Aeterna Zentaris NDA for Macimorelin Acetate in AGHD Accepted for Filing by the FDA

Aeterna Zentaris Inc. (NASDAQ:AEZS) (TSX: AEZ) (the "Company") today announced that the U.S. Food and Drug Administration ("FDA") has accepted for filing the Company's New Drug Application ("NDA") for its ghrelin agonist, macimorelin acetate, in Adult Growth Hormone Deficiency ("AGHD"). The acceptance for filing of the NDA indicates the FDA has determined that the application is sufficiently complete to permit a substantive review.

The Company's NDA, submitted on November 5, 2013, seeks approval for the commercialization of macimorelin acetate as the first orally-administered product that induces growth hormone release to evaluate AGHD.  Phase 3 data have demonstrated the compound to be well tolerated, with accuracy comparable to available intravenous and intramuscular testing procedures.

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Peregrine Pharmaceuticals Receives FDA Fast Track Designation for Its Immunotherapy Bavituximab as a Potential Treatment of Second-Line Non-Small Cell Lung Cancer

SUNRISE Pivotal Phase III Trial of Bavituximab in Second-Line NSCLC Underway

Peregrine Pharmaceuticals, Inc. (NASDAQ: PPHM), today announced that the company has received Fast Track designation by the U.S. Food and Drug Administration (FDA) for its lead investigational immunotherapy bavituximab for the potential treatment of second-line non-small cell lung cancer (NSCLC). Recently, the company initiated SUNRISE, a pivotal Phase III clinical trial comparing bavituximab plus the chemotherapy docetaxel against placebo plus docetaxel in this indication.

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Oxygen Biotherapeutics Announces Key Details of Phase 3 Trial Protocol for levosimendan

Oxygen Biotherapeutics, Inc. (“OBI”) (OXBT) a specialty pharmaceutical company focused on developing and commercializing a portfolio of products for the critical care market, today announced that the protocol of their phase 3 trial for levosimendan has been published on ClinicalTrials.gov, “Levosimendan in Patients with Left Ventricular Systolic Dysfunction Undergoing Heart Surgery on Cardiopulmonary Bypass.” http://www.clinicaltrials.gov/ct2/show/NCT02025621?term=levosimendan&rank=12

Oxygen Biotherapeutics previously announced that it had selected Duke University’s Duke Clinical Research Institute (DCRI) to conduct the Phase 3 trial of the levosimendan. The Phase 3 trial will be conducted in approximately 50 major cardiac surgery centers in North America.

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Agilis Biotherapeutics and Intrexon to Pursue Transformative Therapies for Rare Genetic Disease

Exclusive Channel Collaboration Focused on DNA-based Therapeutics for Children and Adults with Friedreich's ataxia

Agilis Biotherapeutics, LLC, a synthetic biology-based company focused on rare genetic diseases, and Intrexon Corporation (XON), a leader in synthetic biology, announced today an Exclusive Channel Collaboration (ECC) to develop DNA-based therapeutics for Friedreich's ataxia (FRDA), a rare genetic neurodegenerative disease.

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Oxygen Biotherapeutics Provides a Business Review and Update in Conjunction with Filing of Second Quarter Fiscal Year 2014 Financials

Oxygen Biotherapeutics, Inc.,(“OBI”) (OXBT) a specialty pharmaceutical company focused on developing and commercializing a portfolio of products for the critical care market, today announced that it has filed its Quarterly Report on Form 10-Q for its second quarter fiscal year (FY) 2014 ended October 31, 2013. In connection with that filing, the company is providing a review of recent achievements and an update on business operations and future milestones.

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