This section highlights FDA-related milestones and regulatory updates for drugs developed by Lantern Pharma (LTRN).
Over the past two years, Lantern Pharma has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
LP-184, LP-300, and RADR. 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.
LP-184 FDA Regulatory Timeline and Events
LP-184 is a drug developed by Lantern Pharma for the following indication: Prostate 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:
- LP-184
- Announced Date:
- May 29, 2025
- Indication:
- Prostate cancer
Announcement
Lantern Pharma Inc. announced promising preclinical data for LP-184 in atypical teratoid rhabdoid tumors (ATRT), a rare and aggressive pediatric brain cancer.
AI Summary
Lantern Pharma Inc. announced promising preclinical results for its drug candidate LP-184 in treating atypical teratoid rhabdoid tumors (ATRT), a rare and aggressive pediatric brain cancer. Independent research from Johns Hopkins University presented at a recent neuro-oncology conference demonstrated that LP-184 significantly improved survival rates in mouse models. In one model, the median survival increased from 20 days to 89 days, and in another model, from 68 days to 98 days, highlighting LP-184’s potent anti-tumor activity. The data also showed that LP-184 effectively reduced cancer cell growth, increased cell death, and successfully penetrated the blood-brain barrier, all without apparent toxicity.
This compelling preclinical evidence supports Lantern Pharma’s plans to move forward with pediatric clinical trials beginning in late 2025 or early 2026, offering hope for improved treatment options for children suffering from this devastating disease.
Read Announcement- Drug:
- LP-184
- Announced Date:
- May 15, 2025
- Indication:
- Prostate cancer
Announcement
Lantern Pharma Inc. announced operational highlights
AI Summary
Lantern Pharma Inc. announced key operational highlights for the first quarter of 2025. The company is nearing the completion of its LP-184 Phase 1a clinical trial enrollment, expecting to include 62–65 patients with various solid tumors by the end of June 2025. Additionally, Lantern anticipates a new patient data readout from its LP-300 HARMONIC trial for non-small cell lung cancer in Q3 2025, which will include results from an Asian expansion cohort.
Lantern also highlighted significant advances in its RADR® AI platform. An innovative ADC development module was added, and the company filed a patent application for a blood–brain barrier penetration prediction tool, receiving a favorable report with no significant prior art. Lantern plans to release select RADR® modules to the scientific community, supporting collaborative innovation in cancer drug development while maintaining a strong financial position for future operations.
Read Announcement- Drug:
- LP-184
- Announced Date:
- May 12, 2025
- Indication:
- Prostate cancer
Announcement
Lantern Pharma Tell Benzinga Co. Secures FDA Clerance For Planned Phase 1b/2 Trial Of LP-184 In Biomarker-Defined, Treatment-Resistant NSCLC Patients With High Unmet Clinical Need
AI Summary
The FDA has granted clearance to Lantern Pharma Inc. for an amended Investigational New Drug application, allowing the company to launch a Phase 1b/2 trial of LP-184 in a specific group of advanced non-small cell lung cancer (NSCLC) patients. This unique trial targets individuals with high-risk NSCLC characterized by genetic mutations such as KEAP1 and/or STK11 along with low levels of PD-L1 expression.
In this study, LP-184 will be used in combination with Bristol-Myers Squibb’s immune checkpoint inhibitors Opdivo (nivolumab) and Yervoy (ipilimumab). The trial is set to evaluate the safety of this treatment approach, gather early evidence of its effectiveness, and study relevant biomarkers. Lantern Pharma aims to leverage the trial results to pursue fast track or accelerated approval, addressing a serious unmet need for treatment-resistant NSCLC patients.
Read Announcement- Drug:
- LP-184
- Announced Date:
- May 5, 2025
- Indication:
- Prostate cancer
Announcement
Lantern Pharma Tells Benzinga Co. Advances Drug Candidate LP-184 With IND Clearance For Phase 1b/2 Trial In Triple Negative Breast Cancer
AI Summary
Lantern Pharma recently received IND clearance from the FDA to begin a Phase 1b/2 trial for its LP-184 treatment in triple-negative breast cancer (TNBC). The trial will have two parts. The first part is an open-label study where approximately 30 patients with advanced TNBC will receive LP-184 alone to help find the best dose while assessing safety and early signs of effectiveness. The second part tests LP-184 in combination with olaparib for patients with BRCA1 or BRCA2 alterations who have already received other treatments. Early studies in animal models showed that LP-184 could help overcome resistance to PARP inhibitors. This trial aims to provide important data on safety and optimal dosing, and the results may lead to a faster regulatory approval path for LP-184 as a promising option for TNBC patients.
