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Biofrontera Announces Last Patient Out in Phase 3 Study of Ameluz® (aminolevulinic acid HCI) Topical Gel, 10% Photodynamic Therapy (PDT) for the Treatment of Actinic Keratoses (AK) on the Extremities, Neck and Trunk

September 16
Last Trade: 0.86 0.03 3.04

All 172 patients have now entered the 12-month follow-up phase Trial involves larger surface areas, building on the approval in October 2024 for use of up to 3 tubes of Ameluz® per treatment Study results expected to form the basis of a supplemental New Drug Application (sNDA) planned for submission in Q2 2026 WOBURN, Mass., Sept. 16, 2025 (GLOBE NEWSWIRE) -- Biofrontera Inc. (Nasdaq: BFRI) (“Biofrontera” or the “Company”), a...Read more


Aptevo Therapeutics: Mipletamig Delivers 100% Remission Rate in Cohort 3 of RAINIER Trial for AML

September 16
Last Trade: 1.87 0.43 29.86

No dose-limiting toxicities or cytokine release syndrome observed in RAINIER to date; mipletamig shows consistently favorable safety and tolerability Trial progressing efficiently, Cohort 4 open for enrollment SEATTLE, WA / ACCESS Newswire / September 16, 2025 / Aptevo Therapeutics ("Aptevo" or "the Company") (NASDAQ:APVO), a clinical-stage biotechnology company developing novel bispecific and trispecific immuno-oncology...Read more


Lantern Pharma’s LP-184 Phase 1a Clinical Trial Achieves All Primary Endpoints with Robust Safety Profile and Promising Antitumor Activity in Multiple Advanced Solid Tumors

September 16
Last Trade: 4.21 0.40 10.37

LP-184 achieves all primary endpoints and demonstrates a favorable safety and tolerability profile positioning it for both monotherapy or synergistic combinations with PARP inhibitors and immunotherapies. Clinical benefit observed in 48% of evaluable cancer patients at or above the therapeutic dose threshold. Durable clinical benefits were observed in hard-to-treat tumors like glioblastoma multiforme (GBM), gastrointestinal stromal...Read more


Coya Therapeutics' COYA 303 Shows Promising Central Nervous System (CNS) Anti-inflammatory Effects and Systemic Regulatory T Cell (Treg) Enhancing Effects in a Preclinical Animal Inflammation Model

September 16
Last Trade: 5.63 -0.05 -0.88

COYA 303 is an investigational proprietary combination of LD-IL-2 and GLP-1RA for subcutaneous administration, under development for the treatment of diseases, including Alzheimer's Disease, driven by chronic and sustained inflammation; COYA 303 demonstrated significant attenuation of neuroinflammation in cortex and hippocampus brain regions and upregulation of anti-inflammatory markers, and significant improvement of systemic Treg...Read more


Pasithea Therapeutics Announces Activation of Clinical Trial Sites in South Korea for Phase 1/1b Trial of PAS-004 in Adult NF1 Patients

September 16
Last Trade: 0.74 -0.03 -4.29

First patient in South Korea dosed MIAMI, Sept. 16, 2025 (GLOBE NEWSWIRE) -- Pasithea Therapeutics Corp. (NASDAQ: KTTA) (“Pasithea” or the “Company”), a clinical-stage biotechnology company developing PAS-004, a next-generation macrocyclic MEK inhibitor today announced activation of two South Korean clinical trial sites participating in its Phase 1/1b open label study to assess the safety, tolerability, pharmacokinetics (PK) and...Read more


Oncolytics Biotech Provides Update on GOBLET Study Progress and U.S. Site Expansion

September 16
Last Trade: 1.23 -0.01 -1.13

SAN DIEGO, Sept. 16, 2025 /CNW/ -- Oncolytics Biotech® Inc. (Nasdaq: ONCY) ("Oncolytics" or the "Company"), a clinical-stage immunotherapy company developing pelareorep, today announced updates on enrollment progress, U.S. site expansion, and expected data readouts from the ongoing GOBLET trial evaluating pelareorep in gastrointestinal cancers. The study is supported in part by a grant from the Pancreatic Cancer Action Network...Read more


Medtronic initiates global pivotal study of cardiac pacing in a new patient population

September 15
Last Trade: 94.79 1.35 1.44

Study to evaluate whether a new approach to pacing the heart can improve the lives of patients with heart failure with preserved ejection fraction (HFpEF) who have limited treatment options today GALWAY, Ireland, Sept. 15, 2025 /PRNewswire/ -- Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced the initiation of a pivotal study evaluating the use of elevated and personalized cardiac pacing rates for...Read more


Spyre Therapeutics Doses First Patient in Pioneering Phase 2 SKYWAY Basket Trial of SPY072, the First Anti-TL1A Antibody Studied in Rheumatic Diseases

September 15
Last Trade: 15.10 0.26 1.75

SPY072 is a potential first- and best-in-class anti-TL1A antibody for rheumatic diseases targeting quarterly or twice-yearly subcutaneous dosing SKYWAY study is evaluating SPY072 in patients with moderate-to-severely active rheumatoid arthritis (RA), psoriatic arthritis (PsA), and axial spondyloarthritis (axSpA) Proof-of-concept data for all three indications are expected in 2026 SKYLINE and SKYWAY trials are expected to provide 9...Read more


aTyr Pharma Announces Topline Results from Phase 3 EFZO-FIT™ Study of Efzofitimod in Pulmonary Sarcoidosis

September 15
Last Trade: 1.15 0.14 13.86

Study did not meet primary endpoint in change from baseline in mean daily oral corticosteroid (OCS) dose at week 48, although clinical benefit for efzofitimod observed across multiple study parameters. 52.6% of patients treated with 5.0 mg/kg efzofitimod achieved complete steroid withdrawal at week 48 vs 40.2% on placebo (p=0.0919). Clinical improvement in King’s Sarcoidosis Questionnaire (KSQ)-Lung score at week 48 observed in the...Read more


Viridian Therapeutics Announces Completion of Enrollment in both REVEAL Clinical Trials and Positive Portfolio Updates

September 15
Last Trade: 18.71 0.70 3.89

Enrollment complete in VRDN-003’s phase 3 clinical trials in thyroid eye disease (TED), REVEAL-1 and REVEAL-2, with each study exceeding its enrollment target due to strong patient demand; topline data on track for first half of 2026  VRDN-003 composition of matter patent granted by the USPTO with term to 2041 and potential to extend exclusivity  Veligrotug Biologics License Application (BLA) submission on track and...Read more


Perspective Therapeutics Progresses Dose Finding for [212Pb]VMT01 in Combination with Nivolumab in its Ongoing Phase 1/2a Study of MC1R-Positive Metastatic Melanoma

September 15
Last Trade: 3.40 -0.17 -4.76

First patient dosed with [212Pb]VMT01 3.0 mCi in combination with nivolumab [212Pb]VMT01 3.0 mCi single agent dose Cohort re-opened SEATTLE, Sept. 15, 2025 (GLOBE NEWSWIRE) -- Perspective Therapeutics, Inc. ("Perspective" or the "Company") (NYSE AMERICAN: CATX), a radiopharmaceutical company that is pioneering advanced treatments for cancers throughout the body, announced today that the first patient was dosed in a new cohort...Read more


