BDTX vs. Cullinan Therapeutic: Which EGFR Challenger Is the Better Buy?

Black Diamond Therapeutics, Inc. (BDTX) is a clinical-stage oncology company developing therapies that target families of oncogenic mutations in patients with cancer.Cullinan Therapeutics, Inc. (CGEM) is a clinical-stage biopharmaceutical company with a broad pipeline of candidates in both autoimmune diseases and cancer. It is dedicated to creating new standards of care for patients.Both these biotech companies are developing next-generation epidermal growth factor receptor (EGFR) inhibitors for treating cancer.In such a scenario, the focal point of a face-off between these two players is largely their oncology portfolio strength. Let us delve deeper into each company’s profile to make a prudent choice.The Case for BDTXBDTX is developing MasterKey therapies that target families of oncogenic mutations in patients with cancer. The company has made good progress with its lead pipeline candidate, silevertinib.Silevertinib is a brain penetrant, fourth-generation epidermal growth factor receptor (EGFR) MasterKey inhibitor targeting epidermal growth factor receptor mutant (EGFRm) non-small cell lung cancer (NSCLC) and glioblastoma (GBM).The candidate was well tolerated and achieved durable clinical responses in a phase I study in patients with recurrent EGFRm NSCLC whose tumors expressed a range of mutation subtypes, including the acquired C797S resistance mutation and a broad spectrum of non-classical mutations.BDTX is currently evaluating silevertinib in a phase II study in patients with EGFRm NSCLC in both the recurrent setting (cohorts 1 and 2) and the frontline setting (cohort 3). The company has completed enrollment in frontline patients harboring non-classical EGFR mutations (cohort 3, n=43) in July 2025. Initial results from this cohort are anticipated in the fourth quarter of 2025.The developmental plan for silevertinib includes FDA feedback on a potential registrational path in frontline EGFRm NSCLC in the first half of 2026, when progression-free survival data from the ongoing phase II study are available.Last year, BDTX announced initial data that demonstrated encouraging clinical responses and durability of silevertinib in 27 patients with EGFRm NSCLC in the second and third-line settings (cohorts 1 and 2). BDTX expects to present final results from this trial in the first half of 2026. The company is also exploring potential combination opportunities for silevertinib in the recurrent setting.BDTX entered into a global licensing agreement with Servier Pharmaceuticals in March 2025 for its second clinical-stage asset, BDTX-4933, a potential best-in-class targeted therapy for RAF/RAS-mutant solid tumors. The company received an upfront payment of $70.0 million.Following the outlicensing of its other pipeline candidate, BDTX-4933, to Servier Pharmaceuticals, BDTX is solely focused on the development of silevertinib.The Case for CGEMCullinan Therapeutic is co-developing zipalertinib (CLN-081/TAS6417) with an affiliate of Taiho Pharmaceutical.Zipalertinib is an orally available small-molecule, irreversible EGFR inhibitor that is designed to selectively target cells expressing EGFR exon 20 insertion mutations (EGFR ex20ins) with relative sparing of cells expressing wild-type EGFR.The companies are evaluating zipalertinib in the phase IIb portion of the REZILIENT1 study in patients with EGFR ex20ins NSCLC who progressed after prior systemic therapy.The phase IIb portion of the REZILIENT1 study met the primary endpoint of overall response rate in patients with EGFR ex20ins NSCLC who had received prior therapy. Cullinan plans to share updated efficacy and safety data in patients previously treated with amivantamab during a mini oral abstract session at the IASLC 2025 WCLC.Taiho plans to submit a new drug application seeking approval of zipalertinib in relapsed EGFR ex20ins NSCLC by the end of 2025, pending discussions with the FDA. Taiho expects to complete enrolment of the pivotal study REZILIENT3 in first-line EGFR ex20ins NSCLC in the first half of 2026.Taiho also plans to share initial data from the REZILIENT2 cohort exploring zipalertinib in patients with uncommon EGFR mutations during a mini oral abstract session at the IASLC 2025 WCLC.CGEM also has other candidates in the pipeline. The company is evaluating CLN-619 (Anti-MICA/MICB monoclonal antibody) for the treatment of NSCLC and multiple myeloma.Enrolment is ongoing in the phase I expansion cohorts in patients with NSCLC and the phase I study in patients with relapsed/refractory multiple myeloma.Other oncology candidates include CLN-049 (FLT3xCD3 bispecific T cell engager) for acute myeloid leukemia and myelodysplastic syndrome and CLN-617 (IL-2 and IL-12 cytokine fusion protein) for solid tumors.A Look at Estimates: BDTX versus CGEMThe Zacks Consensus Estimate for BDTX’s 2025 earnings per share (EPS) suggests an increase of 125.98%. In the past 60 days, the bottom-line estimate for 2025 and 2026 has moved north.BDTX’s Estimate MovementImage Source: Zacks Investment ResearchOn the other hand, the Zacks Consensus Estimate for CGEM’s EPS estimates for both 2025 and 2026 has moved south in the past 60 days.CGEM Estimate MovementImage Source: Zacks Investment ResearchPrice Performance and Valuation of BDTX and CGEMFrom a price-performance perspective, BDTX has fetched far better returns than CGEM so far this year. Shares of BDTX have surged 59.8%, while those of CGEM have lost 48.4%. The industry has gained 5.2% in the said period.Price Performance YTDImage Source: Zacks Investment ResearchFrom a valuation standpoint, BDTX is inexpensive compared to CGEM. BDTX’s shares currently trade at 5.87X forward sales, lower than 15.56X for CGEM.Image Source: Zacks Investment ResearchWhich Stock Is a Better Pick for Now?Both these biotechs have made good pipeline progress with their NSCLC candidates.BDTX currently carries a Zacks Rank #2 (Buy), while CGEM has a Zacks Rank #4 (Sell). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here. While CGEM has a deeper pipeline compared to BDTX and a better cash runway, the latter’s lead candidate, silevertinib, looks promising in the crowded but lucrative NSCLC space.According to BDTX, silevertinib has the potential to treat both newly diagnosed patients with EGFRm NSCLC and those with recurrent disease, due to its ability to target more than 50 classical and non-classical oncogenic driver mutations with greater potency than other EGFR tyrosine kinase inhibitors (TKIs). Furthermore, it targets the C797S resistance mutation, which can emerge after treatment with the leading lung cancer drug, Tagrisso (osimertinib).Hence, we believe BDTX is a better pick at present given its cheaper valuation, solid fundamentals and recent positive estimate revisions. Zacks Names #1 Semiconductor StockThis under-the-radar company specializes in semiconductor products that titans like NVIDIA don't build. It's uniquely positioned to take advantage of the next growth stage of this market. And it's just beginning to enter the spotlight, which is exactly where you want to be.With strong earnings growth and an expanding customer base, it's positioned to feed the rampant demand for Artificial Intelligence, Machine Learning, and Internet of Things. Global semiconductor manufacturing is projected to explode from $452 billion in 2021 to $971 billion by 2028.See This Stock Now for Free >>Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Black Diamond Therapeutics, Inc. (BDTX): Free Stock Analysis Report Cullinan Therapeutics, Inc. (CGEM): Free Stock Analysis ReportThis article originally published on Zacks Investment Research (zacks.com).Zacks Investment ResearchWeiter zum vollständigen Artikel bei Zacks Weiter zum vollständigen Artikel bei Zacks