The FDA accepted a 12-month registrational Phase 3 plan for EB613 in about 750 patients, with study start late 2026 and topline data expected in 2H 2028.
Miranda Toledano called the $275 million BVF-led private placement “transformational,” funding EB613 through anticipated NDA submission and advancing EB612 toward a 1H 2027 IND.
Q2 loss widens as R&D spending rises
Entera Bio posted a net loss of $7.3 million, or $0.14 per share, for the quarter ended June 30, 2026, versus $2.7 million, or $0.06 per share, a year earlier.
R&D expense more than doubled to $3.2 million, due to EB613 Phase 3 preparations and OPKO-collaboration activities; G&A rose 27.27% to $1.4 million.
Cash and cash equivalents were $11.3 million, restricted cash totaled $7.1 million; pro forma cash after the July private placement expected to fund operations into 2030.
ENTX•
