BioDelivery Sciences International, Inc. (NASDAQ: BDSI) provided an update that top-line results from their pivotal Phase 3 trial for Clonidine Topical Gel for the treatment of painful diabetic neuropathy (PDN), are due near the end of 1Q 2015. They also noted that they intend to submit a New Drug Application (NDA) by year-end or early 2015 for BEMA Buprenorphine. […]
Exelixis, Inc. (NASDAQ:EXEL) provided an update noting that top-line results from their pivotal Phase 3 trial METEOR in metastatic renal cell carcinoma, are now anticipated in 2Q 2015. XenoPort, Inc. (Nasdaq: XNPT) provided an update noting that top-line data from their Phase 2 XP23829 trial as a potential treatment for patients with moderate-to-severe chronic plaque-type psoriasis and/or relapsing forms of […]
Neurocrine Biosciences, Inc. (NASDAQ:NBIX) provided an update noting that Phase 3 topline efficacy data for elagolix in endometriosis are due in January 2015 and Phase 2b efficacy data for elagolix in uterine fibroids are due later in 2015. Also, top-line efficacy data from the initial six weeks of the Kinect 3 trial of NBI-98854 in tardive dyskinesia are due […]
Nymox Pharmaceutical Corporation (NASDAQ: NYMX) announced on Sunday that the their two Phase 3 studies of NX-1207 for the treatment of BPH, NX02-0017 and NX02-0018, failed to meet their primary efficacy endpoints. Full results will be reported at a later date. The company will hold a teleconference for shareholders on Monday, November 3, 2014 at 4:30 pm Eastern […]
Incyte Corporation(Nasdaq: INCY) provided an update noting that data from two pivotal double-blind, placebo-controlled Phase 3 trials (JANUS 1 and JANUS 2) of ruxolitinib for advanced or metastatic pancreatic cancer are expected in 2016. Data from the first of the Phase 3 trials of baricitinib in patients with rheumatoid arthritis, being conducted by Lilly are is expected […]
CTI BioPharma Corp. (CTI) (NASDAQ: CTIC) provided an update, maintaining previous guidance that they continue to expect data from their PERSIST-1 pivotal Phase 3 trial of pacritinib for patients with myelofibrosis in 1Q 2015. Cempra, Inc. (Nasdaq:CEMP) also provided an update noting that data from their Phase 3 trial of oral solithromycin in adult patients with moderate […]
RCPT hits endpoints. PFE returns Remoxy rights. SRPT NDA filing delay. RGLS VNDA offerings + HTBX ADMS updates.
Receptos, Inc. (Nasdaq:RCPT) announced that TOUCHSTONE, the Phase 2 trial of RPC1063 in ulcerative colitis (UC), met its primary endpoint and all secondary endpoints with statistical significance in patients on the 1 mg dose of RPC1063 in the 8-week induction period. A Phase 3 trial is planned for 2015. The company also plan to initiate a […]
As a result of recent Initial Public offerings since July 2014, BioPharmCatalyst is pleased to let readers know that 25 companies have been added to the Company Pipeline Database. These companies all have candidates in at least Phase 2 development (or pending). Companies with upcoming data releases have also been added to the FDA Calendar. […]
NPS Pharmaceuticals, Inc. (NASDAQ:NPSP) announced that their PDUFA date for its Natpara Biologics License Application (BLA) has been extended by three months from October 24, 2014 to January 24, 2015. The company cited the need for the the FDA to review a major amendment, and also requested the company to submit a Risk Evaluation and […]
Alkermes plc (NASDAQ: ALKS) announced that the FDA has set a PDUFA date of August. 22, 2015 for aripiprazole lauroxil, for the treatment of schizophrenia. Relypsa, Inc. (Nasdaq:RLYP) announced that they have submitted a New Drug Application (NDA) to the FDA seeking approval for Patiromer for Oral Suspension (Patiromer FOS) for the treatment of hyperkalemia.
Synageva BioPharma Corp. (Synageva) (NASDAQ: GEVA) announced the start of a rolling submission of a Biologics License Application (BLA) to the FDA for sebelipase alfa as a treatment for patients with lysosomal acid lipase deficiency (LAL Deficiency). The company anticipates completing the rolling submission of the BLA to the FDA and submitting the Marketing Authorization Application (MAA) […]