FDA Approves Aquestive's Libervant for Seizures
Ticker: AQST · Form: 8-K · Filed: Jun 7, 2024 · CIK: 1398733
| Field | Detail |
|---|---|
| Company | Aquestive Therapeutics, Inc. (AQST) |
| Form Type | 8-K |
| Filed Date | Jun 7, 2024 |
| Risk Level | low |
| Pages | 2 |
| Reading Time | 2 min |
| Key Dollar Amounts | $0.001 |
| Sentiment | bullish |
Sentiment: bullish
Topics: fda-approval, drug-launch, pharmaceutical
Related Tickers: AQST
TL;DR
FDA greenlights Aquestive's Libervant for seizure treatment!
AI Summary
Aquestive Therapeutics, Inc. announced on June 6, 2024, that the U.S. Food and Drug Administration (FDA) has approved its New Drug Application (NDA) for Libervant (diazepam) Buccal Film, a treatment for frequent, repetitive, stereotypic episodes of acute repetitive seizures. This approval marks a significant milestone for the company and patients suffering from this condition.
Why It Matters
The FDA approval of Libervant provides a new, potentially more convenient treatment option for patients experiencing acute repetitive seizures, addressing an unmet medical need.
Risk Assessment
Risk Level: low — The filing is an 8-K reporting an FDA drug approval, which is generally positive news and not inherently risky.
Key Players & Entities
- Aquestive Therapeutics, Inc. (company) — Registrant
- Libervant (drug) — Approved product
- diazepam (drug_ingredient) — Active ingredient in Libervant
- U.S. Food and Drug Administration (FDA) (government_agency) — Approving body
- June 6, 2024 (date) — Date of report
FAQ
What is the approved indication for Libervant?
Libervant is approved for the treatment of frequent, repetitive, stereotypic episodes of acute repetitive seizures.
What is the active ingredient in Libervant?
The active ingredient in Libervant is diazepam.
Which regulatory body approved Libervant?
The U.S. Food and Drug Administration (FDA) approved Libervant.
On what date was this Form 8-K filed?
This Form 8-K was filed on June 7, 2024.
What is the principal executive office address for Aquestive Therapeutics, Inc.?
The principal executive offices are located at 30 Technology Drive, Warren, NJ 07059.
Filing Stats: 569 words · 2 min read · ~2 pages · Grade level 11.1 · Accepted 2024-06-07 08:13:32
Key Financial Figures
- $0.001 — ich registered Common Stock, par value $0.001 per share AQST Nasdaq Global Market I
Filing Documents
- aqst-20240606.htm (8-K) — 27KB
- aqstcorppres0624.htm (EX-99.1) — 35KB
- aqstcorppres0624001.jpg (GRAPHIC) — 86KB
- aqstcorppres0624002.jpg (GRAPHIC) — 286KB
- aqstcorppres0624003.jpg (GRAPHIC) — 112KB
- aqstcorppres0624004.jpg (GRAPHIC) — 97KB
- aqstcorppres0624005.jpg (GRAPHIC) — 157KB
- aqstcorppres0624006.jpg (GRAPHIC) — 106KB
- aqstcorppres0624007.jpg (GRAPHIC) — 124KB
- aqstcorppres0624008.jpg (GRAPHIC) — 68KB
- aqstcorppres0624009.jpg (GRAPHIC) — 84KB
- aqstcorppres0624010.jpg (GRAPHIC) — 95KB
- aqstcorppres0624011.jpg (GRAPHIC) — 98KB
- aqstcorppres0624012.jpg (GRAPHIC) — 22KB
- aqstcorppres0624013.jpg (GRAPHIC) — 103KB
- aqstcorppres0624014.jpg (GRAPHIC) — 111KB
- aqstcorppres0624015.jpg (GRAPHIC) — 106KB
- aqstcorppres0624016.jpg (GRAPHIC) — 100KB
- aqstcorppres0624017.jpg (GRAPHIC) — 66KB
- aqstcorppres0624018.jpg (GRAPHIC) — 130KB
- aqstcorppres0624019.jpg (GRAPHIC) — 92KB
- aqstcorppres0624020.jpg (GRAPHIC) — 22KB
- aqstcorppres0624021.jpg (GRAPHIC) — 70KB
- aqstcorppres0624022.jpg (GRAPHIC) — 120KB
- aqstcorppres0624023.jpg (GRAPHIC) — 97KB
- aqstcorppres0624024.jpg (GRAPHIC) — 111KB
- aqstcorppres0624025.jpg (GRAPHIC) — 129KB
- aqstcorppres0624026.jpg (GRAPHIC) — 119KB
- aqstcorppres0624027.jpg (GRAPHIC) — 116KB
- aqstcorppres0624028.jpg (GRAPHIC) — 71KB
- aqstcorppres0624029.jpg (GRAPHIC) — 22KB
- aqstcorppres0624030.jpg (GRAPHIC) — 89KB
- aqstcorppres0624031.jpg (GRAPHIC) — 104KB
- aqstcorppres0624032.jpg (GRAPHIC) — 25KB
- aqstcorppres0624033.jpg (GRAPHIC) — 80KB
- aqstcorppres0624034.jpg (GRAPHIC) — 24KB
- 0001628280-24-027167.txt ( ) — 4663KB
- aqst-20240606.xsd (EX-101.SCH) — 2KB
- aqst-20240606_lab.xml (EX-101.LAB) — 22KB
- aqst-20240606_pre.xml (EX-101.PRE) — 13KB
- aqst-20240606_htm.xml (XML) — 3KB
01
Item 7.01 Regulation FD Disclosure The Company is furnishing this Current Report on Form 8-K in connection with the disclosure of information, in the form of an investor presentation, to be given at meetings with institutional investors, analysts and others. This information may be amended or updated at any time and from time to time through another Current Report on Form 8-K, a later Company filing or other means. A copy of the Company's investor presentation is attached hereto as Exhibits 99.1 to this Current Report on Form 8-K and incorporated into this Item 7.01 by reference. The investor presentation is available on the Company's website located at www.aquestive.com, although the Company reserves the right to discontinue that availability at any time. The information in this Item 7.01 (including Exhibit 99.1) shall not be deemed to be "filed" for purposes of, or otherwise subject to the liabilities of, Section 18 of the Exchange Act, nor shall it be deemed to be incorporated by reference in any filing under the 33 Act or the Exchange Act, except as shall be expressly set forth by specific reference in any such filing.
Financial Statements and Exhibits
Financial Statements and Exhibits (d) Exhibits. Exhibit Number Description 99.1 Aquestive Therapeutics, Inc. Corporate Presentation dated J une 6, 24 SIGNATURE Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized. Dated: June 6, 2024 Aquestive Therapeutics, Inc. By: /s/ A. Ernest Toth, Jr Name: A. Ernest Toth, Jr. Title: Chief Financial Officer (Principal Financial Officer)