ENTERA BIO IS-,0000769

The FDA has agreed to a shortened approval study design for EB613: a 12-month, double-blind, placebo-controlled Phase III trial instead of the originally planned 24 months. Entera Bio raised $275 million and plans to begin recruitment in 2026. EB613 is an oral teriparatide tablet targeting patients who refuse injectable therapies; in Phase II it showed total-hip BMD increases of 1.34–1.57% after six months. Despite the milestone, the stock fell sharply on the conference day as investors remain cautious pending additional efficacy and safety data. » More on de.investing.com

Entera Bio reported a Q2 net loss of $7.3 million, or $0.14 per share, versus analyst expectations of a $0.09 per-share loss, driven by a $2.7 million non-cash warrant remeasurement and higher R&D spending. R&D rose to $3.2 million as the company prepares registrational work for its oral osteoporosis candidate EB613 after reaching FDA alignment on a 12-month Phase 3 design. Entera plans to start the pivotal trial in late 2026 with topline results targeted in H2 2028 and completed a $275 million private placement expected to extend its cash runway into 2030 (cash was $11.3 million at June 30). » More on finance.yahoo.com

Entera Bio completed a private placement of approximately $10 million, issuing 7,827,789 units at $1.2775 each; each unit includes a common share or a pre-funded warrant and a five-year warrant to purchase 1.5 shares at $1.24. Gross proceeds are about $10 million; if the warrants are fully exercised, an additional roughly $14.5 million could be raised, bringing total potential proceeds to about $24.5 million. Entera intends to use the funds to start the pivotal Phase 3 trial of EB613 in postmenopausal women with osteoporosis and for working capital; the company notes a strong liquidity position (current ratio 6.94). The stock rose 26% last week and is currently trading at $1.22, though InvestingPro considers the shares overvalued at this level. » More on de.investing.com