3.1100 +0.02 (0.65%)
After hours: 4:30PM EDT
|Bid||3.0900 x 3100|
|Ask||3.2500 x 3100|
|Day's Range||3.0300 - 3.4300|
|52 Week Range||1.9700 - 5.5300|
|Beta (3Y Monthly)||1.71|
|PE Ratio (TTM)||N/A|
|Earnings Date||Nov 5, 2019 - Nov 11, 2019|
|Forward Dividend & Yield||N/A (N/A)|
|1y Target Est||15.33|
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)
REHOVOT, Israel and BRIDGEWATER, N.J. , Oct. 10, 2019 /PRNewswire/ -- Foamix Pharmaceuticals Ltd. (Nasdaq: FOMX) ("Foamix" or the "Company"), a clinical stage specialty pharmaceutical ...
Foamix (FOMX) enrolls first patient in phase II study on its topical combination foam, FCD105, for the treatment of moderate-to-severe acne vulgaris.
REHOVOT, Israel and BRIDGEWATER, N.J., Sept. 20, 2019 -- Foamix Pharmaceuticals Ltd. (NASDAQ: FOMX) (“Foamix” or the “Company”), a clinical stage specialty pharmaceutical.
Foamix Pharmaceuticals Ltd. (FOMX), today announced that the first patient has been enrolled in its Phase 2 clinical trial to evaluate the efficacy and safety of its topical combination foam, comprised of minocycline 3% and adapalene 0.3%, FCD105 for the treatment of moderate-to-severe acne vulgaris. “FCD105 combines minocycline and adapalene, which are two leading agents for treating inflammatory and non-inflammatory comedonal acne lesions, respectively, in a convenient, foam-based product.
Foamix Pharmaceuticals Ltd. (FOMX) (“Foamix” or the “Company”), a clinical stage specialty pharmaceutical company focused on developing and commercializing proprietary topical therapies to address unmet needs in dermatology, today announced that the U.S. Patent and Trademark Office has issued U.S. Patent No. 10,398,641 covering a method of treating acne that expires in 2037. U.S. Patent No. 10,398,641 is directed to a method related to the use and topical administration of certain minocycline formulations once daily for at least seven consecutive days to treat acne vulgaris within middle adolescence. This newly issued patent is the latest U.S. patent to issue to Foamix in connection with Foamix’s drug development programs for treating acne vulgaris, and expires in September 2037.
Foamix Pharmaceuticals (FOMX) may be the best drug stock opportunity you've never heard of -- and you should probably prepare yourself to hear a lot more about it.Over the past 12 months, tiny Foamix has reported a bare $2 million in revenue. So naturally, when British investment bank Barclays revealed two months ago that it thinks Foamix could do $272 million in annual sales by 2025 -- and grow its stock price four times over the next year -- that caused quite a stir. Last week, Bank of America analyst Jason Gerberry seconded the emotion in a note positing 350% upside in the stock.Even that prediction pales in comparison to what a third analyst -- this time Ken Cacciatore of Cowen & Co. -- is now saying. In a bull argument to beat all bull arguments, Cacciatore stated that in his opinion, Foamix could be on track to do as much as $600 million in peak annual sales, and Foamix stock could be worth as much as $30 a year from now --as much as 1,000% more than what it costs today.This seems like just outlandish enough of a proposal to justify taking a look, even if Foamix is doing essentially no sales whatsoever today. So let's go ahead and do that.First, a brief recap of the company and its business. Foamix has two products in development, both targeting the dermatology market. Both products are topical minocycline products, with the main difference being that "FMX101" is a formulation targeting acne, while "FMX103" addresses rosacea.Both products are wrapping up Phase III clinical trials with the FDA, and both work essentially the same way, even though they treat different conditions. To wit, a liquid medication is salved into the skin, and it acts to lower the melting point of facial "sebum" (an oily substance that can block pores and permit bacteria to grow within the skin, resulting in acne or rosacea), with the result that the oil melts away, allowing the pores (and any bacteria within them) to be exposed to the air, inhibiting microbial growth.In late 2018 results from the clinical trials, reports Cacciatore, FMX103 was proven to be "safe and effective" for the treatment of "moderate-to-severe papulopustular rosacea." More than that, says the analyst: The results of the study were "impressive," and statistically significant to boot, with "81.6%" of patients in the trial showing improvement in their condition after 52 weeks of treatment.At this point, Cacciatore says he sees "essentially no clinical development risk" attached to either formulation, meaning that once the FDA approves them for sale, Foamix should see no obstacle to marketing the treatments through its sales force of "50+ sales reps focusing on the 6,000 prescribers that cover roughly 75% of the acne prescription market." FMX101 could be approved as early as October 20, 2019, and FMX103 could follow in a few months. Its New Drug Application was filed with the FDA just last week.Nor will financing be an issue once approvals are in hand. "Foamix is well-financed for the initial FMX101 commercialization period," argues the analyst, "having raised $64MM in July ... and ending Q2 with $70MM in cash." At current cash burn rates, that should be enough to keep Foamix afloat for more than a year as sales ramp up -- longer, if the costs of running clinical trials abate, as seems likely.With financing in hand and a likely receptive market in the form of anxious teens and long-suffering rosacea patients seeking a solution to their little-understood disease, Foamix looks well positioned to prosper once the FDA gives it the green light. Whether the stock will rise 1,000% though, as Cowen promises ... well, let's see how the product sells once it's on the market before we say any more about that.All in all, Wall Street’s confidence on the drug maker speaks for itself; FOMX has received a whopping 4 'buy' ratings in the last three months. Meanwhile, the $15.75 consensus price target suggests a potential upside of 488% from the current share price.To discover Wall Street’s best-rated trending stocks on TipRanks, click here.