Belite Bio Announces Completion of DRAGON, a 2-Year, Phase 3 Trial of Oral Tinlarebant in the Treatment of Stargardt Disease

September 12
Last Trade: 66.89 0.27 0.41

Tinlarebant has been granted Breakthrough Therapy, Fast Track, and Rare Pediatric Disease Designations in the U.S.; Orphan Drug Designation in the U.S., Europe, and Japan; and Pioneer Drug Designation in Japan for Stargardt disease Last subject visit completed in the pivotal Phase 3 DRAGON trial of Tinlarebant in Stargardt disease Topline data expected in Q4 2025 SAN DIEGO, Sept. 12, 2025 (GLOBE NEWSWIRE) -- Belite Bio...Read more


OS Therapies Announces Last Patient Enrolled in OST-504 (previously ADXS-504) Phase 1b Prostate Cancer Clinical Trial Completes Last Visit

September 12
Last Trade: 2.26 0.06 2.73

Clinical data from Phase 1b prostate cancer trial to be released in Q4/25 Additionally, updated 2-year overall survival data from all 40 patients in the Phase 2b clinical trial of OST-HER2 in the prevention of delay of recurrent, fully resected, pulmonary metastatic osteosarcoma to be released on October 10, 2025 New York, New York--(Newsfile Corp. - September 12, 2025) - OS Therapies Inc. (NYSE American: OSTX) ("OS Therapies" or...Read more


MAIA Biotechnology Highlights Positive Efficacy Data from THIO-101 Phase 2 Clinical Trial in Non-Small Cell Lung Cancer

September 11
Last Trade: 1.66 -0.05 -2.92

CHICAGO, Sept. 11, 2025 (GLOBE NEWSWIRE) -- MAIA Biotechnology, Inc. (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer, today highlighted positive efficacy data from its Phase 2 clinical trial, THIO-101, evaluating ateganosine (THIO) sequenced with the immune checkpoint inhibitor (CPI) cemiplimab (Libtayo®) in patients with advanced non-small...Read more


GRI Bio Reports 6-Week Interim Lung Function Data in Ongoing Phase 2a Study in Idiopathic Pulmonary Fibrosis (“IPF”)

September 11
Last Trade: 2.02 0.16 8.60

No decline in lung function observed at 6-week interim analysis builds upon positive safety and biomarker data Phase 2a study fully enrolled; Topline data on track for Q3 2025 Currently available treatments for IPF are limited to only two approved drugs that come with significant side-effects, limited patient compliance and no impact on survival LA JOLLA, CA, Sept. 11, 2025 (GLOBE NEWSWIRE) -- GRI Bio, Inc. (NASDAQ: GRI) (“GRI...Read more


Smith+Nephew unveils major clinical evidence and patient access updates for its REGENETEN™ Bioinductive Implant

September 11
Last Trade: 37.49 0.10 0.27

Smith+Nephew (LSE:SN, NYSE:SNN), the global medical technology company, today announces new evidence and market updates that highlight the clinical performance of its REGENETEN Bioinductive Implant and support its further adoption. Substantial investment into research to expand access and indications have led to these important results designed to help surgeons treat more patients who suffer from rotator cuff tears and other tendon and...Read more


Maze Therapeutics Announces Positive First-in-Human Results from Phase 1 Trial of MZE782, Establishing Proof of Mechanism for a Potent, Oral SLC6A19 Inhibitor with Potential to Treat Phenylketonuria (PKU) and Chronic Kidney Disease (CKD)

September 11
Last Trade: 0 0.00 0.00

Phase 1 data in healthy volunteers exceed expectations and support best-in-class potential, enabling Phase 2 advancement for both intended indications of PKU and CKD Dose-dependent urinary amino acid excretion demonstrated across all SAD and MAD cohorts, including up to a 42-fold increase in urinary phenylalanine (Phe) excretion, a well-validated biomarker for PKU and predictive for CKD Dose-dependent initial eGFR dip similar to SGLT2...Read more


PureTech Health Founded Entity Seaport Therapeutics Advances Second Therapeutic Candidate into Clinical Development with Dosing of First Participant in Phase 1 Study of GlyphAgo™ (SPT-320) in Healthy Volunteers

September 11
Last Trade: 15.39 0.00 0.00

GlyphAgo is an oral prodrug of agomelatine, a medicine with established clinical efficacy in generalized anxiety disorder (GAD) GlyphAgo is designed to overcome a key limitation of agomelatine by shifting absorption toward the intestinal lymphatics, avoiding first-pass liver metabolism, and increasing systemic exposure of the drug Phase 1 proof-of-concept study will evaluate the safety, tolerability, and pharmacokinetics of GlyphAgo and...Read more


Silexion Therapeutics Reports Positive Preclinical Data Demonstrating SIL204’s Reach and Activity in Major Pancreatic Cancer Metastatic Sites Following Systemic Administration

September 11
Last Trade: 3.56 -0.06 -1.52

New Positive Preclinical Data Shows Succesful Drug Distribution to Liver, Peritoneum, and Lung with Measurable Reductions in Tumor Burden at Clinically Relevant Doses Results Provide Further Validation of the Systemic Component of a Dual-Route Administration Strategy Enabeling Potential Targeting of Both Primary Tumors and Metastatic Disease  Silexion Remains on Track for Phase 2/3 Trial Initiation in H1 2026 Following Planned Q4...Read more


Merck: CAPVAXIVE® (Pneumococcal 21-valent Conjugate Vaccine) Demonstrates Positive Immune Responses in Children and Adolescents at Increased Risk of Pneumococcal Disease

September 11
Last Trade: 80.72 -0.30 -0.37

Results from the Phase 3 STRIDE-13 trial presented at the 6th ESCMID Conference on Vaccines Merck to share STRIDE-13 results with global regulatory authorities RAHWAY, N.J. / Sep 11, 2025 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced positive results from the Phase 3 STRIDE-13 trial evaluating CAPVAXIVE® (Pneumococcal 21-valent Conjugate Vaccine) at the 6th European Society...Read more


Teleflex: First Patient Enrolled in DUBSTENT DIABETES Trial: Targeting Improved PCI Outcomes for Diabetic Patients

September 11
Last Trade: 126.96 1.06 0.84

The Trial Evaluates a Combined PCI Approach Using Drug-Coated Balloons and Drug-Eluting Stents WAYNE, Pa., Sept. 11, 2025 (GLOBE NEWSWIRE) -- Teleflex Incorporated (NYSE:TFX), a leading global provider of medical technologies, today announced the enrollment of the first patient in the DUBSTENT DIABETES trial. The randomized, investigator-initiated clinical study will evaluate a dual-device strategy for percutaneous coronary...Read more


Vaxart Reports Additional Phase 1 Data Supporting the Potential Efficacy of its Second-Generation Norovirus Oral Pill Vaccine Candidate

September 10
Last Trade: 0.37 0.01 3.00

Second-generation constructs induce robust increases in fecal IgA, which was shown to be correlated with protection against infection in the company’s previous Phase 2b challenge study  SOUTH SAN FRANCISCO, Calif., Sept. 10, 2025 (GLOBE NEWSWIRE) -- Vaxart, Inc. (OTCQX: VXRT), a clinical-stage biotechnology company developing a range of oral recombinant pill vaccines based on its proprietary delivery platform, today reported...Read more


