FDA Approves Roche’s Enspryng For Adults With Thyroid Eye Disease, First At-Home Subcutaneous Option; SatraGO-2 Proptosis Response 52.9% Vs 23.4% Placebo, SatraGO-1 Missed Primary Endpoint

Roche Licenses Rona’s ALK7-Targeting RNAi Candidate For Obesity And Metabolic Diseases, With Rona Eligible For Up To $1.06B In Milestones Plus Royalties

Reported Saturday, FDA Accepts Genentech’s Vamikibart BLA For Uveitic Macular Edema With Approval Decision Expected By July 2027, Following Phase III Data Showing Sustained Improvements At 52 Weeks

In the MEERKAT and SANDCAT studies, vamikibart demonstrated sustained improvements in vision and reductions in macular thickness in patients with UME at 52 weeksUME is the leading cause of moderate and severe vision

Roche Wins FDA Nod For Tecentriq Combination In Adjuvant Stage III DMMR Colon Cancer As 36-Month Disease-Free Survival Reaches 86% Versus 76% With Chemotherapy Alone In ATOMIC Trial

FDA approval is based on results from the landmark phase III ATOMIC study, published in The New England Journal of Medicine, which showed Tecentriq plus chemotherapy reduced the risk of disease recurrence or death by

2 Under-the-Radar Stocks to Buy and Hold

The article recommends two underrated biotech stocks: Axsome Therapeutics, which is experiencing strong growth with its drug Auvelity (51% YoY sales growth) and has a promising pipeline including potential new indications; and Exelixis, a cancer-focused biotech with a dominant drug Cabometyx protected until at least 2030, plus encouraging progress on pipeline candidates like zanzalintinib.

Roche Secures FDA Approval for First At-Home Thyroid Eye Disease Therapy

Roche earns FDA approval for Enspryng in thyroid eye disease, offering the only at-home subcutaneous treatment for TED.

FDA approves Roche’s Enspryng, a first-in-class IL-6R inhibitor, as the first and only at-home subcutaneous treatment option for thyroid eye disease (TED)

The FDA has approved Roche's Enspryng (satralizumab) as the first at-home subcutaneous treatment for thyroid eye disease (TED). The approval was based on Phase III SatraGO-1 and -2 studies, with SatraGO-2 demonstrating significant reductions in eye bulging (proptosis) and improvements in double vision (diplopia). Enspryng is an IL-6R inhibitor using novel recycling antibody technology and represents the second indication for the drug, following its 2020 approval for neuromyelitis optica spectrum disorder (NMOSD).