Black Diamond Therapeutics(BDTX)
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Black Diamond Therapeutics, Inc. (BDTX) Price Target Trimmed as Piper Updates Biotech Models and 2026 Catalyst Tracker
Yahoo Finance· 2026-02-02 14:56
We recently compiled a list of the 20 Best Biotech Stocks Under $20 to Buy Now. Black Diamond Therapeutics, Inc. is one of the twenty best biotech stocks. TheFly reported on January 16 that Piper Sandler lowered the price target for BDTX to $8 from $9 and maintained an Overweight rating. The change coincided with the company’s revision of several models and price estimates throughout its biotechnology coverage, as well as an update to its 2026 Catalyst Tracker. Separately, on December 3, 2025, Black Dia ...
Is Black Diamond Therapeutics (BDTX) Stock Outpacing Its Medical Peers This Year?
ZACKS· 2026-01-23 15:41
For those looking to find strong Medical stocks, it is prudent to search for companies in the group that are outperforming their peers. Is Black Diamond (BDTX) one of those stocks right now? A quick glance at the company's year-to-date performance in comparison to the rest of the Medical sector should help us answer this question.Black Diamond is a member of our Medical group, which includes 932 different companies and currently sits at #8 in the Zacks Sector Rank. The Zacks Sector Rank gauges the strength ...
What Makes Black Diamond (BDTX) a New Strong Buy Stock
ZACKS· 2026-01-09 18:00
Core Viewpoint - Black Diamond (BDTX) has been upgraded to a Zacks Rank 1 (Strong Buy), indicating a positive outlook on its earnings estimates, which is a significant factor influencing stock prices [1][3]. Earnings Estimates and Stock Performance - The Zacks rating system is based on changes in earnings estimates, which are closely correlated with stock price movements, making it a valuable tool for investors [2][4]. - The recent upgrade for Black Diamond reflects an improvement in the company's underlying business, likely leading to increased stock prices due to investor confidence [5]. Earnings Estimate Revisions - For the fiscal year ending December 2025, Black Diamond is expected to earn $0.48 per share, unchanged from the previous year, but the Zacks Consensus Estimate has increased by 34.5% over the past three months [8]. Zacks Rank System - The Zacks Rank system classifies stocks into five groups based on earnings estimates, with Zacks Rank 1 stocks historically generating an average annual return of +25% since 1988 [7]. - Black Diamond's upgrade to Zacks Rank 1 places it in the top 5% of Zacks-covered stocks, indicating strong potential for market-beating returns in the near term [10].
Black Diamond Therapeutics (NasdaqGS:BDTX) FY Conference Transcript
2025-12-04 19:02
Summary of Black Diamond Therapeutics FY Conference Call Company Overview - **Company**: Black Diamond Therapeutics (NasdaqGS: BDTX) - **Industry**: Precision oncology, specifically focusing on EGFR tyrosine kinase inhibitors - **Lead Asset**: BDTX-1535, a fourth-generation EGFR TKI targeting both classical and non-classical mutations in lung cancer and glioblastoma [4][6][26] Key Highlights BDTX-1535 Development - **Phase 2 Trial**: Initial data from a phase 2 trial in frontline lung cancer patients was released, showing a response rate benchmark of 60% was met [12][14] - **Patient Population**: The trial included 43 patients with 35 different non-classical mutations, with over a third presenting with untreated brain metastases [12][14] - **CNS Activity**: BDTX-1535 demonstrated an 86% CNS response rate among patients with measurable brain lesions, significantly higher than competitor Furmonertinib's 43% [14] Mechanism of Action - **Targeting Non-Classical Mutations**: BDTX-1535 is designed to address a broad spectrum of non-classical EGFR mutations, which are not effectively treated by existing therapies like Osimertinib [6][10] - **Brain Penetration**: The drug is engineered to penetrate the blood-brain barrier, which is critical for treating CNS metastases in lung cancer patients [6][28] Future Expectations - **Upcoming Data**: Progression-free survival (PFS) data is expected in the second quarter of 2026, which will be crucial for discussions with the FDA regarding pivotal trials [22][40] - **Partnerships**: The company is seeking a global partner, particularly one with a presence in Asia, to support the execution of a large phase 3 study while preserving shareholder value [24][25] Glioblastoma Research - **Phase 2 Trial Initiation**: BDTX-1535 will advance into a phase 2 trial for newly diagnosed glioblastoma patients, addressing the lack of effective EGFR inhibitors in this area [27][35] - **Unique Attributes**: The drug shows potent preclinical activity against EGFR variant 3, which is prevalent in glioblastoma, and has demonstrated high brain penetration [28][30] Financial and Strategic Outlook - **Cash Runway**: The company has a financial runway until the second half of 2028, supported by a $70 million upfront payment from a partnership with Servier for a RAF inhibitor [39][40] - **Market Opportunity**: The potential market for BDTX-1535 in non-small cell lung cancer is estimated at $2 billion, with significant opportunities in the recurrent setting and glioblastoma [26][27] Conclusion - Black Diamond Therapeutics is positioned to make significant advancements in the treatment of lung cancer and glioblastoma with BDTX-1535, focusing on addressing unmet medical needs through innovative drug design and strategic partnerships [4][24][40]
