2.0700 0.00 (0.00%)
After hours: 5:54PM EST
|Bid||2.0500 x 4000|
|Ask||2.0600 x 4000|
|Day's Range||2.0000 - 2.0700|
|52 Week Range||0.3500 - 2.9700|
|Beta (5Y Monthly)||0.73|
|PE Ratio (TTM)||N/A|
|Earnings Date||Oct 28, 2019|
|Forward Dividend & Yield||N/A (N/A)|
|1y Target Est||4.40|
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 Nov. 14) 10X Genomics Inc (NASDAQ: TXG )(IPOed Sept. 12) 89bio ...
Agile Therapeutics, Inc. (AGRX), a women’s healthcare company, today announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) goal date for its review of the New Drug Application (NDA) of Twirla® (levonorgestrel/ethinyl estradiol) transdermal system, an investigational combined hormonal contraceptive patch, from November 16, 2019 to February 16, 2020. On October 30, 2019, the FDA’s Bone, Reproductive, and Urologic Drugs Advisory Committee (BRUDAC) met to discuss the benefits and risks of Twirla and voted 14 to 1, with one abstention, that the benefits of Twirla (AG200-15) in the prevention of pregnancy outweigh the risks to support approval.
Global investment bank, RBC Capital, is one of the finance world’s heavy hitters. It is the 5th largest in North America, and with 70 offices in 15 countries around the world, it has a stellar reputation. This international reputation and the financial clout that comes with it, naturally attracts top talent, and top talent can bring home the bacon, so to speak. It is no wonder then that RBC leads TipRanks’ list of Top Performing Research Firms.With this in mind, we decided to take a look at some of the recent stock recommendations from RBC analysts, specifically ones with potential for 30%+ gains ahead.Agile Therapeutics (AGRX)Agile Therapeutics shares took a nosedive in late October after briefing documents released by the FDA expressed concern regarding the “effectiveness in proportion to its safety,” of Twirla, the company’s contraceptive patch, ahead of an AdCom review. As it happens, the review panel voted in favor of approval, which coincidentally, sent the stock skyrocketing.Following the AdCom’s positive outcome, RBC surveyed physicians to better understand the experts’ view on Twirla. The results echoed those of the AdCom, and with the PDUFA set for November 16, the impression is that Twirla will most likely be granted approval by the FDA.RBC analyst Randall Stanicky noted, “We could see approval this week or alternatively a potential ~3month delay as FDA works through labeling; either way we think shares at these levels show attractive near-term upside… Our survey of 40 OB/GYNs was surprisingly bullish on desire for Twirla as a contraceptive option; this increases our conviction that there is a place for it in the market.”As a result, Stanicky reiterates a Buy rating on AGRX along with a $5.00 price target, which implies a whopping upside of 130% from current levels. (To watch Stanicky’s track record, click here)How does Stanicky's bullish bet weigh in against the Street? It appears the analyst is not the only one enthusiastic on this healthcare stock, with TipRanks analytics demonstrating AGRX as a Strong Buy. This breaks down into 5 "buy" ratings in the last three months. With a return potential of over 100%, the stock’s consensus target price stands at $4.50. (See Agile stock analysis on TipRanks)Rapid7 (RPD)Cyber-security firm, Rapid7, provides data and analytics software to help organizations keep their networks safe from malicious cyber threats. Basically, it does what it says on the tin and reduces risk across a connected environment.Last week, Rapid7 delivered stronger quarterly results than expected, with annualized recurring revenue (ARR) growing by 43% on top of 17% customer growth. Overall, the company posted earnings of one cent per share on revenue of $83.16 million, beating the loss of 3 cents and revenue of $80.12 million analysts expected. Therefore, the company has now raised 2019 revenue guidance from $319 million to $323.5 million.Citing Rapid7 as a favorite SMID-cap, RBC’s 5-star analyst Matthew Hedberg believes that although estimates have gone higher, they still look beatable. Hedberg noted, “ARR growth is the key metric, as management expects it to remain at or above 30% through 