"Â, "We are delighted to join with the NeuroBo team in order to bring ANA-001 to the millions of patients infected with COVID-19. Forward-looking statements are usually identified by the use of words, such as “believes,” “anticipates,” “expects,” “intends,” “plans,” “may,” “potential,” “will,” “could” and similar expressions. The company's third program, Gemcabene, was developed for the treatment of dyslipidemia, a serious medical condition that increases the risk of life-threatening cardiovascular disease. In pre-clinical studies in animal models of diabetes, NB-01 reduced general inflammation and neuro-inflammation as measured by IL-6 and TNF-α, reduced advanced glycation end products (AGEs), which are implicated in diabetic neuropathy, and elevated levels of nerve growth factor (NGF) to normal physiological levels, which has been shown to promote nerve growth, survival and repair. In the interim, NeuroBo is exploring a potential orphan drug indication targeting chronic pain for NB-01. NeuroBo Pharmaceuticals, Inc., a clinical-stage biotechnology company, announced that on December 31, 2020 it acquired ANA Therapeutics, a privately held biotechnology company developing ANA-001, a proprietary capsule formulation of niclosamide for coronavirus indications, currently in phase 2/3 clinical trials as a treatment for Covid-19. The new combined company, known as NeuroBo Pharmaceuticals began trading on the Nasdaq exchange under the ticker “NRBO” on December 31, 2019. Any statements in this press release that are not statements of historical fact constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Its therapeutics programs include NB-01 for the treatment of painful diabetic neuropathy; NB-02 to treat cognitive impairment and modify the progression of neurodegenerative diseases associated with the malfunction of protein; and Gemcabene, which is … ANA-001 is a proprietary oral niclosamide formulation in development as a treatment for patients with moderate to severe COVID-19 (patients not requiring ventilators). A … Actual results may differ materially from those indicated by forward-looking statements as a result of various important factors and risks. These forward-looking statements should not be relied upon as representing NeuroBo's views as of any date subsequent to the date hereof. NeuroBo Pharmaceuticals was jointly founded by Dr. Roy Freeman, professor of neurology at Harvard Medical School and renowned expert in neuropathic pain, and JK BioPharma Solutions, a biotechnology consulting company, to commercialize natural product-based research into ethical medicines. In preclinical research by an independent academic group published in Antimicrobial Agents and Chemotherapy, niclosamide inhibited viral replication in vitro and was more potent than remdesivir in the same assay. NeuroBo Pharmaceuticals, Inc., a clinical-stage biotechnology company focused on developing and commercializing multimodal, disease-modifying therapies for neurodegenerative and cardiometabolic diseases, has a current portfolio of four drug candidates. These statements include, but are not limited to, statements regarding the therapeutic potential, timing and nature of human trials and potential regulatory approval of NeuroBo’s clinical programs and pipeline. “We believe that the closing of the merger signifies a transformative event that will provide NeuroBo with the opportunity to achieve its next level of corporate growth as we continue to advance our promising pipeline for neurodegenerative diseases,” said Richard J. Kang, Ph.D., president and chief executive officer of the combined company. Rx Communications GroupMichael Miller+1-917-633-6086mmiller@rxir.com, View original content:http://www.prnewswire.com/news-releases/neurobo-pharmaceuticals-acquires-ana-therapeutics-for-late-stage-oral-antiviral-development-program-301201781.html, NeuroBo Pharmaceuticals Acquires ANA Therapeutics for Late-Stage Oral Antiviral Development Program, http://www.prnewswire.com/news-releases/neurobo-pharmaceuticals-acquires-ana-therapeutics-for-late-stage-oral-antiviral-development-program-301201781.html. This multi-component drug approach has the potential to address the underlying mechanisms of PDN, reduce neuropathic pain symptoms and slow disease progression. These factors, risks and uncertainties include, but are not limited to: the failure to obtain all of the benefits or recognize all of the synergies anticipated from the ANA acquisition; the integration of ANA potentially diverting management resources from operational matters and other strategic opportunities; the effect of future milestone payments and royalties specified in the acquisition agreement on the results of operations and financial position of NeuroBo; the occurrence of health epidemics or contagious diseases, such as COVID-19, and potential effects on NeuroBo's business, clinical trial sites, supply chain and manufacturing facilities; NeuroBo's ability to continue as a going concern; the timing of completion of NeuroBo's planned clinical trials, including with respect to ANA-001; the timing of the availability of data from NeuroBo's clinical trials, including with respect to ANA-001;  the clinical utility, potential benefits and