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WARREN, N. J. , Oct. 24, 2022 (GLOBE NEWSWIRE) — Aquestive Therapeutics, Inc. (NASDAQ: AQST), a pharmaceutical company that promotes existing criteria of care for resolving patient disorders by simplifying complex delivery methods, announced that the U. S. State has been working on a patient’s condition for its decision. U. S. The U. S. District Court for the Eastern District of Pennsylvania issued an order on Oct. 19, 2022, dismissing all claims opposed to Aquestive in Suboxone’s antitrust lawsuit filed through an organization of state attorneys general opposing Indivior Inc. (f/k/a Reckitt Benckiser Pharmaceuticals, Inc. ) and Aquestive, File No. 16-CV-5073.
“We are pleased that the Court has granted our abstract judgment move and agreed to dismiss all claims opposed to Aquestive similar to the ongoing litigation relevant to this case, building that the company deserves never to have been named at trial. This ruling is yet another step to improve our business,” said Daniel Barber, CEO of Aquestive. “With this decision, we will continue to focus our efforts on advancing our portfolio and preparing for our upcoming End-of-Phase 2 assembly with the FDA. for our main program AQST-109 (sublingual epinephrine film) for the remedy of severe allergic reactions, adding anaphylaxis.
Aquestive Therapeutics, Inc. (NASDAQ: AQST) is a pharmaceutical company that promotes today’s popular care to resolve patient disorders by simplifying complex delivery methods. We expand orally administered products to deliver complex molecules, bringing new opportunities to invasive and impractical therapies of the world. . Aquestive has five products marketed in the U. S. market. In the USA, 4 authorized products and one independent patented product to date, the oral film Sympazan® (clobazam) for the remedy of seizures related to Lennox-Gastaut syndrome. Our licensees market their products in the United States and around the world. The company also collaborates with pharmaceutical corporations to commercialize new molecules employing proprietary technologies, such as PharmFilm®, and has demonstrated drug progression and commercialization capabilities. central nervous system, or CN S, and an early-stage pipeline for treating severe allergic reactions, adding anaphylaxis. For more information, stop by Aquestive. com and follow us on LinkedIn.
Forward-Looking Statement Certain statements in this press release come with “forward-looking statements” within the meaning of the Private Securities Litigation Remodeling Act of 1995. Words such as “believe”, “anticipate”, “plan”, “expect” , “estimate”, “intend”, “may”, “will”, or the negative form of those terms, and similar expressions, are intended to identify forward-looking statements. These forward-looking statements are not old facts. Preliminary statements relate to the dubious effect of the global COVID-19 pandemic on our business, including with respect to our clinical trials, including site start-up, patient recruitment, and the timing and appropriateness of clinical trials; in regulatory filings and regulatory reviews and approvals of our product candidates; supply chain, production and distribution of pharmaceutical ingredients and other raw materials; sale and demand of our products; our liquidity and availability of capital resources; visitor calls l about our products and services; the ability of consumers to pay for goods and services; and the continued availability of an adequate workforce and professional professionals. Given those concerns, the Company cannot assure you that operations can be maintained as planned prior to the COVID-19 pandemic.
These forward-looking statements are based on our existing expectations and ideals and are subject to a number of threats and uncertainties that may also cause actual effects to differ materially from those described in the forward-looking statements. These threats and uncertainties include, but are not limited to, threats that the order of the United States District Court for the Eastern District of Pennsylvania dismissing all of the company’s opposing claims in the Suboxone antitrust litigation could be appealed. by the plaintiffs. in the case and that thereafter the Company would possibly be forced to pursue its defense of the claims presented in such case and that such plaintiffs would possibly be entitled to a judgment against the Company; material threats to the Company’s progression work, including any delays or adjustments in the timing, charge and good fortune of our clinical trial and product progression activities for AQST-109 and our other product applicants; threat of delays through the US Food and Drug Administration (FDA) in the approval of Libervant® (diazepam) buccal film for the US market position position position position position; threat of our ability to demonstrate to the FDA Libervant’s “clinical superiority” within the meaning of FDA regulations relating to a competitor’s FDA-approved diazepam nasal spray product in the United States, in addition to building a major contribution to patient care within the meaning of FDA regulations for approved products, as well as similar threats to other possible pathways or positions that are or could potentially be long-term complex for FDA to trump drug subsidy FDA seven-year exclusivity orphans for the approved nasal spray product, and there can be no guarantee that we will have good luck; threatened delays in FDA approval of AQST-109 and our other drug applicants, or lack of FDA approval at all; threat that a competitor will discharge FDA orphan drug exclusivity for a product with the same active moiety as any of our other drug products for which we seek FDA approval and that the competitor’s orphan drug has been approved in the past block those other product applicants in the United States for seven years for the same indication; threat to download access marketpositionpositionpositionpositionposition for other reasons; the threat inherent in launching a new product to marketpositionpositionpositionpositionpositionpositionpositionpositionpositionpositionpositionpositionpositionpositionpositionpositionpositionpositionpositionpositionpositionpositionpositionpositionpositionpositionpositionpositionpositionpositionpositionpositionpositionpositionpositionpositionpositionpositionpositionpositionpositionpositionpositionpositionpositionpositionpositionpositionpositionpositionpositionpositionpositionpositionpositionpositionpositionpositionposition. threat to increase our sales and market positioning capabilities; the threat of sufficient capital and money resources, adding access to debt and equity financing and operating income, to meet all of our money and money and other short-term and long-term money desires, when and in the amounts necessary; threats similar to the outsourcing of certain operational control purposes and the body of workers to third parties; threat related to the rate and degree of market position position acceptance of our products and product applicants; the good fortune of any competing product, adding generics; similar threat to the duration and expansion of our product market positionpositionpositionpositionpositionpositions; compliance threats to all FDA regulations and other government and visitor needs for our production facilities; material threats to intellectual asset rights and claims of infringement related to the Company’s products; threat of unforeseen patent progressions; the effect of existing and long-term laws and regulations on product exclusivity; law or regulatory action affecting pricing, reimbursement, or access to pharmaceuticals; claims and threats that could possibly be maintained regarding the protection or effectiveness of the Company’s products and product applicants; threat of wasting significant visitors; threats related to legal proceedings and relevant charges, including patent infringement, securities, advertising crimes, antitrust investigations and litigation; adjustments in government legislation and regulations; threat of recalls and product recalls; guarantees related to general economic, political, commercial, industrial, regulatory and market situations and other unusual elements; and other uncertainties affecting the Company described in the “Risk Factors” and other sections included in our Annual Report on Form 10-K, our Quarterly Reports on Form 10-Q and our Current Reports on Form 8-K filed with the Securities and Exchange Commission. Given those concerns, you deserve not to place undue reliance on such forward-looking statements, which speak only as of the date they are made. All of the following forward-looking statements attributable to us or anyone acting on our behalf are expressly qualified in their entirety by this cautionary statement. The Company assumes no legal responsibility to update any forward-looking statement, outlook or guidance after the date of this press release, whether as a result of new information, long-term events or otherwise, unless required by law. . applicable as required.
PharmFilm®, Sympazan® and the Aquestive logo are registered by Aquestive Therapeutics, Inc.
Investor Inquiries:ICR Westwicke Stephanie Carringtonstephanie. carrington@westwicke. com646-277-1282