Monte Rosa Therapeutics Announces Clinical Supply Agreement to Support Phase 2 Trial Evaluating MRT-2359 in Combination with Apalutamide for the Treatment of Metastatic Castration-Resistant Prostate Cancer

On March 16, 2026 Monte Rosa Therapeutics, Inc. (Nasdaq: GLUE), a clinical-stage biotechnology company developing novel molecular glue degrader (MGD)-based medicines, reported the company has entered into a supply agreement with Johnson & Johnson to evaluate MRT-2359 in combination with ERLEADA (apalutamide) for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC) with androgen receptor (AR) mutations in a planned Phase 2 study expected to initiate in the third quarter of 2026. MRT-2359 is an investigational, orally bioavailable, GSPT1-directed MGD discovered and developed by Monte Rosa. ERLEADA is an AR inhibitor developed by Janssen Research and Development, LLC, indicated for the treatment of patients with metastatic castration-sensitive prostate cancer (mCSPC) and patients with non-metastatic castration-resistant prostate cancer (nmCRPC).

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Under the terms of the agreement, Monte Rosa will conduct and sponsor the trial and Johnson & Johnson will provide ERLEADA as part of a supply agreement.

"We are pleased to enter into this supply agreement with Johnson & Johnson to further explore the potential of MRT-2359 in combination with next-generation AR inhibitors such as apalutamide in patients with advanced prostate cancer," said Markus Warmuth, M.D., Chief Executive Officer of Monte Rosa Therapeutics. "Based on the compelling clinical activity observed to date in heavily pretreated patients with AR mutations, we believe this combination approach holds significant promise. Data generated from these studies have the potential to further confirm MRT-2359’s clinical activity and may position the program for advancement into registrational studies, representing an important step forward for prostate cancer patients with limited therapeutic options for this respective patient population."

The planned Phase 2 study of up to 25 mCRPC patients is designed to efficiently assess the efficacy and safety of MRT-2359 plus ERLEADA in mCRPC patients with AR mutations, with potential to expand the study into additional patient subsets, including patients naïve to next-generation AR inhibitors, should the activity in the AR mutant patient population confirm. The study will evaluate PSA response, RECIST response, duration of response, progression-free survival (PFS), radiographic progression-free survival (rPFS), and safety.

Monte Rosa recently announced additional, positive data from the company’s ongoing Phase 1/2 clinical study evaluating MRT-2359 in combination with enzalutamide in heavily pretreated patients with mCRPC. The data were presented at the 2026 ASCO (Free ASCO Whitepaper) Genitourinary (GU) Cancers Symposium on February 26, 2026.

About MRT-2359
MRT-2359 is a potent, highly selective, and orally bioavailable investigational molecular glue degrader (MGD) of GSPT1. MYC-driven cancers, including prostate cancer, depend on enhanced translation of oncoproteins to support rapid growth. MRT-2359 exploits this therapeutic vulnerability by disrupting translation through selective degradation of the translation termination factor GSPT1. MRT-2359 treatment reduced cellular abundance of many prostate cancer-relevant oncoproteins, including AR, MYC, and Cyclin D1-E2F, and demonstrated robust anti-tumor activity across multiple preclinical models of metastatic castration-resistant prostate cancer (mCRPC). MRT-2359 in combination with the AR inhibitor enzalutamide is being investigated in an ongoing Phase 1/2 study (clinicaltrials.gov identifier NCT05546268) in patients with mCRPC. In heavily pretreated mCRPC patients, MRT-2359 plus enzalutamide demonstrated encouraging early signals of clinical response.

(Press release, Monte Rosa Therapeutics, MAR 16, 2026, View Source [SID1234663586])

Nerviano Medical Sciences S.r.l. Announces Discontinuation of the Clinical Trial to Evaluate NMS-153 in combination with checkpoint inhibitor/cancer immunotherapy due to Lack of Efficacy in Immune Treatment Experienced Patients.

On March 16, 2026 Nerviano Medical Sciences S.r.l. (NMS), a global oncology-focused biopharmaceutical company reported that it is discontinuing its Phase 2 clinical study1 of the investigational Monopolar Spindle 1 (MPS1) inhibitor NMS-153 for the treatment of immune-experienced hepatocellular cancer patients in combination with atezolizumab (Tecentriq).

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The trial confirmed favorable safety profile, but no favorable overall benefit-risk profile. The novel anti-cancer mechanism targeting the mitotic checkpoint showed prior monotherapy activity, likely involving innate immunity, but in this more immune-experienced population the effects seem to be less strong," noted Lisa Mahnke, MD, PhD, Chief Medical Officer of NMS. "The mitotic checkpoint kinase mechanism of NMS-153 is unique, and NMS remains committed to developing novel therapeutics that can address unmet medical needs in cancer," stated Hugues Dolgos, PharmD, CEO of NMS.

