BDTX Stock Surges 51.1% in Six Months: Is There More Room for Growth?

Black Diamond Therapeutics, Inc. (BDTX) has put up a stellar performance so far this year. Shares of this clinical-stage oncology company surged 51.1% in the past six months against the industry’s decline of 1.6%.

The stock has also outperformed the sector and the S&P 500 Index in this time frame.

The outperformance can be attributed to encouraging pipeline progress. BDTX 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.

BDTX Outperforms Industry, Sector and Index

Let us delve deeper to analyze BDTX’s strengths and weaknesses in such a scenario to make a prudent investment choice.

BDTX Makes Encouraging Pipeline Progress

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 rate and preliminary duration of response data from all patients in frontline NSCLC with non-classical EGFR mutations in the fourth quarter of 2025.

In September 2024, 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).

We note that osimertinib is marketed by AstraZeneca (AZN) as Tagrisso and is one of the leading drugs for lung cancer.

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.

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 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 1.23x book value, lower than its mean of 1.31x and the biotech industry’s 3.13x.

In the past sixty days, the bottom-line estimate for 2025 and 2026 has moved north.

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) and AZN, silevertinib has shown promise.

BDTX’s silevertinib has the potential to treat newly diagnosed patients with EGFRm NSCLC, as well as those with recurrent disease, based upon silevertinib’s ability to address greater than 50 classical and non-classical oncogenic driver mutations with greater potency than other EGFR tyrosine kinase inhibitors. The candidate also has the ability to uniquely target the C797S resistance mutation, which can be acquired after treatment with osimertinib.

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 carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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This article originally published on Zacks Investment Research (zacks.com).

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