aTyr Pharma

ATYR

時価総額 $1707万

Findings highlight ATYR0101's potential as a transformative therapy for disrupting the process of chronic tissue fibrosis. ATYR0101 is currently undergoing IND-enabling studies and expects to be advanced into the clinic in 2027.

aTyr Pharma Inc. (NASDAQ:ATYR) secured a formal agreement with the U.S. Food and Drug Administration (FDA) regarding the Phase 3 study protocol for its lead therapeutic candidate, efzofitimod.

Global Phase 3 study will evaluate efzofitimod in patients with pulmonary sarcoidosis with restrictive lung disease utilizing FVC as primary endpoint. Company expects to initiate study-related activities in the fourth quarter of 2026.

SAN DIEGO, Sept. 01, 2026 (GLOBE NEWSWIRE) -- aTyr Pharma, Inc. (Nasdaq: ATYR) (“aTyr” or the “Company”), a clinical stage biotechnology company engaged in the discovery and development of first-in-class medicines from its proprietary tRNA synthetase platform, today provided an update on the expected timing of a response from the U.S. Food and Drug Administration (FDA) related to the protocol the Company submitted in June 2026 for a planned Phase 3 study of efzofitimod in patients with chronic, symptomatic pulmonary sarcoidosis with restrictive lung disease.

Company awaiting comments from FDA by the end of August 2026 on protocol submitted for planned Phase 3 study of efzofitimod in patients with pulmonary sarcoidosis. Workforce reduction of approximately 60% and program prioritization conserves capital and aligns resources on efzofitimod program in ILD.

Patients with restrictive lung disease demonstrate clinically meaningful benefit in FVC and improvements in multiple PROs for 5.0 mg/kg efzofitimod compared to placebo. Company submitted protocol to FDA in June 2026 for planned Phase 3 study of efzofitimod in patients with chronic, symptomatic pulmonary sarcoidosis with restrictive lung disease.

Company to continue development of efzofitimod in pulmonary sarcoidosis following Type C meeting with the FDA. Company plans to submit an IND in June 2026 for a Phase 3 study of efzofitimod in patients with chronic, symptomatic pulmonary sarcoidosis with restrictive lung disease utilizing FVC as primary endpoint and KSQ-Lung as key secondary endpoint.

SAN DIEGO, May 13, 2026 (GLOBE NEWSWIRE) -- aTyr Pharma, Inc. (Nasdaq: ATYR), a clinical stage biotechnology company engaged in the discovery and development of first-in-class medicines from its proprietary tRNA synthetase platform, today announced that the company will participate in two upcoming investor conferences scheduled to take place in May and June 2026. Details of the conferences appear below: Conference: RBC Capital Markets Global Healthcare ConferenceDate: Wednesday, May 20, 2026Location: New York, NYFormat: 1x1 Investor Meetings Conference: Jefferies Global Healthcare ConferenceDate: Thursday, June 4, 2026Time: 3:45pm ETLocation: New York, NYFormat: Fireside ChatSpeaker: Sanjay S.

aTyr Pharma, Inc. (ATYR) Discusses FDA Feedback and Next Steps for Efzofitimod in Pulmonary Sarcoidosis After Phase III Results Transcript

aTyr Pharma NASDAQ: ATYR said it plans to conduct a new Phase III trial of efzofitimod in pulmonary sarcoidosis after receiving feedback from the U.S. Food and Drug Administration at a recent Type C meeting.