This section highlights FDA-related milestones and regulatory updates for drugs developed by Black Diamond Therapeutics (BDTX).
Over the past two years, Black Diamond Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
silevertinib, BDTX-4933, and BDTX-1535. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
Silevertinib FDA Regulatory Timeline and Events
Silevertinib is a drug developed by Black Diamond Therapeutics for the following indication: patients with cancer.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- silevertinib
- Announced Date:
- May 19, 2026
- Indication:
- patients with cancer
Announcement
Black Diamond Therapeutics, Inc to present updated results from its ongoing Phase 2 trial of silevertinib in frontline patients with EGFR mutated non-small cell lung cancer on Thursday, May 21, 2026, at 5:30 p.m. ET.
AI Summary
Black Diamond Therapeutics, Inc. plans to present updated results from its ongoing Phase 2 trial of silevertinib in frontline patients with EGFR-mutated non-small cell lung cancer on Thursday, May 21, 2026, at 5:30 p.m. ET. The company said the webcast will be available on the Investors section of its website under “Events and Presentations.” A replay will also be posted for a limited time after the event.
The update is important because it will share new findings from a trial that is still underway. Silevertinib is being studied as a possible treatment for people with a specific type of lung cancer linked to EGFR mutations. The presentation may help investors and the medical community better understand the drug’s progress and future potential.
Read Announcement- Drug:
- silevertinib
- Announced Date:
- April 21, 2026
- Indication:
- patients with cancer
Announcement
Black Diamond Therapeutics, Inc announced multiple presentations at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting from May 29 – June 2, 2026, in Chicago.
AI Summary
Black Diamond Therapeutics announced multiple presentations at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, May 29–June 2 in Chicago, including an oral presentation and several posters. Posters will cover Phase 2 data of silevertinib in recurrent EGFR‑mutant non‑small cell lung cancer (NSCLC) and a trial‑in‑progress poster for a randomized Phase 2 study of silevertinib in newly diagnosed EGFRvIII‑positive glioblastoma (GBM). The posters will be posted on June 1, 2026 at 8:00 AM EDT on Black Diamond’s website.
Silevertinib is an oral, covalent, brain‑penetrant fourth‑generation tyrosine kinase inhibitor that targets classical and more than 50 non‑classical EGFR mutations in NSCLC and key EGFR alterations in GBM, including EGFRvIII, while avoiding paradoxical EGFR activation seen with some reversible TKIs. More than 200 patients have been treated with silevertinib. Initial Phase 2 frontline NSCLC data shared in December 2025 showed a 60% objective response rate, 86% CNS response rate, and 91% disease control rate with no new safety signals. A randomized Phase 2 GBM trial is starting in Q2 2026.
Read Announcement- Drug:
- silevertinib
- Announced Date:
- December 3, 2025
- Indication:
- patients with cancer
Announcement
Black Diamond Therapeutics, Inc. announced topline data from its Phase 2 trial of silevertinib in frontline (1L) non-small cell lung cancer (NSCLC) patients with non-classical epidermal growth factor receptor (EGFR) mutations (NCMs) and outlined plans for a randomized Phase 2 trial of silevertinib in patients with newly diagnosed glioblastoma (ND GBM).
AI Summary
Black Diamond Therapeutics reported topline Phase 2 results for silevertinib in frontline (1L) non‑small cell lung cancer patients with non‑classical EGFR mutations. In 43 patients representing 35 distinct mutations, the objective response rate was 60% (25 partial responses, 1 complete), disease control rate 91%, and central nervous system response rate 86%. Median follow‑up was 7.2 months and 29 patients remain on therapy. No new safety signals were observed; adverse events were managed with supportive care and dose adjustments.
The company expects progression‑free survival (PFS) data for the 1L NSCLC group in Q2 2026 and is exploring partnerships to support pivotal development.
Based on the strong CNS activity, Black Diamond plans a randomized Phase 2 trial in newly diagnosed glioblastoma in H1 2026. About 150 patients will be randomized to temozolomide or silevertinib + temozolomide, initially focusing on EGFRvIII‑positive, MGMT‑unmethylated patients. The primary endpoint is PFS with an interim analysis; initial data are expected in 2028.
As of Sept. 30, 2025, cash and investments were about $135.5 million, which the company expects will fund operations into H2 2028.
Read Announcement- Drug:
- silevertinib
- Announced Date:
- December 2, 2025
- Indication:
- patients with cancer
Announcement
Black Diamond Therapeutics will host a webcast to present results from its Phase 2 clinical trial of silevertinib and provide a program update on Wednesday, December 3, 2025, at 8:00am ET.
AI Summary
Black Diamond Therapeutics will host a live webcast Wednesday, December 3, 2025, at 8:00am ET to present results from its Phase 2 clinical trial of silevertinib and to provide a program update. The company is a clinical-stage oncology firm developing "MasterKey" therapies that target families of oncogenic mutations.
