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JanOne Inc. (Nasdaq: JAN) is a pioneering clinical-stage pharmaceutical and biopharmaceutical company headquartered in Las Vegas, Nevada. Since its inception in 1976, JanOne has been committed to developing innovative, non-addictive pain relief therapies to address severe pain conditions and ultimately reduce dependency on opioid prescriptions. Through its lead candidate Jan101, a slow-release formulation of sodium nitrite, the company targets the treatment of Peripheral Artery Disease (PAD). Another promising drug, Jan123, focuses on treating Complex Regional Pain Syndrome (CRPS), a debilitating orphan disease lacking FDA-approved treatments.
The company's mission is significantly impactful in light of the ongoing opioid crisis, one of the deadliest epidemics in U.S. history. JanOne’s unique approach targets the root causes of pain, providing non-opioid alternatives that could potentially mitigate the risks associated with opioid abuse.
In recent developments, JanOne has filed an international patent application for low dose naltrexone to treat chronic pain, which could bolster its intellectual property portfolio and help patients worldwide. The company has also made significant strides in the fintech sector by acquiring ALT 5 Sigma Inc., a blockchain financial technology provider, diversifying its operations into the digital asset market.
JanOne operates through two main segments: Biotechnology and fintech (through its subsidiary ALT 5). ALT 5 offers innovative blockchain-powered technologies like ALT 5 Pay and ALT 5 Prime, facilitating crypto-currency payments and electronic over-the-counter trading of digital assets.
JanOne has received accolades for its research, such as the
JanOne Inc. (Nasdaq: JAN) has appointed CPC Clinical Research as the manager for its upcoming Phase 2b clinical trial of JAN101, targeting Peripheral Artery Disease (PAD). The trial will assess the efficacy of two doses of JAN101 in a placebo-controlled study involving 300 diabetic adults over six months. The primary endpoint is the ability to walk without pain, with secondary endpoints including pain reduction and improved blood flow. This trial follows positive results from a prior Phase 2a study, highlighting JanOne's commitment to developing non-addictive pain treatments.
JanOne Inc. (Nasdaq: JAN) has announced that its clinical packaging partner, Xerimis, has received the bottled clinical batch of JAN101 for the Phase 2b trial aimed at treating Peripheral Artery Disease (PAD). The drug is set for distribution to clinical sites across the U.S. Following positive Phase 1 and 2a results, which indicated pain reduction among PAD patients, the company anticipates that JAN101 could yield a multibillion-dollar market opportunity if approved. JanOne aims to provide a non-addictive alternative for the 8.5 million Americans suffering from PAD.
JanOne has selected Avania as its regulatory partner for the upcoming Phase 2b trial of its lead product candidate JAN101, aimed at treating Peripheral Artery Disease (PAD). This collaboration will enhance compliance with FDA requirements, as Avania oversees regulatory operations. The company has also completed the initial batch production of JAN101, marking significant progress towards trial initiation. Following the filing of a pre-Phase 2 briefing package this summer, JanOne anticipates recruiting PAD subjects, potentially benefiting over 8.5 million Americans suffering from this condition.
JanOne Inc. (Nasdaq: JAN) announced the appointment of Dr. Nicholas E. Goeders to its Scientific Advisory Board. Dr. Goeders is a leading expert on stress and addiction, aiming to support JanOne's mission of developing non-addictive pain medications. CEO Tony Isaac emphasized Dr. Goeders' relevance as they advance their treatment for peripheral artery disease (PAD) into Phase 2b clinical trials. JanOne's lead candidate, JAN101, has shown promise in earlier trials, with plans for further development to address the pain and addiction risk associated with opioid prescriptions.
JanOne (Nasdaq: JAN) has engaged DC Consulting LLC to enhance its government and private sector initiatives aimed at pain management. The collaboration targets reducing opioid prescriptions through JanOne's lead candidate, JAN101, which is in the pipeline for Phase 2b trials post positive Phase 2a results. The consulting firm, led by experienced former drug enforcement officials, will assist in legislative and regulatory strategies related to the company's healthcare objectives. JanOne focuses on innovative, non-addictive pain relief solutions, especially for conditions like peripheral artery disease.
JanOne Inc. (Nasdaq: JAN) has successfully completed the CGMP production of the first batch of JAN101, a sustained-release medication aimed at treating Peripheral Artery Disease (PAD). The initial batch produced contains approximately 200,000 tablets and placebos. This marks a significant milestone as JanOne prepares for its Phase 2b trial, focusing on improving vascular function and alleviating neuropathic pain. The FDA-regulated CGMP compliance indicates JanOne's commitment to quality manufacturing. The company also explores the use of JAN101 for other vascular complications.
JanOne Inc. (Nasdaq: JAN) has entered a definitive agreement to sell its subsidiary ARCA Recycling to CFO Virland Johnson for approximately $25 million. This move is part of JanOne's strategy to focus on its core life science assets. The transaction is set to close by August 18, 2021, with immediate payments of $7.5 million and an additional $17.5 million via a subordinated promissory note at 6% interest. Proceeds will support a pivotal Phase 2b trial for the company's lead candidate, JAN101, aimed at treating peripheral artery disease.
JanOne Inc. (Nasdaq: JAN) announced the successful closing of a securities offering, generating $6.0 million in gross proceeds by selling 571,428 shares at $10.50 each to institutional investors. The funds will be allocated for working capital and to plan clinical trials for JAN101, its lead drug candidate aimed at treating peripheral artery disease affecting over 8.5 million Americans. The offering was facilitated by A.G.P./Alliance Global Partners and conducted under a previously filed shelf registration statement.
JanOne Inc. (NASDAQ: JAN) announced a securities purchase agreement to sell 571,428 shares at $10.50 each, raising gross proceeds of $6 million. The offering is part of a registered direct offering and is expected to close around February 2, 2021, pending customary conditions. A.G.P./Alliance Global Partners is the sole placement agent. JanOne focuses on non-addictive pain relief treatments, with its lead candidate, JAN101, undergoing Phase 2b trials for peripheral artery disease, affecting over 8.5 million Americans. More details can be found on their website.
JanOne Inc. (Nasdaq: JAN) has initiated the production of JAN101 under cGMP for Phase 2b trials targeting Peripheral Artery Disease (PAD) and potential treatment for Covid-19 vascular complications. The first production batch will consist of 250,000 sustained release tablets. The Phase 2b trial is expected to commence in early 2021. With no effective treatments for PAD currently available, JAN101 aims to improve vascular function and reduce pain. Positive results from prior studies underline its potential in addressing severe pain conditions.
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