|Bid||1.7100 x 800|
|Ask||2.3800 x 1200|
|Day's Range||1.7500 - 2.0200|
|52 Week Range||1.4100 - 10.0000|
|Beta (5Y Monthly)||N/A|
|PE Ratio (TTM)||N/A|
|Earnings Date||May 05, 2020 - May 10, 2020|
|Forward Dividend & Yield||N/A (N/A)|
|1y Target Est||17.17|
Company founder Robert Coates becomes Executive Chairman Houston, Texas--(Newsfile Corp. - March 17, 2020) - Memgen, a private biotechnology company developing innovative immuno-oncology drugs, announced today that its Board of Directors has appointed Gregory B. Brown, MD, as Chief Executive Officer. He currently serves and will remain on the Memgen board of directors. The company also announced that Robert Coates, PhD, founder and prior Chief Executive Officer, will become Executive Chairman."Having seen the scientific capability ...
There's been a major selloff in Aquestive Therapeutics, Inc. (NASDAQ:AQST) shares in the week since it released its...
Aquestive Therapeutics (AQST) delivered earnings and revenue surprises of -6.67% and 4.08%, respectively, for the quarter ended December 2019. Do the numbers hold clues to what lies ahead for the stock?
Expects to submit IND application for AQST-108 (epinephrine) in second quarter 2020 and commence pharmacokinetics (PK) clinical trials before end of 2020FDA sets Libervant™.
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.
Cheap stocks - that is, really cheap stocks that trade for single-digit prices - are among the most divisive stocks on Wall Street.Some investors tend to avoid these names entirely. While nominal prices typically don't matter (there's little difference between a $50 stock and a $500 stock), stocks under $10 are different. They often face some sort of difficulty, such as weak fundamentals or overwhelming headwinds. Also, institutional buyers such as pensions and hedge funds often won't buy stocks that are cheaper than $10, and they really become sparse under the $5 mark. Thus, these companies miss out on the steadiness that accompanies institutional ownership.But other investors love cheap stocks. In many cases, they see opportunity in these often battered shares, and some people simply prefer to buy their stocks in "lots" (typically 100 shares at a time) - something that's a little more difficult to do with the triple- and quadruple-digit crowd.The reality is, low-priced stocks are a mix of high-return opportunity but also high risk. The crazy volatility introduced by the coronavirus outbreak certainly doesn't help. Further complicating things is that many of them are largely ignored by the media, making information difficult to come by. So if you are going to take a moonshot, take a cue from the pros that routinely cover these companies.Here are seven of the best cheap stocks under $7. Using TipRanks' Stock Screener tool, we identified seven low-priced stocks that still have decent Wall Street analyst coverage and extremely bullish sentiment. Note that every one of these stocks still comes with colossal risk. But if you're looking to get aggressive and buy cheap on dips, the pros think each of these can offer some promise. SEE ALSO: 13 Super Small-Cap Stocks to Buy for 2020 and Beyond
Aquestive Therapeutics, Inc. (AQST), a specialty pharmaceutical company focused on developing and commercializing differentiated products that address patients’ unmet needs and solve therapeutic problems, today announced that it will report results for the fourth quarter and full year ended December 31, 2019 and provide a business update on Thursday, March 12, 2020 before the market open. The Company will host an investment community conference call at 8:00 a.m. ET on Thursday, March 12, 2020. There will also be a simultaneous, live webcast available on the Investors section of the Company’s website at https://investors.aquestive.com/events-and-presentations.
Aquestive Therapeutics, Inc. (AQST), a specialty pharmaceutical company focused on developing and commercializing differentiated products that address patients’ unmet needs and solve therapeutic problems, announced today that, as anticipated, the U.S. Food and Drug Administration (FDA) accepted the Company’s New Drug Application (NDA) for Libervant™ (diazepam) Buccal Film for the management of seizure clusters. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of September 27, 2020.
Aquestive Therapeutics, Inc. (AQST), a specialty pharmaceutical company focused on developing and commercializing differentiated products that meet patients’ unmet needs and solve therapeutic problems, announced today that it had a constructive face-to-face pre-Investigational New Drug (IND) Application meeting with the U.S. Food and Drug Administration (FDA) for its drug candidate, AQST-108, a “first of its kind” oral sublingual film formulation delivering systemic epinephrine that is in development for the treatment of anaphylaxis using Aquestive’s proprietary PharmFilm® technologies. A pre-IND meeting provides an opportunity for an open communication between a drug sponsor and the FDA to discuss the sponsor’s IND development plan and to obtain the agency’s guidance for clinical studies for the sponsor’s new drug candidate.
