S&P Futures
4,158.00-25.50(-0.61%)Dow Futures
34,583.00-85.00(-0.25%)Nasdaq Futures
13,205.50-151.25(-1.13%)
Savara Inc. (SVRA)
1.6000 +0.01 (0.63%)
After hours: 7:13PM EDT
Chart Events
Performance Outlook
| Previous Close | 1.6300 |
| Open | 1.6300 |
| Bid | 1.5900 x 4000 |
| Ask | 1.6000 x 3200 |
| Day's Range | 1.5700 - 1.6405 |
| 52 Week Range | 0.9950 - 3.5800 |
| Volume | 1,257,357 |
| Avg. Volume | 4,163,358 |
| Market Cap | 180.591M |
| Beta (5Y Monthly) | 1.14 |
| PE Ratio (TTM) | N/A |
| EPS (TTM) | -0.8370 |
| Earnings Date | Nov 05, 2020 |
| Forward Dividend & Yield | N/A (N/A) |
| Ex-Dividend Date | N/A |
| 1y Target Est | 3.80 |
- InvestorPlace
7 Reddit Penny Stocks to Buy for a Biotech Boom
Penny stocks across all sectors have been popular with investors active on Reddit’s r/WallStreetBets subreddit. But, one area, in particular, they’ve found many of their favorites has been in the biotech space. Not only a lot of penny, or low-priced stocks, are in this industry. The high-risk, high-potential return nature of biotech investing makes it no surprise retail speculators online are active in this area. Earlier this year, Reddit investors sent many low-priced biotech names “to the moon.” But, in recent weeks, many of these popular names have pulled back from their highs. For some, this is justified. There was little going on to justify their inflated valuations. For others, though, there’s more in their corner than just online hype. For biotech names, things can be very make-or-break. News of Food and Drug Administration (FDA) approval can turn a stock parabolic. But, one hiccup, misstep, or stumble can send a biotech stock down 50%, 60%, even 75% in a day.InvestorPlace - Stock Market News, Stock Advice & Trading Tips In short, this isn’t an area you should bet the ranch on one opportunity. Yet, for those with an adequate risk appetite, and the discipline to size positions? You can find many opportunities where the potential for gains more than makes up for the high risk. 10 Stocks to Buy for Your $5K Robinhood Portfolio So, which biotech penny stocks, popular with the Reddit set, offer such opportunity? Consider these seven as ones with potential to live up to online enthusiasm: 180 Life Sciences (NASDAQ:ATNF) Citius Pharmaceuticals (NASDAQ:CTXR) Jaguar Health (NASDAQ:JAGX) Ocugen (NASDAQ:OCGN) Savara (NASDAQ:SVRA) Timber Pharmaceuticals (NYSEAMERICAN:TMBR) Zosano Pharma (NASDAQ:ZSAN) Penny Stocks: 180 Life Sciences (ATNF) Source: Iryna Imago / Shutterstock.com With its epic run over the past month, ATNF stock has rallied far above penny-stock status (less than $5 per share). But, with pulling back to single-digit prices, you may want to keep it on your radar. What’s been behind the dramatically increased interest in 180 Life Sciences? Increased awareness of the potential of its therapeutic candidates by Reddit investors helped to fuel its initial surge starting in March. But, recent news of insider buying helped this former penny stock rally above $10 per share. So, why could shares pull back? And, why may it be a great opportunity at lower prices? Namely, its possibility in bringing fibrosis and anti-TNF (anti-tumor necrosis factor) therapies to market. However, recent developments have been minimal. In turn, it’s hard to tell whether shares can continue to climb. Or, if there’s risk of a selloff just around the corner. Yet, if the company down the road makes progress with its pipeline, such news could give shares yet another boost. With Reddit investors onto something here, keep ATNF stock on your radar. Citius Pharmaceuticals (CTXR) Source: Shutterstock As has been par for the course with Reddit penny stocks, CTXR stock peaked during February’s madness. But, while news of a dilutive capital raise, along with fading enthusiasm for meme stocks, has resulted in shares pulling back nearly 39% off their highs, it may be premature to say