Inside Bar (Bullish)
|Bid||2.0400 x 1300|
|Ask||2.0600 x 1800|
|Day's Range||1.9000 - 2.1000|
|52 Week Range||1.0000 - 7.4800|
|Beta (5Y Monthly)||N/A|
|PE Ratio (TTM)||N/A|
|Earnings Date||May 11, 2020|
|Forward Dividend & Yield||N/A (N/A)|
|1y Target Est||8.81|
The decline came after the company announced the pricing of a stock offering Friday morning. The number of shares being offered represents nearly 20% of the total number of outstanding shares. Stocks usually fall on public offerings because the value of existing shares is diluted.
Menlo Therapeutics Inc. (“Menlo”) (MNLO), a specialty pharmaceutical company focused on developing and commercializing proprietary therapies to address unmet needs in dermatology, today announced the pricing of an underwritten public offering of 27,050,000 shares of common stock at a price to the public of $1.85 per share. All of the shares of common stock to be sold in the offering will be offered by Menlo. In addition, Menlo has granted the underwriters a 30-day option to purchase up to an additional 4,057,500 shares of its common stock.
Menlo Therapeutics Inc. (“Menlo”) (MNLO), a specialty pharmaceutical company focused on developing and commercializing proprietary therapies to address unmet needs in dermatology, today announced that it intends to offer and sell, subject to market conditions, shares of its common stock in an underwritten public offering. All of the common stock to be sold in the offering will be offered by Menlo. In addition, Menlo expects to grant the underwriters a 30-day option to purchase up to an additional 15% of the shares of common stock offered in the public offering.
2020 has been kind to small-cap biotechs. Some have spiked upwards dramatically this year, mostly on the hope of finding solutions to COVID-19, be it a treatment or vaccine. Those who haven’t gotten in on the action yet still yearn to join the fray, might justifiably feel a sense of apprehension. An investment in a stock that has already posted double, or in some cases, triple digit gains feels like risky business.However, the volatile biotech world always presents fresh opportunities. Northland Securities analyst Tim Chiang argues the case for dermatology-focused Menlo Therapeutics (MNLO). Shares are down by a depressing 49% so far this year, but Chiang is anticipating hefty returns from the small-cap.Based on what, you ask?Last Friday, the FDA gave its nod of approval for Zilxi, Menlo’s topical 1.5% minocycline treatment for adults with rosacea. Rosacea is a skin condition marked by redness and clearly noticeable blood vessels on the face.Additionally, Zilxi is the first topical foam formulation containing minocycline to receive the FDA’s stamp of approval, and Chiang believes that by 2026, the product’s sales could reach $120 million. That will make it Menlo’s second largest selling product, only behind acne treatment Amzeeq, which is expected to reach sales of $272 million by 2026.The company plans to launch Zilxi in 4Q20. Based on Chiang’s calculations, the acne and rosacea treatment markets are substantial, believing the former’s TAM (total addressable market) to be worth $5 billion, and the latter around $1 billion.Chiang opined, “With MNLO's focused 50-person sales force already in place, we think the Co. will have the benefit of having two new topical foam products (both containing low doses of minocycline) to detail to dermatologists. We believe the recent approval of ZIlxi adds a complementary product to MNLO's dermatology arsenal. Combined with Amzeeq, we estimate total revenues are likely to increase to $77 million in CY21, and $140 million in CY22.”All of the above prompted Chiang to reiterate an Outperform rating on Menlo. Adding to the good news, he bumped up the price target from $3.50 to $6. There’s upside of 164%, should Chiang’s target be met over the coming months. (To watch Chiang’s track record, click here)The rest of the Street is also optimistic. Based solely on Buys – 8, in fact - Menlo has a Strong Buy consensus rating. With an average price target of $6.93, the analysts forecast gains in the shape of 197% over the next 12 months. (See Menlo stock analysis at TipRanks)To find good ideas for healthcare stocks trading at attractive valuations, visit TipRanks’ Best Stocks to Buy, a newly launched tool that unites all of TipRanks’ equity insights.
Study FX2016-40 enrolled 447 patients in the United States who were randomized to either FCD105 foam, 3% minocycline foam, 0.3% adapalene foam, or vehicle foam. The Company has begun preparations to conduct an End of Phase 2 meeting with the FDA before the end of this year. FCD105 showed a highly statistically significant improvement compared to vehicle for the endpoints of (1) Investigator’s Global Assessment (IGA) treatment success (IGA score “0” or “1” and at least a two-grade improvement from baseline) and (2) absolute change from baseline in mean inflammatory counts at Week 12.
