4Q setbacks

4Q setbacks

Company Setback
Acorda Therapeutics Inc. (NASDAQ:ACOR)/ Elan Corp. plc (NYSE:ELN) FDA extends the PDUFA date for an NDA for Fampridine-SR to improve walking ability in patients with multiple sclerosis by three months to Jan. 22 after Acorda submitted additional information on its proposed risk evaluation and mitigation strategy (REMS)
Addex Pharmaceuticals Ltd. (SIX:ADXN) Discontinues development of ADX10059 for chronic indications based on elevated levels of alanine transaminase (ALT) in the Phase IIb ADX10059-206 trial to prevent migraine
Aeterna Zentaris Inc. (TSX:AEZ; NASDAQ:AEZS) sanofi-aventis Group (Euronext:SAN; NYSE:SNY) ends deal after cetrorelix fails in the Phase III Z-036 trial in benign prostatic hyperplasia (BPH)
Amarin Corp. plc (NASDAQ:AMRN) Withdraws MAA for AMR101 to treat Huntington's disease after EMEA's CHMP indicated that additional clinical trials would be needed
Amgen Inc. (NASDAQ:AMGN) Receives complete response letters from FDA for BLAs for Prolia denosumab to treat

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