|Bid||8.00 x 900|
|Ask||8.05 x 1300|
|Day's Range||7.86 - 8.48|
|52 Week Range||2.95 - 10.00|
|Beta (3Y Monthly)||N/A|
|PE Ratio (TTM)||N/A|
|Earnings Date||Nov 4, 2019|
|Forward Dividend & Yield||N/A (N/A)|
|1y Target Est||18.83|
Aquestive Therapeutics, Inc. (AQST), a specialty pharmaceutical company focused on developing and commercializing differentiated products that meet patients’ unmet needs and solve therapeutic problems, today announced that it will host an investor & analyst update forum related to the Company’s therapeutic candidate Libervant™ (diazepam) Buccal Film on Monday, December 9 from 4 pm to 5:30 pm ET at the American Epilepsy Society (AES) 2019 Annual Meeting in Baltimore. Aquestive has recently completed its rolling submission of a New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA) for Libervant. Please RSVP in advance by contacting Stephanie Carrington at email@example.com if you plan to attend, as space is limited.
The following is a roundup of top developments in the biotech space over the last 24 hours: Scaling The Peaks (Biotech stocks that hit 52-week highs Dec. 2.) Aquestive Therapeutics Inc (NASDAQ: AQST ) ...
Aquestive Therapeutics, Inc. (AQST), a specialty pharmaceutical company focused on developing and commercializing differentiated products that meet patients’ unmet needs and solve therapeutic problems, today announced the completion, as planned, of the rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its therapeutic candidate Libervant™ (diazepam) Buccal Film for the management of seizure clusters. Libervant has received orphan drug designation from the FDA.
Which stocks can go from zero to one hundred overnight? Wall Street pros point to biotechs. For more risk-tolerant investors, these names represent exciting opportunities as a single positive catalyst such as promising trial results or a favorable FDA ruling can send shares skyrocketing. Naturally, a negative outcome can have the opposite effect.As a result, it can be hard for even the most seasoned investors to gauge which biotech stocks are primed for explosive growth. Not to worry, there are strategies that can help make this process a little easier like taking a cue from the analysts.With this in mind, we turned to Wedbush’s Liana Moussatos to get some investing inspiration. Using TipRanks.com, we got a closer look at three of her Buy-rated picks in the space that could more than double in 2020.Aquestive Therapeutics (AQST)Aquestive has developed a novel approach to delivering the active ingredients in established drugs using its unique PharmFilm technology. On the heels of a favorable FDA decision, Moussatos tells investors that this latest development solidified her position that now is the time to buy.On Monday, AQST broke the news that the FDA had approved its Exservan drug for the treatment of amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's disease. The disease is characterized by the deterioration of the neurons that control voluntary muscles. As patients with ALS often have trouble swallowing, Exservan eliminates the need to do so because it adheres to the tongue and dissolves quickly.Moussatos points out that this drug is able to meet the huge unmet need for ALS patients as it doesn’t require swallowing a tablet with water, suggesting that it could be a major profit generator. She stated, “We estimate Exservan gross sales worldwide of a little over $20 million starting in 2025.”This comes after AQST’s solid Q3 performance featuring a revenue beat. On top of this, management bumped up its revenue guidance for 2019 to between $45 million and $47 million, up from the original forecast of $38 million to $45 million. With the sales of its already approved Sympazan drug to treat Lennox-Gastaut Syndrome (LGS) continuing to grow, Moussatos predicts that annual U.S. Sympazan sales could reach $108 million in 2027.Based on all that, the analyst reiterated an Outperform rating on AQST while lifting the price target by $1 to $37. This implies that shares could soar a whopping 391% over the next twelve months.In terms of other analyst activity, it has been relatively quiet. 2 Buy ratings assigned in the last three months add up to a ‘Moderate Buy’ analyst consensus. In addition, the $25 average price target puts the upside potential at 225%. (See Aquestive stock analysis on TipRanks)Intercept Pharmaceuticals (ICPT)Intercept is a rising star in the biotech industry, developing small-molecule treatments for progressive non-viral liver diseases.Investors got some good news on Monday as the FDA just accepted ICPT’s obeticholic acid (OCA) NDA for the treatment of fibrosis due to nonalcoholic steatohepatitis (NASH) and granted priority review. With the PDUFA date scheduled for March 26, 2020 and a possible AdCom, Moussatos believes that big things are on the way.