Show Me The Money: Did You Miss CGEM's Rally? Here's What Comes Next

rttnews

Aug 13, 2026 at 06:26 AM

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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.

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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.