ISTA and RIGL pipeline updates. CRTX NDA filing + NEOL GEVA NAVB news

Jan 05, 2012 No Comments by

Cornerstone Therapeutics (NASDAQ: CRTX) yesterday announced that it had acquired Cardiokine Inc. Cardiokine filed a New Drug Application (NDA) for its lead compound, lixivaptan for treatment of hyponatremia on Dec. 29, 2011.

INSYS Therapeutics (pinksheets:NEOL) today announced it had received FDA approval of its cancer pain medication, SUBSYS fentanyl sublingual spray.

ISTA Pharmaceuticals, Inc. (NASDAQ: ISTA) gave a pipeline update after hours yesterday. There were some subtle changes in the wording of their update compared with previous guidance.

  • NDA for Prolensa, a once-daily formulation of BROMDAY for postoperative inflammation and reduction of ocular pain pos-cataract extraction, is due to be filed 1H 2012. It mentioned in November 2011 that it hoped to file the NDA during 1Q 2012.
  • Phase 2 preliminary data of its Beposone Mountain Cedar Pollen results for seasonal allergic rhinitis are due 1H 2012.
  • Phase 3 initiation of T-PRED for uveitis and allergic conjunctivitis is expected during 2H 2012.

Rigel Pharmaceuticals, Inc. (RIGL: Nasdaq) today gave an update noting that it expects to initiate a Phase 2 trial of R343, an inhaled SYK inhibitor, for patients with allergic asthma in mid-2012. In addition, its collaborator on fostamatinib, AstraZeneca (AZ), has indicated that the Phase 3 studies in rheumatoid arthritis are continuing as planned with the first study completing enrolment during 4Q 2011.   AZ expects to file a New Drug Application (NDA) for fostamatinib in 2013.

Synageva BioPharma Corp. (NASDAQ:GEVA), announced a $60m public offering of 3,108,057 shares at $25.18 per share.

Neoprobe Corporation (NYSE Amex: NEOP) changed its company name and ticker today. It is now called Navidea Biopharmaceuticals, Inc. and trades under the ticker, NAVB.

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About the author

Currently residing in New Zealand, Mr. A.Burden holds a Master of Commerce in International Business from the University of Sydney and used these skills together with his passion for investing to establish BioPharmCatalyst in June 2010 as a tool for investing decisions in the US pharmaceutical market. He spends much of his free time mountain biking, playing squash and hiking.
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