Acorda Shares Triple on MS Drug Data
Acorda Therapeutics Shares Triple As Multiple Sclerosis Drug Succeeds in FDA Recommended Study
Shares of Acorda Therapeutics Inc. more than tripled Monday, hitting a new 52-week high, after the biotech drug developer announced the success of a late-stage clinical trial to test its treatment to improve the walking ability of multiple sclerosis patients.
Acorda shares rose $5.25 to $7.47 in midday trading on the Nasdaq. Earlier in the session, shares went as high as $7.75. They hit an all-time low of $2.20 on Thursday after sliding from a previous high of $7.48 on their first day of trading on Feb. 10.
The company released results from its Phase III study of Fampridine-SR showing that nearly 35 percent of patients taking the drug improved their walking speed compared with just over 8 percent of patients taking a placebo. Of those patients who responded, those given Fampridine rated significantly better on a walking scale than those given a placebo. Improvements lasted over the 14-week treatment period.
The three criteria were those outlined by the Food and Drug Administration's Special Protocol Assessment, a study design that is most likely to yield the best results. The company said it plans to meet with the agency soon to discuss how to advance the drug closer to a possible approval.
The results represent one of the two positive trials the company will need for FDA approval. The drug has Orphan Drug status from the agency for improving walking in multiple sclerosis patients, meaning the company will have seven years of marketing exclusivity for that use should it be approved.
Multiple sclerosis is an incurable disease which causes the body's immune system to destroy the insulation of nerve fibers. The company said lab studies have shown that Fampridine can improve communication between damaged nerves.
In a research note, Rodman & Renshaw analyst Elemer Piros maintained his "Outperform" rating on the company with a target price of $14.
Acorda Therapeutics Shares Triple As Multiple Sclerosis Drug Succeeds in FDA Recommended Study
Shares of Acorda Therapeutics Inc. more than tripled Monday, hitting a new 52-week high, after the biotech drug developer announced the success of a late-stage clinical trial to test its treatment to improve the walking ability of multiple sclerosis patients.
Acorda shares rose $5.25 to $7.47 in midday trading on the Nasdaq. Earlier in the session, shares went as high as $7.75. They hit an all-time low of $2.20 on Thursday after sliding from a previous high of $7.48 on their first day of trading on Feb. 10.
The company released results from its Phase III study of Fampridine-SR showing that nearly 35 percent of patients taking the drug improved their walking speed compared with just over 8 percent of patients taking a placebo. Of those patients who responded, those given Fampridine rated significantly better on a walking scale than those given a placebo. Improvements lasted over the 14-week treatment period.
The three criteria were those outlined by the Food and Drug Administration's Special Protocol Assessment, a study design that is most likely to yield the best results. The company said it plans to meet with the agency soon to discuss how to advance the drug closer to a possible approval.
The results represent one of the two positive trials the company will need for FDA approval. The drug has Orphan Drug status from the agency for improving walking in multiple sclerosis patients, meaning the company will have seven years of marketing exclusivity for that use should it be approved.
Multiple sclerosis is an incurable disease which causes the body's immune system to destroy the insulation of nerve fibers. The company said lab studies have shown that Fampridine can improve communication between damaged nerves.
In a research note, Rodman & Renshaw analyst Elemer Piros maintained his "Outperform" rating on the company with a target price of $14.
posted by doublezero at
10:11 AM
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