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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) 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.
Lantheus Holdings, Inc. (NASDAQ: LNTH) announced that CFO Bob Marshall will present at the 2020 Evercore ISI HealthCONx Conference on December 1 at 3:30 p.m. ET. The event will be accessible via a live webcast on the Company’s website, with a replay available for 30 days post-presentation. Lantheus is a leader in diagnostic and therapeutic agents, offering products like DEFINITY®, TechneLite®, AZEDRA®, and RELISTOR®. The Company is headquartered in North Billerica, Massachusetts, with additional offices across North America and Europe.
Lantheus Holdings, Inc. (NASDAQ: LNTH) has received FDA approval for its new product, DEFINITY Room Temperature (RT), a room-temperature stable formulation of the existing DEFINITY echocardiography agent. This innovation enhances portability for healthcare providers and addresses a growing need in imaging services. DEFINITY RT, activated using the VIALMIX RFID device, is expected to broaden its clinical use. The composition patent for DEFINITY RT expires in 2035, allowing for significant market presence. Lantheus aims to leverage its microbubble franchise for improved cardiac imaging.
Lantheus Holdings (NASDAQ: LNTH) announced FDA 510(k) clearance for its AI-enabled automated bone scan index (aBSI) on GE Healthcare's Xeleris platform. This approval is pivotal for enhancing diagnostic capabilities in managing advanced prostate cancer. The global licensing agreement allows GE Healthcare to integrate aBSI into its platform, with Lantheus receiving tiered licensing fees. The aBSI product, recognized for its clinical value, automates the detection of metastatic disease hotspots and aids clinical decisions. This partnership could expand Lantheus's reach in precision medicine.
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Lantheus Holdings, Inc. (NASDAQ: LNTH) announced executive presentations at two investor conferences in November 2020. The first is the Credit Suisse 29th Annual Virtual Healthcare Conference on November 11, at 9:30 AM ET, featuring CEO Mary Anne Heino and CFO Bob Marshall. The second is the Jefferies Virtual London Healthcare Conference on November 17, at 8:20 AM ET, with CFO Bob Marshall. Live webcasts will be available on the company's website, with replays accessible for 30 days post-event.
Lantheus Holdings (NASDAQ: LNTH) has announced a strategic collaboration with Insightec Ltd. to utilize its microbubbles with Insightec's investigational MR-guided Focused Ultrasound (MRgFUS) platform. This partnership aims to assess treatments for glioblastoma and neurodegenerative diseases by temporarily disrupting the blood-brain barrier to enhance chemotherapy delivery. Lantheus will supply microbubbles, while Insightec handles regulatory submissions and commercialization. The collaboration aligns with Lantheus' growth strategy in oncology and addresses significant unmet medical needs in aggressive cancer treatment.