it’s time to throw in the towel. What’s the “story” behind Citius? As InvestorPlace’s Louis Navellier broke it down March 22, the company has three promising candidates in its pipeline. These are blood infection treatment Mino-Lok, Mino-Wrap, a product to be used for preventing infections that can occur during breast reconstruction surgery, and Halo-Lido, an anti-inflammatory treatment for hemorrhoids. As discussed in its March 2021 investor presentation, Mino-Wrap and Halo-Lido have yet to move far down the pipeline. But, Mino-Lok is already in Phase 3 clinical trials. Further news signaling Mino-Lok’s eventual approval and commercialization will definitely be a needle-mover for CTXR stock. With a total addressable market of $1.5 billion, the financial rewards for this company could be massive. 10 Stocks to Buy for Your $5K Robinhood Portfolio While down from its February highs, shares at today’s prices (around $1.66 per share) are still up big from the start of 2020 (when it traded for around $1 per share). Yet, given the possible game-changers in its pipeline, consider it well worth the risk. Jaguar Health (JAGX) Source: Spyro the Dragon/Shutterstock.com What’s the story with JAGX stock, once one of the most popular penny stocks among Reddit investors? It’s a biotech name with a novel coronavirus catalyst. No, it doesn’t have a vaccine in its pipeline. As I discussed back in February, the company is one of many names focused on chronic Covid treatment. How? Via its Mytesi treatment. Mytesi was first created for HIV/AIDS patients with antiretroviral therapy-related chronic diarrhea. But, it may have potential as a treatment for those suffering from long-term Covid-19 symptoms. Before, Reddit investors got carried away with JAGX stock. Its valuation rose to levels way beyond the possible Covid-related upside. But, now, the stock has fallen by more than 50%. That’s not to say the stock is cheap, by any means. But, following its selloff, any positive news on Mytesi may be enough to fuel a rebound. Jaguar Health has other promising candidates in its pipeline, including its Canalevia chemotherapy-induced diarrhea treatment for dogs. Yet, so much riding on Mytesti, exercise some caution. Any positive news could send it surging again. But, negative developments could send it back to prices well below $1 per share. Penny Stocks: Ocugen (OCGN) Source: Shutterstock Like with ATMF stock, OCGN stock is a former penny stock that’s moved beyond $5 per share. Hype with this Covid-19 vaccine play may be off-the-charts. But, even with its vaccine contender a long shot, that doesn’t mean shares could again make another rip higher. How so? While it’s a bit late to the party, with Moderna (NASDAQ:MRNA) and Pfizer (NYSE:PFE) now widely distributing their vaccines, Ocugen may find success, as it tries to bring India-based Bharat Biotech’s Covaxin candidate to the United States. With U.S. Government pausing distribution of Johnson & Johnson’s (NYSE:JNJ) vaccine, there may be opportunity for some of the also-rans to get emergency use authorization (EUA). Initial news of the Covaxin deal sent it from around $1 per share to more than $19 per share. But, the stock has since sold off. So far, the JNJ vaccine news hasn’t done much to renew confidence in Ocugen’s prospects. 10 Stocks to Buy for Your $5K Robinhood Portfolio Yet, with this recent news possibly paving the way for this long-shot Covid-19 vaccine contender to get U.S. regulatory approval, it may be worth it to take a calculated bet on OCGN at today’s prices. Savara (SVRA) Source: Shutterstock Since moving from around $1.20 per share to around $1.80 per share, Savara stock has traded sideways. But, this developer of respiratory therapies may have a shot of breaking out to substantially higher price levels. At least, that’s the view of Oppenheimer’s Francois Brisebois, who last month initiated coverage on the