2020. While the stock has performed well, we continue to believe it represents an attractive investment… In addition to new customer additions, we believe 2020 should see the cross-sale of additional products like InsightIDR and InsightAppSec and longer-term InsightConnect. This value generation was shown in ARR per customer, which grew 22% y/y… Our estimates move higher, but we still believe upside remains through 2020…”This has led Hedberg to keep his Buy rating along with a price target of $81.00. With RPD currently trading at $51.08, this provides upside of about 60%. (To watch Hedberg’s track record, click here).Looking at the consensus breakdown, the cyber-security firm has amassed 8 Buys and 1 Hold in the last three months, making Rapid7 a Strong Buy. The average stock-price forecast is $65.50. Not quite as bullish as Hedberg, this target still provides upside of 28% from its current price. (See Rapid7 price targets and analyst ratings on TipRanks)Aprea Therapeutics (APRE)Aprea Therapeutics is a Boston, Massachusetts-based biopharma focused on developing and bringing to market novel cancer therapeutics that reactivate mutant tumor suppressor protein p53. Aprea’s main drug candidate is APR-246, a small molecule in clinical development designed to treat various forms of cancer with TP53 mutations. These are found in half of all cancers. Through its unique design, APR-246 is able to restore immune defenses and promote apoptosis of cancer cells.The company will present updated data from its phase II trial in December, and it believes APR-246 will be a first-in-class therapy if approved by regulators.RBC’s Gregory Renza agrees, saying, “We believe APRE’s small molecule p53 reactivator pipeline in oncology, led by APR-246, has ample potential given the data to date and catalyst setup expected over the year. We see APRE emerging as a competitive player in the oncology space, especially in severe TP53 populations where unmet need is high, and believe in its potential for long-term share appreciation as the programs continue to de-risk… If approved, we see prospects of $800M WW peak sales in MDS at a ~35% POS, driving 2/3 of our valuation.”Renza initiated coverage with a bullish call and set a price target of $33.00, indicating upside of over 32%. (To watch Renza’s track record, click here)It’s a tad quiet when it comes to analyst coverage, with only two other analysts currently providing ratings for APRE, both recommending a Hold. With an average price target of $26.33 providing a modest 5% upside from its current price, the biopharma newbie ranks as a Moderate Buy. (See Aprea price targets and analyst ratings on TipRanks)
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 Nov. 4) Agile Therapeutics Inc (NASDAQ: AGRX )(follow-on rally ...
Agile therapeutics (AGRX) has had a, shall we say, crazy week in the market. On Monday, October 28, its share price was sent on a downward spiral following the release of negative briefing documents by the FDA which expressed concerns about its contraceptive patch, Twirla. The FDA’s main points of concern regarded Twirla’s “effectiveness in proportion to its safety,” as the estimated Pearl Index (PI) in the Phase 3 ATI-CL23 study exceeded the required level. Furthermore, it rejected Agile’s proposal of a limitation of use label following results which showed 2x pregnancy rate in obese women.Well, what a difference two days makes. On Wednesday, the AdCom review caused a major upset, with a 14-1 vote in favor of supporting Twirla for approval. This sent the stock price soaring, with gains of over 370% since.But how much further can the stock grow? H.C. Wainwright’s Oren Livnat may have the answer. Following the positive outcome, the analyst reiterated a Buy rating on AGRX stock, while raising his price target to $5 (from $4), which implies about 185% upside from current levels. (To watch Livnat's track record, click here)Livnat admits the FDA’s negativity initially took him by surprise, believing the FDA’s alarmist concerns were unjustified. Still, the analyst thinks there is much left to work out between Agile and the FDA, not least the product’s label. The AdCom panel agreed the label must include a “clear Limitation of Use (LOU) for obese women with BMI over 30 due to lower contraceptive efficacy." Most on the panel are against a stricter contraindication in obese women, but the FDA might want to go that way, regardless.