BOSTON, MA and SURESNES, FRANCE--(Marketwired - January 05, 2017) - Pieris and Servier, an independent international pharmaceutical company headquartered in France with annual sales of more than EUR4 billion, to jointly pursue several bispecific therapeutic programs including Pieris' proprietary dual checkpoint inhibitor PRS-332

Alliance includes four additional bispecific programs and may be expanded to a total of eight immuno-oncology programs (including PRS-332); Pieris has option to co-develop and retain US rights for 4 of these programs, including PRS-332

Pieris to receive EUR30 million ($31.3 million USD) upfront, up to EUR324 million ($338 million) in success-based payments for PRS-332, up to EUR193 million ($201 million) in success-based payments for each of the other programs and up to double-digit royalties

2017-01-05 08:00 ET - News Release -- EXTON, Pa., Jan. 05, 2017 - Fibrocell Science, Inc. (NASDAQ:FCSC), a gene therapy company focused on transformational autologous cell-based therapies for skin and connective tissue diseases, today announced that the U. S. Food and Drug Administration (FDA) has granted Fast Track designation to FCX-007, the Company’s clinical-stage candidate for the treatment of Recessive Dystrophic Epidermolysis Bullosa (RDEB)—a rare, devastating genetic skin disease for which no FDA-approved therapies exist.

 

“Fast Track designation represents a significant milestone in advancing clinical development of FCX-007 for the treatment of RDEB,” said John Maslowski, Chief Executive Officer of Fibrocell. “We are pleased the Agency has awarded this designation to FCX-007 which, we believe, has the potential to be the first gene therapy to treat the underlying cause of RDEB and to bring relief to patients suffering from this debilitating, painful disease.”

WARREN, N.J., Jan. 04, 2017 -- Bellerophon Therapeutics, Inc. (Nasdaq:BLPH), a clinical-stage biotherapeutics company, today announced that it received confirmation from the U.S. Food and Drug Administration (FDA) of the Agency’s acceptance of all modifications proposed by the Company to its Phase 3 program for INOpulse in Pulmonary Arterial Hypertension (PAH).  Under the newly modified Phase 3 program, the ongoing one-year INOvation-1 study, and a second confirmatory randomized withdrawal study with approximately 40 patients who will be crossing over from the INOvation-1 study, can serve as the two adequate and well-controlled studies to support a New Drug Application filing for INOpulse in PAH subjects on long term oxygen treatment (LTOT).  INOvation-1 and the randomized withdrawal study are planned to be conducted on near parallel timelines, which could reduce the time to market for INOpulse in PAH by approximately two years.   

SOLANA BEACH, CA, Jan. 04, 2017 -- Evoke Pharma, Inc. (NASDAQ:EVOK), a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) diseases, today provided additional data from the Phase 3 trial of Gimoti, its nasal delivery of metoclopramide for the relief of symptoms associated with acute and recurrent diabetic gastroparesis in adult women. Although the Phase 3 trial failed to reach its primary endpoint, data also demonstrated that patients with moderate to severe symptoms, which included 105 of the 205 patients (51%) enrolled in the study, responded statistically significantly better when treated with Gimoti than those treated with placebo at multiple time points in the Intent-to-Treat (ITT) and Per Protocol populations (Table 1). There were also clinically and statistically significant improvements in nausea and abdominal pain, which are two of the more severe and debilitating symptoms of gastroparesis (Table 2).