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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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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