Phase 1 Clinical Data for SYS6002 (CRB-701) to be presented at 2024 ASCO GU

NORWOOD, Mass., Jan. 23, 2024 (GLOBE NEWSWIRE) -- Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) (“Corbus” or the “Company”), announced today that the abstract for the first-in-human Phase 1 dose escalation study of SYS6002 (CRB-701) has been released, and the corresponding up-to-date data will be presented at the 2024 American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU). The data referred to in the abstract dates to September of 2023; the upcoming presentation will include data as of December 2023. The study is being conducted by Corbus’s partner CSPC Pharmaceutical Group in China. ASCO GU will be held January 25-27, 2024 in San Francisco, CA and online.

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Phase 1 Clinical Data for SYS6002 (CRB-701) to be presented at 2024 ASCO GU

Outlook Therapeutics® Receives FDA Agreement Under Special Protocol Assessment (SPA) for 90 Day Non-Inferiority Study, NORSE EIGHT, and Announces…

ISELIN, N.J., Jan. 23, 2024 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to achieve FDA approval for the first ophthalmic formulation of bevacizumab for the treatment of retinal diseases, today announced that it has received written agreement from the FDA under an SPA for the NORSE EIGHT clinical trial protocol evaluating ONS-5010 in neovascular age-related macular degeneration (AMD) subjects. Additionally, Outlook Therapeutics entered into securities purchase agreements with certain institutional and accredited investors for up to $172 million in gross proceeds to fund the advancement of ONS-5010.

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Outlook Therapeutics® Receives FDA Agreement Under Special Protocol Assessment (SPA) for 90 Day Non-Inferiority Study, NORSE EIGHT, and Announces...

4DMT Receives Rare Pediatric Disease Designation from FDA for Aerosolized 4D-710 for Treatment of Cystic Fibrosis Lung Disease

EMERYVILLE, Calif., Jan. 23, 2024 (GLOBE NEWSWIRE) -- 4D Molecular Therapeutics (Nasdaq: FDMT, 4DMT or the Company), a leading clinical-stage genetic medicines company focused on unlocking the full potential of genetic medicines to treat large market diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation (RPDD) for the Company’s product candidate aerosolized 4D-710 for treatment of cystic fibrosis (CF) lung disease. 4D-710 is being evaluated in the Phase 1/2 AEROW clinical trial in people with CF who are not eligible for, or cannot tolerate any of, the currently approved CFTR modulators.

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4DMT Receives Rare Pediatric Disease Designation from FDA for Aerosolized 4D-710 for Treatment of Cystic Fibrosis Lung Disease

NAYA Biosciences To Acquire Clinical Stage Gene Therapy Program for Leber’s Hereditary Optic Neuropathy (LHON)

AVENTURA, Fla. and SARASOTA, Fla., Jan. 23, 2024 (GLOBE NEWSWIRE) -- NAYA Biosciences Inc. ("NAYA"), a company which has recently signed a definitive merger agreement with INVO Bioscience to establish an expanded, publicly-traded life science company dedicated to increasing patient access to breakthrough treatments in oncology, regenerative medicine, and fertility, today announced that it has entered into a binding letter of intent to acquire Florida Biotechnologies, Inc. a gene therapy company focusing on the treatment of mitochondrial diseases.

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NAYA Biosciences To Acquire Clinical Stage Gene Therapy Program for Leber's Hereditary Optic Neuropathy (LHON)

Recce Pharmaceuticals Reports Positive Phase I/II Trial Results of RECCE® 327 for the Treatment of Diabetic Foot Infections

SYDNEY, Australia, Jan. 23, 2024 (GLOBE NEWSWIRE) -- Recce Pharmaceuticals Ltd (ASX: RCE, FSE: R9Q), (the Company), the Company developing a new class of synthetic anti-infectives, today announced positive results from a Phase I/II trial assessing the safety and efficacy of its lead synthetic anti-infective candidate, RECCE® 327 (R327), in patients with diabetic foot infections (DFI).

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Recce Pharmaceuticals Reports Positive Phase I/II Trial Results of RECCE® 327 for the Treatment of Diabetic Foot Infections

Rezolute Receives Innovation Passport Designation from the U.K. Innovative Licensing and Access Pathway Steering Group for RZ358 in the Treatment of…

REDWOOD CITY, Calif., Jan. 23, 2024 (GLOBE NEWSWIRE) -- Rezolute, Inc. (Nasdaq: RZLT), a clinical-stage biopharmaceutical company committed to developing novel, transformative therapies for serious metabolic and rare diseases, today announced that the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) has awarded the innovative medicine designation, the Innovation Passport, to RZ358 for the treatment of hypoglycemia due to congenital hyperinsulinism (HI). The Innovation Passport designation was granted based on the substantial unmet medical need in this condition and the potential for RZ358 to benefit patients as evidenced by the Phase 2 RIZE study in congenital HI, which safely demonstrated significant improvements in hypoglycemia events.

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Rezolute Receives Innovation Passport Designation from the U.K. Innovative Licensing and Access Pathway Steering Group for RZ358 in the Treatment of...

Diagnostics Industry Leader Jack Kenny Appointed as Chairman of the Board at Biomerica

IRVINE, Calif., Jan. 23, 2024 (GLOBE NEWSWIRE) -- Biomerica, Inc. (NASDAQ: BMRA), a global biomedical company leading the way in innovative gastroenterology solutions, today announced the appointment of Jack Kenny, former CEO and board member of Meridian Bioscience, Inc., to serve as the Chairman of the Board of Directors of Biomerica. Mr. Zack Irani will continue to serve as CEO. Mr. Kenny joined the Biomerica Board of Directors in August 2023 as an independent director.

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Diagnostics Industry Leader Jack Kenny Appointed as Chairman of the Board at Biomerica

Artelo Biosciences Announces Publication of New Peer-Reviewed Pre-Clinical Research Demonstrating ART26.12’s Effectiveness in Treating and…

SOLANA BEACH, Calif., Jan. 23, 2024 (GLOBE NEWSWIRE) -- Artelo Biosciences, Inc. (Nasdaq: ARTL), a clinical-stage pharmaceutical company focused on modulating lipid-signaling pathways to develop treatments for people living with cancer, pain, and neurological conditions, today announced new research published in the peer-reviewed Journal of Pain. The research article, titled “Discovery and preclinical evaluation of a novel inhibitor of FABP5, ART26.12, effective in Oxaliplatin-induced Peripheral Neuropathy,” highlights Artelo’s pre-clinical asset, ART26.12, and its potential ability to treat and prevent Oxaliplatin-Induced Peripheral Neuropathy (OIPN) in a series of separate studies.

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Artelo Biosciences Announces Publication of New Peer-Reviewed Pre-Clinical Research Demonstrating ART26.12’s Effectiveness in Treating and...