025, at 8:00 AM Eastern Time SOUTH SAN FRANCISCO, Calif., Aug. 30, 2025 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that primary results from MAPLE-HCM (Metoprolol...Read more


Merck Provides New Results for VERQUVO® (vericiguat) in Patients with Chronic Heart Failure and Reduced Ejection Fraction

August 30
Last Trade: 84.71 0.53 0.63

Results from the Phase 3 VICTOR trial and a pooled analysis of the VICTOR and VICTORIA trials were presented today at the ESC Congress 2025 and simultaneously published in The Lancet RAHWAY, N.J. / Aug 30, 2025 / Business Wire / Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced results evaluating VERQUVO® (vericiguat) in adult patients with stable chronic heart failure and reduced ejection fraction...Read more


Natera: Signatera Test Selected for NRG-Sponsored Phase III ARCHER Trial in Bladder Cancer

August 28
Last Trade: 168.02 0.49 0.29

Randomized study aims to reduce treatment burden for patients and utilizes Signatera to monitor for disease recurrence AUSTIN, Texas / Aug 28, 2025 / Business Wire / Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, today announced the activation of the NRG Oncology trial, ARCHER (NRG-GU015), a randomized, phase III study in muscle-invasive bladder cancer (MIBC). The study is evaluating whether a...Read more


UPDATE -- BioXcel Therapeutics Announces SERENITY At-Home Pivotal Phase 3 Safety Trial Met its Primary Endpoint in Support of sNDA Submission for Label Expansion of IGALMI®

August 27
Last Trade: 3.79 0.17 4.70

BXCL501 achieved SERENITY At-Home’s primary endpoint of being well tolerated in the at-home treatment of agitation episodes in patients with bipolar disorders or schizophrenia No discontinuations for tolerability in the BXCL501 arm While not the primary objective of the SERENITY At-Home trial, the preliminary results demonstrate continued effects and consistent benefit with repeat dosing across the course of the trial Following...Read more


Telitacicept Achieved Primary Endpoint in Phase 3 Clinical Study for IgA Nephropathy

August 27
Last Trade: 1.96 -0.04 -2.00

Results reinforce telitacicept’s potential across multiple autoimmune diseases Data anticipated to be presented at an upcoming medical conference CAMBRIDGE, Mass., Aug. 27, 2025 (GLOBE NEWSWIRE) -- Vor Bio (Nasdaq: VOR), a clinical-stage biotechnology company transforming the treatment of autoimmune diseases, today announced that its collaborator, RemeGen Co., Ltd (HKEX: 9995, SHA: 688331), achieved the primary endpoint in Stage A...Read more


Merck: HERTHENA-Breast04 Phase 3 Trial of Patritumab Deruxtecan Initiated in Patients with Metastatic Hormone Receptor Positive, HER2 Negative Breast Cancer Previously Treated with Endocrine Therapy

August 27
Last Trade: 84.71 0.53 0.63

BASKING RIDGE, N.J. & RAHWAY, N.J. / Aug 27, 2025 / Business Wire / The first patient has been dosed in the HERTHENA-Breast04 phase 3 trial evaluating the efficacy and safety of investigational patritumab deruxtecan (HER3-DXd) versus investigator’s choice of treatment in patients with unresectable locally advanced or metastatic hormone receptor (HR) positive, HER2 negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer with disease...Read more


BioXcel Therapeutics Announces SERENITY At-Home Pivotal Phase 3 Safety Trial Met its Primary Endpoint in Support of sNDA Submission for Label Expansion of IGALMI®

August 27
Last Trade: 3.79 0.17 4.70

BXCL501 achieved SERENITY At-Home’s primary endpoint of being well tolerated in the at-home treatment of agitation episodes in patients with bipolar disorders or schizophrenia No discontinuations for tolerability in the BXCL501 arm While not the primary objective of the SERENITY At-Home trial, the preliminary results demonstrate continued effects and consistent benefit with repeat dosing across the course of the trial Following...Read more


Eli Lilly's Verzenio® (abemaciclib) increases overall survival in HR+, HER2-, high-risk early breast cancer with two years of therapy

August 27
Last Trade: 727.21 -10.62 -1.44

Treatment with Verzenio plus endocrine therapy demonstrated a statistically significant and clinically meaningful improvement in overall survival compared to endocrine therapy alone In the seven-year landmark analysis of monarchE, treatment with Verzenio also resulted in sustained invasive disease-free survival and distant relapse-free survival benefit Results reinforce two years of Verzenio plus endocrine therapy as the standard of...Read more


Eli Lilly's oral GLP-1, orforglipron, is successful in third Phase 3 trial, triggering global regulatory submissions this year for the treatment of obesity