“Of course, there remains material risk here, as the AdCom vote is just a non-binding recommendation, and approval clearly requires a total 180degree turn in agency thinking, and we’d be surprised if final approval is reached on the November 16 PDUFA just two weeks away. However, specific timing aside, we have to think Twirla’s ultimate approval is quite likely now, so we increase our probability of success to 70% from 60%,” Livnat said.Maxim's Jason McCarthy also believes the market over reacted to the briefing document, yet amidst the new found optimism, posted a note of caution, saying, “The PDUFA is 11/16 and it is important to note that while FDA typically follows the Adcom's recommendation, it does not always do so, which really must be considered since the FDA briefing docs appeared to be against approval… We see the probability favoring Agile, but this could be considered aggressive and as such would say that risk averse investors may want to step aside.” The analyst keeps his price target at $3.00. While not quite as bullish as Livnat, this still gives AGRX upside of over 70%.Not many sectors offer the potential for such big time gains like biotech. Especially when you’re looking at smaller clinical-stage names such as Agile therapeutics. After all, the thrill of getting a big-time approval can send a stock's price surging. Conversely, one mishap can send shares crashing. That said, Wall Street’s confidence on AGRX speaks for itself; the stock has received a 5 'buy' ratings in the last three months. Meanwhile, the $4.50 consensus price target suggests a potential upside of 160% from the current share price. (See Agile stock analysis on TipRanks)
Shares of Agile Therapeutics Inc. rocketed nearly 4-fold (up 270%) in very active afternoon trading, after the women's healthcare company said a U.S. Food and Drug Administration advisory committee voted in favor of its contraceptive patch Twirla. Trading volume was 46.3 million shares, compared with the full-day average of about 2.3 million shares. The FDA's Bone, Reproductive and Urologic Drugs Advisory Committee (BRUDAC) met to discuss Agile's New Drug Application (NDA) for Twirla, the company's lead product candidate, and voted 14 to 1, with 1 abstention, that the benefits of Twirla in the prevention of pregnancy outweigh the risks to support approval. The stock's rally comes after it plunged 59% on Oct. 28, after said in its third-quarter report that the FDA has issued a document that expresses a number of concerns regarding Twirla's approvability, and that the FDA didn't appear to agree with Agile's proposal to include a limitation of use based on patient weight in the product label. The stock has not gained 17.7% over the past three months, while the iShares Nasdaq Biotechnology ETF has edged up 1.1% and the S&P 500 has gained 1.7%.
Agile Therapeutics Inc (NASDAQ: AGRX) shares were galloping higher Thursday in a notable turnaround following the precipitous drop they experienced earlier in the week. FDA's Bone, Reproductive and Urologic Drugs Advisory Committee, which discussed the NDA for Twirla, voted 14-1 Wednesday that the benefits of Twirls outweigh the risks to support approval. Twirla, or AG200-15, is Agile's investigational, once-weekly combined hormonal contraceptive patch containing a type of estrogen and a type of progestin as active ingredients.
Apple (NASDAQ: AAPL ) - Reported Q4 earnings of $3.03 per share on sales of $64.04 billion. Analysts had been expecting $2.83 in EPS on $62.99 billion in sales. Apple said is expecting Q1 sales $85.5 billion ...
Agile Therapeutics, Inc. (AGRX), a women’s healthcare company, announced a positive outcome from today’s meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee (BRUDAC) of the U.S. Food and Drug Administration (FDA). The BRUDAC met to discuss the Company’s New Drug Application (NDA) for its lead product candidate, Twirla® (AG200-15), an investigational combined hormonal contraceptive patch. “We are very pleased that BRUDAC voted in favor of Twirla.
