Forex News
FDA Accepts Cogent's Bezuclastinib NDA for AdvSM
The FDA accepted Cogent Biosciences' NDA for bezuclastinib in AdvSM, with a PDUFA target action date of June 29, 2027.
- FDA accepted the New Drug Application for bezuclastinib in advanced systemic mastocytosis.
- The AdvSM NDA carries a PDUFA target action date of June 29, 2027.
- Separate NDAs for GIST and non-advanced SM carry PDUFA target action dates of November 30, 2026 and December 30, 2026.
- APEX trial data, presented at the 2026 European Hematology Association Congress, showed a 79% 12-month progression-free survival rate.
- Cogent's Compensation Committee approved inducement grants of 39,300 stock options and 33,600 restricted stock units on September 10, 2026.
NDA Acceptance
The FDA accepted the NDA for bezuclastinib in patients with advanced systemic mastocytosis. The agency has no plan to hold an advisory committee at this time.
NDA acceptance is another important regulatory milestone for bezuclastinib.
— Andrew Robbins, CEO, Cogent Biosciences
Regulatory Timeline
The GIST NDA carries a PDUFA target action date of November 30, 2026. The non-advanced SM NDA carries a PDUFA target action date of December 30, 2026. The AdvSM NDA carries a PDUFA target action date of June 29, 2027.
APEX Trial Data
Bezuclastinib is a selective tyrosine kinase inhibitor targeting KIT D816V and exon 17 mutations. KIT D816V drives systemic mastocytosis.
The APEX trial data cutoff was March 31, 2026. Results were presented at the 2026 European Hematology Association Congress.
- CR/CRh/PR response rate reached 57%.
- Pure pathological response rate reached 81%.
- 12-month progression-free survival rate reached 79%.
- 12-month overall survival rate reached 87%.
- Median PFS and OS remain not yet mature.
Expanded Access
Cogent has active expanded access programs for U.S. patients with SM or GIST.
Inducement Grants
Cogent's Compensation Committee approved inducement grants on September 10, 2026. Grants were dated September 10 and September 14, 2026.
The grants total 39,300 stock options with a 10-year term. Options vest 25% at the one-year anniversary, with the remainder monthly over 36 months.
The grants also include 33,600 restricted stock units. RSUs vest annually in equal installments over four years.
The awards comply with Nasdaq Listing Rule 5635(c)(4).
Company
Cogent Biosciences is headquartered in Waltham, MA and Boulder, CO. Its shares trade on Nasdaq under the ticker COGT.