Eton Pharmaceuticals, Inc. filed a Form 8-K on November 2, 2026, announcing the launch of ET-900, a new development program evaluating mecasermin injection for the treatment of infantile and epileptic spasms.

Key Highlights

  • New program announced: ET-900 evaluates mecasermin injection for infantile and epileptic spasms, according to the filing.
  • License agreement: Eton has entered into a license agreement with Baylor College of Medicine covering patent rights related to the use of insulin-like growth factor 1 (IGF-1) for the treatment of spasms.
  • IND submitted: A research Investigational New Drug application has been submitted to the U.S. Food and Drug Administration for an investigator-sponsored Phase 2 clinical study.
  • Study population: The Phase 2 study evaluates mecasermin in children with refractory epileptic spasms, as disclosed in the filing.
  • Enrollment target: Initial enrollment and patient dosing are targeted for the first quarter of 2027, the company disclosed.

Eton Pharmaceuticals Discloses ET-900 Mecasermin Program and Baylor License

According to the Form 8-K filed with the U.S. Securities and Exchange Commission on November 2, 2026, Eton Pharmaceuticals, Inc. (NASDAQ:ETON) announced the ET-900 development program, which is evaluating mecasermin injection as a potential treatment for infantile and epileptic spasms. The company, headquartered in Deer Park, Illinois, described the program as a new initiative under Item 8.01 (Other Events) of the filing.

The filing disclosed that Eton has entered into a license agreement with Baylor College of Medicine. The agreement covers patent rights related to the use of insulin-like growth factor 1 (IGF-1) for the treatment of spasms. No financial terms of the license agreement were disclosed in the filing.

The company further reported that a research Investigational New Drug application has been submitted to the U.S. Food and Drug Administration. The application supports an investigator-sponsored Phase 2 clinical study evaluating mecasermin in children with refractory epileptic spasms. According to the filing, initial enrollment and patient dosing are targeted for the first quarter of 2027. The filing notes that these statements regarding targeted timelines are the company's own and are subject to its cautionary language. The 8-K was signed by Judith M. Matthews, Chief Financial Officer and Secretary, as Principal Financial Officer.

What Was Disclosed

Eton Pharmaceuticals disclosed the launch of its ET-900 program on November 2, 2026, including a license agreement with Baylor College of Medicine and the submission of a research IND to the FDA for a Phase 2 study targeting children with refractory epileptic spasms.