Shelf filed by ARNA and ZIOP. NGSX Phase 2 data. Pipeline updates from ACHN OREX OMER CYTR ASTM LGND HALO ISIS
Arena Pharmaceuticals, Inc. (NASDAQ:ARNA) filed a $50m shelf today.
Achillion Pharmaceuticals, Inc. (Nasdaq:ACHN) said today it is on track to release interim early virologic response (EVR) results by the end of 2011.
Orexigen Therapeutics, Inc. (Nasdaq: OREX) maintained previous guidance that it intends to initiate a cardiovascular outcomes trial (CVOT) in 1H 2012 for its obesity drug Contrave, in response to its CRL issued earlier this year.
Omeros Corporation (NASDAQ: OMER) maintained guidance that it expects to report OMS103HP data for arthroscopy in mid-2012 and OMS302 for intra-ocular lens replacement surgery in 1Q 2012.
CytRx Corporation (Nasdaq: CYTR) said today it is on track for a December 2011 start of its International Phase 2b clinical trial with INNO-206 in soft tissue sarcomas.
NeurogesX, Inc. (Nasdaq:NGSX) announced today positive top-line results from its Phase 2 clinical study of NGX-1998, a topical liquid formulation of high-concentration capsaicin, in patients with postherpetic neuralgia (PHN). It believes that the data support moving forward to a Phase 3 clinical development program following an End-of- Phase 2 meeting with the FDA which could occur in 1H 2012. The 12-week, multicenter, randomized, double-blinded, placebo-controlled clinical trial met its protocol-specified objectives, which include the primary endpoint of a percentage change from baseline vs. placebo in a patient-reported numeric pain rating scale (NPRS) score during Weeks 2 through 8. A total of 183 patients were enrolled in the Phase 2 study. Patients were randomized into one of three groups: NGX-1998 capsaicin 10 percent solution, NGX-1998 capsaicin 20 percent solution or placebo, according to an unequal allocation scheme of 2:2:1. NGX-1998 exhibited a dose response. Although no topical anesthetic was used during the second stage of the study the patients were able to tolerate the treatment procedure. No patients discontinued the study due to adverse events, and the incidence of adverse events and serious adverse events in patients treated with NGX-1998 were similar to the placebo-treated group.
Aastrom Biosciences, Inc. (Nasdaq:ASTM) reiterated plans to initiate a Phase 2b study of ixmyelocel-T in the treatment of Dilated Cardiomyopathy (DCM) in the first half of 2012. It also maintained its previous timeline that it hopes to initiate a Phase 3 REVIVE-CLI clinical trial by the end of 2011 for ixmyelocel-T in patients with critical limb ischemia.Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) gave an update noting its partner Onyx Pharmaceuticals announced submission of the carfilzomib New Drug Application (NDA in September and is seeking accelerated approval for carfilzomib in 2012. TUESDAY NEWS
ZIOPHARM Oncology, Inc (NASDAQ:ZIOP) filed a $150m mixed shelf yesterday.
VIVUS, Inc. (NASDAQ: VVUS) gave an update on its Marketing Authorization Application (MAA) for Qnexa that was submitted to the European Medicines Agency (EMA) in December 2010. It gave guidance that it expects the Committee for Medicinal Products for Human Use (CHMP) to issue an opinion in 1Q 2012. The MAA for avanafil is being prepared and it plans to file it with the EMA in the first quarter of 2012.
Isis Pharmaceuticals, Inc. (Nasdaq: ISIS) maintained previous guidance that it will file its NDA of Kynamro(TM) (mipomersen) during 4Q 2011 for patients with homozygous Familial Hypercholesterolemia (FH). It also mentioned that Genzyme reached an agreement with the FDA on the design of the FOCUS FH study via a Special Protocol Assessment (SPA). The 12 month clinical study is titled Evaluating the saFety and atherOgeniC lipoprotein redUction of mipomerSen in FH (FOCUS FH), and is to support additional indications in the United States and Europe, and an alternative dosing regimen.
Halozyme Therapeutics, Inc. (NASDAQ: HALO) gave a pipeline update yesterday noting the following –
Discuss top line results from a Phase 1/2 study with HTI-501 in women with moderate to severe cellulite – 1H 2012.
Present HannaH Phase 3 clinical trial data – 2012.
Regulatory Submission Herceptin SC – 2012.
Regulatory Submission Mabthera SC – 2012.
PDUFA for Subcutaneous IgG Baxter Biosciences BLA – 2Q 2012.
Complete Phase 2 study with Viropharma for SC Cinryze – 1H 2012.