MELBOURNE, Australia and INDIANAPOLIS, June 23, 2025 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, “Telix”, “the Company”) today announces that the United States (U.S.) Food and Drug Administration (FDA) has approved a label expansion for Illuccix® (kit for the preparation of gallium Ga-68 gozetotide, for injection) to include patient selection for radioligand therapy (RLT) in the pre-taxane setting. The update applies to Illuccix’s third indication, for selection of patients who ...

Lantheus (LNTH) FY Conference June 10, 2025 02:40 PM ET Speaker0 Following session is not open to the press. Okay. Speaker1 Good afternoon, everyone. I'm Paul Choi, and I cover the biotechnology sector here at the firm at Goldman Sachs. It's my pleasure to welcome Lampius. Joining me on stage to my immediate left is Brian Markinson, CEO, and Bob Marshall to my far left. What I'll do is turn it over to Brian maybe for some introductory or overview comments and then we'll get into Q and A after that. Speaker0 ...

Core Insights - Novartis announced positive topline results from the Phase III PSMAddition trial, demonstrating a significant benefit in radiographic progression-free survival (rPFS) for Pluvicto™ in combination with standard of care (SoC) compared to SoC alone in patients with PSMA-positive metastatic hormone-sensitive prostate cancer (mHSPC) [2][4][7] Group 1: Trial Results - The PSMAddition trial met its primary endpoint with a statistically significant and clinically meaningful benefit in rPFS, along with a positive trend in overall survival (OS) [2][4] - The trial involved adult patients with PSMA-positive mHSPC, comparing the efficacy and safety of Pluvicto combined with SoC (androgen receptor pathway inhibitor therapy and androgen deprivation therapy) versus SoC alone [6][7] Group 2: Treatment Context - Most mHSPC patients eventually progress to metastatic castration-resistant prostate cancer (mCRPC), highlighting the need for new treatment options that can delay progression and improve OS [3] - Pluvicto is already approved for mCRPC and shows potential for earlier use in mHSPC, addressing significant unmet needs in hormone-sensitive prostate cancer [4][8] Group 3: Future Plans - Novartis plans to present the trial results at an upcoming medical meeting and will submit data for regulatory review in the second half of the year based on FDA feedback [5][7] - The company is expanding its portfolio of radioligand therapies (RLTs) for various advanced cancers and enhancing manufacturing capabilities to meet growing demand [9]

Summary of Molecular Partners Conference Call Company Overview - **Company**: Molecular Partners - **Focus**: Development of DARPins, small binding proteins for targeted therapies in oncology [4][5] Key Platforms and Pipeline - **DARPins Platforms**: - **Radiotherapy DARPin Platform**: Utilizes small size to deliver radioisotopes effectively [6] - **T Cell Engager Platform**: Capable of creating bispecific to tetraspecific DARPins targeting multiple tumor antigens [6] - **Clinical Candidates**: - **MPO-712 (DLL3)**: Expected to enter Phase 1 trials in the second half of the year, targeting small cell lung cancer [12][15] - **MPO-533**: Involved in an ongoing Phase 1 trial for acute myeloid leukemia (AML) [44] DLL3 and Small Cell Lung Cancer - **Target**: DLL3, a marker for neuroendocrine tumors, particularly expressed in small cell lung cancer [15] - **Clinical Need**: High unmet medical need in small cell lung cancer, which is often chemo-resistant [15][13] - **Phase 1 Trial**: Aiming to start in the second half of the year, with a focus on relapsed refractory patients [16][19] Radioligand Therapy Insights - **Advantages of DARPins**: Selected for targets that are not easily ligandable, providing a solution for over 70% of targets [9][10] - **Imaging and Dosimetry**: Early imaging data expected to inform dosing and therapeutic windows, with results anticipated in H2 [19][20] - **Lead-212**: Chosen for its short half-life and effective energy delivery, partnered with OranoMed for supply [31][34] MPO-533 and AML Trial Adjustments - **Targeting Strategy**: Trispecific and tetraspecific DARPins designed to target multiple antigens on AML cells [46] - **Trial Adjustments**: Shifted to more frequent dosing to improve patient exposure and response rates, achieving a 30% complete response rate in recent evaluations [51][52] Future Developments - **Switched DARPin Platform**: Aiming to develop smart drugs that utilize logic gating to enhance T cell engagement [58][61] - **Investor Interest**: The new platform is generating interest from potential investors and pharmaceutical partners [62] Additional Considerations - **Supply Chain Management**: OranoMed's ability to provide a consistent supply of Lead-212 is crucial for the success of the radioligand therapy [39][41] - **Regulatory Engagement**: Ongoing constructive discussions with regulators to ensure effective clinical trial designs [29][42] This summary encapsulates the key points discussed during the conference call, highlighting Molecular Partners' innovative approaches in oncology and their strategic focus on DARPins and radioligand therapies.

Positive IND-enabling data on MP0712 targeting DLL3, the most advanced Radio-DARPin program in co-development with Orano Med, entering clinical development in 2025 First preclinical data of novel targeted Radio-DARPin against mesothelin (MSLN), in co-development with Orano Med Additional preclinical proof-of-concept data on logic-gated CD3 Switch-DARPin T cell engager with CD2 co-stimulation ZURICH-SCHLIEREN, Switzerland and CONCORD, Mass., April 25, 2025 (GLOBE NEWSWIRE) -- Ad hoc announcement pursuant to ...