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. 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. 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. The company’s current pipeline consists of three therapeutic programs targeting … With the transaction now complete, the merged firm will continue to work on NeuroBo’s clinical-stage drug candidates for neurodegenerative disorders. About NeuroBo Pharmaceuticals NeuroBo Pharmaceuticals , Inc. is focused on novel treatments for neurodegenerative and cardiometabolic diseases affecting millions of patients worldwide. In addition, the forward-looking statements included in this press release represent NeuroBo’s views as of the date hereof. 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 Get the hottest stocks to trade every day before the market opens 100% free. 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 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. Niclosamide is a potential oral antiviral and anti-inflammatory agent with a long history of use and a well-understood safety profile in humans. About NeuroBo Pharmaceuticals NeuroBo Pharmaceuticals , Inc. is focused on novel treatments for neurodegenerative and cardiometabolic diseases affecting millions of patients worldwide. 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. nfranklin@racepointglobal.com. Ms. Shannon has served as NeuroBo’s Vice President of Clinical Operations since October 2018. Click here now. 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 the interim, NeuroBo is exploring a potential orphan drug indication targeting chronic pain for NB-01. 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. 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. The first phase of the trial will enroll 60 patients. 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. The new combined company, known as NeuroBo Pharmaceuticals began trading on the Nasdaq exchange under the ticker "NRBO" on December 31, 2019. As a result, the company believes ANA-001 has the potential to reduce the viral load and inflammation associated with cytokine dysregulation, acute respiratory distress syndrome (ARDS), and coagulation abnormalities and thus improve time to clinical improvement as defined as hospital discharge recorded using the WHO Ordinal Scale for Clinical Improvement. 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. A … NeuroBo will focus on … "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. “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. 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. The Investor Relations website contains information about NeuroBo Pharmaceuticals, Inc.'s business for stockholders, potential investors, and financial analysts. The company's multimodal approach has the potential to address the multiple underlying mechanisms of neurodegenerative diseases, alleviate symptoms and slow disease progression. Racepoint Global Actual results may differ materially from those indicated by forward-looking statements as a result of various important factors and risks. Under the terms of the acquisition agreement, ANA became a wholly-owned subsidiary of NeuroBo and ANA equity holders were issued an aggregate of approximately 3.24 million shares of Neurobo common stock, representing 19.7% of NeuroBo's outstanding shares. 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 … 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. View the basic NRBO option chain and compare options of NeuroBo Pharmaceuticals, Inc. on Yahoo Finance. About NeuroBo Pharmaceuticals NeuroBo Pharmaceuticals, Inc. has a current portfolio of three drug candidates. About NeuroBo Pharmaceuticals NeuroBo Pharmaceuticals , Inc. has a current portfolio of three drug candidates. The company's multimodal approach has the potential to address the multiple underlying mechanisms of neurodegenerative diseases, alleviate symptoms and slow disease progression. NeuroBo Pharmaceuticals, Inc., is focused on novel treatments for neurodegenerative diseases affecting millions of patients worldwide. 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. NeuroBo will focus on … These factors, risks and uncertainties include, but are not limited to: NeuroBo’s plans to develop and commercialize its product candidates; the timing of completion of NeuroBo’s planned clinical trials; the timing of the availability of data from NeuroBo’s clinical trials; NeuroBo’s plans to research, develop and commercialize its current and future product candidates; NeuroBo’s ability to successfully collaborate with existing collaborators or enter into new collaborations and to fulfill its obligations under any such collaboration agreements; the clinical utility, potential benefits and market acceptance of NeuroBo’s product candidates; NeuroBo’s commercialization, marketing and manufacturing capabilities and strategy; the impact of government laws and regulations; NeuroBo’s ability to protect its intellectual property position; and NeuroBo’s need for additional financing to fulfill its stated goals; and other factors discussed in the "Risk Factors" section of SEC filings the combined company makes with the SEC from time to time. 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. 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. NeuroBo Pharmaceuticals, a clinical-stage biotechnology company provides therapies for neurodegenerative and cardiometabolic diseases. 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. About NeuroBo Pharmaceuticals NeuroBo Pharmaceuticals, Inc. is focused on novel treatments for neurodegenerative diseases affecting millions of patients worldwide. 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. NB-01 increases levels of the neurotrophin, nerve growth ... Cantex’s pipeline consists of two product candidates – DSTAT (formerly known as CX-01) and Dicopp®. Niclosamide is a potential oral antiviral and anti-inflammatory agent with a long history of use and a well-understood safety profile in humans. 