Welcome to our dedicated page for Nutriband news (Ticker: NTRB), a resource for investors and traders seeking the latest updates and insights on Nutriband stock.
Nutriband Inc. (NASDAQ: NTRB, NTRBW) is a developer of prescription transdermal pharmaceutical products, with a primary focus on its AVERSA abuse-deterrent transdermal technology and its lead product candidate, an abuse-deterrent fentanyl patch. The Nutriband news stream highlights how the company is advancing this technology platform, interacting with regulators, and managing its corporate structure to support product development.
Readers of the Nutriband news page can follow regulatory and clinical development updates, including the company’s reported meetings with the U.S. Food and Drug Administration on the Chemistry, Manufacturing, and Controls plans and the 505(b)(2) NDA pathway for AVERSA Fentanyl. News items also cover Nutriband’s summaries of FDA feedback on in vitro studies to characterize abuse-deterrent properties and its intention to move toward an IND filing in support of a Human Abuse Potential clinical study.
The company’s releases also describe intellectual property developments, such as a provisional patent application to enhance AVERSA technology and U.S. patent actions related to abuse and misuse deterrent transdermal systems, alongside references to a broad patent portfolio covering AVERSA in multiple countries. Corporate and capital markets news includes announcements of a preferred stock dividend tied to future FDA approval of AVERSA Fentanyl, the sale of a majority stake in subsidiary Pocono Pharmaceutical to EarthVision Bio, and Nutriband’s inclusion in Russell indexes.
Additional coverage includes partnership and collaboration news, such as agreements with Kindeva Drug Delivery for product development, Brand Institute for commercial brand name creation, and a non-binding Letter of Intent with the Qvanta Group to explore advanced technology support for abuse-deterrent pharmaceutical innovation. Investors and observers can use this page to review how Nutriband presents its progress on AVERSA Fentanyl, its stance on issues like illicit versus prescription fentanyl, and its participation in investor conferences and public communications.
Nutriband Inc. (NASDAQ:NTRB)(NASDAQ:NTRBW), a developer of transdermal pharmaceutical solutions, is hosting an exclusive live investor webinar and Q&A session on October 17, 2024, at 4:15 p.m. ET. The event, hosted by RedChip Companies, will feature Nutriband Founder and CEO Gareth Sheridan and Founder and President Serguei Melnik, who will discuss the company's current operations and upcoming milestones.
Nutriband is addressing the global opioid crisis with its AVERSA™ abuse-deterrent transdermal technology. The company's lead product, AVERSA™ Fentanyl, is targeting peak annual sales of $80 million to $200 million upon FDA approval. Nutriband is pursuing a streamlined 505(b)(2) NDA regulatory pathway, requiring only a single Phase 1 trial with potential for an expedited six-month FDA review.
Nutriband Inc. (NASDAQ:NTRB) has received a Notice of Allowance from the Chinese National Intellectual Property Administration (CNIPA) for its patent application covering the AVERSA™ abuse deterrent transdermal technology. This technology incorporates aversive agents into transdermal patches to prevent abuse, diversion, misuse, and accidental exposure of drugs with abuse potential, including opioids and stimulants.
The AVERSA™ technology is now protected by patents in 46 countries, including major markets like the US, Europe, Japan, and China. Nutriband is collaborating with Kindeva Drug Delivery to develop AVERSA Fentanyl, potentially the world's first abuse-deterrent opioid patch. This product could reach annual US sales of $80 million to $200 million.
The proprietary aversive agent coating employs taste aversion and has shown resistance to removal in preliminary studies. It also features a patented immediate and extended-release profile for additional deterrence.
Nutriband Inc. (NASDAQ:NTRB) has signed a trademark licensing agreement for Bitrex® brand denatonium benzoate, the world's most bitter substance, as an aversive agent in its lead product, AVERSA™ Fentanyl. This abuse-deterrent fentanyl patch incorporates Nutriband's proprietary technology to prevent abuse, diversion, misuse, and accidental exposure of drugs with abuse potential.
The AVERSA™ technology uses a taste aversion coating that is difficult to remove and has a patented immediate and extended-release profile. This additional layer of deterrence prevents easy separation of the drug from the aversive agents. Bitrex® is known for its extremely bitter taste, making products unpalatable and helping prevent accidental ingestion, especially in children.
Nutriband is collaborating with Kindeva Drug Delivery to develop the commercial scale manufacturing process. AVERSA Fentanyl has the potential to be the world's first abuse-deterrent opioid patch, with estimated peak annual US sales of $80 million to $200 million.
