Triple Moving Average Crossover
|Bid||5.45 x 800|
|Ask||5.51 x 1100|
|Day's Range||5.03 - 5.58|
|52 Week Range||1.41 - 10.00|
|Beta (5Y Monthly)||N/A|
|PE Ratio (TTM)||N/A|
|Earnings Date||Aug 04, 2020 - Aug 10, 2020|
|Forward Dividend & Yield||N/A (N/A)|
|1y Target Est||17.50|
Investors need to pay close attention to Aquestive Therapeutics (AQST) stock based on the movements in the options market lately.
Aquestive Therapeutics (AQST) has seen solid earnings estimate revision activity over the past month, and belongs to a strong industry as well.
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 May 21) * ADC Therapeutics SA (NYSE: ADCT) (IPOed May 15) * Allogene Therapeutics Inc (NASDAQ: ALLO) * AstraZeneca plc (NYSE: AZN) ( announced $1 billion BARDA funding for coronavirus vaccine program) * Biondvax Pharmaceuticals Ltd - ADR (NASDAQ: BVXV) * Cellectis SA (NASDAQ: CLLS) * ChemoCentryx Inc (NASDAQ: CCXI) * Corbus Pharmaceuticals Holdings Inc (NASDAQ: CRBP) * Cue Biopharma Inc (NASDAQ: CUE) * Fate Therapeutics Inc (NASDAQ: FATE) * Harpoon Therapeutics Inc (NASDAQ: HARP) * Horizon Therapeutics PLC (NASDAQ: HZNP) * Intellia Therapeutics Inc (NASDAQ: NTLA) * Kamada Ltd. (NASDAQ: KMDA) * Minerva Neurosciences Inc (NASDAQ: NERV) * Ovid Therapeutics Inc (NASDAQ: OVID) * Passage Bio Inc (NASDAQ: PASG)(FDA granted Rare Pediatric Disease designation to its gene therapy PBGM01 broadly for the treatment of GM1 gangliosidosis) * Soleno Therapeutics Inc (NASDAQ: SLNO) * Surface Oncology Inc (NASDAQ: SURF)Down In The Dumps (Biotech Stocks Hitting 52-week Lows May 21) * Akorn, Inc. (NASDAQ: AKRX) (filed for Chapter 11 bankruptcy) * Digirad Corporation (NASDAQ: DRAD) * Genfit SA (NASDAQ: GNFT)Related Link: These 6 Coronavirus Vaccine Candidates Are The Likeliest To Succeed, Says Morgan StanleyStocks In Focus Aquestive's Partnered Parkinson's Drug Gets FDA Nod Aquestive Therapeutics Inc's (NASDAQ: AQST) development partner Sunovion announced FDA approval for Kynmobi sublingual film - APL-130277 - for the acute, intermittent treatment of OFF episodes in patients with Parkinson's disease. The drug is expected to be available in the U.S. pharmacies in September.Following the approval, Aquestive said it plans to monetize its PharmFilm based therapies."We continue to expect that we will receive between $50 to $100 million of non-dilutive capital from the monetization, in one or a series of transactions," the company said.The stock rose 5.2% to $6.47 in after-hours trading.Syndax's Lead Breast Cancer Drug Flunks Late-stage Study Syndax Pharmaceuticals Inc (NASDAQ: SNDX) said a late-stage study that evaluated its investigational compound entinostat along with exemestane in patients with HR+, HER2- breast cancer who have progressed on a non-steroidal aromatase inhibitor did not achieve the primary endpoint of demonstrating a statistically significant overall survival benefit over hormone therapy alone.The study was conducted by ECOG-ACRIN Cancer Research Group and sponsored by the National Cancer Institute.The stock slumped 19.41% to $16.52 in after-hours trading.Tiziana To Spin-off Its Personalized Medicines Businesses TIZIANA LF SCIE/S ADR (NASDAQ: TLSA) said it intends to demerge its StemPrintER and SPARE genomics-based personalized medicine businesses into a separate company and effect a capital reduction to facilitate the spin-out and listing of StemPrintER as an independent entity.Amarin To Support Pilot Study Of Vascepa In Treating COVID-19 Amarin Corporation plc (NASDAQ: AMRN) said it supports a clinical trial to investigate the effects of its Vascepa on inflammatory biomarkers and other patient outcomes in individuals with COVID-19. The trial is sponsored by the Canadian Medical and Surgical Knowledge Translation Research Group, the company said.Separately, generic pharma company Hikma Pharmaceuticals announced its wholly-owned U.S. subsidiary Hikma Pharmaceuticals USA Inc. has received FDA approval for its generic equivalent to Vascepa.In pre-market trading Friday, Amarin stock was adding 3.85% to $7.56.Navidea Reports Positive Mid-stage Results For Rheumatoid Arthritis Treatment Navidea