Read Announcement- Drug:
- LP-184
- Announced Date:
- December 3, 2024
- Indication:
- Prostate cancer
Announcement
Lantern Pharma Inc announced that the FDA has granted Fast Track Designation for investigational drug candidate, LP-184, for treatment of Triple Negative Breast Cancer (TNBC).
AI Summary
Lantern Pharma Inc announced that the U.S. FDA has granted Fast Track Designation to its investigational drug candidate LP-184 for the treatment of Triple Negative Breast Cancer (TNBC). This designation aims to speed up the review process for therapies that address urgent medical needs in serious conditions. TNBC affects nearly 29,000 patients in the U.S. each year, with over 50% of patients relapsing within 3–5 years. Early studies have shown that LP-184 can significantly slow tumor growth, including in cases resistant to other treatments like PARP inhibitors, and it may work well with checkpoint inhibitors. The drug is now being evaluated in a Phase 1A clinical trial across multiple solid tumors, including TNBC. The Fast Track Designation will allow Lantern Pharma to work closely with the FDA during development, potentially speeding access to this promising treatment for patients in need.
Read Announcement- Drug:
- LP-184
- Announced Date:
- November 26, 2024
- Indication:
- Prostate cancer
Announcement
Lantern Pharma Inc announced the presentation of new preclinical data and Phase 1b trial design for LP-184 (to be developed as STAR-001 for CNS indications) in glioblastoma at the Society for Neuro-Oncology (SNO) 2024 Annual Meeting in Houston, Texas.
AI Summary
Lantern Pharma Inc. recently announced new preclinical data and a detailed Phase 1b trial design for LP-184, to be developed as STAR-001 for central nervous system (CNS) indications in glioblastoma. The Phase 1b trial, to be presented at the SNO 2024 Annual Meeting in Houston, Texas, will evaluate LP-184 both as a stand-alone treatment and in combination with spironolactone. Preclinical studies have shown that adding spironolactone can increase glioblastoma cell sensitivity to LP-184 by up to six-fold. This enhanced response is believed to be due to the degradation of ERCC3, which makes the cancer cells less able to repair damage. The advanced brain penetrance properties of LP-184 together with its promising mechanism of action highlight its potential as a new treatment option for patients with recurrent glioblastoma, a disease with very limited effective therapies.
Read Announcement- Drug:
- LP-184
- Announced Date:
- September 23, 2024
- Indication:
- Prostate cancer
Announcement
Lantern Pharma Inc. announced that the company has been granted three rare pediatric disease designations (RPDD) by the FDA.
AI Summary
Lantern Pharma Inc., an artificial intelligence company focused on developing cancer therapies, announced that the FDA has granted three rare pediatric disease designations for its drug candidate LP-184. The designations address malignant rhabdoid tumors, rhabdomyosarcoma, and hepatoblastoma, which are serious cancers affecting a small number of children in the United States. These awards recognize LP-184’s potential to treat life-threatening pediatric conditions with few available treatment options.
The FDA’s Rare Pediatric Disease designation could help speed up the drug development process. It may also make Lantern Pharma eligible for a Priority Review Voucher if LP-184 gains marketing approval, potentially shortening review times for future applications. Early evidence from studies has shown promise in tumor regression and improved patient outcomes, offering new hope for children with these devastating cancers.
Read Announcement- Drug:
- LP-184
- Announced Date:
- August 7, 2024
- Indication:
- Prostate cancer
Announcement
Lantern Pharma announced a significant advancement demonstrating the preclinical synergy of LP-184 with checkpoint inhibitors and the ability of LP-184 to resensitize tumors that have become non-responsive to Anti-PD1 therapies.
