SLXP PGNX issued CRL. FURX resubmits NDA. ARIA initiates Phase 3 CML. CTIC confirms possibility of reverse split + ACUR
Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) and Progenics Pharmaceuticals (NASDAQ:PGNX) today received a Complete Response Letter (CRL) for its Supplemental New Drug Application (sNDA) for RELISTOR injection for subcutaneous use for the treatment of opioid-induced constipation (OIC) in adult patients with chronic, non-cancer pain. The CRL requests additional clinical data. Salix and Progenics intend to request an End-of-Review meeting with the Division of Gastroenterology and Inborn Errors Products.
ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) announced the initiation of a randomized Phase 3 trial of ponatinib in adult patients with newly diagnosed chronic myeloid leukemia (CML). ARIAD expects to complete patient enrollment in the trial by the end of 2013.
Furiex Pharmaceuticals, Inc. (NASDAQ: FURX) announced that Takeda Pharmaceutical has resubmitted its New Drug Applications (NDAs) to the FDA for alogliptin and fixed-dose combination therapy alogliptin and pioglitazone for the treatment of type 2 diabetes in adults. Takeda anticipates the applications will be reviewed within the next six months. These NDAs were resubmitted in response to a complete response letter Takeda received from the FDA on April 25, 2012.
Cell Therapeutics, Inc. (NASDAQ: CTIC) confirmed in a SEC filing that its Shareholders’ Meeting will be held at 10:00 a.m. Pacific Daylight Time (PDT), on Friday, August 31, 2012. It will, among other proposals, ask voters for permission to raise the number of authorised shares form 383,333,333 to 750,000,000 shares. In addition, it noted that the Board may unilaterally determine that it is in the best interests of the shareholders and the Company to effectuate a reverse stock split. If CTIC does not have any shares of preferred stock outstanding, it is NOT required to seek shareholder approval of such action before effectuating a reverse stock split. The company currently expects that if the reverse split is implemented, it will have a ratio of between one-for-three and one-for-five.
Acura Pharmaceuticals, Inc. (NASDAQ:ACUR) announced today that Pfizer Inc. provided notice on July 26, 2012 that it is exercising its right to terminate the license to three development stage products, oxycodone hydrochloride with acetaminophen, hydrocodone bitartrate with acetaminophen and another undisclosed opioid.