Geneva-based Obseva SA’s phase III Primrose 2 trial with gonadotropin-releasing hormone (GnRH) antagonist linzagolix in heavy menstrual bleeding (HMB) due to uterine fibroids (UFs) hit the primary endpoint in 94% of patients, and the company in the second quarter of 2020 will report six-month data from the Primrose 1 study, which is also a phase III experiment, in the same indication.
DBV Technologies SA officials took pains to reassure investors that data wanted by the FDA with regard to the BLA for Viaskin Peanut allergy therapy are already in hand and need only be turned over to the agency, but that didn’t stop shares (NASDAQ:DBVT) from sliding 55.7%, or $2.93, to close March 17 at $2.33.
Anti-drug antibodies noted in the phase Ib portion of the PREVAIL study in lupus drew queries for Oldwick, N.J.-based Provention Bio Inc. during a conference call related to earnings, but analysts seemed more interested in the company’s later-stage push in type 1 diabetes (T1D).
With a phase IIb readout coming in the third quarter of 2020, Cambridge, Mass.-based Fulcrum Therapeutics Inc. might be set up for a win in facioscapulohumeral muscular dystrophy (FSHD), a genetic muscle disorder for which there’s no treatment.
Kala Pharmaceuticals Inc. plans to use its positive phase III data in dry eye disease (DED) with KPI-121 (loteprednol etabonate ophthalmic suspension 0.25%) as the basis for the resubmission of its NDA in the second quarter of 2020.
During its Feb. 27, 2020, conference call on the previous year’s fourth-quarter results – though not in a related press release – Nektar Therapeutics Inc. let news drop that the prospective breast cancer (BC) therapy Onzeald (etirinotecan pegol) for patients with brain metastases had failed in top-line phase III outcomes.
Keros Therapeutics Inc. CEO Jasbir Seehra told BioWorld that he plans to use at his new company lessons learned as co-founder of Acceleron Pharma Inc., where work with receptors in the TGF-beta superfamily “taught me the potential of the biology and those molecules, but also the limitations” with regard to safety that need to be surmounted.
Strongly favorable six-month data disclosed on Jan. 9 by Applied Genetic Technologies Corp. (AGTC) from its ongoing phase I/II program with an adeno-associated virus (AAV) gene therapy for X-linked retinitis pigmentosa (XLRP) did more than provide a whopping stock boost.
With new phase III multiple myeloma (MM) data in hand from Newton, Mass.-based Karyopharm Therapeutics Inc.’s Xpovio (selinexor), Wall Street began speculating about what the results might mean in the marketplace.
Paris-based Sanofi SA won FDA clearance of the intravenously given CD38-directed cytolytic antibody Sarclisa (isatuximab-irfc) in combination with pomalidomide (Pomalyst, Celgene Corp.) and dexamethasone (dex) for adults with multiple myeloma (MM) who have received at least two prior therapies, including lenalidomide (Revlimid, Celgene Corp.) and a proteasome inhibitor.