Down 30.5% in 4 Weeks, Here's Why You Should You Buy the Dip in Black Diamond (BDTX)
ZACKS· 2025-12-04 15:35
Core Viewpoint - Black Diamond (BDTX) has experienced a significant decline of 30.5% over the past four weeks, but it is now positioned for a potential trend reversal as it enters oversold territory, with analysts predicting better-than-expected earnings [1] Group 1: Technical Indicators - The Relative Strength Index (RSI) is a momentum oscillator that indicates whether a stock is oversold, with readings below 30 typically signaling this condition [2] - BDTX has an RSI reading of 25.36, suggesting that the heavy selling pressure may be exhausting, indicating a potential bounce back towards equilibrium [5] Group 2: Fundamental Analysis - There is strong consensus among sell-side analysts that earnings estimates for BDTX have increased by 36.2% over the last 30 days, which often correlates with price appreciation [7] - BDTX holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimate revisions and EPS surprises, further supporting the potential for a turnaround [8]
Black Diamond's Lung Cancer Drug Shows 60% Response Rate In Phase 2 Data
Benzinga· 2025-12-03 18:31
Core Insights - Black Diamond Therapeutics, Inc. released topline data from its Phase 2 trial of silevertinib for frontline non-small cell lung cancer patients with non-classical EGFR mutations [1] Trial Results - All patients were treated with a daily oral dose of 200mg of silevertinib, with a median follow-up time of 7.2 months as of the data cutoff on November 3, 2025 [2] - The trial reported 25 confirmed partial responses and one confirmed complete response, resulting in a 60% Objective Response Rate (ORR) [6] - The Central Nervous System (CNS) ORR was 86%, and the disease control rate (DCR) was 91% [6] - No new safety signals were observed, with common adverse events including rash, stomatitis, diarrhea, and paronychia [2] Future Plans - The company plans to present updated results, including Duration of Response (DOR) and Progression-free Survival (PFS) data, at a medical meeting in the second quarter of 2026 [3] - Black Diamond intends to initiate a randomized Phase 2 trial in newly diagnosed glioblastoma patients in the first half of 2026, expecting to enroll approximately 150 patients [4] Financial Position - As of September 30, 2025, the company reported cash, cash equivalents, and investments of approximately $135.5 million, which is expected to fund operations and capital expenditures into the second half of 2028 [7] Stock Performance - BDTX stock experienced a decline of 23.77%, trading at $2.62 at the time of publication [4]
Black Diamond Therapeutics (NasdaqGS:BDTX) Update / Briefing Transcript
2025-12-03 14:02
Summary of Black Diamond Therapeutics Phase 2 Update Company Overview - **Company**: Black Diamond Therapeutics (NasdaqGS: BDTX) - **Focus**: Development of Silveritinib, a fourth-generation EGFR TKI, for treating non-small cell lung cancer (NSCLC) and glioblastoma (GBM) Key Points from the Call Industry and Product Insights - **Silveritinib**: Demonstrated robust activity in frontline patients with non-small cell lung cancer (NSCLC) harboring non-classical EGFR mutations, addressing a significant unmet medical need [2][3][4] - **Market Potential**: Non-classical EGFR mutations account for approximately 25% of the EGFR mutation space in newly diagnosed patients, representing a large market opportunity [5][6] - **CNS Activity**: Silveritinib shows remarkable anti-tumor activity in the brain, with significant responses observed in patients with CNS disease [3][9][14] Clinical Trial Results - **Patient Enrollment**: 126 patients enrolled across three cohorts, with 43 patients presenting with 35 unique non-classical mutations in the frontline setting [7][8] - **Response Rates**: - Overall response rate (ORR) of 60%, with 26 of 43 patients achieving a confirmed radiographic response [8][14] - Disease control rate exceeds 90% [8] - CNS response observed in 6 out of 7 patients with target CNS lesions [9][14] - **Durability of Response**: Preliminary trends indicate encouraging durability, especially in patients with CNS disease, with a median time to first response of 42 days [10][11] Safety