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Ocuphire Pharma, Inc. (OCUP)

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4.4000-0.1500 (-3.30%)
At close: 4:00PM EDT

4.8700 +0.47 (10.68%)
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Neutralpattern detected
Previous Close4.5500
Open4.5800
Bid4.5600 x 800
Ask4.6500 x 3200
Day's Range4.3500 - 4.5800
52 Week Range3.6800 - 14.8000
Volume324,015
Avg. Volume232,195
Market Cap50.739M
Beta (5Y Monthly)N/A
PE Ratio (TTM)N/A
EPS (TTM)N/A
Earnings DateMar 10, 2021
Forward Dividend & YieldN/A (N/A)
Ex-Dividend DateN/A
1y Target Est23.50
  • Ocuphire Granted Two New U.S. Patents Covering Late-Stage Drug Candidate Nyxol®, Including for the Treatment of Presbyopia
    GlobeNewswire

    Ocuphire Granted Two New U.S. Patents Covering Late-Stage Drug Candidate Nyxol®, Including for the Treatment of Presbyopia

    Newly Issued Claims Extend Patent Protection to Year 2039 for Nyxol® Combination Therapy for Presbyopia Provides Broader Protection for Nyxol® Across Indications on Methods of Use as Daily Administration FARMINGTON HILLS, Mich. , May 18, 2021 (GLOBE NEWSWIRE) -- Ocuphire Pharma, Inc. (Nasdaq: OCUP), a clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing therapies for the treatment of several eye disorders, announced today that the United States Patent and Trademark Office (USPTO) has issued two patents covering the Company’s late-stage product candidate, Nyxol (phentolamine mesylate). Both patents are directed to categories of subject matter eligible for listing in the U.S. FDA Orange Book: Nyxol for Treatment of Presbyopia: U.S. Patent No. 10,993,932 issued on May 4, 2021 with claims to methods of treating presbyopia using a combination of phentolamine mesylate and low-dose pilocarpine. The term of this patent is to year 2039.Nyxol for Daily Administration: U.S. Patent No. 11,000,509 issued on May 11, 2021 with claims to methods of improving visual performance by daily administration of phentolamine mesylate at or near bedtime of the patient alone or in combination with one or more additional therapeutic agents. The term of the patent is to year 2034. “We are quite pleased to announce the issuance of these two new U.S. patents that further strengthen our already robust patent portfolio for Nyxol,” said Mina Sooch, MBA, President and CEO of Ocuphire Pharma. “As we continue to meet milestones in our ongoing clinical trials investigating Nyxol for various refractive indications, patents like these provide the protection necessary to ensure commercial success. Importantly, Ocuphire owns all of the worldwide rights to Nyxol for all indications. These broader and new claims for daily use and presbyopia respectively reflect several years of strategic effort by our team and our patent counsel Dechert LLP. The timing is ideal with our recent announcement of enrollment completion in the VEGA-1 Phase 2 presbyopia trial and the upcoming expected top-line results by the end of June.” Nyxol® Eye Drops Patent Estate Ocuphire’s patent estate for Nyxol includes patents and patent applications for phentolamine mesylate formulations and methods of using phentolamine mesylate. Patent expiry on issued patents in the U.S. and globally are at least through 2034. As of May 17, 2021, Ocuphire’s patent estate relating to Nyxol contains seven issued U.S. patents, five pending U.S. non-provisional patent applications, one pending U.S. provisional patent application, as well as issued patents in Australia, Europe, Japan, and Mexico and pending patent applications in Australia, Canada, Japan, and other foreign countries. Ocuphire owns all of the worldwide rights to Nyxol for all indications. About Ocuphire Pharma Ocuphire is a publicly traded (NASDAQ: OCUP), clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing therapies for the treatment of several eye disorders. Ocuphire’s pipeline currently includes two small-molecule product candidates targeting front and back of the eye indications. The company’s lead product candidate, Nyxol® (0.75% phentolamine ophthalmic solution) Eye Drops, is a once-daily preservative-free eye drop formulation of phentolamine mesylate, a non-selective alpha-1 and alpha-2 adrenergic antagonist designed to reduce pupil size, and is being developed for several indications, including dim light or night vision disturbances (NVD), reversal of pharmacologically-induced mydriasis (RM), and presbyopia, and has been studied in 8 clinical trials including the recently completed Phase 3 trial in RM. Ocuphire reported positive topline data in March 2021 for MIRA-2, a Phase 3 FDA registration study for treatment of RM. Nyxol is also currently in Phase 3 clinical development for NVD and in Phase 2 for presbyopia. Ocuphire’s second product candidate, APX3330, is an oral tablet designed to inhibit angiogenesis and inflammation pathways relevant to retinal and choroidal vascular diseases, such as diabetic retinopathy (DR) and diabetic macular edema (DME) and has been studied in 11 Phase 1 and 2 trials. APX3330 is currently enrolling subjects in a Phase 2 clinical trial in subjects with DR/DME. As part of its strategy, Ocuphire will continue to explore opportunities to acquire additional ophthalmic assets and to seek strategic partners for late-stage development, regulatory preparation, and commercialization of drugs in key global markets. Please visit www.clinicaltrials.gov to learn more about Ocuphire’s completed Phase 2 trials, recently completed Phase 3 registration trial (NCT04620213), ongoing Phase 3 registration trial (NCT04638660), Phase 2 trial in presbyopia (NCT04675151), and Phase 2 trial in DR/DME (NCT04692688). For more information, please visit www.ocuphire.com. Forward Looking Statements Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements concerning Ocuphire’s product candidates, results of ongoing and future clinical trials, and commercialization and market opportunities. These forward-looking statements are based upon Ocuphire’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, including, without limitation: (i) the success and timing of regulatory submissions and pre-clinical and clinical trials, including enrollment and data readouts; (ii) regulatory requirements or developments; (iii) changes to clinical trial designs and regulatory pathways; (iv) changes in capital resource requirements; (v) risks related to the inability of Ocuphire to obtain sufficient additional capital to continue to advance its product candidates and its preclinical programs; (vi) legislative, regulatory, political and economic developments, (vii) changes in market opportunities, (viii) the effects of COVID-19 on clinical programs and business operations, (ix) the success and timing of commercialization of any of Ocuphire’s product candidates and (x) the maintenance of Ocuphire’s intellectual property rights. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the risk factors detailed in documents that have been and may be filed by Ocuphire from time to time with the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. Ocuphire undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made. Ocuphire Contacts Mina Sooch, President & CEO Ocuphire Pharma, Inc. ir@ocuphire.com www.ocuphire.com Corey Davis, Ph.D. LifeSci Advisors cdavis@lifescieadvisors.com

