Aquestive Therapeutics Inc. (NASDAQ:AQST) stock is trading lower on Friday, with a session volume of 5.68 million compared to the average volume of 2.79 million, as per data from Benzinga Pro.Why Did It Fall?The company on Friday said the U.S. Food and Drug Administration (FDA) has identified deficiencies in Anaphylm’s New Drug Application (NDA) that preclude discussion of labeling and post-marketing commitments at this time.Although the notification did not specify the deficiencies, Aquestive is working to ...

Anaphylm (dibutepinephrine) Sublingual Film - The FDA confirmed that it will not require an Advisory Committee to review the Company's New Drug Application for Anaphylm[8] - The company is preparing for a U S launch in Q1 2026, if approved by the FDA[8] - The company broadened the patent estate for Anaphylm with the issuance of two new patents, extending patent protection into 2037[8] AQST-108 and AdrenaVerse Platform - The company plans to open Investigational New Drug application for AQST-108 with FDA in Q4 2025[11] - The company expects to initiate a clinical study for AQST-108 for Alopecia Areata in 1H 2026[11] Financial Position - The company successfully completed an equity raise of $85 million in August 2025[11] - The company also completed a strategic financing for $75 million with RTW Investments, LP, subject to FDA approval of Anaphylm and refinancing of the Company's existing debt[11] - The company's ending cash balance in Q3 2025 was $129.1 million[17] - The company expects to meet near-term milestones with projected cash runway into 2027[16] - The company's 2025 outlook includes total revenues of approximately $44-$50 million and a non-GAAP adjusted EBITDA loss of approximately $47-$51 million[23]

Group 1 - U.S. stocks experienced an upward trend, with the Nasdaq Composite increasing by over 100 points on Friday [1] - CoreWeave, Inc. (CRWV) saw a significant rise in shares, jumping 4.8% to $127.15 after Loop Capital initiated coverage with a Buy rating and set a price target of $165 [1] - Quantum Computing Inc. (QUBT) shares surged by 22.5% to $22.47, indicating strong market interest [3] Group 2 - WhiteFiber, Inc. (WYFI) gained 17.6% to $27.53, with Roth Capital analyst maintaining a Buy rating and raising the price target from $25 to $28 [3] - Serve Robotics Inc. (SERV) rose 17% to $15.09, reflecting positive investor sentiment [3] - Aquestive Therapeutics, Inc. (AQST) increased by 16.5% to $5.75 after receiving news from the FDA that an advisory committee meeting is not required for its product [3] Group 3 - PureTech Health plc (PRTC) gained 16.2% to $17.08, showing strong performance in the market [3] - NANO Nuclear Energy Inc. (NNE) rose 15.3% to $44.10, indicating robust investor confidence [3] - Newegg Commerce, Inc. (NEGG) jumped 15% to $53.51, reflecting a positive market reaction [3] Group 4 - Oklo Inc. (OKLO) gained 14.4% to $120.13, continuing a remarkable 60% rally over the past month [3] - NuScale Power Corporation (SMR) rose 12.6% to $42.99, indicating strong market interest [3] - Centrus Energy Corp. (LEU) gained 9.4% to $287.38, reflecting positive investor sentiment [3] Group 5 - Symbotic Inc. (SYM) shares rose 8.5% to $55.59, indicating strong market performance [3] - Rigetti Computing, Inc. (RGTI) gained 8.5% to $26.98 after being awarded a three-year $5.8 million contract from the Air Force Research Laboratory [3] - Barrick Mining Corporation (B) rose 7% to $32.17, with B of A Securities analyst maintaining a Neutral rating and raising the price target from $29 to $34 [3] Group 6 - FedEx Corporation (FDX) gained 2.4% to $231.98 after reporting better-than-expected first-quarter EPS and sales, leading multiple analysts to raise their price targets [3]

Core Viewpoint - The FDA has informed Aquestive Therapeutics that no advisory committee meeting is required for the NDA of Anaphylm, indicating the target action date remains January 31, 2026 [1][5][7]. Company Developments - Shares of Aquestive Therapeutics rose by 28.1% following the FDA announcement [2][7]. - The stock has increased by 42.2% year-to-date, outperforming the industry average increase of 11.7% [4]. - The NDA for Anaphylm was accepted by the FDA in June 2025, with the target action date set for January 31, 2026 [5][7]. - Anaphylm is being developed as a non-invasive oral epinephrine product for treating severe allergic reactions, including anaphylaxis [6][8]. Market Potential - If approved, Anaphylm would be the first non-invasive, orally delivered epinephrine product approved by the FDA for severe allergic reactions [6][8]. - The management believes Anaphylm offers greater convenience compared to traditional autoinjectors [7]. - The company has secured $160 million in financing to support the potential launch of Anaphylm in the U.S. in Q1 2026 [8].