Menlo Therapeutics Inc. (Nasdaq: MNLO) ("Menlo" or the "Company"), a specialty pharmaceutical company focused on developing and commercializing proprietary therapies to address unmet needs in dermatology, today announced that the U.S. Food and Drug Administration (FDA) has approved ZILXI™ (minocycline) topical foam, 1.5%, for the treatment of inflammatory lesions of rosacea in adults. ZILXI, developed as FMX103 by Menlo's wholly-owned subsidiary Foamix Pharmaceuticals Ltd. ("Foamix"), is the first minocycline product of any kind to be approved by the FDA for use in rosacea.
Coverage Effective Immediately on One of the Largest Payor Networks in the U.S. AMZEEQ® is the First FDA Approved Topical Form of Minocycline for the Treatment of Moderate to.
BRIDGEWATER, N.J., May 26, 2020 -- Menlo Therapeutics Inc. (Nasdaq: MNLO) (“Menlo” or the “Company”), a specialty pharmaceutical company focused on developing and.
Robbins Geller Rudman & Dowd LLP Announce Proposed Settlement in the Menlo Therapeutics Inc. Securities Settlement
Out on the Street, small-cap biotechs have taken center stage. Those racing to develop a COVID-19 vaccine or treatment have been thrust into the spotlight, receiving a standing ovation in the form of skyrocketing valuations. But not all names inhabiting this space are involved in the search for coronavirus solutions and the accompanying share gains. Take dermatology-focused Menlo therapeutics (MNLO), for example. The stock is down by 61% year-to-date. That being said, H.C. Wainwright analyst Oren Livnat sees opportunity ahead and highlights the bullish case for the biotech.2020 has marked Menlo’s transition to a commercial stage company. Earlier this year, Menlo merged with fellow dermatology-focused company, Foamix, and during the first quarter, the company launched Foamix’s acne treatment, AMZEEQ, the first-ever FDA approved topical form of minocycline.Having already taken COVID-19’s impact into account when he previously reduced 2020 estimates for AMZEEQ, Livnat is confident the product is about to take off, and projects peak AMZEEQ sales of over $200 million.“We still believe there is high interest in Menlo’s novel topical minocycline, and expect volume to resume a steep upward trajectory post-COVID. Recall that before COVID, AMZEEQ’s initial Rx ramp was strong, exceeding our initial 1Q forecasts by 25% and quickly reaching over 15% of or peak projected volume several years out,” the analyst said.Adding to the good news, there’s another possible catalyst ahead. A June 2 PDUFA date has been set for FMX103 — a potential treatment of papulopustular rosacea. Should the treatment gain approval, Menlo has set its sights on a 4Q launch and has “conservatively” projected peak sales of $66 million.Down to the nitty gritty, what does it all mean for investors? Livnat reiterated a Buy rating on Menlo and based on “higher projected gross margins,” raised the price target from $2 to $2.50. Upside potential from current levels is a solid 37%. (To watch Livnat’s track record, click here)The rest of the Street has even higher hopes for the dermatology specialist. A clean sweep of 6 Buy ratings coalesce into a Strong Buy consensus rating. At $7.10, the average price target could provide upside of a massive 320%, should it be met over the next 12 months. (See Menlo stock analysis on TipRanks)To find good ideas for healthcare stocks trading at attractive valuations, visit TipRanks’ Best Stocks to Buy, a newly launched tool that unites all of TipRanks’ equity insights.
Menlo Therapeutics Inc (MNLO) delivered earnings and revenue surprises of -90.00% and -20.64%, respectively, for the quarter ended March 2020. Do the numbers hold clues to what lies ahead for the stock?
Conference Call Today at 8:30am Eastern Time BRIDGEWATER, N.J., May 11, 2020 -- Menlo Therapeutics Inc. (Nasdaq: MNLO) (“Menlo” or the.
BRIDGEWATER, N.J., May 05, 2020 -- Menlo Therapeutics Inc. (Nasdaq: MNLO) (“Menlo” or the “Company”), a specialty pharmaceutical company focused on developing and.