With the closure of this Phase 2 trial, NMS has decided to discontinue further development of the NMS-153 program.

Phase II Combination Study of NMS-01940153E and Atezolizumab with or without a prior priming with low dose decitabine for the Treatment of Adult Patients with Unresectable Hepatocellular Carcinoma (HCC) Previously Treated with Immune Checkpoint Inhibitors" (EUCT Number: 2024-516737-12-00)
About NMS-153

NMS-153 is a potent, highly selective small-molecule inhibitor of MPS1 (TTK) with a dual anti-cancer mechanism, inducing mitotic catastrophe and apoptosis while potentially activating anti-tumor immunity via the cGAS/STING pathway. It shows prolonged target engagement and broad in vivo activity as a single agent and in combination therapies. In January 2024, the FDA granted Orphan Drug designation for the treatment of hepatocellular carcinoma (HCC).

About NMS

NMS is a global, integrated biopharmaceutical company focused on the discovery and development of innovative oncology therapies. With affiliates in Nerviano/Corsico (Italy), Boston (USA), and Shanghai (China). NMS leverages deep expertise in drug discovery and translational medicine to advance a pipeline of novel candidates from bench to bedside.

(Press release, Nerviano Medical Sciences, MAR 16, 2026, View Source [SID1234663569])

Perspective Therapeutics Provides Recent Business Highlights and Reports Full Year 2025 Results

On March 16, 2026 Perspective Therapeutics, Inc. ("Perspective," the "Company," "we," "us," and "our") (NYSE AMERICAN: CATX), a radiopharmaceutical development company pioneering advanced treatments for cancers throughout the body, reported a business update and announced full year results for the year ended December 31, 2025.

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"The rich flow of data readouts in 2026 reflects years of dedication by our team to develop transformational new treatment options for patients in need of more choices," said Thijs Spoor, Perspective’s CEO. "We look forward to evaluating how these results will inform next steps for advancing our lead program VMT-α-NET and contribute to our understanding of the broader potential of our proprietary next-generation targeted radiopharmaceutical technology."

Advancing the current clinical pipeline

VMT-α-NET

We are conducting a multi-center, open-label, dose-finding study (clinicaltrials.gov identifier NCT05636618) of [212Pb]VMT-α-NET in patients with unresectable or metastatic somatostatin receptor type 2 (SSTR2)-positive neuroendocrine tumors (NETs) who have not received prior radiopharmaceutical therapies (RPT).

Updated interim data from the study, as of a data-cut off (DCO) date of December 10, 2025, were presented at the 2026 ASCO (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium ("ASCO-GI 2026"). Highlights from the updated analysis included the following:

Safety findings based on 56 patients who received at least one treatment:

The 56 patients in this safety analysis comprised 2 patients in Cohort 1 (2.5 mCi), 46 patients in Cohort 2 (5.0 mCi), and 8 patients in Cohort 3 (6.0 mCi).
There were no reports of dose limiting toxicities (DLTs), treatment-related discontinuations, serious renal complications, dysphagia, or clinically significant treatment-related myelosuppression.
Grade 3 or higher treatment-emergent adverse events were reported in 21 patients (37.5%). One of these patients, who was enrolled in Cohort 3, experienced a transient Grade 4 event (lymphocyte count decrease). This event was transient and resolved without medical intervention. The patient continues to receive [212Pb]VMT-α-NET treatment. There were no Grade 5 events.
Serious adverse events were reported in 5 patients, with none deemed related to the study medication.
Anti-tumor activity reported at ASCO (Free ASCO Whitepaper)-GI in January 2026, based on both patients in Cohort 1 and 23 (half) of the patients enrolled in Cohort 2:

Updated efficacy analysis in the same 25 patients from ESMO (Free ESMO Whitepaper) Congress 2025 ("ESMO 2025") in October 2025 was presented with an additional ~13 weeks of follow-up since the previous presentation at ESMO (Free ESMO Whitepaper) 2025.
19 of the 25 patients (76%) were without progression and remained alive, including both patients in Cohort 1.
Nine (39%) patients in Cohort 2 were observed to have response according to investigator-assessed RECIST v1.1. Eight (35%) of those responses were confirmed and previously reported at ESMO (Free ESMO Whitepaper) 2025. One additional patient experienced an initial response in their most recent tumor assessment after the prior update at ESMO (Free ESMO Whitepaper) 2025. As the patient remains on study, the patient is expected to receive a subsequent tumor assessment.
Seven patients were observed to have deepening of best response, including one patient with stable disease.
As of February 28, 2026, the first 23 patients in Cohort 2 would have had the opportunity for at least 48 weeks of follow-up since beginning treatment. By mid-2026, we expect all 46 patients in Cohort 2 would have had the opportunity for at least 48 weeks of follow-up since beginning treatment.

