News

Jun 3 2019

Pivotal Phase 3 ARTEMIS Trial Data Demonstrates Consistent Safety and Efficacy of AR101 in Children and Adolescents with Peanut Allergy

Jun 3 2019

LISBON, Portugal–(BUSINESS WIRE)–Jun. 2, 2019– Aimmune Therapeutics, Inc. (Nasdaq: AIMT), a biopharmaceutical company developing treatments for life-threatening food allergies, today presented topline results from the pivotal European Phase 3 ARTEMIS clinical trial, which it previously announced had met its primary endpoint, demonstrating the efficacy and safety of AR101 in peanut-allergic children and adolescents after six months of dose escalation and a three-month therapeutic dosing phase. The findings from the ARTEMIS trial reinforce the consistent clinical profile of AR101, demonstrating that patients tolerated 1,000 mg of peanut protein after only nine months of treatment, which was the primary endpoint of the study. The ARTEMIS study builds on the results of the landmark PALISADE trial, which met its primary endpoint of patients tolerating 600 mg of peanut protein at 12 months. AR101 is an investigational biologic drug for use in oral immunotherapy as a treatment to reduce the frequency and severity of allergic reactions following exposure to peanuts. These data were presented here today in an oral session at the European Academy of Allergy and Clinical Immunology (EAACI) Congress 2019 in Lisbon.

READ MORE

May 28 2019

TransEnterix Announces Japanese Regulatory Approval of the Senhance Surgical System

May 28 2019

RESEARCH TRIANGLE PARK, N.C.–(BUSINESS WIRE)–May 28, 2019– TransEnterix, Inc. (NYSE American: TRXC), a medical device company that is digitizing the interface between surgeons and patients to improve minimally invasive surgery, today announced that it has received Japanese regulatory approval for the Senhance™ Surgical System. “Regulatory approval in Japan is a pivotal milestone for our company, as Japan is second only to the U.S. as the world’s largest surgical robotics market,” said Todd M. Pope, president and chief executive officer of TransEnterix. “Japan’s high penetration of laparoscopic surgery coupled with their rapid adoption of robotics and the intense focus on procedure cost creates a considerable market opportunity for Senhance.”

READ MORE

May 10 2019

FDA Approves Prior Approval Supplement For Bivigam®

May 10 2019

RAMSEY, N.J. and BOCA RATON, Fla., May 10, 2019 (GLOBE NEWSWIRE) — ADMA Biologics, Inc. (NASDAQ: ADMA) (“ADMA” or the “Company”), a vertically integrated commercial biopharmaceutical and specialty immunoglobulin company that manufactures, markets and develops specialty plasma-derived biologics for the treatment of immune deficiencies and the prevention of certain infectious diseases, announces that the U.S. Food and Drug Administration (“FDA”) has approved the Company’s Prior Approval Supplement (“PAS”) for BIVIGAM® (immune globulin intravenous (human), 10% liquid). The FDA’s approval of the PAS for BIVIGAM® approves the use of the Company’s optimized intravenous immune globulin (“IVIG”) manufacturing process and enables ADMA to commence the marketing of BIVIGAM® in the U.S. to patients with Primary Humoral Immunodeficiency (“PI”).

READ MORE

May 8 2019

Biohaven Announces Expanded Safety And Preliminary Preventive Efficacy Data From Ongoing Long-Term Safety Study, And Presents Case Reports Of Using Rimegepant To Successfully Treat Breakthrough Migraine Attacks In Patients Taking Preventive CGRP-Targeting Monoclonal Antibodies

May 8 2019

NEW HAVEN, Conn., May 7, 2019 /PRNewswire/ — Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN) today announced additional safety and preliminary efficacy results from its ongoing long-term, open-label safety study of its oral calcitonin gene-related peptide (CGRP) receptor antagonist, rimegepant. Based upon this interim analysis of Study BHV3000-201 (NCT03266588 or “Study 201”), database cutoff of February 20, 2019, rimegepant was well tolerated with long-term dosing up to one year in patients with migraine.

Biohaven, for the first time, also reported the safety and preliminary efficacy data from the scheduled dosing cohort. In this cohort of patients with a history of 4 to 14 moderate to severe migraine attacks per month, patients were treated with rimegepant 75 mg every other day for up to 12 consecutive weeks. During the on-treatment period, no rimegepant-treated patients (N=281) experienced ALT or AST levels >3x the ULN. There were also no rimegepant-treated patients who experienced alkaline phosphatase or bilirubin >2x the ULN. With regard to efficacy, 48.4% of subjects in the scheduled dosing cohort experienced a ≥50% reduction in the frequency of monthly migraine days with moderate-to-severe pain intensity during the third month of treatment. The company also presented the first clinical reports suggesting that oral rimegepant has the potential to be safe and consistently effective for the treatment of breakthrough migraine attacks in patients taking injectable CGRP-targeting monoclonal antibody (mAb) preventive therapy.

READ MORE

May 3 2019

ObsEva SA Reports Consistent Long-Term Findings from Phase 2b EDELWEISS trial of Linzagolix for Endometriosis-Associated Pain

May 3 2019

Geneva, Switzerland and Boston, MA – May 3, 2019 – ObsEva SA (NASDAQ: OBSV / SIX: OBSN), 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 follow-up results from the Phase 2b EDELWEISS clinical trial of its oral gonadotropin releasing hormone (GnRH) receptor antagonist, linzagolix, for the treatment of endometriosis-associated pelvic pain.

