Shares of Amylin Pharma (NASDAQ: AMLN) are rising by about 10% during early trading today on the issuance of a Complete Response Letter (CRL) from the FDA for its once-weekly formulation of its diabetes drug Byetta (exenatide), which would be marketed as Bydureon. The issues raised in the CRL appear to be minor and related to labeling issues with expected resubmission in the next few weeks and likely Class I (60-day) review designation by the FDA upon resubmission by AMLN. Eli Lilly (NYSE: LLY) and Alkermes (NASDAQ: ALKS) also have stakes in the drug, with ALKS also trading up 10% and LLY up slightly during early trading.
Meanwhile, MannKind (NASDAQ: MNKD) is trading down by about 10% on news of a CRL for its inhaled insulin product candidate Afrezza, requesting updated clinical / safety data, information on the MedTone inhaler device, and changes to proposed labeling of packaging.
Shares of Savient Pharma (NASDAQ: SVNT) are flat this morning on news of its Biologics License Application (BLA) resubmission in response to a July 2009 CRL for Krystexx (pegloticase, PEGylated uricase), which is seeking approval as a treatment for chronic gout in patients refractory to conventional therapy.
The actively managed HavRx Regulatory Catalyst Index tracks the performance of select companies which meet any of the following requirements: (1) pending new drug, biological agent, medical device, or diagnostic product applications at the FDA; (2) pending pivotal clinical trial results that are designed to support a new filing or resubmission for FDA marketing clearance; and (3) pending early stage clinical study results. Categories (1) and (2) will comprise two-third (67%) or greater of all index components while companies with pending early stage clinical trial results will comprise one-third (33%) or less of all index components.
Disclosure: No positions