Biopharmaceuticals Inc (NYSE: NAVB) announced positive preliminary results from the second interim analysis of its ongoing NAV3-31 Phase 2B study"Analysis demonstrates that these interim data further corroborate Navidea's hypotheses that Tc99m tilmanocept imaging can provide robust, quantitative imaging in healthy controls and in patients with active rheumatoid arthritis, and that this imaging can provide an early indicator of treatment efficacy in patients with active RA," the company said.The stock was seen skyrocketing 65.35% to $2.10 in pre-market trading.Roche Buys Gene Sequencing Tech Company Roche Holdings AG (OTC: RHHBY) announced acquisition of Stratos Genomics, an early-stage sequencing technology company to advance the development of its nanopore sequencer.The company did not disclose the financial terms of the dealTetraphase Deems Melinta's Latest All-Cash Offer As Superior, Notifies AcelRx Tetraphase Pharmaceuticals Inc (NASDAQ: TTPH), which has been pursued by multiple companies, said its board has determined that the latest proposal from Melinta Therapeutics, Inc. is a "Superior Offer."'Melinta has offered $27 million in cash, plus an additional $12.5 million in cash potentially payable under contingent value rights to be issued in the proposed acquisition.View more earnings on IBBTetraphase, which agreed to a deal to be bought byAcelRx Pharmaceuticals Inc (NASDAQ: ACRX), said it has informed about its determination concerning the Melinta offer and given AcelRx time until May 29 to either terminate the merger or revise the terms of the merger.Incidentally, La Jolla Pharmaceutical Company (NASDAQ: LJPC) had also tabled an offer for Tetraphase.In pre-market trading, AcelRx shares were adding 2.74% to $1.50.Amag Divests Intrarosa For Upto $125M AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) said it has completed the sale of its rights to Intrarosa to Millicent Pharma Limited, for up to $125 million, including upfront fixed consideration of $20 million and contingent, sales-based milestone payments of up to $105 million.The company said the sale is consistent with its previously announced strategic decision to divest its women's health assets. It also said it remains committed to the divestiture of Vyleesi and associated expense reductions as previously announced.Offerings ContraFect Corp Stock (NASDAQ: CFRX) said it has priced its underwritten public offering of 11.8 million shares of its common stock and related warrants to purchase 8.85 million shares. The gross proceeds from the public offering will be approximately $52.5 million, it said. All shares in the public offering are to be sold by ContraFect.In premarket trading Friday, the stock was slipping 11.87% to $4.75.Hoth Therapeutics Inc (NASDAQ: HOTH) priced its underwritten public offering of 1.82 million shares of common stock at $2.75 per share, for raising gross proceeds of $5 million. The offering is expected to close on or about May 27.The stock was slipping 5.36% to $3 in premarket trading Friday.Dynavax Technologies Corporation (NASDAQ: DVAX) priced its previously announced underwritten public offering of 14 million shares of its common stock at $5 per share. The gross proceeds to Dynavax from the offering are expected to be approximately $70. The offering is expected to close on or about May 27.The stock was retreating 10.25% to $5.08 in premarket trading Friday.PPD Inc (NASDAQ: PPD) said it upsized and finalized the terms of the offering of $500 million aggregate principal amount of 4.625% senior notes due 2025 and $700 million aggregate principal amount 5.000% senior notes due 2028. The aggregate principal amount of the notes to be issued in the offering was increased to $1.2 billion from the previously announced $700 million, the company said.In premarket trading Friday, the stock was adding 1.23% to $28.Geron Corporation (NASDAQ: GERN) said it intends to offer and sell shares of its common stock and accompanying warrants to purchase shares of its common stock in an underwritten public offering. All the securities earmarked for the offering are being sold by the company.The stock was slipping 