AGRX - Agile Therapeutics, Inc.

NasdaqCM - NasdaqCM Real Time Price. Currency in USD
2.8300
+0.0400 (+1.43%)
At close: 4:00PM EST

2.8600 +0.03 (1.06%)
After hours: 5:52PM EST

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Previous Close2.7900
Open2.7900
Bid2.8100 x 2900
Ask2.8700 x 2900
Day's Range2.7000 - 2.8900
52 Week Range0.3500 - 3.1200
Volume1,889,019
Avg. Volume5,869,285
Market Cap197.534M
Beta (5Y Monthly)0.77
PE Ratio (TTM)N/A
EPS (TTM)-0.3870
Earnings DateOct 27, 2019
Forward Dividend & YieldN/A (N/A)
Ex-Dividend DateN/A
1y Target Est4.40
  • The Zacks Analyst Blog Highlights: Agile Therapeutics, Air Industries, Dermira, Microbot Medical and Cassava Sciences
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    The Zacks Analyst Blog Highlights: Agile Therapeutics, Air Industries, Dermira, Microbot Medical and Cassava Sciences

    The Zacks Analyst Blog Highlights: Agile Therapeutics, Air Industries, Dermira, Microbot Medical and Cassava Sciences

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  • GlobeNewswire

    Agile Therapeutics to Present at the 38th Annual J.P. Morgan Healthcare Conference in San Francisco

    PRINCETON, N.J., Jan. 06, 2020 -- Agile Therapeutics, Inc. (Nasdaq: AGRX), a women’s healthcare company, today announced that the company will present at the 38th Annual J.P..

  • Benzinga

    The Daily Biotech Pulse: Acorda Surges As Point72 Hikes Stake, Novan Sinks On Failed Study, Illumina-Pac Bio Terminate Merger

    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 Jan. 2) Agile Therapeutics Inc (NASDAQ: AGRX (announced the ...

  • GlobeNewswire

    Agile Therapeutics Strengthens Commercial Leadership Team

    PRINCETON, N.J., Jan. 02, 2020 -- Agile Therapeutics, Inc. (Nasdaq: AGRX), a women’s healthcare company, today announced the appointment of Kimberly Whelan as Vice President of.

  • Implied Volatility Surging for Agile Therapeutics (AGRX) Stock Options
    Zacks

    Implied Volatility Surging for Agile Therapeutics (AGRX) Stock Options

    Investors need to pay close attention to Agile Therapeutics (AGRX) stock based on the movements in the options market lately.

  • GlobeNewswire

    Agile Therapeutics to Present at Biotech Showcase™ 2020 in San Francisco

    PRINCETON, N.J., Dec. 19, 2019 -- Agile Therapeutics, Inc. (Nasdaq: AGRX), a women’s healthcare company, today announced that it has scheduled a company presentation at Biotech.

  • Hedge Funds Have Never Been More Bullish On Agile Therapeutics Inc (AGRX)
    Insider Monkey

    Hedge Funds Have Never Been More Bullish On Agile Therapeutics Inc (AGRX)

    Amid an overall bull market, many stocks that smart money investors were collectively bullish on surged through the end of November. Among them, Facebook and Microsoft ranked among the top 3 picks and these stocks gained 54% and 51% respectively. Our research shows that most of the stocks that smart money likes historically generate strong […]

  • Benzinga

    The Daily Biotech Pulse: Amarin Gets Unanimous Backing For Vascepa Expansion, BeiGene's Blood Cancer Drug Gets Approval

    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 ...

  • GlobeNewswire

    Agile Therapeutics Announces FDA Extension of Twirla® NDA Review Period

    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.

  • RBC: 3 Stock Picks Set to Soar 30%+
    TipRanks

    RBC: 3 Stock Picks Set to Soar 30%+

    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)

  • Benzinga

    The Daily Biotech Pulse: FDA Nod For Sanofi, BioCryst's Edema Drug In Japan, Myriad's Q1 Disappointment

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  • Agile (AGRX) Stock Surges Over 370%, What’s Next?
    TipRanks

    Agile (AGRX) Stock Surges Over 370%, What’s Next?

    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)

  • MarketWatch

    Agile Therapeutics' stock rockets nearly 4-fold after contraceptive patch Twirla gets favorable FDA committee nod

    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%.

  • Benzinga

    Agile Therapeutics Rallies After FDA Panel Backs Contraceptive Patch

    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.

  • Benzinga

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  • GlobeNewswire

    Agile Therapeutics Announces Favorable Outcome of FDA Advisory Committee Meeting for its Investigational Transdermal Contraceptive Patch, Twirla® (AG200-15)

    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.

  • Agile (AGRX): Should You Catch this Falling Knife?
    TipRanks

    Agile (AGRX): Should You Catch this Falling Knife?

    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)

  • Benzinga

    The Daily Biotech Pulse: Mirati Tastes Success With KRAS Inhibitor, Roche-Spark Deal Delayed Further, Morphosys Halts Study

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  • GlobeNewswire

    Agile Therapeutics Reports Third Quarter 2019 Financial Results

    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.

  • Is Agile Therapeutics (AGRX) Outperforming Other Medical Stocks This Year?
    Zacks

    Is Agile Therapeutics (AGRX) Outperforming Other Medical Stocks This Year?

    Is (AGRX) Outperforming Other Medical Stocks This Year?

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

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

    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.

  • 5 'Strong Buy' Biotech Stocks With Rapidly Approaching Catalysts
    Kiplinger

    5 'Strong Buy' Biotech Stocks With Rapidly Approaching Catalysts

    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