Tonix Pharmaceuticals Holding Corp. discovers, acquires, develops, and licenses small molecules and biologics to treat and prevent human diseases and alleviate suffering. Its immunology product candidates include vaccines to prevent infectious diseases and biologics to address immunosuppression, cancer, and autoimmune diseases; and central nervous system (CNS) product candidates comprise small molecules and biologics to treat pain, neurologic, psychiatric, and addiction conditions. The company's lead vaccine candidate is TNX-1800, a live replicating vaccine based on the horsepox viral vector platform to protect against COVID-19. Its vaccines also comprise TNX-801, a live horsepox virus vaccine to protect against smallpox and monkeypox and serves as the vector platform; and TNX-2300 for the prevention of COVID-19. The company's lead CNS candidate is TNX-102 SL, a sublingual tablet formulation of cyclobenzaprine for fibromyalgia, and for the treatment of agitation in Alzheimer's disease, posttraumatic stress disorder (PTSD), and alcohol use disorder. Its products include TNX-1300 for the treatment of cocaine intoxication; TNX-601 CR for depression disorder, PTSD, and neurocognitive dysfunction from corticosteroids; and TNX-1900 for migraine and craniofacial pain treatment. Its preclinical pipeline includes TNX-1600 for PTSD, depression, and attention deficit hyperactivity disorder; TNX-1700 for gastric and pancreatic cancers; TNX-701 for radioprotection; TNX-1200, a smallpox vaccine; TNX-1500, a monoclonal antibody anti-CD40-L for organ transplant rejection autoimmunity; and TNX-2900, an intranasal potentiated oxytocin for the treatment of Prader-Willi syndrome. It also develops TNX-2100, a COVID-19 skin test. It has collaboration agreements with Southern Research Institute, Columbia University, the University of Alberta, and Massachusetts General Hospital. The company was incorporated in 2007 and is headquartered in Chatham, New Jersey.
IPO Year:
Exchange: NASDAQ
Website: tonixpharma.com
Date | Price Target | Rating | Analyst |
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4/18/2022 | Outperform | Noble Capital Markets |
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Thomas brings more than 20 years of commercial and operations experience in the biopharmaceutical industry to Tonix Tonix is on track to submit an NDA for TNX-102 SL for fibromyalgia in October of 2024 CHATHAM, N.J., Sept. 10, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company), a biopharmaceutical company with marketed products and a pipeline of development candidates, today announced the appointment of Thomas (Tom) Englese as Executive Vice President of Commercial Operations, effective immediately. Mr. Englese brings significant leadership across several functions, including commercial operations, sales and marketing, and launching and mana
TNX-801 vaccination demonstrated efficacy in protecting animals from lethal challenge with clade I monkeypox and is in development as an mpox vaccine New data show improved tolerability in immunocompromised animals and no evidence of spreading to blood or tissues even at high doses Tonix's synthetic horsepox vaccine platform has been selected by NIH's Project NextGen for clinical testing CHATHAM, N.J., Sept. 09, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company), a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, today announced data presented at a symposium hosted by the Department
Gastroparesis slows the ability of the stomach to empty into the small intestine and thereby can delay absorption of oral medications into the bloodstream Non-oral medications including nasal and injectables can bypass the digestive system providing better absorption and faster relief CHATHAM, N.J., Sept. 06, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company), a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, today announced the launch of its new educational campaign, "Does Your Migraine Pill Work Every Time?" at this week's PAINWeek National Conference in Las Vegas. The goal of the
CHATHAM, NJ / ACCESSWIRE / September 4, 2024 / (Brain Image)This post was written and published as a collaboration between the in-house editorial team at Benzinga and Tonix Pharmaceuticals Holding Corp. with financial support from Tonix. The two organizations work to ensure that any and all information contained within is true and accurate as of the date hereof to the best of their knowledge and research. This content is for informational purposes only and not intended to be investing advice.Research into the causes and nature of pain is accelerating and broadening as evidenced by the more than 400 scientific presentations at the 2024 Word Congress on Pain, held August 6-9 in Amsterdam, whic
