Following the death of a patient, the U.S. FDA halted Arcellx Inc.’s phase II pivotal trial of its CAR T-cell therapy for relapsed or refractory multiple myeloma (MM), putting Gilead Sciences Inc., which in December made the risky decision to part with $225 million up front for rights to the immunotherapy, in likely turmoil.
For the second time in a week, measures of serum neurofilament light chain (NfL) took center stage, this time as Denali Therapeutics Inc. unveiled interim data from the open-label, single-arm phase I/II study testing DNL-310 in children with mucopolysaccharidosis II (MPS II), also known as Hunter syndrome.
Sirnaomics Ltd. is advancing lead siRNA candidate STP-705 for the treatment of squamous cell carcinoma in situ into late-stage clinical testing after sharing encouraging phase II trial results with the U.S. FDA in an end-of-phase II meeting. The company plans to move forward in 2023 with a single-dose study as a subgroup of subjects in a large phase III study. Positive results will provide the basis for completion of this large registrational phase III trial.
Curocell Inc. is inching closer to realizing Korea’s first domestically developed CAR T therapy, presenting “encouraging” interim phase II trial results for anbalcabtagene-autoleucel at the International Conference on Malignant Lymphoma in Lugano, Switzerland.
If Eli Lilly and Co. had been hoping its migraine drug, Emgality (galcanezumab), would emerge with unequivocal superiority against Pfizer Inc.’s Nurtec ODT (rimegepant orally disintegrating tablet), giving the once-monthly injectable biologic an advantage in the highly competitive CGRP space, the pharma firm likely was disappointed. Findings from the phase IV Challenge-MIG study did not meet the primary endpoint, which called for Emgality’s statistical superiority over Nurtec ODT on the percentage of patients achieving a 50% or greater reduction in monthly migraine days.
In a move that saw shares tumble by 26%, Biosenic SA has halted a phase IIb trial for its allogeneic stem cell therapy, Allob, after it failed to accelerate healing when given to patients two days after they sustained tibial fractures. The company plans to shift its focus to its late-stage arsenic trioxide candidate for chronic graft-vs.-host disease (GVHD).
Clene Inc. plans to sit down in the third quarter of this year with the U.S. FDA for talks about approval for gold nanocrystal suspension CNM-Au8, bolstered by favorable biomarker findings in amyotrophic lateral sclerosis (ALS) from the phase II/III Healey ALS platform trial – along with a sizeable time-to-event and survival data package that should drive the conversation.
Avenda Health Inc. reported new study results showing its Unfold AI platform, which uses artificial intelligence (AI) to map a tumor’s location within the prostate, encapsulates all of the clinically significant cancer present in the gland more effectively than standard care.
Eli Lilly and Co.’s phase II data with LY-3462817 (peresolimab), a monoclonal antibody (MAb) that functions as a PD-1 agonist for rheumatoid arthritis (RA), juiced hopes for the approach being tried by a handful of firms.
With the drug already under review by the U.S. FDA for dry eye disease (DED), Aldeyra Therapeutics Inc.’s reproxalap hit statistical significance in the second phase III study for allergic conjunctivitis (AC), and the firm is mulling what CEO Todd Brady called the “high-class problem” of how to best commercialize the product. A partner may help puzzle that out.
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