AI Summary
Lantern Pharma announced a significant breakthrough in its preclinical studies, demonstrating that its experimental drug LP-184 can work in synergy with checkpoint inhibitors. The drug was shown to re‑sensitize tumors that stopped responding to anti‑PD1 therapies in animal models of triple negative breast cancer. By combining LP‑184 with an anti‑PD1 agent, researchers observed a stronger anti‑tumor response, offering hope for patients with cancers that no longer respond to standard immunotherapy.
The results suggest that LP‑184 can change "cold" tumors, which are usually resistant to immunotherapy, into "hot" tumors that respond better by affecting the tumor microenvironment. This includes modifying T cell activity and reducing immunosuppressive M2 macrophages. Lantern Pharma will present these findings at The Immuno‑Oncology Summit 2024 in Philadelphia, potentially paving the way for new combination treatment strategies in oncology.
Read Announcement
LP-300 + Chemotherapy (Harmonic) FDA Regulatory Timeline and Events
LP-300 + Chemotherapy (Harmonic) is a drug developed by Lantern Pharma for the following indication: Never Smokers with 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:
- LP-300 + Chemotherapy (Harmonic)
- Announced Date:
- March 27, 2025
- Indication:
- Never Smokers with Non-Small Cell Lung Cancer (NSCLC)
Announcement
Lantern Pharma Provides Business Updates
AI Summary
Lantern Pharma provided key business updates alongside its Q4 and full year 2024 financial results. The company highlighted continued progress in its precision oncology programs, with its Phase 2 HARMONIC trial for LP‑300 showing an 86% clinical benefit rate and a 43% objective response rate in never‑smoker NSCLC patients. Lantern is expanding patient enrollment in Japan and Taiwan, regions with a significant percentage of NSCLC cases in never‑smokers, and expects multiple clinical readouts in 2025.
Additionally, Lantern is advancing its clinical pipeline with Phase 1 trials for LP‑184 and LP‑284 in various solid tumors, supported by their RADR® AI platform. This platform helps optimize drug candidates and improve patient targeting by processing extensive oncology data. The company also announced strategic collaborations and plans for further clinical studies, setting the stage for meaningful advancements in oncology treatment options in the near future.
Read Announcement- Drug:
- LP-300 + Chemotherapy (Harmonic)
- Announced Date:
- December 9, 2024
- Indication:
- Never Smokers with Non-Small Cell Lung Cancer (NSCLC)
Announcement
Lantern Pharma Inc announced that the first patient has been enrolled and dosed in Taiwan for its Phase 2 HARMONIC™ clinical trial evaluating LP-300 in never-smoker patients with non-small cell lung cancer (NSCLC) who have progressed after receiving treatment with tyrosine kinase inhibitors (TKIs).
AI Summary
Lantern Pharma Inc. announced that the first patient has been enrolled and dosed in Taiwan as part of its Phase 2 HARMONIC™ clinical trial. The trial is evaluating LP-300 in never-smoker patients with non-small cell lung cancer (NSCLC) who have experienced disease progression after treatment with tyrosine kinase inhibitors (TKIs). This milestone is especially important because over 50% of lung cancer cases in Taiwan occur in never-smokers—a group that shows unique clinical and genetic characteristics compared to smokers. The expansion into Taiwan is part of a broader strategy to advance the trial in Asia, where never-smoker NSCLC cases are more common than in Western populations. Multiple sites across Taiwan are now screening patients, highlighting the region’s potential to accelerate enrollment and address a critical unmet need for targeted cancer therapies. The trial aims to enroll up to 90 patients across two treatment arms.
Read Announcement- Drug:
- LP-300 + Chemotherapy (Harmonic)
- Announced Date:
- November 19, 2024
- Indication:
- Never Smokers with Non-Small Cell Lung Cancer (NSCLC)
Announcement
Lantern Pharma Inc announced that the first patient has been dosed – as part of the expansion cohort – in Japan for its Phase 2 HARMONIC™ clinical trial evaluating LP-300 in never-smoker patients with non-small cell lung cancer (NSCLC) who have progressed after receiving treatment with tyrosine kinase inhibitors (TKIs).
AI Summary
Lantern Pharma Inc. has reached an important milestone by dosing the first patient in Japan as part of the expansion cohort of its Phase 2 HARMONIC™ clinical trial. This trial is evaluating LP-300, a potential new treatment option for never-smoker patients with non-small cell lung cancer (NSCLC) who have progressed after receiving tyrosine kinase inhibitors (TKIs). The study is significant for Asia, where never-smoker NSCLC cases occur at much higher rates—up to 33-40% in Japan—compared to Western regions.
