Associated tags: FDA, Elective surgery, Surgeon, Injury, Patient, Pharmaceutical, Biotechnology, Therapy, Nerve, Health, Physician, Neurology, Pharmaceutical industry, Research, Wallerian degeneration, Nerve injury, Science, EVP, Pfizer, Axon, Other Health, General Health, Clinical Trials
Locations: PENNSYLVANIA, UNITED STATES, NORTH AMERICA, US, PHILADELPHIA
Retrieved on:
Thursday, February 22, 2024
Biotechnology,
Neurology,
Health,
Pharmaceutical,
Clinical Trials,
Therapy,
Regeneration,
EVP,
Multimedia,
MD,
Neuropathic pain,
Physician,
FDA,
Standard of care,
Orthopedic surgery,
MHQ,
Safety,
Associate,
Nerve,
Patient,
Sympathetic nervous system,
Lead author At the 24-week mark, NTX-001 continues to demonstrate an encouraging safety profile, with lower treatment-emergent adverse event rates than the standard of care.
Key Points:
- At the 24-week mark, NTX-001 continues to demonstrate an encouraging safety profile, with lower treatment-emergent adverse event rates than the standard of care.
- The secondary endpoints, including the Numerical Pain Rating Scale, also showed statistically significant improvements, favoring NTX-001 at the 24-week timepoint.
- Neuraptive Therapeutics, Inc. is dedicated to the innovation and development of medical products and therapeutics to repair and regenerate peripheral nerves.
- Neuraptive Therapeutics, Inc. disclaims any obligation to update the information contained in these forward-looking statements.
FDA,
Health,
Neurology,
Clinical Trials,
Pharmaceutical,
Biotechnology,
Patient,
Therapy,
Nerve,
Orphan,
Orphan drug,
Axon,
EVP,
Food,
Food and Drug Administration,
Wallerian degeneration,
Physician,
Pharmaceutical industry Neuraptive Therapeutics Inc., a leader in innovative medical solutions, is pleased to announce that it has received Orphan Drug Designation from the United States (US) Food and Drug Administration (FDA) for its fusogen contained in the NTX-001 treatment kit.
Key Points:
- Neuraptive Therapeutics Inc., a leader in innovative medical solutions, is pleased to announce that it has received Orphan Drug Designation from the United States (US) Food and Drug Administration (FDA) for its fusogen contained in the NTX-001 treatment kit.
- Dr. Seth Schulman, Chief Medical Officer of Neuraptive Therapeutics Inc., stated, “Receiving the Orphan Drug Designation for NTX-001 is a testament to our commitment to advancing healthcare solutions for patients impacted by peripheral nerve injuries who today have limited options.” The Orphan Drug Designation is granted to drugs intended to treat rare diseases or conditions in the US.
- Highlights of Orphan Designation are:
Eligibility to receive regulatory assistance and guidance from the FDA in the design of an overall drug development plan.
- “ Following this designation, Neuraptive Therapeutics plans to accelerate the development of NTX-001, aiming to bring this promising treatment to patients as soon as possible.” Said Mr. Tzanis.
FDA,
Health,
Neurology,
Clinical Trials,
Pharmaceutical,
Biotechnology,
Quality of life,
Science,
Axon,
Multimedia,
Physician,
Regeneration,
Pain,
Hope,
Participation,
Nerve,
MHQ,
Therapy,
SAE,
Randomness,
Wallerian degeneration,
Control,
Standard of care,
Nerve injury,
Clinical trial,
PGIC,
Patient,
Safety,
SOC,
EVP Neuraptive Therapeutics, Inc. is dedicated to revolutionizing patient care through innovative therapies, and NTX-001 has the potential to redefine the standard of care.
Key Points:
- Neuraptive Therapeutics, Inc. is dedicated to revolutionizing patient care through innovative therapies, and NTX-001 has the potential to redefine the standard of care.
