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Aquestive Therapeutics, Inc. (AQST)

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8.86-0.19 (-2.10%)
At close: 4:00PM EDT

8.82 -0.04 (-0.45%)
After hours: 4:21PM EDT

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Neutralpattern detected
Previous Close9.05
Open8.95
Bid8.66 x 800
Ask8.90 x 1000
Day's Range8.52 - 9.09
52 Week Range1.41 - 10.00
Volume1,127,565
Avg. Volume936,211
Market Cap297.871M
Beta (5Y Monthly)3.72
PE Ratio (TTM)N/A
EPS (TTM)-1.68
Earnings DateNov 02, 2020 - Nov 06, 2020
Forward Dividend & YieldN/A (N/A)
Ex-Dividend DateN/A
1y Target Est17.83
  • 3 “Strong Buy” Healthcare Stocks With Major Catalysts Approaching
    TipRanks

    3 “Strong Buy” Healthcare Stocks With Major Catalysts Approaching

    Reflecting the ultimate risk and reward, healthcare stocks are capable of delivering big returns at what feels like the drop of a hat, but investors need to be prepared for big risk, too.Unlike companies in other sectors, the survival of many healthcare players, especially when they are in the early stages, hinges on only clinical trials of their therapies or products in development and regulatory rulings, with updates on either front acting as catalysts that can send shares in either direction.So, any piece of good news can propel shares to sky-high levels. Disappointing outcomes, however, can send investors running for the hills.Given the inherently volatile nature of the space, due diligence is necessary before making investment decisions. That’s where the Wall Street pros can lend a hand, as they know the ins and outs of the industry.Bearing this in mind, we used TipRanks’ database to pinpoint healthcare stocks that have received overwhelmingly bullish support from the Street ahead of potential catalysts. Locking in on three in particular, each ticker boasts a “Strong Buy” consensus rating from the analyst community.Aquestive Therapeutics (AQST)Using its patented PharmFilm technology, Aquestive Therapeutics works to improve the delivery of approved drug active ingredients. Ahead of the fast-approaching PDUFA date for one of its products, some members of the Street think that now is the time to get in on the action.Back in February, AQST announced that the FDA had accepted the NDA for Libervant, its diazepam buccal film designed to manage refractory and repetitive seizures (ARRS; seizure clusters), and the PDUFA date had been set for September 27. The NDA was based on results from a single-dose crossover study, which demonstrated comparable systemic diazepam exposures to Diastat (a diazepam rectal gel that was used as a reference) with significantly less variability.Writing for Wedbush, 5-star analyst Liana Moussatos points out that VALTOCO, a nasal spray product developed for use in cluster seizures, got the FDA’s stamp of approval in January, with seven-year orphan drug U.S. marketing exclusivity also granted. “Of note, VALTOCO orphan drug exclusivity approval may prevent a subsequent product approval (same active moiety as well as an indication) during the exclusivity period unless the new product can demonstrate ‘clinical superiority’ to the approved products,” she explained.To this end, Moussatos remains optimistic and sees Libervant’s approval as a major potential catalyst. “Aquestive is confident that Libervant (oral) is clinically superior to the two currently approved device-driven products (rectal gel and nasal spray) and that it meets one or more attributes required by the FDA to be considered a major contribution to patient care. In our view, Libervant may expand patient choice as the first orally delivered diazepam product available to ARRS patient,” she stated.While the COVID-19 pandemic has led to many delays throughout the industry, management doesn’t expect any delays for the review of Libervant. Additionally, if approved, the company has said it’s ready for a launch, with it estimating U.S. net revenues of about $300 million at its peak.Based on the above, Moussatos keeps an Outperform (i.e. Buy) rating and $33 price target on the stock. Should her thesis play out, a potential twelve-month gain of 326% could be in the cards. (To watch Moussatos’ track record, click here)All in all, other analysts echo Moussatos’ sentiment. 3 Buys and no Holds or Sells add up to a Strong Buy consensus rating. With an average price target of $18.67, the upside potential comes in at 136%. (See AQST stock analysis on TipRanks)Eton Pharmaceuticals (ETON)Primarily focused on developing, acquiring and commercializing hospital injectable and pediatric rare disease products, Eton Pharmaceuticals wants to improve the lives of patients from all over the world. With several product candidates currently under review at the FDA, it’s no wonder Wall Street focus has zeroed in on this name.On September 16, ETON announced that its partner hadn’t received any update from the FDA regarding its decision on the review of EM-100, its eye drop product for allergic conjunctivitis. Although the candidate’s Generic Drug User Fee Act (GDUFA) target