Should I sell my stake in tnxp or wait till August to see if they can get their fibromyalgia drug to market
2/6/2025 11:31am
**Consider holding your stake in TNXP**, and monitor the company's progress toward bringing its fibromyalgia drug to market. Here's why:
1. **Potential for FDA Approval**: TNX-102 SL has been granted Fast Track designation by the FDA, which could expedite its review process. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of August 15, 2025, for a decision on marketing authorization. If approved, TNX-102 SL could become the first new drug for treating fibromyalgia in over 15 years, addressing a significant unmet medical need.
2. **Clinical Trial Results**: The drug's efficacy has been demonstrated in two Phase 3 trials, RELIEF and RESILIENT, which showed statistically significant improvements in pain reduction compared to placebo. TNX-102 SL was also generally well-tolerated, with a safety profile that included minimal systemic adverse events.
3. **Market Potential**: Fibromyalgia is a chronic pain condition affecting over 10 million adults in the U.S., with significant unmet medical needs. TNX-102 SL has the potential to be a non-opioid treatment option, which could address the issue of opioid misuse and addiction associated with current therapies.
4. **Company's Financial Position**: Tonix Pharmaceuticals has been working to improve its financial position, including a recent reverse stock split aimed at boosting its per-share trading price to comply with NASDAQ's minimum bid price requirement. The company has also received positive analyst ratings, with a consensus growth in revenue estimated at $12.8 million, representing a significant year-over-year increase.
5. **Market Sentiment**: There has been a recent positive sentiment around TNXP stock, with a 6.7% increase on January 28, 2025, and an 11.5% increase on February 1, 2025. This could be indicative of investor optimism about the company's potential success with TNX-102 SL.
In conclusion, while there are risks associated with investing in a biopharmaceutical company, the potential for TNX-102 SL to gain FDA approval and the significant market need for a new fibromyalgia treatment suggest that holding your stake in TNXP could be a viable option. However, it's important to continue monitoring the company's progress and market conditions. If you are concerned about the risks, you may consider adjusting your position based on new developments and your investment strategy.