Tonix Pharmaceuticals Announces Positive Pre-NDA CMC Meeting with FDA for Tonmya™ for the Management of Fibromyalgia [Yahoo! Finance]
Tonix Pharmaceuticals Holding Corp. (TNXP)
Last tonix pharmaceuticals holding corp. earnings: 3/24 05:15 pm
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tonixpharma.com
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Source: Yahoo! Finance
nonclinical, clinical pharmacology and clinical matters with the FDA, formal minutes pending On track to submit NDA to the FDA in the second half of 2024 CHATHAM, N.J., June 20, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, today announced receipt of the formal minutes from a recent pre-New Drug Application (NDA) Type-B Chemistry, Manufacturing, and Controls (CMC) meeting with the U.S. Food and Drug Administration (FDA) for Tonmya™ for the management of fibromyalgia. The purpose of the meeting was to seek alignment and agreement with the FDA on key CMC topics to support a planned NDA submission for Tonmya for the management of fibromyalgia. Based on formal written feedback, the Company believes it is aligned with the FDA on key topics, including proposed drug substance and drug product commercial specifications, shelf l
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News
- Tonix Pharmaceuticals Announces Pricing of Approximately $4.0 Million Public OfferingGlobeNewswire
- Tonix Pharmaceuticals Announces Proposed Public OfferingGlobeNewswire
- Tonix Pharmaceuticals Regains Compliance with Nasdaq Minimum Bid Price Requirement [Yahoo! Finance]Yahoo! Finance
- Tonix Pharmaceuticals Regains Compliance with Nasdaq Minimum Bid Price RequirementGlobeNewswire
- Tonix Pharmaceuticals Presents Vaccine Platform Data in Keynote Talk at the Vaccine Congress 2024 [Yahoo! Finance]Yahoo! Finance
TNXP
Sec Filings
- 6/26/24 - Form 424B5
- 6/26/24 - Form 8-K
- 6/20/24 - Form SC
- TNXP's page on the SEC website