Foamix (FOMX) hasn't had a great year, with shares falling 33% since the start of 2019. But things aren’t as bad as they may seem, argues Bank of America analyst Jason Gerberry.The analyst reiterated a Buy rating on the stock, citing an attractive valuation and pipeline optionality. Gerberry also went out on a limb and maintained an ultra-bullish price target of $11. For perspective, Foamix's stock closed at $2.39 yesterday, so this implies upside of more than 350%.Yesterday, the company outlined its ambitious strategy in its earnings conference call. Gerberry has compiled the following takeaways from the call: 1. NDA review - FOMX is through mid-cycle review with the FDA and remains confident for the anticipated approval of '101 in October. 2. Launch preparation - sales force alignment is underway (hiring offer to be made contingent on FDA approval). FOMX remains on track for early January launch of FMX-101, and plans to have 51 sales rep ready at launch. 3. Pricing - launch price has not been finalized for FMX101, but mgmt. reiterated expectation that reimbursement access with limited restriction (tier 2 to tier 3) is feasible for FMX-101 with a net-to plan pricing range of $200-$400m. 4. FCD105 (acne) - FMX plans to initiate a Phase 2 trial of FCD105, a topical foam formulation that combines 3% minocycline (anti-bacterial) and 0.3% of adapalene (anti-inflammatory), for the treatment of acne in 3Q19. The trial will be a randomized US study of ~400 patients, with topline results expected mid-2020.Overall, this acne drug maker stands as a 'Strong Buy' name among Wall Street analysts. In the last three months, FOMX has won three bullish recommendations. With a return potential of close to 360%, the stock's consensus price target lands at $11.00.To discover Wall Street’s best-rated trending stocks on TipRanks, click here.
REHOVOT, Israel and BRIDGEWATER, N.J., Aug. 5, 2019 /PRNewswire/ -- Foamix Pharmaceuticals Ltd. (FOMX), a clinical stage specialty pharmaceutical company focused on developing and commercializing proprietary topical therapies to address unmet needs in dermatology, today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for FMX103 for the treatment of moderate-to-severe papulopustular rosacea in patients 18 years of age and older. Rosacea is a common skin condition that causes redness and visible blood vessels in the face. Rosacea can be mistaken for acne, an allergic reaction or other skin problems.
Foamix (FOMX) doesn't possess the right combination of the two key ingredients for a likely earnings beat in its upcoming report. Get prepared with the key expectations.
Foamix Pharmaceuticals Ltd. (FOMX), (“Foamix”), a clinical stage specialty pharmaceutical company focused on developing and commercializing proprietary topical therapies to address unmet needs in dermatology, today announced that it has secured up to $64 million in financing from Perceptive Advisors and OrbiMed. The financing consists of term loans of up to $50 million under a Credit Agreement, with $15 million provided immediately upon satisfaction of certain closing conditions, $20 million available upon the achievement of certain regulatory milestones and $15 million available upon the achievement of certain revenue milestones. Additionally, the Company will receive $14 million in gross proceeds from Perceptive Advisors through a direct registered offering of the Company’s ordinary shares.
REHOVOT, Israel, and BRIDGEWATER, N.J., July 24, 2019 -- Foamix Pharmaceuticals Ltd. (NASDAQ: FOMX), (“Foamix”), a clinical-stage pharmaceutical company that specializes in.