  • 2 “Strong Buy” Penny Stocks That Could See Outsized Gains
    TipRanks

    2 “Strong Buy” Penny Stocks That Could See Outsized Gains

    Market volatility is up in recent sessions, and while that may have applied a brake to the upward trend, it also opens up opportunities for investors willing to shoulder some extra risk. Because in the markets, we frequently see that what goes down, must come back up. It’s logic behind the old cliché to ‘buy low and sell high,’ and while it may sound obvious, it’s still a sound way to make money. And in the stock market, there are no ‘lower’ stocks than the penny stocks. These are equities that trade for less than $5 per share, the very bottom of the price range. While they are priced that low for a reason – and the reasons may vary – low price in itself doesn’t mean that the stock’s fundamentals are sour. Smart investors can find some true bargains among the penny stocks, and set themselves up for outsized gains. What’s the flip side? Minor share price depreciation can fuel major percentage losses. By nature of these massive movements, penny stocks are notoriously volatile. Using TipRanks’ database, we identified two penny stocks the pros believe could see outsized gains in the coming months. Not to mention each one gets a “Strong Buy” consensus rating from the analyst community. GlycoMimetics (GLYC) The first penny stock we're looking at is a pharmaceutical company with a focus on oncology therapies. GlycoMimetics' mission is to discover, develop, and commercialize new small-molecule glycomimetic drug candidates. The company’s research is focused on the complex carbohydrates that coat all human cells – and are frequently involved various disease processes, including cancers and inflammatory disorders. GlycoMimetics is working with several compounds – five in all – that are designed to selectively target particular molecular mechanisms functioning in carbohydrate biology. The company’s lead candidate, farthest along the development pathway, is GMI-1271, also called uproleselan. This is a first-in-class targeted inhibitor of E-selectin, and has received Breakthrough Therapy Designation from the FDA as a treatment for adults with Acute myelogenous leukemia (AML). The drug is currently in a Phase 3 trial. Earlier trials showed positive results when uproleselan was combined with existing chemotherapy treatments, including better than expected remission rates and higher overall survival. The drug was well-tolerated, and adverse effects were fewer than had been anticipated. In the Phase 3 study for uproleselan, the company is optimistic on reaching year-end 2021 targets for completing enrollment in a pivotal trial on patients with relapsed or refractory AML. GlycoMimetics has also received, through its collaborator in China, Apollomics, Breakthrough Therapy Designation for that country, and in March the collaborator began dosing patients in a Phase 1 study. GlycoMimetics second leading drug candidate, GMI-1359, target tumor trafficking and metastatic spread, through inhibition of E-selectin and CXCR4, two adhesion molecules. The drug candidate showed promise in pre-clinical tests, and this past April the company reported additional positive results, including immune activation, in the first two patients to be dosed in a proof-of-concept Phase 1b study. The study evaluates GMI-1359 as a treatment for advanced breast cancer with bone metastases. Based on the company's clinical programs and its $2.25 share price, major returns could be on the horizon, according to Roth Capital analyst Zegbeh Jallah. Jallah points out the continued success of studies involving uproleselan, writing of the company’s program update: “Most important, it seemed, was the expected 2H21 enrollment completion of the ongoing Phase 3 studies of Uproleselan (E-selectin) in AML... Regarding the exact timing of the readouts, management noted that more color will be provided later, given that the readouts are event-dependent. As soon as those events occur, they'll be able to provide more granular timelines. However, it is likely that the NCI-sponsored study could meet the criteria to trigger an analysis