FDA Approves Lantern's Clinical Trial Amendments
Written by Emily J. Thompson, Senior Investment Analyst
Updated: May 19 2026
0mins
Source: Newsfilter
- Trial Amendments Approved: The FDA raised no objections to Lantern's key amendments to the HARMONIC™ clinical trial, including enriching enrollment for patients with EGFR exon 21 L858R mutations, extending LP-300 dosing to a maximum of eight cycles, and transitioning to a single-arm study design, which will provide a clearer regulatory path for this high-need patient population.
- Focus on EGFR Mutant Patients: The revised trial will concentrate on patients with the EGFR exon 21 L858R mutation, which accounts for approximately 40% of all EGFR-mutant NSCLC globally and up to 50% in Asian populations, as this subgroup consistently shows inferior outcomes, with Lantern aiming to offer a differentiated therapeutic benefit through LP-300.
- Extended LP-300 Dosing: Lantern plans to increase the maximum number of LP-300 treatment cycles from six to eight based on historical safety data, aiming to maximize the depth and durability of response without adding clinically meaningful toxicity, thereby enhancing treatment outcomes for patients.
- Advantages of Single-Arm Design: The HARMONIC™ trial will transition to a single-arm design focusing on EGFR exon 21 L858R mutant patients, which is expected to accelerate enrollment and sharpen clinical signals, positioning Lantern for more effective discussions with regulators and potential collaborators regarding future strategies.
Trade with 70% Backtested Accuracy
Stop guessing "Should I Buy LTRN?" and start using high-conviction signals backed by rigorous historical data.
Sign up today to access powerful investing tools and make smarter, data-driven decisions.
Analyst Views on LTRN
Wall Street analysts forecast LTRN stock price to rise
1 Analyst Rating
1 Buy
0 Hold
0 Sell
Moderate Buy
Current: 3.500
Low
25.00
Averages
25.00
High
25.00
Current: 3.500
Low
25.00
Averages
25.00
High
25.00
No data
About LTRN
Lantern Pharma Inc. is an artificial intelligence (AI) company. The Company is developing cancer therapies and transforming the cost, pace, and timeline of oncology drug discovery and development. Its proprietary AI and machine learning (ML) platform, RADR, leverages over 100 billion oncology-focused data points and a library of over 200+ advanced ML algorithms to help solve problems in oncology drug development. It is engaged in the development of its pipeline of therapies that span multiple cancer indications, including both solid tumors and blood cancers and an antibody drug conjugate (ADC) program. It has active clinical programs for its three lead small molecule drug candidates: LP-300, LP-184, and LP-284. These programs are focused on multiple cancer indications, including both solid tumors and blood cancers. It is also focused on the clinical execution of its therapies for CNS and brain cancers through Starlight Therapeutics Inc.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Lantern Pharma (LTRN) Q1 2025 Earnings Transcript
See More
FDA Approves Lantern's Clinical Trial Amendments
- Trial Amendments Approved: The FDA raised no objections to Lantern's key amendments to the HARMONIC™ clinical trial, including enriching enrollment for patients with EGFR exon 21 L858R mutations, extending LP-300 dosing to a maximum of eight cycles, and transitioning to a single-arm study design, which will provide a clearer regulatory path for this high-need patient population.
- Focus on EGFR Mutant Patients: The revised trial will concentrate on patients with the EGFR exon 21 L858R mutation, which accounts for approximately 40% of all EGFR-mutant NSCLC globally and up to 50% in Asian populations, as this subgroup consistently shows inferior outcomes, with Lantern aiming to offer a differentiated therapeutic benefit through LP-300.
- Extended LP-300 Dosing: Lantern plans to increase the maximum number of LP-300 treatment cycles from six to eight based on historical safety data, aiming to maximize the depth and durability of response without adding clinically meaningful toxicity, thereby enhancing treatment outcomes for patients.
- Advantages of Single-Arm Design: The HARMONIC™ trial will transition to a single-arm design focusing on EGFR exon 21 L858R mutant patients, which is expected to accelerate enrollment and sharpen clinical signals, positioning Lantern for more effective discussions with regulators and potential collaborators regarding future strategies.
See More
Lantern Pharma Q1 Financial Results and Funding Update
- Financial Performance: Lantern Pharma reported a Q1 GAAP EPS of -$0.30, indicating challenges in profitability that may affect investor confidence and stock performance.
- Liquidity Position: As of March 31, 2026, the company had approximately $6.3 million in cash and marketable securities, and with an additional $4.4 million from financing on May 14, 2026, its pro forma liquidity is expected to fund operations into the middle of Q1 2027.
