Enrollment completed for the Phase 2 trial of silevertinib (BDTX-1535) in 1L patients with non-classical EGFRm NSCLC (n=43); ORR and preliminary DOR data on track for Q4 2025 Exploring partnership opportunities to advance pivotal development of silevertinib in NSCLC and GBM Plan to meet with FDA regarding 1L NSCLC development path in 1H 2026, when PFS data becomes available Cash, cash equivalents, and investments of $142.8... Read More

CAMBRIDGE, Mass., May 29, 2025 (GLOBE NEWSWIRE) -- Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a clinical-stage oncology company developing MasterKey therapies that target families of oncogenic mutations in patients with cancer, today announced that its Chief Executive Officer, Mark Velleca, M.D., Ph.D., will participate in a fireside chat at the Jefferies Global Healthcare Conference on June 4, 2025 in New York, NY. In... Read More

Clinical data on track for Q4 2025 from Phase 2 trial of BDTX-1535 in 1L patients with non-classical EGFRm NSCLC Expansion of investigator sponsored Phase 0/1 trial into newly diagnosed glioblastoma patients with EGFR alterations initiated in Q1 2025 Cash, cash equivalents, and investments of $152.4 million as of March 31, 2025; expected to be sufficient to fund operations into Q4 of 2027 CAMBRIDGE, Mass., May 12, 2025... Read More

CAMBRIDGE, Mass., March 31, 2025 (GLOBE NEWSWIRE) -- Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a clinical-stage oncology company developing MasterKey therapies that target families of oncogenic mutations in patients with cancer, today announced its participation in upcoming investor conferences. Presentation details with President and Chief Executive Officer, Mark Velleca, M.D., Ph.D., are as follows: 24th Annual... Read More

The partnership underscores Servier’s commitment to developing targeted therapies that address unmet medical needs in oncology Servier will develop and commercialize BDTX-4933, a Phase 1 asset with best-in-class potential targeting both RAS mutations and RAF alterations, in solid tumors, including non-small cell lung cancer Black Diamond will receive an upfront payment of $70 million and up to $710 million in development and... Read More

Clinical data on track for Q2 2025 in Phase 2 trial of BDTX-1535 in 1L patients with non-classical EGFRm NSCLC Expansion of investigator sponsored “window of opportunity” trial into newly diagnosed glioblastoma patients with EGFR aberrations expected in Q1 2025 Cash, cash equivalents, and investments of $98.6 million as of December 31, 2024, expected to be sufficient to fund operations into Q4 2026 CAMBRIDGE, Mass., March... Read More

Announced encouraging initial Phase 2 data of BDTX-1535 in patients with recurrent EGFRm NSCLC with a broad spectrum of classical, non-classical, and C797S resistance mutations in September 2024 Presented real-world treatment practices and patient outcomes in newly diagnosed NSCLC patients with non-classical EGFR mutations at the 2024 ESMO Congress Clinical updates of BDTX-1535 in EGFRm NSCLC and regulatory feedback expected... Read More

CAMBRIDGE, Mass., Nov. 01, 2024 (GLOBE NEWSWIRE) -- Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a clinical-stage oncology company developing MasterKey therapies that target families of oncogenic mutations in patients with cancer, today announced its participation in upcoming investor conferences. Presentation details with President and Chief Executive Officer, Mark Velleca, M.D., Ph.D., are as follows: Stifel Healthcare... Read More

Company advancing BDTX-1535 in EGFRm NSCLC towards key inflection points in Q1 2025 Will deprioritize BDTX-4933 and seek potential partners Anticipated cost savings expected to extend cash runway into Q2 2026 CAMBRIDGE, Mass., Oct. 07, 2024 (GLOBE NEWSWIRE) -- Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a clinical-stage oncology company developing MasterKey therapies that target families of oncogenic mutations in... Read More

BDTX-1535 dose of 200 mg daily selected for pivotal development; favorable tolerability profile and no new safety signals observed Preliminary ORR of 42% in 19 patients at 200 mg with on-target resistance EGFR mutations Encouraging durability with DOR of approximately 8 months or more for first 3 patients with a PR; 14 of 19 patients remain on treatment Regulatory feedback on registration path anticipated in Q1 2025 Initial... Read More

Webcast to be held Monday, September 23, at 8:00 a.m. ET CAMBRIDGE, Mass., Sept. 22, 2024 (GLOBE NEWSWIRE) -- Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a clinical-stage oncology company developing MasterKey therapies that target families of oncogenic mutations in patients with cancer, will host a webcast to disclose initial phase 2 clinical trial results for BDTX-1535 in patients with recurrent EGFRm NSCLC on Monday,... Read More

