News

NEW HAVEN, Conn., March 26, 2018 /PRNewswire/ -- Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN) today announced positive top-line results from both of its two Phase 3 clinical trials (BHV3000-301 and BHV3000-302) of rimegepant (formerly known as BHV-3000), an oral CGRP receptor antagonist for the acute treatment of migraine. In each trial, rimegepant met the co-primary efficacy endpoints of superiority to placebo, at two hours post-dose, on pain freedom and freedom from the most bothersome symptom (MBS) (Figure 1, Table 1). Even without additional rimegepant dosing, or use of rescue medications, these studies showed an early separation from placebo and a profile of continued improvement over the dosing interval. Overall, efficacy and safety results were consistent across both Phase 3 trials.

LONDON, March 26, 2018 (GLOBE NEWSWIRE) --  Verona Pharma plc (AIM:VRP) (Nasdaq:VRNA) (“Verona Pharma” or “the Company”), a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapies for respiratory diseases, announces today positive top-line data from its Phase 2b study evaluating RPL554, a first-in-class, inhaled, dual inhibitor of the enzymes phosphodiesterase 3 and 4 with bronchodilator and anti-inflammatory properties, as a maintenance treatment for chronic obstructive pulmonary disease (COPD).

The study met its primary endpoint, with RPL554 producing a clinically and statistically significant improvement in peak forced expiratory volume in one second (FEV₁) at four weeks in patients with moderate-to-severe COPD compared to placebo. Furthermore, the peak FEV₁ was significantly improved at all time points over the four weeks of dosing. Secondary endpoints measuring 12 hour average FEV₁, COPD symptoms and Quality of Life were also met and support the potential clinical benefits of RPL554 for the treatment of COPD.

MEMPHIS, Tenn.--(BUSINESS WIRE)--Mar. 5, 2018-- GTx, Inc. (Nasdaq:GTXI) today announced additional results from a Phase 2 proof-of-concept clinical trial of 3 mg enobosarm administered orally in postmenopausal women with stress urinary incontinence (SUI), including magnetic resonance imaging (MRI) results from patients’ pelvic floor muscle. New data in a subset of women also suggests a positive treatment effect of enobosarm for urge incontinence (UI) suggesting a possible treatment effect for women with mixed incontinence. Results from a pre-specified analysis of MRI data demonstrate a statistically significant increase in pelvic floor muscle thickness and urethral muscle diameter after enobosarm treatment. Treatment with enobosarm also reduced mean UI episodes by approximately 68 percent in patients who experienced UI as well as SUI, based on a post hoc analysis of a subset of women with both UI and SUI.

Geneva, Switzerland and Boston, MA – 26 February, 2018 – ObsEva SA (NASDAQ: OBSV), a clinical-stage biopharmaceutical company focused on the development and commercialization of novel therapeutics for serious conditions that compromise a woman’s reproductive health and pregnancy, today reported positive top line results of the IMPLANT2 Phase 3 clinical trial of its oral oxytocin receptor antagonist, nolasiban, which is being developed for improving pregnancy rate following in vitro fertilization/intracytoplasmic sperm injection (IVF/ICSI) procedures. Importantly, infertility impacts approximately 10% of reproductive aged couples, and is influenced by the trend of pregnancy desired later in reproductive lives, with annual assisted reproduction technology (ART) cycles approximating 1.6 million worldwide.

STAMFORD, Conn., Feb. 21, 2018 (GLOBE NEWSWIRE) -- Loxo Oncology, Inc. (Nasdaq:LOXO), a biopharmaceutical company innovating the development of highly selective medicines for patients with genetically defined cancers, and Bayer AG, Germany, today announced a publication in the February 22^nd issue of the New England Journal of Medicine (NEJM) for larotrectinib in the treatment of pediatric and adult patients whose tumors harbor tropomyosin receptor kinase (TRK) gene fusions. The NEJM publication provides additional clinical details and patient follow-up from the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting presentation. It includes the first 55 consecutively enrolled adult and pediatric patients with TRK fusion cancers treated across Loxo Oncology’s Phase 1 adult trial, Phase 2 trial (NAVIGATE), and Phase 1/2 pediatric trial (SCOUT) and uses a July 17, 2017 data cutoff.

BRISBANE, Calif.--(BUSINESS WIRE)--Feb. 20, 2018-- Aimmune Therapeutics, Inc. (Nasdaq:AIMT), a biopharmaceutical company developing treatments for potentially life-threatening food allergies, today announced that its pivotal Phase 3 PALISADE efficacy trial of AR101 met the primary endpoint. In the United States, AR101 has U.S. Food and Drug Administration (FDA) Breakthrough Therapy Designation for peanut-allergic patients ages 4–17.

HORSHAM, PA, February 14, 2018 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has approved ERLEADA™ (apalutamide), a next-generation androgen receptor inhibitor,[1] for the treatment of patients with non-metastatic castration-resistant prostate cancer (NM-CRPC). ERLEADA™ is the first FDA-approved treatment for these patients. Today’s approval follows an FDA Priority Review designation based upon data from the Phase 3 SPARTAN study, which demonstrated a 72 percent reduction in risk of distant metastasis or death, and an increase in median metastasis-free survival (MFS) by more than two years (difference of 24.31 months) in patients with NM-CRPC.

CAMBRIDGE, Mass.--(BUSINESS WIRE)--AVROBIO, Inc., a clinical-stage biotechnology company developing transformative, life-changing gene therapies for rare diseases, announced today that it has completed a $60 million Series B financing. Proceeds from the financing will be used to advance multiple gene therapies from AVROBIO’s proprietary lentiviral platform, including the company’s lead gene therapy, AVR-RD-01, currently in Phase 1 for Fabry disease, as well as three additional gene therapies for other lysosomal storage disorders, Gaucher disease, cystinosis and Pompe disease. The Series B round was co-led by Cormorant Asset Management and Surveyor Capital (a Citadel company), and included participation by Aisling, Brace Pharma Capital, Eventide Asset Management and Morningside, along with existing investors Atlas Venture, SV Health Investors and Clarus Ventures.

REDWOOD CITY, Calif., Jan. 24, 2018 (GLOBE NEWSWIRE) -- Menlo Therapeutics Inc. (NASDAQ:MNLO) today announced the pricing of the Company’s initial public offering of 7,000,000 shares of common stock at a public offering price of $17.00 per share, before underwriting discounts. All of the shares of common stock are being offered by Menlo. The Company has also granted the underwriters a 30-day option to purchase from the Company an additional 1,050,000 shares of common stock at the initial public offering price, less the underwriting discount. Menlo’s common stock has been approved for listing on The Nasdaq Global Select Market and is expected to begin trading under the ticker symbol “MNLO” on January 25, 2018. The offering is expected to close on January 29, 2018, subject to customary closing conditions.

Audentes Therapeutics, Inc. (Nasdaq: BOLD), a biotechnology company focused on developing and commercializing gene therapy products for patients living with serious, life-threatening rare diseases, today announced positive interim data from the first dose cohort of ASPIRO, a Phase 1/2 clinical trial of AT132 in patients with X-Linked Myotubular Myopathy (XLMTM).  ASPIRO is a multicenter, multinational, open-label, ascending dose study to evaluate the safety and preliminary efficacy of AT132 in approximately 12 XLMTM patients less than five years of age.