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Investment banker Barclays announced it has initiated coverage of 20 U.S. specialty pharmaceuticals stocks.But which 20 stocks within this sector are we talking about today? They include generic drugs companies Mylan (MYL), which Barclays rates Overweight (i.e. 'buy') and Teva Pharmaceutical Industries (TEVA), which the analyst rates Underweight (i.e. 'sell'), as well as: * Amneal Pharmaceuticals (AMRX) * Endo International (ENDP) * Reddy's Laboratories (RDY) * and Mallinckrodt plc (MNK)Each of which is rated Equal weight (i.e. 'hold').Within the animal health sector (i.e. veterinary medicine), Barclays initiates coverage with Overweight ratings on Zoetis (ZTS) and Kindred Biosciences (KIN), but gives Phibro Animal Health Corporation (PAHC) an Underweight rating.Among developmental and commercial stage companies "with unique products & segments," Barclays has two 'sells' -- Allergan (AGN) and Evolus (EOLS) -- and one hold: Ligand Pharmaceuticals (LGND). As for Barclays' 'buy' ratings, it rates the following companies Overweight ratings: * AMAG Pharmaceuticals (AMAG) * Jazz Pharmaceuticals (JAZZ) * Osmotica Pharmaceuticals (OSMT) * Coherus BioSciences (CHRS) * Pacira BioSciences (PCRX) * Revance Therapeutics (RVNC) * Bausch Health Companies (BHC) * and Foamix Pharmaceuticals (FOMX)Today, we really only have time to glance at just one of these stocks: Rehovot, Israel-based Foamix.Foamix is a late clinical-stage specialty pharmaceutical company focusing on foam-based medications for the treatment of acne and rosacea. Foamix stands out in this report primarily by virtue of the extremely high hopes Barclays' has for it, namely, valued at just $2.53 per share today, Barclays believes that within a year, Foamix stock will be selling for $10 -- a four-bagger in just one year.Why is Barclays so optimistic? As the analyst explains, Foamix is on the cusp of becoming a "commercial stage company" -- i.e. a company with actual revenue from sales, a rarity in small drugs stocks -- thanks to its topical Minocycline product for acne and rosacea. Designated "FMX-101" for acne treatment and "FMX-103" for rosacea, both these foam-based products "combine [the] proven efficacy of minocycline with a more tolerable side effect profile" says Barclays. From $3 million in annual revenue today, the banker predicts Foamix could do as much as $272 million in annual sales by 2025E.Considering that the entire company has a market cap of barely half that number -- $138 million -- today, Foamix at least seems to have earned its place on Barclays' list.Foamix has a few upcoming catalysts that could send its shares surging higher: * There is a scheduled PDUFA for FMX-101 on October 20, 2019. This is a key event for Foamix, as FMX-101 is its lead product in acne. * Foamix anticipates filing an NDA in mid-2019 for FMX-103 in moderate-to-severe papulopustular rosacea. * FCD-105 Phase II study initiation in mid-2019: FCD-105 is another pipeline product being evaluated in patients with acne and is a foam-based combination of minocycline and adapalene."We value Foamix on a DCF basis, assuming an 11.5% discount rate and a 3% terminal growth. We include risk adjusted pipeline values for both FMX-101 (90% probability of success) and FMX-103 (70% probability of success). We also assume base uptake of FMX-101, reaching 2025 risk-adj. sales of ~$200mm. This scenario yields a value of ~$10/share and serves as the basis for our price target," Barclays noted.Read more: Foamix (FOMX): A Beaten-Down Biotech Stock That Looks Like a Bargain Now More recent articles from Smarter Analyst: * Why Pot Stock Giant Canopy Growth (CGC) Will Continue to Struggle * Wall Street’s 1 Analyst Sees Over 25% Upside for These 3 Tech Stocks * RBC: 3 Semiconductor Stocks Primed for Gains * 3 "Strong Buy" Energy Stocks Ready to Rally
REHOVOT, Israel and BRIDGEWATER, N.J., June 04, 2019 (GLOBE NEWSWIRE) -- Foamix Pharmaceuticals Ltd. (FOMX), a clinical-stage pharmaceutical company that specializes in developing and commercializing proprietary topical therapies for dermatological conditions, announced today the peer review publication of the Phase 3 study FX2017-22 (“Study 22”) in the Journal of the American Academy of Dermatology (JAAD). Study 22 was conducted by Foamix to support the New Drug Application (NDA) submission of FMX101, which is currently under review by the FDA for the treatment of inflammatory lesions of non-nodular moderate-to-severe acne vulgaris in patients nine years of age and older. “We are pleased that the prestigious JAAD has chosen to highlight Study 22 in its current edition,” said Dr. Iain Stuart, Chief Scientific Officer of Foamix. “The American Academy of Dermatology is the largest and most influential dermatology group in the United States and JAAD is the ideal platform to share the results from this successful Phase 3 study with the broader clinical dermatology community.
