Record mula sa primary source
Decision-gradePag-apruba ng FDA
Tonix: Inaprubahan ng FDA ang TONMYA (cyclobenzaprine HCl) para sa fibromyalgia
Binigyan ng FDA ng pag-apruba ang TONMYA para sa fibromyalgia sa mga nasa hustong gulang noong Agosto 2025, ang unang bagong gamot para sa indikasyong ito sa loob ng >15 taon. Inilunsad nang komersyal ang produkto noong Nobyembre 17, 2025, na may maagang pagtanggap na nagpapakita ng >1,500 nagreseta at ~4,200 reseta hanggang sa huling bahagi ng Pebrero 2026.
Mahahalagang fact
- Na-file
- Mar 13, 2026, 10:01 AM
- Kaganapan
- Pag-apruba ng FDA
- Direksyon
- Positibo
- Kumpanya
TNXPTonix- Asset
- TNX-102 SL
- Pinagmulan
- SEC 8-K
- Kumpiyansa
- May source
- 30% na tumugon sa Trial 1
- 46% kumpara sa 27%
- 30% na tumugon sa Trial 3
- 47% kumpara sa 35%
- pangunahing endpoint trial1
- -0.4 (p=0.010)
- pangunahing endpoint trial3
- -0.7 (p<0.001)
Sipi mula sa source
EX-99.01 2 ex99-01.htm PRESS RELEASE TONIX PHARMACEUTICALS HOLDING CORP Exhibit 99.01 Tonix Pharmaceuticals Reports Fourth Quarter and Full Year 2025 Financial Results and Operational Highlights TONMYA™ (cyclobenzaprine HCl sublingual tablets) launched November 17, 2025, for the treatment of fibromyalgia; through February 27, 2026, more than 1,500 healthcare providers have prescribed TONMYA to patients, approximately 2,500 patients have initiated treatment with TONMYA, and cumulative prescriptions totaled approximately 4,200 Expect to initiate U.S. field study in 2027 for TNX-4800 for seasonal prevention of Lyme disease pending FDA clearance Completed $20.0 million registered direct offering with Point72 on December 29, 2025 Approximately $207.6 million in cash and cash equivalents