August 26
Last Trade: 727.21 -10.62 -1.44

In ATTAIN-2, orforglipron met the primary and all key secondary endpoints, with compelling efficacy results and a safety profile consistent with injectable GLP-1 medicines Participants with obesity or overweight and type 2 diabetes, a population with increased difficulties losing weight, lost an average of 22.9 lbs (10.5%) on the highest dose, with A1C reduced by an average of 1.8% INDIANAPOLIS, Aug. 26, 2025 /PRNewswire/ --...Read more


Regeneron Pharmaceuticals Announces Positive Results from Phase 3 Trial in Generalized Myasthenia Gravis

August 26
Last Trade: 573.38 9.58 1.70

Cemdisiran monotherapy, dosed subcutaneously every three months, met the primary and key secondary endpoints, showing a 2.3-point placebo-adjusted improvement in Myasthenia Gravis Activities of Daily Living (MG-ADL) total score U.S. regulatory submission for cemdisiran monotherapy is planned for the first quarter of 2026, pending discussions with the FDA TARRYTOWN, N.Y., Aug. 26, 2025 (GLOBE NEWSWIRE) -- Regeneron...Read more


Theravance Biopharma Completes Enrollment in Pivotal Phase 3 CYPRESS Study of Ampreloxetine in Patients with Symptomatic Neurogenic Orthostatic Hypotension due to Multiple System Atrophy

August 25
Last Trade: 13.95 0.21 1.53

Topline results anticipated in Q1 2026 and, if successful, planning for expedited NDA submission  If approved, ampreloxetine could address a critical unmet need as the first therapy with the potential to provide durable benefit for the 40,000 patients in the U.S. with symptomatic neurogenic orthostatic hypotension (nOH) in patients with multiple system atrophy (MSA) Ampreloxetine has Orphan Drug Designation in the U.S.,...Read more


argenx Announces Positive Topline Results from ADAPT SERON Study of VYVGART in Patients with AChR-Ab Seronegative gMG

August 25
Last Trade: 750.78 28.77 3.98

Study met primary endpoint (p-value=0.0068) First global phase 3 study to demonstrate clinically meaningful improvements in disease activity across all three subtypes – MuSK+, LRP4+, triple seronegative Supplemental Biologics License Application (sBLA) to be submitted to U.S. Food and Drug Administration (FDA) by end of 2025 August 25, 2025, 7:00 AM CET - Amsterdam, the Netherlands – argenx SE (Euronext & Nasdaq: ARGX), a...Read more


AbbVie Announces Positive Topline Results from Second Phase 3 UP-AA Trial Evaluating Upadacitinib (RINVOQ®) for Alopecia Areata

August 21
Last Trade: 212.56 0.70 0.33

In the second replicate study (Study 1) of the pivotal Phase 3 UP-AA clinical program, upadacitinib (RINVOQ®) achieved the primary endpoint, demonstrating that 45.2% and 55.0% of patients with severe alopecia areata treated with upadacitinib 15 mg and 30 mg, respectively, reached 80% or more scalp hair coverage at week 24 as defined by the severity of alopecia tool (SALT) score ≤ 201 Key secondary endpoints, including improvements in...Read more


HUTCHMED Completes Patient Enrollment of SANOVO Phase III Trial of ORPATHYS® and TAGRISSO® Combination as a First-Line Therapy for Certain Lung Cancer Patients in China

August 19
Last Trade: 15.97 0.70 4.58

HONG KONG and SHANGHAI and FLORHAM PARK, N.J., Aug. 20, 2025 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:​HCM; HKEX:​13) today announces the completion of patient enrollment of SANOVO, a China Phase III study of ORPATHYS® (savolitinib) and TAGRISSO® (osimertinib) as a first-line treatment in certain non-small cell lung cancer (“NSCLC”) patients whose tumors harbor epidermal growth factor receptor (“EGFR”)...Read more


BioXcel Therapeutics Announces Database Lock in SERENITY At-Home Pivotal Phase 3 Safety Trial for Acute Treatment of Agitation Associated with Bipolar Disorders or Schizophrenia

August 19
Last Trade: 3.79 0.17 4.70

Data from more than 2,600 agitation episodes collected Topline data readout is on track for August         NEW HAVEN, Conn., Aug. 19, 2025 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience, today announced completion of the database lock for its SERENITY At-Home...Read more


Biodexa Pharmaceuticals Announces Enrolment of First Patients into Pivotal Phase 3 Serenta Trial in Familial Adenomatous Polyposis (FAP)

August 18
Last Trade: 5.65 -0.04 -0.70

August 18, 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 enrolment of the first two patients by the Pan American Center for Oncology Trials in San Juan, Puerto Rico into its pivotal Phase 3 Serenta trial of eRapa in patients with...Read more


Natera: IMvigor011 Bladder Cancer Trial Achieves Positive Results, with Signatera™ Strongly Predicting Adjuvant Immunotherapy Benefit

