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Primary endpoint in Intention to Treat (ITT) was not met despite large absolute reductions in Systolic Blood Pressure (SBP) 12.6 mmHg placebo-adjusted reduction in SBP with 2 mg baxdrostat in a pre-specified subgroup that represents approximately 81-89% of the U.S. hypertension population (nominal p-value = 0.001) Safety profile and tolerability consistent with BrigHtn Phase 2…
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Excerpt from the Press Release: WOBURN, Mass., Nov. 21, 2022 (GLOBE NEWSWIRE) — Biofrontera Inc. (Nasdaq: BFRI), a biopharmaceutical company specializing in the commercialization of dermatological products, announced today the launch of a randomized, double-blind, vehicle-controlled, multicenter Phase 3 clinical study to evaluate the safety and efficacy of Ameluz® and BF-RhodoLED® XL in the field-directed…
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KING OF PRUSSIA, PA, USA This historic approval provides a new treatment option that reduces the rate of annual bleeds, reduces or eliminates the need for prophylactic therapy and generates elevated and sustained factor IX levels for years after a one-time infusion. Excerpt from the Press Release: This historic approval provides a new treatment option…
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Study finds patients with Fragile X who have a highly methylated FMR1 gene that were treated with Zygel showed a significant reduction in behavioral symptoms compared to those treated with placebo Topline results from follow-on RECONNECT confirmatory pivotal Phase 3 trial of Zygel in patients with a completely methylated FMR1 gene expected in second half…
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– PK Data and Safety Profile Consistent with Previous Studies in Healthy Subjects – – Results Support Potential Utility of Lefamulin in Patients with Cystic Fibrosis – Excerpt from the Press Release: DUBLIN, Ireland and FORT WASHINGTON, Pa., Nov. 28, 2022 (GLOBE NEWSWIRE) — Nabriva Therapeutics plc (NASDAQ: NBRV), a biopharmaceutical company engaged in the…
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IMM-1-104 being tested in first all-comers RAS clinical trial believed to be conducted to date First patient dosed follows swiftly from IND clearance at the end of Septembe Excerpt from the Press Release: CAMBRIDGE, Mass., Nov. 28, 2022 (GLOBE NEWSWIRE) — Immuneering Corporation (Nasdaq: IMRX), a clinical stage biopharmaceutical company that aims to create medicines…
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First patient dosed in global study of oral α4β7 integrin inhibitor Excerpt from the Press Release: WALTHAM, Mass., Nov. 22, 2022 (GLOBE NEWSWIRE) — Morphic Therapeutic (Nasdaq: MORF), a biopharmaceutical company developing a new generation of oral integrin therapies for the treatment of serious chronic diseases, today announced that the EMERALD-2 phase 2b study of…
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Excerpt from the Press Release: BOSTON, Nov. 28, 2022 (GLOBE NEWSWIRE) — Praxis Precision Medicines, Inc. (NASDAQ: PRAX), a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system (CNS) disorders characterized by neuronal excitation-inhibition imbalance, today announced plans to initiate the PRAX-562 Phase 2 EMBOLD study for the treatment of…
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The company partners with QURE and Curta to assess value of early identification in high-risk cohorts Excerpt from the Press Release: SAN DIEGO, Nov. 22, 2022 /PRNewswire/ — Biological Dynamics, an exosome-isolation technology and early disease detection diagnostic company, today announced that it has partnered with both QURE Healthcare and Curta to explore how the…
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Excerpt from the Press Release: CARLSBAD, Calif.–(BUSINESS WIRE)–Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, announced today that its partner Genentech, a member of the Roche Group, has launched a Phase 2a, multicenter, open-label, single arm clinical study of RG6501 (OpRegen), a…
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