AGRX - Agile Therapeutics, Inc.

NasdaqGS - NasdaqGS Real Time Price. Currency in USD
1.2900
-0.0100 (-0.77%)
At close: 4:00PM EDT
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Previous Close1.3000
Open1.3300
Bid0.0000 x 1400
Ask0.0000 x 40000
Day's Range1.2700 - 1.3400
52 Week Range0.3230 - 1.7000
Volume668,218
Avg. Volume468,587
Market Cap76.5M
Beta (3Y Monthly)-0.48
PE Ratio (TTM)N/A
EPS (TTM)N/A
Earnings DateN/A
Forward Dividend & YieldN/A (N/A)
Ex-Dividend DateN/A
1y Target EstN/A
Trade prices are not sourced from all markets
  • Agile Therapeutics (AGRX) Upgraded to Strong Buy: Here's What You Should Know
    Zacks

    Agile Therapeutics (AGRX) Upgraded to Strong Buy: Here's What You Should Know

    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.

  • 3 “Strong Buy” Biotech Stocks Ahead of FDA Verdicts
    SmarterAnalyst

    3 “Strong Buy” Biotech Stocks Ahead of FDA Verdicts

    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

  • Agile (AGRX) Stock Could Be Ready to Break Out
    TipRanks

    Agile (AGRX) Stock Could Be Ready to Break Out

    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.

  • New Strong Buy Stocks for August 22nd
    Zacks

    New Strong Buy Stocks for August 22nd

    New Strong Buy Stocks for August 22nd

  • Associated Press

    Agile Therapeutics: 1Q Earnings Snapshot

    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 ...

  • Zacks Small Cap Research

    AGRX: Numerous Catalysts in 2019…

    Agile Therapeutics, Inc. (AGRX) is a women’s healthcare company focused on developing healthcare products to fulfill the unmet contraceptive needs of women. The company’s lead candidate product, Twirla® (AG200-15), is a once-weekly low-dose hormonal contraceptive patch that contains the active ingredients ethinyl estradiol (EE, a synthetic estrogen) and levonorgestrel (LNG, a type of progestin). The patch utilizes the company’s Skinfusion technology, which allows Twirla® to be the first contraceptive patch capable of delivering LNG across the skin in a reliable manner.

  • Associated Press

    Agile Therapeutics: 4Q Earnings Snapshot

    The Princeton, New Jersey-based company said it had a loss of 11 cents per share. The results exceeded Wall Street expectations. The average estimate of three analysts surveyed by Zacks Investment Research ...

  • Zacks Small Cap Research

    AGRX: Positive Results for Twirla® Adhesion Study; NDA Resubmission in 2Q19

    On February 11, 2019, Agile Therapeutics, Inc. (AGRX) announced positive topline results for the comparative adhesion study that tested the company’s investigational low-dose once-weekly contraceptive patch (Twirla®) against Xulane®, the generic version of the contraceptive patch Ortho Evra®. The trial was designed to show non-inferiority in adhesion between Twirla® and Xulane®.

  • Zacks Small Cap Research

    AGRX: Twirla® Adhesion Study Underway; NDA Resubmission in 2Q19…

    The meeting was held to discuss the company’s comparative wear study between Twirla® and Xulane®, the generic version of the contraceptive patch Ortho Evra®, including the specific design and success criteria. The trial is designed to show non-inferiority in adhesion between Twirla® and Xulane®. Following receipt of the official meeting minutes, Agile has initiated the adhesion study in approximately 80 healthy women with a body mass index (BMI)

  • Benzinga

    The Daily Biotech Pulse: Agile Gives Regulatory Update On Contraceptive Patch, Advaxis Misses Estimates, Ocular Submits sNDA

    Here's a roundup of top developments in the biotech space over the last 24 hours: Scaling The Peaks The following biotech stocks hit 52-week highs Jan. 10:  Takeda Pharmaceutical Co Ltd (NYSE: TAK*) Veracyte ...

  • Agile Therapeutics Inc (NASDAQ:AGRX): Are Analysts Optimistic?
    Simply Wall St.

    Agile Therapeutics Inc (NASDAQ:AGRX): Are Analysts Optimistic?

    Agile Therapeutics Inc’s (NASDAQ:AGRX): Agile Therapeutics, Inc., a women’s healthcare company, focuses on the development and commercialization of prescription contraceptive products for women. With the latest financial year loss of Read More...

  • Zacks Small Cap Research

    AGRX: Awaiting Details of Adhesion Study for Twirla®…

    On October 9, 2018, Agile Therapeutics, Inc. (AGRX) announced that the company has concluded the formal dispute resolution with the U.S. Food and Drug Administration (FDA) regarding the complete response letter (CRL) issued for the new drug application (NDA) of Twirla®. While the FDA’s Office of New Drugs (OND) denied the company’s appeal, the agency did provide the company with a potential path to an NDA resubmission that would not include reformulating Twirla® or doing any type of bridging studies.

  • Associated Press

    Agile Therapeutics: 3Q Earnings Snapshot

    On a per-share basis, the Princeton, New Jersey-based company said it had a loss of 11 cents. The results surpassed Wall Street expectations. The average estimate of four analysts surveyed by Zacks Investment ...

  • Zacks Small Cap Research

    AGRX: FDA Provides Path to NDA Resubmission for Twirla®…

    On October 9, 2018, Agile Therapeutics, Inc. (AGRX) announced that the company has concluded the formal dispute resolution with the U.S. Food and Drug Administration (FDA) regarding the complete response letter (CRL) issued for the new drug application (NDA) of Twirla®. While the FDA’s Office of New Drugs (OND) denied the company’s appeal, the agency did provide the company with a potential path to an NDA resubmission that would not include reformulating Twirla® or doing any type of bridging studies.