August 18
Last Trade: 168.02 0.49 0.29

Topline results from the trial show that Signatera-positive patients treated with atezolizumab (Tecentriq®) had statistically significant and clinically meaningful improvements in disease-free survival and overall survival IMvigor011 is the first prospective phase III study in muscle-invasive bladder cancer to read out that uses a personalized, ctDNA MRD*-guided approach AUSTIN, Texas / Aug 18, 2025 / Business Wire / Natera, Inc....Read more


Vor Bio: Telitacicept Achieved Primary Endpoint in Phase 3 Clinical Study for Primary Sjögren's Disease with Telitacicept, a Dual BAFF/APRIL Inhibitor

August 13
Last Trade: 1.96 -0.04 -2.00

Phase 3 results position telitacicept as potential best-in-disease profile in primary Sjögren's disease Telitacicept demonstrated a favorable safety profile Vor evaluating timing of global Phase 3 clinical study in primary Sjögren's disease Data anticipated to be presented at an upcoming medical conference CAMBRIDGE, Mass., Aug. 13, 2025 (GLOBE NEWSWIRE) -- Vor Bio (Nasdaq: VOR), a clinical-stage biotechnology company transforming...Read more


Spectral Medical and Vantive Announce Topline Results from Spectral’s Tigris Trial Evaluating PMX Hemoadsorption Therapy for Endotoxic Septic Shock

August 12
Last Trade: 1.63 0.04 2.52

Results exceed prespecified primary endpoint of 95% posterior probability of benefit for PMX on 28-day mortality Pooled absolute risk reduction of 8.3%; Relative risk reduction of 18% Key secondary endpoint: 90-day Mortality 17.4% lower with PMX and >99% posterior probability of benefit 38.7% Mortality at 28 days with PMX confirms results of prior trial subset TORONTO, Ontario and DEERFIELD, Ill., Aug. 12, 2025 (GLOBE...Read more


Pfizer: PADCEV™ Plus KEYTRUDA™ Significantly Improves Survival for Certain Patients with Bladder Cancer When Given Before and After Surgery

August 12
Last Trade: 24.84 0.05 0.20

PADCEV plus KEYTRUDA is the first and only regimen to improve survival when used before and after standard of care (surgical cystectomy) in cisplatin-ineligible patients with muscle-invasive bladder cancer Results will be discussed with global health authorities for potential regulatory filings NEW YORK & TOKYO / Aug 12, 2025 / Business Wire / Pfizer Inc. (NYSE: PFE) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki...Read more


Merck: KEYTRUDA® (pembrolizumab) plus Padcev® (enfortumab vedotin-ejfv) Significantly Improved Event-Free and Overall Survival and Pathologic Complete Response Rate for Certain Patients with Muscle-Invasive Bladder Cancer When Given Before and After Surge...

August 12
Last Trade: 84.71 0.53 0.63

First and only systemic therapy to improve survival when used before and after surgery for patients with MIBC who are ineligible for cisplatin-based chemotherapy First ever positive Phase 3 study in this cisplatin-ineligible patient population, representing significant advancement in MIBC RAHWAY, N.J. / Aug 12, 2025 / Business Wire / Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced positive topline...Read more


IO Biotech Announces Clinical Improvement in Progression Free Survival Demonstrated in Pivotal Phase 3 Trial of Cylembio® plus KEYTRUDA® (Pembrolizumab) for the Treatment of First-line Advanced Melanoma, but Statistical Significance Narrowly Missed

August 11
Last Trade: 1.95 0.20 11.43

Patients treated with Cylembio (imsapepimut and etimupepimut, adjuvanted) plus pembrolizumab achieved improvement in progression free survival (PFS) compared to patients treated with pembrolizumab monotherapy, HR=0.77 (CI 0.58-1.00), (p=0.056), with median PFS (mPFS) of 19.4 months vs. 11.0 months, respectively; the results on the primary endpoint narrowly missed the study’s statistical significance threshold of p≤0.045 In patients...Read more


Stoke Therapeutics and Biogen Announce First Patient Dosed in Phase 3 EMPEROR Study of Zorevunersen, a Potential Disease-Modifying Treatment for Dravet Syndrome

August 11
Last Trade: 20.68 0.91 4.60

Global, pivotal Phase 3 study will evaluate efficacy and safety of zorevunersen compared to sham over a 52-week treatment period  Dravet syndrome is a rare genetic disease characterized by refractory seizures and neurodevelopmental impairments, with no currently approved medicines that address the underlying cause of the disease  BEDFORD, Mass., & CAMBRIDGE, Mass. / Aug 11, 2025 / Business Wire / Stoke Therapeutics, Inc....Read more


Biogen and Stoke Therapeutics Announce First Patient Dosed in Phase 3 EMPEROR Study of Zorevunersen, a Potential Disease-Modifying Treatment for Dravet Syndrome

August 11
Last Trade: 140.67 -0.95 -0.67

Global, pivotal Phase 3 study will evaluate efficacy and safety of zorevunersen compared to sham over a 52-week treatment period  Dravet syndrome is a rare genetic disease characterized by refractory seizures and neurodevelopmental impairments, with no currently approved medicines that address the underlying cause of the disease  CAMBRIDGE, Mass. and BEDFORD, Mass., Aug. 11, 2025 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq:...Read more


