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Can NSCLC Drug Silevertinib Drive Sustainable Growth for BDTX?
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Key Takeaways
Black Diamond Therapeutics is advancing silevertinib, a fourth-gen EGFR MasterKey inhibitor.
Silevertinib is in phase II trials for EGFR-mutant NSCLC, with FDA feedback expected in 2026.
After licensing BDTX-4933 to Servier, BDTX's pipeline now centers solely on silevertinib.
Black Diamond Therapeutics, Inc. (BDTX - Free Report) is developing MasterKey therapies that target families of oncogenic mutations in patients with cancer.
BDTX’s 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).
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 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.
While BDTX's progress with silevertinib is encouraging, it is the only candidate in its pipeline as of now. 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.
Hence, any pipeline setbacks in the development of silevertinib will adversely impact BDTX’s growth prospects.
Competition for BDTX’s EGFR Inhibitor
Although silevertinib holds potential, the NSCLC space is dominated by pharma bigwigs like AstraZeneca (AZN - Free Report) and Johnson & Johnson (JNJ - Free Report) among others.
AZN’s Tagrisso is a leading NSCLC drug. It is third-generation, irreversible EGFR-TKI with proven clinical activity in NSCLC. Tagrisso is approved as monotherapy in more than 120 countries, including the United States, the EU, China and Japan.
AZN is evaluating Tagrisso in the early-stage adjuvant resectable setting in the ADAURA2 phase III study.
In August 2024, JNJ obtained FDA approval for 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 Tagrisso approved for the first-line treatment of patients with EGFR-mutated NSCLC.
Earlier, in March 2024, JNJ obtained FDA approval for 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.
BDTX Price Performance, Valuation and Estimates
Shares of BDTX have surged 75.7% year to date compared with the industry’s growth of 9.5%.
Image Source: Zacks Investment Research
From a valuation standpoint, BDTX is inexpensive. Going by the price/book ratio, BDTX’s shares currently trade at 1.61x book value, lower than its mean of 1.31x and the biotech industry’s 3.36x.
Image Source: Zacks Investment Research
In the past 60 days, the bottom-line estimate for 2025 and 2026 has remained unchanged.
Image: Bigstock
Can NSCLC Drug Silevertinib Drive Sustainable Growth for BDTX?
Key Takeaways
Black Diamond Therapeutics, Inc. (BDTX - Free Report) is developing MasterKey therapies that target families of oncogenic mutations in patients with cancer.
BDTX’s 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).
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 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.
While BDTX's progress with silevertinib is encouraging, it is the only candidate in its pipeline as of now. 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.
Hence, any pipeline setbacks in the development of silevertinib will adversely impact BDTX’s growth prospects.
Competition for BDTX’s EGFR Inhibitor
Although silevertinib holds potential, the NSCLC space is dominated by pharma bigwigs like AstraZeneca (AZN - Free Report) and Johnson & Johnson (JNJ - Free Report) among others.
AZN’s Tagrisso is a leading NSCLC drug. It is third-generation, irreversible EGFR-TKI with proven clinical activity in NSCLC. Tagrisso is approved as monotherapy in more than 120 countries, including the United States, the EU, China and Japan.
AZN is evaluating Tagrisso in the early-stage adjuvant resectable setting in the ADAURA2 phase III study.
In August 2024, JNJ obtained FDA approval for 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 Tagrisso approved for the first-line treatment of patients with EGFR-mutated NSCLC.
Earlier, in March 2024, JNJ obtained FDA approval for 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.
BDTX Price Performance, Valuation and Estimates
Shares of BDTX have surged 75.7% year to date compared with the industry’s growth of 9.5%.
Image Source: Zacks Investment Research
From a valuation standpoint, BDTX is inexpensive. Going by the price/book ratio, BDTX’s shares currently trade at 1.61x book value, lower than its mean of 1.31x and the biotech industry’s 3.36x.
Image Source: Zacks Investment Research
In the past 60 days, the bottom-line estimate for 2025 and 2026 has remained unchanged.
Image Source: Zacks Investment Research
BDTX currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.