Month: August 2023

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

08/17/2023

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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The OBIO® Women in Health Initiative (WiHI)

08/17/2023

Women-led companies face significant barriers when it comes to accessing financing and support systems, receiving just over 2% of venture capital funding. The OBIO® Women in Health Initiative (WiHI) is committed to breaking down these barriers and creating a more equitable and supportive environment for entrepreneurship in the health science sector. Continue Reading

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HyBryte™ Expanded Treatment Trial in Cutaneous T-Cell Lymphoma Opens Enrollment

08/16/2023

Study Supported by $2.6 Million FDA Orphan Products Development Grant Excerpt from the Press Release: PRINCETON, N.J., Aug. 10, 2023 /PRNewswire/ — Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that patient enrollment…

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

08/15/2023

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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Palisade Bio Announces Topline Results from U.S. Phase 2 PROFILE Study Evaluating LB1148 for Post-Surgical Abdominal Adhesions

08/14/2023

– Study did not achieve primary efficacy endpoint of reducing adhesions in LB1148 treated patients compared to placebo treated patients post bowel resection surgery Excerpt from the Press Release: Carlsbad, CA, Aug. 09, 2023 (GLOBE NEWSWIRE) — Palisade Bio (Nasdaq: PALI), a biopharmaceutical company advancing therapies for acute and chronic gastrointestinal (GI) complications, today reported that…

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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

08/11/2023

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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Results from XyloCor Therapeutics’ Phase 1 Portion of EXACT Trial of XC001 for Cardiovascular Disease Published in Circulation: Cardiovascular Interventions

08/10/2023

– Findings from the Phase 1 dose escalation portion of the EXACT trial of XC001 in refractory angina provided the dose selection and safety justification for the recently completed Phase 1/2 study -XC001 is a one-time gene therapy candidate designed to reduce ischemic burden by creating new blood vessels in the heart through the local…

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Bolt Biotherapeutics Initiates Phase 2 Clinical Studies of BDC-1001 in Patients With HER2-Positive Cancer

08/09/2023

Excerpt from the Press Release: REDWOOD CITY, Calif., Aug. 03, 2023 (GLOBE NEWSWIRE) — Bolt Biotherapeutics, Inc. (Nasdaq: BOLT), a clinical-stage biopharmaceutical company developing novel immunotherapies for the treatment of cancer, today announced that the first patients have been dosed in a Phase 2 dose-expansion clinical trial investigating BDC-1001, a HER2-targeting Boltbody™ Immune-Stimulating Antibody Conjugate…

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Perfuse Therapeutics Announces Initiation of Enrollment to the Phase 2A Clinical Trial of PER001 Intravitreal Implant in Diabetic Retinopathy

08/08/2023

Excerpt from the Press Release: SAN FRANCISCO, Aug. 3, 2023 /PRNewswire/ — Perfuse Therapeutics, a biopharmaceutical company pioneering transformational therapies to treat ischemia-induced ocular diseases is pleased to announce the initiation of enrollment into the Ph2a clinical trial of PER-001 intravitreal implant in Diabetic Retinopathy. The Phase 2a trial is a patient masked, randomized, sham-controlled…

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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

08/07/2023

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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