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March 2, 2013
15:57 EDTKYTHKythera announces positive interim results from SMF study
KYTHERA Biopharmaceuticals announced positive interim results from a Phase IIIb, multi-center, open-label study (ATX-101-11-26) to evaluate the safety and efficacy of ATX-101, an investigational injectable drug for the reduction of unwanted submental fat, SMF, commonly known as double chin. The results, presented at the Late Breaking Research Symposium at the 71st American Academy of Dermatology (AAD) Annual Meeting in Miami Beach, Fla., found that ATX-101 is well-tolerated and may be effective in reducing SMF by both clinician and patient reported outcome measures. The ATX-101 global clinical development program has enrolled more than 2,500 total patients, of which more than 1,500 have been treated with ATX-101.
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January 23, 2015
09:07 EDTKYTHKythera announces FDA advisory committee to review ATX-101 on March 9
Kythera announced the Dermatology and Ophthalmic Drugs Advisory Committee of the FDA is scheduled to review Kythera's New Drug Application, or NDA, for ATX-101 for improvement in the appearance of moderate to severe submental fullness in a half-day meeting on the morning of March 9. The date and details of the meeting are subject to confirmation by the FDA in a Federal Register notice. Kythera submitted the ATX-101 NDA to the FDA on May 12, 2014. The NDA will be subject to a standard review and has a Prescription Drug User Fee Act, or PDUFA, action date of May 13. The PDUFA date is the goal date for the FDA to complete its review of the NDA.

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