Personalis: CATE Clinical Trial Launched to Demonstrate the Clinical Utility of ctDNA-Guided Treatment in Breast Cancer Using the Ultrasensitive NeXT Personal Test

September 10
Last Trade: 5.83 -0.10 -1.69

FREMONT, Calif. / Sep 10, 2025 / Business Wire / Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for precision oncology, today announced its collaboration with a leading breast cancer team from Yale Cancer Center for a clinical trial titled “A single arm phase II trial of circulating tumor DNA-guided adjuvant therapy with elacestrant in hormone receptor positive HER2 negative breast cancers at risk for late recurrence...Read more


Revolution Medicines Shares New Clinical Results Supporting Initiation of RASolute 303, a Global Phase 3 Registrational Trial of Daraxonrasib in First Line Metastatic Pancreatic Ductal Adenocarcinoma

September 10
Last Trade: 46.20 -0.01 -0.02

Long-term follow-up data for daraxonrasib monotherapy in second line metastatic pancreatic ductal adenocarcinoma reinforces promising clinical activity and durability Highly encouraging initial clinical results for daraxonrasib monotherapy and daraxonrasib plus chemotherapy in first line metastatic pancreatic ductal adenocarcinoma support planned initiation of three-arm Phase 3 trial in Q4 2025 Revolution Medicines to host webcast...Read more


Intensity Therapeutics Reports INVINCIBLE-4, Presurgical Triple-Negative Breast Cancer Study Update

September 10
Last Trade: 0.24 0.0016 0.68

A pathological complete response ("pCR") has been observed in the first patient evaluated in Cohort A, where each patient receives two doses of INT230-6 eight days apart, followed by the standard of care immunochemotherapy ("SOC") Safety looks favorable in Cohort A Some INT230-6 patients begin to show localized skin irritation, and new patient enrollment has been paused to implement modifications to resolve the issue Patients being...Read more


Arrowhead Pharmaceuticals Requests Regulatory Clearance to Initiate Phase 1/2a Study of ARO-MAPT for the Treatment of Alzheimer’s Disease and Other Tauopathies

September 10
Last Trade: 28.71 0.04 0.14

In preclinical studies presented today at the RNA Leaders USA Congress 2025, investigational ARO-MAPT demonstrated potent and long-lasting MAPT mRNA and Tau protein suppression with uniform distribution throughout the CNS after subcutaneous administration in non-human primates PASADENA, Calif. / Sep 10, 2025 / Business Wire / Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced that it has filed a request for regulatory...Read more


Avidity Biosciences' Del-zota Demonstrated Reversal of Disease Progression Across Key Functional Endpoints in EXPLORE44® and EXPLORE44-OLE™ Phase 1/2 Trial in People Living with DMD44

September 10
Last Trade: 40.92 0.70 1.74

Unprecedented improvement compared to baseline and natural history in multiple functional measures including Time to Rise from Floor (TTR), 4-Stair Climb (4SC), Performance of Upper Limb (PUL) and 10-Meter Walk/Run Test (10mWRT) at approximately one year  Unprecedented rapid reduction in creatine kinase (CK) to near normal levels maintained over 16 months of follow-up and 25% increase of normal in dystrophin production, reflecting...Read more


Karyopharm Therapeutics Announces Completion of Enrollment in the Phase 3 SENTRY Trial in Myelofibrosis

September 10
Last Trade: 6.29 0.03 0.48

Top-Line Results Anticipated in March 2026  NEWTON, Mass., Sept. 10, 2025 /PRNewswire/ -- Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today announced that it has completed enrollment in the Phase 3 SENTRY trial, which is evaluating selinexor in combination with ruxolitinib in JAKi-naïve myelofibrosis patients. "We are excited to announce that we have...Read more


PMV Pharmaceuticals Announces Promising Rezatapopt Monotherapy Interim Data From PYNNACLE Phase 2 Trial Across Multiple Solid Tumors With a TP53 Y220C Mutation

September 10
Last Trade: 1.23 0.09 7.89

PYNNACLE Phase 2 pivotal clinical trial interim data include confirmed responses observed in eight tumor types spanning ovarian, lung, breast, endometrial, head and neck, colorectal, gallbladder, and ampullary carcinoma 33% overall response rate (ORR) observed among 97 evaluable patients across all cohorts with a median duration of response of 6.2 months 43% ORR observed among 44 evaluable patients in ovarian cancer cohort with a...Read more


BioXcel Therapeutics Reports Positive Topline Exploratory Efficacy Data from SERENITY At-Home Pivotal Phase 3 Safety Trial for Agitation Associated with Bipolar Disorders or Schizophrenia

September 10
Last Trade: 3.08 -0.10 -3.00

BXCL501 demonstrated a significant mean reduction in mCGI-S score from baseline compared to placebo at 2 hours across 2,433 treated episodes (p<.05) Complete resolution of agitation was significantly higher with BXCL501 compared to placebo across agitation episode severity (p<.0001) BXCL501 showed a similar reduction in agitation symptoms over both the duration of the trial and number of treated episodes, demonstrating continued...Read more


Telix Pharmaceuticals Doses First Patient in Phase 3 BiPASS Trial: PSMA-PET Imaging for Prostate Cancer Diagnosis

September 9
Last Trade: 9.37 -0.14 -1.47

MELBOURNE, Australia and INDIANAPOLIS, Sept. 10, 2025 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, “Telix”) today announces it has dosed the first patient in a Phase 3 clinical trial aimed at expanding the indications for Illuccix® and Gozellix® (kits for the preparation of gallium-68 (68Ga) gozetotide injection) to include prostate cancer diagnosis. BiPASS™ (Biopsy of the Prostate Avoidance Stratification...Read more


Moleculin Biotech Accelerates Recruitment in Phase 3 Acute Myeloid Leukemia “MIRACLE” Clinical Trial

September 9
Last Trade: 0.37 -0.0057 -1.53

European expansion in September across Georgia, Italy, Lithuania, Poland, Romania, Spain, and US 13 subjects recruited (treated, enrolled, or screened) Forecasts total recruitment of 20 or more subjects by end of September On track to recruit to 45 patients in Q4 25 for initial data unblinding HOUSTON, Sept. 09, 2025 (GLOBE NEWSWIRE) -- Moleculin Biotech, Inc., (Nasdaq: MBRX) (“Moleculin” or the “Company”), a late-stage...Read more


Revelation Biosciences Announces Groundbreaking Top-line Results from PRIME Clinical Study

September 9
Last Trade: 1.64 0.08 4.81

Gemini normalized the inflammatory response at the cellular level in stage 3 and 4 CKD patients  Gemini could potentially revolutionize the treatment of acute and chronic inflammatory disease  Data discussion webcast/conference call will be held on Wednesday, September 10th at 8:30 am Eastern Time SAN DIEGO, CA / ACCESS Newswire / September 9, 2025 / Revelation Biosciences, Inc. (NASDAQ:REVB) (the "Company" or...Read more