market acceptance of NeuroBo's product candidates, including ANA-001; ; and NeuroBo's need for additional financing to fulfill its stated goals; and other factors discussed in the "Risk Factors" section of NeuroBo's Annual Report on Form 10-K and in our other filings with the Securities and Exchange Commission. Richard J Kang will act as president and CEO of the combined company. Niclosamide is a potential oral antiviral and anti-inflammatory agent with a long history of use and a well-understood safety profile in humans. The company's multimodal approach has the potential to address the multiple underlying mechanisms of neurodegenerative diseases, alleviate symptoms and slow disease progression. About NeuroBo Pharmaceuticals NeuroBo Pharmaceuticals, Inc. is focused on novel treatments for neurodegenerative diseases affecting millions of patients worldwide. The first phase of the trial will enroll 60 patients. The Investor Relations website contains information about NeuroBo Pharmaceuticals, Inc.'s business for stockholders, potential investors, and financial analysts. Specifically, studies have shown that niclosamide prevents replication of SARS-CoV-2 at very low concentrations and that the compound appears to exhibit three distinct mechanisms of action: 1) acting as a potent antiviral to a broad homology of other viruses including influenza; 2) reducing inflammation without suppressing the immune system; and 3) providing bronchodilation, which is a useful pulmonary mechanism for at-risk patients with underlying cardiovascular and/or pulmonary conditions. The primary objective of the first phase of the trial is to assess safety and tolerability; secondary objectives include measurements of efficacy (median time to hospital discharge) and pharmacokinetics. 617.624.3264 The company believes ANA-001 has distinct competitive advantages in this market, including (1) offering an effective treatment for moderate to severe COVID-19 (patients not requiring ventilators); (2) having 3+ year marketing exclusivity in the U.S. upon U.S. Food and Drug Administration (FDA) approval; (3) providing ease of administration via a capsule formulation and potential to dramatically lower overall treatment cost; and (4) possessing a proven safety profile (generic niclosamide has been used safely for 50 years as a treatment for tapeworm infections). Email. - Shares of the Combined Company, NeuroBo Pharmaceuticals, Began Trading on the Nasdaq Exchange Under the Symbol NRBO on December 31, 2019, - NeuroBo Pharmaceuticals to Focus on Advancing Clinical Stage Pipeline for Neurodegenerative Diseases. The first study in our Phase 3 program for our lead drug candidate, NB-01, for painful diabetic neuropathy (PDN), will begin screening patients soon in the U.S. and we are designing a first-in-human trial for NB-02, targeted at Alzheimer’s disease and diseases associated with the pathological dysfunction of tau proteins in the brain.”. BOSTON, Nov. 13, 2020 /PRNewswire/ -- NeuroBo Pharmaceuticals, Inc. ... timing and nature of clinical trials and potential regulatory approval of NeuroBo's clinical programs and pipeline. From May 2018 until September 2018, Ms. Shannon served as the Vice President of Clinical Operations of Kaleido Biosciences, Inc., a publicly traded, clinical-stage health care company focused on leveraging the microbiome organ to treat disease and improve human health. Find the latest NeuroBo Pharmaceuticals, Inc. (NRBO) stock discussion in Yahoo Finance's forum. The combined company expects to submit an application with results of a preclinical mouse safety study to the Food and Drug Administration (FDA) in early 2020 to address a partial clinical hold related to gemcabene’s activation of peroxisome proliferation-activated receptor (PPAR) and, if approved, would be poised to progress into Phase 3 human studies. NeuroBo Pharmaceuticals, a clinical-stage biotechnology company provides therapies for neurodegenerative and cardiometabolic diseases. Forward-looking statements are usually identified by the use of words, such as "believes," "anticipates," "expects," "intends," "plans," "may," "potential," "will," "could" and similar expressions. The board of directors of the combined organization is comprised of seven directors: two directors from the former NeuroBo board, one director from the former Gemphire board and four newly appointed members designated by NeuroBo prior to the merger. About NeuroBo Pharmaceuticals NeuroBo Pharmaceuticals , Inc. has a current portfolio of three drug candidates. However, while NeuroBo may elect to update these forward-looking statements at some point in the future, NeuroBo specifically disclaims any obligation to do so. Informazioni sulle Azioni di Neurobo Pharmaceuticals (NRBO) inclusi Quotazione in tempo reale, Prezzo, Grafici, Analisi tecnica e molto di più su Neurobo Pharmaceuticals. As part of the merger, Gemphire stockholders received non-transferable contingent value rights (CVRs) entitling the holders to receive in aggregate, after the retention of $500,000 by the combined company and certain other permitted deductions, 80% of the net proceeds, if any, in the event the gemcabene assets are sold or licensed during the 10-year period following