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. 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. Immediately after the closing of the merger, NeuroBo shareholders owned 96.24%, and current Gemphire stockholders owned 3.76% of NeuroBo’s common stock. 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 multimodal approach has the potential to address the multiple underlying mechanisms of neurodegenerative diseases, alleviate symptoms and slow disease progression. The new combined company, known as NeuroBo Pharmaceuticals began trading on the Nasdaq exchange under the ticker "NRBO" on December 31, 2019. Richard J Kang will act as president and CEO of the combined company. Contact Info NeuroBo Pharmaceuticals. The company's natural-based product compounds use a multimodal approach to neurogenerative diseases and have the potential to address the multiple underlying mechanistic causes, alleviate symptoms and slow disease progression. The new combined company, known as NeuroBo Pharmaceuticals began trading on the Nasdaq exchange under the ticker “NRBO” on December 31, 2019. NeuroBo Pharmaceuticals, Inc. is a clinical-stage biotechnology company focused on developing and commercializing multimodal, disease-modifying therapies for neurodegenerative and cardiometabolic diseases. The combined unit will operate as NeuroBo Pharmaceuticals with NeuroBo shareholders holding a 96.24% stake in the firm. NeuroBo anticipates that subsequent events and developments will cause its views to change. 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. Secondary objectives will evaluate clinical improvement and the need and duration for rescue therapy. "ANA-001 is advancing through the 505(b)(2) clinical pathway, which allows us to leverage earlier data on niclosamide and streamlines and accelerates the timelines to bring this potentially life-saving therapy to patients suffering with COVID-19. 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.”. NeuroBo Pharmaceuticals' novel lead candidate NB-01 is targeting diabetic neuropathic pain. The combined organization will operate under the leadership of NeuroBo’s new President and Chief Executive Officer, Richard J. Kang, Ph.D., and Chief Medical Officer, Mark Versavel, M.D., Ph.D., MBA. These statements include, but are not limited to, statements regarding the development timeline for niclosamide for the treatment of COVID-19, the market size for COVID-19-related therapeutics and the competitive advantages of ANA-001, the potential benefits of ANA-001 as a treatment for patients with moderate to severe COVID-19 (patients not requiring ventilators), and potential milestone payments and royalties that may become due to the former equity holders of ANA under the acquisition agreement. In addition, the forward-looking statements included in this press release represent NeuroBo's views as of the date hereof. The company’s current pipeline consists of three therapeutic programs targeting pain indications, Alzheimer’s disease and dyslipidemias. "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. NeuroBo Pharmaceuticals, Inc. is focused on novel treatments for neurodegenerative and cardiometabolic diseases affecting millions of patients worldwide. “As we look ahead, we have some important milestones on the horizon. This multi-component drug approach has the potential to address the underlying mechanisms of PDN, reduce neuropathic pain symptoms and slow disease progression. NeuroBo will … 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 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). Share your opinion and gain insight from other stock traders and investors. For more information visit: https://www.neurobopharma.com. 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. Ms. Na Yeon (Irene) Kim, M.S., MBA, was appointed as chairman of the board. Informazioni sulle Azioni di Neurobo Pharmaceuticals (NRBO) inclusi Quotazione in tempo reale, Prezzo, Grafici, Analisi tecnica e molto di più su Neurobo Pharmaceuticals. NeuroBo will focus on … 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. Clinical Pipeline & Technology. The new combined company, known as NeuroBo Pharmaceuticals began trading on the Nasdaq exchange under the ticker “NRBO” on December 31, 2019. 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. "This is an exciting and transformative acquisition for NeuroBo that expands our pipeline with a late-stage clinical development program that addresses the urgent need for new treatments to address COVID-19, a highly-infectious and often deadly virus," stated Richard J. Kang, Ph.D., President and Chief Executive Officer of NeuroBo. Find out all the key statistics for NeuroBo Pharmaceuticals, Inc. (NRBO), including valuation measures, fiscal year financial statistics, trading record, share statistics and more. - 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. 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. NeuroBo anticipates that subsequent events and developments will cause its views to change. 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 new combined company, known as NeuroBo Pharmaceuticals began trading on the Nasdaq exchange under the ticker “NRBO” on December 31, 2019. NeuroBo Pharmaceuticals, Inc. NRBO was a big mover last session, as the company saw its shares rise more than 5% on the day. Preclinical animal disease model studies of NB-02 have provided evidence of efficacy and safety in neurodegeneration. 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. 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. 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. 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. 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. 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). 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. 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