Aquestive Therapeutics Inc (AQST)

Downgraded to hold, are we still in the money with AQST?

AQST Investor Alert: AQUESTIVE THERAPEUTICS, INC. Securities Fraud Lawsuit - Investors With Losses May Seek to Lead the Class Action After Analyst Slashed Price Target: SueWallStApril 23, 2026 9:00 AM
PR Newswire (US)

Wall Street Reassessment: Analyst Opinion Evolution on AQSTNEW YORK, April 23, 2026 /PRNewswire/ -- On January 9, 2026, Cantor slashed its price target on Aquestive Therapeutics, Inc. (NASDAQ: AQST) from $15 to $8, warning that "the history of CRLs following similar letters increases the risk of a potential delay for Anaphylm." Shareholders who purchased AQST securities between June 16, 2025 and January 8, 2026 lost over 37% of their investment value in a single trading session. Find out if you qualify to recover your investment losses. You may also contact Joseph E. Levi, Esq. at jlevi@SueWallSt.com or (888) SueWallSt.







AQST shares fell from $6.21 to $3.91 per share, a loss of $2.30 per share, after Aquestive disclosed that the FDA had identified deficiencies in its Anaphylm NDA that precluded labeling discussions. The lead plaintiff deadline is May 4, 2026.Initial Analyst OptimismThroughout the Class Period, sell-side analysts covering AQST built their models around management's repeated assurances that Anaphylm was on track for FDA approval by the January 31, 2026 PDUFA date. The complaint recounts that the Company described its FDA interactions as routine, characterized the review process as progressing normally, and stated commercial launch preparations were underway for Q1 2026. Analysts set price targets and issued coverage reflecting these representations.The Downgrades BeginThe January 9, 2026 disclosure triggered rapid reassessment across Wall Street:Cantor reduced its price target by 47%, from $15 to $8, citing the elevated risk of a Complete Response LetterOppenheimer published a report stating that the FDA's communication was "a meaningful setback" and that the stock was "currently pricing in a CRL, the most likely scenario"Oppenheimer outlined three scenarios, with the worst case sending shares "below cash (~$1/sh)" depending on the FDA's consideration of a Citizen PetitionOppenheimer compared the situation to prior FDA delays at SPRY (neffy) and ASND (Yorvipath), which resulted in 12 to 15 month approval delaysExecution Concerns on Wall StreetThe analyst commentary reveals a critical disconnect. As alleged in the action, management portrayed the FDA review as entirely routine. On the November 6, 2025 earnings call, the Company described the review process by stating the different functions in the FDA were "doing their jobs, completing their checklists and asking us the questions you would expect." Yet within weeks, the FDA flagged deficiencies serious enough to halt labeling discussions entirely. Analysts had no basis to anticipate this outcome given the information provided.Why Analyst Shifts Matter for Investors"When analyst expectations are built on incomplete or misleading company disclosures, the resulting corrections can cause significant investor harm. The magnitude of the target price reductions here reflects how heavily the market relied on management's characterizations of the FDA review." — Joseph E. Levi, Esq.The breadth and speed of the analyst downgrades underscore that the market treated management's statements about FDA progress as material. When those statements proved inconsistent with the FDA's actual findings, analysts and investors repriced AQST accordingly, causing substantial losses to Class Period purchasers.Speak with an attorney about recovering your AQST losses or call (212) 363-7500.LEAD PLAINTIFF DEADLINE: May 4, 2026Levi & Korsinsky, LLP, Top 50 securities litigation firm (ISS, seven consecutive years). Over 70 professionals. Hundreds of millions recovered for investors.CONTACT:SueWallStJoseph E. Levi, Esq.33 Whitehall Street, 27th FloorNew York, NY 10004jlevi @Icons1