stock. Giving SVRA stock the equivalent of a “buy” rating, and a price target of $4 per share, the analyst is bullish on the prospects of the company’s Molgradex candidate. This candidate is a treatment for aPAP, or autoimmune pulmonary alveolar proteinosis. So, why haven’t investors been more excited about this stock? The on-the-fence view of Savara may have to do with its recent $130 million secondary offering. This transaction raised much-needed capital to sustain its operations. But, it’s come at the cost of heavy shareholder dilution. This dilution could limit to what extent SVRA stock gains if Molgradex becomes a marketable product. Even so, with the high confidence this flagship candidate will live up to expectations, buying this stock, as investors remain on the fence, could be a profitable move in hindsight. Timber Pharmaceuticals (TMBR) Source: Shutterstock Timber Pharmaceuticals is yet another of the Reddit penny stocks that’s been a roller-coaster ride so far this year. Shares in this developer of treatments for rare dermatologic diseases started the year off trading for around 80 cents per share. But, at the height of meme stock/Reddit stock madness, shares briefly hit prices above $3 per share. But, except for another brief spike above $3 per share in March, shares have since fallen back to around $1.50 per share. As much of its Reddit hype has begun to fade, focus now returns to the underlying fundamentals of TMBR stock. So, does Timber have potential to become a long-term winner? Or, will shares pull back to prior levels? Admittedly, it’s too hard to tell right now. With most of its pipeline still in Phase 2 trials, it may take some time to determine whether it has a marketable product in its hands. 10 Stocks to Buy for Your $5K Robinhood Portfolio But, biotech penny stocks remain popular with retail traders. This may be enough to keep TMBR stock steady. News related to its BPX-01 and BPX-04 candidates, currently in late stage clinical trials, could help fuel another rally back to $3 per share and above. Approach it cautiously, but this remains a Reddit biotech play to keep an eye on. Penny Stocks: Zosano Pharma (ZSAN) Source: Shutterstock Zosano Pharma, which is developing a transdermal microneedle treatment for migraines called Qtrypta, grabbed the attention of Reddit traders earlier this year. Like many other biotech names, shares saw a dramatic uptick in February, followed by an extended cooling off period. Today, ZSAN stock is down more than 65% off its highs. But, given shares were trading for around 60 cents per share at the end of 2020, at today’s prices ($1 per share) it’s still up substantially. That may leave some worried shares have more room to fall, as enthusiasm continues to cool. But, to some extent, the story’s improved with Zosano. The company has made some progress obtaining approval for Qtrypta. Last fall, the FDA rejected Zozano’s initial application for Qtrypta. But, it’s not giving up on its flagship candidate. With plans for a new study, the company has high hopes the second go-around with the FDA will be a success. Yet, this slight improvement in its prospects may already be factored into the stock price. More positive news will likely produce another outsized rally for ZSAN stock. It’s still a gamble, but it may be one that pays off in the end. On the date of publication, Thomas Niel did not have (either directly or indirectly) any positions in the securities mentioned in this article. Thomas Niel, a contributor to InvestorPlace, has written single stock analysis since 2016. More From InvestorPlace Why Everyone Is Investing in 5G All WRONG It doesn’t matter if you have $500 in savings or $5 million. Do this now. Top Stock Picker Reveals His Next Potential 500% Winner Stock Prodigy Who Found NIO at $2… Says Buy THIS Now The post 7 Reddit Penny Stocks to Buy for a Biotech Boom appeared first on InvestorPlace.