of event-free-survival (EFS) during 1H22... This has been viewed by many as a non near-term catalyst, but as we race through 2021 the opportunity is indeed coming into view." The analyst summed up, "With the progress of Uproleselan, which helps validate multiple other off-shoot programs in the pipeline that also target E-selectin, this remains a good long-term buy... We would expect more interest in this program as we make it through the year, given the strong scientific rationale and the drug being selected for an NCI-sponsored study... Overall, we continue to believe that Uproleselan could become a broadly used drug, with multi-blockbuster sales potential." To this end, Jallah rates GLYC a Buy along with a $15 price target. Shares could appreciate by 567%, should the analyst’s thesis play out in the coming months. (To watch Jallah’s track record, click here) The company’s progress has attracted 3 unanimous positive reviews from Wall Street, giving it a Strong Buy consensus rating. Based on the $14.50 average price target, the upside potential comes in at 544%. (See GLYC stock analysis on TipRanks) OcuPhire Pharma (OCUP) Sticking with the biotech sector, we’ll shift from cancer research to eye disorders. OcuPhire Pharma is focused on developing and marketing new treatments for disorders at both the front and back of the eye. The company’s pipeline has two main products under development; Nyxol, an eyedrop product, is designed to both reduce pupil size and improve visual acuity, and has indications for disturbances of night vision or low-light-level vision, presbyopia, and pharmacologically-induced mydriasis. The drug candidate has completed seven Phase 1 and 2 trial studies, on a total of 230 patients. The second leading candidate, APX3330, is an oral tablet targeting retinal and choroidal vascular diseases that affect the back of the eyeball. The drug inhibits angiogenesis and inflammation pathways, and is indicated for treatment of diabetic retinopathy and diabetic macular edema. Like Nyxol above, APX3330 has completed numerous early stage trials, including six Phase 1 studies and five Phase 2 studies. The drug has been followed in over 440 patients across those studies. During the first quarter, OcuPhire reported positive early results in the Phase 3 MIRA-2 trial with Nyxol. The product met primary and secondary endpoints on efficacy. In addition, Nyxol was initiated in the Phase 2 VEGA-1 trial, evaluating it in combination with pilocarpine as a treatment for presbyopia. Also in the quarter, APX3330 was initiated in the Phase 2 ZETA-1 trial, an investigation of the drug as a treatment for diabetic-related eye disorders. This study continues from those referenced above. Among the bulls is Canaccord analyst John Newman who rates OCUP a Buy along with a $25 price target. Investors could be sitting on gains of ~589%, should Newman’s forecast play out over the next 12 months. (To watch Newman's track record, click here) "The positive results from the MIRA-2 study... increase the probability of approval for Nyxol in Reversal of Mydriasis and has positive implications for other Nyxol indications, such as presbyopia and Night Vision Disturbances... We expect additional positive Nyxol data from presbyopia in 2Q21 and from night vision disturbances in 3Q21, as well as potentially positive data from APX3330 in diabetic retinopathy and Nyxol in a second reversal of mydriasis trial by early 2022," Newman opined. Do other analysts agree with Newman? They do. Only Buy ratings, 4, in fact, have been issued in the last three months, so the consensus rating is a Strong Buy. The average price target of $23.50 suggests an impressive 458% upside from the share price of $4.21. (See OCUP stock analysis on TipRanks) To find good ideas for penny stocks trading at attractive valuations, visit TipRanks’ Best Stocks to Buy, a newly launched tool that unites all of TipRanks’ equity insights. Disclaimer: The opinions expressed in this article are solely those of the featured analysts. The content is intended to be used for informational purposes only. It is very important to do your own analysis before making any investment.

