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RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)-- TransEnterix, Inc. (NYSE MKT:TRXC) today announced that the United States Food and Drug Administration ("FDA") notified the Company on April 19, 2016 that the FDA has determined that the SurgiBot™ System does not meet the criteria for substantial equivalence based upon the data and information submitted by TransEnterix in its 510(k) submission.

Fort Worth, Texas, April 18, 2016 – Alcon, the global leader in eye care and a division of Novartis, announced today that it has entered into a strategic alliance with PowerVision, Inc., a privately-held, US-based medical device company focused on developing fluid-based lens implants. PowerVision, Inc. has developed an accommodating IOL (AIOL) which has demonstrated in pilot studies the ability to change focus via a fluid-driven shape-changing technology. The AIOL is intended for cataract patients who also have presbyopia. The technology utilizes the eye's natural accommodating muscles to transport fluid in the intraocular lens which is implanted in the eye's capsular bag.

STAMFORD, Conn., April 17, 2016 (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 new results from its Phase 1 open-label, dose-escalation trial of LOXO-101, a selective inhibitor of tropomyosin receptor kinase (TRK). A presentation at the 2016 American Association for Cancer Research (AACR) Annual Meeting in New Orleans on April 17, 2016 provided updated data from the Phase 1 trial, which was last reported at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics inNovember 2015.

— Aimmune Discussed Phase 2 Data, Including Peanut-Specific IgE Values, at FARE Research Retreat — BRISBANE, Calif.--(BUSINESS WIRE)--Apr. 11, 2016-- Aimmune Therapeutics, Inc. (Nasdaq:AIMT), a biopharmaceutical company developing CODIT™ (Characterized Oral Desensitization ImmunoTherapy) treatments for life-threatening food allergies, today announced that the company’s CEO, Stephen Dilly, M.B.B.S., Ph.D., presented data over the weekend as part of its participation in the annual Food Allergy Research and Education (FARE) Research Retreat. In addition to reviewing efficacy and safety data from Phase 2 trials of Aimmune’s lead product, AR101 for the treatment of peanut allergy, Dr. Dilly also discussed biomarker data from the studies.

MENLO PARK, Calif., April 04, 2016 (GLOBE NEWSWIRE) -- Versartis, Inc. (NASDAQ:VSAR), an endocrine-focused biopharmaceutical company that is developing somavaratan (VRS-317), a novel, long-acting form of recombinant human growth hormone (rhGH) for growth hormone deficiency (GHD), announced that Year 2 safety and efficacy data from its ongoing Extension Study of somavaratan in children with GHD were presented yesterday in a late-breaker oral presentation at the Endocrine Society's 98th Annual Meeting & Expo (ENDO 2016), in Boston, MA. George Bright, MD, Versartis' Global Pediatric Clinical Development Advisor, presented the results at the late breaker oral session (LB-OR02-2) titled "Somavaratan (VRS-317) Treatment of Children with Growth Hormone Deficiency (GHD): Results at 2 Years" on Sunday, April 3, 2016.

MENLO PARK, Calif., April 01, 2016 (GLOBE NEWSWIRE) -- Versartis, Inc. (NASDAQ:VSAR), an endocrine-focused biopharmaceutical company that is developing somavaratan (VRS-317), a novel, long-acting form of recombinant human growth hormone (rhGH) for growth hormone deficiency (GHD), announced that adherence data from its ongoing Extension Study of somavaratan in children with GHD will be presented today in a late-breaker poster presentation at the Endocrine Society's 98th Annual Meeting & Expo (ENDO 2016), in Boston, MA. Eric Humphriss, MBA, Vice President of Clinical Operations at Versartis, will discuss the results at the Late Breaker poster session (poster LBFri-01) on Friday, April 1, 2016 from 1:15 p.m. — 3:15 p.m. Eastern Time (ET).

SAN DIEGO, March 30, 2016 /PRNewswire/ -- Zavante Therapeutics, Inc., a privately held, late clinical-stage biopharmaceutical company, today announced that it has closed a $45 million Series A financing, consisting of $35 million from new investors and $10 million from the conversion of outstanding convertible notes. Proceeds from the financing will be used for the development of the Company's lead product candidate, ZTI-01 (fosfomycin for injection), an injectable antibiotic with a differentiated mechanism of action designed for use in the hospital setting. In the second quarter of 2016, Zavante plans to initiate the ZEUS Study, a single pivotal clinical trial for ZTI-01, a first-in-class broad spectrum IV antibiotic under development to treat multidrug resistant (MDR) pathogens.

RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)-- TransEnterix, Inc. (NYSE MKT: TRXC), a medical device company that is pioneering the use of robotics to improve minimally invasive surgery, today announced that the Company has received an update from the FDA on the status of the 510(k) submission for the SurgiBot™ System.

MENLO PARK, Calif.--(BUSINESS WIRE)--Spirox Inc., a privately held medical device company, announced today the closing of a $45 million Series C round of financing led by KKR, a leading global investment firm. In leading the round, KKR joins a strong syndicate of existing investors in the company. Also participating in the financing is new investor HealthQuest Capital along with major existing shareholders Aisling Capital, Aperture Venture Partners and Venrock. Spirox, which is developing a novel, minimally invasive system to be used by Ear, Nose and Throat (ENT) physicians and plastic surgeons to treat patients with nasal obstruction, looks forward to partnering with KKR to help scale the business and better serve the greater ENT community.

Phase 2/3 Pivotal Trial Will Test Intravenous, Oral Capsule and Oral Suspension Formulations of Solithromycin in Pediatric Patients From Age 2 Months to 17 Years Cempra to Receive $25.5 Million in Funding for the Next Phase of Its Existing Agreement With BARDA CHAPEL HILL, N.C. , March 07, 2016 (GLOBE NEWSWIRE) -- Cempra, Inc. (Nasdaq:CEMP), a clinical-stage pharmaceutical company focused on developing antibiotics to meet critical medical needs in the treatment of bacterial infectious diseases, today announced it has received authorization under its existing contract with the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services, to receive funding of $25.5 million through mid-2018 for a Phase 2/3 clinical study of solithromycin. Cempra is responsible for an additional designated portion of the cost of the planned Phase 2/3 study. Pediatric patients from age 2 months to 17 years with community-acquired bacterial pneumonia (CABP) who are enrolled in the study may receive intravenous, oral suspension or oral capsule formulations of solithromycin, an investigational, fourth generation macrolide antibiotic, or a comparator treatment. The planned enrollment of 400 patients for the Phase 2/3 study is expected to begin during the first half of 2016, with full enrollment expected during the first half of 2018.