Silevertinib is a brain-penetrant, fourth-generation EGFR MasterKey inhibitor being tested in EGFR-mutant non-small cell lung cancer (NSCLC) and glioblastoma. The Phase 2 NSCLC trial is designed to evaluate the drug’s activity and safety in patients with EGFR mutations, with attention to overcoming resistance and treating central nervous system disease.
The webcast can be accessed under "Events and Presentations" in the Investors section at www.blackdiamondtherapeutics.com, and a replay will be posted after the event. Investors can also find company updates and materials on the website and LinkedIn page.
Read Announcement
BDTX-4933 FDA Regulatory Events
BDTX-4933 is a drug developed by Black Diamond Therapeutics for the following indication: A Targeted Oncology Therapy.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- BDTX-4933
- Announced Date:
- March 19, 2025
- Indication:
- A Targeted Oncology Therapy
Announcement
Servier and Black Diamond Therapeutics, Inc announced a strategic worldwide licensing agreement for BDTX-4933, a potential best-in-class targeted therapy for solid tumors.
AI Summary
Servier and Black Diamond Therapeutics have entered a strategic worldwide licensing agreement to develop BDTX-4933, a promising targeted therapy for solid tumors. BDTX-4933 is currently in Phase 1 clinical trials and is designed as a small molecule treatment aimed at patients with RAF/RAS-mutant cancers, including non-small cell lung cancer. Servier will lead the development and commercialization efforts globally, advancing this therapy as a potential best-in-class treatment for cancer patients.
Under the agreement, Black Diamond Therapeutics will receive an upfront payment of $70 million, with the possibility of earning up to $710 million in further development and sales milestones, plus additional royalties based on global net sales. Both companies share a commitment to addressing unmet medical needs in oncology, hoping that BDTX-4933 will eventually offer a breakthrough treatment option for patients battling aggressive forms of cancer.
Read Announcement
BDTX-1535 FDA Regulatory Timeline and Events
BDTX-1535 is a drug developed by Black Diamond Therapeutics for the following indication: Glioblastoma Multiforme (GBM) and Non-small cell lung cancer (NSCLC).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- BDTX-1535
- Announced Date:
- March 6, 2025
- Indication:
- Glioblastoma Multiforme (GBM) and Non-small cell lung cancer (NSCLC)
Announcement
Black Diamond Therapeutics, Inc. provided a corporate update.
AI Summary
Black Diamond Therapeutics has provided a corporate update on its efforts to advance cancer treatments. The company is focused on its drug BDTX-1535, targeting patients with EGFR-mutant non-small cell lung cancer (NSCLC). Initial Phase 2 clinical data for newly diagnosed patients with non-classical EGFR mutations is expected in the second quarter of 2025. In addition, the company will expand its "window of opportunity" trial into newly diagnosed glioblastoma patients with EGFR aberrations, with this study expected to begin in the first quarter of 2025.
CEO Mark Velleca highlighted these initiatives as part of their effort to address significant unmet medical needs. Furthermore, Black Diamond plans to seek FDA feedback later in 2025 on a potential registrational pathway for BDTX-1535. With approximately $98.6 million in cash and investments as of December 2024, the company expects ample funding to support operations into the fourth quarter of 2026.
Read Announcement- Drug:
- BDTX-1535
- Announced Date:
- September 23, 2024
- Target Action Date:
- Q1 2025
- Estimated Target Date Range:
- January 1, 2025 - March 31, 2025
- Indication:
- Glioblastoma Multiforme (GBM) and Non-small cell lung cancer (NSCLC)
Announcement
Black Diamond Therapeutics, Inc announced that Regulatory feedback on registration path anticipated in Q1 2025
AI Summary
Black Diamond Therapeutics announced promising Phase 2 data for its oral treatment BDTX-1535, highlighting a well-tolerated 200 mg daily dose that achieved an encouraging response rate in patients with resistant EGFR mutations. The treatment showed a favorable safety profile with most side effects being mild or moderate, and no new safety issues were observed. In addition to these encouraging findings, the company expects to receive regulatory feedback on its registration path in Q1 2025. This feedback is a key step that could define how the treatment is advanced in patients with non-small cell lung cancer (NSCLC), particularly those who have developed resistance to previous therapies. Black Diamond also looks forward to sharing initial Phase 2 data from first-line NSCLC patients with non-classical EGFR mutations in early 2025.