Telomir Pharmaceuticals Announces New Cancer Data in Aggressive Human Prostate Cancer Cells Showing Telomir-1 Resets DNA Methylation to Reactivate CDKN2A, a Master Tumor Suppressor, Outperforming Rapamycin and Chemotherapy

September 9
Last Trade: 1.32 -0.006 -0.45

New preclinical findings highlight Telomir-1's ability to reverse CDKN2A gene silencing by DNA methylation, reactivating this gene - often called the body's natural "cell cycle brake." These results build on prior STAT1 data, supporting Telomir-1's profile as a potential first-in-class broad-spectrum DNA methylation reset therapy. MIAMI, FLORIDA / ACCESS Newswire / September 9, 2025 / Telomir Pharmaceuticals, Inc. (NASDAQ:TELO), a...Read more


HCW Biologics Reports Positive Results from Non-Human Primate Study for Its Proprietary Second-Generation T-Cell Engager Program

September 9
Last Trade: 4.84 -0.06 -1.22

HCW Biologics conducted investigative study to show safe dose levels of its lead drug candidate in non-human primates that were well tolerated at a level significantly higher than the identified efficacious dose level Program has addressed key challenges for first generation T-cell engagers related to manufacturability, preclinical safety profile, and ability to treat a wide spectrum of solid tumors Program is positioned...Read more


Xilio Therapeutics Announces Initiation of Phase 2 Trial for Efarindodekin Alfa (XTX301), a Tumor-Activated IL-12, and Achievement of $17.5 Million Development Milestone Under Exclusive License Agreement with Gilead

September 9
Last Trade: 0.75 -0.0007 -0.09

Phase 1 data for efarindodekin alfa (XTX301) demonstrate promising anti-tumor activity in patients with advanced solid tumors Achievement of milestone extends anticipated cash runway into first quarter of 2027 WALTHAM, Mass., Sept. 09, 2025 (GLOBE NEWSWIRE) -- Xilio Therapeutics, Inc. (Nasdaq: XLO), a clinical-stage biotechnology company discovering and developing tumor-activated immuno-oncology therapies for people living with...Read more


Anavex Life Sciences Announces Oral Blarcamesine Cognitive Resilience Results Approximating Normal Aging in New Precision Medicine Clinical Data from Phase IIb/III Alzheimer’s Disease Trial

September 9
Last Trade: 9.12 0.03 0.33

New clinical Precision Medicine population 48-week data demonstrates unprecedented cognitive stabilization in early Alzheimer’s disease Cognitive outcomes observed in the oral blarcamesine 30 mg Precision Medicine cohort move toward normal aging profiles across validated clinical scales, supporting its relevance in early-stage Alzheimer’s care 84.7% reduction in decline at 48 weeks of blarcamesine treatment vs placebo on the primary...Read more


Regeneron Pharmaceuticals: Libtayo® (cemiplimab) Plus Chemotherapy Results at Five Years Reinforce Significant and Durable Improvements in Survival Outcomes for Advanced Non-small Cell Lung Cancer

September 9
Last Trade: 573.37 0.78 0.14

Late-breaking data from exploratory analyses at WCLC show Libtayo plus chemotherapy demonstrates a more than double five-year overall survival rate of 19.4%, compared to 8.8% with chemotherapy alone In a five-year analysis, consistent efficacy was observed across histologies with especially notable benefit in the squamous patient population where median overall survival was 22.3 months TARRYTOWN, N.Y., Sept. 09, 2025 (GLOBE...Read more


Amgen and Kyowa Kirin Announce Top-Line Results From Rocatinlimab Phase 3 Ascend Long-Term Extension Study in Adults with Moderate to Severe Atopic Dermatitis

September 8
Last Trade: 274.56 0.16 0.06

THOUSAND OAKS, Calif. and TOKYO, Sept. 8, 2025 /PRNewswire/ -- Amgen (NASDAQ: AMGN) and Kyowa Kirin Co., Ltd. (TSE: 4151) today announced preliminary top-line results from the ASCEND study evaluating rocatinlimab, an investigational T-cell rebalancing therapy targeting the OX40 receptor, in adults and adolescents with moderate to severe atopic dermatitis (AD). The ongoing ASCEND study, which includes approximately 2,600...Read more


Ultragenyx Pharmaceutical Announces Positive Longer-term Data from Phase 3 Study of DTX401 AAV Gene Therapy for the Treatment of Glycogen Storage Disease Type Ia (GSDIa)

September 8
Last Trade: 29.66 0.66 2.28

At Week 96 participants experienced even greater reductions in daily cornstarch intake while maintaining low levels of hypoglycemia, improved levels of euglycemia and improved fasting tolerance Phase 3 results are further supported by early data from open-label Japanese cohort (n=3) where all participants were able to eliminate daily cornstarch while maintaining or improving glycemic control DTX401 was well tolerated with an...Read more


First Disclosure of Global Interim Phase 2 Data for BioNTech and Bristol Myers Squibb PD-L1xVEGF-A Bispecific Antibody Pumitamig (BNT327/BMS986545) in Patients with Extensive-Stage Small Cell Lung Cancer Shows Encouraging Antitumor Activity

September 8
Last Trade: 99.85 1.97 2.01

PD-L1xVEGF-A bispecific antibody pumitamig (BNT327/BMS986545) plus chemotherapy continues to show encouraging antitumor activity in patients with extensive-stage small cell lung cancer (”ES-SCLC”), expanding evidence for its potential to set a new standard of care in first-line ES-SCLC and beyond Global interim Phase 2 data showed a 76.3% confirmed objective response rate (cORR), 100% disease control rate (DCR), a median progression...Read more


CASI Pharmaceuticals Announces Safety Monitoring Committee Recommendation to Escalate CID-103 Dose to Next Cohort in Phase 1 Immune Thrombocytopenia (ITP) Study

September 8
Last Trade: 2.11 0.02 0.96

CID-103 is a potential best-in-class, clinical stage anti-CD38 monoclonal antibody Safety profile observed in first four dose cohorts supports continued development No serious adverse events or dose-limiting toxicities have been reported SOUTH SAN FRANCISCO, CALIFORNIA / ACCESS Newswire / September 8, 2025 / CASI Pharmaceuticals, Inc. (NASDAQ:CASI), a clinical-stage biopharmaceutical company focused on developing innovative...Read more


CERo Therapeutics Announces Dose Intensification in Phase 1 Study of CER-1236 in Acute Myeloid Leukemia

September 8
Last Trade: 0 0.00 0.00

Study investigator of Phase 1 trial presented poster at Society of Hematologic Oncology 13th annual conference highlighting original study protocol SOUTH SAN FRANSCISCO, Calif., Sept. 08, 2025 (GLOBE NEWSWIRE) -- CERo Therapeutics Holdings, Inc., (Nasdaq: CERO) (“CERo” or the “Company”) an innovative cellular immunotherapy company seeking to advance the next generation of engineered T cell therapeutics that employ phagocytic...Read more


ImmunityBio’s ANKTIVA® Reverses Lymphopenia and Extends Overall Survival in Patients With Advanced Non-Small Cell Lung Cancer Resistant to Checkpoint Therapy