At the very moment it looked like the market was down for the count, stocks bounced back. After being dealt hefty blows earlier in the week due to the record-breaking drop in oil prices, all three of the major U.S. stock indexes rallied on Friday April 24. The surge was supported by rising crude prices, but it wasn’t quite enough to drive a week-to-date gain, with this figure landing in the red as earnings reports revealed the economic fallout of COVID-19-induced shutdowns. As investors digest all of this, it becomes apparent that there’s an opportunity for those able to take on more risk. Within the biotech space, the effects of COVID-19 have pushed several compelling names’ share prices lower, presenting more affordable entry points. That being said, Wall Street pros remind market watchers that due diligence is required before making any investment decisions as both the volatile nature of the biotech industry and a bargain price tag add up to significant risk. What’s the flip side? Any favorable outcome can catapult a company’s shares through the roof, with even minor share price appreciation translating to huge returns. Bearing this in mind, we used TipRanks’ database to find three compelling biotech stocks all trading for under $4 per share. The cherry on top? Each of the Buy-rated tickers could see their share prices take flight in the next year. Here are all of the details. Menlo Therapeutics Inc. (MNLO) Menlo’s recent rough going has certainly sounded the alarm bells for some investors, with it now going for only $1.41 per share. The company, which develops foam-based products to treat dermatologic conditions, recently announced that it will be discontinuing serlopitant development after the therapy failed to meet the required endpoints in two Phase 3 trials in Prurigo Nodularis Itch. However, several analysts are standing firmly behind MNLO. Cowen’s Ken Cacciatore notes that the June 2 PDUFA date for its FMX-103 candidate in rosacea is keeping him optimistic about the biotech’s long-term growth prospects. Based on the almost perfect clinician overlap, FMX-103 can leverage the infrastructure put in place for its Amzeeq product in moderate-to-severe acne. Expounding on this, Cacciatore said, “...our clinicians continue to highlight their even greater enthusiasm for FMX-103, given that rosacea – although a smaller overall market than acne – has very limited treatment options. Taking the likely lower penetration of Amzeeq into the massive acne market, combined with the likely high penetration of FMX-103 into the smaller rosacea market, we continue to believe that these opportunities could eventually each exceed $250 million-plus in peak sales, which is clearly not reflected in the current valuation.” Additionally, Cacciatore points out that Amzeeq’s initial release was impressive before COVID-19 took hold of the market, with “the launch was progressing as well as – and if not better – than any recent launch in acne.” Total prescriptions hit the 2,150 mark for the week ending March 13, indicating a revenue run-rate of about $20-$25 million.“We are encouraged by the initial response to Amzeeq, and believe it bodes well for the likely re-acceleration that will occur following the normalization post the virus pause,” Cacciatore notedAs MNLO has enough capital to establish both FMX-103 and Amzeeq, it’s no wonder Cacciatore left an Outperform rating on the stock. The analyst's $10 price target leaves room for shares to skyrocket 609% in the next year. (To watch Cacciatore’s track record, click here) All in all, the analyst community echoes Cacciatore’s sentiment. Only Buys have been assigned in the last three months, 6 to be exact, and thus the consensus rating is a unanimous Strong Buy. At $6.80, the average price target puts the upside potential at 382%. (See Menlo price targets and analyst ratings on TipRanks) Aquestive Therapeutics Inc. (AQST) Next up is biotech Aquestive Therapeutics, which uses innovative drug delivery technology to redesign important medicines. With not one but two upcoming PDUFA dates, it’s not surprising that members of the Street think its $3.55 share price represents the ideal entry point. Weighing in for H.C. Wainwright, five-star analyst Raghuram Selvaraju believes that the most valuable piece of the puzzle is its anti-seizure candidate, Libervant, the PDUFA date for which is slated for September 27. “We estimate that Libervant could generate U.S. sales approaching $300 million by 2030. Libervant has been accorded Orphan Drug status, which would confer seven-year market exclusivity upon the product if approved,” he explained. Regarding Libervant’s launch, Selvaraju argues the fact that Sympazan (clobazam), an oral film for Lennox-Gastaut syndrome (LGS)-associated seizures, was launched prior to Libervant provides Aquestive with the opportunity to set up its commercial infrastructure.It should also be noted that Selvaraju sees the recent share price weakness as not fully reflecting AQST’s value, with it boasting several other promising candidates in its pipeline. “In our view, the recent coronavirus crisis-driven market disruption has resulted in massively overdone attrition in Aquestive's share price. The company currently trades at a sub-$60 million market cap, which we believe does not reflect even the value of its manufacturing and licensing-related revenue, let alone revenue generated from its proprietary products,” he commented. One of these candidates is APL-130277, which could be approved on May 21. On top of this, AQST-108 could enter clinical testing this year, and with the annual U.S. epinephrine product market potentially totaling $5.2 billion by 2026, according to Coherent Market Insights, Selvaraju highlights the large opportunity for the biotech.As a result, Selvaraju reiterated a Buy rating