- Market Potential: Lantern Pharma outlines a market potential of $15 billion to $20 billion for its AI-driven drug discovery pipeline, highlighting its strategic positioning in innovative drug development.
- Intensified Funding Needs: As the AI-driven pipeline advances, Lantern Pharma's funding requirements are increasing, indicating a potential need for further financing to support its R&D and operational activities.
See More
Lantern Pharma to Report Q1 2026 Financial Results on May 15
- Earnings Announcement: Lantern Pharma has announced it will release its Q1 2026 financial and operational results on May 15, covering data up to March 31, 2026, which is expected to provide insights into clinical trials and AI platform developments, potentially influencing investor confidence in the company's future.
- AI Platform Advantage: The company leverages its proprietary AI and machine learning platform, RADR®, in collaboration with Zeta.ai, to rapidly identify biomarker signatures and accelerate the development of targeted therapies for difficult-to-treat cancers, showcasing its technological leadership in precision oncology.
- Drug Development Pipeline: Lantern Pharma is advancing a pipeline of small molecule drug candidates and an antibody-drug conjugate program focused on various solid tumors and hematologic malignancies, indicating a diversified strategy and market potential in cancer treatment.
- Forward-Looking Statements: The press release includes forward-looking statements highlighting uncertainties regarding future financial performance and clinical trial progress, cautioning investors about potential risk factors that could impact the company's stock price and market performance.
See More
Lantern Pharma Unveils New Features for withZeta.ai Platform
- Feature Launch: Lantern Pharma has introduced new capabilities for the withZeta.ai platform, including ZetaSwarm™ and ZetaOmics™, aimed at enhancing efficiency in oncology research and drug development, which is expected to attract more biomedical research institutions.
- Significant Market Potential: With the AI-driven drug development market projected to reach $15 billion, the commercial subscription model of withZeta.ai provides Lantern Pharma shareholders with a new non-dilutive revenue stream, enhancing the company's financial stability.
- Multi-Agent Intelligence System: ZetaSwarm™ is designed to process scientific sub-problems in parallel using 34 tools and real data, providing more precise support for drug development, which is anticipated to significantly improve R&D efficiency and outcome quality.
- Enterprise-Grade Platform Capabilities: The newly developed enterprise features will support research deployments for pharmaceutical companies and academic institutions, offering role-based access controls and comprehensive audit trails to ensure compliance and enhance user experience.
See More
Lantern Pharma Unveils New Features for withZeta.ai Platform
- Platform Upgrade: Lantern Pharma's withZeta.ai platform will integrate ZetaSwarm™ and ZetaOmics™ capabilities, aiming to enhance efficiency in oncology research and drug development through real-time multi-omic computational analyses and multi-agent reasoning, thereby securing a competitive edge in the nearly $15 billion AI drug development market.
- New Revenue Stream: withZeta.ai is now commercially available with a fully enabled subscription payment model serving the biomedical research and drug development community, expected to provide Lantern Pharma shareholders with a new non-dilutive revenue stream, further enhancing the company's financial stability.
- Enterprise Features Development: The platform is developing enterprise-grade capabilities to support research deployments at pharmaceutical companies and academic medical centers, with planned features including workspace and organization-level accounts, comprehensive audit trails, and private knowledge bases to meet compliance requirements and enhance user experience.
- Agent Collaboration Innovation: ZetaSwarm™ will utilize a coordinated network of specialist AI agents to tackle complex scientific questions, leveraging 34 tools and real data for in-depth analysis, which is expected to significantly shorten research cycles and improve the speed and accuracy of drug development.
See More
Lantern Pharma (LTRN) Q1 2025 Earnings Transcript
See More
FDA Approves Lantern's Clinical Trial Amendments
- Trial Amendments Approved: The FDA raised no objections to Lantern's key amendments to the HARMONIC™ clinical trial, including enriching enrollment for patients with EGFR exon 21 L858R mutations, extending LP-300 dosing to a maximum of eight cycles, and transitioning to a single-arm study design, which will provide a clearer regulatory path for this high-need patient population.
- Focus on EGFR Mutant Patients: The revised trial will concentrate on patients with the EGFR exon 21 L858R mutation, which accounts for approximately 40% of all EGFR-mutant NSCLC globally and up to 50% in Asian populations, as this subgroup consistently shows inferior outcomes, with Lantern aiming to offer a differentiated therapeutic benefit through LP-300.
