Ongoing Securities Investigation into Aquestive Therapeutics (AQST) After FDA Flags NDA Deficiencies for Anaphylm

On January 19, 2026, the law firm Levi & Korsinsky, LLP announced it had started a securities investigation involving Aquestive Therapeutics, Inc. (NASDAQ: AQST). The announcement came after investors reacted to news that the U.S. Food and Drug Administration (FDA) identified deficiencies in the company’s New Drug Application (NDA) for Anaphylm, a product candidate intended for the emergency treatment of anaphylaxis (a severe, fast allergic reaction).

According to the investigation notice, Aquestive had disclosed that it received an FDA letter stating the agency had found issues in the NDA that prevented labeling discussions and post-marketing commitment talks at that time. Following the market’s response to the regulatory update, AQST shares reportedly fell sharply—opening down about 35% on the day referenced in the notice.

This rewritten report explains what happened, why it matters, and what the situation could mean for investors and the broader biotech market—using plain, careful language. It is not investment advice, and it does not assume any wrongdoing occurred. It simply summarizes the public information and the context around it.

What Happened: The Timeline Behind the AQST Investigation

January 9, 2026: FDA Identifies NDA Deficiencies

Public reporting indicates that on January 9, 2026, Aquestive disclosed it had received FDA communication stating that the agency had identified deficiencies in the NDA for Anaphylm. The key point: the issues were serious enough that the FDA said it could not proceed with labeling discussions and post-marketing commitments at that moment.

January 19, 2026: Levi & Korsinsky Announces an “Ongoing Securities Investigation”

On January 19, 2026, Levi & Korsinsky published a notice saying it had commenced an investigation into whether there may have been violations of federal securities laws connected to the situation. These announcements are typically invitations for shareholders who experienced losses to contact the firm to discuss potential legal options.

Market Reaction: AQST’s Share Price Drop

The notice states that, in response to the news, AQST shares fell by $2.18 (35.1%) to open around $4.03. Price moves like this often happen when a biotech company’s major regulatory milestone becomes uncertain, because timelines and revenue expectations can change quickly in the market’s eyes.

Understanding Anaphylm: What the Product Is and Why It’s Important

Anaphylm’s Goal: A Needle-Free Emergency Option

Anaphylm is described in public materials as a sublingual film (a small strip placed under the tongue) intended to deliver an epinephrine-based treatment for severe allergic reactions, including anaphylaxis. The concept is simple: many people carry injectable epinephrine auto-injectors, but some patients hesitate to use needles or may not have the device at the right moment. A compact film could be easier to carry and use—if proven safe and effective and approved by regulators.

What “Sublingual Film” Means (In Plain English)

A sublingual film is a thin strip designed to dissolve under the tongue. In general, this route can allow medicine to enter the body through tissue in the mouth. Public reporting about Anaphylm says it is designed to dissolve on contact and does not require water or swallowing, focusing on portability and quick use during an emergency.

Why the FDA Review Matters So Much in Biotech

For many biotech companies, a single “lead” product candidate can represent a major part of future growth. When a regulator flags problems in an NDA, markets often re-price the company quickly, because approval timing (and even the possibility of approval) may become less certain. That does not automatically mean the drug won’t be approved—but it does raise questions that investors try to price in immediately.

What the FDA Deficiency Notice Actually Suggests (And What It Doesn’t)

Deficiencies Can Range from Fixable to Serious

The phrase “FDA identified deficiencies” can cover a wide range of issues. In some cases, deficiencies may involve data presentation, manufacturing documentation, labeling details, or requests for clarification. In other situations, they can be more significant, such as needing additional clinical data. The public reporting referenced here indicates that the FDA did not specify the exact deficiencies in the initial notification described by the company, while also emphasizing that the review was ongoing and that the notice was not a final decision.

