Via Nova Therapeutics Announces FDA clearance of Investigational New Drug (IND) application for VNT-101, a novel direct-acting antiviral against Influenza A virus


Excerpt from the Press Release: OAKLAND, Calif., Sept. 21, 2023 /PRNewswire/ — Via Nova Therapeutics, Inc., a biotechnology company focused on discovering and developing therapeutics to treat viral infections with significant unmet medical need, today announced the clearance of its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) for its…

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Ocugen Announces Positive Clinical Study Update from the Phase 1/2 Trial of OCU400, a Modifier Gene Therapy Product Candidate, for the Treatment of Retinitis Pigmentosa (RP) and Leber Congenital Amaurosis (LCA)


Excerpt from the Press Release: MALVERN, Pa., Sept. 13, 2023 (GLOBE NEWSWIRE) — Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines, today announced a clinical study update for Retinitis Pigmentosa (RP) participants treated in the Phase 1/2 trial…

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NeuroBo Pharmaceuticals Doses First Patient in Its Phase 2a Clinical Trial Evaluating DA-1241 for the Treatment of NASH


Two-Part Design Provides Optionality for Interim Analysis in First Half of 2024 Full Data Readout Expected in the Second Half of 2024 Excerpt from the Press Release: BOSTON, Sept. 15, 2023 /PRNewswire/ — NeuroBo Pharmaceuticals, Inc. (Nasdaq: NRBO), a clinical-stage biotechnology company on a quest to transform cardiometabolic diseases, today announced dosing of the first…

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AusperBio Announces FDA Clearance of IND Application of AHB-137 in Chronic Hepatitis B Treatment


Excerpt from the Press Release: SAN FRANCISCO, Aug. 25, 2023 /PRNewswire/ — AusperBio Therapeutics, Inc. and Ausper Biopharma Co., Ltd. (Together AusperBio), a clinical-stage biotech company committed to advancing antiviral therapies and vaccines, with a primary focus on achieving a functional cure for chronic hepatitis B (CHB) infection, today announced the U.S. Food and Drug…

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Bioxytran Announces FDA Clearance of its IND Application for ProLectin-M in Clinical Trials


Excerpt from the Press Release: BOSTON, MASSACHUSETTS, Aug. 24, 2023 (GLOBE NEWSWIRE) — BIOXYTRAN, INC. (BIXT), (the “Company”), a clinical stage biotechnology company developing oral drugs to treat COVID-19 and other viral diseases, announced that it has received clearance of its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA), to…

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Neurophth Announces First Patient Dosed in Phase I/II Clinical Trial of Second Gene Therapy


Excerpt from the Press Release: WUHAN, China and SAN DIEGO, Aug. 17, 2023 /PRNewswire/ — Neurophth Therapeutics, Inc. (“Neurophth”) announced today that the first patient has been dosed in the international multi-region, multi-center Phase I/II clinical trial for the treatment of Leber hereditary optic neuropathy caused by ND1 mutation (ND1-LHON). Neurophth is conducting a Phase I/II,…

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CymaBay Initiates IDEAL, a Phase 3 Placebo-Controlled, Randomized Study of Seladelpar in Patients with Primary Biliary Cholangitis and Incomplete Control of Alkaline Phosphatase


valuates seladelpar 10 mg vs. placebo for alkaline phosphatase normalization at 52 weeks Patients enroll with alkaline phosphatase levels between 1- and 1.67-times upper limit of normal Excerpt from the Press Release: NEWARK, Calif., Aug. 10, 2023 /PRNewswire/ — CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a biopharmaceutical company focused on developing and providing access to innovative therapies…

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Jnana Therapeutics Announces Dosing of First Participant in Phase 1b Clinical Trial of JNT-517 in Individuals with PKU


JNT-517 is a Potential First-in-Class Oral Treatment for PKU; Phase 1b Study Follows Positive Clinical Proof of Mechanism Data in Healthy Individuals Upcoming Oral Presentation of Phase 1a Study Results at the Society for the Study of Inborn Errors of Metabolism (SSIEM) Annual Symposium 2023 Excerpt from the Press Release: BOSTON, Aug. 09, 2023 (GLOBE…

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LianBio Announces First Patient Treated in Phase 1 Trial of SHP2 Inhibitor BBP-398 in Combination with Osimertinib in Patients with Non-Small Cell Lung Cancer with EGFR Mutations


Excerpt from the Press Release: SHANGHAI, China and PRINCETON, N.J., Aug. 03, 2023 (GLOBE NEWSWIRE) — LianBio (Nasdaq: LIAN), a biotechnology company dedicated to bringing innovative medicines to patients in China and other major Asian markets, today announced the first patient has been dosed in its Phase 1 clinical trial of BBP-398, an investigational SHP2 inhibitor,…

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Celsius Therapeutics Announces Initiation of Dosing in Phase 1 Clinical Trial of CEL383, an Anti-TREM1 Antibody for the Treatment of Inflammatory Bowel Disease


Excerpt from the Press Release: CAMBRIDGE, Mass.–(BUSINESS WIRE)–Celsius Therapeutics, a biotechnology company pioneering new precision medicines for patients with inflammatory disease by harnessing the power of single-cell RNA sequencing and human biology at scale, today announced the initiation of dosing in the company’s first-in-human Phase 1 clinical trial of CEL383 in healthy volunteers. CEL383 is…

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