Shares of Agile Therapeutics (AGRX), a biotech which specializes in women’s healthcare, are in a nose dive, down about 66% in the past two days. The downturn was a result of the FDA issuing briefing documents expressing concerns regarding the company's Twirla, a contraceptive patch pending approval on November 16. This comes ahead of Wednesday’s meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee which is set to review and discuss the marketing application for Twirla.Containing a blend of hormonal contraceptives such as ethinyl estradiol and levonorgestrel, Twirla works through a patch which delivers similar amounts to those provided by its oral counterparts. It is applied once a week, consecutively for 3 weeks, with a week’s break in between doses.The documents highlighted a number of concerns, among them Twirla’s effectiveness in proportion to its safety, as the estimated Pearl Index (PI) in the Phase 3 ATI-CL23 study exceeds the required level. Approved combined hormonal contraceptives (CHCs) must come in under a threshold of 5.0, whereas the trial’s PI came in at 5.83.Further adding to the gloom were trial results which showed 2x pregnancy rate in obese women. As almost 30% of females ages 18-44 were classified as obese by the CDC in 2017, this is a concern. Agile’s proposal to include a limitation of use label based on the patient’s weight and BMI were not deemed enough by the FDA.Clearly, there is a significant amount of frustration from the bulls. Yet, AGRX is still trading well below price target expectations.In a report issued following the release of the briefing documents, RBC Capital’s Randall Stanicky says Twirla still has about 30% chance of approval. Considering this best-case scenario, the analyst reiterates a Buy rating on AGRX stock, while cutting his price target to $2.00 (from $3.00). That said, the analyst believes the stock could drop as low as $0.25 on the back of a rejection from the FDA."Though not binding, outcome of this AdCom is going to be increasingly important for Twirla's approval opportunity on its 11/16 PDUFA,” Stanicky noted. If approved, the analyst believes it can “capture 2.2% TRx share in the sizable ~$3.9 billion CHC market that is growing annually in the mid-single digits given the unique benefits that a CHC patch product without a unique black box safety warning could bring."In addition, Oppenheimer analyst Leland Gershell has lowered his price target to $4.00 (from $5.00), saying, “We were particularly surprised by the apparent rejection of AGRX's proposal to include label language stating reduced effectiveness in overweight/obese women, which we had seen as a reasonable regulatory strategy.” The analyst believes the violent sell-off could provide an opportunity for risk tolerant investors should the panel reach a more supportive conclusion. This would give the stock an increase of over 900% from its current levels.All in all, Agile has a lot of disappointed bulls out this week as the stock plummets. According to TipRanks, out of 5 analysts polled in the last 3 months, all 5 rate the stock a "buy." The 12-month average price target stands at $3.40, marking over 800% upside from where the stock is currently trading, which is most likely a result of analysts’ inability to turnaround new price targets so quickly. (See Agile stock analysis on TipRanks)
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 Oct. 28.) AstraZeneca plc (NYSE: AZN ) ( reported positive ...
Regulatory update: The FDA completed its pre-approval inspection (PAI) at Corium International, Inc. (Corium), our third-party manufacturer, and the Company continues its preparations for the October 30, 2019 meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) to review the Company’s new drug application (NDA) for Twirla. The FDA has assigned the Twirla NDA a Prescription Drug User Fee Act (PDUFA) goal date of November 16, 2019. In advance of the Advisory Committee meeting, the FDA issued its briefing document in which it expresses a number of concerns regarding Twirla’s approvability, including, but not limited to, concerns related to Twirla’s efficacy when balanced against its safety. The FDA also did not appear to agree with the Company’s proposal to include a limitation of use based on patient weight and BMI in the product label.
Agile Therapeutics (AGRX) 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.