and Tolerability - **Adverse Events**: Consistent with the EGFR TKI class, common adverse events include rash, diarrhea, and stomatitis [11][12] - **Dose Management**: Patients often underwent dose reductions, yet many continued to show deepening responses post-reduction, indicating a favorable therapeutic index [11][13][54] Future Development Plans - **GBM Trial**: Plans to initiate a randomized phase 2 trial for newly diagnosed GBM patients, focusing on those with EGFR alterations, particularly variant 3 [25][32] - **Trial Design**: Emphasis on robust statistical analysis and independent data monitoring to ensure trial integrity and success [33][36] Market Positioning and Competitive Landscape - **Differentiation**: Silveritinib's broad-spectrum activity against various non-classical mutations and superior CNS penetrance set it apart from existing therapies like Osimertinib and Afatinib [49][50] - **Regulatory Strategy**: Ongoing discussions with the FDA regarding trial design and potential partnerships to enhance development and commercialization efforts [48][56] Expert Commentary - **Unmet Medical Need**: Experts emphasize the critical need for effective treatments for patients with non-classical EGFR mutations and CNS metastasis, highlighting Silveritinib's potential to fill this gap [15][19][20] - **Optimism for Future**: Despite past failures in GBM treatments, there is optimism surrounding Silveritinib's unique properties and the advancements in understanding EGFR biology [43][44] Conclusion - Black Diamond Therapeutics is positioned to make significant strides in treating NSCLC and GBM with Silveritinib, leveraging its unique properties to address unmet medical needs in these patient populations. The upcoming trials and ongoing data collection will be crucial in validating its efficacy and safety profile.
Black Diamond Therapeutics Announces Preliminary Phase 2 Data for Silevertinib in 1L NSCLC and Plans for a Phase 2 Trial of Silevertinib in GBM
Globenewswire· 2025-12-03 12:01
Core Insights - Black Diamond Therapeutics announced topline data from its Phase 2 trial of silevertinib in frontline non-small cell lung cancer (NSCLC) patients with non-classical epidermal growth factor receptor (EGFR) mutations and plans for a randomized Phase 2 trial in newly diagnosed glioblastoma (GBM) patients [1][2] Group 1: Phase 2 Trial Results - The Phase 2 trial enrolled 43 frontline NSCLC patients with 35 distinct non-classical EGFR mutations, including 16 patients with brain metastases [3][4] - Silevertinib demonstrated an objective response rate (ORR) of 60% and a central nervous system (CNS) response rate of 86% among the enrolled patients [5][4] - 29 out of 43 patients remain on therapy, with the longest ongoing treatment exceeding 19 months [4][3] Group 2: Safety and Efficacy - No new safety signals were observed, with common adverse events including rash, stomatitis, diarrhea, and paronychia [6][7] - Adverse events were managed effectively without compromising the depth or durability of the response [7] Group 3: Future Plans and Financials - The company plans to initiate a randomized Phase 2 trial of silevertinib in newly diagnosed GBM patients in the first half of 2026, with initial data expected in 2028 [9][10] - As of September 30, 2025, the company reported cash, cash equivalents, and investments totaling $135.5 million, sufficient to fund operations into the second half of 2028 [4][13]
Black Diamond Therapeutics to Host Webcast Presentation Highlighting Silevertinib Phase 2 Clinical Trial Results and Program Update
Globenewswire· 2025-12-02 21:01
Core Insights - Black Diamond Therapeutics, Inc. is a clinical-stage oncology company focused on developing MasterKey therapies targeting oncogenic mutations in cancer patients [1][3] - The company will present results from its Phase 2 clinical trial of silevertinib and provide a program update on December 3, 2025 [1] Company Overview - Black Diamond Therapeutics specializes in MasterKey therapies designed to address a wide range of genetically defined tumors, overcome resistance, and minimize toxicities associated with wild-type [3] - The company is advancing a Phase 2 trial for silevertinib, a fourth-generation EGFR MasterKey inhibitor, specifically targeting EGFR-mutant non-small cell lung cancer (NSCLC) and glioblastoma [3]
Black Diamond Therapeutics: Underappreciated Despite An Upcoming Key Readout (NASDAQ:BDTX)
Seeking Alpha· 2025-11-20 13:57
Core Insights - Black Diamond Therapeutics, Inc. (BDTX) has shown potential for growth, particularly noted in early 2025 [1] Company Overview - The company is involved in the biotech sector, focusing on clinical trials and drug development [1] Analyst Background - The analysis is conducted by an individual with a PhD in biochemistry and extensive experience in analyzing clinical trials and biotech companies [1]