Black Diamond Therapeutics (NASDAQ:BDTX) Announces Quarterly Earnings Results, Misses Estimates By $0.08 EPS

Black Diamond Therapeutics (NASDAQ:BDTX) issued its quarterly earnings results on Tuesday. The company reported ($0.17) earnings per share (EPS) 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:

• Black Diamond said its FDA end-of-phase II meeting established a path toward accelerated approval for silevertinib in non-classical EGFR-mutant lung cancer, using CNS objective response rate as an endpoint. The planned phase III trial is expected to begin in the second quarter and will include a randomized brain-metastasis cohort and a single-arm cohort for patients without brain metastases.
• In the company’s 43-patient phase II study, silevertinib produced an 86% CNS response rate and median progression-free survival of 12.2 months among patients with brain metastases, according to management. The company compared these results favorably with published data for existing drugs, while noting the comparisons are across different studies.
• The FDA accepted the company’s proposed 150 mg phase III dose subject to additional safety data, particularly on dose reductions; Black Diamond said it expects to provide that data before starting the trial. Management said dose reductions at the 200 mg phase II dose were relatively frequent, though it characterized the side effects as familiar EGFR-related events.
• Black Diamond said its plans include a randomized phase II glioblastoma study, with interim progression-free-survival data expected in the first half of 2028, but acknowledged that it will need additional capital to reach its clinical and approval milestones. The company is considering both dilutive and non-dilutive funding, as well as potential partnerships for ex-U.S. rights.

Black Diamond Therapeutics Price Performance

BDTX stock opened at $1.59 on Wednesday. The company’s fifty day moving average price is $1.89 and its 200-day moving average price is $2.16. Black Diamond Therapeutics has a one year low of $1.58 and a one year high of $4.94.

Black Diamond Therapeutics News Roundup

Here are the key news stories impacting Black Diamond Therapeutics this week:

• Positive Sentiment: Updated Phase 2 results for silevertinib were positive, and the FDA provided feedback supporting a clear Phase 3 path toward potential registration for first-line EGFR non-classical mutation (NCM) non-small cell lung cancer. This progress could strengthen the drug’s commercial prospects. Company announcement
• Neutral Sentiment: The company planned a webcast to discuss the updated silevertinib data and FDA feedback, giving investors an opportunity to hear more about the results and development plans. Webcast announcement
• Negative Sentiment: BDTX reported a third-quarter loss of $0.17 per share, wider than analysts’ expected loss of $0.09 per share. The earnings miss may have pressured the stock despite the clinical update. Quarterly earnings results

Wall Street Analysts Forecast Growth

Several brokerages have commented on BDTX. TD Cowen restated a “buy” rating on shares of Black Diamond Therapeutics in a report on Thursday, August 6th. HC Wainwright restated a “buy” rating on shares of Black Diamond Therapeutics in a report on Thursday, October 29th. Wall Street Zen raised Black Diamond Therapeutics from a “sell” rating to a “hold” rating in a research report on Saturday, October 24th. Weiss Ratings reiterated a “sell (d-)” rating on shares of Black Diamond Therapeutics in a report on Friday, October 9th. Finally, Jefferies Financial Group reaffirmed a “buy” rating on shares of Black Diamond Therapeutics in a research report on Thursday, August 6th. Seven investment analysts have rated the stock with a Buy rating, two have given a Hold rating and one has given a Sell rating to the stock. Based on data from MarketBeat, the company presently has an average rating of “Moderate Buy” and an average 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.