Oxford spinout Alethio Therapeutics closed a $90 million Series A to take ATX-011, a monoclonal antibody against the G6B receptor, into Phase 1/2a studies in essential thrombocythemia. It is also developing a G6B-targeted ADC for myelofibrosis.
|Articles|April 7, 2014
Genzyme to Resubmit Lemtrada Application for FDA Review
Author(s)BioPharm International Editors
Sanofi and Genzyme to resubmit FDA application for approval of Lemtrada, for the treatment of relapsing forms of multiple sclerosis.
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Genzyme had previously announced its intention to appeal the FDA's Complete Response Letter. As a result of the planned resubmission, the company does not expect to pursue an appeal at this time.
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T-Therapeutics closed an oversubscribed $133 million Series B backed by Eli Lilly, JJDC, and others. The funding will take its first T-cell receptor bispecifics in cancer and autoimmune disease into clinical trials.
FDA’s draft framework would let sponsors add patient-specific genome editing variants to an approved BLA using in vitro data. Here is what the guidance proposes, what evidence it asks for, and what remains unresolved.
Healthy-volunteer data show sustained TL1A suppression and a profile supporting infrequent subcutaneous dosing. Caldera also licensed a second bispecific, targeting IL-17 and TL1A, from Qyuns Therapeutics.
The half-life-extended antibody failed its primary endpoints in two Phase 2 SKYWAY sub-studies, so Spyre is dropping it in rheumatic diseases and moving it into a combination trial in hidradenitis suppurativa.
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FDA set a May 1, 2027 target date for AMT-130, a one-time gene therapy that silences the huntingtin gene, and plans an advisory committee meeting.
The first-in-class molecule, licensed to Dianthus as DNTH212 outside Greater China, is designed to block type 1 interferon production and BAFF/APRIL-driven B-cell activity with a single drug.
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