September 8
Last Trade: 2.82 0.08 2.74

Severe lymphopenia, an adverse treatment effect associated with chemotherapy, radiotherapy, and immunotherapy, significantly lowers overall survival in non-small cell lung cancer and multiple types of cancer.1,2 With ANKTIVA, the first FDA-approved lymphocyte-stimulating agent, 80% of patients exceeded or maintained absolute lymphocyte count (ALC) above 1,000 cells/µL. With ALC counts greater than 1,500 cells/µL, statistically...Read more


Moleculin Biotech Doses First EU Patient in Phase 3 Pivotal MIRACLE Trial for Treatment of Acute Myeloid Leukemia

September 8
Last Trade: 0.37 -0.0057 -1.53

Spain site opens with two R/R AML subjects enrolled; One treated On track to recruit 45 subjects in 4Q25 for initial data unblinding HOUSTON, Sept. 08, 2025 (GLOBE NEWSWIRE) -- Moleculin Biotech, Inc., (Nasdaq: MBRX) (“Moleculin” or the “Company”), a late-stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat cancers and viral infections, today announced that it has enrolled the first two...Read more


Anixa Biosciences and Moffitt Cancer Center Complete Dosing of Fourth Cohort in Ovarian Cancer CAR-T Clinical Trial; Multiple Patients Surpassing Median Expected Survival

September 8
Last Trade: 3.46 -0.06 -1.76

Continue to observe a positive safety profile—no dose limiting toxicities, cytokine release syndrome or immune effector cell-associated neurotoxicity SAN JOSE, Calif., Sept. 8, 2025 /PRNewswire/ -- Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, today announced it has completed dosing of the fourth cohort in its ongoing Phase 1 clinical...Read more


IDEAYA Biosciences Announces Positive Data From Phase 1/2 Combination Trial of IDE397, a potential first-in-class MAT2A inhibitor, and Trodelvy® in MTAP-Deletion Urothelial Cancer

September 8
Last Trade: 24.80 0.27 1.10

Overall response rate (ORR) of 57% (4/7; 3cPR+1uPR) in patients treated with a combination of 30 mg IDE397 plus 7.5mg/kg Trodelvy® (Dose level 2); ORR of 33% (3/9; 3cPR) at 15 mg IDE397 plus 10mg/kg Trodelvy® (Dose level 1) Manageable safety profile at both expansion doses, consistent with known adverse events observed with each agent alone, with no treatment related serious adverse events observed at the IDE397 30mg and Trodelvy® 7.5...Read more


Mirum Pharmaceuticals Announces Enrollment Completion in the Phase 2b VISTAS Study

September 8
Last Trade: 74.68 0.49 0.66

Topline data announcement expected second quarter of 2026 FOSTER CITY, Calif. / Sep 08, 2025 / Business Wire / Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM) today announced the completion of enrollment in the Phase 2b VISTAS study of volixibat, an investigational oral IBAT inhibitor, for the treatment of cholestatic pruritus in patients with primary sclerosing cholangitis (PSC). The trial previously met its pre-specified efficacy and...Read more


Medicus Pharma Provides Update on United Arab Emirates (UAE) SKNJCT-004 Phase 2 Clinical Study to Non-Invasively Treat Basal Cell Carcinoma of the Skin (BCC)

September 8
Last Trade: 5.69 0.00 0.00

CLEVELAND CLINIC ABU DHABI (CCAD) HAS COMMENCED RECRUITMENT IN THIS 36 PARTICIPANT STUDY PHILADELPHIA, PENNSYLVANIA / ACCESS Newswire / September 8, 2025 / Medicus Pharma Ltd. (NASDAQ:MDCX) ("Medicus" or the "Company"), a biotech/life sciences company focused on advancing the clinical development programs of novel and potentially disruptive therapeutics assets, is pleased to announce that the SKNJCT-004 phase 2 clinical study, to...Read more


Cybin Completes Enrollment in Phase 2 Study Evaluating CYB004 for the Treatment of Generalized Anxiety Disorder

September 8
Last Trade: 6.17 0.16 2.66

The Phase 2 GAD study has enrolled 36 participants to evaluate the safety and efficacy of CYB004 at 12 weeks after first dose  Reaffirms top-line data guidance for Q1 2026  TORONTO / Sep 08, 2025 / Business Wire / Cybin Inc. (NYSE American:CYBN) (Cboe CA:CYBN) (“Cybin” or the “Company”), a clinical-stage breakthrough neuropsychiatry company committed to advancing mental healthcare by developing new and innovative...Read more


TG Therapeutics Announces Phase 3 Trial for Subcutaneous BRIUMVI Commenced Enrollment

September 8
Last Trade: 31.61 -0.14 -0.44

Phase 3 trial to evaluate two subcutaneous BRIUMVI dosing regimens NEW YORK, Sept. 08, 2025 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), announced today that enrollment has commenced in a Phase 3 trial evaluating subcutaneous BRIUMVI (ublituximab-xiiy), the company’s anti-CD20 monoclonal antibody, in people with relapsing forms of multiple sclerosis (RMS). BRIUMVI is currently approved in the United States, as well as...Read more


Oncolytics Biotech Highlights Strong Efficacy and Translational Data in Metastatic Colorectal Cancer; Will Advance Regulatory Pathway Discussions

September 8
Last Trade: 1.23 -0.01 -1.13

In KRAS mutant 2L mCRC, pelareorep delivers prolonged survival benefit with a median PFS and median OS approximately 2.5x the current standard of care Translational data from multiple studies confirm pelareorep replication in CRC tumors and immune activation Company to define regulatory pathway and advance potential IST in KRAS mutant CRC patient population SAN DIEGO, Sept. 8, 2025 /CNW/ -- Oncolytics Biotech® Inc....Read more


Pasithea Therapeutics Announces Enrollment of Cohort 2 following Positive Safety Review Committee (SRC) Recommendation for its Ongoing Phase 1/1b Clinical Trial of PAS-004 in Adult NF1 Patients

September 8
Last Trade: 0.74 -0.03 -4.29

Recommendation that trial escalate to next dose level of 8mg tablet  Initial interim clinical data from first two cohorts expected in Q1 2026  MIAMI, Sept. 08, 2025 (GLOBE NEWSWIRE) -- Pasithea Therapeutics Corp. (NASDAQ: KTTA) (“Pasithea” or the “Company”), a clinical-stage biotechnology company developing PAS-004, a next-generation macrocyclic MEK inhibitor today announced that the external Safety Review Committee...Read more


Biodexa Pharmaceuticals Moves Into Phase 3 With eRapa For FAP With First Patients Enrolled

September 8
Last Trade: 6.03 0.00 0.00

On Track To Be First Mover In $7Bn Addressable Market With No Current Therapeutic Options By: Benzinga Staff Writer CARDIFF, UK / ACCESS Newswire / September 8, 2025 / Biodexa Pharmaceuticals PLC. (NASDAQ:BDRX), a late clinical-stage biopharmaceutical company developing a pipeline of innovative products for the treatment of diseases with unmet medical needs, has launched its registrational Phase 3 trial of eRapa - its proprietary...Read more


Insight Molecular Diagnostics Enrolls First Patient in GraftAssureDx Clinical Trial and Welcomes New Hospital Participants

