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 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. 

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