- InvestorPlace
7 Penny Stocks With Interesting Catalysts
Alluring for their cheap price on paper, penny stocks invariably find their way into many, if not most, people’s portfolios. It’s one thing to buy one share of a technology blue chip. It’s quite another to get 6,000 or more shares in an up-and-coming firm that could potentially be the next big thing. The question is, will it ever get there? While you can never say never, the most realistic answer is no. True, I cannot give you a specific failure rate of penny stocks, as they come in all shapes and sizes. Some start off being priced in the mud whereas others were formerly recognizable names that fell onto hard times. However, TheBalance.com contributor Joshua Kennon has a much more declarative take, noting that investing in penny stocks is “almost always a bad idea.” Among the many dangers of this investment category Kennon cites is the bid-ask spread. Blue chips have strong liquidity and therefore feature narrower spreads.InvestorPlace - Stock Market News, Stock Advice & Trading Tips On the other hand, penny stocks are very illiquid, as evidenced by their often wide spreads. Therefore, even if you buy shares at six cents and they move up by a factor of 10, you might not find a buyer. Even if you do, the wide spread may mean that your actual profit is much less than your paper profit. To keep you away from the really speculative stuff, I’ve amassed a list of penny stocks with credible or interesting catalysts. But please be warned: even “credible” wagers in this arena are still very much speculative. 7 Great Stocks to Buy Under $10 Before we dive in, most of these companies are not what you would call literal penny stocks. When you start getting into six-cent shares, the odds of total failure rise exponentially — and yes, I would know! VerifyMe (NASDAQ:VRME) RF Industries (NASDAQ:RFIL) Elys Game Technology (NASDAQ:ELYS) Savara (NASDAQ:SVRA) Patriot One Technologies (OTCMKTS:PTOTF) Geely Automobile (OTCMKTS:GELYF) BIGG Digital Assets (OTCMKTS:BBKCF) Penny Stocks: VerifyMe (VRME) Source: Shutterstock Not all penny stocks are backroom operations with websites that look like they came straight out of 1994. Case in point is VerifyMe, a brand protection and consumer engagement firm. Through its verification products — tamper-resistant labels, QR codes, NFC chips and invisible inks and pigments — companies can help secure their products against counterfeiting. At the point of sale, consumers can scan labels with their smartphones, which gives them the peace of mind that what they’re purchasing is the real McCoy. Further, this engagement allows product manufacturers to communicate vital information to their customers, promoting brand loyalty. As well, VerifyMe’s product labels can enhance the supply-chain experience, providing track-and-trace capabilities. However, like all penny stocks, you should be prepared for volatility with VerifyMe. On a year-to-date basis, VRME stock is up over 25%. Yet compared to this year’s peak price, shares are down more than 33%. Before you make your decision, you should note that counterfeiting is a $250-billion-a-year problem. Though nothing is going to take the risk factor away from penny stocks, VerifyMe is certainly one of the more credible. RF Industries (RFIL) Source: Shutterstock On the surface, I must admit that RF Industries doesn’t sound very interesting. As a designer and manufacturer of interconnect products, its product portfolio includes “RF connectors, coaxial cables, data cables, wire harnesses, fiber optic cables, custom cabling, energy-efficient cooling systems and integrated small cell enclosures.” But what does intrigue astute investors toward RFIL stock is the reopening of the economy. When the novel coronavirus first disrupted our nation, the ensuing lockdowns meant that RF Industries’ business suffered an imbalanced impact. Demand for wireless/wireline telecom and data communications industries increased due to work-from-home initiatives while sales from the transportation and distributed antenna systems (such as live concert venues) utterly collapsed. 