- Key highlights from the NEUROFUSE Study:
The NEUROFUSE Study is a 48-week, Multicenter, Randomized, Controlled, Evaluator-Blinded Study comparing NTX-001 as an adjunct treatment to standard of care vs. standard of care alone.
- The study was to enroll 60 patients, and patients were randomized in a 1:1 ratio between treatments.
- For more information about Neuraptive Therapeutics, Inc., and our pioneering work in peripheral nerve injury treatments, please visit Neuraptive.com.
Retrieved on:
Monday, February 27, 2023
Biotechnology,
Pharmaceutical,
Health,
Neurology,
Nerve,
Therapy,
Bar,
Law,
Patient,
New England Law Boston,
Physician,
Binghamton University,
Pharmaceutical industry to the company’s Board of Directors.
Key Points:
- to the company’s Board of Directors.
- “On behalf of the Neuraptive Board and its directors, we are excited to welcome Cary to the board,” said Robert Radie, chairman, and chief executive officer of Neuraptive.
- “Cary’s extensive background in the capital markets, corporate strategy, legal, and compliance make him an important addition to the Neuraptive board of directors.
- Mr. Sucoff has been a member of the Bar of the State of New York (now retired) since 1978.
Retrieved on:
Thursday, November 17, 2022
Science,
Biotechnology,
Research,
Pharmaceutical,
Medical Supplies,
General Health,
Health,
Other Health,
Ohio State University,
GlaxoSmithKline,
Therapy,
Multimedia,
Nerve injury,
Physician,
Development,
Nerve,
Eli Lilly and Company,
Patient,
Pharmaceutical industry,
Pharmacology,
Pfizer,
Pharmacy,
Research Key Points:
- View the full release here: https://www.businesswire.com/news/home/20221117005443/en/
On behalf of the Neuraptive Board and its directors, we are excited to welcome Bob to the board, said Robert Radie, chairman, and chief executive officer of Neuraptive.
- His extensive experience in drug research and development is a great addition to the Neuraptive board at this important time.
- Dr. Ruffolo is the retired President of Research and Development of Wyeth Pharmaceuticals, and Corporate Senior Vice President of the Wyeth Corporation (now Pfizer).
- Prior to Wyeth, Dr. Ruffolo held executive roles at SmithKline Beecham Pharmaceuticals (now GlaxoSmithKline) and Lilly Research Laboratories.
Biotechnology,
General Health,
Other Health,
Health,
Pharmaceutical,
Physician,
Therapy,
Hotel des Indes (The Hague),
NDA,
Research and development,
Patient,
Nerve,
Pediatrics,
Executive,
University,
CHOP,
Wyeth,
Neurology,
CEO,
Faculty,
Associate,
Fast Track,
Pharmaceutical industry,
Management,
Pfizer,
Research Neuraptive Therapeutics, Inc., a biotechnology company dedicated to developing novel therapeutics and medical products to address the unmet needs of physicians and patients impacted by peripheral nerve injuries, announced key organizational and financial updates.
Key Points:
- Neuraptive Therapeutics, Inc., a biotechnology company dedicated to developing novel therapeutics and medical products to address the unmet needs of physicians and patients impacted by peripheral nerve injuries, announced key organizational and financial updates.
- Evan Tzanis has been appointed to the role of Chief Operating Officer and Executive Vice President of Research and Development.
- Additionally, Mr. Tzanis has played an integral role guiding the company through significant organizational transition and fundraising.
- Neuraptive Therapeutics, Inc. is a biotechnology company dedicated to developing novel therapeutics and medical products to address the unmet needs of physicians and patients impacted by peripheral nerve injuries.
We hope to initiate this study later this year.\xe2\x80\x9d\nDr.
Key Points:
- We hope to initiate this study later this year.\xe2\x80\x9d\nDr.
- Klebuc is the director of the Center for Facial Paralysis Surgery and Functional Restoration at the Methodist Hospital in Houston, Texas.