Nutriband Inc. (NASDAQ:NTRB)(NASDAQ:NTRBW) has authorized a $1 million share buyback program for its common stock. As of September 16, 2024, the company had 11,106,185 outstanding common shares. Nutriband is primarily focused on developing transdermal pharmaceutical products, with its lead product being an abuse deterrent fentanyl patch incorporating the AVERSA™ abuse deterrence technology. The company maintains its target of submitting an NDA to the FDA in Q1/Q2 2025 for AVERSA Fentanyl. AVERSA™ technology can be integrated into any transdermal patch to prevent abuse, misuse, diversion, and accidental exposure of drugs with abuse potential.
Nutriband Inc. (NASDAQ:NTRB) has released its Q2 2024 financial report, highlighting a strong cash position of $6.75 million and strategic progress towards its NDA filing for AVERSA Fentanyl in 2025. The company is expanding its kinesiology tape contract manufacturing through Pocono Pharma, targeting major retailers. Nutriband aims to submit an NDA for AVERSA Fentanyl to the FDA in Q1/Q2 2025, relying on a single phase 1 Human Abuse Potential study. If approved, AVERSA Fentanyl could be the first abuse-deterrent transdermal patch globally, with estimated peak annual sales of $80-$200 million. The company's total assets are valued at $13.63 million, with stockholders' equity at $12.5 million.
Nutriband Inc. (NASDAQ:NTRB)(NASDAQ:NTRBW), a developer of transdermal pharmaceutical solutions, is hosting an exclusive live investor webinar and Q&A session on July 25, 2024, at 4:15 p.m. ET. The event, hosted by RedChip Companies, will feature Chairman and President Serguei Melnik and CEO Gareth Sheridan discussing current operations and upcoming milestones.
Nutriband is focusing on addressing the global opioid crisis with its AVERSA™ abuse-deterrent transdermal technology. Their lead product, AVERSA™ Fentanyl, is targeting peak annual sales of $80 million to $200 million upon FDA approval. The company is pursuing a streamlined 505(b)(2) NDA regulatory pathway, requiring only a single Phase 1 trial with potential for an expedited six-month FDA review.
Nutriband Inc. (NASDAQ:NTRB) has received a Notice of Allowance from the USPTO for its AVERSA™ trademark, a key component of its abuse-deterrent transdermal patch technology. The company's lead product, AVERSA™ Fentanyl, is progressing towards commercial manufacturing scale-up in partnership with Kindeva Drug Delivery. Nutriband plans to file an IND application with the FDA, preceding pivotal studies to demonstrate the abuse-deterrent properties of AVERSA™ Fentanyl.
The upcoming human abuse potential study will compare AVERSA™ Fentanyl to a current fentanyl patch without abuse-deterrent features. Preliminary studies indicate AVERSA™ technology's high resistance to manipulation. A market analysis projects potential peak annual U.S. sales of $80 million to $200 million for AVERSA™ Fentanyl, highlighting its significant market potential in abuse-deterrent pharmaceuticals.
Nutriband has provided an update on its Aversa Fentanyl product development program. The company, in collaboration with Kindeva Drug Delivery, has progressed in developing the commercial manufacturing process for a transdermal fentanyl patch incorporating Nutriband's AVERSA™ abuse-deterrent technology. This follows a feasibility agreement and a commercial development and clinical supply agreement between the two companies.
Kindeva has validated analytical methods for handling aversive agents required for the product. Nutriband plans to file an Investigational New Drug (IND) application with the FDA, including chemistry, manufacturing, and clinical study protocols for a Phase 1 human abuse potential study, which is pivotal for the New Drug Application (NDA) process. No Phase 2 or Phase 3 trials are needed.
The AVERSA Fentanyl patch aims to prevent drug misuse while ensuring accessibility for patients in need, with potential peak annual US sales estimated between $80 million to $200 million.
Nutriband reported Q1 revenues of $408,532, highlighting a 219% YoY increase in sports tape sales via its Pocono Pharma subsidiary. The company is leveraging penetration pricing to secure deals with major brands like KT Tape, Reebok, Adidas, and New Balance.
In Q1, Nutriband completed an $8.4M private placement at $4 per share, bringing its cash position to $8,347,739 as of April 30, 2024.
The company is advancing its AVERSA line, targeting a Q1 2025 NDA filing for AVERSA Fentanyl, projected to achieve peak annual sales of $80-$200M. AVERSA Buprenorphine could reach up to $130M in annual sales.
Nutriband (NASDAQ:NTRB), a developer of transdermal pharmaceuticals and technology, will host an exclusive live investor webinar on May 30, 2024, at 4:15 p.m. ET.
Organized by RedChip Companies, the event will feature Chairman Serguei Melnik and CEO Gareth Sheridan, who will provide insights into the company's current operations and future milestones.
Investors can register for the free webinar and submit questions beforehand or during the live session.