Treatment data were analyzed from 3,276 cases of patients with newly diagnosed EGFR mutant NSCLC from Guardant Health Analyses of patients with non-classical EGFR mutations reveal that the majority receive frontline chemotherapy and the remainder are treated with osimertinib or afatinib Short time to treatment discontinuation ranging from four to eight months demonstrates clear unmet need for patients with non-classical EGFR... Read More

Initial Phase 2 data of BDTX-1535 in 2L/3L patients with EGFRm NSCLC on track for later in Q3 2024 On track to announce initial Phase 2 data of BDTX-1535 in 1L patients with non-classical EGFRm NSCLC in Q1 2025, and initial Phase 1 data of BDTX-4933 in KRASm NSCLC in Q4 2024 Upcoming poster presentation at 2024 ESMO Congress in September, titled “Real World Evidence of Treatment Practices and Therapeutic Outcomes for Newly... Read More

Results from Phase 1 dose escalation trial of BDTX-1535 in GBM patients demonstrated a favorable safety and tolerability profile, and encouraging anti-tumor activity and duration of treatment Initial data from Phase 0/1 “trigger” (“window of opportunity”) investigator-sponsored trial demonstrated BDTX-1535 achieved clinically meaningful drug levels in brain tumor tissue CAMBRIDGE, Mass., June 01, 2024 (GLOBE NEWSWIRE) --... Read More

CAMBRIDGE, Mass., May 29, 2024 (GLOBE NEWSWIRE) -- Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a clinical-stage oncology company developing MasterKey therapies that target families of oncogenic mutations in patients with cancer, today announced that its Chief Executive Officer, Mark Velleca, M.D., Ph.D., will participate in a fireside chat at the Jefferies Global Healthcare Conference taking place June 4-6, 2024, in New... Read More

Initial Phase 2 data of BDTX-1535 in 2L/3L EGFRm NSCLC patients on track for Q3 2024 Enrollment ongoing in Phase 2 trial of BDTX-1535 in 1L patients with non-classical EGFRm NSCLC; initial data expected Q1 2025 Presented real world evidence on the evolving EGFR mutation landscape in NSCLC, and the potential of BDTX-1535 across multiple lines of therapy at the 2024 AACR annual meeting Poster presentations upcoming June 1 st... Read More

CAMBRIDGE, Mass., April 24, 2024 (GLOBE NEWSWIRE) -- Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a clinical-stage oncology company developing MasterKey therapies that target families of oncogenic mutations in patients with cancer, today announced forthcoming presentations during the 2024 ASCO Annual Meeting, taking place May 31 – June 4 in Chicago, IL. The two poster presentations describe data for BDTX-1535 in patients... Read More

CAMBRIDGE, Mass., April 11, 2024 (GLOBE NEWSWIRE) -- Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a clinical-stage oncology company developing MasterKey therapies that target families of oncogenic mutations in patients with cancers, today announced that industry veterans Shannon Campbell and Prakash Raman, Ph.D., have been appointed to the Company’s Board of Directors. The Company also announced that Wendy Dixon, Ph.D.,... Read More

Real-world data demonstrate non-classical mutations are present in 20-30% of all patients with EGFRm NSCLC Emerging data show non-classical EGFR mutations can be co-expressed with the classical L858R mutation, a setting characterized by shorter duration of response to osimertinib BDTX-1535 profile differentiated as the most advanced fourth-generation oral TKI in clinical development addressing the full spectrum of classical,... Read More

CAMBRIDGE, Mass. and NEW YORK, April 03, 2024 (GLOBE NEWSWIRE) -- Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a clinical-stage oncology company developing MasterKey therapies that target families of oncogenic mutations in patients with cancer, today announced its participation in upcoming investor conferences. Presentation details with President and Chief Executive Officer, Mark Velleca, M.D., Ph.D., are as follows:... Read More

Dosed first patient in Phase 2 trial of BDTX-1535 in 1L patients with non-classical EGFRm NSCLC Clinical data on track for Q3 2024 in Phase 2 trial of BDTX-1535 in 2L/3L patients with acquired resistance or non-classical EGFRm NSCLC Oral presentation at AACR annual meeting in April 2024 describing real world evidence of an evolving EGFR mutation landscape in NSCLC, and the potential of BDTX-1535 to benefit patients across... Read More

CAMBRIDGE, Mass., March 05, 2024 (GLOBE NEWSWIRE) -- Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a clinical-stage oncology company developing MasterKey therapies that target families of oncogenic mutations in patients with cancer, today announced an upcoming oral presentation at the American Association for Cancer Research (AACR) Annual Meeting 2024, taking place April 5-10 in San Diego, California. The presentation... Read More