“Based on robust safety and efficacy data to date, we anticipate a positive AdCom vote and approval for OCA/NASH and project potential achievement of blockbuster ($1 billion) revenue in 2024 after a potential U.S. launch in October 2020,” she commented.At the American Association for the Study of Liver Diseases, the company presented data from its Phase 3 REGENERATE trial. The findings suggest that OCA-treated patients demonstrated continued improvement across several low-cost and noninvasive markers of fibrosis and NASH. While some patients reported that after treatment they experienced significant pruritus, or itchiness of the skin, it didn’t affect measures of quality of life.As a result, Moussatos notes that she is staying with the bulls. Along with her Outperform rating, the analyst increased the price target from $243 to $257. This updated target conveys her confidence in ICPT’s ability to climb 167% higher in the next twelve months.In general, the rest of the Street is in agreement. With 9 Buys and 1 Hold received in the last three months, the consensus is that ICPT is a ‘Strong Buy’. While less than Moussatos’ forecast, the $151 average stock-price forecast still indicates substantial upside potential of 57%. (See Intercept stock analysis on TipRanks)Clearside Biomedical (CLSD)Clearside is best known for offering a uniquely designed suprachoroidal space (SCS) microinjection platform to improve the delivery of drugs to treat various eye diseases. Its lead candidate, Xipere, was developed to treat macular edema associated with noninfectious uveitis (ME-NIU), which can threaten eyesight.Following the company’s announcement that it had postponed its Xipere for ME-NIU NDA resubmission as a result of delays at its contract manufacturer, investors have definitely expressed concern. Back in October, CLSD received a complete response letter (CRL) for Xipere from the FDA requesting further information and analysis but not any additional clinical efficacy studies before approval. That being said, Moussatos remains optimistic as she expects potential approval and commercial launch of Xipere in the U.S. in Q4 2020 and Q1 2021, respectively.She also notes that CLSD is planning to file an IND application sometime in mid-2020 for a proprietary suspension of axitinib (CLS-AX) for suprachoroidal injection. Axitinib is a small molecule multi-receptor tyrosine kinase inhibitor that the company hopes will be an effective treatment for advanced renal cell carcinoma.Despite posting an EPS loss of $0.17 per share in its third quarter, the Wedbush analyst advocates patience as she sees huge gains in store based on these two programs. To this end, she reaffirmed her bullish thesis. Her $3 price target brings the potential twelve-month rise to 138%.Looking at the consensus breakdown, analysts are split right down the middle when it comes to CLSD. 1 Buy vs 1 Hold lend itself to a ‘Moderate Buy’ Street consensus. Additionally, the $3 average price target places the upside potential right in-line with Moussatos’ estimate. (See Clearside stock analysis on TipRanks)
Aquestive Therapeutics Inc (NASDAQ: AQST) made a move this week, gaining about 17% Monday after the FDA approved one of its drugs ahead of a Nov. 30 PDUFA action date. The company is expected to complete the rolling regulatory submission for another investigational drug before the end of November. Aquestive is a specialty pharma company that primarily focuses on therapies for central nervous system conditions.
Company to Host Scientific Exhibit on Monday, December 9 from 8:00 am ET to 11:00 am ET Company to Host Investor & Analyst Libervant Update Forum and Webcast on Monday,.
Shares of Aquestive Therapeutics Inc. jumped 20% in premarket trading on the news that the Food and Drug Administration on Friday approved Exservan Oral Film as a treatment for amyotrophic lateral sclerosis (ALS), an orphan disease that affects about 30,000 people in the U.S. The newly approved therapy is in the form of a film placed on the tongue that dissolves, making it easier for ALS patients who have trouble swallowing to receive a dose of Rilutek, the only FDA-approved treatment for ALS patients. The company has not yet established a commercial partner in the U.S. but said it is in discussions with "potential licensees." Aquestive received an orphan-drug designation from the FDA for the therapy in 2018. Aquestive's shares are up 2% year-to-date, while the S&P 500 has risen 24%.
