ALXA resubmits NDA. RGEN receives CRL. Mixed CHMP recommendations for NPSP and PLX+ ASTX news BIOD raises cash
Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) announced today that it has resubmitted its ADASUVE New Drug Application (NDA), for treatment of agitation associated with schizophrenia or bipolar I disorder in adults. The resubmission is in response to a Complete Response Letter (CRL) received in May 2012. A PDUFA date will be announced in the coming weeks but is likely to be determined as a Class 2 response, requiring a 6 month review period, resulting in a PDUFA date in late December 2012.
Repligen Corporation (NASDAQ:RGEN) today announced that it has received a Complete Response Letter (CRL) regarding the its New Drug Application (NDA) for RG1068 for detection of pancreatic duct abnormalities in combination with MRI in patients with known or suspected pancreatitis. Additional clinical efficacy and safety trial data will be required to support potential approval.
Pfizer Inc. (NYSE:PFE) andProtalix BioTherapeutics, Inc. (NYSE-MKT:PLX) (TASE:PLX) today announced that the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) could not recommend the Marketing Authorization for taliglucerase alfa for the treatment of Gaucher disease, as Shire’s velaglucerase alfa had already received prior Marketing Authorization with orphan drug designation for the same condition. Shire has orphan market exclusivity in the European Union (EU) until 2020.
Takeda Pharmaceutical Company Limited and NPS Pharmaceuticals, Inc.(NASDAQ: NPSP) announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product teduglutide as a once-daily treatment for adult patients with short bowel syndrome (SBS).
Astex Pharmaceuticals, Inc. (Nasdaq:ASTX) announced that it has initiated the Phase 2 dose expansion segment of the clinical trial of SGI-110, in patients with intermediate-2 or high-risk myelodysplastic syndromes (MDS) or acute myeloid leukemia (AML). Solid tumor Phase 2 trials of SGI-110 are expected to begin before the end of 2012.
Biodel Inc. (NASDAQ: BIOD) today announced a private placement of approximately 7.9 million shares of its capital stock and warrants to purchase approximately 2.7 million shares of its common stock for gross proceeds of approximately $18.5 million.