News

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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Jun 22 2018

Eidos Therapeutics Announces Closing Of Initial Public Offering And Exercise In Full Of The Underwriters' Option To Purchase Additional Shares

Jun 22 2018

SAN FRANCISCO, June 22, 2018 /PRNewswire/ — Eidos Therapeutics, Inc. (Nasdaq: EIDX), a clinical stage biopharmaceutical company focused on addressing the large and growing unmet need in diseases caused by transthyretin (TTR) amyloidosis (ATTR), today announced the closing of its initial public offering of 7,187,500 shares of common stock, including the exercise in full of the underwriters’ option to purchase 937,500 additional shares of common stock, at a public offering price of $17.00 per share. The aggregate gross proceeds to Eidos from the offering were approximately $122.2 million, before deducting underwriting discounts and other offering expenses. All of the shares in the offering were offered by Eidos. Eidos’ common stock is listed on The NASDAQ Global Select Market under the ticker symbol “EIDX.”

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Jun 19 2018

Biohaven And Royalty Pharma Announce Royalty Funding And Stock Purchase Agreements Totaling $150 Million

Jun 19 2018

NEW HAVEN, Conn. and NEW YORKJune 18, 2018 /PRNewswire/ — Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN) (“Biohaven” or the “Company”) and Royalty Pharma announced today that Biohaven has sold tiered, sales-based participation rights on future global net sales of products containing rimegepant (BHV-3000) or BHV-3500 and certain derivative compounds thereof to Royalty Pharma for $100 million. Royalty Pharma has also agreed to purchase $50.0 million in common shares of Biohaven, at a price of $45.00 per share, representing an approximately 19% premium over the 15-day volume-weighted average price through June 15, 2018.

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Jun 18 2018

ObsEva SA Achieves Primary and Secondary Endpoints for EDELWEISS Phase 2b Clinical Trial of Linzagolix (OBE2109) in Women with Endometriosis

Jun 18 2018

Geneva, Switzerland and Boston, MA – June 18, 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 12-week results from the EDELWEISS Phase 2b clinical trial of linzagolix, its oral GnRH receptor antagonist, for the treatment of endometriosis-associated pain. The company is also identifying the two doses of linzagolix intended to be studied in the upcoming Phase 3 program, one for full estradiol (E2) suppression and one targeting partial suppression.

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Jun 11 2018

Aimmune Therapeutics Appoints Dr. Jayson Dallas as CEO

Jun 11 2018

BRISBANE, Calif.–(BUSINESS WIRE)–Jun. 11, 2018– Aimmune Therapeutics, Inc. (Nasdaq:AIMT), a biopharmaceutical company developing treatments for potentially life-threatening food allergies, today announced the appointment of Jayson Dallas, M.D., as President and Chief Executive Officer. Dr. Dallas, a biotech and pharmaceutical industry executive with decades of global strategic and commercial experience, will join Aimmune as President and CEO on June 19th, and will also become a member of the Aimmune Board of Directors.

Dr. Dallas joins Aimmune from Ultragenyx, a biopharmaceutical company focused on the development of products for rare and ultra-rare diseases, where he served as the company’s first Chief Commercial Officer. In nearly three years in that role, he oversaw commercial operations, including sales, marketing, reimbursement, and new product planning, and led the launches of Ultragenyx’s first two products, both of which received U.S. Food and Drug Administration (FDA) approvals in the past year.

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