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Lantheus Holdings, Inc. reports news on its radiopharmaceutical business, including diagnostic imaging agents, radiotherapeutic assets, regulatory decisions and financial results. The company organizes revenue around Radiopharmaceutical Oncology, Precision Diagnostics and Strategic Partnerships and Other Revenue, with products used by hospitals, independent imaging centers, government facilities and distribution partners in the United States and abroad.
Recurring updates include quarterly earnings, business guidance, FDA activity for products such as PYLARIFY TruVu, PYLARIFY, Lutetium Lu 177 Dotatate (PNT2003) and LNTH-2501, share repurchases, investor presentations and strategic updates involving radiodiagnostics and radiotherapeutic programs.
Lantheus Holdings (NASDAQ: LNTH) presented updated biochemical tumor marker data from its Phase 2 trial of AZEDRA® at ENDO 2021. The trial showed significant reductions in tumor biomarkers in patients with advanced pheochromocytoma and paraganglioma. Notably, 80% of patients had a reduction in Chromogranin A levels, with responses correlating with the study's endpoints. AZEDRA remains the first approved treatment for these conditions, with the data reinforcing its clinical utility. However, caution is advised due to potential severe side effects, including myelosuppression and radiation risks.
Lantheus Holdings (NASDAQ: LNTH) announced the publication of pivotal studies for PyL™, a PET imaging agent targeting prostate-specific membrane antigen (PSMA). Results from the OSPREY Phase 2/3 trial and the CONDOR Phase 3 trial were published in respected journals, indicating high predictive values for locating prostate cancer. The data supports FDA review for marketing authorization. The OSPREY trial achieved a specificity of 96-99% and sensitivity of 93-99%. The CONDOR trial reported a Correct Localization Rate of 84.8% to 87.0% and 63.9% of patients had treatment plan changes based on imaging results.
Lantheus Holdings reported Q4 2020 revenue of $94.2 million, an increase of 5.4% year-over-year, despite a full-year revenue decline of 2.3% to $339.4 million. The company faced a net loss of $3.4 million in Q4, down from a $10.5 million profit in Q4 2019. Adjusted EPS fell by 79.9% year-over-year to $0.07. The company expects Q1 2021 revenue between $85 million and $89 million and full-year guidance of $385 million to $400 million. Lantheus emphasizes ongoing growth and development following strategic acquisitions and FDA approvals in 2020.
Lantheus Holdings, (NASDAQ: LNTH), a leader in innovative imaging diagnostics and therapeutics, announced that Mary Anne Heino, President and CEO, along with Bob Marshall, CFO, will present at the 10th Annual SVB Leerink Global Healthcare Conference on February 26 at 3:00 p.m. ET. The live webcast can be accessed on Lantheus's website, with a replay available for 30 days. Lantheus offers a wide range of products, including DEFINITY® and TechneLite®, and operates globally with headquarters in North Billerica, Massachusetts.
Lantheus Holdings, Inc. (NASDAQ: LNTH) will host a conference call on February 25, 2021, at 4:30 p.m. ET to discuss its financial results for Q4 and the full year of 2020. The call can be accessed via telephone or through a live webcast at their website. Lantheus is recognized for its innovative imaging diagnostics and therapeutic solutions, offering products like DEFINITY®, TechneLite®, AZEDRA®, and RELISTOR®, aimed at serious medical conditions.
Lantheus Holdings, Inc. (NASDAQ: LNTH) announced that three abstracts related to its PSMA-targeted product candidates will be presented at the 2021 ASCO GU Virtual Meeting on February 11-13, 2021. These include two studies on PyL™, a PET/CT imaging agent for prostate cancer, and one on 1095, a radiopharmaceutical for metastatic castration-resistant prostate cancer. The studies focus on the efficacy and safety of these agents, showcasing Lantheus's commitment to advancing prostate cancer diagnostics and therapeutics.
Lantheus Holdings (NASDAQ: LNTH) announced the filing of a Drug Master File (DMF) with the FDA for NM-01, a PD-L1 imaging biomarker aimed at enhancing immuno-oncology clinical trials beginning in 2021. NM-01 is a proprietary radiopharmaceutical that detects PD-L1 expression in tumors, potentially improving patient evaluation for I/O therapies. The checkpoint inhibitor market, projected to grow from $25B in 2019 to $68B by 2026, highlights the relevance of this innovation. Lantheus licensed NM-01 from NanoMab Technology Limited and plans to support its use in clinical research.
Lantheus Holdings, Inc. (NASDAQ: LNTH) announced that the FDA has accepted the New Drug Application (NDA) for PyL™, a PSMA-targeted PET imaging agent for prostate cancer, granting it Priority Review. The PDUFA action date is set for May 28, 2021. The NDA is supported by data from pivotal studies OSPREY and CONDOR, showing significant improvements in diagnostic performance. Approximately 3,500 subjects have received PyL, which exhibits a favorable safety profile. The company aims to address the unmet need for reliable imaging in prostate cancer management.
Lantheus Holdings, Inc. (NASDAQ: LNTH) announced a strategic collaboration with POINT Biopharma, Inc. to advance cancer precision medicine. They will utilize Lantheus’ investigational PSMA-targeted PET imaging agent, PyL, in POINT's Phase 3 trial for metastatic castration-resistant prostate cancer (mCRPC). This partnership aims to enhance patient selection for therapy with POINT’s radioligand, 177Lu-PNT2002. Progenics Pharmaceuticals, a Lantheus subsidiary, will supply PyL at a predetermined price, underscoring the potential of combining diagnostics with therapy in cancer treatment.
Lantheus Holdings (NASDAQ: LNTH) announced a stock purchase agreement to sell its Puerto Rico radiopharmacy and PET manufacturing facility to PharmaLogic Holdings Corp for $18 million. This deal includes a long-term supply agreement, ensuring Lantheus continues supplying its nuclear medicine products in Puerto Rico. The transaction aims to streamline Lantheus' distribution model in the region and reinvest proceeds into its core businesses and product pipeline. The closing is expected in early Q1 2021, pending customary conditions.