- Dr. Klebuc added, \xe2\x80\x9cWe have put together a multi-centered group of physician-scientists who are eager to evaluate this new technology.
- Private Securities Litigation Reform Act of 1995. including, among others, statements we make regarding the time for the commencement of clinical trials.
Biotechnology,
Finance,
Surgery,
Health,
Professional services,
Companies,
Life sciences,
CAC 40,
Sanofi,
Industries,
Neuraptive Therapeutics,
New Rhein Healthcare Investors Neuraptive Therapeutics, Inc. (Neuraptive), a clinical-stage biotechnology company dedicated to developing novel therapeutics and medical products for the treatment of peripheral nerve injuries (PNI), today announced the hiring of Robert (Bob) S. Radie as Chief Executive Officer.
Key Points:
- Neuraptive Therapeutics, Inc. (Neuraptive), a clinical-stage biotechnology company dedicated to developing novel therapeutics and medical products for the treatment of peripheral nerve injuries (PNI), today announced the hiring of Robert (Bob) S. Radie as Chief Executive Officer.
- Mr. Radie also will serve as Chairman of Neuraptive's Board of Directors.
- View the full release here: https://www.businesswire.com/news/home/20200623005779/en/
Robert Radie joins Neuraptive Therapeutics, Inc. as Chairman and CEO.
- He has held senior executive positions in six companies, including serving as Chief Executive Officer of Zyla Life Sciences, Inc. Transmolecular Inc, and Topaz Pharmaceuticals, Inc., which was acquired by Sanofi Pasteur.
Research,
Medical devices,
Surgery,
FDA,
Other Health,
Biotechnology,
Pharmaceutical,
Health,
Science,
Other Science,
Fast track,
Food and Drug Administration,
Life sciences,
Biotechnology,
Industries,
FDA Fast Track Designation,
Neuraptive Therapeutics,
New Rhein Healthcare Investors Neuraptive Therapeutics, Inc. (Neuraptive), a clinical-stage biotechnology company dedicated to developing novel therapeutics and medical products for treatment of peripheral nerve injuries (PNI), today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for its franchise therapeutic product, NTX-001, in the treatment of patients with peripheral nerve injuries.
Key Points:
- Neuraptive Therapeutics, Inc. (Neuraptive), a clinical-stage biotechnology company dedicated to developing novel therapeutics and medical products for treatment of peripheral nerve injuries (PNI), today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for its franchise therapeutic product, NTX-001, in the treatment of patients with peripheral nerve injuries.
- Fast Track designation provides several important advantages that could expedite the development of NTX-001.
- We are very pleased that NTX-001 has been granted Fast Track designation, said Ivan Gergel, MD, Neuraptives Executive Chairman of the Board.
- ( https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated... )
Neuraptive is creating innovative novel therapies for nerve repairs to improve clinical outcomes for patients and surgeons who care for them.
Research,
Medical devices,
Surgery,
FDA,
Other Health,
Biotechnology,
Pharmaceutical,
Health,
Science,
Other Science,
Neurosurgery,
Syndromes,
Overuse injuries,
Medical specialties,
Neuraptive Therapeutics,
New Rhein Healthcare Investors "We look forward to working with investigators as we advance Neuraptives NTX-001 into the clinic for the treatment of peripheral nerve injuries."
Key Points:
- "We look forward to working with investigators as we advance Neuraptives NTX-001 into the clinic for the treatment of peripheral nerve injuries."
- Peripheral nerve injuries resulting in surgeries are common, occurring in more than 600,000 patients annually in the United States, with approximately 80% of nerve injuries occur in the upper extremities.
- Neuraptives Phase 2 study will evaluate the safety and efficacy of NTX-001 versus the current standard of care in upper extremity injuries.
- Neuraptive is creating innovative novel therapies for nerve repairs to improve clinical outcomes for patients and surgeons who care for them.
