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On Monday, Leerink Partners upheld a positive outlook for Aquestive Therapeutics (NASDAQ:AQST) stock, maintaining both an Outperform rating and a $13.00 price target. The firm’s stance comes in light of new data presented for Aquestive’s Anaphylm, an oral epinephrine film, which was showcased at the 2025 American Academy of Allergy, Asthma & Immunology (AAAAI) meeting. The data supports Anaphylm’s potential as a no-needle epinephrine product for Type 1 allergy (T1A) and anaphylaxis, pending approval.
Leerink Partners believes that the increasing awareness and interest in alternative epinephrine delivery methods among key opinion leaders, physicians, and patients could expand the market for autoinjector alternatives in T1A treatment. With a market capitalization of $247.55 million and impressive revenue growth of 22.56% in the last twelve months, Aquestive shows promising momentum. The firm highlighted discussions with Aquestive team members at the AAAAI meeting, where it was confirmed that the New Drug Application (NDA) for Anaphylm is on track for submission in the first quarter of 2025. Additionally, data from the pediatric trial for patients weighing 30 kilograms or more is expected to be included in the NDA.
Aquestive Therapeutics is actively engaging with both the medical community and patients to raise awareness about Anaphylm. This includes non-promotional continuing medical education (CME) activities and outreach to T1A advocacy groups. Leerink Partners anticipates that following the successful submission of the NDA, investors should look out for the FDA’s acceptance of the filing, which is expected within 60 days of submission. This acceptance could potentially drive Aquestive’s stock value higher than current levels.
The firm also cited a survey of allergy doctors, suggesting that the market for T1A treatments is sufficiently large to accommodate multiple competing products. If Anaphylm is approved, it is expected to be well-received as a second-to-market, no-needle epinephrine option. This preference is based on its convenience compared to existing autoinjectors, potentially leading to significant adoption rates. With a strong gross profit margin of 69.39% and a FAIR overall financial health score from InvestingPro, the company appears well-positioned for growth. Investors should note that Aquestive’s next earnings report is scheduled for March 5, 2025, which could provide additional insights into the company’s development progress. Leerink Partners reiterated their Outperform rating, reflecting their confidence in the product’s market potential.
In other recent news, Aquestive Therapeutics has been in the spotlight due to several key developments. The company reported that the FDA has granted seven years of Orphan Drug exclusivity to its product, Libervant, for the treatment of seizure clusters in young epilepsy patients. This exclusivity is based on the drug’s buccal administration route, which offers an easier alternative to existing methods. Additionally, H.C. Wainwright maintained a Buy rating for Aquestive, highlighting the potential market exclusivity and benefits of Libervant’s buccal film.
In another development, Cantor Fitzgerald initiated coverage on Aquestive Therapeutics with an Overweight rating, setting a price target of $17.00. The firm noted the company’s proprietary PharmFilm technology and projected revenue between $57 million and $60 million for 2024. Meanwhile, Leerink Partners maintained their Outperform rating and $13.00 price target, despite legal challenges surrounding Libervant. The firm emphasized the potential of Aquestive’s pipeline products, including Anaphylm and AQST-108.
JMP Securities also reaffirmed a Market Outperform rating with a $9.00 price target, citing positive findings from the Oral Anaphylm Symptom Intervention Study. Aquestive’s Anaphylm product demonstrated rapid resolution of allergen-related symptoms, reinforcing its potential as a treatment option. These recent developments underscore the company’s strategic advancements and ongoing efforts to enhance its product offerings.
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