After an eight-year odyssey, the first cytidine triphosphate synthase 1 (CTPS1) inhibitor has entered the clinic, with Step Pharma SAS announcing it has simultaneously begun studies in the U.S. and the U.K. The phase I/II trial is assessing Step’s lead program, STP-938, in relapsed/refractory B- and T-cell lymphomas, with the first U.S. site opening for enrollment this week.
The U.S. FDA’s summer 2021 approval of Skytrofa (lonapegsomatropin) from Ascendis Pharma A/S served to sharpen appetites for an even better therapy to treat for pediatric growth hormone deficiency (GHD). Among players in the forefront is Lumos Pharma Inc., with an oral candidate that could disrupt the competitive space.
Wall Street apparently wants to see longer-term data from Bridgebio Pharma Inc. with oral infigratinib in children with achondroplasia (ACH) before deciding about the drug’s chances against the approved therapy Voxzogo (vosoritide) from Biomarin Pharmaceutical Inc.
After political leaders across the globe made patents and other intellectual property safeguards the scapegoat for disparities in access to COVID-19 vaccines, the biopharma industry is sharing its vision for how to deal with the foundational issues of equitable access in pandemics to come – and it has nothing to do with IP waivers like the one World Trade Organization members adopted last month.
Ipsen SA’s $247 million buyout of Epizyme Inc., and the recent decision by Nordic Nanovector SA to dump its phase IIb program with CD-37-targeted Betalutin (177Lu lilotomab satetraxetan), served to highlight the hot space of relapsed/refractory follicular lymphoma, where bispecifics have been showing particular promise.
The U.S. FDA has granted Alpheus Medical Inc. orphan drug and fast track designations for a therapeutic platform that could improve outcomes for patients suffering from recurrent glioblastoma (GBM), the most common primary brain cancer and among the hardest to treat.
Top-line results from Vistagen Therapeutics Inc.’s Palisade-1 phase III study of PH-94B for treating social anxiety disorder showed the therapy fell shy of the primary endpoint. The South San Francisco-based company’s stock (NASDAQ:VTGN) fell dramatically on the results July 22 as shares closed 86% lower at 15 cents each.
With enrollment set to finish any day in Selecta Biosciences Inc.’s Dissolve II study testing SEL-212 in chronic refractory gout (CRG), investor appetite runs high in the space, as contenders line up to take on Horizon Therapeutics plc’s Krystexxa (pegloticase), the only product approved for CRG.
Nanostics Inc. launched a new trial of its Claritydx Bladder with support from Alberta Innovates to the tune of C$600,000 (US$465,690). The test uses extracellular vesicle detection technology and artificial intelligence to identify bladder cancer and could provide a valuable alternative to cystoscopy for detection of bladder cancer at earlier stages.
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