News

Policy Update Facilitates Access to Nearly 14.7 Million Members MENLO PARK, Calif.--Intersect ENT, Inc. (NASDAQ:XENT), a company seeking to improve the quality of life for patients with ear, nose and throat conditions, today announced that Health Care Service Corporation (HCSC), the country’s largest customer owned health insurer, has updated its sinus surgery coverage policy. HCSC will now cover PROPEL® and PROPEL® mini, steroid releasing sinus implants, as “medically necessary” for patients meeting the criteria for endoscopic sinus surgery.

– Synergistic Fit Expands Commercial Footprint, Builds Strong Product Portfolio – MORRISTOWN, N.J. – April 24, 2015 – Pernix Therapeutics Holdings, Inc. (Nasdaq: PTX) (the “Company” or “Pernix”), a specialty pharmaceutical company, announced today that it has closed its acquisition of the Zohydro® ER (hydrocodone bitartrate) franchise, comprising three extended release hydrocodone products, including an abuse-deterrent pipeline and all related intellectual property. Pernix first announced the agreement with Zogenix, Inc. to acquire this franchise on March 10th.

Pharmacokinetics show good systemic exposure of LOXO-101 after oral dosing, with drug levels approaching therapeutic ranges LOXO-101 has been well tolerated; dose escalation is ongoing The Phase 1b study, examining proof of concept exclusively in patients with NTRK alterations, is expected to begin in the second half of 2015 STAMFORD, Conn., April 21, 2015 (GLOBE NEWSWIRE) -- Loxo Oncology, Inc. (Nasdaq:LOXO), a biopharmaceutical company focused on the discovery, development, and commercialization of targeted cancer therapies, today announced the presentation of initial Phase 1a safety and pharmacokinetic data for LOXO-101, the only selective inhibitor of the TRK family of tyrosine kinase receptors in clinical development, in a poster session at the American Association for Cancer Research (AACR) 2015 Annual Meeting in Philadelphia, PA. The poster, entitled "Pharmacokinetics (PK) of LOXO-101 during the first-in-human Phase I study in patients with advanced solid tumors: Interim update," will be presented in the Experimental and Molecular Therapeutics session today from 1:00 PM - 5:00 PM ET in poster section 32. The poster is also available at www.loxooncology.com.

MORRISTOWN, NJ – (BUSINESS WIRE) – April 20, 2015 – Pernix Therapeutics Holdings, Inc. (NASDAQ: PTX), a specialty pharmaceutical company, today announced that Pediatric Exclusivity has been granted by the U.S Food and Drug Administration (FDA) for studies conducted on Treximet® (sumatriptan/naproxen sodium), effective April 16, 2015, under section 505A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a). Based on this decision, an additional six months of U.S. market exclusivity will attach to the patents that are listed in FDA’s Orange Book for Treximet, or until February 14, 2018.

MENLO PARK, Calif., April 20, 2015 /PRNewswire/ -- Spirox Inc., a privately held medical device company, announced today the closing of an $18.5 million Series B round of financing led by Venrock and Aisling Capital. Existing investors Aperture Venture Partners, Correlation Ventures and Western Technology Investment also participated in the round. 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, intends to use the funding to complete development, seek US marketing authorization, and initiate product commercialization.

Morristown, New Jersey, April 17, 2015 – Pernix Therapeutics Holdings, Inc. (NASDAQ: PTX) (the “Company”) today announced that it has priced a private offering of $130 million aggregate principal amount of the Company’s 4.25% Convertible Senior Notes due 2021, which will be sold only to qualified institutional buyers in accordance with Rule 144A under the Securities Act of 1933, as amended (the “Securities Act”) or institutional accredited investors as defined in Rule 501(a)(1), (2), (3) or (7) of Regulation D under the Securities Act. The size of the offering was increased from the previously announced aggregate principal amount of $120 million.

RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)-- TransEnterix, Inc. (NYSE MKT: TRXC), a medical device company that is pioneering the use of robotics and flexible instruments to improve minimally invasive surgery, today announced the successful completion of its GLP Studies using the SurgiBot system, its patient-side robotic surgery system. Management also commented that the Company remains on track to submit its FDA 510(k) filing in mid-2015.

SAN DIEGO, April 15, 2015 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (Nasdaq:CDTX), a biotechnology company developing novel anti-infectives and immunotherapies to treat fungal and other infections, today announced the pricing of its initial public offering of 4,800,000 shares of common stock, an increase of 800,000 shares from the number of shares originally offered, at a public offering price of $16.00 per share. The shares are expected to begin trading on the NASDAQ Global Market today (April 15, 2015) under the ticker symbol "CDTX." In addition, Cidara has granted the underwriters a 30-day option to purchase up to an additional 720,000 shares of common stock at the initial public offering price.

MENLO PARK, Calif., April 13, 2015 (GLOBE NEWSWIRE) -- Versartis, Inc. (Nasdaq:VSAR), an endocrine-focused biopharmaceutical company that is developing a novel, long-acting form of recombinant human growth hormone (rhGH), today announced the initiation of its Phase 2/3 study of VRS-317 in Japan for children with growth hormone deficiency (GHD).

Study to Enroll Approximately 400 Patients With Moderate-to-Severe Acne Vulgaris MENLO PARK, Calif., April 9, 2015 (GLOBE NEWSWIRE) -- Dermira, Inc. (Nasdaq:DERM), a specialty biopharmaceutical company focused on bringing innovative and differentiated products to dermatologists and their patients, today announced the initial dosing of the first patient in a Phase 2b dose-ranging trial for DRM01 in patients with facial acne vulgaris. The randomized, multi-center, double-blind, parallel-group, vehicle-controlled study is designed to assess the safety and efficacy of DRM01 compared to vehicle. The goal of the study is to establish the optimal dose for a potential Phase 3 program.