When searching for big rewards, look no further than biotech stocks.Just be prepared for big risk, too.Biotechs offer gobs of price potential. That's because unlike many companies that can slowly but steadily build up their businesses over time, the survival of biotechnology companies (especially early on) hinges on just a few trials of their developing treatments. Eventual approval of the drug means life-sustaining revenues for the company, so positive trial news can send shares skyrocketing. Setbacks, however, can spark an exodus.While it's impossible for regular investors to gauge what's going on in testing labs, you can give yourself a small leg up by paying attention to the analysts who cover the biotechnology industry. If you find a stock that's mostly surrounded by bulls, that might be a signal that something rewarding is around the bend.Here are five biotech stocks that have a "Strong Buy" consensus analyst rating and have potential catalysts right around the corner. We've used TipRanks' Smart Score system to identify this health-care short list. Also remember that biotechnology stocks come with a considerable amount of risk, and that sharp drops are not uncommon. Consider using only a small allocation from the portion of your portfolio dedicated to aggressive investments. SEE ALSO: 10 High-Quality, High-Growth Stocks to Buy
Along with healthcare stocks in general, biotechnology stocks are not hitting any near-term highs in terms of share price performance. Chalk it up to continued fears that the industry will see increased regulation on (largely unfounded) concerns on domestic drug pricing and how to effectively keep citizens with sufficient health insurance while keeping a lid on costs.Regardless of the political climate, drug candidates with proven market potential will always put profits in investor pockets. Below are overviews of three biotech stocks that are far from their 52-week highs and have some potential near-term catalysts. Namely, they have important pending news flow from the Food and Drug Administration (FDA) regarding recent drug applications from their portfolios of promising drug candidates.Agile Therapeutics (AGRX)Agile Therapeutics has finally made it through the late stages of clinical trials for Twirla, its lead product that management is dedicating all of the company’s resources to currently. The latest official status on Twirla is that Agile submitted it for FDA review and received a complete response letter in December 2017. It resubmitted its new drug application (NDA) to the FDA in May of this year, and an advisory committee meeting is scheduled for October 30, followed by PDUFA date on November 16.Twirla is a contraceptive (or more specifically, a low-dose combination hormonal contraceptive, or CHC) patch that, if and once approved, should be much easier to take than daily oral contraceptive pills, which, after many decades, is still the most popular form of birth control. Two of Twirla’s active ingredients are the same that have been used in contraceptives for the past 25 years. Twirla simply requires a weekly patch for three weeks out of every month. Competitors to Twirla include Ortho Evra and its generic equivalent, Xulane, but there is plenty of market share to be taken from the older products.In a research note issued Friday, Maxim analyst Jason McCarthy stated: "Twirla has already received two CRLS, the most recent of which was in December of 2017 and has since been resolved with completion of the adhesion/wear test earlier in 2019. In addition, the company previously completed its third phase 3 trial, the SECURE trial, demonstrating pearl index (PI) and upper bound (UB) 4.8 and 6.06, respectively. The data are in-line with other products recently approved in the space like Slynd demonstrating more 'real-world' PIs and UBs." The analyst concluded, "A combination of activity in the space around contraceptives (regulators too), the steps taken by management to complete clinical work and other requests by regulators and a stronger balance sheet, point to a favorable risk/reward profile."Oppenheimer analyst Leland Gershell shares a similar enthusiasm with McCarthy when it comes to Agile. If the approval plays out as hoped, Gershell sees $261 million in sales by 2024, and pegs Agile’s stock price at $5 per share – well above a current $1.12.Of the five analysts tracked on TipRanks in the past 3 months, the consensus price target is $3.80, which suggests 236% upside from the current share price. Clearly, Agile’s success depend on Twirla, and investors should know later this month what the FDA’s conclusion on the current submission will be. (See Agile stock analysis on TipRanks)Foamix Pharmaceuticals (FOMX)Foamix Pharmaceuticals is also hopeful of getting to market and has two promising late-stage dermatological drugs in its pipeline. FMX101 targets the treatment of moderate-to-severe acne and has already had its NDA submitted. Management is also hopeful to hear some news from the FDA very soon. FMX103 targets moderate-to-severe rosacea, which has much less competition than competing acne treatments in the marketplace. It also made it through clinical three trials and an FDA decision is expected somewhere in the middle of 2020.Cantor analyst Louise Chen reported on Foamix’s presentation at the firm's healthcare conference in early October, noting: "After listening to FOMX's presentation, we continue to look forward to the potential launches of FOMX's two late-stage products in the 2019/20 timeframe. We expect approval for the company's lead product candidate FMX101 for the treatment of moderate-to-severe acne." Chen rates FOMX an Overweight with $15 