News

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).

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.

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.”

RAMSEY, N.J. and BOCA RATON, Fla., May 14, 2018 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (NASDAQ:ADMA) (“ADMA” or the “Company”) announced today that it has negotiated the receipt and immediate retirement of approximately 8.6 million shares of its non-voting common stock previously issued to Biotest Pharmaceuticals Corporation (“BPC”) and its former parent, Biotest AG (collectively, “Biotest”), as consideration for the waiver and release of certain ADMA rights under the Master Purchase and Sale Agreement, dated as of January 21, 2017, among ADMA and Biotest and certain of their subsidiaries (the “Master Purchase Agreement”).

“We believe the retirement of the non-voting common stock simplifies ADMA’s capital structure, while reducing our total common stock outstanding by approximately 19%, from 45.3 million shares to 36.7 million shares,” stated Adam Grossman, ADMA’s President and Chief Executive Officer.

FREMONT, Calif., May 14, 2018 (GLOBE NEWSWIRE) -- Zosano Pharma Corp. (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 the 250^TH subject has enrolled and received M207 in the M207-ADAM study (the "Study"), a long-term safety study for the acute treatment of migraines. Enrollment in the Study will close on May 18th; however, the investigators will continue enrolling subjects that are scheduled or currently in the run-in period. "The M207-ADAM study continues to progress at a brisk pace. Importantly, our observed pain freedom and pain relief score at two hours are consistent with the data reported in our pivotal efficacy study," said Dr. Donald Kellerman, Zosano's VP, Clinical Development and Medical Affairs. "The 250^TH enrolled subject is an important milestone in the study. We believe that at least 150 subjects will complete six months of evaluation in the Study and 50 will complete one year.  The Study is on track to have more than 50 subjects complete one year of evaluation by the end of March 2019."

INDIANAPOLIS and REDWOOD CITY, Calif., May 10, 2018 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) and ARMO BioSciences, Inc. (NASDAQ: ARMO) today announced a definitive agreement for Lilly to acquire ARMO for $50 per share, or approximately $1.6 billion, in an all-cash transaction. ARMO BioSciences is a late-stage immuno-oncology company that is developing a pipeline of novel, proprietary product candidates designed to activate the immune system of cancer patients to recognize and eradicate tumors. The acquisition will bolster Lilly's immuno-oncology program through the addition of ARMO's lead product candidate, pegilodecakin, a PEGylated IL-10 which has demonstrated clinical benefit as a single agent, and in combination with both chemotherapy and checkpoint inhibitor therapy, across several tumor types. Pegilodecakin is currently being studied in a Phase 3 clinical trial in pancreatic cancer, as well as earlier-Phase trials in lung and renal cell cancer, melanoma and other solid tumor types. ARMO also has a number of other immuno-oncology product candidates in various stages of pre-clinical development.

MALVERN, Pa., May 07, 2018 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a dermatologist-led biopharmaceutical company, today announced that ESKATA™ is now available for purchase by dermatologists in the United States. ESKATA is the first and only FDA-approved topical treatment for raised seborrheic keratoses (SKs) – benign skin growths that may be a cosmetic concern, especially when they appear on the face, neck or chest area. “With ESKATA, dermatologists may now offer their patients a topical treatment option for raised SKs,” said Brett Fair, Chief Commercial Officer of Aclaris.  “Our mission at Aclaris is to identify, develop and commercialize innovative therapies to address unmet needs in aesthetics and medical dermatology and immunology.  The introduction of ESKATA – six years in the making – delivers on this goal.”

HAYWARD, Calif.--(BUSINESS WIRE)-- Arcus Biosciences, Inc. (NYSE:RCUS), a clinical-stage biopharmaceutical company focused on creating innovative cancer immunotherapies, will present data today from its Phase 1 trial for AB928, its dual adenosine receptor antagonist, in healthy volunteers in a poster presentation titled “Clinical Pharmacokinetic-Pharmacodynamic Relationship for AB928, a Dual Antagonist of the A_2aR and A_2bR Adenosine Receptors,” at the 2018 American Association for Cancer Research (AACR) Annual Meeting in Chicago, Illinois. “We are extremely encouraged by the results from our ongoing Phase 1 trial of AB928. The compound has been shown to be safe and well tolerated at all doses evaluated and achieves near complete inhibition of A_2aR adenosine receptor activation in blood samples from healthy volunteers,” said Terry Rosen, Ph.D., Chief Executive Officer at Arcus. “Importantly, we achieved this level of inhibition under conditions that we believe are representative of the large concentrations of adenosine found in the tumor microenvironment. These results have informed the selection of the starting dose for our clinical trials of AB928 in combination with other anti-cancer agents, and we look forward to starting these trials shortly.”

STAMFORD, Conn. and SAN DIEGO, April 10, 2018 (GLOBE NEWSWIRE) -- Loxo Oncology (Nasdaq:LOXO) and Illumina, Inc. (Nasdaq:ILMN) today announced a global strategic partnership to develop and commercialize a multi-gene panel for broad tumor profiling, resulting in a distributable, next-generation sequencing (NGS) based companion diagnostic (CDx) with a pan-cancer indication. The co-development partnership will seek approval for a version of the Illumina TruSight Tumor 170 as a companion diagnostic (CDx) for Loxo Oncology’s larotrectinib, which targets NTRK gene fusions, and LOXO-292, which targets RET gene alterations, across tumor types. TruSight Tumor 170 is a comprehensive, state-of-the-art, next-generation sequencing test that interrogates point mutations, fusions, amplifications and splice variants in 170 genes associated with common solid tumors. The CDx version of TruSight Tumor 170 will allow local laboratories to provide referring physicians with comprehensive genomic information, so that patients can be matched to the most appropriate therapeutic options. This version of TruSight Tumor 170 will run on the NextSeq 550Dx platform.