Novartis announces both ianalumab Phase III clinical trials met primary endpoint in patients with Sjögren's disease

August 11
Last Trade: 129.73 1.50 1.17

NEPTUNUS-1 and NEPTUNUS-2 are the first ever global Phase III trials to demonstrate statistically significant reduction in disease activity for Sjögren's disease1 Ianalumab has the potential to become the first and only targeted treatment approved for patients with Sjögren's disease Ianalumab was well tolerated and demonstrated a favorable safety profile in Sjögren's disease1,2 Novartis plans to present its data at an upcoming...Read more


Genmab Announces Phase 3 EPCORE® FL-1 Clinical Trial Met Dual Primary Endpoints in Patients with Relapsed/Refractory (R/R) Follicular Lymphoma (FL)

August 7
Last Trade: 27.54 0.47 1.74

Epcoritamab in combination with rituximab and lenalidomide (R2) demonstrated statistically significant improvement in Overall Response Rate (ORR; 95.7%, p < 0.0001) and Progression-Free Survival (HR 0.21, p-value <0.0001) versus R2 alone in patients with relapsed/refractory (R/R) Follicular Lymphoma (FL) Results from EPCORE FL-1 form the basis of global regulatory submissions U.S. FDA has accepted for priority review new...Read more


SELLAS Life Sciences Announces Independent Data Monitoring Committee Periodic Review and Positive Recommendation to Continue Pivotal Phase 3 REGAL Trial of GPS in AML Without Modification

August 7
Last Trade: 1.91 0.13 7.30

Final Analysis Anticipated by Year-End Upon Occurrence of 80 Events      NEW YORK, Aug. 07, 2025 (GLOBE NEWSWIRE) -- SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) (“SELLAS’’ or the “Company”), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, today announced that the Independent Data Monitoring Committee (IDMC) has completed a...Read more


vTv Therapeutics Announces First Study Participant Randomized in CATT1 Phase 3 Trial of Cadisegliatin in Type 1 Diabetes

August 7
Last Trade: 18.20 -0.67 -3.55

Topline results from CATT1 Phase 3 trial expected in second half of 2026 HIGH POINT, N.C., Aug. 07, 2025 (GLOBE NEWSWIRE) -- vTv Therapeutics Inc. (Nasdaq: VTVT), a late-stage biopharmaceutical company with an innovative clinical portfolio of small molecules and lead program in diabetes, today announced the first study participant has been randomized in the Company’s CATT1 Phase 3 trial investigating cadisegliatin as an adjunctive...Read more


Eli Lilly's oral GLP-1, orforglipron, delivers weight loss of up to an average of 27.3 lbs in first of two pivotal Phase 3 trials in adults with obesity

August 7
Last Trade: 727.21 -10.62 -1.44

In ATTAIN-1, the investigational once-daily oral pill showed significant efficacy, and a safety and tolerability profile consistent with injectable GLP-1 therapies at 72 weeks Orforglipron achieved the primary and all key secondary endpoints, including demonstrating improvements in a number of cardiovascular risk factors With these results, Lilly is on track to submit orforglipron to global regulatory agencies by year-end and is...Read more


UroGen Pharma Announces 24-Month Duration of Response of 72.2% from the Pivotal Phase 3 ENVISION Trial of ZUSDURI, the First and Only FDA-Approved Medicine for Recurrent Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer

August 5
Last Trade: 18.88 -0.49 -2.53

24-month Duration of Response (DOR) of 72.2% by Kaplan-Meier estimate was attained in patients who achieved a complete response (CR) at three months (79.6%) PRINCETON, N.J., Aug. 05, 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 the 24-month DOR of 72.2% (95% CI 64.1%,...Read more


BioXcel Therapeutics Announces Last Patient Last Visit in SERENITY At-Home Pivotal Phase 3 Safety Trial for Acute Treatment of Agitation Associated with Bipolar Disorders or Schizophrenia

August 1
Last Trade: 3.79 0.17 4.70

Vast majority of patients dosed completed the full 12-week study Data from more than 2,200 agitation episodes collected Topline data readout anticipated this month NEW HAVEN, Conn., Aug. 01, 2025 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience, today announced completion of the last patient last visit...Read more


Genentech’s Susvimo Maintains Vision Over Five Years With Two Refills Per Year in People With Wet Age-Related Macular Degeneration (AMD)

August 1
Last Trade: 43.00 0.27 0.63

Susvimo is the only continuous delivery treatment to provide reliable, long-term vision outcomes in wet AMD, the leading cause of vision loss in people over the age of 60 With two refills per year, Susvimo maintained vision and stabilized the retina for five years, with durability maintained in approximately 95% of patients Susvimo was well tolerated over five years and has a well-characterized safety profile SOUTH SAN FRANCISCO,...Read more


