Reaffirming Buy on Anaphylm: Navigable FDA CRL, Limited Incremental Costs, and Intact 2027 Approval Timeline

Ram Selvaraju, an analyst from H.C. Wainwright, reiterated the Buy rating on Aquestive Therapeutics. The associated price target remains the same with $10.00.

Ram Selvaraju has given his Buy rating due to a combination of factors that suggest the recent regulatory setback for Anaphylm is manageable and does not materially undermine its path to approval. He views the FDA’s Complete Response Letter as primarily focused on human factors and labeling issues—such as package opening and film placement—rather than on core efficacy, safety, chemistry, or manufacturing concerns, which he interprets as confirmation that the drug’s fundamental approvability remains intact. The company’s plan to promptly adjust packaging, instructions, and labeling, along with its intention to run a new human factors validation study and a single pharmacokinetics trial in parallel, supports his confidence that the identified deficiencies can be resolved efficiently. He also notes that no additional clinical studies were requested beyond these limited, short-term trials, reinforcing the view that the outstanding issues are operational rather than scientific.

Selvaraju further bases his Buy rating on the manageable financial and timing implications of the additional work required by the FDA. He estimates that the incremental cost of the required human factors and pharmacokinetics studies should be relatively modest, likely under $5 million, which is not expected to meaningfully strain the company’s resources. In his view, the anticipated resubmission of the Anaphylm NDA in the third quarter of 2026, coupled with a potential six‑month (or possibly shorter) review period, still supports a credible timeline for U.S. approval and commercial launch around early 2027. Overall, he regards the CRL as risk‑reducing rather than value‑destructive, and this underpins his decision to reaffirm a Buy recommendation and a $10 twelve‑month price target.

In another report released yesterday, Lake Street also reiterated a Buy rating on the stock with a $8.00 price target.