Cohort 3 opened in June 2025 after alignment was reached with the FDA, as previously agreed prior to the initiation of this study in 2023. Patients in Cohort 3 are receiving up to four fixed administered doses of [212Pb]VMT-α-NET at 6.0 mCi, every eight weeks, if they weigh more than 60kg (133lb), or 100μCi/kg of body weight if they weigh less than or equal to 60kg.

After the opening of Cohort 3 was announced in June 2025, eight Cohort 3 patients commenced treatment and contributed to dose-limiting toxicity (DLT) assessment by a safety monitoring committee (SMC). The DLT assessment is now complete, and we are cleared to treat more patients at this dose, with an additional eight patients already treated as of February 28, 2026, for a total of 16 patients in Cohort 3.

By mid-2026, the eight DLT patients in Cohort 3 would have had the opportunity for at least 32 weeks of follow-up since beginning treatment, sufficient time to have completed at least one scan following the full course of treatment.

We believe our clinical data package positions us for meaningful regulatory engagement in 2026 to align on the path forward.

During the dose finding phase of the study, we enrolled primarily NETs patients whose disease originated in the pancreas or the digestive track. We have allowance for enrollment of NETs patients whose disease originated in the lung (of which small cell lung cancer is a subset), and pheochromocytoma/paraganglioma NETs, as well as SSTR2+ meningioma.

VMT01

VMT01 is a MC1R-targeted RPT that can be radiolabeled with either 203Pb for patient selection and dosimetry assessments, or 212Pb for alpha particle therapy.

We are conducting a multi-center, open-label, dose-finding study (clinicaltrials.gov identifier NCT05655312) in heavily pre-treated patients with histologically confirmed melanoma and MC1R-positive imaging scans.

Most recently, patients have received treatments at 3.0 mCi, either as monotherapy or in combination with nivolumab, a PD-1 blocking antibody developed and marketed by Bristol Myers Squibb as Opdivo.

Since dosing re-opened for 3.0 mCi of VMT01 as monotherapy, and was initiated for 3.0 mCi of VMT01 in combination with nivolumab in September 2025, 10 patients had received VMT01 3.0 mCi treatment as of February 28, 2026; six patients had received VMT01 at 3.0 mCi in combination with nivolumab, and four patients had received 3.0 mCi of VMT01 as monotherapy, in addition to the three patients who received this monotherapy dose in late 2023. Both cohorts are now closed for enrollment.

By late 2026, the 10 patients who had received VMT01 3.0 mCi treatment since the initiation or re-opening of these cohorts in September 2025 would have had the opportunity for at least 24 weeks of follow-up after their initial doses, sufficient time to have completed at least one scan after the full course of treatment (up to three doses every eight weeks).

PSV359

We designed PSV359 to target and deliver 212Pb to tumor sites expressing fibroblast activation protein-α, or FAP-α, associated with multiple highly prevalent solid tumors, with patients in need of additional treatment options. The targeting moiety may also be radiolabeled with 203Pb or 68Ga and 64Cu to detect FAP-α expression in individual patients. Preclinical imaging and therapy as well as human imaging results suggest our proprietary targeting ligand has improved levels of target engagement and uptake in tumors, as well as reduced retention in healthy tissues, which may result in a desirable therapeutic index.

As of February 28, 2026, two patients in Cohort 1 had been treated with [212Pb]PSV359 at 2.5 mCi, and six patients in Cohort 2 had been treated at 5.0 mCi, for a total of eight patients. By late 2026, these patients would have had the opportunity for at least 32 weeks of follow-up after their initial doses, sufficient time to have completed at least one scan after the full course of treatment (up to four doses every eight weeks). Activation activities are underway for additional sites.

Updates to the preclinical pipeline

Our discovery team is preparing additional novel constructs for potential first-in-human (FIH) imaging. If and when those constructs meet our criteria for further development, we plan to proceed with pre-IND filing activities. During the fourth quarter of 2025, we decided not to pursue further development of one early-stage preclinical asset, while activities continue on multiple other preclinical assets.

Updates on manufacturing infrastructure

We continue to make progress on expanding our manufacturing capabilities by increasing and enhancing capacity at existing facilities and building out recently acquired sites.