the closing of the merger or pursuant to the license agreement with Beijing SL. In a randomized, placebo-controlled Phase 2 clinical trial, NB-01 significantly improved pain scores from baseline as measured by the NRS, an 11-point numeric rating scale commonly used in pain studies, and showed an excellent safety profile when compared to retrospective safety data on existing therapies. NeuroBo Pharmaceuticals, Inc. is focused on novel treatments for neurodegenerative and cardiometabolic diseases affecting millions of patients worldwide. Find out all the key statistics for NeuroBo Pharmaceuticals, Inc. (NRBO), including valuation measures, fiscal year financial statistics, trading record, share statistics and more. NeuroBo anticipates that subsequent events and developments will cause its views to change. Preclinical data has demonstrated niclosamide's ability to inhibit viral replication of SARS-CoV-2 and underscores ANA-001's potential to effectively address the ongoing need for safe and effective COVID-19 treatments on a global scale. For more information visit: https://www.neurobopharma.com. However, while NeuroBo may elect to update these forward-looking statements at some point in the future, NeuroBo specifically disclaims any obligation to do so. NeuroBo is advancing the development of multimodal, disease-modifying therapies for neurodegenerative and cardiometabolic diseases. NeuroBo has the leadership and platform to support the accelerated development of this important compound as a potential treatment for this viral pandemic," said Akash Bakshi, Chief Executive Officer of ANA Therapeutics.Â. Contact Info NeuroBo Pharmaceuticals. NeuroBo will focus on … The new combined company, known as NeuroBo Pharmaceuticals began trading on the Nasdaq exchange under the ticker "NRBO" on December 31, 2019. NeuroBo Pharmaceuticals Acquires ANA Therapeutics for Late-Stage Oral Antiviral Development Program Transformative Acquisition Deepens Pipeline … Initiation of enrollment in the first Phase 3 study with NB-01 is anticipated in the first half of 2020 and will enroll approximately 460 subjects with PDN across the U.S. NeuroBo’s IND-ready second drug candidate, NB-02, is targeted for the treatment of Alzheimer’s disease and neurodegenerative diseases associated with the pathological dysfunction of tau proteins in the brain. As a result, the development timeline supports a number of value-creating milestones over the coming 12 to 18 months, including the data readout of the Phase 2 portion of the trial, expected in the third quarter of 2021. Nicole Franklin NeuroBo Pharmaceuticals, Inc., is focused on novel treatments for neurodegenerative diseases affecting millions of patients worldwide. Preclinical animal disease model studies of NB-02 have provided evidence of efficacy and safety in neurodegeneration. The new combined company, known as NeuroBo Pharmaceuticals began trading on the Nasdaq exchange under the ticker “NRBO” on December 31, 2019. About NeuroBo Pharmaceuticals NeuroBo Pharmaceuticals, Inc. has a current portfolio of three drug candidates. The company’s novel lead program, NB-01, is an oral drug candidate for painful diabetic neuropathy (PDN). In both phases of the study, hospitalized patients with moderate to severe COVID-19 (patients not requiring ventilators) will be administered a seven-day course of ANA-001 (niclosamide capsules) in addition to standard-of-care treatment. The company's NB-01 candidate has been shown in a Phase 2 study to significantly reduce pain symptoms associated with painful diabetic neuropathy (PDN), with a superior safety profile when compared to currently available treatments. These forward-looking statements should not be relied upon as representing NeuroBo’s views as of any date subsequent to the date hereof. Gemcabene has been studied in more than 1,100 human subjects in a total of 25 Phase 1 and Phase 2 trials with demonstrated efficacy and safety. ANA-001 is currently being studied in a 60-subject Phase 2/3 clinical trial conducted at up to 20 clinical sites in the U.S. Niclosamide has demonstrated both antiviral and immunomodulatory activity with possible downstream effects on coagulation abnormalities observed in COVID-19. The new combined company, known as NeuroBo Pharmaceuticals began trading on the Nasdaq exchange under the ticker “NRBO” on December 31, 2019. Immediately after the closing of the merger, NeuroBo shareholders owned 96.24%, and current Gemphire stockholders owned 3.76% of NeuroBo’s common stock. NeuroBo will focus on advancing the company’s clinical-stage pipeline for neurodegenerative diseases. NeuroBo Pharmaceuticals, Inc., a clinical-stage biotechnology company provides therapies for neurodegenerative and cardiometabolic diseases. The company expects to complete enrollment of the first phase of the study and to have topline data from this segment of the trial in the third quarter of 2021.