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Acorda Stock Up Despite Phase III Trial on Tozadenant Stops
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Acorda Therapeutics, Inc. announced that it has decided to immediately discontinue the phase III study on one of its lead Parkinson’s disease (“PD”) candidates, tozadenant.
The decision was based on some serious safety issues -- reported last week -- observed in the study.
Shares of Acorda climbed almost 10% following this news release as investors probably consider the company’s decision to be a prudent as it will reduce the company’s R&D spending and allow it to focus on its other late-stage PD candidate, Inbrija. Shares of the company have outperformed the industry year to date. The stock has gained 3.7% compared with the industry’s 0.6% increase.
We remind investors that last week, the company reported that in the phase III study, some patients were diagnosed with sepsis associated with agranulocytosis, a condition leading to deficiency of white blood cells, causing lack of immunity to fight infection. The company suspects that this issue is probably related to use of tozadenant. Also, cases of death were detected in the study.
Total of seven cases of sepsis were identified in the tozadenant groups including the previously conducted phase IIb study, of which, five were fatal. As a result, the company started monitoring the blood cell count on a weekly basis. Eventually, it expressed dissatisfaction over the patient’s safety status as seen from the weekly outcomes on blood cell count.
However, Acorda expects to report the efficacy and safety data from the aforesaid phase III study in the first quarter of 2018.
We further remind investors that the company faced another setback in August when the FDA had issued a refusal to file letter in connection with the new drug application (“NDA”) for Inbrija.
The FDA had deemed the application incomplete after a preliminary review and therefore, the regulatory body now requires additional supporting information to review the application. The FDA’s refusal for Inbrija’s NDA will delay its commercial launch, previously expected in the first half of 2018.
Apart from Acorda, many companies are trying to introduce Parkinson’s disease treatments to the market namely, Prothena Corporation’s (PRTA - Free Report) PRX002, AstraZeneca’s (AZN - Free Report) MEDI1341, Prexton Therapeutics’ Foliglurax and Prana Biotechnology’s PBT434.
Also, Adamas Pharmaceuticals’ Gocovri received an FDA approval on August, for treating dyskinesia in patients with Parkinson’s disease. The company expects to make the drug available in the fourth quarter of 2017 and a formal launch is planned ahead for January 2018.
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Starting now, for the next month, I invite you to follow all Zacks' private buys and sells in real time from value to momentum...from stocks under $10 to ETF to option movers...from insider trades to companies that are about to report positive earnings surprises (we've called them with 80%+ accuracy). You can even look inside portfolios so exclusive that they are normally closed to new investors.
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Acorda Stock Up Despite Phase III Trial on Tozadenant Stops
Acorda Therapeutics, Inc. announced that it has decided to immediately discontinue the phase III study on one of its lead Parkinson’s disease (“PD”) candidates, tozadenant.
The decision was based on some serious safety issues -- reported last week -- observed in the study.
Shares of Acorda climbed almost 10% following this news release as investors probably consider the company’s decision to be a prudent as it will reduce the company’s R&D spending and allow it to focus on its other late-stage PD candidate, Inbrija. Shares of the company have outperformed the industry year to date. The stock has gained 3.7% compared with the industry’s 0.6% increase.
We remind investors that last week, the company reported that in the phase III study, some patients were diagnosed with sepsis associated with agranulocytosis, a condition leading to deficiency of white blood cells, causing lack of immunity to fight infection. The company suspects that this issue is probably related to use of tozadenant. Also, cases of death were detected in the study.
Total of seven cases of sepsis were identified in the tozadenant groups including the previously conducted phase IIb study, of which, five were fatal. As a result, the company started monitoring the blood cell count on a weekly basis. Eventually, it expressed dissatisfaction over the patient’s safety status as seen from the weekly outcomes on blood cell count.
However, Acorda expects to report the efficacy and safety data from the aforesaid phase III study in the first quarter of 2018.
We further remind investors that the company faced another setback in August when the FDA had issued a refusal to file letter in connection with the new drug application (“NDA”) for Inbrija.
The FDA had deemed the application incomplete after a preliminary review and therefore, the regulatory body now requires additional supporting information to review the application. The FDA’s refusal for Inbrija’s NDA will delay its commercial launch, previously expected in the first half of 2018.
Apart from Acorda, many companies are trying to introduce Parkinson’s disease treatments to the market namely, Prothena Corporation’s (PRTA - Free Report) PRX002, AstraZeneca’s (AZN - Free Report) MEDI1341, Prexton Therapeutics’ Foliglurax and Prana Biotechnology’s PBT434.
Also, Adamas Pharmaceuticals’ Gocovri received an FDA approval on August, for treating dyskinesia in patients with Parkinson’s disease. The company expects to make the drug available in the fourth quarter of 2017 and a formal launch is planned ahead for January 2018.
Acorda Therapeutics, Inc. Price
Acorda Therapeutics, Inc. Price | Acorda Therapeutics, Inc. Quote
Zacks Rank
Acorda carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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