“We are pleased to report long-term data from the EDELWEISS trial of linzagolix, which show that in patients treated with linzagolix for 52 weeks, pelvic pain response rates are maintained with the 75mg or the 200mg dose. Bone mineral density remains within safe limits. Patients that were followed for 6 months after treatment completion continue to experience pain control, and showed BMD increase,” said Ernest Loumaye, Co-Founder and Chief Executive Officer of ObsEva. “These data further support the long term therapeutic potential of linzagolix and support the currently starting Phase 3 program for the endometriosis indication, as we anticipate initial Phase 3 clinical results later this year from the trial in uterine fibroids.”

READ MORE

Apr 22 2019

Poseida Therapeutics Raises $142 Million In Series C Financing

Apr 22 2019

SAN DIEGO, April 22, 2019 — Poseida Therapeutics Inc., a clinical-stage biopharmaceutical company leveraging proprietary non-viral gene engineering technologies to create life-saving therapeutics, today announced closing of a Series C financing round, raising $142 million led by a $75 million equity investment from Novartis Pharma AG, and joined by several new investors including Aisling Capital Management, Pentwater Capital Management, Perceptive Advisors as well as additional undisclosed institutional investors. Current investors Malin Corporation plc., Longitude Capital, Vivo Capital and Boxer Capital, LLC also participated in the financing.

READ MORE

Apr 12 2019

Ajax Health Raises More Than $85 Million to Advance Medical Device Innovations

Apr 12 2019

MENLO PARK, Calif., April 12, 2019 /PRNewswire/ — Ajax Health II, the latest medical device venture from serial healthcare entrepreneur Duke Rohlen, announced today that it has raised more than $85 million, which will be used to strategically operate and expand innovative medical device companies. HealthQuest Capital led the funding, with participation from Aisling Capital and Polaris Partners.

READ MORE

Apr 7 2019

Aeglea BioTherapeutics Announces New Positive Phase 1/2 Data for Pegzilarginase in Patients with Arginase 1 Deficiency at 2019 Annual Meeting of the Society for Inherited Metabolic Disorders

Apr 7 2019

AUSTIN, Texas, April 07, 2019 (GLOBE NEWSWIRE) — Aeglea BioTherapeutics, Inc. (NASDAQ:AGLE), a clinical-stage biotechnology company that designs and develops innovative human enzyme therapeutics for patients with rare genetic diseases and cancer, today presented new positive Phase 1/2 data for pegzilarginase in patients with Arginase 1 Deficiency (ARG1-D) at the 2019 Annual Meeting of the Society for Inherited Metabolic Disorders (SIMD) in Bellevue, Washington. The oral presentation was delivered by Dr. George Diaz, M.D., Ph.D., Division Chief of Medical Genetics in the Department of Genetics and Genomic Sciences at the Icahn School of Medicine at Mt. Sinai, New York, NY, and a Principal Investigator on the pegzilarginase Phase 1/2 trial.

READ MORE

Apr 1 2019

FDA Approves ASCENIV™, A Novel Intravenous Immune Globulin

Apr 1 2019

RAMSEY, N.J. and BOCA RATON, Fla., April 01, 2019 (GLOBE NEWSWIRE) — ADMA Biologics, Inc. (NASDAQ: ADMA) (“ADMA” or the “Company”), a vertically integrated commercial biopharmaceutical and specialty immunoglobulin company that manufactures, markets and develops plasma-derived biologics for the treatment of immune deficiencies and the prevention of certain infectious diseases, announces that the U.S. Food and Drug Administration (“FDA”) has approved ASCENIV™, Immune Globulin Intravenous, Human – slra 10% Liquid, formerly referred to as RI-002. ASCENIV™ is an Intravenous Immune Globulin (“IVIG”) drug product for the treatment of Primary Humoral Immunodeficiency Disease (“PIDD” or “PI”) in adults and adolescents (12 to 17 years of age). The Company anticipates having the product available for commercial launch during the second half of 2019.

READ MORE

Mar 25 2019

European Phase 3 Trial of Aimmune Therapeutics’ AR101 Meets Primary Endpoint

Mar 25 2019

BRISBANE, Calif.–(BUSINESS WIRE)–Mar. 25, 2019– Aimmune Therapeutics, Inc. (Nasdaq: AIMT), a biopharmaceutical company developing treatments for life-threatening food allergies, today announced that its phase 3 European clinical trial of AR101 for the treatment of peanut allergy, known as ARTEMIS (AR101 Trial in Europe Measuring oral Immunotherapy Success), met its primary efficacy endpoint. Topline data show that the proportion of AR101-treated patients who tolerated a 1,000-mg dose of peanut protein (2,043 mg cumulative) in a blinded exit challenge after approximately nine months of AR101 treatment was significantly higher (p<0.00001) than in the placebo group. Specifically, the median tolerated dose of peanut protein for AR101-treated patients improved 100-fold, from 10 mg at baseline to 1,000 mg at exit. The trial also greatly exceeded a 15% lower-bound of the 95% confidence interval (CI) of the difference between treatment arms for all endpoints. In addition, the safety profile and completion rate observed in ARTEMIS are consistent with the results seen in previous AR101 clinical trials. Notably, no cases of anaphylaxis or of eosinophilic esophagitis (EoE) were observed. Aimmune plans to present full results in an oral presentation at the European Academy of Allergy and Clinical Immunology (EAACI) Congress in early June.

READ MORE