7 Big Names That Could Be the Next Tesla Presumably, with the declining Covid-19 cases along with the expanding footprint of the vaccination rollout, society will gradually return to normal. To be fair, I have my doubts about this. But if you’re more optimistic than me and have the conviction to boot, RFIL stock might be worth a look for the rebound effect. Elys Game Technology (ELYS) Source: NYCStock / Shutterstock.com If you’re going to bet on penny stocks, you might as well increase your odds of success by focusing on relevant growth markets. And one of the most exciting is online sports gambling. According to SportsProMedia.com, in 2018, any state in the U.S. that desired to legalize gambling could do so thanks to a landmark ruling. This led to an explosion of wagers: “In October 2020, Americans legally bet an estimated US$3 billion on sports for the first time in a single month, according to the American Gaming Association. Sports betting revenue was up nationwide by 53.5 per cent year-over-year to US$237.5 million. In December alone, New Jersey set the national sports betting record for the fifth consecutive month, taking an eye-watering US$996.3 million in bets.” Elys Game Technology fits neatly into this narrative, featuring a “fully integrated international betting technology company providing an innovative, world-class betting platform.” Shares spiked recently in February, though they have tapered off a bit. To be sure, ELYS stock is risky. However, it’s also possible that it can ride the momentum that has carried up other gambling-related companies. Savara (SVRA) Source: Shutterstock Ironically, one of the worst-hit sectors of this health crisis was the biotechnology and pharmaceutical industries. Unless a company decided to pivot to Covid-19 treatments or vaccines, they were often forced to wait out the storm. Many long-term medical patients experienced disruption as hospitals and care facilities scrambled to address the immediate threat of the pandemic. But now that Covid-19 cases are declining, it may be time to consider biotech plays such as Savara. Specializing in rare respiratory diseases, Savara’s primary focus is IMPALA 2, which the company’s website describes as a “second Phase 3 clinical study of Molgradex for the treatment of autoimmune pulmonary alveolar proteinosis (aPAP).” The appeal for SVRA is this. To treat aPAP in the conventional form requires “a whole lung lavage, a procedure in which one lung is cleansed with a salt solution while the other is pumped with pure oxygen.” That doesn’t sound fun. 7 Monthly Dividend Stocks That Pay the Bills With Savara’s Molgradex therapy, the drug targets the autoimmune dysfunction that prevents the lung from naturally cleaning itself. While there’s still much work to be done, SVRA stock could benefit from a game-changing innovation. Patriot One Technologies (PTOTF) Source: Shutterstock What made 2020 such a terrible year wasn’t just the coronavirus. Of course, the pandemic is a memory that none of us will ever forget. But what happened next is, in some ways, just as tragic. Rather than working together as Americans to address a common scourge, deep resentments across political and social boundaries contributed to unprecedented incidents of social unrest. I don’t need to go into all the gory details. However, I think it’s fair to say that public safety and security is a concern for many. That’s where Patriot One Technologies comes in. A security solutions expert, Patriot One offers its PATSCAN multi-sensor covert threat detection platform, designed to detect and combat active weapons and explosive threats before they are deployed for nefarious reasons. Given the recent series of mass shootings we’ve witnessed, it’s time for private and public institutions to get serious about preventative security. This could bode well for PTOTF stock. Though Patriot One puts the penny in penny stocks, the necessity for its services could win many investors over. Geely Automobile (GELYF) Source: nrqemi / Shutterstock.com Honestly, I’m not sure how Geely Automobile does it. One of China’s biggest automakers, Geely features an array of cars that look alarmingly like leading European luxury brands. For instance, the Xing Yue looks like a Mercedes Benz GLC Coupe, at least from the side. The Icon? I don’t know about you, but this just screams Range Rover through and through. But let’s give credit where it’s due. Stereotypically, Chinese counterfeit products are often associated with obviously fake apparel. With Geely, you’re dealing with a high-end (and apparently legal) counterfeit — or I should say, heavily influenced design. Still, GELYF hasn’t graduated with other automotive penny stocks into the big leagues yet. Its product portfolio focuses on combustion engine cars — that is, until recently. As Car and Driver noted, Geely will launch its Zeekr electric vehicle (EV), a brand that’s designed to compete with the best in the EV space. 