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Ipsen completes acquisition of Memo Therapeutics AG, adding first-in-class asset to Ipsen’s Rare Disease pipeline

On July 22, 2026 Ipsen (Euronext: IPN; ADR: IPSEY) reported it has completed the acquisition of Memo Therapeutics AG, a late-stage biotech company focused on potravitug, an anti-BK polyomavirus monoclonal antibody.

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About potravitug
Potravitug is a first-in-class monoclonal antibody targeting BK polyomavirus (BKPyV) reactivation in kidney transplant recipients. It has shown promising results in clinical trials, demonstrating a significant anti-viral response and resolution of BKPyV associated nephropathy. These findings are based on the Phase II SAFE KIDNEY II trial, the largest placebo-controlled study conducted in this patient population, with additional analyses presented at leading international renal and transplant congresses further supporting its clinical profile and the next stages of clinical development.

About BK polyomavirus
BK polyomavirus (BKPyV) is a common virus that most people are exposed to in childhood and usually remains inactive in the body.i However, in people with a weakened immune system, including kidney transplant recipients taking anti-rejection medication, the virus can reactivate and multiply. Around 90% of kidney transplant recipients are positive for BKPyV serotype,ii and high levels of BKPyV in the blood affect approximately 30% of patients within the first year after transplant indicating reactivation of the virus.iii BK polyomavirus reactivation and associated nephropathy (BKVAN) can have serious consequences, including an increased risk of graft loss and the need for dialysis or re-transplantation. There are currently no approved targeted therapies for BKPyV and clinical management is focused on balancing graft protection with BKPyV control through reducing the immunosuppression.iv,v Over 100,000 kidney transplants are performed each year worldwide, and in the U.S. >28,000 are performed each year, with a further >90,000 patients on the waiting list for a transplant.

(Press release, Ipsen, JUL 22, 2026, View Source [SID1234669385])

Healx Announces First Patient Dosed in Phase 1/2 Trial to Evaluate the Effect of HLX-4310 on Metastatic Recurrence and Progression in Sarcomas with a Focus on Osteosarcoma

On July 22, 2026 Healx, an AI-powered, clinical-stage biotech company dedicated to rare diseases, reported that the first patient has been dosed in its Phase 1/2 dose-escalation and dose-confirmation clinical trial to evaluate the safety and efficacy of HLX-4310, an investigational oral combination of a class I selective HDAC inhibitor and an mTOR inhibitor, in adolescents and adults with relapsed, refractory sarcoma, with a focus on osteosarcoma.

Osteosarcoma is a rare, aggressive bone cancer that most often affects children, adolescents, and young adults. Patients who develop metastatic disease face particularly poor outcomes, with a five-year survival rate of less than 30% ¹. The past 40 years have brought little improvement in survival outcomes for patients with osteosarcoma, underscoring a critical need for new approaches designed to reduce relapse risk and improve long-term outcomes.

HLX-4310 represents the first clinical proof point for Healx’s broader rare oncology strategy focused on preventing metastatic recurrence, which is responsible for the vast majority of cancer-related deaths. Healx is leveraging its AI-driven discovery capabilities together with rapid iterative laboratory testing and translational validation to advance this initial therapeutic combination and generate new drug combinations designed to explore a new approach to preventing metastatic recurrence in rare oncology settings.

The trial is being advanced in collaboration with the National Pediatric Cancer Foundation’s (NPCF) flagship research program, the Sunshine Project.

Addressing an Unmet Need in Rare Oncology

"Metastatic osteosarcoma is so difficult to treat because patients can undergo intensive therapy, reach remission, and still relapse within months or within several years," said David Warshawsky, Ph.D., Global Head of Metastatic Prevention at Healx. "We believe that HLX-4310 provides a novel and differentiated approach focused on the unique biology hypothesized to drive cancer recurrence, and we are delighted to see it advance into trials."

"I’m excited to see this study begin dosing patients and to evaluate a strategy that is explicitly focused on preventing metastatic recurrence," said Amy Armstrong, M.D., Principal Investigator for the Phase 1/2 HLX-4310 trial. "This trial will evaluate the safety and tolerability of HLX-4310 and assess efficacy, including its potential to reduce cancer recurrence risk."

Partnership with NPCF’s Sunshine Project

"We are proud to support the advancement of HLX-4310 through the Sunshine Project," said David Frazer, President of the National Pediatric Cancer Foundation. "Our consortium brings together leading pediatric cancer centers to accelerate promising science into clinical studies. This trial reflects the shared commitment of the Sunshine Project and Healx to drive progress for children and young adults facing high-risk cancers like osteosarcoma."

About HLX-4310
HLX-4310 is a combination approach built around the concept of preventing metastatic recurrence rather than focusing only on overt tumors. The scientific hypothesis behind this novel strategy is based on targeting biological programs that enable micro-metastatic tumors to survive and persist at distant sites and later re-emerge as deadly metastatic disease.

HLX-4310 combines two agents with complementary activity profiles:

An investigational class I selective histone deacetylase (HDAC) inhibitor being evaluated for its epigenetic modulation of gene expression programs involved in tumor cell survival and in tumor-immune interactions; and
An mTOR inhibitor, which targets a central pathway involved in cell growth, metabolism, and stress responses.

