Biopharmaceutical

Praxis Precision Medicines Announces Topline Results from the Essential1 Study of Ulixacaltamide for the Treatment of Essential Tremor and Continued Advancement of Program to Phase 3

03/13/2023

Based upon observed efficacy and safety profile, Praxis intends to engage with the FDA in an end of Phase 2 meeting and initiate a ulixacaltamide Phase 3 study for the treatment of essential tremor in 2H23 Ulixacaltamide demonstrated improvement in modified Activities of Daily Living (mADL) primary efficacy endpoint relative to placebo that did not…

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Denali Therapeutics Announces New Interim Data from DNL310 Phase 1/2 Study for MPS II and DNL126 Preclinical Data for MPS IIIA at WORLDSymposium™

02/28/2023

Over 49 weeks of DNL310 (ETV:IDS) treatment in the Phase 1/2 study, positive changes across measures of exploratory clinical outcomes including VABS-II (adaptive behavior) and BSID-III (cognitive capabilities) scores and global impression scales were observed Interim Phase 1/2 data also suggest that DNL310 improves hearing, as assessed by auditory brainstem response testing Additional biomarker data…

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MediciNova Announces Health Canada Grants Authorization to Commence Multi-arm Phase 2/3 Clinical Trial to Evaluate MN-166 (ibudilast) in Long COVID

02/21/2023

Excerpt from the Press Release: LA JOLLA, Calif., Feb. 08, 2023 (GLOBE NEWSWIRE) — MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ:MNOV) and the JASDAQ Market of the Tokyo Stock Exchange (Code Number: 4875), today announced that Health Canada has completed its review of the clinical trial application and has granted…

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Technoderma Medicines Initiates TDM-180935 Atopic Dermatitis Clinical Program with Phase 1 Dose Escalation Trial

02/21/2023

Excerpt from the Press Release: SAN DIEGO, Feb. 9, 2023 /PRNewswire/ — Technoderma Medicines, Inc. (“the Company”), a clinical stage biopharmaceutical company, is pleased to report the Company has begun dosing healthy volunteer subjects in its Phase 1 clinical trial of topical TDM-180935 ointment. This first clinical trial in the Atopic Dermatitis (AD) program includes…

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Palisade Bio Promotes Robert McRae to Chief Operating Officer

02/20/2023

Mr. McRae is an industry veteran with a proven track record of operational, clinical, and strategic business development execution Excerpt from the Press Release: Carlsbad, CA, Feb. 08, 2023 (GLOBE NEWSWIRE) — Palisade Bio, Inc. (Nasdaq: PALI) (the “Company”), a clinical stage biopharmaceutical company advancing therapies for acute and chronic gastrointestinal (GI) complications, today announced the promotion…

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Astria Therapeutics Initiates ALPHA-STAR Phase 1b/2 Clinical Trial of STAR-0215 in People with HAE

02/17/2023

— Initial Proof-of-Concept Results Anticipated in Mid-2024 — Excerpt from the Press Release: BOSTON–(BUSINESS WIRE)–Astria Therapeutics, Inc. (NASDAQ:ATXS), a biopharmaceutical company developing STAR-0215 for the treatment of hereditary angioedema (HAE) and focused on life-changing therapies for rare and niche allergic and immunological diseases, today announced the initiation of the ALPHA-STAR Phase 1b/2 clinical trial of…

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Kura Oncology Announces First Patients Dosed in Phase 2 Registration-Directed Trial of Ziftomenib in NPM1-Mutant Acute Myeloid Leukemia

02/16/2023

– Phase 1 trial showed 30% CR rate among 20 NPM1-mutant AML patients treated at recommended Phase 2 dose – – Phase 2 registration-directed trial expected to enroll 85 patients in the U.S. and Europe – Excerpt from the Press Release: SAN DIEGO, Feb. 09, 2023 (GLOBE NEWSWIRE) — Kura Oncology, Inc. (Nasdaq: KURA), a…

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Phio Pharmaceuticals Announces Positive DMC Recommendation and Continued Enrollment of Advanced Melanoma Study Without Modification

02/16/2023

Excerpt from the Press Release: MARLBOROUGH, Mass., Feb. 10, 2023 /PRNewswire/ — Phio Pharmaceuticals Corp. (Nasdaq: PHIO), a clinical stage biotechnology company whose proprietary INTASYL™ RNAi platform technology is designed to make immune cells more effective in killing tumor cells, today announced that an independent Data Monitoring Committee (DMC) completed its prespecified review of interim…

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KalVista Pharmaceuticals Announces Publication of Sebetralstat Phase 2 Data in The Lancet

02/15/2023

Excerpt from the Press Release: CAMBRIDGE, Mass. & SALISBURY, England–(BUSINESS WIRE)–KalVista Pharmaceuticals, Inc. (NASDAQ: KALV), a clinical stage pharmaceutical company focused on the discovery, development, and commercialization of oral, small molecule protease inhibitors today announced that results from the phase 2 trial evaluating the efficacy and safety of oral sebetralstat for the on-demand treatment of…

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Artelo Biosciences Completes Enrollment of the Phase 1b Stage of its CAReS Clinical Trial Evaluating ART27.13 for the Treatment of Cancer-Related Anorexia and Weight Loss

02/10/2023

Expects to Commence Phase 2a of CAReS During the First Quarter of 2023 Excerpt from the Press Release: SOLANA BEACH, Calif., Feb. 02, 2023 (GLOBE NEWSWIRE) — Artelo Biosciences, Inc. (Nasdaq: ARTL), a clinical-stage pharmaceutical company focused on modulating lipid-signaling pathways to develop treatments for people living with cancer, pain, and neurological conditions, today announced that enrollment in…

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