7 Micro-Cap Stocks to Buy That Are Shining Right Now For GELYF stock, it may benefit from strong enthusiasm for EVs. On the other hand, the sector has been struggling recently, so you’ll want to tread these waters carefully. BIGG Digital Assets (BBKCF) Source: Marko Aliaksandr/ShutterStock.com You should know right off the bat that BIGG Digital Assets is a blockchain company. Therefore, it generates tremendous attention from the cryptocurrency crowd. That’s good when prices are soaring. But as I write these words, many crypto tokens are tumbling, which may not augur well for BBKCF stock. In other words, please choose your entry point wisely. But if you have the stomach for extreme volatility, BIGG Digital is one of the more intriguing penny stocks available. Through BIGG’s subsidiary, Blockchain Intelligence Group, the company provides various compliance and regulatory services associated with cryptocurrencies and their transactions. Of particular importance in my view is the law enforcement business. While virtual currencies have fostered a new way of thinking about peer-to-peer transactions, they’ve been a nightmare for law enforcement and intelligence agencies because many blockchain technologies feature hard-to-crack anonymous records. Moving forward, cryptocurrencies will probably represent the universal choice of compensation for illicit activities. That’s why it’s vital for authorities to stay ahead of the game. Blockchain Intelligence Group does this with its suite of forensic tools. To be completely transparent, this doesn’t take away from the riskiness associated with BBKCF stock. But it also has a chance to be an extremely pertinent investment in the years ahead. On the date of publication, Josh Enomoto did not have (either directly or indirectly) any positions in the securities mentioned in this article. A former senior business analyst for Sony Electronics, Josh Enomoto has helped broker major contracts with Fortune Global 500 companies. Over the past several years, he has delivered unique, critical insights for the investment markets, as well as various other industries including legal, construction management, and healthcare. More From InvestorPlace Why Everyone Is Investing in 5G All WRONG It doesn’t matter if you have $500 in savings or $5 million. Do this now. Top Stock Picker Reveals His Next Potential 500% Winner Stock Prodigy Who Found NIO at $2… Says Buy THIS Now The post 7 Penny Stocks With Interesting Catalysts appeared first on InvestorPlace.
- TipRanks
2 “Strong Buy” Penny Stocks That Could Go Boom
Arguably the most controversial on the Street, penny stocks are a hot-button issue. Usually, there isn’t a lot of middle-ground with respect to these tickers priced for less than $5 apiece. Dividing market watchers into two distinct groups, both sides present valid arguments laying out the pros and cons. Sure, there is reason enough to be skeptical. Often, a cheap stock is cheap for a reason, with the low share price potentially reflecting an underlying problem with the business, whether it be poor fundamentals or unbeatable headwinds. That said, a bargain price tag isn’t always indicative of a lost cause. For some, better days are on the horizon, and for very little money, investors can control a lot more shares. Therefore, even minor upward movements could result in massive percentage gains, and thus, significant returns. As the nature of these investments makes it difficult to gauge the strength of their long-term growth prospects, one effective stock selecting strategy is to follow the analysts’ advice. Using TipRanks’ database, we locked in on two penny stocks that have garnered glowing reviews from the Street, enough to earn a “Strong Buy” consensus rating. Not to mention each offers massive upside potential. Savara, Inc. (SVRA) We’ll start with Savara, a biotech company focused on orphan lung diseases. Savara’s main focus is on autoimmune pulmonary alveolar proteinosis (aPAP), a rare condition in which protein material builds up in the lungs and prevents effective breathing. Current treatment involves a patient admission to intensive care, full anesthesia, and a literal ‘washing out’ of the lungs – an invasive and difficult procedure. Savara is researching medical alternatives. The company’s lead drug candidate, molgradex, is an inhalant medication designed as a granulocyte-macrophage colony-stimulating factor; in short, it is targeted on the autoimmune flaw that prevents the body’s natural self-cleansing of the lungs. Molgradex has an Orphan Drug designation from the FDA, and has completed its Phase 3 IMPALA clinical study, with some mixed results. It missed the primary endpoint, but met a key secondary endpoint, and the company in December stated that it planned to meet with regulatory authorities to discuss further studies. Those discussions led to an open-label follow-up period, a study that focused on long-term safety in the use of molgradex for patients with aPAP. The study followed 128 patients over periods between 48 and 72 weeks, and showed improvements