Â. Due to global COVID-19 crisis, a planned Phase 3 study was postponed. ANA-001 is currently being studied in a 60-subject Phase 2/3 clinical trial conducted at up to 20 clinical sites in the U.S. Niclosamide has demonstrated both antiviral and immunomodulatory activity with possible downstream effects on coagulation abnormalities observed in COVID-19. "Â, "While the introduction of vaccines is expected to play a significant role in stemming the tide of the COVID-19 pandemic, the ongoing complexities and mutation of the disease will require therapies to treat the infected population for the foreseeable future," commented Irene Kim, Chair of the Board of NeuroBo. "Similar to influenza, taking a COVID-19 vaccine and therapy could become an annual routine. The second phase of the trial is expected to enroll several hundred patients, with the primary endpoints of the study being median time to hospital discharge, safety and tolerability. Click here now. NeuroBo Pharmaceuticals, Inc. (NASDAQ:NRBO) price on Wednesday, Jan 06, rose 19.93% above its previous day’s close as an upside momentum from buyers pushed the stock’s value to $6.68. NeuroBo Pharmaceuticals, Inc., a clinical-stage biotechnology company focused on developing and commercializing multimodal, disease-modifying therapies for neurodegenerative and cardiometabolic diseases, has a current portfolio of four drug candidates. In addition, Mr. Bakshi has joined NeuroBo's board of directors.Â. Get the hottest stocks to trade every day before the market opens 100% free. Share your opinion and gain insight from other stock traders and investors. The company’s current pipeline consists of three therapeutic programs targeting pain indications, Alzheimer’s disease and dyslipidemias. 200 Berkeley St. FL 19 Boston, MA 02116. NeuroBo will focus on … Racepoint Global Enrollment in the first study in the Phase 3 program for NB-01 in the U.S. is expected to begin in the first half of 2020, with a target enrollment of approximately 460 subjects with PDN. NeuroBo will focus on … BOSTON, Jan. 6, 2021 /PRNewswire/ -- NeuroBo Pharmaceuticals, Inc. (Nasdaq: NRBO), a clinical-stage biotechnology company, today announced that on December 31, 2020 it acquired ANA Therapeutics, a privately held biotechnology company developing ANA-001, a proprietary capsule formulation of niclosamide for coronavirus indications, currently in Phase 2/3 clinical trials as a treatment for COVID-19. View the basic NRBO option chain and compare options of NeuroBo Pharmaceuticals, Inc. on Yahoo Finance. ANA shareholders will receive additional payments (in cash or NeuroBo common shares) upon the achievement of various development and net sales milestones for ANA-001 and will also receive royalties based on net sales of ANA-001. The company's NB-01 candidate has been shown in a Phase 2 study to significantly reduce pain symptoms associated with painful diabetic neuropathy (PDN), with a superior safety profile when compared to currently available treatments. Any statements in this press release that are not statements of historical fact constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The company's recently acquired ANA-001 candidate is a proprietary oral niclosamide formulation in development as a treatment for patients with moderate to severe COVID-19 (patients not requiring ventilators). The company's multimodal approach has the potential to address the multiple underlying mechanisms of neurodegenerative diseases, alleviate symptoms and slow disease progression. Niclosamide is a potential oral antiviral and anti-inflammatory agent with a long history of use and a well-understood safety profile in humans. For more information contact:info@neurobopharma.com For information on partnering contact:bd@neurobopharma.com For investor information contact: ir@neurobopharma.com For career information contact:hr@neurobopharma.com In October 2020, a Phase 2/3 clinical trial evaluating ANA-001 as a treatment for COVID-19 was initiated.  The two-part Phase 2/3 multi-center, double blind, placebo-controlled study to assess the safety, tolerability, and efficacy of ANA-001 is being conducted at up to 20 clinical sites in the U.S. NeuroBo's NB-02 drug candidate is focused on the treatment of Alzheimer's disease and neurodegenerative diseases associated with the pathological dysfunction of tau proteins in the brain. The new combined company, known as NeuroBo Pharmaceuticals began trading on the Nasdaq exchange under the ticker "NRBO" on December 31, 2019. BOSTON, May 20, 2020 /PRNewswire/ -- NeuroBo Pharmaceuticals, Inc. ... timing and nature of clinical trials and potential regulatory approval of NeuroBo's clinical programs and pipeline. The corporate headquarters of the combined organization is located in Boston, Massachusetts. In addition, NeuroBo plans to continue the advancement of gemcabene, which has been in development by Gemphire for the treatment of dyslipidemia. For more information, visit: https://www.neurobopharma.com/. The company’s multimodal approach has the potential to address the multiple underlying mechanisms of neurodegenerative diseases, alleviate symptoms and slow disease progression. Three key executives from ANA Therapeutics have joined the NeuroBo management team including, Akash Bakshi, as Senior Vice President and Chief Operating Officer, Nadja Mannowetz, Ph.D., as Senior Vice President, and Andrew Bartynski, Ph.D., as Senior Vice President. NB-01 increases levels of the neurotrophin, nerve growth ... 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