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Anavex’s Phase 2b/3 Trial of Blarcamesine (ANAVEX®2-73) in Patients with Alzheimer’s Disease Shows Robust Clinical Efficacy and Slows Neurodegeneration

September 14
Last Trade: 6.97 -0.27 -3.73

NEW YORK, Sept. 14, 2023 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders announced today that a follow-on analysis of the landmark Phase 2b/3 study to treat early Alzheimer’s disease with the investigational drug blarcamesine (ANAVEX®2-73) did...Read more


AN2 Therapeutics commences Phase 3 Part of Phase 2/3 Clinical Trial Evaluating Epetraborole for Treatment-Refractory Mycobacterium avium complex (MAC) Lung Disease

September 13
Last Trade: 13.81 0.63 4.78

Company announces Phase 2 part of the EBO-301 trial is now fully enrolled with 80 patients; Topline Phase 2 trial results expected in summer 2024 Over 100 sites across four countries (U.S., Japan, S. Korea & Australia) as epetraborole enters Phase 3 portion of EBO-301; expected to enroll ~230 patients MENLO PARK, Calif. / Sep 13, 2023 / Business Wire / AN2 Therapeutics, Inc. (Nasdaq: ANTX), a clinical-stage biopharmaceutical...Read more


Humacyte Announces Positive Top Line Results from Phase 2/3 Trial of Human Acellular Vessel™ (HAV™) in Treatment of Patients with Vascular Trauma

September 12
Last Trade: 2.93 -0.01 -0.34

Single-arm clinical trial was a success and showed the HAV had higher rates of patency, and lower rates of amputation and infection, compared to historic synthetic graft benchmarks  BLA planned to be filed with FDA in 4th Quarter 2023 Conference call and live webcast with Key Opinion Leaders at 8:00 a.m. ET today  DURHAM, N.C., Sept. 12, 2023 (GLOBE NEWSWIRE) --  Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage...Read more


Acelyrin Announces Top-Line Results from Placebo-Controlled Clinical Trial of Izokibep for Moderate-to-Severe Hidradenitis Suppurativa

September 11
Last Trade: 10.04 0.19 1.93

The primary endpoint of HiSCR75 at week 16 did not meet statistical significance in the Non-Responder Imputation (NRI) primary analysis. HiSCR75 did meet statistical significance at week 16 in a Last Observation Carried Forward sensitivity analysis. HiSCR response rates of izokibep 160mg weekly (QW) were consistent with Part A open label results, demonstrating early onset of HiSCR100 at week 4, increasing through week 12 to 38%...Read more


Oncotelic Therapeutics: Sapu BioScience and Cromos Pharma initiating P201 – A Registrational trial for OT-101 in Pancreatic Cancer

August 23
Last Trade: 0.03 0.003 11.32

AGOURA HILLS, Calif., Aug. 23, 2023 (GLOBE NEWSWIRE) -- Oncotelic Therapeutics, Inc (OTCQB:OTLC) ("Oncotelic", the "Company" or "We" or “Our”), announced today its joint venture partner, GMP Biotechnology Limited’s wholly owned subsidiary – Sapu Bioscience, LLC (“Sapu”), together with with Cromos Pharma, LLC (“Cromos”), a US-based international contract research organization (“CRO”), to conduct Sapu’s registrational trial for OT-101 in...Read more


Humanigen Announces First Participant Dosed in RATinG Trial of Lenzilumab for Early Treatment of Acute Graft Versus Host Disease Following Allogeneic Stem Cell Transplantation

August 7
Last Trade: 0.02 0.00 0.00

The RATinG (Risk Adapted Therapy in Acute GvHD) is the first trial to explore granulocyte-macrophage colony-stimulating factor (GM-CSF) neutralization for the early treatment of participants with high-risk acute Graft versus Host Disease Planned interim assessment expected in 2024 following treatment of first 20 participants Short Hills, New Jersey--(Newsfile Corp. - August 7, 2023) - Humanigen, Inc. (OTC Pink: HGEN), a...Read more


Humacyte Completes Enrollment in Phase 2/3 Trial of Human Acellular Vessel™ (HAV™) for Vascular Trauma Repair

July 26
Last Trade: 2.93 -0.01 -0.34

Top-line results planned to be released in third quarter 2023 Trial results are intended to support Biologics License Application (BLA) planned for fourth quarter 2023 DURHAM, N.C., July 26, 2023 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale, today announced completion of enrollment of its Phase...Read more


