Brian Markison to Retire as Chief Executive Officer; Board Conducting Search for Next CEO Continued Execution of Company’s Strategy to be Led by Prior CEO Mary Anne Heino as Executive Chairperson BEDFORD, Mass., Nov. 06, 2025 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. (the “Company”) (NASDAQ: LNTH), the leading radiopharmaceutical-focused company committed to enabling clinicians to Find, Fight and Follow disease to deliver better patient outcomes, today announced that Chief Executive Officer Brian Markis ...

Core Insights - The FDA has set a Prescription Drug User Fee Act (PDUFA) date of March 29, 2026, for Lantheus Holdings' LNTH-2501, a diagnostic kit for neuroendocrine tumors [1][2] Company Overview - Lantheus Holdings, Inc. is a leading radiopharmaceutical-focused company dedicated to improving patient outcomes through innovative diagnostic solutions [5] - The company has been providing radiopharmaceutical solutions for nearly 70 years and operates globally with offices in multiple countries [5] Product Details - LNTH-2501 (Gallium-68 edotreotide) is designed for use with positron emission tomography (PET) imaging to localize somatostatin receptor-positive neuroendocrine tumors (SSTR+ NETs) in both adult and pediatric patients [1][4] - The product is submitted under the FDA's 505(b)(2) pathway, supported by extensive evidence from multiple published studies [2][4] - If approved, LNTH-2501 may complement Lantheus' therapeutic candidate PNT2003, enhancing the company's strategy for integrated diagnostic and therapeutic solutions [4] Market Context - Neuroendocrine tumors (NETs) are rare cancers, with over 170,000 individuals in the U.S. living with these conditions, and gastroenteropancreatic NETs (GEP-NETs) account for 55-70% of cases [3] - Due to their slow growth and non-specific symptoms, up to 50% of NETs are initially misdiagnosed, leading to delays in treatment [3]

NASDAQ: RADX / ASX: RAD CLINICAL UPDATE AND CAPITAL RAISING OCTOBER 20th , 2025 For personal use only Notice & Disclaimer The information in this presentation does not constitute personal investment advice. The presentation is not intended to be comprehensive or provide all information required by investors to make an informed decision on any investment in Radiopharm Theranostics Ltd ACN 647 877 889 (Company). In preparing this presentation, the Company did not take into account the investment objectives, f ...

Core Insights - ITM Isotope Technologies Munich SE has appointed Annette Breunig as Chief People Officer to enhance its human resources strategy and support organizational growth [1][2] - Breunig has over 25 years of HR leadership experience in international pharmaceutical and technology companies, including Siemens AG and Sanofi [1][2] - The company aims to improve outcomes for cancer patients through innovative radiopharmaceuticals, with a focus on employee empowerment and company culture [2][3] Company Overview - ITM is a leading radiopharmaceutical biotech company dedicated to developing therapeutics and diagnostics for hard-to-treat tumors [4] - The company is advancing a precision oncology pipeline, including multiple Phase 3 studies, to provide more effective targeted treatments [4] - ITM leverages two decades of expertise and a global network to improve clinical outcomes and quality of life for patients [4]

Core Insights - Lantheus Holdings and GE HealthCare have entered into an exclusive licensing agreement for the development, manufacturing, and commercialization of piflufolastat F18 (PYLARIFY) in Japan for prostate cancer diagnostics [1][2] - The partnership aims to enhance the reach of PYLARIFY in international markets, particularly in Japan, which has the third highest number of prostate cancer cases globally [3][4] - GE HealthCare will leverage its manufacturing network and R&D expertise, especially following its acquisition of Nihon Medi-Physics Co., Ltd. in March 2025 [2][3] Company Overview - Lantheus is a leading radiopharmaceutical-focused company, providing solutions for nearly 70 years, with a mission to improve patient outcomes through innovative diagnostics [19] - GE HealthCare is a global healthcare solutions provider with a focus on medical technology and pharmaceutical diagnostics, serving patients and providers for over 125 years [20] Product Information - PYLARIFY is a PSMA-targeted PET imaging agent approved by the FDA in 2021, and it has been utilized in over 500,000 scans across the U.S. [4] - The product is designed to visualize lymph nodes, bone, and soft tissue metastases in men with prostate cancer, combining the accuracy of PET imaging with the precision of PSMA targeting [5] Financial Terms - Under the agreement, GE HealthCare will pay Lantheus an upfront license fee, development milestones, and tiered royalties based on product sales in Japan [2][3]

Core Insights - Telix Pharmaceuticals Limited is recognized as one of the most oversold healthcare stocks in 2025, focusing on precision oncology and targeted radiotherapies with active clinical programs in prostate cancer and rare oncologic conditions [1] Financial Performance - In the 2025 half-year update, Telix reported a 30% revenue increase in its Precision Medicine segment, driven by strong demand for its PET imaging agent, Illuccix, and the launch of new products like Gozellix, Zircaix, and Pixclara in international markets [2] - The company has expanded its manufacturing capabilities through Telix Manufacturing Solutions to support clinical and commercial operations globally [2] Research and Development - Telix increased its R&D spending by 47% year-over-year to $81.6 million, continuing to invest in its therapeutics pipeline despite being oversold [3] - Key milestones include the completion of target enrollment for the Phase 3 TLX591 trial in advanced metastatic castration-resistant prostate cancer (mCRPC), initiation of a Phase 1 trial for TLX592, and the start of the pivotal IPAX BrIGHT trial for TLX101 in metastatic brain cancer [3][4] - The company also gained IND approval for a Phase 1 study of TLX090 to manage bone pain in osteoblastic metastatic disease [3] Strategic Positioning - Diagnostic growth is further supported by the dosing of the first patient in the pivotal Phase 3 BiPASS trial, aimed at expanding indications for Illuccix and Gozellix in prostate cancer imaging [4] - Telix's dual strategy of commercial expansion and clinical innovation positions it as a leader in radiopharmaceuticals and precision oncology globally [4]