- Extended LP-300 Dosing: Lantern plans to increase the maximum number of LP-300 treatment cycles from six to eight based on historical safety data, aiming to maximize the depth and durability of response without adding clinically meaningful toxicity, thereby enhancing treatment outcomes for patients.
- Advantages of Single-Arm Design: The HARMONIC™ trial will transition to a single-arm design focusing on EGFR exon 21 L858R mutant patients, which is expected to accelerate enrollment and sharpen clinical signals, positioning Lantern for more effective discussions with regulators and potential collaborators regarding future strategies.
See More
Lantern Pharma Q1 Financial Results and Funding Update
- Financial Performance: Lantern Pharma reported a Q1 GAAP EPS of -$0.30, indicating challenges in profitability that may affect investor confidence and stock performance.
- Liquidity Position: As of March 31, 2026, the company had approximately $6.3 million in cash and marketable securities, and with an additional $4.4 million from financing on May 14, 2026, its pro forma liquidity is expected to fund operations into the middle of Q1 2027.
- Market Potential: Lantern Pharma outlines a market potential of $15 billion to $20 billion for its AI-driven drug discovery pipeline, highlighting its strategic positioning in innovative drug development.
- Intensified Funding Needs: As the AI-driven pipeline advances, Lantern Pharma's funding requirements are increasing, indicating a potential need for further financing to support its R&D and operational activities.
See More
Lantern Pharma to Report Q1 2026 Financial Results on May 15
- Earnings Announcement: Lantern Pharma has announced it will release its Q1 2026 financial and operational results on May 15, covering data up to March 31, 2026, which is expected to provide insights into clinical trials and AI platform developments, potentially influencing investor confidence in the company's future.
- AI Platform Advantage: The company leverages its proprietary AI and machine learning platform, RADR®, in collaboration with Zeta.ai, to rapidly identify biomarker signatures and accelerate the development of targeted therapies for difficult-to-treat cancers, showcasing its technological leadership in precision oncology.
- Drug Development Pipeline: Lantern Pharma is advancing a pipeline of small molecule drug candidates and an antibody-drug conjugate program focused on various solid tumors and hematologic malignancies, indicating a diversified strategy and market potential in cancer treatment.
- Forward-Looking Statements: The press release includes forward-looking statements highlighting uncertainties regarding future financial performance and clinical trial progress, cautioning investors about potential risk factors that could impact the company's stock price and market performance.
See More
Lantern Pharma Unveils New Features for withZeta.ai Platform
- Feature Launch: Lantern Pharma has introduced new capabilities for the withZeta.ai platform, including ZetaSwarm™ and ZetaOmics™, aimed at enhancing efficiency in oncology research and drug development, which is expected to attract more biomedical research institutions.
- Significant Market Potential: With the AI-driven drug development market projected to reach $15 billion, the commercial subscription model of withZeta.ai provides Lantern Pharma shareholders with a new non-dilutive revenue stream, enhancing the company's financial stability.
- Multi-Agent Intelligence System: ZetaSwarm™ is designed to process scientific sub-problems in parallel using 34 tools and real data, providing more precise support for drug development, which is anticipated to significantly improve R&D efficiency and outcome quality.
- Enterprise-Grade Platform Capabilities: The newly developed enterprise features will support research deployments for pharmaceutical companies and academic institutions, offering role-based access controls and comprehensive audit trails to ensure compliance and enhance user experience.
See More
Lantern Pharma Unveils New Features for withZeta.ai Platform
- Platform Upgrade: Lantern Pharma's withZeta.ai platform will integrate ZetaSwarm™ and ZetaOmics™ capabilities, aiming to enhance efficiency in oncology research and drug development through real-time multi-omic computational analyses and multi-agent reasoning, thereby securing a competitive edge in the nearly $15 billion AI drug development market.
- New Revenue Stream: withZeta.ai is now commercially available with a fully enabled subscription payment model serving the biomedical research and drug development community, expected to provide Lantern Pharma shareholders with a new non-dilutive revenue stream, further enhancing the company's financial stability.
- Enterprise Features Development: The platform is developing enterprise-grade capabilities to support research deployments at pharmaceutical companies and academic medical centers, with planned features including workspace and organization-level accounts, comprehensive audit trails, and private knowledge bases to meet compliance requirements and enhance user experience.
- Agent Collaboration Innovation: ZetaSwarm™ will utilize a coordinated network of specialist AI agents to tackle complex scientific questions, leveraging 34 tools and real data for in-depth analysis, which is expected to significantly shorten research cycles and improve the speed and accuracy of drug development.
See More
