Aquestive’s Film Takes Aim at EpiPen as FDA Decision Nears

WARREN, NJ – November 24, 2025 – When Aquestive Therapeutics’ management team takes the stage at the Piper Sandler Healthcare Conference next week, the investment community will be listening for more than just a routine corporate update. The scheduled fireside chat is a pivotal moment, a carefully orchestrated signal that the company believes it is on the cusp of challenging one of the most entrenched products in modern medicine. The subject of discussion—commercial readiness for its lead product candidate, Anaphylm™—transforms a standard conference appearance into a declaration of intent. With a regulatory decision from the FDA expected by January 31, 2026, Aquestive is positioning itself to disrupt the multi-billion dollar anaphylaxis treatment market, long dominated by the EpiPen auto-injector.

For decades, patients and caregivers have relied on needle-based devices for emergency allergy treatment, a solution often fraught with fear, hesitation, and user error. Aquestive’s upcoming presentation suggests the company is preparing to offer a fundamentally different approach, and investors are now tasked with weighing the promise of innovation against the immense challenge of unseating an incumbent.

Beyond the Needle: A New Delivery Paradigm

At the heart of Aquestive’s strategy is Anaphylm™, an epinephrine prodrug delivered via a sublingual film. This is not merely an incremental improvement but a potential paradigm shift in emergency care. The product, similar in size to a postage stamp, utilizes the company’s proprietary PharmFilm® technology to dissolve under the tongue and deliver epinephrine into the bloodstream without a needle, water, or the need to swallow. Its design directly addresses the primary complaints associated with auto-injectors: needle phobia, which can cause life-threatening delays in administration, and the sheer inconvenience of carrying bulky devices.

The clinical data underpinning Anaphylm™ suggests its advantages are more than just cosmetic. In its pivotal Phase 3 study in adults, the film demonstrated it could achieve peak epinephrine concentrations comparable to market-leading auto-injectors like EpiPen and AUVI-Q. Critically, its median time to maximum concentration (Tmax) was consistently faster, clocking in at 15 minutes in one study versus 20 minutes for EpiPen. For a condition where every second counts, this speed could be a significant clinical differentiator. Furthermore, a successful pediatric study in children aged 7 to 17 showed similar rapid absorption and tolerability, paving the way for a broad market label. By creating a discreet, user-friendly, and potentially faster-acting alternative, Aquestive is betting that it can capture a significant share of patients who are either non-compliant with or intimidated by current options.

De-Risking the Path to Market

Innovation alone does not guarantee market success, a fact well understood by seasoned pharmaceutical investors. The true story for Aquestive lies in its methodical navigation of the regulatory process. The company submitted its New Drug Application (NDA) in the first quarter of 2025, which the FDA accepted for review in June, setting the PDUFA target action date for January 31, 2026.

A major signal of regulatory confidence came in September 2025, when the FDA informed Aquestive that it would not require an Advisory Committee (AdCom) meeting to review Anaphylm™. In the world of drug development, the absence of an AdCom is a significant de-risking event. These committees are typically convened for novel drugs with complex data or potential safety concerns. The FDA’s decision to bypass this step suggests that the agency may have a clear path to rendering a decision based on the robust clinical package submitted, which includes data from eleven studies and nearly a thousand administrations. This development has substantially increased optimism that Anaphylm™ is on a trajectory for approval early next year.

The Billion-Dollar Battleground

The market Aquestive hopes to enter is both lucrative and fiercely competitive. The emergency epinephrine space is a multi-billion dollar industry where Viatris’s EpiPen has maintained a near-monopoly for years, despite persistent controversies over pricing and usability. However, the fortress may not be as impregnable as it once was. The FDA’s recent approval of ARS Pharmaceuticals’ Neffy, an epinephrine nasal spray, signaled the agency’s willingness to embrace needle-free alternatives.

While Neffy’s approval established a beachhead for non-invasive treatments, its initial commercial performance has been modest, with just $12.8 million in net product revenues in the second quarter of 2025. This provides a crucial piece of context for Aquestive’s potential launch. It demonstrates that simply being needle-free is not enough; a successful challenger must also execute a flawless commercial strategy, particularly around physician education and payer coverage. Aquestive appears to be planning for this, signaling a commercial approach that includes cash-pay options and co-pay programs to avoid the “sticker shock” that can hamstring a new product’s uptake.

Capitalizing on the Catalyst

Anticipating a blockbuster launch requires significant upfront investment, a reality reflected in Aquestive’s recent financial reports. The company’s Selling, General, and Administrative (SG&A) expenses swelled to $15.3 million in the third quarter of 2025, a deliberate “front-loading” of costs to build out the commercial infrastructure, from hiring leadership to preparing marketing materials. While this led to a net loss of $15.4 million for the quarter, management has framed it as a necessary and strategic deployment of capital.

That capital appears secure. Aquestive ended the quarter with a strong liquidity position of $129.1 million in cash. This war chest was fortified by a recent $85 million equity raise and, more importantly, a $75 million commercial launch facility from RTW Investments. This debt facility, contingent on FDA approval of Anaphylm™, is designed to fund the company’s operations well into 2027, providing the financial runway needed to support a full-scale product launch. With analyst price targets climbing as high as $10 and Piper Sandler reiterating an “outperform” rating, the market is pricing in a high probability of approval. The lingering skepticism, and the force that keeps the stock from breaking out pre-decision, revolves entirely around post-approval execution.

As Aquestive’s leadership prepares for their fireside chat, they are not just presenting data; they are making their case to a market hungry for disruption but wary of execution risk. The upcoming conference and the fast-approaching PDUFA date represent the culmination of years of clinical development and strategic financial planning. For Aquestive Therapeutics, the race to approval is nearly over, but the battle for the future of allergy care is just about to begin.