CAMBRIDGE, Mass., Feb. 28, 2024 (GLOBE NEWSWIRE) -- Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a clinical-stage oncology company developing MasterKey therapies that target families of oncogenic mutations in patients with genetically defined cancers, today announced that its Chief Executive Officer, Mark A. Velleca, M.D., Ph.D., will participate in a panel discussion on lung cancer at the TD Cowen 44th Annual Health... Read More

FDA feedback on BDTX-1535 enables initiation of Phase 2 cohort in first-line treatment of non-classical EGFR mutant NSCLC Fast Track Designation granted for BDTX-1535 as second-line treatment for EGFR mutant/C797S NSCLC BDTX-1535 Phase 2 results for 2L/3L patients with EGFR mutant NSCLC expected Q3 2024 BDTX-1535 Phase 1 clinical trial results and “window of opportunity” data in patients with EGFR mutant GBM expected to be... Read More

Initial results show promising clinical activity in heavily pretreated patients 22 patients evaluable for efficacy: 3 patients on therapy longer than 10 months, 1 patient longer than 6 months, and 5 patients longer than 4 months 19 patients with measurable disease by RANO criteria: 1 patient with confirmed partial response and 8 patients with stable disease BDTX-1535 generally well tolerated, consistent with prior... Read More

CAMBRIDGE, Mass. and NEW YORK, Nov. 07, 2023 (GLOBE NEWSWIRE) -- Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a clinical-stage oncology company developing MasterKey therapies that target families of oncogenic mutations in patients with genetically defined cancers, today announced that its President and Chief Executive Officer, Mark A. Velleca, M.D., Ph.D., will participate in fireside chats during two upcoming investor... Read More

Presented BDTX-1535 Phase 1 dose escalation data showing durable anti-tumor activity and favorable safety profile in NSCLC patients across heterogeneous EGFR mutations at the October 2023 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics BDTX-1535 NSCLC expansion cohorts enrolling, initial data expected in 2024 BDTX-1535 Phase 1 dose escalation data in GBM expected later this year Dosed... Read More

Initial results from BDTX-1535 dose escalation show durable activity in patients with NSCLC across heterogeneous EGFR mutation subtypes No new safety or tolerability signal reported across all three active once daily doses of 100mg, 200mg and 300mg Initial NSCLC expansion cohort data expected in 2024 Initial GBM dose escalation data expected later this year CAMBRIDGE, Mass. and NEW YORK, Oct. 14, 2023 (GLOBE NEWSWIRE) --... Read More

CAMBRIDGE, Mass. and NEW YORK, Oct. 04, 2023 (GLOBE NEWSWIRE) -- Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a clinical-stage precision oncology company developing therapies that target families of oncogenic mutations in patients with genetically defined cancers, today announced forthcoming presentations during the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in Boston, October... Read More

Current Chairman of the Board and industry veteran Mark Velleca appointed CEO CAMBRIDGE, Mass. and NEW YORK, Sept. 18, 2023 (GLOBE NEWSWIRE) -- Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a clinical-stage precision oncology company developing therapies that target families of oncogenic mutations in patients with genetically defined cancers, announced that current Chairman of the Board, Mark Velleca, M.D., Ph.D., has... Read More

Company to present BDTX-1535 dose escalation data in NSCLC at the AACR-NCI-EORTC Conference in October 2023 CAMBRIDGE, Mass. and NEW YORK, Sept. 11, 2023 (GLOBE NEWSWIRE) -- Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a clinical-stage precision oncology company developing therapies that target families of oncogenic mutations in patients with genetically defined cancers, today announced the first patients dosed in... Read More

CAMBRIDGE, Mass. and NEW YORK, Sept. 05, 2023 (GLOBE NEWSWIRE) -- Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a clinical-stage precision oncology company developing MasterKey therapies that target families of oncogenic mutations in patients with genetically defined cancers, today announced that company management will participate in three upcoming investor conferences: The 2023 Wells Fargo Healthcare Conference on... Read More

Announced initial clinical data from dose-escalation portion of Phase 1 clinical trial of BDTX-1535, an EGFR MasterKey inhibitor, demonstrating a favorable tolerability profile and clinical proof of activity based on radiographic tumor responses and circulating tumor DNA changes in NSCLC patients harboring acquired resistance and intrinsic driver EGFR mutations Initiated BDTX-1535 NSCLC expansion cohorts in July 2023;... Read More

CAMBRIDGE, Mass and NEW YORK, June 29, 2023 (GLOBE NEWSWIRE) -- Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a clinical-stage precision oncology company developing MasterKey therapies that target families of oncogenic mutations in patients with genetically defined cancers, today announced the pricing of an underwritten public offering of 15,000,000 shares of its common stock at a public offering price of $5.00 per share.... Read More

