News

Sep 28 2018

Final results of ObsEva SA Phase 2b EDELWEISS trial of Linzagolix show sustained efficacy and Bone Mineral Density safety, for the treatment of endometriosis-associated pain

Sep 28 2018

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.

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Sep 23 2018

TransEnterix Acquires Assets, Intellectual Property and Retains R&D Team from MST Medical Surgery Technologies

Sep 23 2018

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.

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Sep 19 2018

Zosano Pharma Completes Manufacture of M207 Registration Batches

Sep 19 2018

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.

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Sep 17 2018

Eidos Therapeutics Presents Data From Its Phase 1 Clinical Trial Of AG10 At The 22nd Annual Scientific Meeting Of The Heart Failure Society Of America

Sep 17 2018

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.

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Jul 26 2018

ADMA Biologics Receives PDUFA Date for BIVIGAM® Regulatory Submission

Jul 26 2018

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”).

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Jul 24 2018

Nabriva Therapeutics Strengthens Antibiotics Leadership Position with Acquisition of Zavante Therapeutics

Jul 24 2018

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.

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Jul 24 2018

ViewRay Appoints Scott Drake as President, Chief Executive Officer and a Member of the Board of Directors, Shar Matin as Chief Operating Officer, and D. Keith Grossman as a Member of the Board of Directors

Jul 24 2018

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.

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Jul 17 2018

Arcus Biosciences Announces Final Safety Results From Phase 1 Trial for AB928 in Healthy Volunteers

Jul 17 2018

HAYWARD, Calif.–(BUSINESS WIRE)– Arcus Biosciences, Inc. (NYSE:RCUS), a clinical-stage biopharmaceutical company focused on creating innovative cancer immunotherapies, today announced the final unblinded safety data from its Phase 1 trial for AB928, its dual adenosine receptor antagonist, in healthy volunteers. These results demonstrated that AB928 was safe and well tolerated at all doses evaluated. Pharmacokinetic and pharmacodynamic data from this trial were previously presented in April at the 2018 American Association for Cancer Research (AACR) Annual Meeting.

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Jul 9 2018

Ajax Health Announces Closing of $120 Million Series B Financing

Jul 9 2018

MENLO PARK, Calif.–(BUSINESS WIRE)–Ajax Health (“Ajax”), a privately held clinical-stage platform company focused on developing medical technologies, announced today the closing of an oversubscribed $120 million Series B round of financing with participation from a strong syndicate of new and existing investors. New investors include ICONIQ Capital, HealthQuest Capital, Polaris Partners, WTI, and select other individual and large family office investors. Majority investor KKR and existing investor Aisling Capital also participated in the financing.

Ajax was founded in 2017 by Duke Rohlen, a successful medical technology entrepreneur and executive, in partnership with KKR and Aisling Capital. Ajax’s strategy is focused on de-risked medical technology opportunities. Ajax identifies areas of under-served medical need and matches human and financial capital to advance technologies and build strategic value.

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Jun 25 2018

AVROBIO, Inc. Announces Closing of Initial Public Offering and Full Exercise of Underwriters' Overallotment Option

Jun 25 2018

CAMBRIDGE, Mass., June 25, 2018 (GLOBE NEWSWIRE) — AVROBIO, Inc. (NASDAQ:AVRO) (the “Company”), a Phase 2 clinical stage gene therapy company focused on developing potentially curative ex vivo lentiviral-based gene therapies to treat rare diseases following a single dose, today announced the closing of its initial public offering of 6,035,151 shares of common stock at a public offering price of $19.00 per share. This includes the exercise in full by the underwriters of their overallotment option to purchase up to 787,193 additional shares of common stock from the Company at the same price. Including the proceeds from the sale of these additional shares, the Company received total gross proceeds of $114.7 million before underwriting discounts and commissions.

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