Lake Street lowered the firm’s price target on Aquestive Therapeutics (AQST) to $6 from $8 and keeps a Buy rating on the shares after the company announced the receipt of a CRL for Anaphylm and a planned resubmission in Q3. The firm adjusted its revenue estimates accordingly and lowered its price target to account for the delay in the approval of Anaphylm. Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>> See Insiders’ Hot Stocks on TipRanks > ...

NEW YORK, Feb. 03, 2026 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Aquestive Therapeutics, Inc. (“Aquestive” or the “Company”) (NASDAQ: AQST).  Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, ext. 7980. The investigation concerns whether Aquestive and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices.  [Click here for information about joining the class action] ...

Leerink analyst Roanna Ruiz was not surprised that Aquestive Therapeutics (AQST) received a Complete Response Letter for Anaphylm given the FDA’s prior deficiency letter. That said, the “silver lining” is that this outcome appears recoverable with a relatively defined path to approval, the firm adds. The good news is that no additional studies beyond these seem to have been requested by the FDA, the CRL does not appear to raise any concerns about comparability data or CMC, and Leerink sees these studies ar ...

Company Overview - Aquestive Therapeutics, Inc. (NASDAQ:AQST) is a pharmaceutical company focused on developing and commercializing innovative products to address unmet medical needs, specializing in oral film-based drug delivery systems [2][4] - Competitors include Teva Pharmaceuticals and Viatris, which also focus on drug delivery technologies [2] Recent Developments - New Street set a price target of $12 for AQST, indicating a potential upside of approximately 193% from its trading price of $4.10 [3] - Despite receiving a Complete Response Letter (CRL) from the FDA for Anaphylm, AQST's stock has increased by 38.98%, rising by $1.15 [3][4] - The CRL highlighted deficiencies in the human factors validation study, temporarily halting discussions on labeling and post-marketing commitments [4] - AQST's stock has shown volatility, with a daily trading range between $3.79 and $4.39, and has fluctuated between a high of $7.55 and a low of $2.12 over the past year [4] Market Position - AQST's market capitalization stands at approximately $500.21 million, with a trading volume of 60.81 million shares on the NASDAQ exchange [4] - The outcome of discussions to address the FDA's concerns regarding Anaphylm is crucial for the company's future, as it represents a significant opportunity in the treatment of anaphylaxis [5]

Core Viewpoint - Aquestive Therapeutics, Inc. is focused on developing innovative oral film-based drug delivery systems to meet unmet medical needs, despite facing regulatory challenges with its Anaphylm product [1][2]. Group 1: Company Overview - Aquestive Therapeutics specializes in oral film-based drug delivery systems [1]. - The company has maintained a stable financial position, expecting substantial cash reserves by the end of the year [3]. Group 2: Regulatory Developments - Recently, the FDA issued a Complete Response Letter (CRL) for the Anaphylm Epinephrine Sublingual Film, citing deficiencies in packaging and administration [2]. - The company plans to address the FDA's concerns and resubmit the application by the third quarter of 2026 [3]. Group 3: Market Performance - The current stock price for AQST is $4.18, reflecting a significant increase of 41.69% with a change of $1.23 [4]. - Over the past year, AQST's stock has fluctuated between a high of $7.55 and a low of $2.12, with a market capitalization of approximately $415.1 million [4].

LOS ANGELES--(BUSINESS WIRE)--The Schall Law Firm, a national shareholder rights litigation firm, announces that it is investigating claims on behalf of investors of Aquestive Therapeutics, Inc. ("Aquestive†or "the Company†) (NASDAQ: AQST) for violations of the securities laws. The investigation focuses on whether the Company issued false and/or misleading statements and/or failed to disclose information pertinent to investors. Aquestive announced on January 9, 2026, that, "As part of its ongoing review o ...

On Monday, Aquestive Therapeutics, Inc. (NASDAQ:AQST) received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for the New Drug Application (NDA) seeking approval of Anaphylm (dibutepinephrine) Sublingual Film for Type I allergic reactions, including anaphylaxis, in patients weighing 30kg or more (approximately 66 pounds).  In January, the FDA identified deficiencies in Anaphylm's NDA that preclude discussion of labeling and post-marketing commitments at this time.“While it ...

Stock of Aquestive Therapeutics, Inc. (AQST) is soaring about 43 percent on Monday morning trading following its announcement about a Complete Response Letter received from the FDA for the New Drug Application seeking approval of Anaphylm Sublingual Film for the treatment of Type I allergic reactions.Currently, AQST is trading at $4.22, up 42.98 percent, over the previous close of $2.95. The stock opened at $3.79 and has climbed as high as $4.39 so far in today's session. Over the past year, it has traded ...

Group 1 - The conference call is hosted by Aquestive Therapeutics, featuring key executives including the CEO and CFO [1] - The call includes an overview of recent business developments followed by a Q&A session with additional executives [1] - A press release was issued prior to the call, and a recording along with supplemental materials will be available on the company's website [2]

U.S. stocks were higher, with the Dow Jones index gaining more than 350 points on Monday.Shares of Peakstone Realty Trust (NYSE:PKST) rose sharply during Monday's session.Brookfield announced plans to acquire Peakstone Realty Trust in a $1.2 billion all-cash transaction.Peakstone Realty Trust shares surged 32.5% to $20.70 on Friday.Here are some other big stocks recording gains in today’s session.Photo via Shutterstock ...