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aTyr expects mid-September FDA reply on Phase 3 protocol for efzofitimod in pulmonary sarcoidosis
ATyr (ATYR) says it anticipates an FDA response by mid-September 2026 to the protocol submitted in June for a planned Phase 3 study of efzofitimod in chronic, symptomatic pulmonary sarcoidosis with restrictive lung disease. The proposed global, randomized, double-blind, placebo-controlled 54-week trial would enroll up to ~372 patients, randomize 1:1 to 5.0 mg/kg IV efzofitimod or placebo every 3 weeks (17 doses), and use change in FVC at week 48 as the primary endpoint with King's Sarcoidosis Questionnaire‑Lung score as a key secondary.
aTyr cuts ~60% of staff to focus on efzofitimod in ILD; FDA feedback on Phase 3 protocol due end‐Aug
ATyr announced a corporate restructuring that will reduce headcount by approximately 60% to prioritize efzofitimod for interstitial lung disease and conserve cash while awaiting FDA feedback on a Phase 3 protocol submitted in June (response expected by the end of August 2026). The company has completed enrollment in the Phase 2 EFZO‐CONNECT SSc‐ILD study (23 patients) with topline results expected in Q1 2027, ended Q2 with $58.9M in cash and says the runway extends into late 2028 but will require additional capital to fund a global Phase 3.
Life Sciences Virtual Investor Forum set for June 24–25; aTyr (ATYR) to present
Virtual Investor Conferences released the agenda for a Life Sciences Virtual Investor Forum on June 24–25 with live presentations and scheduled 1:1 investor meetings; participation is free. aTyr Pharma (ATYR) is scheduled to present June 25 at 3:30 PM ET alongside other biotech and medtech companies including PHIO, IMNN, JAGX and CTSO.
ATYR director Paul Schimmel buys 100,000 shares at $0.4963 (Form 4)
ATYR filed SEC Form 4. The filing also reports beneficial holdings of 779,143 shares held by the Schimmel Revocable Trust and 1,413,023 shares held by Paul Schimmel Prototype PSP, and a reported disposition of 8,890 shares.