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Monday, H.C. Wainwright reaffirmed a Buy rating on Aquestive Therapeutics (NASDAQ:AQST), currently trading at $2.65, with a steady price target of $10.00. The $262 million market cap company has received strong support from analysts, with an average target ranging from $4.75 to $15.00. The firm highlighted Aquestive’s progress with Anaphylm, its innovative non-device-based epinephrine product candidate for severe allergic reactions, which has shown clinical results on par with existing autoinjectors like EpiPen and Auvi-Q.According to InvestingPro, there are 8 additional key insights about AQST’s financial health and market position available to subscribers, including crucial metrics that could impact investment decisions.
Aquestive completed all adult clinical trials for Anaphylm by the end of 2024 and has received encouraging feedback from the FDA in a pre-New Drug Application (NDA) meeting. The company, which maintains a healthy current ratio of 4.68 and holds more cash than debt on its balance sheet, is nearing the completion of the pediatric clinical trial for Anaphylm, with initial top-line data meeting expectations. Following the successful clinical program, Aquestive has initiated the NDA submission process, which will include pediatric data to potentially support a product label that matches the EpiPen autoinjector’s weight and age guidelines.
The FDA is expected to accept the Anaphylm NDA submission in the next quarter. The agency has indicated that a Pulmonary-Allergy Drugs Advisory Committee might be convened during Anaphylm’s review process. Aquestive is actively preparing for this potential advisory committee meeting, which would offer an opportunity to underscore Anaphylm’s advantages for patients.
H.C. Wainwright analysts pointed out that the advisory committee meeting for Anaphylm is anticipated to be significantly less challenging than the one for the nasal spray-based epinephrine product neffy. This is due to Anaphylm’s sublingual administration, which avoids the complications associated with nasal sprays. The firm reiterated its confidence in Anaphylm’s potential and maintained its Buy rating and 12-month price target for Aquestive Therapeutics.
In other recent news, Aquestive Therapeutics announced its fourth-quarter 2024 earnings, which revealed a net loss of $0.19 per share, falling short of analyst expectations of a $0.13 loss. Revenue also missed forecasts, coming in at $11.87 million against a projected $13.08 million. Despite these quarterly setbacks, the company reported a 14% increase in full-year revenue, reaching $57.6 million. Aquestive has made strategic progress with the FDA filing for ANIFILM and new product developments. The company bolstered its financial position by raising $78 million in capital. Looking ahead, Aquestive projects 2025 revenue between $47 million and $56 million, with plans to launch ANIFILM in the first quarter of 2026. During an earnings call, executives discussed ongoing preparations for a potential FDA Advisory Committee meeting and strategies for ANIFILM’s commercialization. The company continues to face challenges, including ongoing net losses and market competition in the epinephrine and alopecia markets.
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