Cogent's Bezuclastinib NDA Accepted For Advanced Systemic Mastocytosis; PDUFA Set For June 2027

Cogent Biosciences, Inc. (COGT) filed an SEC Form 8-K — Results of Operations and Financial Condition. Exhibit 99.1 Cogent Biosciences Reports Recent Business Highlights and Second Quarter 2026 Financial Results On track for potential approval of bezuclastinib for GIST patients (PDUFA November 30) and NonAdvSM patients (PDUFA December 30) later this year; AdvSM New Drug Applicatio

Cogent Biosciences (NASDAQ:COGT) said it filed a New Drug Application with the U.S. FDA for bezuclastinib to treat advanced systemic mastocytosis, citing encouraging results from its APEX key trial. CEO Andrew Robbins said the company is working with the FDA on three submissions and expects initial approvals by end-2026.

The FCC granted Intel a one-year waiver to use foreign-made robotics in its U.S. semiconductor production. The waiver allows Intel to continue operating its Automated Guided Vehicles (AGVs), which are critical to its chip manufacturing. Intel cited a lack of domestic alternatives and the potential disruption to its supply chain if it had to replace the AGVs. The FCC's quick approval and Intel's importance to U.S. chip manufacturing plans are noted.

Citi received approval from China's CSRC to establish a wholly-owned securities firm, Citigroup Securities (China) Company Limited (CSCCL). The license allows CSCCL to offer equities brokerage, underwriting, research, and trading services. Citi will complete regulatory procedures for operations to begin. CSCCL, based in Shanghai, will serve domestic and foreign clients with onshore capital markets services.

The FAA issued a directive requiring inspections of 1,987 US-registered Boeing 737NG aircraft due to potential control issues from excessive horizontal stabilizer movement. The order, effective November 23, follows reports of pitch oscillations. Airlines like United and Alaska requested delays or adjustments, but the FAA rejected them. Inspections are estimated to cost over $1 million for the US fleet. Southwest Airlines operates the largest 737NG fleet worldwide.

Sheryl Sandberg, former Facebook COO, testified in a 2026 New Mexico trial that she was unaware of certain app developer vetting practices between 2012 and 2018. The jury found 26 of 29 Facebook statements misleading, leading to a $25 billion penalty. Sandberg defended Facebook's data practices, stating it does not sell user data. The case involves 43.9 million alleged violations under New Mexico's Unfair Practices Act.