“Labeling Discussions Are Precluded” Is a Big Signal

In the FDA review process, discussions about labeling (what the drug’s instructions, warnings, and approved uses would say) typically occur as the review progresses. Reporting indicates the FDA’s message was that deficiencies were preventing those discussions at that time. That can be taken by investors as a sign the review has hit a meaningful obstacle, even if the final outcome is still uncertain.

PDUFA Date: A Key Deadline Investors Watch

Public reporting connected to this situation referenced a PDUFA target action date of January 31, 2026 for Anaphylm. A PDUFA date is a goal date for the FDA to take action on an application (such as approval, a complete response, or other regulatory outcome). If the FDA requests more information or if major issues remain, timelines can change.

Why Levi & Korsinsky Announced an Investigation

What “Securities Investigation” Usually Means

When a law firm announces a securities investigation after a sharp stock drop, it is typically looking into whether investors may have been harmed by potentially misleading statements or omissions that could violate securities laws. Importantly, an investigation notice is not proof of wrongdoing. It is a public statement that the firm is reviewing the situation and inviting shareholders to reach out.

Why These Announcements Often Follow Biotech Regulatory News

Biotech stocks can swing dramatically on FDA updates because regulatory milestones can make or break near-term expectations. When the market reacts strongly, plaintiff-side securities firms often review public statements, timelines, and disclosures to determine whether there may be a basis for claims. That is a common pattern across the sector, especially around NDAs, clinical trial readouts, and FDA communications.

What Investors Should Keep in Mind

It’s wise to separate three different things:

A regulatory setback (FDA questions or deficiencies)
A market reaction (share price movement)
A legal review (a law firm investigating possible claims)

These can be connected in timing, but they are not the same thing—and none of them alone confirms fraud or misconduct.

How This Could Affect AQST’s Business Story

Company Focus: Film-Based Drug Delivery

Aquestive describes itself as a leader in developing and delivering medications via film technology (often referred to as PharmFilm). Public company materials show Anaphylm listed as a key program in its pipeline for anaphylaxis.

Why Anaphylm Appears Central

Based on the public emphasis placed on Anaphylm in pipeline descriptions and reporting, the product candidate appears to be a significant part of the company’s future narrative. That can help explain why the market reacted sharply to the FDA deficiency notice—because uncertainty around a flagship program can ripple into the entire valuation.

Global Regulatory Plans Add Another Layer

Reporting about the Anaphylm program also discussed potential engagement with regulators outside the U.S., including Canada and parts of Europe, with expectations of future submissions and feedback. While global plans can diversify opportunity, U.S. FDA progress often remains the most closely watched catalyst for a NASDAQ-listed biotech company.

What “NDA Deficiencies” Might Involve: A Simple Guide

Possible Category 1: Clinical Evidence Questions

Sometimes, regulators want more clarity around how well a product works, how consistent the effect is across different groups, and whether benefits outweigh risks. In the case of emergency allergy treatment, the FDA may focus heavily on reliability, speed, and safety—because the stakes are life-and-death in real-world use.

Possible Category 2: Chemistry, Manufacturing, and Controls (CMC)

Many NDA delays in pharma come from CMC topics: how the drug is manufactured, tested, packaged, and kept stable over time. For a film-based product, regulators may scrutinize dose uniformity, storage conditions, packaging integrity, and performance under different real-world conditions.

Possible Category 3: Labeling and Use Instructions

Emergency therapies must be simple to use correctly. Labeling discussions often involve the exact instructions, warnings, contraindications, and directions for caregivers and patients. The reporting here emphasizes that the FDA said it could not proceed with those talks at that time due to deficiencies.

Note: The public sources referenced do not list the exact deficiencies. So, any discussion of categories is general FDA process context—not a claim about what the FDA specifically found in this case.

Why Anaphylaxis Treatment Is a High-Impact Space

What Anaphylaxis Is

Anaphylaxis is a severe allergic reaction that can happen quickly and requires fast treatment. Epinephrine is widely recognized as a first-line emergency therapy. Because timing matters, products in this space are evaluated with a strong focus on speed, usability, and real-world performance.

