|Bid||1.1800 x 3200|
|Ask||1.2100 x 2200|
|Day's Range||1.1700 - 1.2200|
|52 Week Range||0.5300 - 1.7000|
|Beta (3Y Monthly)||-0.50|
|PE Ratio (TTM)||N/A|
|Earnings Date||Aug 7, 2017 - Aug 11, 2017|
|Forward Dividend & Yield||N/A (N/A)|
|1y Target Est||3.80|
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)
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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.
Agile Therapeutics, Inc. (AGRX), a women’s healthcare company, today announced that the underwriters of its previously announced public offering of common stock have exercised in full their option to purchase an additional 1,894,736 shares of Agile Therapeutics’ common stock. The additional shares were sold at the public offering price of $0.95 per share, before underwriting discounts and commissions. The closing occurred on August 8, 2019, bringing the total number of shares sold by Agile Therapeutics in the public offering to 14,526,315 and total gross proceeds to approximately $13.8 million. The total net proceeds, after deducting underwriting discounts and commissions and estimated offering expenses, are expected to be approximately $12.6 million from the offering.
Agile Therapeutics, Inc. (AGRX), a women’s healthcare company, today announced the pricing of its underwritten public offering of 12,631,579 shares of its common stock at a public offering price of $0.95 per share. The gross proceeds from the offering, before deducting underwriting discounts and commissions and estimated offering expenses payable by Agile Therapeutics, are expected to be approximately $12 million. In addition, Agile Therapeutics has granted the underwriters a 30-day option to purchase up to 1,894,736 additional shares of common stock at the public offering price, less the underwriting discounts and commissions. All shares in the offering will be sold by Agile Therapeutics.
Agile Therapeutics, Inc. (AGRX), a women’s healthcare company, today announced that it intends to offer and sell shares of its common stock in an underwritten public offering. Oppenheimer & Co., Inc. is acting as the sole book-running manager for the offering. H.C. Wainwright & Co., LLC is acting as lead manager for the offering. The shares of common stock described above are being offered by Agile Therapeutics pursuant to its shelf registration statement on Form S-3 previously filed and declared effective by the Securities and Exchange Commission. The offering is being made only by means of a preliminary prospectus supplement and the accompanying prospectus, copies of which may be obtained, when available, from Oppenheimer & Co., Inc., Attention: Syndicate Prospectus Department, 85 Broad St., 26th Floor, New York, NY 10004, by telephone at (212) 667-8055 or by email at EquityProspectus@opco.com.
FDA Assigned PDUFA (Prescription Drug User Fee Act) Goal Date is November 16, 2019 Cash Expected to Enable Company to Fund Operations through the End of 2019 PRINCETON, N.J.,.
Agile Therapeutics, Inc. (AGRX), a women’s healthcare company, today announced the appointment of Dennis P. Reilly as Chief Financial Officer effective August 5, 2019. “We look forward to Dennis joining the Agile team. He is an experienced CFO who brings a timely combination of financial acumen and commercial and business development experience that can help us prepare for the potential commercialization of our lead product candidate, Twirla®(AG200-15),” said Al Altomari, Chairman and Chief Executive Officer of Agile. Mr. Reilly has had significant experience with commercial companies in the pharmaceutical and diagnostics sectors.
Agile Therapeutics, Inc. (AGRX), a women’s healthcare company, today announced that a meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) has been scheduled for October 30, 2019, to review the Company’s New Drug Application (NDA) for its lead product candidate, Twirla® (AG200-15), an investigational low-dose combined hormonal contraceptive patch. Agile resubmitted the NDA for Twirla (AG200-15) on May 16, 2019, and the FDA has assigned a PDUFA (Prescription Drug User Fee Act) goal date of November 16, 2019, for the completion of its review of the Twirla (AG200-15) NDA. “We look forward to the October 30, 2019, meeting with the Advisory Committee, as well as to continuing our dialogue with the FDA about Twirla and the important data, which we believe supports its approval,” said Al Altomari, Chairman and Chief Executive Officer of Agile.
FDA Assigns Prescription Drug User Fee Act (PDUFA) Goal Date of November 16, 2019 PRINCETON, N.J., May 22, 2019 -- Agile Therapeutics, Inc. (Nasdaq:AGRX), a women’s healthcare.
PRINCETON, N.J., May 17, 2019 -- Agile Therapeutics, Inc. (Nasdaq: AGRX), a women’s healthcare company, today announced it has resubmitted to the U.S. Food and Drug.
PRINCETON, N.J., May 09, 2019 -- Agile Therapeutics, Inc. (Nasdaq: AGRX), a women's healthcare company, announced today that its Chairman and Chief Executive Officer, Al.
Agile Therapeutics, Inc., (AGRX), a women's healthcare company, today announced that the combined safety data from three Phase 3 studies of Twirla® (AG200-15), an investigational, once weekly, low-dose hormonal contraceptive patch, will be presented in an interactive ePoster session at the 2019 Annual Clinical and Scientific Meeting of the American Congress of Obstetricians and Gynecologists (ACOG) being held May 3rd – 6th, 2019 in Nashville, Tennessee. The poster, titled “Safety of AG200-15, an Investigational Transdermal Patch, in Three Phase 3 Studies,” will be presented by lead author Anita Nelson, M.D. Dr. Nelson, Professor and Chair of Obstetrics and Gynecology, Western University of Health Sciences, served as Principle Investigator for SECURE, the pivotal Phase 3 study of Twirla (AG200-15).
The Princeton, New Jersey-based company said it had a loss of 13 cents per share. The results did not meet Wall Street expectations. The average estimate of four analysts surveyed by Zacks Investment Research ...
Comparative Wear Trial Completed: On February 11, 2019, the Company announced topline results of a comparative wear study of Twirla® and Xulane®, which demonstrated that Twirla was statistically non-inferior to Xulane, a product the U.S. Food and Drug Administration (FDA) considers to have adequate adhesion. The Company had previously reported that in its December 2018 meeting with FDA’s Division of Bone, Reproductive and Urologic Products, (DBRUP), DBRUP agreed that Twirla would show adequate adhesion if it demonstrated statistical non-inferiority to Xulane in this study. In Vivo Adhesion Data from Two Phase 1 Studies Presented: An abstract presenting data from two Phase 1 in vivo wear studies on the adhesion of Twirla was selected for a poster presentation during the 2nd Annual Formulation & Drug Delivery USA Congress. The poster, titled “Results of Two Phase 1 Clinical Trials on the Adhesion Profile of AG200-15, An Investigational Transdermal Contraceptive Delivery System,” was presented by lead author Terrance Ocheltree, PhD, a former FDA Reviewer and Director of the Division of New Drug Quality Assessment II at the FDA.
PRINCETON, N.J., March 28, 2019 -- Agile Therapeutics, Inc. (Nasdaq: AGRX), a women's healthcare company, announced today that its Chairman and Chief Executive Officer, Al.