20.92% to $1.55 in pre-market trading.On The Radar Clinical Readouts Atara Biotherapeutics Inc's (NASDAQ: ATRA) abstract on the Phase 1 data for ATA188 in multiple sclerosis, regarding its European Academy for Neurology presentation, will be made available online at 12:30 pm ET.Earnings Teligent Inc (NEW JERSEY) (NASDAQ: TLGT)IPO Inari Medical, a medical device company, priced its upsized initial public offering of 8.203 million shares of its common stock at $19.00 per share, for total gross proceeds of approximately $156 million. The company had earlier planned for a 7.33-million stock offering, with an estimated price of $17-$18 per share. The shares are to be listed on the Nasdaq under the ticker symbol NARI.See more from Benzinga * The Daily Biotech Pulse: Mixed Filgotinib Readout For Gilead-Galapagos, Akorn To File For Chapter 11, D-Day For Aquestive * The Daily Biotech Pulse: Aldeyra Jumps Into COVID-19 Drug Fray, FDA Nod For Myriad's Companion Diagnostic Test * The Daily Biotech Pulse: FDA Nod For Roche, Arbutus Releases Positive Readout For HBV Therapy, Moderna Announces .34B Common Stock Offering(C) 2020 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
Aquestive Therapeutics, Inc. (AQST), a pharmaceutical company focused on developing and commercializing differentiated products that address patients’ unmet needs and solve therapeutic problems, today announced plans to advance its strategy to monetize the anticipated royalties associated with Sunovion Pharmaceuticals’ apomorphine sublingual film APL-130277, which received FDA approval to treat motor fluctuations (OFF episodes) experienced by people living with Parkinson’s disease. As disclosed in Aquestive’s filings with the SEC, in April 2016, Aquestive entered into a license agreement with Cynapsus Therapeutics (which was later succeeded to in interest by Sunovion), pursuant to which Aquestive granted Sunovion an exclusive, worldwide license (with the right to sub-license) to certain intellectual property, including existing and future patents and patent applications, covering all oral films containing APL-130277 (apomorphine) for the treatment of motor fluctuations (OFF episodes) in Parkinson’s disease patients, as well as two other therapeutic fields.
Aquestive Therapeutics (AQST) has been upgraded to a Zacks Rank 2 (Buy), reflecting growing optimism about the company's earnings prospects. This might drive the stock higher in the near term.
Today's 5 Stock Ideas: * Kingsoft Cloud (KC) \- A new issue expected to open Friday morning. The company is one of China's top cloud service providers. Shares were expected in the $16-$18/share range and priced right in the middle at $17/share. * IDEXX (IDXX) \- A play on coronavirus testing. The company reported its OPTI Medical subsidiary was granted FDA Emergency Use Authorization for OPTI coronavirus lab test kit. * Lazydays (LAZY) \- A play on the RV market. Public health workers and nurses have recently used RVs as a way to effectively separate their home environment from their families. * Aquestive Therapeutics (AQST) \- A play on an upcoming FDA date. The company is expected see an FDA PDUFA action date for its Parkinson's treatment New Drug Application within the next two weeks. * AutoNation (AN) - An earnings play. The company will report quarterly results before the market open on Monday.See more from Benzinga * Benzinga Pro's Top 5 Stocks To Watch For Fri., Apr. 3, 2020: USIO, NTDOY, AJRD, AN, OTIS(C) 2020 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
Aquestive Therapeutics, Inc. (AQST), a pharmaceutical company focused on developing and commercializing differentiated products that address patients’ unmet needs and solve therapeutic problems, today announced that management will present at the 2020 RBC Capital Markets Global Healthcare Conference to be held virtually on May 19-20. A webcast of the presentation will be available on the "Events and Presentation" page of the Investors section of the Company's website. Aquestive Therapeutics is a pharmaceutical company that applies innovative technology to solve therapeutic problems and improve medicines for patients.