action date was September 15, H.C. Wainwright’s Raghuram Selvaraju believes approval is imminent. Should approval ultimately be granted, the 5-star analyst thinks it could drive serious upside.On top of this, Eton is awaiting a decision from the FDA for its taste-neutral sprinkle (granule) formulation of hydrocortisone (Alkindi Sprinkle), as a replacement therapy for pediatric adrenal insufficiency (AI). A PDUFA date is set for September 29, 2020."We assign a 90% probability of regulatory approval to EM-100 and Alkindi Sprinkle [...] Currently, we project total revenue of $9M for 2020—essentially unchanged vs. the previous $9.4M—and $43.9M in revenue for 2021, down somewhat from the previous $50.7M. We have accordingly revised our loss per share estimates for 2020 to $1.04 per share vs. the prior net loss of $1.28 per share, while maintaining our net loss per share projection for 2021 of $0.20. We continue to expect Eton to potentially achieve cash flow breakeven during 2H21. [...] Our assumptions yield a roughly $420M firm value," Selvaraju noted.To this end, Selvaraju maintains a Buy rating on ETON shares, along with an $18 price target. This figure suggests 141% upside potential from current levels. (To watch Selvaraju’s track record, click here)Are other analysts in agreement? They are. Only Buy ratings have been issued in the last three months, 3 to be exact. Therefore, the message is clear: ETON is a Strong Buy. Given the $15 average price target, shares could double in the next year. (See Eton stock analysis on TipRanks)Mesoblast (MESO)Last but not least we have Mesoblast, which develops therapeutics and medical devices based on its mesenchymal precursor stem cell platform. After an Oncologic Drugs Advisory Committee (ODAC) voted in favor of its therapy, several of the Street’s pros have high hopes for this healthcare company ahead of the September 30 PDUFA date.On August 13, the FDA held an AdCom meeting to discuss MESO’s biologics license application (BLA) filing for Ryoncil (remestemcel-L), which was designed as a treatment for children with steroid-refractory acute graft versus host disease (SR-aGVHD). Acute GVHD occurs in roughly half of the 30,000 patients who undergo allogeneic bone marrow transplant (BMT).At the meeting, the committee members voted 9-to-1 in support of the drug’s efficacy in a difficult indication. 5-star analyst Jason McCarthy, of Maxim Group, told clients, “This was in contrast to the briefing documents ahead of the Adcom on August 11, which stated concerns related to efficacy that resulted in MESO shares plummeting 35% at that time. Our view is that it was a premature 'knee-jerk' reaction to an Adcom that didn't even happen yet. As such, Ryoncil is very much still on track and the PDUFA is next."Looking more closely at the data, two randomized Phase 3 trials in GvHD, study 265 and study 280, were conducted by Osiris Therapeutics, which previously owned the candidate. Both studies missed their primary endpoints compared to the placebo, but study 265 “was conducted in newly-treated GvHD patients (not steroid refractory), and therefore is not entirely relevant to Ryoncil's BLA,” according to McCarthy. As for study 280, it missed its durable complete response endpoint in the target population, but overall response at day 28 was 64% for Ryoncil and 36% for placebo.“Ultimately, these studies were not in the target population for the current BLA, and in patients that fit the criteria, a positive effect was observed,” McCarthy commented. Additionally, he points out that an aggregated dataset demonstrated a consistent response across three separate trials including study 280.Speaking to the unmet needs in this indication, in patients with severe disease, there is currently a 90% mortality rate and there are no approved therapies for pediatric steroid-refractory patients. Jakafi has been approved for patients aged 12 and older, but McCarthy believes Ryoncil compares favorably. He said, “Considering the positive safety profile of Ryoncil compared to other therapies and the unmet need in the indication, we continue to see a high likelihood of approval.”In line with his optimistic approach, McCarthy reiterated a Buy rating and $22 price target. This target conveys his confidence in MESO’s ability to climb 22% higher in the next year. (To watch McCarthy’s track record, click here)Other analysts don’t beg to differ. 5 Buys and no Holds or Sells add up to a Strong Buy consensus rating. At $21.60, the average price target implies 22% upside potential. (See Mesoblast stock analysis on TipRanks)To find good ideas for healthcare stocks trading at attractive valuations, visit TipRanks’ Best Stocks to Buy, a newly launched tool that unites all of TipRanks’ equity insights.Disclaimer: The opinions expressed in this article are solely those of the featured analysts. The content is intended to be used for informational purposes only. It is very important to do your own analysis before making any investment.

  • Are Insiders Buying Aquestive Therapeutics, Inc. (NASDAQ:AQST) Stock?
    Simply Wall St.

