Black Diamond Therapeutics (NASDAQ:BDTX) Announces Quarterly Earnings Results

Black Diamond Therapeutics (NASDAQ:BDTX) released its earnings results on Tuesday. The company reported ($0.17) earnings per share for the quarter, missing analysts’ consensus estimates of ($0.09) by ($0.08), FiscalAI reports.

Here are the key takeaways from Black Diamond Therapeutics’ conference call:

• In the 43-patient frontline phase II study, systemic response rate remained 60% and median progression-free survival (PFS) 15 months after nearly 16 months of follow-up. The company reported an 86% CNS response rate and 12.2-month median PFS in patients with untreated brain metastases; among 24 patients without brain metastases, none developed them and median PFS was 23.5 months.
• Black Diamond said the FDA aligned on a broad trial population covering non-classical EGFR mutations, and on CNS response rate as the endpoint for potential accelerated approval; systemic PFS would support full approval. The agency also acknowledged the rationale for the 150 mg dose, subject to safety data from an ongoing cohort before phase III begins.
• The planned phase III trial is expected to start in Q2 2027, randomize about 300 patients with brain metastases against investigator-selected afatinib or osimertinib, and produce CNS response data in 2029. Patients without brain metastases are planned for a separate, single-arm cohort, with results potentially supporting guideline inclusion.
• The encouraging efficacy figures come from a small phase II study, and several comparisons cited by the company are against historical results rather than a concurrent control. The pivotal trial has not yet started, and its launch depends on providing the FDA with 150 mg cohort safety data.
• In glioblastoma, the randomized phase II study of silevertinib plus temozolomide versus temozolomide alone has completed its safety run-in and is enrolling at 150 mg. Interim PFS data are expected in the first half of 2028; no efficacy results were reported on the call.

Black Diamond Therapeutics Stock Performance

BDTX traded down $0.14 on Tuesday, hitting $1.72. The company had a trading volume of 408,063 shares, compared to its average volume of 1,003,410. The stock has a market capitalization of $99.04 million, a price-to-earnings ratio of -2.29 and a beta of 3.48. Black Diamond Therapeutics has a 12-month low of $1.60 and a 12-month high of $4.94. The stock has a fifty day moving average price of $1.90 and a 200-day moving average price of $2.17.

Wall Street Analyst Weigh In

A number of equities research analysts recently weighed in on the stock. Weiss Ratings reiterated a “sell (d-)” rating on shares of Black Diamond Therapeutics in a report on Friday, October 9th. Raymond James Financial reaffirmed an “outperform” rating on shares of Black Diamond Therapeutics in a research report on Thursday, August 6th. HC Wainwright reaffirmed a “buy” rating on shares of Black Diamond Therapeutics in a research report on Thursday, October 29th. TD Cowen reaffirmed a “buy” rating on shares of Black Diamond Therapeutics in a research report on Thursday, August 6th. Finally, Jefferies Financial Group reiterated a “buy” rating on shares of Black Diamond Therapeutics in a report on Thursday, August 6th. Seven investment analysts have rated the stock with a Buy rating, two have issued a Hold rating and one has issued a Sell rating to the stock. According to data from MarketBeat, Black Diamond Therapeutics has a consensus rating of “Moderate Buy” and a consensus price target of $11.00.

About Black Diamond Therapeutics

Black Diamond Therapeutics, Inc is a clinical-stage biopharmaceutical company focused on developing precision medicines for genetically defined cancers. The company uses its proprietary MasterKey platform to identify and develop small-molecule therapies designed to address oncogenic mutations across multiple tumor types, including alterations that may be difficult to target with conventional approaches.

Black Diamond’s pipeline has included brain-penetrant therapies for cancers affecting the central nervous system.