--- title: "Show Me The Money: Did You Miss CGEM's Rally? Here's What Comes Next" type: "News" locale: "en" url: "https://longbridge.com/en/news/295789917.md" description: "Cullinan Therapeutics (CGEM) shares surged to $20.78 in premarket trading, up over 6%, following positive Phase 3 REZILIENT3 trial results for Zipalertinib in NSCLC. The stock has gained significantly since its June 2025 mention at $7.93, driven by multiple clinical readouts and FDA interactions. Near-term catalysts include data updates for CLN-978 and CLN-049 in Q3-Q4 2026, with an FDA decision on Zipalertinib expected by February 2027." datetime: "2026-08-13T11:26:46.000Z" locales: - [zh-CN](https://longbridge.com/zh-CN/news/295789917.md) - [en](https://longbridge.com/en/news/295789917.md) - [zh-HK](https://longbridge.com/zh-HK/news/295789917.md) --- # Show Me The Money: Did You Miss CGEM's Rally? Here's What Comes Next Add as your preferred news source on Google Add Now It has been a banner year so far for Cullinan Therapeutics Inc. (CGEM), with multiple positive clinical readouts across its pipeline fueling share price momentum. This clinical-stage biopharmaceutical company is developing potential first- or best-in-class, disease-modifying T cell engagers for autoimmune diseases and cancer. Its pipeline includes Zipalertinib, CLN-049, CLN-978 and Velinotamig. **When did we first highlight CGEM?** Cullinan Therapeutics was first featured on our site on June 29, 2025, when its shares were trading at $7.93. Our report highlighted the key catalyst events to watch, with a focus on Zipalertinib. Originally discovered by Japan-based Taiho Pharmaceutical, Zipalertinib was licensed to Cullinan Therapeutics in 2019. The two companies signed a co-development and co-commercialization agreement for this drug candidate in May 2022. When we revisited the stock on June 9, 2026, the shares had climbed to $13.37. **What's Driving the Stock?** • November 2025: Initiated the rolling New Drug Application (NDA) submission to the FDA seeking accelerated approval of Zipalertinib for patients with previously treated EGFR exon 20 insertion (ex20ins) mutation-positive non-small cell lung cancer (NSCLC). The submission was supported by efficacy data from the Phase 1/2 REZILIENT1 trial. • December 2025: Presentation of promising updated clinical data from a Phase 1 study of CLN-049 in patients with relapsed/refractory (R/R) acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) in December 2025. • April 2026: FDA acceptance of the NDA for Zipalertinib for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion (ex20ins) mutations who have previously received platinum-based systemic chemotherapy. • June 2026: Reported initial single-dose data from the Phase 1 OUTRACE SLE and OUTRACE RA studies of CLN-978, along with multi-dose data from OUTRACE RA at the EULAR Congress. The data demonstrated clinical activity, including remission in patients from both studies. • July 2026: Announced positive feedback from the FDA following an End-of-Phase 1 (EOP1) meeting for CLN-049 being evaluated in patients with acute myeloid leukemia (AML). • August 12, 2026: Announced positive topline results from the REZILIENT3 trial, a global Phase 3 clinical trial evaluating the combination of Zipalertinib and platinum-based chemotherapy compared with chemotherapy alone in the first-line treatment of adult patients with previously untreated, locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 20 insertion (ex20ins) mutations. Shares are up over 6% at $20.78 in premarket trading today (August 13, 2026). **Near-term Catalysts** • Q3, 2026: Additional multi-dose regimen data from the global phase 1 study of CLN-978 in rheumatoid arthritis (OUTRACE RA). • Q3, 2026: Initiation of a potentially registrational Phase 2 study of CLN-049 in patients with relapsed/refractory AML. • Q4, 2026: Initial multi-dose regimen data from the global phase 1 study of CLN-978 in systemic lupus erythematosus (OUTRACE SLE). • Q4, 2026: Initial data from the single target dose escalation portion of Phase 1 trial of CLN-978 in Sjogren's Disease (OUTRACE SjD). • Q4, 2026: Additional multi-dose regimen data from the Genrix Bio Phase 1/2 study of Velinotamig in patients with autoimmune diseases in China. (Cullinan licensed global rights to Velinotamig from Genrix Bio for development in autoimmune diseases in June 2025, excluding Greater China) • Q4, 2026: An update from the dose escalation portion of the Phase 1 study of CLN-049 in patients with relapsed/refractory AML or MDS. • Q4, 2026: Initiate a Phase 1/2 study evaluating the combination of CLN-049, venetoclax, and azacitidine in patients with previously untreated AML. • February 27, 2027: FDA decision on Zipalertinib for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion (ex20ins) mutations who have previously received platinum-based systemic chemotherapy. **Stock Performance Since Publication** • Published Date: June 29, 2025 • Published Price: $7.93 • 52-week High: $19.94 (+151%%) on August 12, 2026 • Closing Price: $19.60 (+147%) on August 12, 2026. 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