price target, which implies huge upside to the current share price of $2.80.Research firm Cowen recently pointed out that Foamix is currently building out its sales force in anticipation of the potential launch of both dermatology candidates. Based off its price target of $30, it is effectively twice as bullish as Cantor.Like many development-stage biotech firms, Foamix is in a precarious financial position and has accumulated a deficit above $200 million to bring these and related drugs to market. But with any positive FDA news, the share price will likely soar and open the gateway to plenty of opportunities to raise growth capital.Returning again to TipRanks’ consensus analyst estimates, FOMX has received 3 "buy," ratings in the last three months, while the 12-month average price target lands at $17.00, or more than 500% ahead of the current share price. (See Foamix stock analysis on TipRanks)Flexion Therapeutics (FLXN)Rounding out the trifecta of appealing development-stage biotechs, Flexion just started pulling in sales from the successful launch of Zilretta for the treatment of osteoarthritis, or OA, in patient’s knees. Management has guided full-year sales of between $65 million and $80 million and has pointed out that OA is a type of degenerative arthritis that breaks down and causes the eventual loss of cartilage in the knee joints.Meanwhile, Flexion is awaiting to hear back from the FDA today regarding its supplemental new drug application (sNDA) filing to remove the Limitation of Use (LOU) language from the Zilretta label and marketing materials regarding repeat administration.Wells Fargo analyst David Maris was recently involved with Flexion’s meetings with investors in New York City and detailed that Flexion "continues to remain hopeful and “cautiously optimistic” that the FDA will approve the sNDA and remove the language given the body of data FLXN has generated regarding the safety of Zilretta and its repeat usage. However, FLXN stated that the sNDA is by no means a certainty and it has been scenario planning for all outcomes. In the best-case scenario if the FDA removes the LOU, FLXN stated that it does not expect an immediate inflection in sales but that the removal should provide a tailwind over the longer-term."Maris rates Flexion stock an Outperform, along with a $26 price target, which implies about 95% upside from current levels.Northland Capital's price target is a couple of bucks higher at $28. In a recent report, analyst Carl Byrnes suggested that Flexion’s “current valuation creates a compelling risk/reward scenario as FLXN shares currently trade at ~4.3x consensus 2020 sales, and less than 1x our peak sales forecast.”Profitability isn’t projected until after 2021, but again revenue coming in makes Flexion much more in control of its own destiny. At the end of 2018, accumulated deficit on the balance sheet was $350 million.Rounding out the coverage, the TipRanks universe tracks three analysts (in the past 3 months) with an average price target just shy of $26, or a near double from the current share price of $13.36. (See Flexion stock analysis on TipRanks)
The Zacks Analyst Blog Highlights: Barrett Business Services, Hibbett Sports, Construction Partners, Agile Therapeutics and Boot Barn
Due to their limited international exposure, domestic firms offer more protection than their large- and mid-cap counterparts during economic upheavals.
Zynerba (ZYNE) announces positive top-line results from the BELIEVE 1 study evaluating the efficacy and safety of Zygel in a heterogeneous group of rare and ultra-rare epilepsies.
Agile Therapeutics (AGRX) has been upgraded to a Zacks Rank 1 (Strong Buy), reflecting growing optimism about the company's earnings prospects. This might drive the stock higher in the near term.
PRINCETON, N.J., Sept. 06, 2019 -- Agile Therapeutics, Inc. (Nasdaq: AGRX), a women's healthcare company, announced today that its Chairman and Chief Executive Officer, Al.
Most biotech stocks have been under pressure recently, but as we approach the end of the year, many analysts are quite bullish as to what is next for these stocks.While the biotech industry carries substantial risk based on the fact that any negative event such as disappointing results from a clinical study can trigger a drop in share prices, analysts argue that a few stocks in this space are set to heal the market flu ahead of their upcoming FDA advisory committee (AdCom) meetings.During an AdCom, both the company and agency will give presentations, with patients often getting a chance to speak as well. A vote will then take place to decide if a drug gets an approval recommendation. This recommendation can help determine whether or not a drug receives final FDA approval, with a positive AdCom outcome acting as a catalyst that can cause shares to skyrocket.We wanted to take a closer look at 3 biotech stocks poised to soar ahead of their upcoming FDA AdCom meetings. Each boasts almost 100% upside potential as well as significant support from the Street with a “Strong Buy” analyst consensus, based on TipRanks’ Stock Screener.With that in mind, let’s dive in:Aimmune Stock Is Looking for a TurnaroundAimmune Therapeutics (AIMT) develops treatments to help protect people with food allergies by potentially reducing the risk of allergic reactions, thus making accidental exposures to allergens less dangerous.Going into its September 13 AdCom for its primary drug AR101, the company’s long-term growth narrative appears healthy. As Food Allergy Research & Education states that 32 million Americans have food allergies, including 5.6 million children under age 18, there’s a large market available for AIMT.While shares are down 18% year-to-date, the panel is expected to put AIMT back on an upward trajectory assuming all goes according to plan.AIMT is on track in terms of its timeline. A regulatory decision for AR101 should be announced in January 2020 but could come before. This means that the company would be able to launch the drug at the beginning of Q4 2019.Adding to the good news, AIMT’s management stated that it would be initiating its P2 AR201 trial for egg allergies. Investors could also get an update regarding its AR301 program for walnut allergies by the end of 2019.5-star Piper Jaffray Christopher Raymond commented: “With all eyes ahead to September, we continue to like the setup and remain buyer.” As a result, he reiterated his Buy rating and $60 price target. Raymond’s price target demonstrates his confidence in AIMT’s potential to surge 207% over the next twelve months. (To watch Raymond’s track record, click here)“As investors are well aware, the AR101 AdCom is scheduled for Sept 13th, an event that we think could help reverse the stock’s downward trend if things go well. With this in mind, we’ve looked beyond the compelling data package and instead focused on factors affecting how the meeting may go, digging deeper on APAC panelists’ views on OIT, and becoming more comfortable that FDA understands that allergen immunotherapies cause allergic reactions during patient desensitization (per sublingual immunotherapy commentary). Though the small minority of (vocal) naysayers might continue to debate the risk/reward of OIT, we feel very comfortable that FDA understands this point well,” Raymond wrote.Wall Street is on the same page. AIMT boasts a ‘Strong Buy’ analyst consensus as well as a $51 average price target, suggesting 158% upside potential. (See AIMT’s price targets and analyst ratings on TipRanks)Agile Therapeutics Shares Can Soar ~250%Agile Therapeutics (AGRX) is working to fulfill the unmet healthcare needs of women globally. Its current product candidates were developed to provide a contraceptive method for women that don’t want to commit to a longer-acting method or take a daily pill.With the U.S. contraceptive market expected to grow from $7.6 billion in 2017 to reach $11.6 billion by 2025 according to a Grand View Research report, AGRX stands to reap the benefits.The FDA announced at the end of June that an AdCom would take place for lead candidate Twirla, its once-weekly transdermal low-dose combination hormonal contraceptive (CHC) patch, on October 30. This news had investors excited as the AdCom will fall closely before AGRX’s November 16 Prescription Drug User Fee Act (PDUFA), the date that the FDA will reveal is if it has approved the treatment. Some have interpreted this timing to mean that the FDA may already have draft labeling ready.4-star H.C. Wainwright analyst, Oren Livnat, argues that the FDA wants to “tease out labeling issues regarding lower CHC efficacy in obese subjects, an issue that has long been ripe for discussion”. However, he thinks the Twirla SECURE Phase 3 trial was “the most robust CHC trial ever”, especially regarding AGRX’s inclusion of a significant number of obese patients.“We can’t predict the final labeling, if approved, but we maintain our current projection of $300M peak sales with just 2.6% market share, or approximately 50% of transdermal share,” he explained.Based on all of the above factors, the four-star analyst reiterated his Buy rating and $4 price target, implying 251% upside. (To watch Livnat’s track record, click here)Livnat is not the only fan of this healthcare company on Wall Street, as TipRanks analytics exhibit AGRX as a Strong Buy. Based on 4 analysts polled in the last 3 months, all 4 rate Agile stock a Buy. The 12-month average price target stands at $3.50, marking a 207% upside from where the stock is currently trading. (See AGRX’s price targets and analyst ratings on TipRanks)Amarin Has What It Takes to Score Crucial FDA approvalAmarin’s (AMRN) primary drug, Vascepa, is a purified fish oil derivative and has already been approved by the FDA as an EPA treatment to lower triglycerides without increasing bad cholesterol levels.Investors were not as happy to hear that the FDA would be holding an AdCom for Vascepa on November 14. The AdCom is related to its pending supplemental new drug application (sNDA) for expansion of Vascepa labeling based on its