Soleno Therapeutics, Inc. (NASDAQ: SLNO) stock is witnessing a remarkable surge of 19.95% in its shares, trading at $45.45 as of the last check during current market. This noteworthy upswing of SLNO stock on the US charts is directly attributable to regulatory greenlights.
Today, Soleno Therapeutics (SLNO) announced that diazoxide choline has been designated as a breakthrough therapy by the U.S. Food and Drug Administration (FDA). This classification is for the therapeutic intervention of adults and children four years of age and older with hyperphagia and genetically proven Prader-Willi syndrome (PWS).
The conferment of this designation underscores the Agency’s discernment that, based on an evaluation of preliminary data emanating from the Phase 3 clinical development program, diazoxide choline exhibits the potential for substantial enhancement on clinically significant endpoint(s) compared to existing therapies.
This milestone, marked by the grant of Breakthrough Therapy Designation, signifies a significant advancement for Soleno Therapeutics’ DCCR clinical development initiative, notably as the first such designation for a drug aimed at PWS treatment.
This pivotal designation serves as affirmation of the FDA’s recognition of PWS as a severe medical condition and indicates the promising prospects of DCCR as a safe and efficacious therapeutic intervention for PWS. SLNO remains steadfast in its commitment to preparing the NDA submission for DCCR in PWS, with an anticipated timeframe around mid-2024.
The FDA’s Breakthrough Therapy Designation is tailored to accelerate the development and evaluation processes of drugs in the U.S. designated for the treatment of severe medical conditions, particularly when initial clinical data suggests significant improvements over existing therapies on clinically relevant parameters.
By bestowing Breakthrough Therapy Designation, the FDA facilitates comprehensive guidance and institutional dedication involving senior management in a proactive, collaborative, interdisciplinary review process, potentially enabling priority review and other measures to expedite assessment.
Diazoxide choline holds Orphan Drug Designation for PWS in both the U.S. and E.U., along with Fast Track Designation in the U.S.