Gilead Sciences: Twice-Yearly Lenacapavir Demonstrates Sustained Impact on Health-Related Quality of Life in People With HIV

July 24
Last Trade: 75.27 -0.55 -0.73

Patient-Reported Outcomes From the CAPELLA Trial Align With the Demonstrated Safety and Tolerability Profile of Lenacapavir Analyses Show Oral Bridging Maintains Virologic Suppression When Subcutaneous Lenacapavir Doses are Missed FOSTER CITY, Calif. / Jul 24, 2023 / Business Wire / Gilead Sciences, Inc. (Nasdaq: GILD) today presented new data reinforcing the efficacy, safety, and tolerability profile of lenacapavir, including...Read more


Incannex Healthcare engages Fortrea to Manage its FDA IND Opening Phase 2/3 Clinical Trial Investigating IHL-42X for Treatment of Obstructive Sleep Apnoea

July 18
Last Trade: 1.11 -0.10 -7.92

Highlights: Incannex has engaged Fortrea as the contract research organisation (‘CRO’) to manage the IND opening Phase 2/3 clinical trial investigating IHL-42X for treatment of OSA. The Phase 2/3 clinical trial will assess the safety and efficacy of IHL-42X in people with OSA who are intolerant, non-compliant, or naïve to continuous positive airway pressure (‘CPAP’). The extensive trial will be conducted across 45 sites, including...Read more


Roche: Four-Year Follow-Up Data for Genentech’s Evrysdi Show Continued Increase in Number of Children With a Severe Form of Spinal ​Muscular ​Atrophy (SMA)​ Able to Sit, Stand and Walk

June 30
Last Trade: 35.93 0.55 1.55

Data from ongoing FIREFISH study confirm long-term efficacy and safety profile of Evrysdi in children with Type 1 SMA  Ninety-one percent of children were alive at month 48  More than 95% maintained the ability to swallow - without treatment they would have required feeding support and majority would have died within 2 years  Evrysdi is now approved in 99 countries with more than 8,500 patients treated...Read more


DiaMedica Therapeutics Announces that the FDA Has Removed Clinical Hold On DM199 Phase 2/3 Trial For Ischemic Stroke

June 21
Last Trade: 3.00 0.02 0.67

MINNEAPOLIS / Jun 21, 2023 / Business Wire / DiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage biopharmaceutical company focused on developing novel treatments for neurological disorders and kidney diseases, announced today that the U.S. Food and Drug Administration (FDA) has removed the clinical hold placed on the investigational new drug application for its ReMEDy2 phase 2/3 clinical trial studying DM199 in the treatment of...Read more


Incannex Healthcare Appoints Principal Investigators for IHL-42X Phase 2/3 Clinical Trial

June 16
Last Trade: 1.11 -0.10 -7.92

MELBOURNE, Australia, June 16, 2023 (GLOBE NEWSWIRE) -- Incannex Healthcare Limited (Nasdaq: IXHL) (ASX: IHL), (‘Incannex’ or the ‘Company’) a clinical-stage pharmaceutical company developing unique medicinal cannabinoid pharmaceutical products and psychedelic medicine therapies for unmet medical needs, is pleased to announce that it has recruited two highly experienced lead principal investigators (PIs) for the IND opening Phase 2/3...Read more


Humanigen Presents Promising New Hematologic Data from PREACH-M Trial for Chronic Myelomonocytic Leukemia Treatment at the 2023 European Hematology Association Congress

June 9
Last Trade: 0.02 0.00 0.00

Of the 14 participants enrolled and treated with lenzilumab plus azacitidine, ten are evaluable with three to eighteen months of follow-up and all ten have had a rapid clinical response Building upon previously reported positive clinical responses, these additional data demonstrate statistically significant and clinically relevant improvements in hematologic outcomes, along with improvements in inflammatory markers, that occur...Read more


Anavex Life Sciences Announces Completion of ANAVEX(®)2-73 (blarcamesine) EXCELLENCE Phase 2/3 Rett Syndrome Clinical Trial

June 6
Last Trade: 6.97 -0.27 -3.73

NEW YORK, June 06, 2023 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders including Alzheimer’s disease, Parkinson’s disease, Rett syndrome and other central nervous system (CNS) disorders, today announced the completion of dosing of all...Read more


Ultragenyx Pharmaceutical and Mereo BioPharma Announce Positive Data from the Ongoing Phase 2/3 Orbit Study of Setrusumab (UX143) in Osteogenesis Imperfecta (OI)