and $13 price target. Should this target be met, a twelve-month gain of 266% could be in the cards. (To watch Selvaraju’s track record, click here) Looking at the consensus breakdown, other analysts also see big things in store. With 100% Street support, the message is clear: AQST is a Strong Buy. The $17.33 average price target is more aggressive than Selvaraju’s and suggests 388% upside potential. (See Aquestive stock analysis on TipRanks) BioCryst Pharmaceuticals (BCRX) BioCryst is among those racing to find an effective and safe COVID-19 treatment. Based on these efforts and its bargain $3.56 price tag, one analyst tells investors that now is the time to snap up shares. The company has already opened up the enrollment for its randomized double-blind pbo-controlled clinical trial evaluating its galidesivir drug in patients with COVID-19. Funded by the National Institute of Allergy and Infectious Diseases (NIAID), the trial will be performed in two separate parts and conducted under an amendment to the existing clinical trial for yellow fever in Brazil to enable the study to start sooner. The first part is designed to optimize the dosing regimen for galidesivir, while the second will hopefully validate its activity against pbo. Based on the safety, viral load reduction in respiratory tract secretions, improvement in COVID-19 signs and symptoms and clinical manifestations as well as mortality results from Part 1, BCRX will be able to select the ideal dosing regimen for Part 2. Then in Part 2, the treatment’s efficacy will be determined by time to clinical improvement, time to hospital discharge, time to undetectable viral levels (as measured by PCR in respiratory specimens) and all-cause mortality. Writing for J.P. Morgan, five-star analyst Jessica Fye sees galidesivir as a significant positive for the company. “While no timelines for data were provided today, mgmt noted that Brazil’s infection count is inflecting and along these lines we see potential for this study to enroll relatively quickly, potentially setting up data this summer. Net-net, in light of the ongoing pandemic, we see progress on galidesivir’s development as a potential treatment for COVID-19 as a driver of near-term stock performance although we acknowledge that the value of the opportunity is difficult to quantify,” she stated. All of this prompted Fye to leave her Overweight rating and $5 price target unchanged. With this target, shares could climb 40% higher in the next twelve months. (To watch Fye’s track record, click here) Turning now to the rest of the Street, BCRX’s Moderate Buy consensus rating breaks down into 4 Buys and 2 Holds published in the last three months. In addition, the $7.40 average price target implies shares could soar 108% in the next year. (See BioCryst price targets and analyst ratings on TipRanks)
Under the terms of the agreement, Cutia will have an exclusive license to obtain regulatory approval of and commercialize AMZEEQ™ and, if approved in the U.S., FMX103 and FCD105 in the Greater China territory. Foamix will supply the finished licensed products to Cutia for clinical and commercial use.
Patients were randomized 1:1 to either serlopitant 5mg or placebo treatment. In the merger, Foamix shareholders received 0.5924 shares of Menlo common stock for each share of Foamix held at the closing, plus a contingent stock right (CSR) that would convert into additional shares of Menlo common stock if both results of the Phase 3 trials of serlopitant for pruritus associated with PN were not positive.
Foamix is the owner of patents that have been licensed to LEO Pharma A/S (“LEO Pharma”) to market Finacea® Foam, a topical prescription medicine used to treat the inflammatory papules and pustules of mild to moderate rosacea. This settlement concludes the litigation relating to Finacea® Foam and comes after the settlements in October 2019 with an affiliate of Teva Pharmaceutical Industries Ltd. and in April 2019 with affiliates of Perrigo Company plc.
Mr. Saik will report to David Domzalski, Chief Executive Officer, and will be responsible for leading the Company’s global finance operations, including, financial planning and analysis, investor relations, accounting, tax, treasury, supply chain and information technology. “Andrew is an accomplished CFO and brings a wealth of experience to the senior management team at Menlo,” said David Domzalski, Chief Executive Officer of Menlo Therapeutics.
At this time, Menlo does not anticipate any changes to key clinical and regulatory milestones in 2020, but is continuing to monitor the situation. All patient visits have been conducted and the Company is now focusing on preparations for analyzing the data. Assuming successful completion of the Phase 3 clinical trials, an NDA submission for serlopitant for the treatment of pruritus in PN is planned in the second half of 2020.
Foamix Became a Wholly Owned Subsidiary of Menlo Therapeutics Upon Closing of Merger on March 9, 2020 Menlo Conference Call and Webcast Scheduled for Thursday, March 12 at.
Menlo Therapeutics Inc. (Nasdaq: MNLO) ("Menlo" or the "Company") announced today the completion of its merger with Foamix Pharmaceuticals Ltd. (Nasdaq: FOMX) ("Foamix") following the satisfaction of all closing conditions required by the merger agreement.
Menlo Therapeutics Inc. (MNLO), a late-stage biopharmaceutical company focused on the development of serlopitant for the treatment of pruritus (itch), today announced financial results for the fourth quarter and year ended December 31, 2019 and reviewed business highlights. On February 6, 2020, in the special meeting of Menlo stockholders, Menlo’s merger with Foamix was approved. On the same date, shareholders of Foamix Pharmaceuticals Ltd. also approved all shareholder proposals necessary to complete the merger.