Read Announcement- Drug:
- BDTX-1535
- Announced Date:
- September 23, 2024
- Target Action Date:
- Q1 2025
- Estimated Target Date Range:
- January 1, 2025 - March 31, 2025
- Indication:
- Glioblastoma Multiforme (GBM) and Non-small cell lung cancer (NSCLC)
Announcement
Black Diamond Therapeutics, Inc announced that Initial results of BDTX-1535 in first-line NSCLC patients with non-classical EGFR mutations expected Q1 2025
AI Summary
Black Diamond Therapeutics, Inc. announced that initial results from its Phase 2 trial of BDTX-1535 in first-line non-small cell lung cancer patients with non-classical EGFR mutations are expected in Q1 2025. These early data are being closely watched as they could shape the drug’s registration path with the FDA. The company selected a daily dose of 200 mg based on favorable safety and pharmacokinetic profiles observed during the trial. Preliminary findings showed a 42% objective response rate in patients with on-target resistance mutations, along with an encouraging duration of response of about eight months or more in early responders.
With BDTX-1535 showing promise as a well-tolerated, brain-penetrant fourth-generation inhibitor, its upcoming results could offer a new therapeutic option for patients who currently have limited treatments. The anticipated data in Q1 2025 is seen as a significant milestone for both the company and patients with NSCLC.
Read Announcement- Drug:
- BDTX-1535
- Announced Date:
- September 23, 2024
- Indication:
- Glioblastoma Multiforme (GBM) and Non-small cell lung cancer (NSCLC)
Announcement
Black Diamond Therapeutics, Inc , today reported initial Phase 2 data demonstrating encouraging clinical responses and durability of BDTX-1535 in patients with relapsed/refractory epidermal growth factor receptor (EGFR)-mutant (EGFRm) non-small cell lung cancer (NSCLC).
AI Summary
Black Diamond Therapeutics, Inc. announced initial Phase 2 data showing that BDTX-1535, a novel, brain-penetrant EGFR inhibitor, produced promising clinical responses in patients with relapsed/refractory EGFR-mutant NSCLC. The study reported a preliminary objective response rate of 42% in 19 patients treated at 200 mg daily, with many patients exhibiting on-target resistance mutations following osimertinib treatment. The responses were durable—about 8 months or more for the first three patients with a partial response—and 14 of 19 patients remain on therapy.
The 200 mg dose was selected for pivotal development as it offered a favorable tolerability profile with mostly mild to moderate side effects such as rash and diarrhea, and no new safety signals were observed. Black Diamond plans to collect additional data, including results from first-line NSCLC patients with non-classical mutations, in Q1 2025 while awaiting further FDA guidance on the regulatory path.
Read Announcement- Drug:
- BDTX-1535
- Announced Date:
- September 22, 2024
- Target Action Date:
- September 23, 2024
- Indication:
- Glioblastoma Multiforme (GBM) and Non-small cell lung cancer (NSCLC)
Announcement
Black Diamond Therapeutics, Inc. 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, September 23, 2024, at 8:00am ET.
AI Summary
Black Diamond Therapeutics, a clinical-stage oncology company, will host a webcast on Monday, September 23, 2024, at 8:00 a.m. ET. During the webcast, the company plans to reveal initial phase 2 clinical trial results for its drug BDTX-1535, which targets patients with recurrent EGFR mutant non-small cell lung cancer (NSCLC).
The webcast will be available to investors on the company’s website under the “Events and Presentations” section. A replay of the webcast will also be made available after the live event. This presentation is part of Black Diamond’s ongoing efforts to develop promising MasterKey therapies that focus on specific oncogenic mutations, potentially improving treatment options and reducing side effects for patients with genetic forms of cancer.
Read Announcement- Drug:
- BDTX-1535
- Announced Date:
- September 14, 2024
- Indication:
- Glioblastoma Multiforme (GBM) and Non-small cell lung cancer (NSCLC)
Announcement
Black Diamond Therapeutics, Inc. today presented a poster analyzing real-world treatment outcomes for newly diagnosed non-small cell lung cancer (NSCLC) patients with non-classical EGFR mutations (NCMs) at the European Society for Medical Oncology (ESMO) Congress 2024 taking place September 13-17, in Barcelona, Spain.
AI Summary
Black Diamond Therapeutics, Inc. presented a poster at the European Society for Medical Oncology (ESMO) Congress 2024 in Barcelona, Spain, where the company analyzed real-world treatment outcomes for newly diagnosed non-small cell lung cancer (NSCLC) patients with non-classical EGFR mutations (NCMs). The poster detailed findings from a study that evaluated treatment data from 3,276 cases, revealing that most patients received frontline chemotherapy while others were treated with targeted therapies such as osimertinib or afatinib.
The analysis showed that patients with NCMs often discontinued their treatment within four to eight months, suggesting that current therapeutic options, including EGFR tyrosine kinase inhibitors, may provide limited benefit. These results highlight a significant unmet need for more effective and less toxic treatments for this subgroup. The study supports continued development of new therapies like Black Diamond’s fourth-generation EGFR inhibitor, BDTX-1535, aimed at addressing these challenges.
Read Announcement