June 5
Last Trade: 36.61 0.43 1.19

Pediatric data show substantial induction of bone production in 1 week and a large increase in bone formation within 3 months of initiating monthly setrusumab treatment Phase 3 sites beginning to screen patients Conference call to discuss data planned for 5 p.m. Eastern Time NOVATO, Calif. and LONDON, June 05, 2023 (GLOBE NEWSWIRE) -- Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE) and Mereo BioPharma Group plc (NASDAQ: MREO) today...Read more


Immutep Doses First Patient in AIPAC-003 Phase II/III Trial for Metastatic Breast Cancer

May 25
Last Trade: 1.97 -0.01 -0.51

SYDNEY, AUSTRALIA, May 25, 2023 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep” or “the Company”), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, today announces the first patient has been enrolled and safely dosed at a European clinical site for its integrated Phase II/III AIPAC-003 trial in metastatic breast cancer. AIPAC-003 is evaluating...Read more


Cantex Pharmaceuticals and Michigan Medicine Announce Initiation of a Randomized, Double-Blind, Placebo-Controlled Phase 2/3 Clinical Study to Determine the Safety and Efficacy of Azeliragon in the Treatment of Patients Hospitalized for COVID-19

April 20
Last Trade: 0.43 0.0069 1.64

WESTON, Fla. and ANN ARBOR, Mich., April 20, 2023 /PRNewswire/ -- Cantex Pharmaceuticals, Inc., a clinical-stage pharmaceutical company focused on developing transformative therapies for cancer and other life-threatening medical conditions, and Michigan Medicine, a part of the University of Michigan and one of the nation's leading academic medical centers, announced today the initiation of a randomized double-blind,...Read more


Annovis Bio Announces Update On Recruitment Into Its Phase 2/3 Alzheimer's Study And Upcoming R&D Webcast

April 19
Last Trade: 10.49 -0.12 -1.13

Phase 2/3 AD Study continues to make steady progress in patient recruitment Company to hold R&D webcast on Thursday, April 20th to review ongoing clinical programs in Alzheimer's disease and Parkinson's disease BERWYN, Pa., April 19, 2023 /PRNewswire/ -- Annovis Bio, Inc. (NYSE: ANVS) ("Annovis" or the "Company"), a clinical-stage drug platform company addressing neurodegenerative diseases, today announced that...Read more


Seelos Therapeutics Doses the First Amyotrophic Lateral Sclerosis (ALS) Patient with SLS-005 in an Expanded Access Program

April 4
Last Trade: 0.19 -0.12 -37.73

The Expanded Access Program is funded by a grant from the National Institute of Neurological Disorders and Stroke (NINDS) under the Accelerating Access to Critical Therapies for ALS (ACT for ALS) for ALS patients who do not qualify for existing clinical trials NEW YORK, April 4, 2023 /PRNewswire/ -- Seelos Therapeutics, Inc. (Nasdaq: SEEL) ("Seelos"), a clinical-stage biopharmaceutical company focused on the development of therapies...Read more


Monopar Therapeutics Announces Result of Interim Analysis of Phase 2b/3 VOICE Trial Evaluating Validive for Severe Oral Mucositis

March 27
Last Trade: 0.60 0.0087 1.47

WILMETTE, Ill., March 27, 2023 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (Nasdaq: MNPR), a clinical-stage biopharmaceutical company focused on developing proprietary therapeutics designed to extend life or improve the quality of life for cancer patients, today announced completion of a pre-specified interim analysis for its Validive Phase 2b/3 VOICE trial for the prevention of severe oral mucositis (SOM) in patients...Read more


NRx Pharmaceuticals Announces Positive Recommendation to Continue Enrollment in the Ongoing Trial of NRX-101 in Patients with Suicidal Treatment-Resistant Bipolar Depression

March 27
Last Trade: 0.26 0.0082 3.26

The independent Data Safety Monitoring Board recommended continuation of patient enrollment as planned No safety or futility signals were reported in the first 50 patients This patient population could represent up to 1 million bipolar depression patients in the US and represents a portion of the indication expansion recommended in recent correspondence with the FDA Trial has been upgraded to a Phase 2b/3 study that may be used for a...Read more


Galectin Therapeutics Reports the Positive Outcome of the Third Data and Safety Monitoring Board Meeting for NAVIGATE, its Seamless, Adaptive Phase 2b/3 Study of Belapectin in Patients with Liver Cirrhosis Caused by Non-Alcoholic Steatohepatitis