Eli Lilly's Mounjaro (tirzepatide), a GIP/GLP-1 dual agonist, demonstrated cardiovascular protection in landmark head-to-head trial, reinforcing its benefit in patients with type 2 diabetes and heart disease

July 31
Last Trade: 727.21 -10.62 -1.44

Mounjaro met the primary objective of non-inferiority vs. Trulicity with an 8% lower rate of MACE-3 events, while delivering greater reductions in A1C and weight In the trial, Mounjaro was associated with a 16% lower rate of all-cause death compared to Trulicity, suggesting more comprehensive health benefits Results from the largest and longest Mounjaro trial to date reaffirm its established safety and tolerability profile...Read more


Ultragenyx Pharmaceutical Completes Enrollment of Phase 3 Aspire Study Evaluating GTX-102 for the Treatment of Angelman Syndrome

July 31
Last Trade: 31.82 0.27 0.86

Company expects to complete Phase 3 Aspire study in the second half of 2026 Aurora study of GTX-102 in additional ages and genotypes on track to initiate in the second half of 2025 NOVATO, Calif., July 31, 2025 (GLOBE NEWSWIRE) -- Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE) today announced that the Phase 3 Aspire study evaluating GTX-102 (apazunersen) as a treatment for Angelman Syndrome is fully enrolled, with approximately 129...Read more


Vir Biotechnology Initiates Second Pivotal Trial in Its Global ECLIPSE Registrational Program for Chronic Hepatitis Delta

July 31
Last Trade: 5.27 -0.25 -4.53

First patient enrolled in ECLIPSE 2 Phase 3 clinical trial evaluating the switch to the combination of tobevibart and elebsiran in patients not achieving undetectable hepatitis delta virus RNA despite bulevirtide treatment ECLIPSE 2 is a pivotal trial designed to support global marketing applications, including in the U.S. and Europe SAN FRANCISCO / Jul 31, 2025 / Business Wire / Vir Biotechnology, Inc. (Nasdaq: VIR) today announced...Read more


BriaCell Therapeutics Adds UCLA Health as Key Site in Pivotal Phase 3 Breast Cancer Study

July 31
Last Trade: 7.87 -0.38 -4.61

PHILADELPHIA and VANCOUVER, British Columbia, July 31, 2025 (GLOBE NEWSWIRE) -- BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW, BCTXZ) (TSX: BCT) (“BriaCell” or the “Company”), a clinical-stage biotechnology company developing novel immunotherapies to transform cancer care, announces the addition of UCLA Health Jonsson Comprehensive Cancer Center, a leading cancer center in California, to its ongoing pivotal Phase 3 clinical study...Read more


AbbVie Announces Positive Topline Results from Phase 3 UP-AA Trial Evaluating Upadacitinib (RINVOQ®) for Alopecia Areata

July 30
Last Trade: 212.56 0.70 0.33

In Study 2 of the pivotal Phase 3 UP-AA clinical program, upadacitinib (RINVOQ®) achieved the primary endpoint, demonstrating that 44.6% and 54.3% of patients with severe alopecia areata treated with upadacitinib 15 mg and 30 mg, respectively, reached 80% or more scalp hair coverage at week 24 as defined by the severity of alopecia tool (SALT) score ≤ 201 Key secondary endpoints, including improvements in eyebrows and eyelashes, as...Read more


IMUNON Announces First Patient Dosed in Phase 3 OVATION 3 Study of IMNN-001 in Newly Diagnosed Advanced Ovarian Cancer

July 30
Last Trade: 5.76 0.02 0.35

Initiation of additional trial sites and patient enrollment activities ongoing with multiple patients in screening LAWRENCEVILLE, N.J., July 30, 2025 (GLOBE NEWSWIRE) -- IMUNON, Inc. (Nasdaq: IMNN), a clinical-stage company in Phase 3 development of its DNA-mediated immunotherapy, today announced that the first patient has been dosed in the pivotal Phase 3 OVATION 3 Study evaluating the Company’s lead candidate, IMNN-001, for the...Read more


Eli Lilly's Kisunla (donanemab-azbt) showed growing benefit over three years in early symptomatic Alzheimer's disease

July 30
Last Trade: 727.21 -10.62 -1.44

Findings from the TRAILBLAZER-ALZ 2 long-term extension study highlight Kisunla continued to demonstrate slowing of decline, with most participants having completed treatment Data underscores the value of early intervention and supports a limited duration dosing approach with sustained long-term benefits INDIANAPOLIS, July 30, 2025 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced results from the long-term extension...Read more


Anika Therapeutics Reports Topline Results from U.S. Pivotal FastTRACK Phase III Study for Hyalofast® Cartilage Repair Scaffold and Provides Program Update