    Are Insiders Buying Aquestive Therapeutics, Inc. (NASDAQ:AQST) Stock?

    We often see insiders buying up shares in companies that perform well over the long term. On the other hand, we'd be...

  • GlobeNewswire

    Aquestive Therapeutics Initiates Phase 1 Pharmacokinetic Trial of AQST-108 (Sublingual Film Formulation Delivering Systemic Epinephrine) In Development for Treatment of Allergic Reactions Including Anaphylaxis

    * First healthy volunteer dosed in a Phase 1 study of AQST-108 for the treatment of allergic reactions including anaphylaxis * Pharmacokinetic and pharmacodynamics data expected in fourth quarter 2020WARREN, N.J., Aug. 20, 2020 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST), a pharmaceutical company focused on developing and commercializing differentiated products that address patients’ unmet needs and solve therapeutic problems, announced today the initiation of a Phase 1 Pharmacokinetic (PK) trial for the Company’s drug candidate AQST-108, a “first of its kind” oral sublingual film formulation delivering systemic epinephrine that is in development for the treatment of allergic reactions (Type 1), including anaphylaxis, using Aquestive’s proprietary PharmFilm® technologies. “The initiation of this Phase 1 trial represents a significant milestone for Aquestive as we progress, on plan, with the development of this important pipeline candidate using our best-in-class PharmFilm technologies,” said Keith J. Kendall, President and Chief Executive Officer of Aquestive. “The Phase 1 study is designed to provide a comparison of PK curves for AQST-108 versus both subcutaneous and intramuscular administrations in healthy volunteers.  We believe this novel administration could change the treatment paradigm for patients who are reluctant to use the current standard of care, subcutaneous and intramuscular injections," concluded Mr. Kendall.About the Phase 1 Healthy Volunteer Study This Phase 1 trial is expected to enroll up to 28 healthy volunteers.  The trial features a four-treatment crossover design comparing the pharmacokinetics and pharmacodynamics of AQST-108, 0.3 mg of epinephrine subcutaneous injection (subQ), 0.3 mg of epinephrine intramuscular (IM) injection, and 0.5 mg epinephrine subQ.  The study includes secondary endpoints for changes in blood pressure and heart rate.About AQST-108 AQST-108 is a “first of its kind” oral sublingual film formulation delivering systemic epinephrine that is in development for the treatment of allergic reactions (Type 1), including anaphylaxis, using Aquestive’s proprietary PharmFilm® technologies. Anaphylaxis is a potentially life-threatening systemic allergic reaction, with an estimated incidence of 50 to 112 episodes per 100,000 people per year. The frequency of hospital admissions for anaphylaxis has increased 500-700% in the last 10-15 years.1 The most common causes of reactions that can include anaphylaxis are medications, foods (such as peanuts), and venom from insect stings. Epinephrine injection is the current standard of treatment intended to reverse the potentially severe manifestation of anaphylaxis, which may include red rash, throat swelling, respiratory problems, gastrointestinal distress and loss of consciousness. Aquestive received confirmation from the U.S. Food and Drug Administration (FDA) in July 2020 that the agency completed its safety review of Aquestive’s IND and concluded that the Company could proceed with the first planned PK clinical trials of AQST-108. The FDA granted AQST-108 Fast Track designation in August 2020.About Aquestive Therapeutics Aquestive Therapeutics is a pharmaceutical company that applies innovative technology to solve therapeutic problems and improve medicines for patients. Aquestive is advancing a late-stage proprietary product pipeline to treat CNS conditions and provide alternatives to invasively administered standard of care therapies. The Company also collaborates with other pharmaceutical companies to bring new molecules to market using proprietary, best-in-class technologies, like PharmFilm®, and has proven capabilities for drug development and commercialization.Forward-Looking Statement This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “believe,” “anticipate,” “plan,” “expect,” “estimate,” “intend,” “may,” “will,” or the negative of those terms, and similar expressions, are intended to identify forward-looking statements. These forward-looking statements include, but are not limited to, statements regarding therapeutic benefits and plans and objectives for regulatory approvals of AQST-108, Libervant™ and our other product candidates; ability to obtain FDA approval and advance AQST-108, Libervant and our other product candidates to the market, statements about our growth and future financial and operating results and financial position, regulatory approval and pathways, clinical trial timing and plans, our and our competitors’ orphan drug approval and resulting drug exclusivity for our products or products of our competitors, short-term and long-term liquidity and cash requirements, cash funding and cash burn, business strategies, market opportunities, and other statements that are not historical facts.  These forward-looking statements are also subject to the uncertain impact of the COVID-19 global pandemic on our business including with respect to our clinical trials including site initiation, patient enrollment and timing and adequacy of clinical trials; on regulatory submissions and regulatory reviews and approvals of our product candidates; pharmaceutical ingredient and other raw materials supply chain, manufacture, and distribution; sale of and demand for our products; our liquidity and availability of capital resources; customer demand for our products and services; customers’ ability to pay for goods and services; and ongoing availability of an appropriate labor force and skilled professionals.  