March 16
Last Trade: 1.79 0.01 0.56

NORCROSS, Ga., March 16, 2023 (GLOBE NEWSWIRE) -- Galectin Therapeutics, Inc. (NASDAQ: GALT), the leading developer of therapeutics that target galectin-3, today reported the positive outcome of its third data and safety monitoring board (DSMB) meeting for NAVIGATE, its seamless, adaptive, phase 2b/3 study of belapectin in patients with liver cirrhosis caused by non-alcoholic steatohepatitis (NASH). NAVIGATE is the first study of its...Read more


Immutep Announces Initiation of Phase II/III Trial for Eftilagimod Alpha plus Paclitaxel in Metastatic Breast Cancer

March 14
Last Trade: 1.97 -0.01 -0.51

Media Release Integrated Phase II/III trial design incorporates feedback from the FDA and EMA and will help inform a BLA and MAA HR+/HER2-neg/low metastatic breast cancer (MBC) patient population has been expanded to include triple-negative breast cancer, which together account for ~78% of breast cancer cases Approval for study start received in US and IRB approval in Spain, with more countries to follow shortly First patient...Read more


Merck: KEYTRUDA® (pembrolizumab) Plus Chemotherapy Significantly Improved Overall Survival Versus Chemotherapy Alone as First-Line Treatment for Advanced Malignant Pleural Mesothelioma

March 10
Last Trade: 106.73 -0.58 -0.54

RAHWAY, N.J. & KINGSTON, Ontario / Mar 10, 2023 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, and the Canadian Cancer Trials Group (CCTG) today announced that the Phase 2/3 CCTG IND.227/KEYNOTE-483 trial evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with chemotherapy met its primary endpoint of overall survival (OS) for the first-line treatment of patients with unresectable...Read more


Ayala Pharmaceuticals Announces Continuation of RINGSIDE Phase 2/3 Study in Desmoid Tumors Following Recommendation of Independent Data Monitoring Committee

March 3
Last Trade: 1.05 0.10 10.53

Registration-enabling Phase 3 segment of RINGSIDE is enrolling patients globally Updated data on AL102 Phase 2 segment of RINGSIDE are planned for presentation at a medical meeting in 2023 REHOVOT, Israel and MONMOUTH JUNCTION, N.J., March 03, 2023 (GLOBE NEWSWIRE) -- Ayala Pharmaceuticals, Inc. (OTCQX: ADXS), a clinical-stage oncology company, today announced that the Independent Data Monitoring Committee (IDMC) for its Phase 2/3...Read more


Galectin Therapeutics Provides Final Randomization Status of NAVIGATE, its Seamless, Adaptive Phase 2b/3 Study of Belapectin in Patients with Liver Cirrhosis Caused by Non-Alcoholic Steatohepatitis

March 2
Last Trade: 1.79 0.01 0.56

NORCROSS, Ga., March 02, 2023 (GLOBE NEWSWIRE) -- Galectin Therapeutics, Inc. (NASDAQ: GALT), the leading developer of therapeutics that target galectin-3, announced that in late December 2022, it ended the enrollment of new patients into NAVIGATE, its seamless, adaptive, phase 2b/3 study of belapectin in patients with liver cirrhosis caused by non-alcoholic steatohepatitis (NASH). The last patient was randomized into NAVIGATE at the...Read more


Seelos Therapeutics Announces Completion of Enrollment of its Phase II/III Trial of SLS-005 in Amyotrophic Lateral Sclerosis on the HEALEY ALS Platform

February 13
Last Trade: 0.19 -0.12 -37.73

The randomized, double-blind, placebo-controlled study is evaluating SLS-005 in 160 patients over 24 weeks and Seelos anticipates delivering topline data in the second half of 2023. Seelos will also enroll patients in an Expanded Access Program that will be fully funded by a grant from the National Institute of Neurological Disorders and Stroke (NINDS) under the Accelerating Access for Critical Therapies for ALS Act (ACT for...Read more


MediciNova Announces Health Canada Grants Authorization to Commence Multi-arm Phase 2/3 Clinical Trial to Evaluate MN-166 (ibudilast) in Long COVID

February 8
Last Trade: 2.01 -0.08 -3.83

LA JOLLA, Calif., Feb. 08, 2023 (GLOBE NEWSWIRE) -- MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ:MNOV) and the JASDAQ Market of the Tokyo Stock Exchange (Code Number: 4875), today announced that Health Canada has completed its review of the clinical trial application and has granted authorization to commence a grant-funded, multi-center, randomized, clinical trial to evaluate MN-166 (ibudilast)...Read more