Good morning, and welcome to today's call to review Aquestive Therapeutics' results for the first quarter of 2020 and business highlights. On today's call I am joined by Keith Kendall, President and Chief Executive Officer; and John Maxwell, Chief Financial Officer, who are going to provide an overview of the recent business developments and performance in the first quarter.
Continues to manufacture and deliver therapies and advance R&D efforts during COVID-19 pandemic Expects to submit AQST-108 (epinephrine) IND by June 2020 and to commence PK.
At the very moment it looked like the market was down for the count, stocks bounced back. After being dealt hefty blows earlier in the week due to the record-breaking drop in oil prices, all three of the major U.S. stock indexes rallied on Friday April 24. The surge was supported by rising crude prices, but it wasn’t quite enough to drive a week-to-date gain, with this figure landing in the red as earnings reports revealed the economic fallout of COVID-19-induced shutdowns. As investors digest all of this, it becomes apparent that there’s an opportunity for those able to take on more risk. Within the biotech space, the effects of COVID-19 have pushed several compelling names’ share prices lower, presenting more affordable entry points. That being said, Wall Street pros remind market watchers that due diligence is required before making any investment decisions as both the volatile nature of the biotech industry and a bargain price tag add up to significant risk. What’s the flip side? Any favorable outcome can catapult a company’s shares through the roof, with even minor share price appreciation translating to huge returns. Bearing this in mind, we used TipRanks’ database to find three compelling biotech stocks all trading for under $4 per share. The cherry on top? Each of the Buy-rated tickers could see their share prices take flight in the next year. Here are all of the details. Menlo Therapeutics Inc. (MNLO) Menlo’s recent rough going has certainly sounded the alarm bells for some investors, with it now going for only $1.41 per share. The company, which develops foam-based products to treat dermatologic conditions, recently announced that it will be discontinuing serlopitant development after the therapy failed to meet the required endpoints in two Phase 3 trials in Prurigo Nodularis Itch. However, several analysts are standing firmly behind MNLO. Cowen’s Ken Cacciatore notes that the June 2 PDUFA date for its FMX-103 candidate in rosacea is keeping him optimistic about the biotech’s long-term growth prospects. Based on the almost perfect clinician overlap, FMX-103 can leverage the infrastructure put in place for its Amzeeq product in moderate-to-severe acne. Expounding on this, Cacciatore said, “...our clinicians continue to highlight their even greater enthusiasm for FMX-103, given that rosacea – although a smaller overall market than acne – has very limited treatment options. Taking the likely lower penetration of Amzeeq into the massive acne market, combined with the likely high penetration of FMX-103 into the smaller rosacea market, we continue to believe that these opportunities could eventually each exceed $250 million-plus in peak sales, which is clearly not reflected in the current valuation.” Additionally, Cacciatore points out that Amzeeq’s initial release was impressive before COVID-19 took hold of the market, with “the launch was progressing as well as – and if not better – than any recent launch in acne.” Total prescriptions hit the 2,150 mark for the week ending March 13, indicating a revenue run-rate of about $20-$25 million.“We are encouraged by the initial response to Amzeeq, and believe it bodes well for the likely re-acceleration that will occur following the normalization post the virus pause,” Cacciatore notedAs MNLO has enough capital to establish both FMX-103 and Amzeeq, it’s no wonder Cacciatore left an Outperform rating on the stock. The analyst's $10 price target leaves room for shares to skyrocket 609% in the next year. (To watch Cacciatore’s track record, click here) All in all, the analyst community echoes Cacciatore’s sentiment. Only Buys have been assigned in the last three months, 6 to be exact, and thus the consensus rating is a unanimous Strong Buy. At $6.80, the average price target puts the upside potential at 382%. (See Menlo price targets and analyst ratings on TipRanks) Aquestive Therapeutics Inc. (AQST) Next up is biotech Aquestive Therapeutics, which uses innovative drug delivery technology to redesign important medicines. With not one but two upcoming PDUFA dates, it’s not surprising that members of the Street think its $3.55 share price represents the ideal entry point. Weighing in for H.C. Wainwright, five-star analyst Raghuram Selvaraju believes that the most valuable piece of the puzzle is its anti-seizure