  • Ocuphire Completes Enrollment in VEGA-1 Phase 2 Clinical Trial Investigating Nyxol® in Combination with Low-Dose Pilocarpine for Treatment of Presbyopia
    GlobeNewswire

    Ocuphire Completes Enrollment in VEGA-1 Phase 2 Clinical Trial Investigating Nyxol® in Combination with Low-Dose Pilocarpine for Treatment of Presbyopia

    Nyxol has Potential to be a New Eye Drop Treatment Option for Presbyopia Top-Line VEGA-1 Data Expected by End of Q2 2021 FARMINGTON HILLS, Mich., May 12, 2021 (GLOBE NEWSWIRE) -- Ocuphire Pharma, Inc. (Nasdaq: OCUP), a clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing therapies for the treatment of several eye disorders, announced today that it has completed enrollment in the VEGA-1 Phase 2 clinical trial (NCT04675151) evaluating the safety and efficacy of a combination kit of Nyxol® and low-dose pilocarpine in presbyopia. VEGA-1 successfully recruited 150 subjects in just under 3 months. “Achieving our enrollment completion target for the VEGA-1 trial is yet another important milestone in our Nyxol program and tracks for top-line results by the end of June,” said Mina Sooch, MBA, President and CEO of Ocuphire Pharma. “Nyxol has the potential to address multiple unmet needs initially with the large market opportunity in reversal of mydriasis supported by our recent positive Phase 3 data results and then adding this very large presbyopia market opportunity that is estimated at over $5 billion in the US alone. We are excited to develop Nyxol with low-dose pilocarpine as a potential option for the growing number of presbyopic patients and to also realize commercial synergies if products are approved given the common targeted optometrists and ophthalmologists.” The global prevalence of presbyopia is estimated to be 2 billion. An estimated 120 million Americans live with presbyopia, a large prevalence that is expected to exceed 150 million by 2034. To assist with their near vision deficiencies, individuals with presbyopia use reading glasses and contact lenses, and in some cases undergo surgical interventions. However, there are currently no approved drug therapies for presbyopia. As there are several drawbacks to reading glasses and contact lenses, including inconvenience, eye strain, and night vision disturbances, eye drops are increasingly being explored as an alternative. As for payment, presbyopia corrective devices have been mostly out-of-pocket cash pay by patients. Marguerite McDonald, M.D., F.A.C.S, Clinical Professor of Ophthalmology at the NYU Langone Medical Center and Ocuphire Medical Advisory Board member, stated, “Presbyopia is a condition that affects nearly everyone over the age of 40. Many patients reliant on reading glasses and contact lenses desire more flexibility and convenience and continually request alternatives or a complementary choice. Development of eyedrop treatments for Presbyopia has recently become very active, led by Allergan having recently submitted an NDA for this indication. There is room for many options given the large unmet need, and I am encouraged by Nyxol eye drops in combination with low-dose pilocarpine eye drops as a differentiated solution that works both on the iris dilator and sphincter muscles. This combination product should allow for moderate unopposed pupil constriction and provide the ability to see both at near and at distance without the side-effects such as brow ache, headache, blurry vision, and loss of distance night vision associated with the use of higher doses of pilocarpine.” Based on a GlobalData market research report, 69% of patients would consider an eye drop as an alternative to reading glasses. Importantly, over 70% of patients indicated that they wear reading glasses in the morning, afternoon, and evening, suggesting that patients desire a solution with durability. Over 50% of responders also indicated that using drops 2 to 4 times per day would be moderately to very convenient to them. In addition, 66% of surveyed eyecare providers indicated interest in a Nyxol and low-dose pilocarpine product profile as a potential therapeutic alternative to reading glasses. About VEGA-1 Phase 2 Clinical Trial The VEGA-1 clinical trial is designed to evaluate the efficacy and safety of Nyxol in combination with low-dose pilocarpine compared to placebo in presbyopic subjects. A total of 150 subjects (planned target was 140 to 152) have been enrolled at 17 investigational sites in the US from mid-February to mid-May this year. The Phase 2 trial is randomized, double-masked, placebo-controlled with 4 treatment arms. At the first visit, subjects are randomized to receive either Nyxol or placebo drops that are instilled at home near bedtime for 3 to 4 days prior to Visit 2; at Visit 2 subjects then receive either low-dose pilocarpine or no treatment with efficacy and safety measurements collected at multiple timepoints through 6 