Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) announced today that it has received a Complete Response Letter (CRL) regarding its New Drug Application (NDA) for ADASUVE. In its press release the company said the CRL was issued due to medical device deficiencies and plans to meet with the FDA to resolve the issues.
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY) reported today that it has completed enrollment in its Phase 2b trial of ALN-RSV for the treatment of Respiratory Syncytial Virus (RSV) Infection and expects to report results in mid-2012. It also expects to initiate a Phase 2 multi-dose study of ALN-TTR02 in transthyretin-mediated amyloidosis (ATTR) patients in 2H 2012.
OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) gave an update today noting that enrollment is currently underway for a randomized Phase 2 clinical trial of OGX-427 in combination with gemcitabine/cisplatin in patients with metastatic bladder cancer. A Phase 2 clinical trial of OGX-427 in combination with Zytiga in patients with CRPC will be initiated later in 2012. It also intends to initiate a Phase 3 trial to evaluate a survival benefit for custirsen in combination with chemotherapy in patients with non-small cell lung cancer in 2H 2012.
NeurogesX, Inc. (Nasdaq:NGSX) said that it anticipates an End-of-Phase 2 meeting will occur in 3Q2012 for NGX-1998 as a treatment for certain neuropathic pain conditions. It hopes to initiate a Phase 3 trial by the end of 2012.
Anthera Pharmaceuticals, Inc. (NASDAQ: ANTH) maintained previous guidance that final top-line data from its Phase 2b PEARL-SC trial of blisibimod in patients with lupus, is expected this quarter (2Q 2012).
Synergy Pharmaceuticals, Inc. (Nasdaq:SGYP) announced the pricing of an underwritten public offering of 10m shares of common stock at an offering price of $4.50 per share, with gross proceeds of $45m, with an option to issue an additional 1.5m shares.
ZIOPHARM Oncology, Inc. (Nasdaq:ZIOP) maintained previous guidance that data is expected in 2H 2012 from its Phase 3 (PICASSO 3) trial of intravenous palifosfamide for the treatment of front-line metastatic soft tissue sarcoma. It also expects to initiate a Phase 3 trial in front-line metastatic small cell lung cancer during early 3Q 2012.
Threshold Pharmaceuticals, Inc. (NASDAQ: THLD) gave an update today noting that it will report overall survival results and updated top-line efficacy analysis from its “404” Phase 2 trial of TH-302 in patients with first-line advanced pancreatic cancer, during 2H 2012. Top-line results from its “408 trial” evaluating TH-302 in patients with multiple myeloma, are due by the end of 2012. Topline data is also expected by the end of the year in its “410” Phase 1/2 trial of TH-302 trial in combination with sunitinib in patients with renal cell carcinoma.
Exelixis, Inc.(Nasdaq: EXEL) maintained guidance that it plans to initiate COMET-1, a Phase 3 pivotal trial in metastatic CRPC, in 2Q 2012. The trial will focus on overall survival.
DURECT Corporation(Nasdaq: DRRX) plans to schedule a pre-NDA meeting with the FDA in the summer of 2012 for POSIDUR, for the treatment of post-operative pain, with a potential NDA submission later in 2012, depending on FDA feedback.