News

Geneva, Switzerland and Boston, MA – October 3, 2018 - ObsEva SA (NASDAQ: OBSV / SIX: OBSN), a Swiss 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 announced additional positive Phase 3 data from the IMPLANT 2 trial of its oral, oxytocin receptor antagonist, Nolasiban in patients undergoing IVF procedures, as well as future development plans following receipt of EU regulatory feedback. Data from the IMPLANT 2 trial showed that Nolasiban significantly increased live birth rate following IVF treatment. Live birth rate (LBR), also called “Take Home Baby” rate is a key secondary endpoint in IMPLANT 2 trial of Nolasiban in IVF, and these new results show a clinically and statistically significant benefit in favor of Nolasiban. In the primary population, combined Day 3 and Day 5 embryo transfer (ET), treatment with Nolasiban as a single 900mg oral dose 4h prior ET resulted in a live birth rate of 34.8% vs. 27.7% for patients receiving placebo, a 25% relative increase (p=0.025). The live birth rate in women undergoing Day 5 ET was 44.8% for those receiving Nolasiban, vs 33.2% for those receiving placebo, a 35% relative increase (p value=0.025). LBR is an important endpoint as live birth is the ultimate goal of couples who undergo IVF treatment. These data are very consistent with the 10-week pregnancy rate of 35.6% for Nolasiban vs. 28.5% for placebo (p=0.031) that were reported in February 2018.

RAMSEY, N.J. and MARIETTA, Ga., Oct. 03, 2018 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (NASDAQ: ADMA) (“ADMA” or the “Company”), a vertically integrated commercial biopharmaceutical company that develops, manufactures and markets specialty plasma-based biologics for the treatment of Primary Immune Deficiency Disease (“PIDD”) and the prevention and treatment of certain infectious diseases, announces that the Company’s wholly-owned subsidiary, ADMA BioCenters, has received U.S. Food and Drug Administration (“FDA”) approval for its third plasma collection center, located at 166 Ernest W Barrett Parkway, NW, Marietta, Georgia. The facility commenced operations and initiated source plasma collection in December 2017, and is now FDA licensed to collect and enter into interstate commerce to sell and use the human source plasma for further manufacturing in the U.S.

CAMBRIDGE, Mass., Oct. 01, 2018 (GLOBE NEWSWIRE) -- AVROBIO, Inc. (Nasdaq: AVRO) (the “Company”), a Phase 2 clinical-stage gene therapy company developing gene therapies to potentially cure rare diseases with a single dose, today announced clinical data and patient updates from the investigator-sponsored Phase 1 study and the AVROBIO-sponsored Phase 2 clinical trial of AVR-RD-01. AVR‑RD‑01 is an ex vivo lentiviral gene therapy being investigated in Fabry disease. Designed to be a one-time therapy, it works by inserting the GLA gene that encodes functional α‑galactosidase A (AGA, the enzyme that is deficient in Fabry disease) to enable continuous AGA production and distribution to tissues and organs. “We are encouraged by the AGA enzyme activity we are seeing after treatment with AVR-RD-01 in the first two patients with Fabry disease in the Phase 1 study. Both of these patients have AGA activity that remains above the diagnostic range for males with classic Fabry disease, and all patients will continue to be followed for assessment of long-term durable response. We are especially pleased that patient 1 was taken off ERT in mid-July and remains off,” said Geoff MacKay, President and CEO of AVROBIO.

Geneva, Switzerland and Boston, MA – September 28, 2018- ObsEva SA (NASDAQ: OBSV / SIX: OBSN), a Swiss 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 announced additional positive results from the EDELWEISS clinical trial of its oral GnRH receptor antagonist, linzagolix, for the treatment of endometriosis-associated pain. In the EDELWEISS trial, hallmark pain symptoms of endometriosis, dysmenorrhea (DYS) and non-menstrual pelvic pain (NMPP), showed sustained reduction or further improvement after 24 weeks of treatment, as compared to the positive 12-week results that were announced in June 2018. Sustained efficacy was also seen in additional endpoints such as dyspareunia and dyschezia, as well as in the assessments of patient well-being, most notably the Patient Global Impression of Change (PGIC) and Endometriosis Health Profile-30 (EHP-30) questionnaire.

RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--Sep. 23, 2018-- 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 acquired substantially all of the assets of MST Medical Surgery Technologies Ltd. (“MST”), an Israelmedical technology company, in a cash and stock transaction with a total consideration, further described below. MST is a leader in the field of surgical technology, having developed a software-based image analytics platform powered by advanced visualization, scene recognition, artificial intelligence, machine learning and data analytics.

