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.
Overview
Nutriband Inc is a Florida-based pharmaceutical company specializing in the development of transdermal drug delivery systems that incorporate advanced abuse-deterrent technologies. Its core business revolves around transdermal pharmaceutical products engineered to mitigate the risks of drug abuse, misuse, diversion, and accidental exposure, with a special emphasis on addressing the global opioid crisis. Utilizing proprietary technology that integrates aversive agents into transdermal patches, Nutriband is dedicated to improving patient safety while ensuring essential medications remain accessible for those in need.
Advanced Abuse-Deterrent Technology
The company’s flagship innovation, AVERSA technology, is designed to deter the oral abuse of potent drugs by utilizing taste aversion methods. This technology can be incorporated into various transdermal patches, a critical step toward preventing accidental exposures—particularly in vulnerable populations such as young children. The patented approach provides an additional safeguard by making the potential for abuse less appealing, thereby enhancing the overall safety profile of drugs with abuse potential.
Business Model and Operations
Nutriband Inc generates revenue primarily through the sale of consumer transdermal and coated products, as well as through contract manufacturing services provided by its wholly owned subsidiary, Pocono Pharma. The company leverages its strategic partnerships with top industry players to extend its market reach, including engagements with major retailers and established pharmaceutical manufacturing organizations. This diversified revenue approach not only supports the current portfolio but also positions Nutriband as a flexible partner in both the healthcare and contract manufacturing sectors.
Strategic Partnerships and Intellectual Property
A cornerstone of Nutriband’s success is its robust global intellectual property portfolio, which spans across more than 40 countries including the United States, Europe, Japan, and Australia. Such extensive protection underpins its innovative AVERSA technology and provides a competitive edge in the increasingly critical field of abuse-deterrent transdermal systems. Strategic alliances with industry experts such as Kindeva Drug Delivery further reinforce its position by ensuring that large-scale manufacturing processes align with FDA guidelines and international industry standards.
Market Position and Industry Significance
Operating at the nexus of pharmaceutical innovation and patient safety, Nutriband Inc is positioned distinctively in the competitive landscape of transdermal drug delivery systems. Its strategic focus on developing abuse-deterrent products addresses a significant unmet need in the market, particularly in the context of managing opioid-related risks without compromising therapeutic access. Through its commitment to evolving industry standards and enhancing product safety, Nutriband has established itself as a forward-thinking entity within a critical market segment.
Product Portfolio and Future Applications
While its lead product, an abuse-deterrent fentanyl patch, remains at the forefront of its development efforts, Nutriband is actively expanding its portfolio to include additional transdermal therapies. By integrating its core AVERSA technology across multiple product lines, the company aims to address a wide spectrum of medications with abuse potential, including opioids and stimulants. This strategy not only diversifies its technology applications but also solidifies its reputation as an innovator in transdermal pharmaceutical solutions.
Commitment to Safety and Regulatory Compliance
At the heart of Nutriband’s mission is a dedication to enhancing patient safety through rigorous research, development, and close adherence to regulatory standards. The company emphasizes clear, methodical approaches that streamline market entry while upholding the highest safety measures. This balance of innovation and compliance is critical in a market where the prevention of misuse and accidental exposure is of paramount concern.
Overall, Nutriband Inc exemplifies a strategic blend of innovative product development, methodical market expansion, and a steadfast commitment to patient safety. Its robust technology platform, significant IP portfolio, and established industry partnerships underscore its role as a key contributor to the evolution of abuse-deterrent pharmaceutical products.
Nutriband Inc. (NASDAQ:NTRB)(NASDAQ:NTRBW) has received approval from the Costa Rica Ministry of Health for its Mosquito Repellent Patch. The product, designed to reduce mosquito bites and associated health risks, will be exclusively distributed through Farmavision S.A. in Costa Rica. Nutriband plans to expand distribution throughout South and Central America.
The global mosquito repellent market is projected to reach USD $9.30 Billion by 2029 with a 5.23% annual growth rate. The patch contains natural ingredients to mask human odors attractive to insects. It's similar to patches approved in African countries like Ghana, Nigeria, and Ivory Coast for reducing malaria and HIV spread.
Nutriband's subsidiary, Pocono Pharmaceutical, will be the exclusive manufacturer of the product.
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.
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