CHATHAM, N.J. - Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP), a biopharmaceutical company, has announced the completion of a key pre-New Drug Application (NDA) meeting with the U.S. Food and Drug Administration (FDA) regarding Tonmya™, its developmental drug for fibromyalgia management.
According to the recent meeting's formal minutes, the company is aligned with the FDA on critical Chemistry, Manufacturing, and Controls (CMC) topics, which are pivotal for the planned NDA submission scheduled for the second half of 2024.
The meeting's agenda was to confirm agreement with the FDA on aspects such as drug substance and product specifications, shelf life, and commercial packaging for Tonmya. Tonix CEO, Seth Lederman, M.D., expressed optimism about the potential of Tonmya being the first new fibromyalgia treatment introduced to the market in over a decade.
He highlighted the importance of the FDA's guidance as the company prepares for the NDA submission and mentioned active preparations for a dual manufacturing launch with global contract development and manufacturing organizations, including Almac Pharma Services.
Fibromyalgia, a chronic pain disorder affecting an estimated 6 to 12 million adults in the U.S., presents with symptoms such as widespread pain, fatigue, and cognitive dysfunction. Current treatments often leave patients and physicians dissatisfied, underlining the need for new therapeutic options.
Tonmya, which is a patented sublingual formulation of cyclobenzaprine hydrochloride, has shown promising results in clinical trials. The company reported statistically significant and clinically meaningful outcomes in two pivotal Phase 3 trials, RESILIENT and RELIEF, with improvements in daily pain, sleep quality, fatigue, and overall fibromyalgia symptoms.
Despite these advancements, Tonix emphasized that Tonmya is still an investigational new drug and has not yet received approval for any indication. The company's broader portfolio includes central nervous system disorder treatments, immunology development for organ transplant rejection, autoimmunity, and cancer, as well as commercialized products for acute migraine management.
Tonix's forward-looking statements are subject to risks including FDA approvals, marketing success, clinical development progression, financial requirements, patent protection, litigation, government or third-party reimbursement, and competition. The information in this article is based on a press release statement from Tonix Pharmaceuticals Holding Corp.
In other recent news, Tonix Pharmaceuticals has announced a public offering of its common stock, aiming to raise approximately $4 million. The proceeds are intended for working capital and general corporate purposes, including the funding of preparations for a new drug application for Tonmya™, a candidate for treating fibromyalgia. Dawson James Securities, Inc. is the sole placement agent for the transaction.
Furthermore, Tonix Pharmaceuticals is preparing to submit a New Drug Application for Tonmya™, following successful outcomes from two Phase 3 trials. The company also implemented a 1-for-32 reverse stock split to comply with NASDAQ's minimum bid price rule.
In addition, the FDA granted Rare Pediatric Disease Designation to Tonix's drug candidate TNX-2900 for the treatment of Prader-Willi syndrome in children and adolescents. However, Noble Capital revised its price target for Tonix's shares, lowering it to $1.50 from the previous $10.00, while maintaining an Outperform rating on the stock. These are recent developments that highlight Tonix's ongoing efforts to advance its portfolio of treatments.
InvestingPro Insights
As Tonix Pharmaceuticals (NASDAQ: TNXP) progresses towards its NDA submission for Tonmya™, investors are closely monitoring the company's financial and market metrics. According to InvestingPro data, Tonix currently has a modest market capitalization of $5.11 million and trades at a low Price / Book multiple of 0.05. This valuation metric can often attract investors looking for potentially undervalued stocks, especially in the biopharmaceutical sector where assets and intellectual property can play a significant role in a company's intrinsic value.
Analysts keeping an eye on TNXP have noted that the stock has experienced significant price volatility, with a 1-week price total return showing an 11.93% increase, while longer-term returns over the last year have seen a staggering 97.85% decline. The stock's volatility may appeal to certain traders, but it also indicates a higher risk level which should be considered.
Adding to the story are InvestingPro Tips that suggest analysts have recently revised their earnings upwards for the upcoming period, indicating a potential positive shift in expectations. However, the company's financials show a substantial operating income loss of $105.83 million over the last twelve months as of Q1 2024, emphasizing the challenges it faces on the path to profitability.
For investors seeking more in-depth analysis, there are additional InvestingPro Tips available, including insights on cash burn rates and the stock's performance over various time frames. Subscribers to InvestingPro can access these tips to inform their investment decisions. Use coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription, and unlock the full suite of analytical tools and expert insights.
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