Investigator-initiated Phase 2 trial to evaluate TNX-102 SL's potential to reduce severity of acute stress reaction (ASR) and frequency of acute stress disorder (ASD) and posttraumatic stress disorder (PTSD) expected to begin third quarter 2024 Currently, no medication approved at or near point-of-care to treat patients suffering from traumatic events and support their long-term health CHATHAM, N.J., Aug. 29, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company), a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, presented clinical data on? acute stress reaction and prevention of PT
Oral presentation highlighted results from confirmatory Phase 3 RESILIENT study of TNX-102 SL (sublingual cyclobenzaprine HCl) treatment demonstrating statistically significant improvement in primary endpoint of fibromyalgia nociplastic pain and in all six key secondary endpoints, including sleep quality NDA submission on track for second half 2024; Fast Track designation granted by FDA; FDA decision expected 2025 TNX-102 SL is a potential non-opiod analgesic targeting non-restorative sleep in fibromyalgia: Post hoc analyses highlight strong correlations between improvements in nociplastic pain and sleep quality Nociplastic pain originates from altered pain perception in the brain and is
World Health Organization declared spread of mpox in multiple African countries a public health emergency of international concern (PHEIC) for the second time in two years Worldwide availability and affordability of single-dose mpox vaccine with durable protection will be required to address global health emergency The newest Clade 1 strain represents a new global threat with mortality up to 10% Bilthoven Biologicals to develop manufacturing processes in preparation for potential GMP manufacturing CHATHAM, N.J., Aug. 26, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix), a fully-integrated biopharmaceutical company with marketed products and a pipeline
This post was written and published as a collaboration between the in-house editorial team at Benzinga and Tonix Pharmaceuticals Holding Corp. with financial support from Tonix. The two organizations work to ensure that any and all information contained within is true and accurate as of the date hereof to the best of their knowledge and research. This content is for informational purposes only and not intended to be investing advice.CHATHAM, NJ / ACCESSWIRE / August 23, 2024 / Following an upsurge of cases in the Democratic Republic of the Congo and several other countries in Africa, the World Health Organization (WHO) declared mpox a public health emergency of international concern on Aug.
Oral presentation highlights TNX-102 SL (sublingual cyclobenzaprine HCl) treatment in Phase 3 RESILIENT study demonstrating statistically significant improvement in fibromyalgia nociplastic pain and in all six key secondary endpoints, including sleep quality Posters highlighting other TNX-102 SL programs in clinical development, including acute stress disorder Poster demonstrating automated high-throughput assay enabling screening for therapeutics to accelerate wound healing CHATHAM, N.J., Aug. 21, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company), a fully-integrated biopharmaceutical company with marketed products and a pipeline of devel
CATALYST is a Phase 2 single-blind, placebo-controlled, proof-of-concept study in patients presenting to the emergency department More than 27,569 individuals in the U.S. died from drug overdose deaths involving cocaine in 2022; there is currently no FDA-approved product for cocaine intoxication Topline results are expected in the first half of 2025 CHATHAM, N.J., Aug. 20, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP), a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, today announced the first patient has been dosed in the Phase 2, single-blind, placebo-controlled, proof of concept trial of TNX-130
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Noble Capital Markets initiated coverage of Tonix Pharma with a rating of Outperform
Alliance Global Partners resumed coverage of Tonix Pharmaceuticals with a rating of Buy and set a new price target of $4.00 from $3.00 previously
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Thomas brings more than 20 years of commercial and operations experience in the biopharmaceutical industry to Tonix Tonix is on track to submit an NDA for TNX-102 SL for fibromyalgia in October of 2024 CHATHAM, N.J., Sept. 10, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company), a biopharmaceutical company with marketed products and a pipeline of development candidates, today announced the appointment of Thomas (Tom) Englese as Executive Vice President of Commercial Operations, effective immediately. Mr. Englese brings significant leadership across several functions, including commercial operations, sales and marketing, and launching and mana
