Tonix Pharmaceuticals Holding Corp TNXP shares are surging higher on roughly 25 times their average volume after the biotech's pipeline candidate was granted fast track designation by the Food and Drug Administration.
What Happened
Tonix announced that its Alzheimer's disease candidate Tonmya, codenamed TNX-102 SL, for treating agitation in Alzheimer's disease has been accorded fast track status.
Why It's Important
Fast track designation is given to facilitate the development and expedited review of drugs for serious conditions and unmet medical needs.
The benefits of a fast track designation include:
- The rolling submission of portions of the new drug application, or, in other words, permission to submit the NDA piecemeal.
- Eligibility for priority review, which cuts the review period from the standard 10 months to six months.
- More frequent meetings and written communication with the FDA in regard to the development plan and trial design.
"The presence of agitation nearly doubles the cost of caring for patients with Alzheimer's disease, and agitation is estimated to account for more than 12 percent of the $256 billion in health care and societal costs associated with Alzheimer's disease for the year 2017 in the United States," Tonix said in the press release.
What's Next
TNX-102 SL is in a Phase 3 study for military-related post-traumatic stress disorder. Interim analysis of the study is expected in the third quarter. It has been designated as a breakthrough therapy for post-traumatic stress disorder by the FDA.
Related Links:
Attention Biotech Investors: Mark Your Calendar For These July PDUFA Dates
The Week Ahead In Biotech: Conferences, Clinical Trial Results, IPOs And More
© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.
