Black Diamond Therapeutics Gains On Positive Phase 2 Data For BDTX-1535 In Patients With NSCLC

(RTTNews) - Black Diamond Therapeutics, Inc. (BDTX) announced positive initial Phase 2 results for BDTX-1535 in patients with relapsed or refractory non-small cell lung cancer also known as NSCLC, caused by epidermal growth factor receptor or EGFR mutations. Following this news, the stock is up 40% in the pre-market trade.

The preliminary data, with a cutoff date of August 17, 2024, included 27 patients receiving a 200 mg dose, with 22 meeting the eligibility criteria for response evaluation.

Key findings indicate that the 200 mg daily dosage is well-tolerated. The preliminary overall response rate was 42% among 19 patients with on-target EGFR mutations. Additionally, there is promising durability, as the first three patients showing a partial response had a duration of response of approximately eight months or longer, with 14 of the 19 patients continuing treatment.

The company expects to receive regulatory feedback regarding the registration path in the first quarter of 2025 and plans to report initial results for BDTX-1535 in first-line NSCLC patients with non-classical EGFR mutations during the same timeframe.

In pre-market activity on the Nasdaq, the shares are trading at $6.69, up 40.55%.