Biopharmaceutical

Nabriva Therapeutics Completes Patient Enrollment in Phase 1 Trial of XENLETA® (lefamulin) in Adult Patients with Cystic Fibrosis

08/18/2022

– Topline Data Expected First Quarter 2023 – Excerpt from the Press Release: DUBLIN, Ireland and FORT WASHINGTON, Pa., Aug. 11, 2022 (GLOBE NEWSWIRE) — Nabriva Therapeutics plc (NASDAQ: NBRV), a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections, announced the completion of patient enrollment in its…

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Satsuma Pharmaceuticals Announces Completion of Enrollment in SUMMIT Pivotal Phase 3 Efficacy Trial of STS101 for the Acute Treatment of Migraine

08/15/2022

– More than 1,400 subjects randomized –– Satsuma expects to announce topline SUMMIT trial results in Q4 2022 – Excerpt from the Press Release: SOUTH SAN FRANCISCO, Calif., Aug. 02, 2022 (GLOBE NEWSWIRE) — Satsuma Pharmaceuticals, Inc. (Nasdaq: STSA), a clinical-stage biopharmaceutical company developing STS101 (dihydroergotamine (DHE) nasal powder), a novel investigational therapeutic product candidate for the…

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Merrimack Provides Ipsen Report of Results From Phase III RESILIENT Trial Evaluating Onivyde® in Second-Line Monotherapy for Small Cell Lung Cancer

08/11/2022

Excerpt from the Press Release: CAMBRIDGE, Mass.–(BUSINESS WIRE)–Merrimack Pharmaceuticals, Inc. (Nasdaq: MACK) [(“Merrimack” or the “Company”)] announced that Ipsen, SA (“Ipsen”) has issued a press release today reporting its primary analysis of the results of its Phase 3 trial of Onivyde® (irinotecan liposomal injection) as a treatment of second line small cell lung cancer (SCLC).…

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Nuvalent Presents New Preclinical Data Supporting Potential Best-in-Class Profile for ALK-Selective Inhibitor NVL-655 at IASLC 2022 World Conference on Lung Cancer Annual Meeting

08/10/2022

Trial in progress poster also to be presented for Phase 1/2 ARROS-1 study of ROS1-selective inhibitor NVL-520 Excerpt from the Press Release: CAMBRIDGE, Mass., Aug. 5, 2022 /PRNewswire/ — Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced new preclinical data…

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Astria Therapeutics Announces Initiation of Phase 1a Trial of STAR-0215, a Monoclonal Antibody Inhibitor of Plasma Kallikrein for Treatment of Hereditary Angioedema

08/09/2022

— Preliminary Results from the Phase 1a Trial Anticipated by Year-End — Excerpt from the Press Release: BOSTON–(BUSINESS WIRE)–Astria Therapeutics, Inc. (NASDAQ:ATXS), a biopharmaceutical company developing STAR-0215 for hereditary angioedema and focused on life-changing therapies for rare and niche allergic and immunological diseases, today announced initiation of a Phase 1a clinical trial of STAR-0215 in…

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Cyclerion Therapeutics Announces Positive Topline Clinical Data for CY6463 in Patients with Cognitive Impairment Associated with Schizophrenia (CIAS)

08/08/2022

Study data demonstrate positive effects of CY6463 on cognition and inflammation after two weeks of dosing in patients with stable schizophrenia on standard of care Oral, once-daily CY6463 was well tolerated, with no reports of serious adverse events (SAEs) or treatment discontinuation due to adverse events (AEs) Data demonstrate the translation of sGC multi-dimensional pharmacology…

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Cortexyme Successfully Completes Phase 1 Single and Multiple Ascending Dose Clinical Trial of COR588

08/08/2022

Once daily dose of COR588 over 10-day period well-tolerated with no serious adverse events observed Excerpt from the Press Release: SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Cortexyme, Inc. (Nasdaq: CRTX), a clinical-stage biopharmaceutical company focused on advancing therapeutics for rare and degenerative diseases, today reported the successful completion of its Phase 1 single ascending dose and multiple…

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AISA Pharma Announces Positive Data Safety Monitoring Board Review of First Phase 2 Data of Profervia® to treat Raynaud’s Disease in Scleroderma Patients

08/05/2022

Company to Move Forward with Key U.S. Regulatory Applications – Investigational New Drug and Orphan Drug Designation BOSTON, July 26, 2022 (GLOBE NEWSWIRE) — Aisa Pharma, Inc. a privately-funded, clinical-stage biopharmaceutical company, today announced that the Data Safety Monitoring Board (DSMB) for the RECONNOITER Phase 2 study of Aisa’s Profervia® once-daily novel, oral calcium-channel antagonist…

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Belite Bio Submits Investigational New Drug (IND) Application to FDA for Approval to Proceed with LBS-008 Phase 3 Clinical Trial for the Treatment of Stargardt Disease

08/02/2022

LBS-008 (a/k/a Tinlarebant) is the Company’s orally administered tablet for the treatment of Stargardt disease (STGD1) There are currently no approved treatments for STGD1 Approximately 30,000 patients in the U.S. suffer from STGD1 A 2-year Phase 2 trial in adolescent STGD1 and a global Phase 3 trial in adolescent STGD1 are ongoing The Phase 3,…

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HyBryte™ Phase 3 FLASH Study for the Treatment of Cutaneous T-Cell Lymphoma Published in JAMA Dermatology

08/01/2022

Published findings demonstrate that HyBryte™ treatment statistically significantly reduced CTCL lesion size HyBryte™ has potential to address a critical gap in treatment of early-stage CTCL Excerpt from the Press Release: PRINCETON, N.J., July 20, 2022 /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…

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