Welcome to our dedicated page for Aquestive Therapeutics news (Ticker: AQST), a resource for investors and traders seeking the latest updates and insights on Aquestive Therapeutics stock.
Aquestive Therapeutics, Inc. develops and manufactures specialty pharmaceutical products using proprietary oral-film and drug-delivery technologies. News about AQST centers on the company’s proprietary pipeline, including Anaphylm™ (dibutepinephrine) sublingual film for Type I allergic reactions, including anaphylaxis, and AQST-108, an epinephrine prodrug topical gel being explored for dermatological conditions such as alopecia areata.
Recurring updates also cover FDA interactions and NDA communications for Anaphylm, pharmacokinetic and human-factor study topics, quarterly financial results, licensee and CDMO manufacturing activity, investor presentations, equity inducement grants, and legal, compliance, and board-governance changes.
Aquestive Therapeutics (AQST) announced significant developments, including the FDA's acceptance of the NDA for Libervant with a PDUFA goal date of December 23, 2021. The company is also on track to report top-line data from its Phase 1 study for AQST-109 in the second half of 2021. Full-year revenue guidance has been increased to $46-$48 million, reflecting a solid performance, especially in Sympazan. Total revenues for Q2 2021 were $15.3 million, with a net loss of $12.4 million.
Aquestive Therapeutics (NASDAQ: AQST) will announce its second-quarter results on August 3, 2021, after market close. An investor conference call is scheduled for August 4, 2021, at 8:00 a.m. ET. The company is known for its innovative pharmaceutical products, including Sympazan and the development of Libervant among other candidates. Investors can access the conference call details through the company's website. The report is expected to cover business updates and strategies, particularly regarding ongoing product developments.
Aquestive Therapeutics (AQST) announced that the FDA has accepted the resubmission of the New Drug Application (NDA) for Libervant™ (diazepam) Buccal Film for managing seizure clusters. The PDUFA goal date is set for December 23, 2021. If approved, Libervant will be the first orally delivered diazepam product for this indication. The company is preparing for a potential commercial launch in early 2022. Libervant aims to provide a non-invasive and consistent alternative to current treatments for refractory epilepsy patients.
Aquestive Therapeutics, Inc. (NASDAQ: AQST) has resubmitted its New Drug Application (NDA) for Libervant™ (diazepam) Buccal Film to the FDA for managing seizure clusters. This follows a Complete Response Letter (CRL) received on September 25, 2020. The company anticipates a six-month review process, with the PDUFA goal date expected in late 2021. Libervant aims to provide a non-invasive alternative to the current standard of care, Diastat, which is often difficult to administer. The resubmission is considered a significant milestone in bringing this innovative treatment to patients in need.
Aquestive Therapeutics (NASDAQ: AQST) has announced that A. Ernest Toth, Jr. has transitioned from interim Chief Financial Officer to permanent Senior Vice President and CFO, effective immediately. Toth, who joined the company in December 2020, has extensive experience in financial leadership across various healthcare sectors. His appointment is expected to enhance the company's financial operations, with the management expressing confidence in his capability to foster key external relationships.
Aquestive Therapeutics (NASDAQ: AQST) will participate in two investor conferences in June. The management team will host a fireside chat at the JMP Securities 2021 Life Sciences Conference on June 16 at 2:30 pm ET, followed by a rare disease panel at BMO Capital Market 2021 Biopharma Day on June 22 at 10:15 am ET. Investors can access a recorded webcast of the fireside chat for 30 days post-event on the company's website. Aquestive focuses on developing innovative therapeutics to address unmet patient needs.
Aquestive Therapeutics, Inc. (NASDAQ: AQST) announced its participation in the 2021 RBC Capital Markets Global Healthcare Conference via a virtual fireside chat on May 19, 2021, at 9:45 ET. The management team will also engage in one-on-one investor meetings during the event. A webcast of the chat will be accessible on the Company’s website, with replay available for 30 days post-event. Aquestive focuses on developing innovative products addressing unmet medical needs, with their pipeline targeting central nervous system treatments.
Aquestive Therapeutics (NASDAQ:AQST) reported first quarter 2021 financial results, showing total revenues of $11.1 million, a 26% increase from $8.8 million in Q1 2020. The company's net loss reduced to $14.7 million ($0.41/share) from $16.5 million ($0.49/share) the previous year. Key developments include plans to refile the Libervant NDA by Q2 2021, launch of a Phase 1 study for AQST-109, and continued growth in Sympazan sales, which rose 56% year-over-year. The full year 2021 financial outlook remains unchanged, targeting revenues of $38 million to $42 million.
Aquestive Therapeutics, Inc. (NASDAQ: AQST) will report its first-quarter results for the period ending March 31, 2021, on May 4, 2021, after market close. A conference call for investors is scheduled for 8:00 a.m. ET on May 5, 2021. The company focuses on developing innovative products addressing unmet patient needs, with its Sympazan® oral film already commercialized. The firm is advancing several product candidates, including Libervant™, while navigating challenges posed by the COVID-19 pandemic.
Aquestive Therapeutics (AQST) recently provided a comprehensive update on its drug delivery program for systemic epinephrine during an R&D event. The company discussed results from two completed Phase 1 pharmacokinetic (PK) trials for AQST-108, a sublingual film candidate, demonstrating promising absorption and conversion profiles. Additionally, the development strategy for AQST-109, another epinephrine prodrug, was outlined. The company seeks patent protection for both candidates until at least 2037, indicating a strong intellectual property position.