Which names are capable of hitting the ball out of the park? The pros will say healthcare stocks. Rookies and seasoned Street veterans alike argue the space contains exciting investment opportunities, with several boasting upside potential that’s often unmatched by stocks in other sectors.For companies that call this area of the market home, a few key milestones such as data readouts, regulatory filings or drug approvals can speak volumes about its future prospects. As a result, all it takes is a single positive outcome to send share prices through the roof. However, there’s a reason these stocks have earned a Wall Street reputation as being risky plays. When a healthcare name’s shares plummet, more often than not, the driver can be traced back to one negative catalyst.It makes sense, then, that the strength of these volatile investment opportunities can be difficult to gauge. So, what’s an investor to do? We suggest heading to TipRanks.Using TipRanks' Stock Screener tool, we were able to narrow our search results and find 3 compelling healthcare stocks. Each of these Buy-rated tickers has been flagged by the analysts as having the potential to double over the next year thanks to new drug applications (NDAs). When a company files an NDA, it is the formal last step that involves applying to the FDA to get the approval required to market a new drug in the U.S. Let's take a closer look.Aquestive Therapeutics (AQST)Initially focused on developing treatments for central nervous system (CNS) conditions, Aquestive Therapeutics wants to drastically improve patients’ quality of life. While shares have taken a 30% hit year-to-date, some members of the Street believe its innovative drug delivery technology makes it a stand-out.On top of this, its recent NDA submission for one of its lead candidates could be a major catalyst for shares. Back in December, the company announced that the final piece of the rolling NDA for Libervant (AQST-203), its buccal (inside of the cheek) soluble film formulation of diazepam for acute refractory/repetitive seizures (ARRS), had been completed.JMP Securities analyst Jason Butler tells investors that this filing is a significant component of his bullish thesis. “We view this as a positive sign of management’s execution and look forward to a likely 2020 launch of Libervant,” he commented.Based on favorable data from the single crossover trial of Libervant as well as the fact that no patients failed on the therapy, Butler sees greatness in store. With this in mind, the five-star analyst attached a $23 price target to his Outperform rating. (To watch Butler’s track record, click here)Like Butler, Wedbush’s Liana Moussatos also takes a bullish approach when it comes to AQST. She predicts the FDA will accept the NDA for review sometime between Q4 2019 and Q1 2020. With the already reported clinical data making approval very likely in her view, the analyst estimates that annual sales could reach $204 million in 2024 after its potential October 2020 U.S. launch.This prompted Moussatos to reiterate an Outperform rating. If that wasn’t enough, her $37 price target suggests massive upside potential. We’re talking 811% here. (To watch Moussatos’ track record, click here)All in all, the rest of the Street is on the same page. With 5 Buy ratings assigned in the last three months versus no Holds or Sells, the message is clear: AQST is a Strong Buy. At $18, the average price target puts the upside potential at 350%. (See Aquestive stock analysis on TipRanks)KemPharm, Inc. (KMPH)KemPharm’s claim to fame is its LAT technology, which it uses to develop proprietary prodrugs. Ahead of its KP415 NDA filing, originally slated for January 2020, investor attention has shifted towards KMPH.Along with its commercial partner, Gurnet Point Capital, the company engineered the candidate as a treatment for ADHD, an attention deficit disorder. H.C. Wainwright analyst Oren Livnat stated, “We continue to think the Street underappreciates that KemPharm may have the ideal ADHD partner in GPC, which is led almost entirely by the former Shire U.S. commercial leadership, is deep-pocketed, and, with KP415 as its first commercial product, is highly incentivized to fully resource the launch to establish a successful CNS platform.”While the drug’s pivotal efficacy study produced somewhat disappointing top-line results, Livnat is “cautiously optimistic”. He argues that the FDA will support the expected 0.5-13 hour profile implied by the data. “FDA understands methylphenidate (MPH) PK/PD well, and if KP415 data are analyzed similar to other approved ADHD drugs, its best-in-class 0.5-13 hour profile is confirmed, in our view,” he explained.Livnat does, however, remind investors that he doesn’t expect to see any abuse-deterrent claims on the drug’s label. That being said, he points out that Vyvanse, the ADHD market leader, also doesn’t have any of these claims. This gives approval in January 2021 and launch in the first half of 2021 a strong likelihood, according to the analyst.As Livnat projects KP415 peak end-sales of $340 million and more than $60 million in peak royalty revenue, it is no surprise, then, that the four-star analyst