Given these uncertainties, the Company is unable to provide assurance that operations can be maintained as planned prior to the COVID-19 pandemic.These forward-looking statements are based on our current expectations and beliefs and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Such risks and uncertainties include, but are not limited to, risks associated with the Company's development work, including any delays or changes to the timing, cost and success of our product development activities and clinical trials and plans; risk of delays in FDA approval of Libervant and our other drug candidates or failure to receive approval; risk of our ability to demonstrate to the FDA “clinical superiority” within the meaning of the FDA regulations of our drug candidate Libervant relative to FDA-approved diazepam rectal gel and nasal spray products including by establishing a major contribution to patient care within the meaning of FDA regulations relative to the approved products as well as risks related to other potential pathways or positions which are or may in the future be advanced to the FDA to overcome the seven year orphan drug exclusivity granted by the FDA for the approved nasal spray product of a competitor in the U.S. and there can be no assurance that we will be successful; risk that a competitor obtains FDA orphan drug exclusivity for a product with the same active moiety as any of our other drug products for which we are seeking FDA approval and that such earlier approved competitor orphan drug blocks such other product candidates in the U.S. for seven years for the same indication; risk inherent in commercializing a new product (including technology risks, financial risks, market risks and implementation risks and regulatory limitations); risks and uncertainties concerning any potential monetization of royalty and other revenue stream of KYNMOBI (apomorphine) and of sufficiency of net proceeds of any such monetization after satisfaction of and compliance with 12.5% Senior Notes obligations, as applicable; risk of development of our sales and marketing capabilities; risk of legal costs associated with and the outcome of our patent litigation challenging third party at risk generic sale of our proprietary products; risk of sufficient capital and cash resources, including access to available debt and equity financing and revenues from operations, to satisfy all of our short-term and longer term cash requirements and other cash needs, at the times and in the amounts needed; risk of failure to satisfy all financial and other debt covenants and of any default; risk related to government claims against Indivior for which we license, manufacture and sell Suboxone® and which accounts for the substantial part of our current operating revenues; risk associated with Indivior’s cessation of production of its authorized generic buprenorphine naloxone film product, including the impact from loss of orders for the authorized generic product and risk of eroding market share for Suboxone and risk of sunsetting product; risks related to the outsourcing of certain sales, marketing and other operational and staff functions to third parties; risk of the rate and degree of market acceptance of our product and product candidates; the success of any competing products, including generics; risk of the size and growth of our product markets; risks of compliance with all FDA and other governmental and customer requirements for our manufacturing facilities; risks associated with intellectual property rights and infringement claims relating to the Company's products; risk of unexpected patent developments; the impact of existing and future legislation and regulatory provisions on product exclusivity; legislation or regulatory actions affecting pharmaceutical product pricing, reimbursement or access; claims and risks that may arise regarding the safety or efficacy of the Company's products and product candidates; risk of loss of significant customers; risks related to legal proceedings, including patent infringement, investigative and antitrust litigation matters; changes in government laws and regulations; risk of product recalls and withdrawals; uncertainties related to general economic, political, business, industry, regulatory and market conditions and other unusual items; and other uncertainties affecting the Company described in the “Risk Factors” section and in other sections included in our Annual Report on Form 10‑K, in our Quarterly Reports on Form 10-Q, and in our Current Reports on Form 8-K filed with the Securities Exchange Commission (SEC). Given those uncertainties, you should not place undue reliance on these forward-looking statements, which speak only as of the date made. All subsequent forward-looking statements attributable to us or any person acting on our behalf are expressly qualified in their entirety by this cautionary statement. The Company assumes no obligation to update forward-looking statements or outlook or guidance after the date of this press release whether as a result of new information, future events or otherwise, except as may be required by applicable law.PharmFilm® and the Aquestive logo are registered trademarks of Aquestive Therapeutics, Inc.  All other registered trademarks referenced herein are the property of their respective owners.Investor Inquiries: Stephanie Carrington stephanie.carrington@icrinc.com 646-277-1282 1 Epidemiology of anaphylaxis. Tejedor Alonso MA, Moro M, Mugica Garcia MV, Clin Exp Allergy. 45(6):1027-39, Jun 2015