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Original: AQST Investor Alert: AQUESTIVE THERAPEUTICS, INC. Securities Fraud Lawsuit - Investors With Losses May Seek to Lead the Class Action After Analyst Slashed Price Target: SueWallSt

if you clowns think changing the packaging will have a result on the HF issues of chewing it, moving it or spitting it out you need to buy a bridge I have for sale....Did you read the CRL? FDA never made it to labeling or addressed ARS petition...This puppy is doa..Oce ARS gets ACNU and gets dual rx/otc, its game over...you do realize fda is following Narcan path for otc and that ARS team and sprayer is the same as Narcan? You realize they will also get 3 yrs exclusitivity? that means a monopoly....and no payor will cover anaphylm or any other candidate.

did we even mention emesis and no kids can ever take anaphylm? which is 60% of the mkt...lol lol lol

I thought it would be worse.
Aquestive Therapeutics reported Q4 2025 results that, overall, show a company still moving forward operationally and financially.
Revenue continues to grow:
Total Q4 revenue reached $13.0 million, up 10% year over year, driven primarily by manufacture and supply revenue of $12.0 million. For full-year 2025, revenue came in at $44.5 million, confirming the stability of the company’s commercial manufacturing platform.
Strong cash position:
The company ended 2025 with $121.2 million in cash and cash equivalents, giving it meaningful runway. Even with continued investment in development programs, the company expects to finish FY 2026 with around $70 million in cash, which still supports ongoing clinical and regulatory work.
Losses look significantly smaller excluding one-time costs:
Reported Q4 net loss was $31.9 million, but drops to $18.7 million when excluding one-time legal expenses. Adjusted EBITDA shows a similar improvement when those extraordinary costs are removed.
Clear regulatory path forward for Anaphylm:
The company plans to resubmit the NDA in Q3 2026 following a Type A meeting with the U.S. Food and Drug Administration within 30 days, keeping the development timeline active.
Pipeline continues to progress:
The topical gel AQST-108 opened an IND in December 2025 and already completed Phase 1 dosing in Q1 2026, with data expected in Q2 2026, providing a near-term catalyst.
Investor support remains in place:
Partner RTW Investments extended the Anaphylm marketing approval deadline to June 30, 2027 and committed to purchase at least $5 million in shares, alongside warrants issued at $4.00.
International expansion in sight:
Aquestive plans to submit regulatory applications for Anaphylm in Canada and the EU during 2026, potentially opening additional markets.

Report Fourth Quarter 2025 Financial Results and Recent Business Highlights on March 4 after market close and Host Conference Call on March 5 at 8:00 a.m. ET
The Company also expects to receive feedback from the Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom in the first quarter of 2026.

Aquestive Therapeutics Inc. will participate in four investor conferences in March: TD Cowen 46th Annual Health Care Conference (1x1 meetings on March 3), Leerink Partners Global Healthcare Conference 2026 (fireside chat on March 9 at 10:40 a.m. ET, plus 1x1 meetings), Citizens Life Sciences Conference (presentation on March 10 at 8:25 a.m. ET, plus 1x1 meetings), and Barclays 28th Annual Global Healthcare Conference (1x1 meetings on March 11).

The real “gem”: control of dissolution profiles over time
The application places strong emphasis on:
Particle size distribution control (D90, D50, D10) to tightly govern release kinetics
Reproducible dissolution profiles maintained after up to 36 months of storage
Demonstrated stability under stressed conditions (up to 60°C and 75% relative humidity)

Evidently, for some shorts the next step is to test the sublingual films while under the influence of the discombobulator — just to see if confusion is a contraindication.

