Acorda Therapeutics (ACOR - Free Report) announced that it has resubmitted the new drug application (NDA) for its late stage pipeline candidate, Inbrija, to the FDA. Following the news, shares of the company gained by about 1.9%. So far this year, shares of the company have increased 10.4% compared with the industry’s gain of 0.7%.
Currently, the company is seeking approval for Inbrija in the United States as a treatment option for symptoms of OFF periods in people with Parkinson’s taking a carbidopa / levodopa regimen.
We remind investors that in August the company received a refusal to file (RTF) letter from the FDA in connection with the new drug application (NDA) that it first submitted in June. However, the FDA declared the application to be incomplete after a preliminary review. As a result, the regulatory body required additional supporting information to review the application.
Notably, the FDA stated two main reasons for the RTF — date specification as to when the manufacturing site can be ready for inspection and questions related to drug master production record. Additionally, the FDA asked for some extra data, unrelated to the main issues of the RTF. Acorda claims that it has addressed these two issues in its resubmission.
Acorda had submitted the NDA as a 505(b)(2) application. The FDA is expected to inform the company within 74 days if the submission is complete and requires a full review.
In this context, we remind investors that in November, Acorda decided to immediately discontinue the phase III study on one of its lead Parkinson’s disease candidates, tozadenant. The decision was based on some serious safety issues observed in the study.
Apart from Acorda, many companies are trying to introduce treatments for Parkinson’s disease in 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’ (ADMS - Free Report) Gocovri received an FDA approval in August for treating dyskinesia in patients with Parkinson’s disease.
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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