Although the highest dose of Bioxcel Therapeutics Inc.’s BXCL-501 hit the primary endpoint in the phase III Tranquility II trial for acute agitation in Alzheimer’s disease patients, shares fell dramatically on June 29 by 64% when investors learned the company received an FDA warning letter over infractions at a trial site.
South Korea’s JW Pharmaceutical Corp. announced a redo of its IND application to the Taiwan FDA on June 27 for its phase III trial on gout treatment URC-102 (epaminurad). The second filing comes in response to a regulatory rejection in March citing a problem with the proposed reference drug.
With the latest data from the phase II Sequel study, Cognition Therapeutics Inc. added new physiological evidence for the neuroprotective effect of CT-1812 in mild to moderate Alzheimer’s disease (AD) bolstering earlier results related to target engagement and the compound’s impact on cognitive changes. But the results failed to hit statistical significance, and shares of New York-based Cognition (NASDAQ:CGTX) closed June 28 at $2.18, down 32 cents, almost 13%.
Later this year, Mendus AB plans to move its allogeneic cell-based cancer vaccine, vididencel, into a phase II combination trial with oral azacitidine to evaluate the regimen’s potential as a maintenance therapy in patients with acute myeloid leukemia (AML).
Less than a week after Eli Lilly and Co.’s $2.4 billion, IL-17-based buyout of Dice Therapeutics Inc., Moonlake Immunotherapeutics Inc. offered more news in the space by way of data from the global phase II trial called Mira evaluating the efficacy and safety of the Nanobody sonelokimab in moderate to severe hidradenitis suppurativa (HS).
The dose-escalation portion of Black Diamond Therapeutics Inc.’s phase I study of BDTX-1535 for treating non-small-cell lung cancer (NSCLC) produced strong data that moved the market in a big way.
Eubiologics Co. Ltd. said it would file for regulatory approval for its COVID-19 vaccine called Eucorvac-19 in the Philippines, after announcing positive interim phase III trial results on June 27.
Enveric Biosciences Inc. is gearing up to begin clinical trials in generalized anxiety disorder with lead candidate, EB-373, a psilocin prodrug. Trials are expected to begin in the fourth quarter of 2023.
A tough spring has settled into a cruel summer for Fibrogen Inc. as the company has stumbled for the third time in two months. The newest problem is top-line results showing the phase III Zephyrus-1 study of pamrevlumab, a monoclonal antibody, missed its primary endpoint for treating idiopathic pulmonary fibrosis.
As earlier-stage efforts in oncology continue with BMF-219, Biomea Fusion Inc. rolled out new clinical data June 23 from the first two cohorts of patients with type 2 diabetes enrolled in the phase II part of its ongoing phase I/II study called Covalent-111 testing the same compound, an oral covalent menin inhibitor.
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