News & Updates

CinCor Pharma Announces Topline Data for Phase 2 HALO Trial Evaluating Selective Aldosterone Synthase Inhibitor Baxdrostat in Uncontrolled Hypertension

12/02/2022

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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Biofrontera to Launch Phase 3 Clinical Study Evaluating Ameluz®-PDT for the Treatment of Actinic Keratosis on the Extremities, Neck and Trunk

12/02/2022

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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U.S. Food and Drug Administration approves CSL’s HEMGENIX® (etranacogene dezaparvovec-drlb), the first gene therapy for hemophilia B

12/01/2022

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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Zynerba Pharmaceuticals Announces Publication of Data from Phase 3 CONNECT-FX Study of Zygel™ in the Journal of Neurodevelopmental Disorders

12/01/2022

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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Nabriva Therapeutics Announces Positive Topline Results from Phase 1 Trial of XENLETA® (lefamulin) in Adult Patients with Cystic Fibrosis

12/01/2022

– 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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Immuneering Announces First Patient Dosed in its Phase 1/2a Clinical Trial of IMM-1-104 in Advanced Solid Tumors with RAS Mutations

11/30/2022

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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Morphic Announces Initiation of EMERALD-2 Phase 2b Clinical Trial of MORF-057 in Patients with Moderate-to-Severe Ulcerative Colitis

11/30/2022

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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Praxis Precision Medicines to Advance PRAX-562 Phase 2 Study in Pediatric Patients with Developmental and Epileptic Encephalopathies

11/30/2022

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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Biological Dynamics collaborates on clinical utility studies to examine the impact of its early pancreatic cancer detection assay

11/29/2022

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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Lineage Announces Launch of Phase 2a Study by Genentech of RG6501 (OpRegen®) in Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration

11/29/2022

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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