Cullinan Therapeutics Provides Business Update for 2026
Cullinan Therapeutics provided a corporate update and shared anticipated business highlights for 2026. Highlights; Data readouts planned for CLN-978 across all three autoimmune indications in 2026, including single dose and repeat dosing data. Company to complete monotherapy expansion cohorts to determine recommended Phase 2 dose for CLN-049 pivotal registrational study and initiate combination study in frontline AML in Q4 2026. Zipalertinib rolling NDA submission expected to be complete in Q1 2026 and full enrollment of REZILIENT3 frontline study expected in H1 2026. Preliminary cash and investments of $439.0 million as of December 31, 2025; Runway into 2029
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Major Stocks on the Rise Monday: Paramount Skydance, Wave Life Sciences, Ocular Therapeutix, Carvana, and More
U.S. Stock Market Performance: U.S. stocks declined, with the Dow Jones dropping over 200 points on Monday, while several companies saw significant gains in their share prices.
Paramount's Acquisition Move: Paramount Skydance Corporation's shares surged nearly 10% after announcing a $30 per share all-cash tender offer to acquire Warner Bros. Discovery, valuing the deal at $108.4 billion.
Biotech Stock Gains: Wave Life Sciences and Structure Therapeutics experienced remarkable increases of 129.1% and 100.5%, respectively, following positive clinical trial results for their obesity treatments.
Other Notable Stock Movements: Companies like Fulcrum Therapeutics and Kymera Therapeutics also saw substantial share price increases due to promising clinical trial data, while Carvana announced its inclusion in the S&P 500, boosting its stock by 11.6%.
Cullinan Therapeutics' CLN-049 Shows 31% Complete Response Rate in R/R AML Patients
- Clinical Trial Results: Among 45 patients treated with CLN-049, a complete response (CR/CRh) rate of 31% was observed at the highest dose of 12 µg/kg, indicating the therapy's efficacy in heavily pretreated acute myeloid leukemia (AML) patients and potentially offering new treatment options in this area.
- Favorable Tolerability: CLN-049 demonstrated a favorable safety profile across all assessed doses, with 35.6% of patients experiencing cytokine release syndrome (CRS), primarily Grade 1 or 2, which did not lead to treatment discontinuation, suggesting its potential for clinical application.
- FDA Fast Track Designation: CLN-049 has recently received Fast Track designation from the U.S. FDA, underscoring its potential in treating relapsed/refractory AML patients and likely accelerating its clinical development timeline.
- Future Development Plans: Cullinan Therapeutics will host an investor event on December 8, 2025, to share the latest clinical data on CLN-049, further enhancing communication with investors and boosting market confidence.