maintained a Buy rating. Despite cutting the price target by 50 cents, the $2.50 forecast still leaves room for a potential twelve-month gain of 558%. (To watch Livnat’s track record, click here)Looking at the consensus breakdown, 2 Buys and 1 Hold published over the previous three months add up to a Moderate Buy analyst consensus. Not to mention the $3.80 average price target suggests 901% upside potential. (See KemPharm price targets and analyst ratings on TipRanks)Fennec Pharmaceuticals (FENC)This biotech develops a unique formulation of sodium thiosulfate (STS), PEDMARK, as a way to potentially prevent cisplatin-induced hearing loss in pediatric patients. With Fennec finalizing its rolling NDA for PEDMARK, one analyst thinks 2020 could be a big year.The company’s management stated during its third quarter earnings release that the application should be completed in Q1 2020. David Nierengarten of Wedbush wrote in a recent note that the biotech brought on Shubh Goel as chief commercial officer in order to get ready for a possible PEDMARK launch in the second half of 2020. “Ms. Goel has extensive experience in marketing and commercial operations/strategy of oncology drugs with positions held at companies including Takeda Oncology, ARIAD Pharmaceuticals, Bayer, AVEO Oncology, Celgene and Odonate Therapeutics,” he noted.Nierengarten added, “If approved we believe STS could be widely adopted in pediatric patients with localized cancers that are recommended cisplatin treatment, particularly in the under-five age group where hearing loss risk is highest. We view the economics in this setting as attractive, especially considering the high cost and limited benefit associated with cochlear implants and hearing aids, the only available treatment options for these patients.”While Nierengarten acknowledged that third quarter 2019 research and development expenses decreased to $0.8 million, from $1.8 million in the prior-year quarter, the five-star analyst cites the completion of a number of activities needed for PEDMARK regulatory approval as being the reason for this.In line with his bullish take on the healthcare name, Nierengarten left his Outperform rating and $16 price target unchanged. Should the target be met, shares could be in for a 156% twelve-month gain. (To watch Nierengarten’s track record, click here)As for the rest of the Street, it has been relatively quiet in terms of other analyst activity. One other analyst has issued a bullish call, making the consensus rating a Moderate Buy. In addition, the $16.50 average price target implies shares could soar 164% over the next twelve months. (See Fennec stock analysis on TipRanks)
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 reported that the U.S. Food and Drug Administration (FDA) issued a response letter (Response) dated January 10, 2020 denying Aquestive’s Citizen’s Petition received by the FDA on November 1, 2019, including the supplement to the Citizen’s Petition received by the FDA on December 4, 2019 (Docket No. FDA-2019-P-5121) (Petition). The Petition requested, among other things, that the FDA stay approval of a New Drug Application for Valtoco® (diazepam nasal spray) submitted by Neurelis, Inc. until additional clinical studies were conducted.
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 reported anticipated preliminary unaudited total revenues for the fourth quarter and full year ended December 31, 2019 and provided initial full year 2020 guidance.
Many investors, including Paul Tudor Jones or Stan Druckenmiller, have been saying before last year's Q4 market crash that the stock market is overvalued due to a low interest rate environment that leads to companies swapping their equity for debt and focusing mostly on short-term performance such as beating the quarterly earnings estimates. In the […]
It is a pleasure to report that the Aquestive Therapeutics, Inc. (NASDAQ:AQST) is up 52% in the last quarter. But that...
In addition, Aquestive granted the underwriters a 30-day option to purchase up to 1,050,000 additional shares of its common stock at the public offering price, less the underwriting discount. BMO Capital Markets is acting as lead book-running manager for this offering and RBC Capital Markets is also acting as a book-running manager. Wedbush PacGrow is acting as lead manager for this offering and Brookline Capital Markets, a division of Arcadia Securities, LLC, and H.C. Wainwright & Co. are acting as co-managers for this offering.
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 Dec. 10) Acceleron Pharma Inc (NASDAQ: XLRN ) Aimmune Therapeutics ...
The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering. BMO Capital Markets is acting as sole book-running manager for this offering. Aquestive intends to use the net proceeds of this offering for the continuation of the commercial launch of Sympazan®, preparations to support the expected launch of its product candidate Libervant™ in late 2020 (if approved by the US Food and Drug Administration (the “FDA”)), continued development of AQST-108 and other product candidates, working capital and general corporate purposes.
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.