Millendo Therapeutics Inc. in April decided to scrap work altogether with livoletide in Prader-Willi syndrome after a phase IIb study fell short of statistical significance, but hope remains alive for – among others in the space – Soleno Therapeutics Inc., another recent newsmaker with once-daily diazoxide choline controlled-release tablets in PWS.
Vancouver, British Columbia-based Sierra Oncology Inc. during its recent earnings call offered an update on momelotinib, in phase III development for myelofibrosis. Enrollment in the study won’t be finished until the fourth quarter of 2021.
Annexon Biosciences Inc.’s handsome $250 million IPO this summer verified the mounting interest in its two front-running C1q inhibitors: ANX-005, which has turned up promising phase Ib data in Guillain-Barre syndrome (GBS), with a phase II/III effort planned for next year, and ANX-007, due to enter a phase II experiment in geographic atrophy (GA) during 2021 as well.
Adverse events (AEs) took the shine off Odonate Therapeutics Inc.’s long-awaited top-line data from the phase III trial called Contessa testing the oral taxane chemotherapy tesetaxel in metastatic breast cancer (MBC), and shares of the San Diego-based firm (NASDAQ:ODT) closed at $18.33, down $15.21, or 45%.
San Diego-based Anaptysbio Inc.’s phase II blowup with anti-IL-33 monoclonal antibody etokimab in chronic rhinosinusitis with nasal polyps (CRwNP), disclosed Aug. 10, followed the compound’s mid-stage atopic dermatitis (AD) fizzle in November of last year, and raised questions not only about the lead candidate but also about the target.
Novartis AG won FDA clearance for the anti-CD20 monoclonal antibody Kesimpta (ofatumumab) in relapsing forms of multiple sclerosis (MS) in adults, with a label that includes clinically isolated syndrome and relapsing-remitting as well as active secondary progressive disease.
Karuna Therapeutics Inc. remains on track to launch a phase III study by the end of this year with Karxt against acute psychosis in schizophrenia by way of the broad-based program called Emergent, and the company continues planning for a phase II study testing the combo drug as adjunctive therapy with standard of care in the same indication.
Tango Therapeutics Inc. CEO Barbara Weber told BioWorld that Gilead Sciences Inc.’s decision to greatly expand their 2018 deal in oncology – a pact then valued as high as $1.7 billion – was based on brisker than expected progress in the original, five-target effort.
The FDA’s go-ahead for Roche Holding AG’s Enspryng (satralizumab-mwge) in anti-aquaporin-4 antibody-positive neuromyelitis optica spectrum disorder had watchers of the space weighing its market odds against two therapies approved earlier: Soliris (eculizumab) from Boston-based Alexion Pharmaceuticals Inc., and the more recently cleared Uplizna (inebilizumab-cdon) from Viela Bio Inc., of Gaithersburg, Md.