Interim Analysis of Registration-Enabling Phase 3 Fibromyalgia Trial of TNX-102 SL Expected Second Quarter 2023; Topline Data Expected Fourth Quarter 2023 Potentially Pivotal Phase 2 Trials of TNX-1900 in Chronic Migraine and TNX-601 ER in Depression Scheduled for Interim Analyses in Fourth Quarter 2023 Potentially Pivotal Phase 2 Fibromyalgia-Type Long COVID Study Enrolling Cash and Cash Equivalents Totaled Approximately $120.2 Million at December 31, 2022 CHATHAM, N.J., March 13, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced financial results for the fourth quarter and fu
CHATHAM, N.J., Feb. 23, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced the appointment of R. Newcomb Stillwell to its Board of Directors, to be effective as of March 15, 2023. "We are pleased to welcome Newcomb to our Board of Directors," said Seth Lederman, M.D., President and Chief Executive Officer of Tonix. "Mr. Stillwell brings nearly four decades of experience in corporate law, having practiced exclusively at Ropes & Gray LLP, where he was the Co-Managing Partner of the Boston office. His extensive advisory experience on numerous transactions in the life science and health
CHATHAM, N.J., Jan. 04, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced the appointment of Zeil Rosenberg, M.D., M.P.H. as its new Executive Vice President, Medical. In this role, Dr. Rosenberg will be responsible for leading Tonix's clinical development efforts for vaccines and antivirals. Dr. Rosenberg will be based in the Company's Chatham, N.J. headquarters, and as part of his role will oversee the clinical development of Tonix's vaccine for smallpox and monkeypox, TNX-801, the vaccine for COVID-19, TNX-1850, and the antiviral anti-SARS-CoV-2 spike protein monoclonal antibodie
Phase 1 Study of TNX-801, a Vaccine in Development for the Prevention of Monkeypox and Smallpox, Expected to Initiate in First Half 2023 in Kenya; the U.S. has Declared Monkeypox a Public Health Emergency U.S. National Institute of Drug Abuse (NIDA) Grant Awarded for the Development of TNX-1300 for Cocaine Intoxication; Phase 2 Study of TNX-1300 Expected to Initiate in Fourth Quarter 2022 Advanced Development Center in Dartmouth, Mass. is Open and Expected to Imminently Conduct Process Development and Clinical Trial Manufacturing of Live-Virus Vaccines Cash and Cash Equivalents Totaled Approximately $145 Million at June 30, 2022 CHATHAM, N.J., Aug. 08, 2022 (GLOBE NEWSWIRE) -- Tonix
CHATHAM, N.J., July 25, 2022 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced the appointment of Sina Bavari, Ph.D. as its new Executive Vice President, Infectious Disease Research and Development. In this role, Dr. Bavari will be responsible for leading Tonix's development of its growing infectious disease pipeline and will serve as a key member of the Company's executive leadership team. Dr. Bavari will be based in Frederick, Md. and, as part of his role, will oversee scientific development at Tonix's Infectious Disease R&D Center located there. "We are delighted that Dr. Bavari has
CHATHAM, N.J., March 09, 2022 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced the appointment of Jeffrey Rosenfeld, Ph.D., as its new Executive Director, Genomics and Bioinformatics. In this role, Dr. Rosenfeld will direct Tonix's pharmacogenomics efforts including applying artificial intelligence, genome-wide association studies and mathematical modeling techniques to the analysis of patient outcomes in Tonix's clinical trials. "Dr. Rosenfeld brings substantial genomics expertise to Tonix that will support our efforts in pharmacogenomics and companion diagnostics," said Seth Lederman
NEW YORK, July 19, 2021 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix), a clinical-stage biopharmaceutical company, today announced the appointment of Carolyn E. Taylor to its Board of Directors, effective as of July 16, 2021. Seth Lederman, M.D., President and Chief Executive Officer of Tonix commented, "We are pleased to welcome Carolyn E. Taylor to the Tonix Board. Ms. Taylor brings over 35 years of experience in corporate law, including 15 years as a partner at Covington & Burling LLP and six years as general counsel of two start-up companies. Her broad-based transactional experience will be invaluable to Tonix as we continue to grow the company. We look