July 30
Last Trade: 8.94 -0.07 -0.78

Hyalofast consistently demonstrated improvements over microfracture, but missed on statistical significance of the pre-specified co-primary endpoints of percent change in KOOS Pain and IKDC function Hyalofast showed statistically significant improvements over microfracture in pre-defined secondary endpoints and other measures that align with prior FDA approvals for cartilage repair products Hyalofast has been used to treat over...Read more


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

July 29
Last Trade: 14.01 2.01 16.75

LUCIA pivotal Phase 3 trial enrolled and randomized over 400 patients in seven months, demonstrating continued strong enthusiasm for the DURAVYU pivotal program across the global retinal community  Over 800 patients enrolled across the LUGANO and LUCIA trials of DURAVYU, representing one of the fastest enrolling Phase 3 pivotal programs for wet AMD  Interim analysis by independent Data Safety Monitoring Committee (DSMC)...Read more


Eli Lilly's Jaypirca (pirtobrutinib), the first and only approved non-covalent (reversible) BTK inhibitor, met its primary endpoint in a head-to-head Phase 3 trial versus Imbruvica (ibrutinib) in CLL/SLL

July 29
Last Trade: 727.21 -10.62 -1.44

Pirtobrutinib met the primary endpoint of response rate non-inferiority, favoring pirtobrutinib with a nominal P-value for superiority < 0.05 Progression-free survival data was immature, but trending in favor of pirtobrutinib BRUIN CLL-314 is the first-ever head-to-head Phase 3 study versus a covalent BTK inhibitor to include treatment-naïve patients INDIANAPOLIS, July 29, 2025 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY)...Read more


Avidity Biosciences Announces Completion of Enrollment for HARBOR™, the First Global Phase 3 Trial of Delpacibart Etedesiran (del-desiran) for Treatment of DM1 and Provides Guidance on Regulatory Submission

July 28
Last Trade: 50.36 2.77 5.82

Topline data readout from HARBOR study anticipated in Q2 2026 Marketing application submissions for del-desiran including in U.S., EU and Japan anticipated to start in H2 2026; on track to potentially be the first globally approved drug for DM1 On track to share updates from ongoing MARINA-OLE™ trial of del-desiran including long-term 4 mg/kg efficacy and safety data in Q4 2025  SAN DIEGO, July 28, 2025 /PRNewswire/ --...Read more


Celcuity Announces Clinically Meaningful Improvement in Both Progression-Free Survival (“PFS”) Primary Endpoints from PIK3CA Wild-Type Cohort of Phase 3 VIKTORIA-1 Trial 

July 28
Last Trade: 55.69 1.48 2.73

Hazard Ratios and Improvements in Median PFS are Unprecedented in HR+/HER2- Advanced Breast Cancer (“ABC”) Gedatolisib + palbociclib + fulvestrant (“gedatolisib triplet”) reduced the risk of disease progression or death by 76% vs. fulvestrant (HR=0.24; 95% CI: 0.17–0.35; p<0.0001). Median PFS was 9.3 months with the gedatolisib triplet versus 2.0 months with fulvestrant Gedatolisib + fulvestrant (“gedatolisib doublet”) reduced...Read more


Celcuity Announces First Patient Dosed in Phase 3 VIKTORIA-2 Clinical Trial of Gedatolisib as a First-Line Treatment for HR+/HER2- Advanced Breast Cancer

July 24
Last Trade: 55.69 1.48 2.73

MINNEAPOLIS, July 24, 2025 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced that the first patient has been dosed in VIKTORIA-2, its Phase 3 clinical trial evaluating gedatolisib plus a CDK4/6 inhibitor and fulvestrant as first-line treatment for patients with HR+/HER2- advanced breast cancer (“ABC”) who are endocrine therapy...Read more


Annexon Announces Completion of Enrollment in Pivotal Phase 3 ARCHER II Trial of Vonaprument (formerly ANX007) for Dry Age-Related Macular Degeneration (AMD) with Geographic Atrophy

July 24
Last Trade: 2.17 0.12 5.85

Expedited Enrollment Surpassing 630 Targeted Participants Underscores the Strong Demand for a Therapy Focused on Vision Preservation Phase 3 ARCHER II Trial Design and Rationale to Be Presented at ASRS, a Leading Meeting for Retina Science and Innovation Topline Pivotal Phase 3 Data Expected in the Second Half of 2026 Potential for Vonaprument to Be the First Treatment Approved in Europe and the U.S. for Dry AMD with Geographic...Read more


Abivax Announces Positive Phase 3 Results from Both ABTECT 8-Week Induction Trials Investigating Obefazimod, its First-in-Class Oral miR-124 Enhancer, in Moderate to Severely Active Ulcerative Colitis 

