WARREN, N.J. - Aquestive Therapeutics , Inc. (NASDAQ: NASDAQ:AQST), a pharmaceutical company, announced positive outcomes from its recent Oral Allergy Syndrome (OAS) challenge study for Anaphylm™, an epinephrine sublingual film. The study met both primary and secondary endpoints, demonstrating rapid symptom resolution beginning two minutes post-administration. These results indicate that Anaphylm could be a viable alternative to current epinephrine treatments for severe allergic reactions.
The OAS challenge study involved subjects with confirmed OAS to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of Anaphylm. Subjects were exposed to a known allergen, and Anaphylm's effectiveness in alleviating symptoms was documented. The median time for complete symptom resolution was twelve minutes, with symptomatic swelling completely resolved within five minutes after Anaphylm administration.
The PK profile after allergen exposure was comparable to the non-allergen PK profile, with no significant differences between subjects with and without allergen exposure. Anaphylm was also found to be safe and well-tolerated, with all adverse events categorized as mild or moderate and resolving without medical intervention.
Jay Lieberman, M.D., a Professor at the University of Tennessee Health Science Center, highlighted the importance of the rapid symptom relief seen in the study and the consistent rapid absorption profile of Anaphylm. Daniel Barber, President and CEO of Aquestive, expressed satisfaction with the study's results and the potential of Anaphylm as a treatment for severe allergic reactions.
Aquestive is on track for a pre-New Drug Application (NDA) meeting with the U.S. Food and Drug Administration (FDA) in the fourth quarter of 2024. The company plans to commence a pediatric study in the same quarter and aims to submit an NDA to the FDA in the first quarter of 2025. If approved, Aquestive anticipates a full product launch of Anaphylm in the first quarter of 2026.
This news report is based on a press release statement from Aquestive Therapeutics.
In other recent news, Aquestive Therapeutics has reported significant developments in its financial performance and product pipeline. The company saw a substantial 52% increase in total revenues for Q2 2024, reaching $20.1 million, primarily driven by license and royalty revenue. However, a decrease in manufacturing and supply revenue and an increase in research and development costs led to a revised 2024 revenue outlook of $57-60 million and an anticipated non-GAAP adjusted EBITDA loss of $20-23 million.
In addition, Aquestive Therapeutics announced immediate amendments to the company's bylaws, part of a routine review of corporate governance. The changes include a reduction in the look-back period for stockholder nominations for the board from three years to two years. The amendments aim to streamline the nomination process.
The company also completed enrollment for its oral allergen challenge study, a critical step in the development of Anaphylm, an epinephrine sublingual film. This novel non-injection-based epinephrine device for severe allergic reactions recently received approval from the U.S. Food and Drug Administration (FDA).
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. The company 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 study results for Anaphylm™ have been reflected in the company's market performance. According to InvestingPro data, AQST has seen a significant 59.35% price return over the last three months, indicating strong investor confidence in the company's potential. This aligns with the promising outcomes of the Oral Allergy Syndrome challenge study and the company's progress towards FDA approval.
Despite the positive news, it's important to note that Aquestive faces some financial challenges. An InvestingPro Tip reveals that the company is not expected to be profitable this year, which is consistent with its current development stage and focus on bringing Anaphylm to market. However, another InvestingPro Tip highlights that Aquestive holds more cash than debt on its balance sheet, suggesting a solid financial position to support its ongoing research and development efforts.
The company's revenue growth is also noteworthy, with a 51.79% increase in quarterly revenue as of Q2 2024. This growth could be attributed to the company's existing product portfolio and partnerships, providing a foundation as they work towards the potential launch of Anaphylm in 2026.
For investors interested in a deeper analysis, InvestingPro offers 11 additional tips for AQST, providing a more comprehensive view of the company's financial health and market position.
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