Company Overview - Lantheus Holdings, Inc. is a leading radiopharmaceutical-focused company dedicated to enabling clinicians to Find, Fight, and Follow disease for improved patient outcomes [3] - The company has been providing radiopharmaceutical solutions for nearly 70 years and is headquartered in Massachusetts, with additional offices in New Jersey, Canada, Germany, Sweden, and Switzerland [3] Upcoming Event - Brian Markison, the Chief Executive Officer of Lantheus, will present at the Morgan Stanley 23rd Annual Global Healthcare Conference on September 9 at 7:00 a.m. ET [1] - A live webcast of the presentation will be accessible through the Investors section of the company's website, with a replay available for at least 30 days post-event [2]

Financial Data and Key Metrics Changes - Group revenues improved by 63% year on year, reaching $390 million, driven by growth in Elucix and the addition of third-party revenue from RLS [7][8][9] - Precision medicine revenues increased by 30% year on year, with EBITDA improving by 24% [7][8] - Gross margins in the precision medicine business remained stable at 64%, while the group's gross margin was 53% [8][11] Business Line Data and Key Metrics Changes - The precision medicine business saw a revenue increase of 29%, with adjusted EBITDA improving by $20 million year on year [12][13] - RLS contributed $79 million in revenues, with gross margins at 7% [14][15] - Selling and marketing expenses increased to 13% of revenue from 10% last year, reflecting preparations for product and geographic expansion [11] Market Data and Key Metrics Changes - The company secured marketing authorizations for Elucix in over 23 countries, with ongoing launches in key markets like France, Germany, Italy, and Spain [42][43] - The global rollout of Elucix is progressing well, with strong uptake in the UK following its launch [41][42] Company Strategy and Development Direction - The company is focused on four strategic pillars: expanding precision medicine, delivering on late-stage therapeutics, building a next-generation pipeline, and expanding global delivery infrastructure [4][17] - The acquisition of RLS is seen as a strategic investment to enhance US presence and improve manufacturing capabilities [27][31] - The company aims to transition from a single product to a multi-product, multi-region organization, leveraging its global infrastructure for future therapeutic rollouts [23][26] Management's Comments on Operating Environment and Future Outlook - Management emphasized the importance of maintaining operational efficiency and investing in R&D to support long-term growth [8][19] - The company is committed to building long-term asset value rather than optimizing near-term EPS growth, focusing on strategic investments to unlock the full potential of its pipeline [19][20] - Management expressed confidence in the company's ability to navigate the current operating environment and continue delivering value to shareholders [74] Other Important Information - The company is responding to an SEC subpoena regarding disclosure activities related to prostate cancer therapeutic candidates, clarifying that there are no allegations or charges against the company [36] - The company is focused on maintaining a healthy cash position, ending the half-year with $27 million in cash on hand [8][16] Q&A Session Summary Question: Outlook for gross margins and impact of PSMA pricing changes - Management noted that Elucix's gross margin remained consistent at 64%, while RLS achieved a 7% gross margin [79][80] - The integration of RLS is expected to improve gross margins as more Elucix products are distributed through the RLS network [81] Question: Guidance and growth of Elucix moving forward - Management confirmed that July 1 marked the end of pass-through status for one product, but reported 7% growth quarter on quarter in volume [86][87] - The company is implementing a stabilization strategy to bridge the gap between products coming off and gaining reimbursement [88][89] Question: Launch readiness for Zurkayx - The commercial team is prepared for the launch, leveraging existing customer relationships from Elucix [94][96] - An expanded access program has been successful, indicating strong market readiness for Zurkayx [95][96]

Company Overview - IBA (Ion Beam Applications S.A.) is the world leader in particle accelerator technology and a leading supplier of equipment and services in proton therapy, which is the most advanced form of radiation therapy available today [6] - The company is also a key player in industrial sterilization, radiopharmaceuticals, and dosimetry [6] - IBA is based in Louvain-la-Neuve, Belgium, and employs approximately 2,100 people worldwide [6] - The company is listed on the pan-European stock exchange EURONEXT [7] Upcoming Financial Results - IBA will publish its consolidated results for the half year 2025 on Thursday, 28 August 2025 at 7am CEST [2] - A conference call and webcast will be hosted by IBA's management team on the same day at 3pm CEST, which will include a Q&A session [3] - The presentation will be available on IBA's investor relations website shortly before the call [4]

Core Viewpoint - Lantheus Holdings, Inc. will host a conference call and webcast on August 6, 2025, to discuss its financial results and provide a business update for the second quarter of 2025 [1]. Group 1: Conference Call Details - The conference call and webcast will take place at 8:00 a.m. ET on August 6, 2025 [1]. - Participants can register online to access the conference call or webcast, with a recommendation to register fifteen minutes in advance to avoid delays [2]. - A replay of the webcast will be available approximately two hours after its completion and will be archived for at least 30 days [2]. Group 2: Company Overview - Lantheus is a leading company focused on radiopharmaceuticals, aiming to improve patient outcomes by enabling clinicians to Find, Fight, and Follow disease [3]. - The company has been providing radiopharmaceutical solutions for nearly 70 years and is headquartered in Massachusetts, with additional offices in New Jersey, Canada, Germany, Switzerland, and Sweden [3].