News & Updates

Valitor Announces Presentation on Novel Anti-VEGF Antibody Conjugate and Multivalent Polymer Technology Platform at Upcoming Ophthalmology Innovation Source (OIS) Summit

12/05/2022

– Preclinical data support twice-yearly dosing in wet AMD – Excerpt from the Press Release: BERKELEY, Calif., Dec. 01, 2022 (GLOBE NEWSWIRE) — Valitor, a biotechnology company engineering better medicines to conquer drug limitations, today announced that its president and chief scientific officer, Wesley Jackson, Ph.D., will present at the Ophthalmology Innovation Source (OIS) XII…

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Otsuka Pharmaceutical & Lundbeck Present Positive Data From Multiple Phase 3 Studies Showing Brexpiprazole Significantly Improved Symptoms of Agitation in Patients With Alzheimer’s Dementia at the 2022 Clinical Trials for Alzheimer’s Disease Congress

12/05/2022

Researchers highlight efficacy and safety data across three Phase 3 studies of brexpiprazole for agitation in Alzheimer’s dementia Agitation is a highly prevalent clinical manifestation in Alzheimer’s dementia and one of the most complex and stressful aspects of care in patients affected by the disease. It is associated with greater caregiver burden, earlier nursing home…

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Ikena Oncology Announces New Program in Next-Generation MEK-RAF Inhibition and Provides Corporate Update

12/02/2022

Novel best-in-class MEK-RAF complex inhibitor IK-595 targets RAS pathway; IND in 2023 Novel paralog-selective TEAD inhibitor IK-930 advancing as planned in dose escalation; clinical data in 2023 Company prioritizes advancement of targeted oncology portfolio; cash runway extended into 2025 Excerpt from the Press Release: BOSTON, Nov. 28, 2022 (GLOBE NEWSWIRE) — Ikena Oncology, Inc. (Nasdaq:…

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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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