Relacorilant, a cortisol modulator from Corcept Therapeutics Inc., produced new and strong phase III results in treating platinum-resistant ovarian cancer. The company also has relacorilant in studies that could eventually lead to approval in other indications. In the near term, though, the positive data led to the company’s stock (NASDAQ:CORT) closing 109% higher at $114.22 per share on March 31.
It was a mixed day for Daewoong Pharmaceutical Co. Ltd., which disclosed separately on March 28 both the termination of a $336 million licensing deal with CS Pharmaceuticals Ltd. and upbeat plans to unveil three new oncology assets at the upcoming American Association for Cancer Research in April.
Acrivon Therapeutics Inc. provided updated phase II data for checkpoint kinase candidate ACR-368, highlighting promising response rates for biomarker-positive patients with endometrial cancer and raising the possibility of an accelerated pathway in the second-line setting.
Equillium Inc. is forging ahead with regulatory plans for itolizumab in first-line treatment of patients with acute graft-vs.-host disease (GVHD), despite a phase III disappointment. Shares of the La Jolla, Calif.-based firm (NASDAQ:EQ) closed March 27 at 46 cents, down 29 cents, or 39%, on top-line data from the Equator study testing itolizumab, which is designed to target the CD6-ALCAM signaling pathway.
Elypta AB’s urine-based test correctly identified 90% of patients whose kidney cancer had returned, according to results from an ongoing study. The company’s metabolism-based liquid biopsy platform, which measures glycosaminoglycan biomarkers to detect cancer-specific signatures and uses algorithms to deliver clinically useful scores, could transform the lives of patients with kidney cancer.
Acrivon Therapeutics Inc. provided updated phase II data for checkpoint kinase candidate ACR-368, highlighting promising response rates for biomarker-positive patients with endometrial cancer and raising the possibility of an accelerated pathway in the second-line setting.
Wave Life Sciences Ltd. plans to file with the U.S. FDA for accelerated approval of WVE-N531, an exon skipping oligonucleotide for boys with Duchenne muscular dystrophy (DMD) who are amenable to exon 53 skipping, a decision based on favorable data from the phase II Forward-53 study. The analysis was conducted after 48 weeks of treatment with 10 mg/kg of the drug dosed every two weeks. Forward-53 achieved all trial goals, turning up sustained exon skipping, muscle concentrations, and dystrophin restoration through 48 weeks and a 61-day tissue half-life that supports giving the DMD therapy once a month.
Taimed Biologics Inc.’s TMB-365/TMB-380 long-acting combination of broadly neutralizing antibodies regimen for HIV maintenance could reshape HIV treatment management, offering a viable alternative to daily combination antiretroviral therapy (cART), the Taipei-based company said after reporting on phase IIa results.
Opthea Ltd. is considering its options after lead candidate sozinibercept (OPT-302) failed the phase III Coast trial in wet age-related macular degeneration (AMD). The global Coast phase III trial evaluated the efficacy and safety of intravitreally administered 2-mg sozinibercept every four or eight weeks in combination with 2-mg aflibercept every eight weeks after a loading phase for the treatment of wet AMD. The trial did not meet its primary endpoint of mean change in best corrected visual acuity from baseline to week 52.
RSS
