BioSpace News Archive

FibroGen, Inc. announced topline data from the Fortis Therapeutics-sponsored Phase 1 study of FG-3246, a potential first-in-class anti-CD46 antibody drug conjugate with an MMAE-containing payload, in a dose-escalation and dose-expansion trial enrolling patients with metastatic castration-resistant prostate cancer whose tumors have progressed on at least one androgen receptor-signaling inhibitor.

Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that the U.S. Food and Drug Administration (FDA) has approved Fanapt® (iloperidone) tablets for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults.

MediciNova, Inc. announced that an abstract regarding results of a clinical trial of MN-166 in glioblastoma has been selected for an oral presentation at the American Society of Clinical Oncology Annual Meeting to be held May 31 – June 4, 2024 in Chicago.

Bristol Myers Squibb announced that the European Commission has expanded approval of Reblozyl® to include the first-line treatment of adult patients with transfusion-dependent anemia due to very low, low and intermediate-risk myelodysplastic syndromes.

StageZero Life Sciences, Ltd. announced a delay in the filing of its audited consolidated financial statements for the year ended December 31, 2023, management’s discussion and analysis for the same period and management certifications of annual filings beyond the deadline of April 2, 2024 prescribed by Canadian securities laws.

RemeGen Co. Ltd., a commercial-stage biotechnology company, obtained Fast Track Designation by the United States Food and Drug Administration recently for its innovative BLyS/APRIL dual-target fusion protein drug, Telitacicept, independently developed by RemeGen for the treatment of patients with primary Sjögren’s syndrome.