Researchers from Recludix Pharma Inc. reported preclinical efficacy data on REX-8756 (SAR-448755), a first-in-class orthosteric STAT6 inhibitor in models of atopic dermatitis (AD). Targeting STAT6, the key downstream mediator, offers a more selective strategy that could reproduce biologic efficacy while reducing off-target effects.
Sanofi SA has synthesized new cyclopropane-aryl and vinyloxy-aryl compounds acting as transcriptional coactivator YAP1/transcriptional enhancer factor (TEAD) and/or WW domain-containing transcription regulator protein 1 (WWTR1; TAZ)/TEAD interaction inhibitors potentially useful for the treatment of cancer.
Reports that Sanofi SA has asked to withdraw its sBLA for Tzield (teplizumab) from the U.S. FDA’s Commissioner’s National Priority Voucher (CNPV) program is once again raising questions about whether leadership skepticism is overruling approval decisions at the agency.
Four months after receiving a complete response letter from the U.S. FDA for tolebrutinib to treat non-relapsing secondary progressive multiple sclerosis, Sanofi SA received a positive opinion recommending approval in the EU.
As Sanofi SA gets ready to welcome a new CEO, the company along with partner Regeneron Pharmaceuticals Inc. said a happy hello as well to robust sales of Dupixent (dupilumab, dupi) and gained U.S. FDA clearance for the IL-4 receptor alpha antagonist to treat children, ages 2 to 11, with chronic spontaneous urticaria who remain symptomatic despite histamine-1 antihistamine treatment.
Researchers from Sanofi SA have detailed the development of a next-generation HER2-targeting T-cell engager (TCE) to increase selectivity for HER2-low tumor cells, while minimizing its effects on normal tissues expressing physiologic levels of HER2.
Introduced last year as a pilot program, the U.S. FDA Commissioner’s National Priority Voucher (CNPV) could be here to stay – at least for the duration of Marty Makary’s tenure as FDA commissioner. Since the FDA unveiled the CNPV last June, it has welcomed 18 products from 16 companies into the “game-changer” program for patients, as Makary described it. The goal is to provide an “ultrafast review pathway,” one to two months instead of the standard 10 to 12 months, for drugs and biologics of strategic national importance while maintaining the FDA’s scientific and regulatory standards, according to the agency.
To overcome the limitations regarding conventional immunotherapy for treating tauopathies, researchers from Sanofi SA aimed to improve brain exposure and targeting pathological tau species by optimizing antibody design.
T-cell engager company Kali Therapeutics Inc. licensed its lead product, CD19/BCMA/CD3 trispecific antibody KT-501, to Sanofi SA in a global deal that could be worth more than $1.2 billion. The San Mateo, Calif.-based biotech first emerged in 2024 and moved KT-501 into a phase Ia trial last week to treat adults with rheumatoid arthritis.