September 8
Last Trade: 2.73 0.00 0.00

iMDx’s ClinicalTrials.gov listing now names 10 leading transplant centers, up from 5 previously GraftAssureDx remains on track for FDA submission by end of 2025, commercial launch in 2026 NASHVILLE, Tenn., Sept. 08, 2025 (GLOBE NEWSWIRE) -- Insight Molecular Diagnostics, or iMDx, (Nasdaq: IMDX), today announced that it is actively enrolling patients in its clinical trial to assess GraftAssureDx and that last week, it enrolled the...Read more


Dianthus Therapeutics Announces Positive Data for Claseprubart (DNTH103) from the Phase 2 MaGic Trial in Generalized Myasthenia Gravis, Supporting Its Potential Best-In-Class Profile

September 8
Last Trade: 37.50 0.45 1.21

Claseprubart 300mg and 600mg Q2W doses both achieved statistically significant and clinically meaningful improvements in Myasthenia Gravis Activities of Daily Living (MG-ADL) and Quantitative Myasthenia Gravis (QMG) scores at Week 13 Claseprubart demonstrated a rapid and sustained onset of action, with both doses achieving statistically significant improvements in MG-ADL and QMG scores at Week 1 Claseprubart 300mg Q2W dose was also...Read more


Eli Lilly's Jaypirca (pirtobrutinib), the first and only approved non-covalent (reversible) BTK inhibitor, significantly improved progression-free survival in patients with treatment-naïve CLL/SLL

September 8
Last Trade: 755.13 6.93 0.93

In the Phase 3 BRUIN CLL-313 study, treatment with pirtobrutinib demonstrated a highly statistically significant and clinically meaningful improvement in progression-free survival versus bendamustine plus rituximab, indicating one of the most compelling effect sizes ever observed for a single agent BTK inhibitor in a front-line CLL study  BRUIN CLL-313 is the third positive Phase 3 study from the pirtobrutinib development program...Read more


Pfizer and BioNTech Announce Topline Data Demonstrating Robust Immune Response With Their LP.8.1-Adapted COVID-19 Vaccine 2025-2026 Formula

September 8
Last Trade: 24.06 0.09 0.38

Phase 3 clinical trial cohort of adults 65+ and 18-64 with at least one underlying risk condition shows at least a 4-fold increase in LP.8.1-neutralizing antibody titers after receiving the LP.8.1-adapted COVID-19 vaccine 2025-2026 Formula First LP.8.1 sublineage clinical findings reinforce pre-clinical data supporting recent FDA approval of 2025-2026 Formula of Pfizer-BioNTech COVID-19 Vaccine Companies have submitted these data to the...Read more


Regeneron Pharmaceuticals Advances Allergy Pipeline with Two Positive Phase 3 Trials Evaluating First-in-Class Antibody-Blockers of Cat and Birch Allergies

September 8
Last Trade: 573.37 0.78 0.14

In separate cat and birch allergen-challenge trials, single doses of allergen-specific antibody blockers significantly reduced allergy symptoms compared to placebo Data from these trials will support further Phase 3 development TARRYTOWN, N.Y., Sept. 08, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced results evaluating its first-in-class investigational allergen-blocking antibodies in...Read more


IDEAYA Biosciences Announces Positive Interim Phase 2 Data for Darovasertib in the Neoadjuvant Setting of Primary Uveal Melanoma

September 8
Last Trade: 24.80 0.27 1.10

Treatment with darovasertib resulted in robust ocular tumor shrinkage, lower simulated radiation doses to the eye and meaningful visual gains and reduced long-term risk of blindness for patients in the neoadjuvant setting of primary uveal melanoma Manageable safety profile with mostly Grade 1 and 2 treatment-related adverse events Phase 3 registration-enabling OptimUM-10 trial of darovasertib in neoadjuvant primary UM initiated during...Read more


Rapport Therapeutics Announces Positive Topline Results from Phase 2a Clinical Trial of RAP-219 in Patients with Focal Onset Seizures

September 8
Last Trade: 25.07 0.34 1.37

Trial met primary long episode endpoints with high statistical significance, and RAP-219 was generally well tolerated Patients achieved 77.8% reduction in clinical seizures (p=0.01), with 24% achieving seizure freedom for the 8-week treatment period (p<0.0001) Data support advancement of RAP-219 into Phase 3 registrational trials Company to host a conference call today at 8:00 a.m. ET BOSTON and SAN DIEGO, Sept. 08, 2025 (GLOBE...Read more


IDEAYA Biosciences and Hengrui Pharma Present Positive Phase 1 Data for IDE849 (SHR-4849), a Potential First-in-Class DLL3 TOP1 ADC, in Small Cell Lung Cancer at the IASLC 2025 World Conference on Lung Cancer

September 7
Last Trade: 24.80 0.27 1.10

80.0% (8/10) ORR and 70.0% (7/10) confirmed ORR in 2L SCLC; a 73.7% (14/19) ORR and 57.9% (11/19) confirmed ORR (1 pending confirmation) were observed across all lines of SCLC at the 2.4 mg/kg expansion dose of IDE849 77.1% (27/35) ORR and 60.0% (21/35) confirmed ORR (4 pending confirmation) in 2L SCLC; a 73.2% (52/71) ORR and 47.9% (34/71) confirmed ORR (10 pending confirmation) were observed across all lines of SCLC at all expansion...Read more


Merck: Ifinatamab Deruxtecan Demonstrated Clinically Meaningful Response Rates in Patients with Extensive-Stage Small Cell Lung Cancer in IDeate-Lung01 Phase 2 Trial

September 7
Last Trade: 80.72 -0.30 -0.37

An objective response rate of 48.2% was observed with ifinatamab deruxtecan in these previously treated patients Discussions with global regulatory authorities underway BASKING RIDGE, N.J. & RAHWAY, N.J. / Sep 07, 2025 / Business Wire / Results from the IDeate-Lung01 phase 2 trial showed that ifinatamab deruxtecan (I-DXd) demonstrated clinically meaningful response rates in patients with previously treated extensive-stage small...Read more


AstraZeneca: TAGRISSO® (osimertinib) plus chemotherapy demonstrated a median overall survival of nearly four years, the longest benefit ever reported in a global Phase III trial in EGFR-mutated advanced lung cancer

September 7
Last Trade: 77.68 -0.38 -0.49

FLAURA2 final overall survival analysis reinforces the favorable benefit-risk profile of this combination Results underscore TAGRISSO as 1st-line standard of care and backbone therapy in EGFRm lung cancer across stages WILMINGTON, Del. / Sep 07, 2025 / Business Wire / Positive results from the final overall survival (OS) analysis of the FLAURA2 Phase III trial showed AstraZeneca’s TAGRISSO® (osimertinib) with the addition of...Read more


Nuvation Bio Announces New Data from Pivotal Clinical Studies of IBTROZI™ (taletrectinib) in Advanced ROS1-Positive Non-Small Cell Lung Cancer at 2025 World Conference on Lung Cancer

September 7
Last Trade: 3.13 -0.02 -0.51

Sustained durability of responses demonstrated in both TRUST-I and TRUST-II with additional follow-up time TKI-naïve patients in TRUST-I achieved a median progression-free survival of 44.6 months; more than half of TKI-naïve patients in TRUST-II were still progression-free at data cut-off The findings showed a favorable safety and tolerability profile for IBTROZI with manageable adverse events Results are from one of the largest global...Read more


