On Friday, Leerink Partners adjusted their outlook on Aquestive Therapeutics (NASDAQ:AQST), raising the price target to $13.00 from $12.00, while maintaining an Outperform rating.
The firm's decision comes after the evaluation of Aquestive's recent oral allergy syndrome (OAS) challenge study, which they view as a significant addition to the data supporting Anaphylm, Aquestive’s investigational therapy for Type 1 allergy, including anaphylaxis.
The successful completion of the OAS study is seen as a critical milestone for Anaphylm's clinical profile, which is expected to keep the company on schedule for its New Drug Application (NDA) filing for Type 1 allergy in the first quarter of 2025. The study was specifically designed to address a question from the FDA, and the results could become a central topic in the upcoming pre-NDA meeting this quarter.
Leerink anticipates that the pre-NDA meeting discussions may revolve around the durability of Anaphylm's pharmacokinetics at various time points and its adverse event profile compared to current injectable epinephrine products.
The firm believes that Anaphylm's oral-film delivery could be a strong contender in the market following ARS Pharma’s intranasal neffy, benefiting from increasing awareness and demand for innovative, non-invasive epinephrine products.
To reflect the positive outcome of the OAS study, Leerink has also increased their probability-of-success assumption for Anaphylm from 75% to 80%, leading to the updated price target. The firm reiterates an Outperform rating, indicating their continued confidence in the potential of Aquestive Therapeutics' Anaphylm.
In other recent news, Aquestive Therapeutics reported significant developments in its financial performance and product pipeline. The company demonstrated a substantial 52% increase in total revenues for Q2 2024, reaching $20.1 million, largely driven by license and royalty revenue.
Despite a decrease in manufacturing and supply revenue and a rise in research and development costs, Aquestive revised its 2024 revenue outlook to $57-60 million and anticipates a non-GAAP adjusted EBITDA loss of $20-23 million.
Analysts from JMP Securities maintained a Market Outperform rating for Aquestive, while H.C. Wainwright increased its price target for Aquestive Therapeutics shares to $10.00, maintaining a Buy rating. Furthermore, Aquestive is preparing for the commercial launch of Anaphylm and is actively exploring partnerships for distribution.
These are recent developments in Aquestive Therapeutics' strategic positioning in the pharmaceutical market with its innovative products.
InvestingPro Insights
Aquestive Therapeutics' recent positive developments align with several key metrics from InvestingPro. The company's market cap stands at $499.01 million, reflecting investor confidence in its potential. Notably, AQST has shown impressive price performance, with a 291.43% total return over the past year and a 171.29% return year-to-date, indicating strong market enthusiasm for the company's prospects, particularly in light of Anaphylm's progress.
InvestingPro Tips highlight that AQST holds more cash than debt on its balance sheet and its liquid assets exceed short-term obligations. These factors suggest financial stability, which is crucial for supporting ongoing research and development efforts, including the advancement of Anaphylm towards NDA filing.
However, it's important to note that AQST is not currently profitable, with a negative P/E ratio of -20.09 for the last twelve months as of Q2 2024. This is not uncommon for biotech companies in the development stage, and the market appears to be valuing AQST based on its future potential rather than current earnings.
For investors seeking a more comprehensive analysis, InvestingPro offers 8 additional tips for AQST, providing a deeper understanding of the company's financial health and market position.
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