Aquestive shares jump despite FDA setback for AnaphylmFebruary 2, 2026 9:47 AM
IH Market News
Aquestive Therapeutics (NASDAQ:AQST) shares surged 18% on Monday even after the company disclosed that it had received a complete response letter (CRL) from the U.S. Food and Drug Administration for Anaphylm, its sublingual film treatment for Type I allergic reactions, including anaphylaxis.The FDA’s feedback focused narrowly on packaging and administration-related concerns, particularly shortcomings identified in the human factors validation study. The agency cited issues such as difficulty opening the pouch and incorrect placement of the film, which could pose safety risks during an anaphylactic event. In addition, the FDA requested a pharmacokinetics study to assess the impact of any changes to the product’s packaging and labeling.Aquestive said it is confident the issues can be addressed quickly through updates to the pouch design, instructions for use and labeling. The company plans to carry out a new human factors validation study incorporating these changes and expects to resubmit its application as early as the third quarter of 2026.“While it is unfortunate to have received a CRL, we believe that, with the clarity we now have from the FDA, we have made significant progress toward approval,” said Daniel Barber, President and CEO of Aquestive. “We are encouraged that the issues in the letter are limited to human factors and a supportive PK study, once human factors are addressed.”The company stressed that the FDA did not raise any concerns about the comparability data included in the Anaphylm new drug application, such as bracketing, repeat-dose or sustainability data. The CRL also did not flag any issues related to chemistry, manufacturing or controls.Looking ahead, Aquestive said it remains well capitalized and expects to end 2026 with a strong cash position. The company also reaffirmed plans to file regulatory submissions in Canada and Europe by the end of 2026, noting that the European Medicines Agency has indicated that no additional clinical trials will be required ahead of submission.Aquestive Therapeutics stock price

Original: Aquestive shares jump despite FDA setback for Anaphylm

Q3 2026 – Resubmission FDA per Anaphylm
H2 2026 – Submission UE (EMA)
H2 2026 – Submission Canada (NDS)
Q1 2026 – Feedback UK (MHRA)
I won't sell below 7, in the short term

AQST...........................................p/m

Double digits here we come!!!

Paradoxically, this CRL may increase strategic appeal: the drug is clinically de-risked, and approval now depends mainly on building the right preparation and administration system to make user error unlikely. In the meantime, while they work through the regulatory alignment, they can safely prepare the commercial launch. Combined with today’s depressed valuation, this looks like a particularly attractive setup for a strategic acquisition.

This is not a clinical rejection: everything was effectively approved except the packaging. They should now run pure usability tests — no drug needed — and redesign it like neonatal devices: single-dose, peel-and-use, impossible to misuse under stress. A separate box with a placebo test sample would also make sense. And if they take it slow until October… that’s not exactly negative news.

02/02/2026 06:55:00 AQST Aquestive Therapeutics Cmn NASDAQ
T1

AQST won't even be told the issues until the CRL. This looks like the end of anaphylm if it is the size of the dose or if FDA wants data on the prodrug conversion or real world data on the prodrug.

Bring on the BOUNCE AQST

If the FDA had already identified serious, structural issues likely to result in a CRL, it would have communicated that more explicitly at this stage of the review, not as a matter of courtesy, but as standard regulatory practice.
I took a handful of them.

Wow… wording looked bad… price looks worse.



Avoid at all costs, before it costs too much

See you in double digits soon! 

AQST BIO BEAST HEADING TO THE TOP OF MONTHLY CLOUD

Could be a good day, possibly a good few months for speculators here. 💰

Just the beginning here see everyone in double digits soon enough

By eoy

Why so quiet? When is estimate time of FDA approval?

About to lift off 

Smart man 

Exactly

No brainer!

May breakout soon. Adding and building large position. I like their drugs.

Building a position here.

$AQST

Seeing how fast Neffy maker moved AQST will make the same move.

NEFFY is approved. Bad news for AQST very behind

Selloff coming

Not true

Nothing. No updates on Libervant after approval. Now Anaphylm won’t be available for 2 more years.

Keep dropping were not done buying!

Huge buy opp!

It’s heading back to $2. Stop the bleeding please! drug approved but not ready to sell wtf is that? Next earnings will be brutal.

added. Great science and beautiful chart.
Offerings became bullish.. dont you know?

Is a bargain

AQST under $5

Big turn around imminent

Yessir absolutely

In other words you’re confident about this one from the clinical stage drug discovery sector

Not for long