Nuvalent Presents Pivotal Data from ARROS-1 Clinical Trial of Zidesamtinib for TKI Pre-treated Patients with Advanced ROS1-positive NSCLC at WCLC 2025

September 7
Last Trade: 79.52 0.14 0.18

Rolling NDA submission for zidesamtinib in TKI pre-treated advanced ROS1-positive NSCLC initiated under FDA's RTOR program, with completion on track for the third quarter of 2025 CAMBRIDGE, Mass., Sept. 7, 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 presented pivotal...Read more


Summit Therapeutics: Longer-Term Follow-Up of Western Patients Showed Improving, Favorable Trend in Overall Survival in Global Phase III HARMONi Clinical Trial for Ivonescimab Plus Chemotherapy in 2L+ EGFRm NSCLC

September 7
Last Trade: 18.61 -0.33 -1.74

With Longer-Term Follow-Up of Western Patients, Ivonescimab Plus Chemotherapy Demonstrated Improving Global OS Trend with Nominal p-value of 0.0332 vs. Chemotherapy Alone; North American Patients’ OS HR=0.70 Consistent Median Overall Survival Observed in Western, Asian Patients in Longer-Term Follow-Up Analysis of Western Patients Presented at Presidential Symposium at WCLC 2025 Conference Call to be Held at 8:00am ET on Monday,...Read more


BridgeBio Pharma: Encaleret Showed Parathyroid Hormone-Independent Normalization of Blood and Urine Calcium in Phase 2 Proof-of-Concept Study in Post-Surgical Hypoparathyroidism

September 6
Last Trade: 50.92 -0.55 -1.07

80% of post-surgical hypoparathyroidism participants achieved concomitant blood and 24-hour urine calcium in the normal reference range within 5 days of encaleret treatment initiation compared to 0% of participants on conventional therapy at baseline Encaleret was well-tolerated with no serious adverse events reported over the study period Based on these findings, BridgeBio intends to initiate a registrational clinical study of...Read more


BioMarin Pharmaceutical Announces Positive Pivotal Phase 3 Data for PALYNZIQ® (pegvaliase-pqpz) in Adolescents with Phenylketonuria at 15th International Congress of Inborn Errors of Metabolism

September 6
Last Trade: 53.96 0.82 1.54

New data from Phase 3 PEGASUS study demonstrates a 49.7% decrease in mean blood Phe levels in adolescents aged 12-17 treated with PALYNZIQ BioMarin's planned submission to global health authorities on track for second half of 2025 SAN RAFAEL, Calif., Sept. 6, 2025 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (Nasdaq: BMRN) today announced new data characterizing the efficacy and safety of PALYNZIQ® (pegvaliase-pqpz) for the...Read more


Johnson & Johnson: RYBREVANT® (amivantamab-vmjw) plus LAZCLUZE® (lazertinib) prevents acquired resistance versus osimertinib in first-line EGFR-mutated non-small cell lung cancer

September 6
Last Trade: 177.24 -0.16 -0.09

RYBREVANT® combination extends survival and significantly reduces common EGFR and MET resistance mutations seen with osimertinib-based treatment BARCELONA, Spain, Sept. 6, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ) today announced new analyses from the Phase 3 MARIPOSA study showing that first-line treatment with RYBREVANT® (amivantamab-vmjw) plus LAZCLUZE® (lazertinib) significantly reduces the development of...Read more


uniQure Announces Initial AMT-191 Phase I/IIa Data Showing Sustained Increases in α-Gal A Enzyme Activity in Patients with Fabry Disease

September 5
Last Trade: 14.99 0.15 1.01

All patients in the first cohort achieved between 27- to 208-fold increases in α-Gal A activity relative to mean normal level All patients in first cohort discontinued enzyme replacement therapy Preliminary data show AMT-191 has a manageable safety profile at the highest dose Updated clinical results expected in the first half of 2026 LEXINGTON, Mass. and AMSTERDAM, Sept. 05, 2025 (GLOBE NEWSWIRE) -- uniQure N.V. (NASDAQ: QURE), a...Read more


Indaptus Therapeutics Provides Clinical Update

September 4
Last Trade: 2.42 0.09 3.65

Decoy20 monotherapy induces Partial Response in patient with urothelial cancer and liver metastases Decoy20 combination with PD-1 inhibitor, tislelizumab, demonstrates safety profiles consistent with each agent NEW YORK, Sept. 04, 2025 (GLOBE NEWSWIRE) -- Indaptus Therapeutics, Inc. (Nasdaq: INDP) (“Indaptus” or the “Company”), a clinical stage biotechnology company dedicated to pioneering innovative cancer and viral infection...Read more


Vyome Announces Positive Interim Data from Phase 2 Study of VT-1953 in Malignant Fungating Wounds (MFW) and Provides Update on MFW market opportunity

September 4
Last Trade: 2.39 0.00 0.00

VT-1953 continues to significantly improve the primary endpoint Co-founder Dr. Shiladitya Sengupta to discuss over a live video conference VT-1953 treatment significantly reduced malignant fungating wound-associated malodor (primary endpoint) (P<0.001). Patients also reported significant improvements in lesion pain (P<0.001) and Quality of Life (P<0.001), both secondary and exploratory endpoints, respectively. CAMBRIDGE,...Read more


Bright Minds Biosciences Announces BMB‑201 Outperforms Sumatriptan in Validated Preclinical Vascular Headache Model

September 4
Last Trade: 49.38 0.72 1.48

NEW YORK, Sept. 04, 2025 (GLOBE NEWSWIRE) -- Bright Minds Biosciences Inc. (NASDAQ: DRUG) today announced compelling preclinical results for its investigational compound BMB‑201, in a validated isosorbide dinitrate (ISDN) rat model of vascular headache. BMB-201 produced statistically significant reductions in facial mechanical allodynia across both male and female cohorts at 1 and 2 hours post-dose, compared to vehicle, and demonstrated...Read more


MBX Biosciences Doses First Participant in Phase 1 Trial of MBX 4291 for the Treatment of Obesity

September 4
Last Trade: 10.23 -0.64 -5.89

Preclinical data support the potential for improved weight loss and tolerability with once-monthly administration of MBX 4291 CARMEL, Ind., Sept. 04, 2025 (GLOBE NEWSWIRE) -- MBX Biosciences, Inc. (Nasdaq: MBX), a clinical-stage biopharmaceutical company focused on the discovery and development of novel precision peptide therapies for the treatment of endocrine and metabolic disorders, today announced dosing of the first participant...Read more


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

September 4
Last Trade: 12.55 0.48 3.98

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


Skye Bioscience’s CB1 Inhibitor, Nimacimab, Demonstrates Superior Weight Loss and Differentiated Mechanisms from Monlunabant, and Continues to Show Enhanced Combination with Tirzepatide with Durable Post-Treatment Weight Maintenance in DIO Model

September 4
Last Trade: 4.03 -0.04 -0.98

Skye shares new preclinical DIO data at virtual KOL event Nimacimab + tirzepatide demonstrates over 40% weight loss in multiple preclinical DIO studies Nimacimab demonstrates durable post-treatment weight loss compared to tirzepatide Nimacimab reduced rebound weight gain following treatment with tirzepatide or nimacimab + tirzepatide Nimacimab outperformed monlunabant head-to-head, and is uniquely positioned as a well-tolerated...Read more


