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BDTX Stock Hits 52 Week High: Is There More Room for Growth?
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Key Takeaways
Black Diamond hit a 52-week high of $4.1 on Oct. 8, soaring 86.4% year to date.
Silevertinib showed durable responses and good tolerability in phase I EGFRm NSCLC data.
BDTX focuses solely on silevertinib after outlicensing BDTX-4933 to Servier Pharmaceuticals.
Black Diamond Therapeutics, Inc. (BDTX - Free Report) performance has been outstanding in 2025. Shares of this clinical-stage oncology company hit a 52-week high of $4.1 on Oct. 8.
Year to date, BDTX shares have skyrocketed 86.4% compared with the industry’s growth of 10.4% so far this year. The stock has also outperformed the sector and the S&P 500 Index in this time frame.
This outperformance can be attributed to BDTX’s encouraging progress with lead pipeline candidate, silevertinib.
BDTX Outperforms Industry, Sector and Index
Image Source: Zacks Investment Research
Let us delve deeper to analyze BDTX’s strengths and weaknesses in such a scenario to make a prudent investment choice.
BDTX Lead Drug Silevertinib Appears Promising
BDTX is developing MasterKey therapies that target families of oncogenic mutations in patients with cancer.
Lead drug 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 shown to be 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).
In July 2025, enrollment in frontline patients harboring non-classical EGFR mutations (cohort 3, n=43) was completed. BDTX plans to disclose objective response rates and preliminary duration of response data from all patients with frontline NSCLC and non-classical EGFR mutations 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.
BDTX is also exploring potential collaborators to advance silevertinib further.
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 then selected the 200 mg daily dose of silevertinib for pivotal development as it showed robust EGFRm target coverage and a favorable tolerability profile with no new safety signals observed.
Based on an August 2024 data cutoff, a preliminary overall response rate of 42% was seen in 19 patients with known osimertinib-resistance EGFR mutations (nine patients from cohort 1 with PACC “P-loop αC-helix compressing” mutations and 10 patients from cohort 2 with C797S mutations).
BDTX expects to present final results (n=83) from this trial in the first half of 2026. The company is also exploring potential combination opportunities for silevertinib in the recurrent setting.
BDTX is Solely Focused on Silevertinib
Black Diamond ended the second quarter of 2025 with approximately $142.8 million in cash and cash equivalents.
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.
BDTX Valuation and Estimates
From a valuation standpoint, BDTX is inexpensive. Going by the price/book ratio, BDTX’s shares currently trade at 1.71x book value, lower than its mean of 1.31x and the biotech industry’s 3.28x.
Image Source: Zacks Investment Research
In the past sixty days, the bottom-line estimate for 2025 and 2026 has moved north.
Image Source: Zacks Investment Research
Invest in BDTX
The oncology market is one of the most lucrative spaces in the pharma sector. While competition is stiff in the NSCLC space from bigwigs like Johnson & Johnson (JNJ - Free Report) and AstraZeneca (AZN - Free Report) silevertinib has shown promise.
Importantly, per 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 AZN’s Tagrisso (osimertinib), a leading NSCLC drug.
The successful development and subsequent commercialization of silevertinib will be a significant boost for this clinical-stage oncology company.
We recommend the stock to prospective investors on the back of rising estimates and impressive returns so far this year. A favorable data readout later in the year should boost shareholders’ value.
Image: Bigstock
BDTX Stock Hits 52 Week High: Is There More Room for Growth?
Key Takeaways
Black Diamond Therapeutics, Inc. (BDTX - Free Report) performance has been outstanding in 2025. Shares of this clinical-stage oncology company hit a 52-week high of $4.1 on Oct. 8.
Year to date, BDTX shares have skyrocketed 86.4% compared with the industry’s growth of 10.4% so far this year. The stock has also outperformed the sector and the S&P 500 Index in this time frame.
This outperformance can be attributed to BDTX’s encouraging progress with lead pipeline candidate, silevertinib.
BDTX Outperforms Industry, Sector and Index
Image Source: Zacks Investment Research
Let us delve deeper to analyze BDTX’s strengths and weaknesses in such a scenario to make a prudent investment choice.
BDTX Lead Drug Silevertinib Appears Promising
BDTX is developing MasterKey therapies that target families of oncogenic mutations in patients with cancer.
Lead drug 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 shown to be 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).
In July 2025, enrollment in frontline patients harboring non-classical EGFR mutations (cohort 3, n=43) was completed. BDTX plans to disclose objective response rates and preliminary duration of response data from all patients with frontline NSCLC and non-classical EGFR mutations 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.
BDTX is also exploring potential collaborators to advance silevertinib further.
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 then selected the 200 mg daily dose of silevertinib for pivotal development as it showed robust EGFRm target coverage and a favorable tolerability profile with no new safety signals observed.
Based on an August 2024 data cutoff, a preliminary overall response rate of 42% was seen in 19 patients with known osimertinib-resistance EGFR mutations (nine patients from cohort 1 with PACC “P-loop αC-helix compressing” mutations and 10 patients from cohort 2 with C797S mutations).
BDTX expects to present final results (n=83) from this trial in the first half of 2026. The company is also exploring potential combination opportunities for silevertinib in the recurrent setting.
BDTX is Solely Focused on Silevertinib
Black Diamond ended the second quarter of 2025 with approximately $142.8 million in cash and cash equivalents.
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.
BDTX Valuation and Estimates
From a valuation standpoint, BDTX is inexpensive. Going by the price/book ratio, BDTX’s shares currently trade at 1.71x book value, lower than its mean of 1.31x and the biotech industry’s 3.28x.
Image Source: Zacks Investment Research
In the past sixty days, the bottom-line estimate for 2025 and 2026 has moved north.
Image Source: Zacks Investment Research
Invest in BDTX
The oncology market is one of the most lucrative spaces in the pharma sector. While competition is stiff in the NSCLC space from bigwigs like Johnson & Johnson (JNJ - Free Report) and AstraZeneca (AZN - Free Report) silevertinib has shown promise.
Importantly, per 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 AZN’s Tagrisso (osimertinib), a leading NSCLC drug.
The successful development and subsequent commercialization of silevertinib will be a significant boost for this clinical-stage oncology company.
We recommend the stock to prospective investors on the back of rising estimates and impressive returns so far this year. A favorable data readout later in the year should boost shareholders’ value.
BDTX currently sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.