Short answer
Terns Pharmaceuticals, Inc. (TERN) filed an 8-K current report with the SEC on April 27, 2026 reporting Item 7.01 (Regulation FD Disclosure), Item 8.01 (Other Events), Item EX-99.1 (Exhibit EX-99.1). Exhibit 99.1 furnished under Regulation FD, making its disclosed information available to investors.
Terns Pharmaceuticals, Inc. 8-K event analysis
AI summary of each reported item and its exhibits
Item 7.01 · Regulation FD Disclosure
- Exhibit 99.1 furnished under Regulation FD, making its disclosed information available to investors
- Disclosure not deemed filed under Exchange Act Section 18
- Exhibit 99.1 excluded from incorporation by reference unless expressly specified
Item 8.01 · Other Events
- FDA granted Breakthrough Therapy Designation to oral TERN-701 for adult Ph+CML patients without T315I after two or more TKIs
- Designation may accelerate TERN-701 development and FDA review, supporting potential differentiation in a serious, underserved leukemia market
- Phase 1/2 CARDINAL showed encouraging major and deep molecular responses at week 24
- Low-grade adverse events predominated, with low severe-event and discontinuation rates supporting continued development
- BTD is not approval; clinical efficacy, safety, trial execution and commercialization remain material risks
Item EX-99.1 · Exhibit EX-99.1
- FDA Breakthrough Therapy Designation for TERN-701 in adult Ph+ CML patients without T315I after two or more TKIs
- Regulatory designation signals potential for expedited development and review in a serious disease with unmet medical need
- Phase 1/2 CARDINAL data showed encouraging major and deep molecular responses at week 24
- Low-grade adverse events predominated, with low severe-event and discontinuation incidence
- Merck acquisition agreement could accelerate TERN-701 toward pivotal testing and patient access
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