Strategic Acquisition Helps Build Tonix's Commercial Capabilities and Infrastructure Ahead of Potential Launch of TNX-102 SL for the Management of Fibromyalgia Acquisition of Zembrace® SymTouch® (sumatriptan injection) and Tosymra® (sumatriptan nasal spray), Indicated for the Treatment of Acute Migraine in Adults, Complements Tonix's Current Intranasal Clinical Development Program of TNX-1900 for Migraine Prevention CHATHAM, N.J., July 03, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix Pharmaceuticals or Tonix), a biopharmaceutical company, and its wholly-owned commercialization subsidiary Tonix Medicines, Inc. (Tonix Medicines), today announced it
Five Potentially Pivotal Phase 2 or 3 Studies for CNS Programs Expected to be in the Clinic by First Quarter 2023 Data from Planned Interim Analyses of TNX-102 SL in Phase 3 Fibromyalgia Study and Phase 2 Long COVID Study Expected Second Quarter 2023 Advanced Development Center in Dartmouth, Mass. and Infectious Disease Research and Development Facility in Frederick, Md. Operational Cash and Cash Equivalents Totaled Approximately $140 Million at September 30, 2022 CHATHAM, N.J., Nov. 07, 2022 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced financial results for the
The ADC is Expected to Accelerate Clinical-Scale Manufacturing of Live Virus Vaccines, Including Vaccines for Monkeypox, Smallpox and COVID-19 Internal Manufacturing Capabilities Expected to Support U.S. Pandemic Preparedness CHATHAM, N.J., June 16, 2022 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced it will hold a ribbon-cutting ceremony at the Company's 45,000 square foot clinical-scale manufacturing facility in the New Bedford Business Park in North Dartmouth, Massachusetts on June 21, 2022 at 1:00 pm ET. The new facility houses Tonix's Advanced Development Center (ADC) for acce
Immunology and CNS Programs Entering the Clinic in 2022 for Organ Transplantation, Cocaine Intoxication, Fibromyalgia, PTSD, Migraine Headache and Binge Eating Disorder Covid-19 Programs Include Upcoming Phase 2 Trial in Long Covid, Results of First-in-Human T Cell Immunity Skin Test and New Versions of Our Live Virus Covid-19 Vaccine That Express Spike Proteins From the Omicron and BA.2 Variants Expansion of Internal Research and Development Capabilities Underway to Accelerate Infectious Disease Programs and Prepare for Future Pandemic Responses Orphan-Drug Designation Granted for TNX-2900 (Intranasal Potentiated Oxytocin) for Prader-Willi Syndrome Cash and Cash
NEW YORK, Feb. 28, 2022 (GLOBE NEWSWIRE) -- New to The Street TV, a nationally syndicated business show and FMW Media production, announces its Fox Business Network televised line-ups for tonight, Monday, February 28, 2022, 10:30 PM PT and for Tuesday night, March 01, 2022, 10:30 PM PT. Episode #312, airing tonight, Monday, February 28, 2022, 10:30 PM PT on the Fox Business Network with the following five (5) Companies and their businesses representatives: 1). Tonix Pharmaceuticals, Inc.'s (NASDAQ:TNXP) interview, Dr. Seth Lederman, MD, CEO.2). GlobeX Data, Ltd.'s (OTCQB:SWISF) (CSE:SWIS) (FRA: GDT) interview, Mr. Alain Ghiai, CEO.3). Rego Payments Architectures, Inc.'s. (OTCQB:RPMT) int
NEW YORK, Feb. 18, 2022 (GLOBE NEWSWIRE) -- FMW Media's New to The Street / Newsmax TV announces the broadcasting line-up of its national syndicated 1- hour TV show this Sunday, February 20, 2022, airing time 10-11 AM ET. New to The Street's 307th TV episode line-up, features eight (8) interviews of the following Companies and their businesses representatives: 1). GOLD – Glint Pay's interview, Mr. Jason Cozens, CEO. 2). Cryptocurrency – Glow Token LLC's (CRYPTO: GLOWV2) ($GLOWV2) interviews, Mr. Bryan Lawrence, CEO & Co-Founder, and Mr. Adam Beier, CFO & Co-Founder. 3). Cryptocurrency – Vulcan Forged's (CRY
Expansion of Internal Research and Development Capabilities Underway to Accelerate Infectious Disease Programs and Prepare for Future Pandemic Responses COVID-19 Pipeline Progressing with First-in-Human Trial of TNX-2100 Novel Skin Test for SARS-CoV-2 Functional T cell Immunity Expected to Start this Quarter Phase 2 Trial of TNX-1300 in Cocaine Intoxication Expected to Start this Quarter At September 30, 2021, Cash and Cash Equivalents Totaled Approximately $183 Million CHATHAM, N.J., Nov. 08, 2021 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced financial results for the third q
R&D Center is Expected to Accelerate Internal Discovery and Development of Vaccines and Antiviral Drugs Against COVID-19, its Variants and Other Infectious Diseases Domestic R&D Capability for Vaccines and Antivirals Intended to Support U.S. Pandemic Preparedness CHATHAM, N.J., Oct. 04, 2021 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, announced it has completed the acquisition of its new research and development center (RDC) located in Frederick, Md. The approximately 48,000 square foot facility will support Tonix's expanding infectious disease pipeline, including: TNX-1800 - a live virus vacci
