Statistically and Clinically Significant Improvement Across Multiple Sign and Symptom Endpoints

Onset of Action Observed Within One Week of Therapy

Phase 2b Clinical Trial Expected to be Initiated in the First Half of 2018

 

LEXINGTON, Mass., Sept. 12, 2017 -- Aldeyra Therapeutics, Inc. (NASDAQ: ALDX) (Aldeyra), a clinical-stage biotechnology company devoted to treating inflammation, inborn errors of metabolism, and other diseases related to endogenous aldehyde toxicity, today announced positive results from a Phase 2a clinical trial of topical ocular ADX-102 in patients with dry eye disease.

EDISON, N.J., Sept. 11, 2017 -- ContraVir Pharmaceuticals, Inc. (NASDAQ:CTRV), a biopharmaceutical company focused on the development and commercialization of targeted antiviral therapies, announced today that the U.S. Food and Drug Administration (FDA) has approved an Investigational New Drug (IND) Application in the U.S. for its lead HBV compound, TXL™ for the treatment of chronic hepatitis B.

 

Earlier this year, ContraVir announced that it had completed a Phase 1, multiple dose study in healthy subjects and a Phase 2a, 28 day study in HBV-infected patients. These studies were conducted in Thailand, a country with a high prevalence of chronic HBV infection. Having successfully achieved proof-of-concept, ContraVir intends to expand the TXL™ clinical program and initiate its first US-based clinical trial for TXL™ in the fourth quarter of 2017, pending approval by the Institutional Review Board. The study will enroll patients with severe renal impairment, and thus will generate data which we believe will further support the favorable safety profile of TXL™.

Substantial and Durable Anti-Seizure Efficacy Shown in Patients Suffering From Severe, 

Rare Genetic Epilepsy -- Marinus to Host Conference Call and Webcast Today at 9:00 am EDT

 

RADNOR, Pa., Sept. 11, 2017 --  Marinus Pharmaceuticals, Inc. (Nasdaq:MRNS), today announced that top-line data from the Phase 2 open-label study in patients with CDKL5 disorder support advancing ganaxolone into a definitive late-stage clinical trial. Oral ganaxolone, in addition to baseline treatment, showed a sizable and durable seizure-frequency reduction in the majority of patients, with some achieving an increase in the number of seizure-free days and reporting behavioral benefits. CDKL5 disorder is a severe, rare genetic epilepsy that results in early-onset, treatment-refractory seizures, pervasive neuro-developmental delay and disabling behavioral issues. There are no approved or effective available treatment options. Marinus plans to meet with regulatory agencies to obtain agreement on the clinical development plan that would be needed for approval of ganaxolone for CDKL5 disorder.

CRANBURY, N.J., Sept. 08, 2017 -- Oncobiologics, Inc. (NASDAQ:ONS) today announced that it entered into a Purchase Agreement on September 7, 2017 with GMS Tenshi Holdings Pte. Limited (“GMS Tenshi”), providing for the private placement of up to $25.0 million of Oncobiologics’ Series A Convertible Preferred Stock (“Series A”), as well as warrants to acquire up to an additional 16,750,000 shares of its common stock (the “Warrants”) having an aggregate exercise price of approximately $15 million.

 

In connection with the entry into the Purchase Agreement, Oncobiologics and GMS Tenshi also entered into a Joint Development and License Agreement (the “License”), providing for the license to GMS Tenshi of rights to ONS-3010 (HUMIRA® biosimilar) and ONS-1045 (AVASTIN® biosimilar) in emerging markets, excluding China, India and Mexico.