FDA grants Breakthrough Therapy Designation to TERN-701; Merck acquisition mentioned in press release

Terns Pharmaceuticals, Inc.

FDA Breakthrough Therapy Designation for TERN-701 in Ph+ CML-CP patients without T315I mutation, previously treated with 2+ TKIs.
Designation based on CARDINAL Phase 1/2 data: encouraging major molecular response and deep molecular response rates at week 24.
TERN-701 safety profile: majority of adverse events low grade; low severe adverse events and discontinuations.
Press release also notes recent agreement for Merck to acquire Terns (Nasdaq: TERN).
CEO Amy Burroughs cites BTD and Merck deal as potential acceleration to pivotal trial and patients.

item 7.01 item 8.01 item 9.01

Machine-readable event card

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accession: 0001193125-26-179062
form_type: 8-K
ticker: TERN
cik: 0001831363
company_name: Terns Pharmaceuticals, Inc.
filed_at: 2026-04-27T23:59:59+00:00
discovered_at: 2026-05-14T18:02:33.052285+00:00
generated_at: 2026-05-15T03:56:22.223732+00:00
sec_items: ["7.01", "8.01", "9.01"]
event_type: regulatory
sentiment: positive
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: high
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json_url: https://secwatch.observer/filing/0001193125-26-179062.json
markdown_url: https://secwatch.observer/filing/0001193125-26-179062.md
text_url: https://secwatch.observer/filing/0001193125-26-179062.txt
edgar_index_url: https://www.sec.gov/Archives/edgar/data/1831363/000119312526179062/0001193125-26-179062-index.htm
edgar_primary_document_url: https://www.sec.gov/Archives/edgar/data/1831363/000119312526179062/d122087d8k.htm
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review_status: machine_generated
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correction_note: null
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superseded_by: null

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