hours. The primary endpoint is the percentage of subjects with ≥ 15 letters of improvement in photopic binocular near vision (i.e. distance-corrected near visually acuity, DCNVA) at 1 hour on Visit 2 for Nyxol + low-dose pilocarpine arm compared to placebo alone arm. Secondary endpoints at multiple timepoints include improvements of 3 lines of DCNVA without any loss of distance vision, pupil diameter, and improvements of DCNVA at 1 and 2 lines compared to placebo as well as to each Nyxol and low-dose pilocarpine alone. Top-line results are expected by the end of Q2 2021. Ocuphire collaborated closely with Oculos Development Services, a Tampa, Florida based clinical research organization and a subsidiary of Iuvo BioScience, on the launch and execution of the VEGA-1 trial. “We are pleased by the rapid enrollment in this Phase 2 trial, which speaks to the unmet need of an eye drop to benefit vision correction for patients with presbyopia. We thank our investigators, clinical coordinators, staff, and subjects for their support and ease of trial execution at 17 sites across the U.S.,” said Chuck Slonim, MD, Chief Medical Officer and Medical Monitor of Oculos Development Services. For more information about the VEGA-1 Phase 2 trial design and its U.S. clinical sites, please visit www.clinicaltrials.gov (NCT04675151). About Ocuphire Pharma Ocuphire is a publicly traded (NASDAQ: OCUP), clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing therapies for the treatment of several eye disorders. Ocuphire’s pipeline currently includes two small-molecule product candidates targeting front and back of the eye indications. The company’s lead product candidate, Nyxol® (0.75% phentolamine ophthalmic solution) Eye Drops, is a once-daily preservative-free eye drop formulation of phentolamine mesylate, a non-selective alpha-1 and alpha-2 adrenergic antagonist designed to reduce pupil size, and is being developed for several indications, including dim light or night vision disturbances (NVD), reversal of pharmacologically-induced mydriasis (RM), and presbyopia, and has been studied in 8 clinical trials including the recently completed Phase 3 trial in RM. Ocuphire reported positive topline data in March 2021 for MIRA-2, a Phase 3 FDA registration study for treatment of RM. Nyxol is also currently in Phase 3 clinical development for NVD and in Phase 2 for presbyopia. Ocuphire’s second product candidate, APX3330, is an oral tablet designed to inhibit angiogenesis and inflammation pathways relevant to retinal and choroidal vascular diseases, such as diabetic retinopathy (DR) and diabetic macular edema (DME) and has been studied in 11 Phase 1 and 2 trials. APX3330 is currently enrolling subjects in a Phase 2 clinical trial in subjects with DR/DME. As part of its strategy, Ocuphire will continue to explore opportunities to acquire additional ophthalmic assets and to seek strategic partners for late-stage development, regulatory preparation, and commercialization of drugs in key global markets. Please visit www.clinicaltrials.gov to learn more about Ocuphire’s completed Phase 2 trials, recently completed Phase 3 registration trial (NCT04620213), ongoing Phase 3 registration trial (NCT04638660), Phase 2 trial in presbyopia (NCT04675151), and Phase 2 trial in DR/DME (NCT04692688). For more information, please visit www.ocuphire.com. Forward Looking Statements Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements concerning Ocuphire’s product candidates, results of ongoing and future clinical trials, and commercialization and market opportunities. These forward-looking statements are based upon Ocuphire’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, including, without limitation: (i) the success and timing of regulatory submissions and pre-clinical and clinical trials, including enrollment and data readouts; (ii) regulatory requirements or developments; (iii) changes to clinical trial designs and regulatory pathways; (iv) changes in capital resource requirements; (v) risks related to the inability of Ocuphire to obtain sufficient additional capital to continue to advance its product candidates and its preclinical programs; (vi) legislative, regulatory, political and economic developments, (vii) changes in market opportunities, (viii) the effects of COVID-19 on clinical programs and business operations, and (ix) the success and timing of commercialization of any of Ocuphire’s product candidates. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the risk factors detailed in documents that have been and may be filed by Ocuphire from time to time with the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. Ocuphire undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made. Ocuphire Contacts Mina Sooch, President & CEO Ocuphire Pharma, Inc. ir@ocuphire.com www.ocuphire.com Corey Davis, Ph.D. LifeSci Advisors cdavis@lifescieadvisors.com