candidate, Libervant, the PDUFA date for which is slated for September 27. “We estimate that Libervant could generate U.S. sales approaching $300 million by 2030. Libervant has been accorded Orphan Drug status, which would confer seven-year market exclusivity upon the product if approved,” he explained. Regarding Libervant’s launch, Selvaraju argues the fact that Sympazan (clobazam), an oral film for Lennox-Gastaut syndrome (LGS)-associated seizures, was launched prior to Libervant provides Aquestive with the opportunity to set up its commercial infrastructure.It should also be noted that Selvaraju sees the recent share price weakness as not fully reflecting AQST’s value, with it boasting several other promising candidates in its pipeline. “In our view, the recent coronavirus crisis-driven market disruption has resulted in massively overdone attrition in Aquestive's share price. The company currently trades at a sub-$60 million market cap, which we believe does not reflect even the value of its manufacturing and licensing-related revenue, let alone revenue generated from its proprietary products,” he commented. One of these candidates is APL-130277, which could be approved on May 21. On top of this, AQST-108 could enter clinical testing this year, and with the annual U.S. epinephrine product market potentially totaling $5.2 billion by 2026, according to Coherent Market Insights, Selvaraju highlights the large opportunity for the biotech.As a result, Selvaraju reiterated a Buy rating and $13 price target. Should this target be met, a twelve-month gain of 266% could be in the cards. (To watch Selvaraju’s track record, click here) Looking at the consensus breakdown, other analysts also see big things in store. With 100% Street support, the message is clear: AQST is a Strong Buy. The $17.33 average price target is more aggressive than Selvaraju’s and suggests 388% upside potential. (See Aquestive stock analysis on TipRanks) BioCryst Pharmaceuticals (BCRX) BioCryst is among those racing to find an effective and safe COVID-19 treatment. Based on these efforts and its bargain $3.56 price tag, one analyst tells investors that now is the time to snap up shares. The company has already opened up the enrollment for its randomized double-blind pbo-controlled clinical trial evaluating its galidesivir drug in patients with COVID-19. Funded by the National Institute of Allergy and Infectious Diseases (NIAID), the trial will be performed in two separate parts and conducted under an amendment to the existing clinical trial for yellow fever in Brazil to enable the study to start sooner. The first part is designed to optimize the dosing regimen for galidesivir, while the second will hopefully validate its activity against pbo. Based on the safety, viral load reduction in respiratory tract secretions, improvement in COVID-19 signs and symptoms and clinical manifestations as well as mortality results from Part 1, BCRX will be able to select the ideal dosing regimen for Part 2. Then in Part 2, the treatment’s efficacy will be determined by time to clinical improvement, time to hospital discharge, time to undetectable viral levels (as measured by PCR in respiratory specimens) and all-cause mortality. Writing for J.P. Morgan, five-star analyst Jessica Fye sees galidesivir as a significant positive for the company. “While no timelines for data were provided today, mgmt noted that Brazil’s infection count is inflecting and along these lines we see potential for this study to enroll relatively quickly, potentially setting up data this summer. Net-net, in light of the ongoing pandemic, we see progress on galidesivir’s development as a potential treatment for COVID-19 as a driver of near-term stock performance although we acknowledge that the value of the opportunity is difficult to quantify,” she stated. All of this prompted Fye to leave her Overweight rating and $5 price target unchanged. With this target, shares could climb 40% higher in the next twelve months. (To watch Fye’s track record, click here) Turning now to the rest of the Street, BCRX’s Moderate Buy consensus rating breaks down into 4 Buys and 2 Holds published in the last three months. In addition, the $7.40 average price target implies shares could soar 108% in the next year. (See BioCryst price targets and analyst ratings on TipRanks)
Aquestive Therapeutics, Inc. (AQST), a 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 first quarter ended March 31, 2020 and provide a business update after market close on Tuesday, May 5, 2020. The Company will host an investment community conference call at 8:00 a.m. ET on Wednesday, May 6, 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.
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...
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™.
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...