Exelixis Announces Fourth Quarter and Full Year 2015 Financial Results and Provides Corporate Update

- Conference Call and Webcast Today at 5:00 PM Eastern Time -

SOUTH SAN FRANCISCO, Calif.--- Exelixis, Inc. (Nasdaq: EXEL) today reported financial results for the fourth quarter and full year of 2015 and provided an overview of key 2016 corporate objectives and clinical development milestones.

Corporate Updates and Key Priorities for 2016

In 2016, Exelixis will continue to focus its development efforts and financial resources on the opportunities for cabozantinib in advanced renal cell carcinoma (RCC) and advanced hepatocellular carcinoma (HCC). With regulatory applications under review for advanced RCC in the United States and European Union (EU), Exelixis is actively preparing for the potential commercialization of cabozantinib as a treatment for patients with advanced RCC and will soon be launch-ready for this indication should a positive regulatory decision come in the United States.

Published: 01 March 2016
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Aldeyra Therapeutics Reports Positive Results From Phase IIa Clinical Trial in Subjects With Allergic Conjunctivitis

NS2 Demonstrates Statistically Significant and Sustained Clinical Effects
Data Suggest Aldehyde Trapping as Novel Approach for the Treatment of Inflammatory Diseases
Conference Call to Be Held Today at 8:00 am ET 

LEXINGTON, Mass., Feb. 29, 2016  -- Aldeyra Therapeutics, Inc. (ALDX) (Aldeyra), a biotechnology company focused on the development of products to treat diseases related to aldehydes, today reported that the results of a randomized, parallel-group, single-center, double-masked, vehicle-controlled Phase IIa clinical trial of topical ocular NS2 in subjects with induced allergic conjunctivitis demonstrated statistically significant activity of NS2 over vehicle in reducing ocular itching and tearing.

Published: 29 February 2016
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Cipher Pharmaceuticals Inc. announces Canadian launch of Actikerall™

MISSISSAUGA, ON, Feb. 22, 2016 - Cipher Pharmaceuticals Inc. (NASDAQ:CPHR; TSX:CPH) ("Cipher" or "the Company") today announced the Canadian launch of Actikerall™ (0.5% fluorouracil and 10% salicylic acid), indicated for the topical treatment of slightly palpable and/or moderately thick hyperkeratotic actinic keratosis (Grade I/II) of the face, forehead, and balding scalp in immunocompetent adult patients1. Actinic keratosis, also known as solar keratosis, is a skin condition caused by exposure to ultraviolet radiation2. Cipher acquired Actikerall™ from Almirall S.A. in May, 2015. The product represents the third marketed product in Cipher's growing Canadian dermatology portfolio.

"We're excited to introduce Actikerall™ as a new treatment option for Canadians who suffer from actinic keratosis," said Shawn O'Brien, President & CEO of Cipher. "Today, 60% of all Canadians2 over the age of 40 have at least one lesion, and it is expected that the incidence will increase as the population ages."

Published: 22 February 2016
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Trevena, Inc. Receives FDA Breakthrough Therapy Designation for Oliceridine for the Management of Moderate-to-Severe Acute Pain

KING OF PRUSSIA, Pa.-- Trevena, Inc. (TRVN), a clinical stage biopharmaceutical company focused on the discovery and development of biased ligands targeting G protein coupled receptors, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to the Company's lead product candidate, intravenous oliceridine (TRV130), for the management of moderate-to-severe acute pain. Following two successful Phase 2 studies, oliceridine is now in Phase 3 development. The ATHENA-1 safety and tolerability study is ongoing, with pivotal studies expected to begin in the second quarter of 2016.

“We are delighted that the FDA has chosen to grant Breakthrough Therapy designation to oliceridine,” said Maxine Gowen, Ph.D., chief executive officer. “There is an urgent need for a novel analgesic that delivers powerful pain relief with improved safety and tolerability. We believe this designation recognizes our promising Phase 2 study data for oliceridine, which showed encouraging differentiation from morphine. We look forward to working even more closely with the FDA to facilitate our development of oliceridine.”

Published: 22 February 2016
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RG-101 Interim Analysis Shows 97% Response at 8 Week Follow-Up

- RG-101 Containing Regimen Has Potential to Reduce Harvoni®, Olysio®, or Daklinza™ Rx to 4 Week Duration -
- Regulus to Accelerate Development of RG-101 as Backbone Therapy in HCV -
- Conference Call at 8:30am EST Today -

LA JOLLA, Calif., Feb. 17, 2016 -- Regulus Therapeutics Inc. (RGLS), a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs, today announced interim results from one of the company's ongoing Phase II studies of RG-101 for the treatment of Hepatitis C Virus infection (HCV).  The study was designed to evaluate a shortened, four-week treatment regimen containing a subcutaneous administration of 2 mg/kg of RG-101 at Day 1 and Day 29, in combination with 4 weeks of once/daily approved anti-viral agents Harvoni®, Olysio®, or Daklinza™.  The study enrolled 79 treatment naïve genotype 1 and 4 HCV patients (Harvoni® arm, n=27, Olysio® arm, n=27, Daklinza™ arm, n=25). 

Published: 17 February 2016
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