Conducted at five sites across Japan, including the prestigious National Cancer Center Japan, the HARMONIC™ trial aims to address the unmet need in these patients by offering an alternative treatment strategy. With active patient screening already underway at multiple sites in Japan and Taiwan, Lantern Pharma’s expansion into the region is expected to accelerate patient enrollment and potentially improve survival outcomes for this specific patient population.
Read Announcement- Drug:
- LP-300 + Chemotherapy (Harmonic)
- Announced Date:
- August 5, 2024
- Indication:
- Never Smokers with Non-Small Cell Lung Cancer (NSCLC)
Announcement
Lantern Pharma announced positive, preliminary results from the initial patient group in the ongoing HARMONIC™ phase 2 clinical trial.
AI Summary
Lantern Pharma announced positive, preliminary results from the first group of patients enrolled in its ongoing HARMONIC™ Phase 2 clinical trial. This study focuses on never-smokers with lung adenocarcinoma whose tumors have developed resistance to tyrosine kinase inhibitors (TKIs). In this early lead-in group of seven patients, six experienced clinical benefit from the combination of LP-300 with standard chemotherapy. Among these, three patients had a partial response with an average tumor size reduction of 51%, while the other three maintained stable disease with an average reduction of 13%. The overall clinical benefit rate was 86% and the objective response rate was 43%. Importantly, the safety profile was predictable, with no dose limiting toxicities or treatment-related serious adverse events observed. These encouraging initial findings suggest that LP-300 may help overcome treatment resistance and improve outcomes for this challenging patient subgroup.
Read Announcement- Drug:
- LP-300 + Chemotherapy (Harmonic)
- Announced Date:
- April 22, 2024
- Indication:
- Never Smokers with Non-Small Cell Lung Cancer (NSCLC)
Announcement
Lantern Pharma Inc. announced that that – the company has received regulatory approval to expand its Harmonic™ trial, a Phase 2 clinical study evaluating LP-300 in non-small cell lung cancer (NSCLC) in never-smokers in both Japan and Taiwan.
AI Summary
Lantern Pharma Inc. announced that it has received regulatory approval to expand its Harmonic™ trial into Japan and Taiwan. This Phase 2 study evaluates the investigational drug LP-300 in treating non-small cell lung cancer (NSCLC) among never-smokers—a significant and growing population in East Asia, where almost one-third of NSCLC patients have never smoked.
The trial will assess the overall and progression-free survival of patients treated with LP-300 alongside standard chemotherapy. Dr. Yashushi Goto from the National Cancer Center of Japan, a renowned lung cancer expert, will serve as a lead investigator in Japan, underscoring the promise of LP-300 for patients with specific driver mutations who have limited treatment options after other therapies fail. This expansion is expected to accelerate data collection and support further development of LP-300 in the Asian market.
Read Announcement
RADR FDA Regulatory Events
RADR is a drug developed by Lantern Pharma for the following indication: AI platform to accelerate and optimize the development of antibody-drug conjugates (ADCs).
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:
- RADR
- Announced Date:
- January 27, 2025
- Indication:
- AI platform to accelerate and optimize the development of antibody-drug conjugates (ADCs).
Announcement
Lantern Pharma Inc. announced advancements in the application of its RADR® AI platform to accelerate and optimize the development of antibody-drug conjugates (ADCs).
AI Summary
Lantern Pharma Inc. has announced significant developments with its RADR® AI platform aimed at speeding up the creation of antibody-drug conjugates (ADCs), which are innovative cancer treatments combining antibodies with potent drugs. This new advancement leverages AI to sift through large amounts of complex biological data, helping to quickly and accurately identify promising ADC targets and payload molecules. By integrating diverse data types and mutation profiles, the platform can pinpoint more effective therapeutic combinations, potentially reducing the time and cost involved in ADC development by up to 50% and 60% respectively. These improvements could pave the way for more targeted, safer treatments for cancer patients while opening up new opportunities for pharmaceutical partnerships and drug innovation in the growing ADC market.
Read Announcement
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