Full Year 2025 Financial Summary

Cash, cash equivalents, and short-term investments as of December 31, 2025 were approximately $145 million as compared to $227 million as of December 31, 2024. In February 2026, we announced the closing of an underwritten offering of securities with net proceeds of approximately $164 million after deducting underwriting discounts and commissions and other offering-related expenses. We believe our cash, cash equivalents and short-term investments as of December 31, 2025, together with the net proceeds from the February 2026 offering, will be sufficient to fund our current clinical milestones and operational investments into late 2027.

As of December 31, 2025, we had approximately 74.3 million shares of common stock and approximately 10.9 million warrants and options to purchase shares of common stock outstanding. In connection with the February 2026 underwritten offering of securities noted above, we issued 39.6 million shares of common stock along with pre-funded warrants to purchase 6.6 million shares of common stock.

Grant revenue was $0.9 million for the year ended December 31, 2025, compared to approximately $1.5 million for the year ended December 31, 2024. Grant revenue is derived from our work with the National Institutes of Health.

Research and development expenses were $84.2 million for the year ended December 31, 2025, compared to $41.6 million for the year ended December 31, 2024, an increase of approximately 102%. The increase in research and development expenses was primarily related to increased clinical site activities, drug program costs and delivery costs along with higher personnel costs, including share-based compensation.

Research and development expenses additionally included a $10.0 million non-cash impairment loss for the three months ended December 31, 2025, in connection with our decision to deprioritize an early-stage preclinical asset within our in-process research and development portfolio. This early-stage preclinical asset was acquired as part of the merger between Viewpoint Molecular Targeting, Inc. and Isoray, Inc. in February 2023.

General and administrative expenses were $30.2 million for the year ended December 31, 2025, compared to $26.6 million for the year ended December 31, 2024, an increase of approximately 14%. The increase in general and administrative expenses for the year ended December 31, 2025 was primarily due to increased personnel costs, partially offset by decreased fees for professional services.

Total operating expenses for the year ended December 31, 2025 were $114.4 million (including a non-cash, one-time impairment loss for a preclinical asset of $10.0 million), compared to $92.3 million for the same period in 2024 (including a non-cash, one-time goodwill impairment charge of $24.1 million), an increase of approximately 24%.

Net loss for the year ended December 31, 2025 was $103.1 million, or $1.40 per basic and diluted share, compared to a net loss of $79.3 million, or $1.23 per basic and diluted share, for the same period in 2024. During the year ended December 31, 2025, there was a net benefit of $7.7 million in net interest income and other expense, compared to a net benefit of $10.5 million in net interest income and other expense during the year ended December 31, 2024.

(Press release, Perspective Therapeutics, MAR 16, 2026, View Source [SID1234663587])

Telix Resubmits NDA to U.S. FDA for TLX101-Px (Pixclara®) Brain Cancer Imaging Candidate

On March 16, 2026 Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, "Telix") reported the resubmission of a New Drug Application (NDA) to the United States (U.S.) Food and Drug Administration (FDA) for TLX101-Px, (Pixclara1, Floretyrosine F 18 or 18F-FET), an investigational PET2 imaging agent for the characterization of recurrent or progressive glioma (brain cancer) from treatment related changes in both adult and pediatric patients.

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Telix has resubmitted the NDA with the additional data requested by the FDA. The Company believes, based on the Type A meeting and ongoing consultation with the FDA, that the additional data and statistical analysis, along with the primary data set provided in the original submission, appropriately addresses the Complete Response Letter3.

Given the potential to address significant unmet medical need, TLX101-Px has been granted Orphan Drug4 and Fast Track5 designations by the FDA. PET imaging with 18F-FET is already included in international clinical practice guidelines for the imaging of gliomas6, however there is currently no FDA-approved targeted amino acid PET agent for adult and pediatric brain cancer imaging commercially available in the U.S.

Dr. David N. Cade, Telix Group Chief Medical Officer, said, "We appreciate the FDA’s recognition of the critical unmet need to improve the diagnosis and management of glioma, particularly in the post-treatment setting. Our resubmission is supported by an extensive and compelling data set – particularly so for an orphan indication. We are grateful to our global clinical collaborators, who share our commitment to ensuring patients in the U.S. can benefit from this important patient management tool."

Maggie Haynes, Executive Director, Head for the Cure Foundation, added: "Our community is encouraged by the FDA’s ongoing engagement and guidance to the sponsor and support for the Expanded Access Program for TLX101-Px. We are hopeful of an expedited review, so this important and proven imaging option can become available to those who urgently need it."