ability to reduce the risk of major adverse cardiovascular events from the REDUCE-IT study. Management stated that the AdCom meeting will most likely extend the original PDUFA date from September 28 to the end of December.That being said, the American Heart Association (AHA) published an update on August 20 to its 2002 scientific statement for omega-3 fatty acids for reducing triglycerides in patients with hypertriglyceridemia, with the update working in Vascepa’s favor. While this wasn’t a formal change to guidelines, it is a step in the right direction.The points from the AHA update noted that a wealth of evidence including epidemiological and genetic studies suggest the treatment of triglycerides is valid method to reduce cardiovascular disease. The AHA also highlighted the fact that over-the-counter fish oil agents should not be used for pharmacological treatment for patients, which bodes well for AMRN.Despite some negative investor sentiment, Jeffries’ Michael Yee remains confident in AMRN’s long-term growth narrative. “Scripts continue to grow every week despite no label change and we think 2020 numbers are too low. In our view, we think the totality of AMRN’s data support approval,” he explained.As a result, the four-star analyst reiterated his Buy rating and $30 price target. He believes share prices could gain 86% over the next twelve months. (To watch Yee’s track record, click here)The Street appears to mirror Yee’s sentiment. With 7 Buy ratings and no Holds or Sells assigned in the last three months, AMRN has a ‘Strong Buy’ analyst consensus. Its $32 average price target suggests 96% upside potential. (See AMRN’s price targets and analyst ratings on TipRanks) More recent articles from Smarter Analyst: * Is 33% Upside Good Enough to Risk Buying Fitbit (FIT) Stock? Deutsche Bank Doesn't Think So * Deutsche Bank Remains Sidelined on AMD Stock; Here's Why * Antitrust Investigation Is Not a Major Threat to Alphabet (GOOGL) Stock, Says Top Analyst * Tesla's (TSLA) Gigafactory Is Impressive, But Its Stock Isn't, Says RBC Capital
At just $68 million in market capitalization, Agile Therapeutics (AGRX) is anything but what you'd call "Big Pharma" -- but it's getting bigger. Over the past 52 weeks, Agile stock has just about quadrupled in market cap, and in two months it could go up even more.On October 30, an FDA Advisory Committee (AdCom) is scheduled to meet to discuss Agile's once-weekly contraceptive patch for women, "Twirla," the subject of a New Drug Application that Agile resubmitted to the FDA in May. That submission, by the way, started the clock running on the drug's "PDUFA date," which refers to the statutorily mandated deadline for the FDA to issue a ruling on a drug application, as set by the Prescription Drug User Fee Act . In Agile's case, Twirla's PDUFA date is November 16, 2019.Janney analyst Esther Hong is optimistic that Twirla will be approved shortly after completion of the AdCom, noting that the SECURE trial showed Twirla to be 95.8% effective at preventing unintended pregnancies, which is actually slightly better than the average 95.2% effectiveness of similar drugs on the market. Furthermore, Hong notes that there have been no concerns regarding Twirla's safety raised. Accordingly, she predicts that the upcoming PDUFA date will mark a "transformative event for AGRX," to wit, FDA approval of its product for sale, generating sales of $23 million in 2020.Hong believes Agile shares would be worth around $4 over the next 12 month, as she rates the stock a 'buy.' For perspective, the stock closed at $1.11 yesterday, so this implies upside of more than 250%.Similarly optimistic about the AdCom is RBC analyst Randall Stanicky. In a separate note, Stanicky rated Agile stock 'outperform' with a $3 price target. He based this price target on somewhat fewer sales than Hong postulated in 2020 -- $21 million, based on Twirla hitting the market in the first half of 2020 immediately following an FDA approval.Stanicky then proceeded to lay out his thoughts on Agile in the years to follow. Sales could more than double to $53 million in 2021, and could peak at perhaps $381 million annually by 2024, at which point Stanicky predicts Twirla will control about 2.2% of the market.For a company that's been in business since 1997 but has yet to record its first dollar of revenue, the $381 million prediction will be more than enough to please Agile Therapeutics investors.Stanicky concluded, "Not only could we see meaningful stock upside on approval (low expectations priced in), we also think AGRX could be a compelling take-out target if approved."All in all, Wall Street’s confidence backing this women's healthcare company is strong, with TipRanks analytics showcasing AGRX as a Strong Buy. Based on 4 analysts polled in the last 3 months, all 4 rate the stock a Buy. The 12-month average price target stands at $3.50, marking a nearly 215% upside from where the stock is currently trading.To discover Wall Street’s best-rated trending stocks on TipRanks, click here.