Black Diamond Therapeutics, Inc.’s BDTX lead pipeline candidate, 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 company recently completed enrollment in the mid-stage study of silevertinib in frontline NSCLC patients with non-classical EGFR mutations.
BDTX plans to disclose objective response rate and preliminary duration of response data from all patients (n=43) from the above-mentioned study 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.
Following the outlicensing of its other pipeline candidate, BDTX-4933, to Servier Pharmaceuticals, BDTX is solely focused on the development of silevertinib.
Black Diamond Therapeutics is currently looking for strategic partners to advance further development of silevertinib for NSCLC and GBM.
In such a scenario, the successful development and subsequent commercialization of silevertinib in the crowded NSCLC space holds the key for this clinical-stage oncology company.
Competition for BDTX’s Oncology Drug
The NSCLC space is quite competitive, with many big pharma and biotech companies developing drugs for the same.
In August 2024, Johnson & Johnson JNJ obtained FDA approval of Rybrevant (amivantamab-vmjw) plus Lazcluze (lazertinib) for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with EFGR exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test.
Following the approval, JNJ’s Rybrevant plus Lazcluze became the first and only multitargeted, chemotherapy-free combination regimen with demonstrated superiority versus AstraZeneca’s AZN Tagrisso (osimertinib) approved for the first-line treatment of patients with EGFR-mutated NSCLC.
Earlier, in March 2024, JNJ obtained FDA approval of Rybrevant in combination with chemotherapy (carboplatin-pemetrexed) for the first-line treatment of patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, based on the phase III PAPILLON study.
In patients with EGFR non-classical mutations, silevertinib will compete with AZN’s Tagrisso, which is a third-generation, irreversible EGFR-TKI with proven clinical activity in NSCLC, including against central nervous system metastases.
AZN is also evaluating Tagrisso in the early-stage adjuvant lung cancer in the resectable setting in a phase III study.
BDTX Price Performance, Valuation and Estimates
Shares of BDTX have lost 34.6% year to date against the industry’s growth of 5.7%.
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From a valuation standpoint, BDTX is inexpensive. Going by the price/book ratio, BDTX’s shares currently trade at 1.24x book value, lower than its mean of 1.28x and the biotech industry’s 3.13x.
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The bottom-line estimate for 2025 is stable at 33 cents and that for 2026 is also unchanged at a loss of 82 cents.
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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).
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
