PERTH, Australia –Australian stem cell therapy company Mesoblast Ltd. announced that the FDA has accepted its BLA for priority review for its allogeneic mesenchymal precursor cell therapy, remestemcel-L, for children with acute steroid-refractory graft-vs.-host disease (aGVHD).
DUBLIN – Without particularly looking for a deal, immunometabolism specialist Sitryx Ltd. landed quite a large one – a licensing agreement in autoimmune disease with Eli Lilly and Co. involving up to four preclinical programs, for which it is receiving $50 million up front, $10 million as equity investment and up to $820 million in development milestones.
Barely a day after its PDUFA date, despite the unfolding COVID-19 pandemic, the FDA has approved Bristol Myers Squibb Co.'s immunomodulator, ozanimod, an oral treatment for adults with relapsing-remitting multiple sclerosis (MS) and active secondary progressive disease branded as Zeposia. The win, a much-anticipated milestone precipitated by the company’s multibillion-dollar acquisition of ozanimod developer Celgene Corp. in November 2019, gives patients a new treatment option amid a growing field of therapies for MS.
Dragonfly Therapeutics Inc., of Cambridge, Mass., has expanded a strategic collaboration with Merck & Co. Inc. on the development of natural killer (NK) cell engager immunotherapies for oncology to add infectious disease and immune disorders. For $47.5 million up front, it's granting Merck the option to license exclusive rights to candidates developed using its TriNKET cell technology platform.
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).
In a second phase III trial for treating progressive forms of multiple sclerosis (MS), designed to confirm the successful first trial, Medday Pharmaceuticals SA’s investigational MD-1003 failed to hit its primary and secondary endpoints.
DUBLIN – Hansa Biopharma AB is nearing a key milestone in its evolution, as a regulatory decision on its first marketing authorization application (MAA) looms. The EMA’s Committee for Medicinal Products for Human Use (CHMP) is expected to deliver an opinion during the second quarter on its application for imlifidase in supporting kidney transplants in sensitized patients.
HONG KONG – U.S., China and the Netherlands-based Harbour Biomed Therapeutics Ltd. has teamed up with Mount Sinai Health System, New York City's largest academic medical system, to develop novel biotherapies in oncology and immunology. The two parties will also be using Harbour’s H2L2 Harbour Mice platform to develop a monoclonal antibody (MAb) against the coronavirus that has turned into a global epidemic.
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.
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