on two independent measures of gas exchange in the lungs. Considering these positive results, the company is starting molgradex on the IMPALA 2 study, an additional Phase 3 clinical trial, to begin in 2Q21. Currently going for $1.71 apiece, some members of the Street believe Savara's share price reflects an attractive entry point. Among the bulls is Piper Sandler analyst Yasmeen Rahimi who believes SVRA is an "ideal value pick." “We believe that Molgradex has the potential to be a game-changing therapeutic for autoimmune pulmonary alveolar proteinosis (aPAP)... With a compelling MOA at its back, we have strong conviction in the clinical POS for Molgradex in a Phase 3 study (IMPALA 2), which we believe can improve upon its existing dataset in the 24-week double-blind Phase 2b/3 IMPALA 1 study in 138 aPAP patients that showed favorable safety... Therefore, we have a strong conviction that SVRA shares have the potential to make a comeback in valuation with Molgradex in IMPALA 2,which is expected to commence in 2Q21," Rahimi opined. "Importantly," the analyst added, "Molgradex has already received Orphan Drug Designation in the U.S. (with eligibility for seven years exclusivity) and EU (potential for 10 years exclusivity) as well as FDA Fast Track Designation and FDA Breakthrough Therapy Designation, building up validation for Molgradex in aPAP." To this end, Rahimi rates SVRA an Overweight (i.e. Buy), while setting a $7 price target. This target suggests shares could soar 309% in the next year. (To watch Rahimi’s track record, click here) Overall, SVRA has 3 recent analyst reviews, and all are Buys, making the analyst consensus rating a Strong Buy. The average price target stands tall at $4.67, which suggests the stock has room for 173% upside in the next 12 months. (See SVRA stock analysis on TipRanks) Aquestive Therapeutics (AQST) Next up, Aquestive Therapeutics, is a diversified biotech firm with a range of products in all stages of the development pipeline, from pre-clinical to fully approved and on the market. Aquestive uses a unique film-based delivery mechanism for its medications. It has adapted the film delivery system for dosing through several locations in the mouth, including inside the cheek, under the tongue, and on the tongue. This company’s major news item in the past few months was the FDA rejection of the New Drug Application (NDA) for Libervant buccal film. This medication is a formulation of diazepam, a well-known tranquilizer frequently used to treat seizures. Libervant, dosed through a buccal (inside the cheek) film, was designed to treat seizure clusters. In response to the NDA, the FDA sent Aquestive a Complete Response Letter (CRL) outlining issues with the drug. The CRL specifically cited lower drug exposure levels in patients in certain weight groups. However, there were no other safety or clinical issues cited. After meeting with the FDA, Aquestive revised the weight-based dosing regimen, and is preparing a new NDA for Libervant. The company does not believe that further clinical studies are necessary, and expects to complete the NDA submission in 2Q21. Once the application is sent, the company anticipates a six month process of review. Analyst Jason Butler, in his coverage of this stock for JMP Securities, points out that the key driver here is the resubmission of the Libervant NDA. “[The] company recently gained clarity from the FDA on the acceptability of the company’s revised proposed weight-based dosing regimen, in combination with new modeling and simulations, in a Type A meeting in October 2020 and the company’s subsequent submission of the planned dosing regimen and modeling in December. In the past few weeks, the agency has asked for formatting changes for the safety section of the resubmission and for the company to show the predictive nature of the PK model vs. the observed data from the cross-over study. We view these activities as readily accomplishable..." Butler noted. Butler summed up, "We remain confident in the regulatory path for Libervant and anticipate approval this year, maintaining our 85% probability of approval." Looking forward to a successful resubmission, Butler rates Aquestive’s shares an Outperform (i.e. Buy), and his $17 price target implies an upside of 315% in the next 12 months. (To watch Butler’s track record, click here) Turning now to the rest of the Street, other analysts are on the same page. With 100% Street support, or 5 Buy ratings to be exact, the message is clear: AQST is a Strong Buy. The $15 average price target brings the upside potential to ~266%. (See AQST stock analysis on TipRanks) To find good ideas for penny 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.