July 22
Last Trade: 88.03 4.38 5.24

Abivax Announces Positive Phase 3 Results from Both ABTECT 8-Week Induction Trials Investigating Obefazimod, its First-in-Class Oral miR-124 Enhancer, in Moderate to Severely Active Ulcerative Colitis   50 mg once-daily dose of obefazimod led to a compelling pooled 16.4% (p<0.0001) placebo-adjusted clinical remission rate at Week 8 in the ABTECT-1 (Study 105) and ABTECT-2 (Study 106) trials. Individually, the 50 mg dose...Read more


AstraZeneca: TAGRISSO® (osimertinib) plus chemotherapy demonstrated statistically significant and clinically meaningful improvement in overall survival in EGFR-mutated advanced lung cancer

July 21
Last Trade: 81.70 -0.41 -0.50

Longer-term follow up in the FLAURA2 Phase III trial confirms the favorable benefit-risk profile of this combination Overall survival results reinforce TAGRISSO as the backbone therapy in EGFRm lung cancer across stages WILMINGTON, Del. / Jul 21, 2025 / Business Wire / Positive high-level results from the final overall survival (OS) analysis of the FLAURA2 Phase III trial showed AstraZeneca’s TAGRISSO® (osimertinib) with the addition...Read more


Nuvalent Announces Initiation of ALKAZAR Phase 3 Randomized, Controlled Trial Evaluating Neladalkib for Patients with TKI-naïve ALK-positive NSCLC

July 21
Last Trade: 80.89 1.35 1.70

CAMBRIDGE, Mass., July 21, 2025 /PRNewswire/ -- Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced that the first patient has been dosed in ALKAZAR, the company's global Phase 3 randomized, controlled trial evaluating neladalkib for TKI-naïve patients with advanced ALK-positive non-small cell...Read more


Bristol Myers Squibb Announces Topline Results from Phase 3 INDEPENDENCE Trial for Reblozyl® (luspatercept-aamt) in Adult Patients with Myelofibrosis-Associated Anemia

July 18
Last Trade: 47.14 -0.36 -0.76

PRINCETON, N.J. / Jul 18, 2025 / Business Wire / Bristol Myers Squibb (NYSE: BMY) today announced the Phase 3 INDEPENDENCE trial evaluating Reblozyl® (luspatercept-aamt) with concomitant janus kinase inhibitor (JAKi) therapy in adult patients with myelofibrosis-associated anemia receiving red blood cell (RBC) transfusions did not meet its primary endpoint of RBC transfusion independence during any consecutive 12-week period, starting within...Read more


Viatris Provides Update on Phase 3 Study of MR-139 for Blepharitis

July 18
Last Trade: 10.50 -0.05 -0.47

PITTSBURGH, July 18, 2025 /PRNewswire/ -- Viatris Inc. (Nasdaq: VTRS), a global healthcare company, today announced that a randomized, double-masked, vehicle-controlled, Phase 3 study to evaluate the efficacy and safety of pimecrolimus 0.3% (MR-139) ophthalmic ointment in subjects with blepharitis, did not meet its primary endpoint of complete resolution of debris after six weeks of twice daily dosing. Viatris Chief R&D Officer...Read more


Keros Therapeutics Announces the First Patient Dosing in the Phase 3 RENEW Clinical Trial of Elritercept

July 17
Last Trade: 15.59 -0.17 -1.08

Milestone payment of $10 million triggered under the global license agreement with Takeda LEXINGTON, Mass., July 17, 2025 (GLOBE NEWSWIRE) -- Keros Therapeutics, Inc. (“Keros”) (Nasdaq: KROS), a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapeutics to treat a wide range of patients with disorders that are linked to dysfunctional signaling of the transforming growth factor-beta (“TGF-ß”)...Read more


Ensysce Biosciences Initiates Pivotal Phase 3 Study of PF614 - A Next-Generation Opioid - Designed to Deliver Powerful Pain Relief and Reduce Abuse

July 16
Last Trade: 2.14 -0.04 -1.61

FDA Protocol Review Completed Rho, Inc. Selected as Clinical Research Partner SAN DIEGO, CA / ACCESS Newswire / July 16, 2025 / Ensysce Biosciences, Inc. (NASDAQ:ENSC) ("Ensysce" or the "Company"), a clinical-stage pharmaceutical company pioneering novel solutions for severe pain with built-in abuse and overdose protection, today announced the initiation of its pivotal Phase 3 study of PF614, the Company's lead product...Read more


Quince Therapeutics Completes Enrollment in Pivotal Phase 3 NEAT Clinical Trial in Ataxia-Telangiectasia

July 16
Last Trade: 1.61 0.00 0.00

SOUTH SAN FRANCISCO, Calif. / Jul 16, 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 the company has completed enrollment in its pivotal Phase 3 NEAT (Neurological Effects of eDSP on Subjects with A-T; NCT06193200/IEDAT-04-2022) clinical trial to evaluate its lead asset,...Read more


BriaCell Therapeutics Adds Mayo Clinic to Phase 3 Study in Metastatic Breast Cancer