About TLX101-Px

TLX101-Px is a PET imaging agent, which has been granted fast track and orphan drug designations by the FDA as an imaging agent for the characterization of recurrent or progressive glioma from treatment related changes. TLX101-Px targets membrane transport proteins known as LAT1 and LAT27. This enables TLX101-Px to be potentially utilized as a companion diagnostic agent to TLX101-Tx (iodofalan 131I), Telix’s LAT1-targeting glioblastoma (GBM) therapy candidate, currently under investigation in the pivotal IPAX-BrIGHT study8.

About gliomas in the U.S.

Gliomas are very diffusely infiltrative tumors that affect the surrounding brain tissue. They are the most common form of central nervous system (CNS) neoplasm that originates from glial cells, accounting for approximately 30% of all brain and CNS tumors and 80% of all malignant brain tumors9. In the U.S., there are six cases of gliomas diagnosed per 100,000 people every year10. GBM is a high-grade glioma and the most common and aggressive form of primary brain cancer, with approximately 22,000 new cases diagnosed annually in the U.S.11. The mainstay of treatment for GBM comprises surgical resection, followed by combined radiotherapy and chemotherapy. Despite such treatment, recurrence occurs in almost all patients12, with an expected survival duration of 12-15 months from diagnosis.

(Press release, Telix Pharmaceuticals, MAR 16, 2026, View Source [SID1234663549])

Nerviano Medical Sciences Announces Presentation of Two Trial-in-Progress Posters for Itareparib at ESMO TAT 2026

On March 16, 2026 Nerviano Medical Sciences S.r.l. ("NMS"), a global oncology-focused biopharmaceutical company, reported the presentation of two Trial-in-Progress posters featuring Itareparib (NMS-03305293) at the ESMO (Free ESMO Whitepaper) Targeted Anticancer Therapies (TAT) Congress 2026, taking place March 16–18, 2026 in Paris, France.

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The presentations highlight ongoing clinical studies of Itareparib, NMS’s non-trapping, PARP1-specificinhibitor, the only third-generation inhibitor in clinical development. Itareparib is highly brain- and tumor-penetrant, providing an advantage for widely metastatic disease. Itareparib is being studied in combination with established DNA-damaging therapies in two areas of high unmet medical need: recurrent non-BRCA-mutated ovarian cancer and relapsed extensivestage small cell lung cancer (ES-SCLC), including patients with brain metastases.

The posters are:

Poster 57TiP – Phase 1a/1b Study of NMS-03305293 (Itareparib), a Brain-Penetrant, Non-Trapping PARP1- Selective Inhibitor, in Combination with Topotecan in Recurrent HR-Proficient / Refractory Ovarian Cancer.
Poster 58TiP – Poster 58TiP – PARPA-293-004: Phase 1b Study of NMS-03305293 (Itareparib), a Brain-Penetrant, Non-Trapping PARP1-Selective Inhibitor, in Combination with Temozolomide in Relapsed Extensive-Stage Small Cell Lung Cancer (ES-SCLC).
Both studies are open and actively recruiting:

Non-BRCA-mutated ovarian cancer study: NCT06930755
ES-SCLC study: NCT06931626
"These studies reflect our strategy of advancing Itareparib in combination settings where conventional PARP1 approaches have historically been constrained," said Lisa Mahnke, MD PhD, Group CMO. "We believe the differentiated profile of Itareparib has the potential to broaden the use of PARP1 biology beyond traditional BRCA-mutated settings and into larger patient populations through rational combinations with DNA-damaging therapies."

Ovarian cancer and ES-SCLC remain aggressive malignancies with significant unmet need, particularly in relapsed or refractory settings where patients often face limited treatment options and poor outcomes. Through these studies, NMS is evaluating Itareparib for its potential to enhance the activity of widely used chemotherapeutic backbones while maintaining a combination-enabling tolerability profile.

Itareparib is currently being developed across multiple tumor settings, with near-term clinical readouts expected from its ongoing combination programs.

About Itareparib
Itareparib is a novel PARP1 inhibitor, designed to be used in combination, and distinguished by a non-trapping mechanism of action as shown preclinically with high potency, PARP1 selectivity and brain penetrance. Clinically (Geurts et al ENA 2023), the profile improves on poor bone marrow features of trapping PARP1 inhibitors (Yap et al AACR (Free AACR Whitepaper) 2024) and thus removes traditional barriers to combining a DNA damage repair inhibitor with a DNA damaging agent in non-BRCA-mutated tumors.

(Press release, Nerviano Medical Sciences, MAR 16, 2026, View Source [SID1234663570])