Central Nervous System Pipeline Progressing with Two Phase 2 Studies (TNX-1300 and TNX-1900) and One Phase 3 Study (TNX-102 SL) Expected to Start This Year COVID-19 Pipeline Progressing with First-in-Human Trial of TNX-2100, a Novel in vivo Skin Test for COVID-19 T cell Immunity, Expected to Start This Year New Advanced Development Center, Currently Under Construction, and Planned Acquisition of Infectious Disease R&D Facility Will Expand Internal R&D and Manufacturing Capabilities for Vaccines and Antiviral Therapeutics, With Initial Focus on COVID-19 At June 30, 2021, Cash and Cash Equivalents Totaled Approximately $166 Million CHATHAM, N.J., Aug. 09, 2021 (GLOBE NEWSWIRE) -- Tonix
Announced Positive Efficacy Data from Animal Studies of COVID-19 Vaccine Candidate, TNX-1800 Interim Analysis of Second Confirmatory Phase 3 Study in Fibromyalgia Expected in Third Quarter 2021 Deep Pipeline Progressing with Three Central Nervous System (CNS) Programs Expected to Enter Phase 2 Trials This Year At March 31, 2021, Cash and Cash Equivalents Totaled Approximately $164 Million CHATHAM, N.J., May 10, 2021 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced financial results for the first quarter ended March 31, 2021 and provided an overview of recent operational highlights.
Alliance Global Partners analyst James Molloy maintains Tonix Pharmaceuticals (NASDAQ:TNXP) with a Buy and raises the price target from $6 to $11.
With the completion of its final pre-NDA meeting with the FDA, Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) announced it is filing an NDA submission in 2H 2024 and laying plans for the commercial launch of Tonmya™* for the management of fibromyalgia, assuming approval by the FDA in 2H 2025.The fibromyalgia market has not seen a new FDA-approved drug in over 15 years. And now with two drugs making their way through the FDA - Tonix's Tonmya and one from another U.S. company - there could be the prospect of a two-drug rivalry reminiscent of the 2010s when two blockbuster fibromyalgia drugs together created $10 billion in peak sales.
Shares of Helen of Troy Limited (NASDAQ:HELE) fell sharply during Tuesday's session after the company reported soft first-quarter earnings and lowered its FY25 guidance. Helen of Troy reported quarterly earnings of 99 cents per share which missed the analyst consensus estimate of $1.59. The company reported quarterly sales of $416.85 million which missed the analyst consensus estimate of $446.22 million, according to data from Benzinga Pro. Helen of Troy shares dipped 30.3% to $62.06 on Tuesday. Here are some other stocks moving in today’s mid-day session. Gainers Soligenix, Inc. (NASDAQ:SNGX) shares jumped 195% to $5.90 after the company announced interim results for extende
Shares of Mainz Biomed N.V. (NASDAQ:MYNZ) rose sharply in today's pre-market trading after the company announced submission for the FDA Breakthrough Device Designation for its next generation CRC screening test. Mainz Biomed shares jumped 16% to $0.5534 in pre-market trading. Here are some other stocks moving in pre-market trading. Gainers Pineapple Energy Inc. (NASDAQ:PEGY) rose 85% to $2.22 in pre-market trading. Pineapple Energy engaged Conduit Capital to provide structural internal support, staffing, and assistance with capital raising activities. Zapp Electric Vehicles Group Limited (NASDAQ:ZAPP) shares rose 43.5% to $13.26 in pre-market trading after gaining 127% on Mon
All of the securities to be sold in the offering are to be offered by Tonix. The Company intends to use the net proceeds from the offering for working capital and general corporate purposes, including the preparation of the new drug application relating to its Tonmya™ product candidate in patients with fibromyalgia, and the satisfaction of any portion of its existing indebtedness.
Tonix Pharmaceuticals Holding Corp (NASDAQ:TNXP) shares are trading lower by 11.3% to $0.71 during Monday’s session after the company announced receipt of the formal minutes from a recent pre-New Drug Application meeting with the FDA for Tonmya for the management of fibromyalgia. What Happened? Tonix Pharmaceuticals earlier Monday announced that it received formal minutes from a recent pre-New Drug Application (NDA) meeting with the FDA regarding Tonmya™ (cyclobenzaprine HCl sublingual tablets) for fibromyalgia management. Both parties agreed that the data package is sufficient for NDA submission, which Tonix plans to submit in the second half of 2024, aiming for potential FDA approval