Lantheus Holding Stock Price, News & Analysis

Lantheus and RefleXion Medical have partnered to develop and commercialize a system for real-time therapeutic guidance in prostate cancer treatment using piflufolastat F 18, a PSMA-targeted PET imaging agent. This collaboration aims to enhance the use of biology-guided radiotherapy (BgRT) via the RefleXion X1 platform, allowing precise radiation delivery to tumor sites. The agreement involves shared responsibilities and potential financial upside from this innovative approach, which could significantly impact treatment outcomes for prostate cancer patients.

Lantheus Holdings (NASDAQ: LNTH) announced promising results from the OSPREY trial regarding piflufolastat F 18, a PSMA-targeted PET imaging agent for high-risk prostate cancer. Data presented at the 2021 AUA Meeting showed that 26.9% of participants had detectable lymph node or distant metastases before definitive therapy. Furthermore, the imaging led to a change in management plans for 43.6% of patients, impacting surgical and radiation therapy recommendations. The trial demonstrated 95-98% specificity but lower sensitivity (28-39%). Overall, piflufolastat F 18 presents significant potential to influence treatment decisions.

Lantheus (NASDAQ: LNTH) has announced that Mary Anne Heino, President and CEO, and Bob Marshall, CFO and Treasurer, will present at upcoming investor conferences. The presentations will take place at the Wells Fargo 2021 Virtual Healthcare Conference on September 9, 2021, and at the Baird 2021 Global Healthcare Conference on September 15, 2021. Investors can access a live webcast of these presentations via Lantheus's website, with replays available for 30 days post-event.

Lantheus Holdings announced that its subsidiary, EXINI Diagnostics AB, received FDA 510(k) clearance for its digital application, aPROMISE™, designed for prostate cancer imaging. This AI-based software enhances efficiency and consistency in PSMA PET/CT assessments, utilizing deep learning algorithms trained on over 3,000 images. The application is intended for healthcare professionals to improve the quantification and reporting of prostate cancer lesions. This follows the recent FDA approval of PYLARIFY®, a PSMA-targeted PET imaging agent, enhancing Lantheus's prostate cancer diagnostic capabilities.

Lantheus Holdings, Inc. (LNTH) reported Q2 2021 revenue of $101.1 million, marking a 53.1% increase from Q2 2020. However, the company posted a GAAP net loss of $26.7 million, compared to $7.0 million in the prior year. Adjusted EPS slightly rose to $0.11 from $0.10. Free Cash Flow jumped to $23.2 million, an increase of approximately $27.6 million year-over-year. The FDA approved PYLARIFY, enhancing their product portfolio. Revised guidance for FY 2021 estimates revenue between $395 million and $402 million.

Lantheus Holdings, Inc. (NASDAQ: LNTH) will host a conference call and webcast on July 28, 2021, at 8:00 a.m. ET to discuss its Q2 2021 financial and operational results. Investors can join the call by dialing U.S. 1-866-498-8390 or international 1-678-509-7599, using passcode 6149638. The live webcast will be accessible on the company's website, with a replay available after the call and archived for 30 days. Lantheus specializes in innovative imaging diagnostics and therapeutics, offering a broad product portfolio, including DEFINITY®, PYLARIFY®, and RELISTOR®.

Lantheus Holdings (NASDAQ: LNTH) announced data from the CONDOR pivotal trial on piflufolastat F 18 (18F-DCFPyL), presented at the Virtual Society of Nuclear Medicine and Molecular Imaging meeting. Dr. Steven Rowe from Johns Hopkins University delivered an oral presentation on June 15, 2021, analyzing disease detection rates and positive predictive values (PPV) in men with biochemically recurrent prostate cancer. The trial revealed high PPV and median detection rates for various anatomic regions, validating PYLARIFY's efficacy in detecting metastatic lesions.

Lantheus has received FDA approval for PYLARIFY, the first PSMA-targeted PET imaging agent for prostate cancer, marking a major advancement in oncology diagnostics. The agent enhances detection of suspected metastasis and recurrence, enabling timely treatment decisions. PYLARIFY is anticipated to be available across the U.S. by year-end following its immediate rollout in select regions. The approval is supported by pivotal studies showing high specificity and localization rates, making PYLARIFY a vital tool for managing prostate cancer.

Lantheus Holdings (NASDAQ: LNTH) announced a poster presentation of data from its Phase 3 CONDOR study at the ASCO Virtual Meeting from June 4-8, 2021. The session will focus on PSMA-targeted imaging in patients with biochemically recurrent prostate cancer, highlighting the correct localization rate and positive predictive value.

Presenter Frederic Pouliot, M.D., Ph.D., from CHU de Québec-Université Laval will showcase abstract No. 5023. Lantheus is a leader in imaging diagnostics and therapeutics, providing a broad portfolio aimed at serious medical conditions.