IDEAYA Biosciences Announces First-Patient-In for Phase 1/2 Combination Trial of IDE397, A Potential First-in-Class MAT2A Inhibitor, and Trodelvy® in MTAP-Deletion Non-Small Cell Lung Cancer

September 4
Last Trade: 24.80 0.27 1.10

SOUTH SAN FRANCISCO, Calif., Sept. 4, 2025 /PRNewswire/ -- IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a leading precision medicine oncology company, today announced they have enrolled their first patient with non-small cell lung cancer (NSCLC) in the ongoing Phase 1/2 combination trial of IDE397, a potential first-in-class, small molecule adenosyltransferase 2a (MAT2a) inhibitor, and Trodelvy® (sacituzumab govitecan-hziy), a Trop2-directed...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: 5.83 -0.10 -1.69

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


Artelo Biosciences Announces Positive Interim Phase 2 CAReS Results for the Treatment of Cancer Anorexia-Cachexia Syndrome (CACS)

September 3
Last Trade: 5.27 0.02 0.38

Catalyst for Advancing Discussions with Pharmaceutical Companies that have Expressed Interest in ART27.13 for CACS Consistent Improvements in Weight Gain, Lean Body Mass, and Activity were Observed Across Treated Patients including +6.4% Mean Weight Gain at 12 Weeks vs −5.4% Mean Weight Loss on Placebo Safety Results Showed ART27.13 was Well Tolerated SOLANA BEACH, Calif., Sept. 03, 2025 (GLOBE NEWSWIRE) -- Artelo Biosciences,...Read more


AbbVie Announces Updated Results From Phase 2 EPCORE® NHL-6 Study Evaluating the Potential for Outpatient Monitoring of Epcoritamab in Patients With Relapsed/Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL)

September 3
Last Trade: 216.40 -1.21 -0.56

Data presented at 13th Society of Hematologic Oncology (SOHO) Annual Meeting NORTH CHICAGO, Ill., Sept. 3, 2025 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced updated results from the Phase 2 EPCORE® NHL-6 trial (NCT05451810) evaluating the feasibility of dosing and monitoring patients in the outpatient setting for the first full dose of epcoritamab monotherapy, a T-cell engaging bispecific antibody administered subcutaneously,...Read more


Genmab Announces Updated Results from Phase 2 EPCORE® NHL-6 Study Evaluating Epcoritamab Monotherapy in the Outpatient Setting in Patients with Relapsed/Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL)

September 3
Last Trade: 28.12 0.13 0.46

Trial demonstrated the feasibility of treating and monitoring adult patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) in an outpatient setting Results showed that 92% of patients with R/R DLBCL received the first full dose of epcoritamab monotherapy in an outpatient setting Adverse event profile and efficacy were consistent with previously reported studies in R/R DLBCL patients Data also demonstrated 64.3%...Read more


Autonomix Medical Demonstrates Sustained Pain Reduction, Quality of Life Gains and 100% Zero Opioid Use in Longer-Term Post Hoc Analysis from PoC 1 Study

September 3
Last Trade: 1.12 -0.001 -0.09

New longer-term post hoc analysis results of responders (n=6)1 showed long-lasting, durable pain reduction of nearly 66%, or a mean 5.08 reduction on the VAS pain scale, in patients with severe pancreatic cancer pain 100% of responders (n=7) 1 showed zero opioid use at their 3-month post-procedure follow-up2 Quality of life markers further improved including sleep quality, energy level and ability to lead normal daily and leisure time...Read more


Envoy Medical Successfully Reaches Three-Month Follow-Up Milestone in Clinical Trial of the Acclaim Fully Implanted Cochlear Implant

September 3
Last Trade: 1.34 0.01 0.75

No Serious Adverse Events or Unanticipated Device Effects Reported; Company Confirms Program Remains On Track White Bear Lake, Minnesota--(Newsfile Corp. - September 3, 2025) - Envoy Medical® Inc. (NASDAQ: COCH) ("Envoy Medical"), a hearing health company focused on developing innovative, fully implanted technologies, today announced that the patients in the first stage of its pivotal clinical trial for the investigational Acclaim®...Read more


CG Oncology Completes Enrollment in PIVOT-006

September 3
Last Trade: 35.89 1.34 3.88

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: 12.99 -0.14 -1.07

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


Cognition Therapeutics Study of Zervimesine (CT1812) in Early Alzheimer’s Disease Reaches 75% Enrollment Target

September 3
Last Trade: 1.70 0.16 10.06

PURCHASE, N.Y., Sept. 03, 2025 (GLOBE NEWSWIRE) -- Cognition Therapeutics, Inc., (the Company or Cognition) (NASDAQ: CGTX), a clinical stage company developing drugs that treat neurodegenerative disorders, announced that the Phase 2 ‘START’ Study has reached the 75% enrollment mark. The START Study is enrolling approximately 540 individuals with mild cognitive impairment (MCI) and early Alzheimer’s disease who will be treated with...Read more


Wave Life Sciences Announces Positive Update from Ongoing RestorAATion-2 Trial of WVE-006 in Alpha-1 Antitrypsin Deficiency

September 3
Last Trade: 6.87 -0.10 -1.43

Achieved durable production of serum AAT protein at levels associated with a lower risk of AATD liver and lung diseases following repeat 200 mg doses of WVE-006 (11.9 µM total AAT, 7.2 µM M-AAT)  First-ever demonstration of therapeutically restored physiological serum AAT production in a Pi*ZZ individual during a non-drug related acute phase response (20.6 µM total AAT, 10.3 µM M-AAT) Single dose of 400 mg achieved 12.8 µM total...Read more


Vaxcyte Advances VAX-31 Infant Phase 2 Dose-Finding Study with First Participants Receiving VAX-31 Optimized Dose

September 3
Last Trade: 31.49 0.49 1.58

VAX-31 Optimized Dose, with Majority of Serotypes Dosed at 4.4mcg and Balance at 3.3mcg, is Designed to Elicit Even Stronger Immune Responses in Infant Population to Protect Against Invasive Pneumococcal Disease (IPD) Company Intends to Release Topline Data from Primary Immunization Series and Booster Dose Either Sequentially or Together by End of First Half of 2027 VAX-31 is Designed to Provide Greater Coverage Against Both Currently...Read more


ProMIS Neurosciences Receives DSMB Approval to Advance to Final Dose Escalation Cohort in Phase 1b Alzheimer’s Trial of PMN310

September 3
Last Trade: 0.42 0.0016 0.38

Cohort 2 fully enrolled; enrollment and dosing now underway for Cohort 3 (final dose level); No cases of amyloid-related imaging abnormalities (ARIA) observed to date; The trial, expected to enroll 128 patients, remains on track to report 6-month interim data in Q2 2026 and final 12-month top-line results in Q4 2026. Cambridge, Massachusetts, Sept. 03, 2025 (GLOBE NEWSWIRE) -- ProMIS Neurosciences, Inc. (Nasdaq: PMN), a...Read more


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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...

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