Latest from Sushmita Panda
Cereno’s decision to include PH-ILD in CS014’s development strategy positions the asset for a Phase II study in a rare indication with limited treatment options, while maintaining its original relevance in IPF.
The FDA’s complete response letter for Aquestive Therapeutics’ allergy drug Anaphylm was limited to human factors validation and a single supportive pharmacokinetics study, defining a narrower path toward resubmission without additional efficacy trials.
Sanofi’s mixed data readout for venglustat lines up regulatory filings in neurological type 3 Gaucher's disease, while additional analyses and a separate trial will guide its future in Fabry's disease.
Attention now shifts to the company’s review of unblinded data and whether changes to patient enrolment could support further evaluation.
Despite the positive update, uncertainty regarding the future of Intellia's second Phase III trial for nex-z, which is till on hold, remains.
Roche's CT-388 shows promise in Phase II obesity trial but analysts question "commercial relevance" in a crowded market.