Get ready, bargain shoppers. Foamix (FOMX) has plummeted 27% since the beginning of the year and it looks like the stock received more lashes than it deserved -- at least, according to Wall Street analysts.2019 is poised to be a transformative year for Foamix. The company's acne treatment FMX101 is currently pending regulatory review in the U.S, and a PDUFA date of October 20, 2019 has been set. Furthermore, Foamix plans to submit a New Drug Application (NDA) for FMX103 during mid-2019, following positive long-term safety data in papulopustular rosacea patients. Now, let's take a closer look at what analysts are expecting ahead of October's FDA decision.FMX101's Approval Chances and ForecastsCredit Suisse analyst Vamil Divan sees a high likelihood of regulatory approval for FMX101, applying a 90% probability of success (POS). The analyst rates FOMX stock an Outperform with a $9.00 price target, which implies nearly 250% upside from current levels. With an FDA approval in hand (100% POS), Divan says his price target will be boosted to $11.00. According to the analyst, "an increase in the sample size (1,507 patients in this trial vs. ~500 each in the two prior trials) and improved site selection and training helped drive statistically significant [clinical] results," which put the company on track to win FDA approval.Similarly, H.C Wainright analyst Ram Selvaraju estimates the probability of regulatory approval at 85%, and assigns a $12.00 price target for the stock. If the price target is reached within 12 months, that would provide a 12-month return of nearly 360%. Selvaraju opined, "We believe that the current valuation situation presents an attractive entry point for value-focused investors, given the fact that Foamix currently trades about 2x book value [...] Our risk-adjusted net present value (rNPV) of FMX101 is $400M, which factors in an 85% probability of regulatory approval [...] We have employed a sum-of-the-parts valuation approach that yields a total projected firm value of $696M, which translates into a price objective of $12.00 assuming ~59M fully-diluted shares outstanding as of end-2019."Commercial Opportunity Selvaraju believes investors seem to be discounting both FMX101 and FMX103 from a commercial standpoint, but "this is unwarranted." Why? "These agents are based on well-known, validated and effective compounds in their respective target indications and have generated statistically significant efficacy data in large, robustlypowered pivotal studies. We also draw investors' attention to the large size and underserved nature of the target markets—namely, acne and rosacea—and the willingness of patients and physicians alike to try new formulations when they are introduced. Furthermore, we point to the user-friendly and well-tolerated nature of the Foamix formulations, which utilize the company's proprietary foam-based delivery technology to enhance efficacy while minimizing off-target systemic side effects," Selvaraju answers.Cowen analyst Ken Cacciatore has recently spoken with 3 dermatology KOLs; they all agreed that "the clinical data were as good or better than they would have expected," and, according to the analyst, one has indicated that "it looked "more impressive" than Aczone (which peaked at over $200MM+ before genericization)." Cacciatore believes that given the wide use of oral minocycline, clinicians are eager to have this option with potential similar efficacy yet without the the systemic side effects, and therefore, the marketing of FMX-101 should be a very easy story to tell. The analyst says "FMX-101 should be able to easily surpass the peak prescription levels of Aczone (via our consultants' feedback)," and "this would place FMX-101 to achieve at least $250MM in revenue." Furthermore, the analyst believes FMX-101 could ultimately reach his target of $350MM given what he believes will be "improved efficacy/outcomes." Cacciatore argues that "even undifferentiated dermatology assets are selling at 3x peak revenue. Using just FMX-101 alone – and the low-end ($250MM) of what we believe will be the ultimate product size – would yield a value of $750MM, or $13-15 per share."Bottom lineFoamix has seen its shares struggle mightily this year, but analysts continue to believe that this beaten-down biotech stock is a sure-fire winner. Analysts are confident that lead asset, FMX101, has substantial potential in treating acne, with an upcoming October 20, 2019 PDUFA date as a key potential positive catalyst for FOMX shares.This latest pullback has arguably skewed the risk-to-reward ratio for the better -- perhaps making FOMX an attractive buy for risk-tolerant investors. More recent articles from Smarter Analyst: * Why Pot Stock Giant Canopy Growth (CGC) Will Continue to Struggle * Wall Street’s 1 Analyst Sees Over 25% Upside for These 3 Tech Stocks * RBC: 3 Semiconductor Stocks Primed for Gains * 3 "Strong Buy" Energy Stocks Ready to Rally
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Foamix (FOMX) delivered earnings and revenue surprises of -16.67% and -67.58%, respectively, for the quarter ended March 2019. Do the numbers hold clues to what lies ahead for the stock?
The Rehovot, Israel-based company said it had a loss of 28 cents per share. The acne treatment developer posted revenue of $308,000 in the period. In the final minutes of trading on Tuesday, the company's ...