Entera Bio Ltd

Entera Bio announced that the U.S. Food and Drug Administration accepted its plan for a single 12-month registrational Phase 3 study of EB613, the first oral anabolic tablet in development for postmenopausal women with osteoporosis, with topline data anticipated in the second half of 2028. The company also reported an oversubscribed $275 million private placement led by BVF Partners to fund EB613 through a potential new drug application submission, and it plans to initiate the Phase 3 trial in late 2026. Additionally, Entera intends to file an Investigational New Drug application for EB612, a first oral peptide replacement tablet for hypoparathyroidism, in the first half of 2027. For the second quarter of 2026, research and development expenses rose to $3.2 million from $1.5 million a year earlier, and the net loss widened to $7.3 million, or $0.14 per share, partly due to a non-cash fair value remeasurement of pre-funded warrants.

Gossamer Bio plans to submit a New Drug Application for Seralutinib to treat pulmonary arterial hypertension in September 2026, while Forte Biosciences has agreed to be acquired by argenx for $77 per share in cash, representing a total equity value of roughly $2.2 billion. Gossamer also regained worldwide rights to Seralutinib from Chiesi and reported cash of approximately $57 million as of June 30, 2026. Entera Bio shares soared over 90% after announcing an oversubscribed private placement expected to generate about $275 million in gross proceeds. Omeros gained more than 15% after AstraZeneca's Ultomiris failed a Phase 3 trial for HSCT-TMA, removing a key competitive threat to Omeros's YARTEMLEA. First Tracks Biotherapeutics rose over 18%, continuing its strong performance since its April 2026 Nasdaq debut.

Entera Bio announced a securities purchase agreement for an oversubscribed private placement expected to generate approximately $275 million in gross proceeds. The company will issue 122.96 million ordinary shares and pre-funded warrants to purchase up to 11.84 million ordinary shares at $2.04 per share, with closing expected on or about July 28. Proceeds will fully fund the Phase 3 registrational program of EB613, an oral PTH 1-34 tablet for osteoporosis, through a planned New Drug Application submission, and support Phase 1 development of EB612 for hypoparathyroidism in collaboration with OPKO Health. The financing is led by existing investor BVF Partners and includes new investors such as Longitude Capital, Vivo Capital, TCGX, and others. Entera shares surged 73.66% to $3.56 following the announcement.

Biotech stocks surged Thursday, led by CareDx which soared over 35% after Medicare finalized a policy confirming coverage for its transplant surveillance portfolio, including AlloSure Kidney and AlloMap Heart, effective August 30, 2026. AtaiBeckley jumped more than 33% on news it will be acquired by Eli Lilly in a deal valued at up to $3.8 billion, comprising $2.8 billion in upfront cash and up to $1.0 billion in contingent value rights tied to milestones for its depression treatments BPL-003 and VLS-01. Abbott Laboratories gained over 10% after reporting second-quarter net sales of $12.6 billion, a 13% increase, and raising its full-year adjusted earnings per share outlook to a range of $5.45 to $5.60. Apollomics added another 21%, bringing its weekly gain to more than 60%, as its lead candidate Vebreltinib advances in a Phase 2 trial for clear cell sarcoma and the company regained Nasdaq compliance. Virax Biolabs rose 13% after its CEO highlighted a narrowed net loss of $5.0 million, a $3.3 million capital raise, and a supply agreement with Fosun Diagnostics, while Entera Bio climbed over 12% ahead of a planned Phase 3 trial for its oral osteoporosis tablet EB613.

Entera Bio has received positive FDA feedback on its Phase 3 protocol for EB613, the first oral anabolic tablet in development for postmenopausal osteoporosis. The FDA accepted a single randomized, double-blind, placebo-controlled trial in approximately 750 postmenopausal women, with total hip bone mineral density at 12 months as the primary endpoint, to support a New Drug Application under the 505(b)(2) pathway. The company plans to initiate the study in late 2026 and expects topline data in the second half of 2028, with an open-label extension following patients through 24 months to provide additional safety and durability data.