Record mula sa primary source
MateryalPagbabago sa trial registry
Nakatanggap ang Rein Therapeutics ng feedback mula sa FDA tungkol sa clinical hold ng LTI-03
Sinuri ng FDA ang karagdagang nonclinical data at kinumpirma na ang mga natuklasan sa MCH/H ay hindi naglilimita sa dosis para sa 24-linggong Phase 2 RENEW protocol sa mga dosis hanggang 10 mg/araw. Pinayuhan ang kumpanya na magsumite ng CRL na tumutugon sa mga alalahanin sa kaligtasan nang walang bagong GLP rat toxicity studies; kasalukuyang inihahanda ang CRL at inaasahang maisusumite sa susunod na ilang linggo.
Mahahalagang fact
- Na-file
- Set 22, 2025, 12:00 PM
- Kaganapan
- Pagbabago sa trial registry
- Direksyon
- Neutral
- Kumpanya
RNTXRein Therapeutics- Asset
- LTI-03
- Pinagmulan
- SEC 8-K
- Kumpiyansa
- May source
Sipi mula sa source
8-K NASDAQ false 0001420565 0001420565 2025-09-16 2025-09-16 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): September 16, 2025 REIN THERAPEUTICS, INC. (Exact Name of Registrant as Specified in Its Charter) Delaware 001-38130 13-4196017 (State or Other Jurisdiction of Incorporation) (Commission File Number) (I.R.S. Employer Identification Number) 12407 N. Mopac Expy. , Suite 250 , #390 Austin , Texas 78758 (Address of principal executive offices) (737) 802-1989 (Registrant’s telephone number, including area code) N/A (Former name or former address, if changed since last report) Check the appropriate box below