Tonix Pharmaceuticals Holding Corp. (TNXP) went up by 8.32% in the premarket, at $0.55 with 137 thousand shares exchanging at the last check. In the previous market session, the stock gained 6.18% to close at $0.5050 on November 26. Intraday trading, the stock went up to $0.51 and down to $0.48 at a volume of 24.92 million. While in the 52-week range, the stock saw a high of $2.12 and a low of $0.455, at an average volume of 14.56 million (65 days). This puts the stock’s gain at 8.49% in the past five days, while it lost 12.93% in the past month. Further, the TNXP stock has lost a value of 25.19% year to date. Currently, it trades at market capital of $221.99 million with 439.59 million shares outstanding. The gain in the stock seems to be continued since the company announced FDA clearance of its product for the prevention of migraine headaches.

Incorporated in 2007, Tonix Pharmaceuticals Holding Corp. (TNXP) is a clinical-stage biopharmaceutical company. Which discovers, acquires, and develops small molecules and biologics for the treatment and prevention of diseases.

FDA Clearance of TNXP’s IND

On November 23, the company announced that its TNX-1900 has received an FDA Investigational New Drug Application (IND) for the prevention of migraine headaches. TNX-1900 (intranasal potentiated oxytocin) is a combination product that delivers oxytocin to the nose. Oxytocin is a hormone, the lower levels of which cause an increased frequency of migraines.

Migraine headaches have proven very tricky to treat for both biotechnology and pharmaceutical companies alike. In the U.S. alone approx. 4 million people suffer from chronic migraines with no proper cure. The FDA’s clearance paves the path for the TNX-1900 to enter its phase 2 study for the prevention of migraines in chronic patients.

Further Developments

Just a day before the TNX-1900 announcement, TNXP issued the details of its publication on TNX-3500 for protection against SARS-CoV-2. The company’s antiviral inhibitor TNX-3500 showed great potential against coronavirus and its various strains, which is now under development.

Q3 Financial Highlights

TNXP announced its third-quarter financial results on November 8, 2021. According to the results, the company incurred a net loss of $18.5 million or $0.05 per share in the third quarter of 2021. While the net loss in the Q3 of 2020 was $12.0 million or $0.09 per share.

As of September 30, 2021, the company had cash and cash equivalents of $183.0 million.