News

BRISBANE, Calif.–(BUSINESS WIRE)–Aug. 21, 2019– Aimmune Therapeutics, Inc. (Nasdaq: AIMT), a biopharmaceutical company developing treatments for life-threatening food allergies, today announced that it has randomized its first patient in a phase 2 clinical trial of AR201 for the treatment of egg allergy. AR201, an investigational biological drug for use in oral immunotherapy for egg allergy, is the second development program that Aimmune is advancing to phase 2 using its Characterized Oral Desensitization ImmunoTherapy (CODIT™) platform.

DUBLIN, Ireland, Aug. 19, 2019 (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 today that the U.S. Food and Drug Administration (FDA) has approved Nabriva’s new drug applications for the oral and intravenous (IV) formulations of Xenleta™ (lefamulin) for the treatment of community-acquired bacterial pneumonia (CABP) in adults. As the first IV and oral antibiotic with a novel mechanism of action approved by the FDA in nearly two decades, XENLETA represents an important new empiric monotherapy treatment option for adults with CABP.

PLYMOUTH MEETING, PA, August 15, 2019 — Harmony Biosciences, LLC (Harmony) announced today that the U.S. Food and Drug Administration (FDA) approved WAKIX® (pitolisant) for the treatment of excessive daytime sleepiness (EDS) in adult patients with narcolepsy. WAKIX is the first and only treatment approved for patients with narcolepsy that is not scheduled as a controlled substance by the U.S. Drug Enforcement Administration (DEA).

NEW HAVEN, Conn., Aug. 7, 2019 /PRNewswire/ — Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN), a clinical-stage biopharmaceutical company with a portfolio of innovative, late-stage product candidates targeting neurological diseases today reported completion of enrollment in its pivotal Phase 3 preventive treatment of migraine trial with rimegepant, its lead oral calcitonin gene-related peptide (CGRP) receptor antagonist product candidate.

LONDON, Aug. 05, 2019 (GLOBE NEWSWIRE) — Verona Pharma plc (AIM: VRP) (Nasdaq: VRNA) (“Verona Pharma”), a biopharmaceutical company focused on respiratory diseases, announces positive Phase 2 data with a dry powder inhaler (“DPI”) formulation of its lead development product, ensifentrine, for the maintenance treatment of chronic obstructive pulmonary disease (“COPD”). All of the primary and secondary lung function endpoints were met in the Phase 2 trial.

WAYNE, Pa., July 30, 2019 (GLOBE NEWSWIRE) — Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a physician-led biopharmaceutical company focused on immuno-inflammatory and dermatological diseases, today announced results from its Phase 2 clinical trial of ATI-501 (AUAT-201 Oral), an investigational oral Janus Kinase (JAK) 1/3 inhibitor, in subjects with alopecia areata (AA). Subjects treated with ATI-501 achieved statistically significant improvement over placebo in several measures of hair growth, including the primary endpoint and certain secondary endpoints of the trial.

SAN DIEGO, July 29, 2019 (GLOBE NEWSWIRE) — Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company developing novel anti-infectives, including immunotherapies, today reported positive topline results from Part B of the global Phase 2 STRIVE trial evaluating the company’s lead antifungal candidate rezafungin. In the STRIVE B trial, rezafungin met all of its objectives for efficacy, safety and tolerability in the treatment of patients with candidemia and/or invasive candidiasis. Rezafungin is a novel echinocandin antifungal being developed as a once-weekly therapy for the first-line treatment and prevention of serious invasive fungal infections.

AUSTIN, Texas, July 24, 2019 (GLOBE NEWSWIRE) — Aeglea BioTherapeutics, Inc. (NASDAQ: AGLE), a clinical-stage biotechnology company that engineers next-generation human enzymes to provide solutions for diseases with unmet medical need, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to the Company’s lead investigational therapy, pegzilarginase, for the treatment of Arginase 1 Deficiency (ARG1-D), a rare progressive disease presenting in early childhood that results in severe complications and early mortality.

San Francisco, CA—July 20, 2019—Marker Therapeutics, Inc. (Nasdaq:MRKR), a clinical-stage immuno-oncology company specializing in the development of next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications, today announced interim data from an ongoing investigator-sponsored clinical trial led by Baylor College of Medicine, evaluating the Company’s MultiTAA T cell therapy in patients with pancreatic adenocarcinoma. The data were reviewed today in an oral presentation during a plenary session, as well as a poster presentation, at the American Association for Cancer Research’s (AACR) Immune Cell Therapies for Cancer: Successes and Challenges of CAR T Cells and Other Forms of Adoptive Therapy conference held in San Francisco, California from July 19-22, 2019.

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Jul. 15, 2019– AVROBIO, Inc. (NASDAQ: AVRO) (the “Company”) today announced the first kidney biopsy result and additional positive data from two ongoing clinical trials of its AVR‑RD‑01 investigational gene therapy in Fabry disease. To date, eight patients have been dosed in the trials – three patients in the Phase 2 FAB-201 trial and five patients in the Phase 1 FACTs trial.