"Cogent Biosciences: FDA Breakthrough Therapy Designation and New Drug Application for Bezuc

Cogent Biosciences received FDA Breakthrough Therapy Designation and accepted its New Drug Application for bezuclastinib in gastrointestinal stromal tumors (GIST). This highlights potential changes for future treatment options if the drug is approved. The stock closed at $35.91 with a 1-year return of 299.4% and 5-year return of 238.8%. Investors should watch for future FDA feedback, efficacy and safety data, and the share price reaction around regulatory dates. Key risks include zero revenue, recent shareholder dilution, and a volatile share price.