News

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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Jun 11 2018

Arcus Biosciences Announces FDA Clearance of INDs for AB928 and AB122 and Initiation of Phase 1/1b Program to Evaluate AB928 Combinations

Jun 11 2018

HAYWARD, Calif.–(BUSINESS WIRE)– Arcus Biosciences, Inc. (NYSE:RCUS), a clinical-stage biopharmaceutical company focused on creating innovative cancer immunotherapies, today announced that the U.S. Food and Drug Administration (FDA) has cleared Investigational New Drug (IND) applications for the Company’s two most advanced product candidates, AB928 and AB122. Clearance of the first IND for AB928 allows the Company to proceed with its planned Phase 1/1b trial to evaluate the safety, tolerability and preliminary efficacy of AB928 in combination with other agents, including AB122 (the Company’s anti-PD-1 antibody) and chemotherapy, in patients with breast and gynecologic malignancies. Two additional IND applications will be submitted this month which, if cleared, will enable the Company to proceed with trials of AB928 combinations in gastrointestinal malignancies, non-small cell lung cancer (NSCLC) and renal cell carcinoma (RCC). In parallel, the Company has been completing the regulatory process to evaluate the combination of AB928 and AB122 in patients in Australia and expects to dose its first patient with this combination shortly.

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Jun 8 2018

TapImmune Announces Pricing of $70 Million Private Placement

Jun 8 2018

JACKSONVILLE, Florida, June 8, 2018 – TapImmune Inc. (NASDAQ: TPIV), a clinical-stage immuno-oncology company, today announced that it has entered into security purchase agreements with certain institutional and accredited investors in connection with a private placement of its equity securities. The private placement will be led by New Enterprise Associates (NEA) with participation from Aisling Capital and Perceptive Advisors, among other new and existing investors. The private placement is expected to be completed concurrently with the closing of the proposed merger between TapImmune Inc. and Marker Therapeutics, Inc., which was previously announced on May 15, 2018.

Upon closing the private placement, TapImmune will issue 17,500,000 shares of its common stock at a price of $4.00 per share. The aggregate offering size, before deducting the placement agent fees and other offering expenses, is expected to be $70 million. Additionally, TapImmune will issue warrants to purchase 13,125,000 shares of TapImmune common stock at an exercise price of $5.00 per share that will be exercisable for a period of five years from the date of issuance. The closing of the transaction, which is subject to the closing of the merger with Marker, the approval by TapImmune’s stockholders as required by NASDAQ Stock Market Rules, and other customary closing conditions, is anticipated to occur by the end of the third quarter of 2018.

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Jun 2 2018

Loxo Oncology Announces Positive Interim Clinical Data from LOXO-292 Dose Escalation Trial in RET-Altered Cancers Presented at the American Society of Clinical Oncology Annual Meeting

Jun 2 2018

STAMFORD, Conn., June 02, 2018 (GLOBE NEWSWIRE) — Loxo Oncology, Inc. (Nasdaq:LOXO), a biopharmaceutical company developing highly selective medicines for patients with genomically defined cancers, today announced interim clinical data from the LOXO-292 global Phase 1 LIBRETTO-001 (LOXO-292 Investigated to Block RET-altered Tumors) dose escalation trial. LOXO-292 is an investigational, highly potent and selective RET inhibitor. These data are being presented today at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago(abstract 102).

“The LOXO-292 Phase 1 data are striking,” said Alexander Drilon, M.D., clinical director in the Early Drug Development Service at Memorial Sloan Kettering Cancer Center and presenting author. “The activity we reported is impressive and I am thrilled to see this promising efficacy with limited adverse events, especially in this heavily pre-treated patient population of RET fusion cancers, including those with brain metastases, and RET mutated MTC.”

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May 29 2018

FDA Accepts Larotrectinib New Drug Application and Grants Priority Review

May 29 2018

STAMFORD, Conn., May 29, 2018 (GLOBE NEWSWIRE) — Loxo Oncology, Inc. (Nasdaq:LOXO), a biopharmaceutical company innovating the development of highly selective medicines for patients with genetically defined cancers, today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s New Drug Application (NDA) and granted Priority Review for larotrectinib for the treatment of adult and pediatric patients with locally advanced or metastatic solid tumors harboring an NTRK gene fusion. The FDA has set a target action date of November 26, 2018, under the Prescription Drug User Fee Act (PDUFA).

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May 29 2018

TransEnterix Announces FDA Clearance for Expanded Indications for Senhance Surgical System

May 29 2018

RESEARCH TRIANGLE PARK, N.C.–(BUSINESS WIRE)–May 29, 2018– TransEnterix, Inc. (NYSE American:TRXC), a medical device company that is digitizing the interface between the surgeon and the patient to improve minimally invasive surgery, today announced that the Company has received FDA 510(k) clearance for expanded indications of its Senhance Surgical System.

The Company received FDA 510(k) clearance for laparoscopic inguinal hernia and laparoscopic cholecystectomy (gallbladder removal) surgery. There are approximately 760,000 inguinal hernia and 1.2 million laparoscopic cholecystectomy procedures performed annually in the U.S. With this clearance, Senhance System’s total addressable annual procedures in the U.S. has more than doubled to over three million.

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May 22 2018

Zosano Appoints Steven A. Elms to Board of Directors

May 22 2018

FREMONT, Calif., May 22, 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 subjects using its proprietary Adhesive Dermally-Applied Microarray (“ADAM™”) technology, today announced that Steven A. Elms, Managing Partner at Aisling Capital, has been appointed to the Company’s Board of Directors. Aisling was a lead investor in the follow-on financing that Zosano recently completed in early-April.

“On behalf of our entire Board, I am pleased to welcome Steven as a member of our Board of Directors,” commented John Walker, Chief Executive Officer and Chairman of the Board. “Steven’s investment banking and Wall Street experience make him an ideal addition to our Board. He adds to the strong industry experience already represented on our Board with his working knowledge of M&A, financings and the full range of capital market transactions. We look forward to having his perspective available as we advance our strategic opportunities.”

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May 21 2018

Harmony Biosciences Receives Breakthrough Therapy And Fast Track Designations For Pitolisant

May 21 2018

PLYMOUTH MEETING, Pa.May 21, 2018 /PRNewswire/ — Harmony Biosciences, LLC (Harmony), today announced that it has received Breakthrough Therapy and Fast Track designations for its investigational product, pitolisant, from the U.S. Food and Drug Administration (FDA). Breakthrough Therapy designation has been granted for pitolisant for the treatment of cataplexy in patients with narcolepsy and is received when a potential new therapy is intended to treat a serious condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapies. Fast Track designation has been granted for the investigation of pitolisant for the treatment of excessive daytime sleepiness in patients with narcolepsy and the treatment of cataplexy in patients with narcolepsy and is received when a potential new therapy is intended to treat a serious condition and data demonstrate the potential to address an unmet medical need. These designations signal FDA’s interest in the development program for pitolisant and provide opportunities for frequent interaction with the Agency, the ability to request a rolling new drug application (NDA) submission, as well as the potential for expedited review.

“We are very pleased that the FDA has granted pitolisant Breakthrough Therapy and Fast Track designations and believe it reflects the Agency’s interest in this investigational product to potentially address an important unmet medical need for patients with narcolepsy,” said Harmony’s Chief Medical Officer, Jeffrey Dayno, M.D. “We look forward to working with the FDA throughout the submission and review of an NDA for this first-in-class molecule with a novel mechanism of action to treat adult patients with narcolepsy with or without cataplexy.”
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