Why “Needle-Free” Concepts Get Attention

Needle-free or alternative delivery methods can attract interest because they may lower barriers to use. If a person hesitates to inject or cannot administer an auto-injector easily, an alternative format might improve readiness—if it meets strict safety and effectiveness standards.

Investor Impact: What a 35% One-Day Move Signals

Volatility Is Common, But Still Serious

A one-day decline of around 35% is a major event for any public company. For biotech firms, it often signals that the market believes the probability of approval or the timeline to approval has changed materially. The Levi & Korsinsky notice explicitly connected the stock move to the FDA deficiency update.

Short-Term vs. Long-Term Narrative

In the short term, investors may focus on what the FDA deficiency notice means for the upcoming decision timeline. Longer term, the story can depend on how clearly the company explains the issue, what additional information the FDA requests, and whether the program can stay on track or needs more work.

What Happens Next: Practical Scenarios to Watch

Scenario A: The Company Addresses Deficiencies Quickly

If deficiencies are administrative or clarifying in nature, companies can sometimes respond quickly. In that case, timelines may remain close to the original plan—though markets may remain cautious until uncertainty is resolved.

Scenario B: FDA Requests Additional Data or Time

If the FDA requires additional analyses, more manufacturing work, or more clinical data, the review could take longer. That kind of delay can affect revenue expectations, financing needs, and strategic planning.

Scenario C: A Formal FDA Action That Requires Resubmission

In some regulatory paths, unresolved deficiencies can lead to a formal response requiring additional work and resubmission. Public reporting at the time emphasized that the notification was not a final decision, but it also noted that delays in clarity could affect approval timing.

FAQs About the AQST Securities Investigation and FDA Anaphylm Update

1) What is the ongoing securities investigation into Aquestive Therapeutics (AQST)?

It is a public notice stating that Levi & Korsinsky is reviewing whether there may have been potential violations of federal securities laws related to recent events and disclosures. An investigation notice is not proof of wrongdoing.

2) Why did AQST stock drop so sharply?

The notice and related reporting link the decline to an FDA communication stating it identified deficiencies in the Anaphylm NDA that prevented labeling discussions at that time. Markets often react strongly to regulatory uncertainty in biotech.

3) Did the FDA reject Anaphylm?

Public reporting states that the FDA communication described deficiencies and that review was ongoing, emphasizing that it was not described as a final regulatory decision at the time of the update.

4) What is Anaphylm and what is it used for?

Anaphylm is described as a sublingual film product candidate intended for the emergency treatment of severe allergic reactions, including anaphylaxis.

5) What is a PDUFA target action date, and why does it matter here?

A PDUFA target action date is the FDA’s target date to take action on a drug application. Reporting connected to this case referenced January 31, 2026 as the target action date for Anaphylm.

6) Should investors contact a law firm or take action right now?

This depends on personal circumstances and should be discussed with a qualified professional. Generally, investors should avoid rushing, gather official documents, and seek independent advice if they believe they were harmed. This article is informational only and is not legal advice.

7) Does a law firm investigation mean the company did something illegal?

No. It means the firm is reviewing available information and inviting shareholders to discuss potential claims. Liability, if any, would depend on evidence and legal findings.

Conclusion: A High-Stakes Regulatory Moment With Legal Scrutiny

The “ongoing securities investigation” announcement related to Aquestive Therapeutics (AQST) landed at a sensitive time: right after public reporting that the FDA identified deficiencies in the Anaphylm NDA and paused labeling discussions.

In biotech, regulatory updates can change sentiment overnight—especially when a product candidate is viewed as central to the company’s future. For now, the most important takeaway is that the story is still developing. The FDA review was described as ongoing, and the exact deficiencies were not detailed in the public reporting referenced here.

As more official updates emerge, investors and observers will likely focus on clarity: what the FDA concerns are, what steps are required to address them, and how timelines may shift. In the meantime, the law firm notice signals that legal scrutiny often follows sharp market moves—whether or not any claims ultimately proceed.

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