Aquestive Therapeutics’ Anaphylm NDA Submission and Strong Clinical Profile Support Buy Rating

Aquestive Therapeutics’ Anaphylm NDA Submission and Strong Clinical Profile Support Buy Rating

Aquestive Therapeutics (AQSTResearch Report), the Healthcare sector company, was revisited by a Wall Street analyst today. Analyst Jason Butler from JMP Securities reiterated a Buy rating on the stock and has a $9.00 price target.

Jason Butler has given his Buy rating due to a combination of factors related to Aquestive Therapeutics’ recent developments and future prospects. The company has submitted its NDA for Anaphylm, setting up the potential for approval in early 2026, which aligns with their strategic guidance. This submission is expected to follow a standard review timeline, with a PDUFA date anticipated at the end of January 2026. The management is proactively preparing for a possible Advisory Committee meeting, indicating their readiness for the approval process.
Furthermore, Butler is confident in Anaphylm’s approval due to its strong clinical profile and consistent communication with the FDA. The Phase 3 trial results demonstrated rapid onset and comparable exposure levels to auto-injectors, with sustained efficacy over two hours. Additional studies, including the pediatric PK/PD study, have shown the treatment to be safe and well-tolerated, bolstering the case for its approval. These factors, combined with the company’s ongoing commercial readiness activities, support the Buy rating.

In another report released yesterday, Lake Street also reiterated a Buy rating on the stock with a $10.00 price target.

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