Aquestive Therapeutics, Inc. (AQST), a specialty pharmaceutical company focused on developing and commercializing differentiated products to solve therapeutic problems, today announced that Exservan™ (riluzole) Oral Film received early-action approval from the U.S. Food and Drug Administration (FDA) for the treatment of amyotrophic lateral sclerosis (ALS), an orphan disease. Development initiatives conducted by Aquestive have included studies demonstrating Exservan's pharmacokinetic bioequivalence to the reference listed drug, Rilutek®, as well as additional studies to assess patients' ability to swallow Exservan.
Biotech stocks experienced some momentum last week amid a few clinical readouts. Karuna Therapeutics Inc (NASDAQ: KRTX ), which went public in June, was among the biggest gainers of the week on a positive ...
Aquestive Therapeutics, Inc. (AQST), a specialty pharmaceutical company focused on developing and commercializing differentiated products that meet patients’ unmet needs and solve therapeutic problems, today announced that it granted a license to Zambon S.p.A. for the development and commercialization of Riluzole Oral Film (ROF) in the European Union for the treatment of amyotrophic lateral sclerosis (ALS). Zambon is a multinational pharmaceutical company strongly committed to innovating cure and care to make patients’ lives better, with a focus on the central nervous system (CNS) therapeutic area. ROF, utilizing Aquestive’s proprietary PharmFilm® technology, is being developed for the treatment of ALS, a debilitating disease affecting as many as 30,000 Americans1 and 52,000 Europeans2.
Aquestive Therapeutics (AQST) might move higher on growing optimism about its earnings prospects, which is reflected by its upgrade to a Zacks Rank 2 (Buy).
Aquestive Therapeutics (AQST) delivered earnings and revenue surprises of 30.77% and 20.39%, respectively, for the quarter ended September 2019. Do the numbers hold clues to what lies ahead for the stock?
Increases full year 2019 revenue and earnings guidanceExpects to complete its rolling New Drug Application (NDA) submission for Libervant™ (diazepam) Buccal Film around the end.
Aquestive Therapeutics (AQST) doesn't possess the right combination of the two key ingredients for a likely earnings beat in its upcoming report. Get prepared with the key expectations.
We've lost count of how many times insiders have accumulated shares in a company that goes on to improve markedly...
Here's a roundup of top developments in the biotech space over the last 24 hours. Scaling The Peaks (Biotech stocks hitting 52-week highs on Oct. 15) Celgene Corporation (NASDAQ: CELG ) Eagle Pharmaceuticals ...
Aquestive Therapeutics, Inc. (NASDAQ: AQST), a specialty pharmaceutical company focused on developing and commercializing differentiated products to solve therapeutic problems, today announced, in response to Indivior PLC’s press release issued earlier today of Indivior’s intent to cease production of its authorized generic buprenorphine-naloxone film product, that the Company is reaffirming its full year 2019 total revenue guidance. Full year 2019 total revenue is now expected to be at the top end of the Company’s guidance range of $38 million to $45 million. Full year 2019 revenue from the Company’s Suboxone® franchise is expected to be at the top end of its guidance range of $29 million to $32 million. As of October 2019, Suboxone and the authorized generic buprenorphine-naloxone film continue to retain approximately 75% of the market for film treatments of opioid dependence, of which a substantial majority of its retained market share is branded Suboxone.
“Anaphylaxis is a serious condition that impacts a large patient population. The only options currently available to patients require an injection. We believe we have the technology that can bring meaningful innovation and positive change for patients. 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.
Aquestive Therapeutics, Inc.'s (NASDAQ:AQST): Aquestive Therapeutics, Inc., a specialty pharmaceutical company...
The market continues to ebb and flow with the direction of trade tensions. Yesterday, markets rallied strongly on some encouraging remarks from the Chinese delegation about the prospects for further trade talks.
WARREN, N.J., Aug. 26, 2019 -- Aquestive Therapeutics, Inc. (NASDAQ:AQST), a specialty pharmaceutical company focused on developing and commercializing differentiated products.