FREMONT, Calif., Sept. 19, 2018 (GLOBE NEWSWIRE) -- Zosano Pharma Corporation (NASDAQ:ZSAN) (“Zosano” or the “Company”), a clinical-stage biopharmaceutical company focused on providing rapid systemic administration of therapeutics to patients using its proprietary Adhesive Dermally-Applied Microneedle (“ADAM™”) technology, today announced the release of three registration batches of M207, the Company’s lead development candidate. The registration batches will be used to support Zosano’s New Drug Application (NDA) filing with the U.S. Food and Drug Administration (FDA). Twelve months of room temperature stability for a product candidate are typically required in order for the FDA to assess manufacturability and stability of a drug product. Zosano’s batches have been placed on stability per regulatory requirements and will complete the 12-month timepoint in September of 2019.

SAN FRANCISCO, Sept. 17, 2018 (GLOBE NEWSWIRE) -- Eidos Therapeutics, Inc. (Eidos) (Nasdaq:EIDX) announced the presentation of results from its Phase 1 clinical trial of AG10 during a poster session at the 22nd Annual Scientific Meeting of the Heart Failure Society of America (HFSA). The poster, entitled “AG10, A Novel, Potent, and Selective Transthyretin Stabilizer, Is Well-Tolerated at Doses Resulting in Target Therapeutic Blood Levels, and Demonstrates Clinical Proof-of-Concept in Healthy Volunteers,” was presented on Saturday, September 15, and is accessible through the science section of the company’s website. In this initial Phase 1 study in healthy adult volunteers, AG10 was well-tolerated with no safety signals of potential clinical concern identified. At the highest tested dose, AG10 achieved 100% transthyretin (TTR) stabilization at peak concentration and over 95% TTR stabilization on average at steady state. Serum TTR concentrations, an in vivo indicator of TTR stability, were increased to a greater degree in AG10-treated patients than placebo-treated patients from baseline to Day 12.

RAMSEY, N.J. and BOCA RATON, Fla., July 26, 2018 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (NASDAQ:ADMA) (“ADMA” or the “Company”), a vertically integrated commercial biopharmaceutical company that manufactures, markets and develops specialty plasma-based biologics for the prevention and treatment of certain infectious diseases, announces that the U.S. Food and Drug Administration (“FDA”) has acknowledged receipt of ADMA’s PAS filing for review which seeks approval to amend the FDA approved BLA for BIVIGAM® (Intravenous Immune Globulin [Human], 10%) (“IVIG”).  Once the PAS is approved, ADMA intends to relaunch BIVIGAM® in the U.S.  The target action date for the PAS is October 25, 2018 under the Prescription Drug User Fee Act (“PDUFA”).

DUBLIN, Ireland, KING OF PRUSSIA, Pa. and SAN DIEGO, July 24, 2018 (GLOBE NEWSWIRE) -- Nabriva Therapeutics plc (NASDAQ:NBRV), a clinical stage biopharmaceutical company engaged in the research and development of novel anti-infective agents to treat serious infections, today announced that it has acquired Zavante Therapeutics, a biopharmaceutical company focused on developing novel therapies to improve the outcomes of hospitalized patients, for upfront consideration of approximately 8.2 million of Nabriva Therapeutics’ ordinary shares (which includes an indemnity holdback) to Zavante Therapeutics’ former stockholders upon completion of the acquisition. In addition, Zavante Therapeutics’ former stockholders are eligible to receive up to $97.5 million upon the achievement of specified regulatory and commercial milestones, which subject to approval by Nabriva Therapeutics’ shareholders and specified limitations, may be settled in Nabriva Therapeutics’ ordinary shares. Nabriva Therapeutics’ ordinary shares issued upon completion of the acquisition, together with shares that may be issuable upon release of an indemnity holdback, constitute approximately 19.9% of Nabriva Therapeutics’ ordinary shares outstanding as of immediately prior to completion of the acquisition.

CLEVELAND, July 24, 2018 — ViewRay, Inc. (Nasdaq: VRAY), maker of the market-leading MRI-guided radiation therapy system,announced today the appointment of medical device industry veterans Scott Drake as its President and Chief Executive Officer and Shar Matin as its Chief Operating Officer, effective immediately. In connection with his appointment, Mr. Drake has also been appointed to the ViewRay Board of Directors. In addition, ViewRay announced the appointment of D. Keith Grossman to the ViewRay Board of Directors. ViewRay announced preliminary unaudited revenue of approximately $16 million for the second quarter ended June 30, 2018, primarily from three revenue units, and reaffirmed full year 2018 revenue guidance of $80 million to $90 million.