Biophytis Announces Positive Final Results of the Phase 2-3 COVA Study with Sarconeos (BIO101) in Severe COVID-19

February 2
Last Trade: 1.02 -0.02 -1.92

COVA study met primary end point with 44% significant reduction in the risk of respiratory failure or early death Filing for Early Access Programs to Sarconeos (BIO101) is being initated while preparing for Marketing Authorisation in Europe and the USA PARIS, FRANCE / CAMBRIDGE, MA / ACCESSWIRE / February 2, 2023 / Biophytis SA (NasdaqCM: BPTS, Euronext Growth Paris:ALBPS) (the "Company" or "Biophytis"), a clinical-stage...Read more


Anavex Life Sciences Announces Exceeding of Enrollment Target for the ANAVEX®2-73 (blarcamesine) EXCELLENCE Phase 2/3 Rett Syndrome Clinical Trial

February 2
Last Trade: 6.97 -0.27 -3.73

NEW YORK, Feb. 02, 2023 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders including Alzheimer’s disease, Parkinson’s disease, Rett syndrome and other central nervous system (CNS) diseases, today announced the total enrollment of 92 patients with...Read more


MannKind’s Inhaled Clofazimine Will Advance to an Adaptive Phase 2/3 Study For Potential Treatment of Rare Lung Disease

January 23
Last Trade: 4.11 -0.04 -0.96

Direct delivery of clofazimine to the lungs may provide a treatment option for nontuberculous mycobacterial (NTM) lung disease that potentially overcomes systemic toxicity and lessens side effects Paper published on clofazimine inhalation suspension demonstrates promising tolerability and toxicokinetics for treating pulmonary NTM infection DANBURY, Conn. and WESTLAKE VILLAGE, Calif., Jan. 23, 2023 (GLOBE NEWSWIRE) -- MannKind...Read more


Ocugen Announces Positive Top-Line Data for COVID-19 Vaccine Candidate COVAXIN™ (BBV152) in Phase 2/3 Immuno-bridging and Broadening Study: Both Co-primary Endpoints Met

January 9
Last Trade: 0.40 0.0044 1.11

Study met both co-primary endpoints with robust immune responses COVAXIN™ was found to be well-tolerated in vaccine-naïve individuals and in individuals previously vaccinated with mRNA vaccines in the United States (U.S.), with no vaccine-related serious adverse events, thrombotic events, or cases of myocarditis or pericarditis These data add to the body of evidence that COVAXIN™, an adjuvated whole SARS-CoV-2 virus inactivated...Read more


Galectin Therapeutics Announces the End of Enrollment of NAVIGATE, its Seamless, Adaptive Phase 2b/3 Study of Belapectin in Patients with Liver Cirrhosis Caused by Non-Alcoholic Steatohepatitis

January 5
Last Trade: 1.79 0.01 0.56

NORCROSS, Ga., Jan. 05, 2023 (GLOBE NEWSWIRE) -- Galectin Therapeutics, Inc. (NASDAQ: GALT), the leading developer of therapeutics that target galectin-3, announced today that in late December 2022, it ended enrollment of NAVIGATE, its seamless, adaptive, phase 2b/3 study of belapectin in patients with liver cirrhosis caused by non-alcoholic steatohepatitis (NASH). NAVIGATE is the first study of its kind and is a global effort that...Read more


Anavex Life Sciences: ANAVEX®2–73 (Blarcamesine) Phase 2B/3 Study Met Primary and Key Secondary Endpoints, Showing Statistically Significant Reduction of Clinical Decline in Global Clinical Study of Patients With Early Alzheimer’s Disease

December 1
Last Trade: 6.97 -0.27 -3.73

Robust, Statistically Significant and Clinically Meaningful Absolute Improvement in Cognitive Function as Measured by ADAS-Cog and ADCS-ADL Key Secondary Endpoint CDR-SB Also Met, Demonstrating Statistically Significant Results Plan to Meet with Regulatory Authorities to Determine Next Steps NEW YORK, Dec. 01, 2022 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage...Read more


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Cue Biopharma

Cue Biopharma is developing the first-ever class of therapeutics for the treatment of cancer that mimic the natural signals, or “Cues”, of the immune system. This novel class of injectable biologics selectively engages and modulates tumor-specific T cells directly within the patient’s body to transform...

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