CAMBRIDGE, Mass. and NEW YORK, June 28, 2023 (GLOBE NEWSWIRE) -- Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a clinical-stage precision oncology company developing MasterKey therapies that target families of oncogenic mutations in patients with genetically defined cancers, today announced that it has commenced an underwritten public offering of $75.0 million of shares of its common stock. Black Diamond also intends to... Read More

BDTX-1535, an epidermal growth factor receptor (EGFR) MasterKey inhibitor, demonstrates clinical proof of activity for MasterKey mutation-targeting approach based on radiographic tumor responses and circulating tumor DNA changes in NSCLC patients with acquired resistance and intrinsic driver EGFR mutations Confirmed radiographic partial response by RECIST 1.1 achieved across predicted therapeutic doses in 5 of 12 NSCLC... Read More

CAMBRIDGE, Mass. and NEW YORK, June 13, 2023 (GLOBE NEWSWIRE) -- Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a clinical-stage precision oncology medicine company developing MasterKey therapies designed to overcome limitations of existing therapies by targeting families of oncogenic driver mutations in patients with genetically defined cancers, today announced the promotion of Melanie Morrison from Senior Vice President,... Read More

CAMBRIDGE, Mass. and NEW YORK, June 02, 2023 (GLOBE NEWSWIRE) -- Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a clinical-stage precision oncology medicine company developing MasterKey therapies designed to overcome limitations of existing therapies by targeting families of oncogenic driver mutations in patients with genetically defined cancers, today announced that its President and Chief Executive Officer, David M.... Read More

On track to provide clinical update from dose-escalation portion of Phase 1 clinical trial of EGFR MasterKey inhibitor BDTX-1535 in the second half of 2023; Dose Expansion cohorts expected to open in 2023 FDA clearance of IND application for BDTX-4933, RAF MasterKey inhibitor; Anticipate first patient dosing in the second quarter of 2023 Announces nomination of development candidate, BDTX-4876, for FGFR 2/3 selective... Read More

CAMBRIDGE, Mass. and NEW YORK, April 18, 2023 (GLOBE NEWSWIRE) -- Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a clinical-stage precision oncology medicine company developing MasterKey therapies designed to overcome limitations of existing therapies by targeting families of oncogenic driver mutations in patients with genetically defined cancers, today announced that its President and Chief Executive Officer, David M.... Read More

BDTX-1535 Phase 1 dose escalation ongoing in NSCLC harboring sensitizing EGFR mutations with or without CNS disease and recurrent GBM expressing EGFR alterations; Dose expansion cohorts expected to open in 2023 In preclinical tumor models, BDTX-4933 exhibits potent inhibition of aberrantly activated RAF as result of BRAF Class I, II, III and RAS mutations, as well as high brain penetration demonstrating survival benefit in... Read More

On track to provide clinical update from dose-escalation portion of Phase 1 clinical trial of EGFR MasterKey inhibitor BDTX-1535 in the second half of 2023 FDA clearance of IND application for BDTX-4933 in the first quarter of 2023, a brain-penetrant RAF MasterKey inhibitor for the treatment of all-class RAF and RAS mutant tumors; initiation of Phase 1 clinical trial expected in the first half of 2023 Presented new... Read More

CAMBRIDGE, Mass. and NEW YORK, Feb. 27, 2023 (GLOBE NEWSWIRE) -- Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a clinical-stage precision oncology medicine company developing novel MasterKey therapies targeting families of oncogenic driver mutations in patients with genetically defined cancers, today announced that its President and Chief Executive Officer, David M. Epstein, Ph.D., will present an update on the Company’s... Read More

CAMBRIDGE, Mass. and NEW YORK, Jan. 05, 2023 (GLOBE NEWSWIRE) -- Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a clinical-stage precision oncology medicine company developing MasterKey therapies designed to overcome limitations of existing therapies by targeting families of oncogenic driver mutations in patients with genetically defined cancers, today announced that its President and Chief Executive Officer, David M.... Read More

CAMBRIDGE, Mass. and NEW YORK, Dec. 19, 2022 (GLOBE NEWSWIRE) -- Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a precision oncology medicine company pioneering the discovery and development of MasterKey therapies, today announced that Chairman of the Board of Directors, Robert (Bob) A. Ingram, has stepped down due to personal reasons. Existing Board member, Mark Velleca, M.D., Ph.D., has been appointed to succeed Mr.... Read More

$30M Series A investment from Versant Ventures and NEA CAMBRIDGE, Mass. and NEW YORK, Dec. 12, 2022 (GLOBE NEWSWIRE) -- Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a precision oncology medicine company pioneering the discovery and development of MasterKey therapies, today announced the formation of Launchpad Therapeutics, Inc. (Launchpad), an antibody-focused precision oncology company, together with a $30 million... Read More