Acorda Therapeutics (NASDAQ:ACOR) is expected to announce trial results for its lead drug Ampyra in a 5mg dose (not an approved strength), which was part of the FDA’s requirements when it approved Ampyra in a 10mg dose. The FDA wanted to explore lower dosage as clinical trials for Ampyra 10mg showed a propensity to cause seizures in some patients. If efficacious, the lower dose may reduce the chance of seizures. While there is no obligation for Acorda to launch a 5mg dose, investors are readying for stock action on the results, which are expected this month. The trial compares Ampyra in 5mg and 10mg strengths. If 5mg proves to be equivalent to, or better than, the 10mg strength in terms of efficacy, shares could lose as much as 20% on fears that patients may start cutting 10mg tablets in half to get more for their money. If patients act accordingly, Acorda’s $250 million franchise could be in danger of losing significant sales.
ACOR shares are trading with some overhang in front of these results, as Acorda investors have indicated that the stock is likely to trade up slightly if the 5mg strength proves less effective than the approved dose. The trial is complete, so watch for results this month, with a trade down to about $19 a share if the 10mg does not handily beat 5mg. Alternatively, ACOR could trade up to about $24 per share on relief that the 10mg dose works better than a half tablet.