July 15
Last Trade: 7.87 -0.38 -4.61

PHILADELPHIA and VANCOUVER, British Columbia, July 15, 2025 (GLOBE NEWSWIRE) -- BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW, BCTXZ) (TSX: BCT) (“BriaCell” or the “Company”), a clinical-stage biotechnology company developing novel immunotherapies to transform cancer care, is pleased to announce the addition of a key clinical site, Mayo Clinic, to its ongoing pivotal Phase 3 clinical study (ClinicalTrials.gov as NCT06072612) in...Read more


Ascendis Pharma: New 3-Year Phase 3 Data Confirmed Sustained Response to TransCon® PTH (Palopegteriparatide) Therapy in Adults with Hypoparathyroidism, Including Improvements in Biochemistries, Kidney Function, and Quality of Life

July 14
Last Trade: 205.91 5.89 2.94

COPENHAGEN, Denmark, July 14, 2025 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced new data from Week 156 of its Phase 3 PaTHway Trial confirming that long-term treatment with TransCon PTH (palopegteriparatide) continued to provide a durable response in adults with hypoparathyroidism regardless of its cause (post-surgical, autoimmune, genetic, or idiopathic), including improvements in biochemistries, kidney...Read more


Daré Bioscience: Positive Interim Phase 3 Results Highlight Potential of Ovaprene®, Novel Hormone-Free Contraceptive

July 14
Last Trade: 2.15 0.11 5.39

Interim Phase 3 Results Support Ovaprene’s Differentiation as a First-in-Category, Hormone-Free, Intravaginal Monthly Contraceptive SAN DIEGO, July 14, 2025 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ: DARE), a biopharmaceutical company driven by a mission to challenge the status quo, making women's health a priority, today announced positive interim safety and efficacy results from its ongoing Phase 3 clinical trial...Read more


AstraZeneca: Baxdrostat met the primary and all secondary endpoints in BaxHTN Phase III trial in patients with uncontrolled or treatment resistant hypertension

July 14
Last Trade: 81.70 -0.41 -0.50

Baxdrostat demonstrated a statistically significant and clinically meaningful reduction of systolic blood pressure compared with placebo WILMINGTON, Del. / Jul 14, 2025 / Business Wire / Positive high-level results from the BaxHTN Phase III trial showed baxdrostat at two doses (2mg and 1mg) demonstrated a statistically significant and clinically meaningful reduction in mean seated systolic blood pressure (SBP) compared with placebo at...Read more


Takeda Announces Positive Results from Two Pivotal Phase 3 Studies of Oveporexton (TAK-861) in Narcolepsy Type 1

July 14
Last Trade: 15.40 0.25 1.65

Both Phase 3 Studies Met all Primary and Secondary Endpoints Demonstrating Statistically Significant Improvements Across Symptoms at All Doses, Building Upon Phase 2b Results Oveporexton was Generally Well-Tolerated in Phase 3 Safety Profile Takeda is Rapidly Advancing Regulatory Submissions and Launch Preparedness with the Aim to Bring Oveporexton to People Living with Narcolepsy Type 1 as Quickly as Possible These Results Mark a...Read more


Merck to Initiate Phase 3 Trials for Investigational Once-Monthly HIV Prevention Pill

July 14
Last Trade: 84.71 0.53 0.63

In collaboration with the Gates Foundation, Merck advances MK-8527 pre-exposure prophylaxis (PrEP) clinical trials globally RAHWAY, N.J. / Jul 14, 2025 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the initiation of the EXPrESSIVE Phase 3 clinical trials, evaluating the safety and efficacy of MK-8527, an investigational once-monthly, oral nucleoside reverse transcriptase...Read more


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: 24.84 0.05 0.20

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: 31.82 0.27 0.86

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: 0.37 -0.0035 -0.93

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: 29.08 1.27 4.57

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: 18.88 -0.49 -2.53

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: 129.73 1.50 1.17

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: 7.27 0.80 12.36

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: 7.87 -0.38 -4.61

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: 65.74 2.23 3.51

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: 3.79 0.17 4.70

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: 30.76 -0.54 -1.73

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: 283.64 -0.21 -0.07

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: 140.67 -0.95 -0.67

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: 25.14 1.09 4.53

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: 24.84 0.05 0.20

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: 2.89 -0.01 -0.34

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: 10.50 -0.05 -0.47

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: 5.65 -0.04 -0.70

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: 9.62 0.08 0.84

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: 27.19 0.36 1.34

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: 3.37 -0.10 -2.88

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: 150.27 0.07 0.05

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


Sign Up To Get Daily
Life Science News

Please review our Disclaimer and Privacy Policy before subscribing.

Featured Stock

Immix Biopharma

Immix Biopharma is a clinical-stage biopharmaceutical company pioneering a novel class of CAR-T cell therapies and Tissue-Specific Therapeutics targeting oncology and immuno-dysregulated diseases with >75 patients treated to-date. Our lead cell therapy asset is NXC-201...

CLICK TO LEARN MORE