Leerink sees ‘silver lining’ in Aquestive CRL given defined path to approval

14 hours ago 2

TipRanks

Tue, February 3, 2026 astatine 9:45 AM CST 1 min read

Leerink expert Roanna Ruiz was not amazed that Aquestive Therapeutics (AQST) received a Complete Response Letter for Anaphylm fixed the FDA’s anterior deficiency letter. That said, the “silver lining” is that this result appears recoverable with a comparatively defined way to approval, the steadfast adds. The bully quality is that nary further studies beyond these look to person been requested by the FDA, the CRL does not look to rise immoderate concerns astir comparability information oregon CMC, and Leerink sees these studies are manageable and capable to execute. The imaginable incremental risks are that this volition hold Anaphylm’s U.S. launch, and it introduces immoderate objective and commercialized hazard arsenic resubmission depends connected favorable HF investigating & PK survey results. The steadfast has an Outperform standing connected the name. Shares jumped implicit 45% to $4.29 successful greeting trading.

Unlock hedge fund-level information and almighty investing tools for smarter, sharper decisions
Stay up of the marketplace with the latest quality and investigation and maximize your portfolio's potential

Published archetypal connected TheFly – the eventual root for real-time, market-moving breaking fiscal news. Try Now>>

See Insiders’ Hot Stocks connected TipRanks >>

Read More connected AQST:

Disclaimer & DisclosureReport an Issue

Aquestive CRL from FDA ‘clearing event,’ says Oppenheimer
FDA Issues Complete Response Letter connected Anaphylm Application
Aquestive Therapeutics announces FDA issuance of CRL for Anaphylm
FDA Calendar: These Are the Remaining Drug Approvals Anticipated This Month
Morning News Wrap-Up: Friday’s Biggest Stock Market Stories!

Read Entire Article