(Press release, Healx, JUL 22, 2026, View Source [SID1234669383])

Radiopharm Theranostics Announces Positive Phase 2b Trial Results of RAD 101 for Diagnosis of Brain Metastases

On July 22, 2026 Radiopharm Theranostics (ASX:RAD, "Radiopharm" or the "Company"), a clinical-stage biopharmaceutical company focused on developing innovative oncology radiopharmaceuticals for areas of high unmet medical need, reported positive data from all thirty evaluable patients in the Phase 2b trial of RAD101 in participants with suspected recurrence of brain metastases after radiotherapy. RAD101 is Radiopharm’s novel imaging small molecule targeting fatty acid synthase (FASN) radiolabelled with Fluorine-18 for the diagnosis of suspected recurrent brain metastases from solid tumors of different origins. The data from these findings will be used to support the initiation of a pivotal multi-center, global Phase 3 imaging trial.

The analysis of the imaging data for all assessed lesions showed 93% concordance between MRI and PET imaging of brain metastases in this patient population with suspected recurrence. The results showed substantial and selective tumor uptake of RAD101. Images confirm metabolic activity in PET compared to equivocal MRI findings.

Additionally, 14 patients with evaluable six-month follow-up and/or biopsy data show preliminary 86% sensitivity, representing a strong positive trend (a secondary objective). Sensitivity measures an imaging test’s ability to correctly identify patients with disease.

"The entirety of this dataset captures the strength and potential of RAD101 to address a difficult diagnostic challenge in neuro-oncology," said Riccardo Canevari, CEO and Managing Director of Radiopharm Theranostics. "Achieving the primary endpoint provides strong validation of our approach and supports the advancement of RAD101 into an intended registrational Phase 3 program. We look forward to continuing our discussions with the U.S. FDA as we finalize the study design and work toward bringing a more precise diagnostic tool to patients and clinicians. With this positive data in hand, we have a strong foundation from which to launch our pivotal trial."

In the U.S. alone, there are more than 300,000 patients diagnosed annually with cerebral metastases. The incidence of Intracranial Metastatic Disease (IMD) continues to increase, in part, due to improvements in systemic therapy resulting in a more durable control of the tumors outside of the central nervous system. Contrast-enhanced Magnetic Resonance Imaging (CE-MRI) is the preferred method for imaging IMD, but has limitations, particularly in follow-up surveillance scans to optimise patient care.1

RAD101 has received U.S. Food and Drug Administration (FDA) Fast Track Designation to distinguish between recurrent disease and treatment effect of brain metastases originating from solid tumors of different origin including leptomeningeal disease. The company also recently announced a partnership with Siemens Healthineers, who will manufacture and distribute doses of 18F-labeled RAD101 to support Radiopharm’s upcoming Phase 3 pivotal trial in the U.S.

About the Phase 2b Clinical Trial of RAD101

The U.S. multicenter, open-label, single arm Phase 2b clinical trial is assessing the diagnostic
performance of 18F-RAD101 in 30 evaluable individuals with suspected recurrent brain metastases from solid tumors of different origins. The primary objective of the study is concordance between 18F-RAD101 PET-positive lesions and those equivocal lesions seen in conventional imaging (MRI with gadolinium) in participants with known brain metastases and suspected relapse after stereotactic radiosurgery (SRS). Secondary endpoints are sensitivity and specificity of RAD101 in identifying tumor recurrence versus radiation-associated changes in previously SRS-treated brain metastases.

About RAD101

RAD101 is the Company’s novel imaging small molecule that selectively binds to fatty acid synthase (FASN), a multi-enzyme protein that catalyses de-novo fatty acid synthesis and is overexpressed in cerebral metastasis from solid tumors. Targeting FASN activity may allow for the more accurate detection of cancer cells in the CNS, representing a clinically relevant method for the imaging of brain metastases. Positive data from the Imperial College of London’s Phase 2a imaging trial of 18F-RAD101 in patients with brain metastases (both SRS pre-treated and treatment naïve patients) showed significant tumor uptake that was independent from the tumor of origin. The study further indicated that PET-MRI may potentially represent a non-invasive prediction of overall-survival, warranting larger studies.

(Press release, Radiopharm Theranostics, JUL 22, 2026, View Source [SID1234669382])

Radiopharm Theranostics Achieves Confirmed Durable Partial Response in Ongoing Phase 1 Trial of RAD204 in Patients with Advanced Solid Tumors Post-Immunotherapy

On July 22, 2026 Radiopharm Theranostics (ASX:RAD, Nasdaq: RADX, "Radiopharm" or the "Company"), a clinical-stage biopharmaceutical company focused on developing innovative oncology radiopharmaceuticals for areas of high unmet medical need, reported updated clinical results from the first two patients in the third cohort of RAD204, the Company’s investigational PD-L1-targeted lutetium-177 nanobody radiotherapeutic being evaluated in a Phase 1 clinical trial in patients with advanced solid tumors in a post-immunotherapy setting.

Radiopharm previously received positive recommendations from the Data and Safety Monitoring Committee, allowing the Company to proceed with enrolling patients in the Phase 1 treatment study after completion of cohorts # 1 and #2 to the current highest dose level #3 (90 mCi). Initial data from all cohorts of the Phase 1 treatment study demonstrated tumor uptake in the PD-L1-positive lesions, which is in line with published results from the previously completed imaging study.

"We are excited to announce positive initial data from the first two patients treated with RAD204 in the third dosing cohort, which showed favorable tolerability and tumor reduction in target lesions, with both patients remaining on treatment," said Riccardo Canevari, CEO and Managing Director of Radiopharm Theranostics. "Importantly, the first patient has achieved a durable confirmed RECIST Partial Response lasting through four treatment cycles and has remained progression-free beyond seven months. The combined preliminary results indicate the broad therapeutic potential of RAD204 in PD-L1-associated malignancies. Additionally, the data demonstrated that RAD204 was generally well-tolerated, reinforcing the safety profile of RAD204 at the highest dose level evaluated and supporting continued dose escalation."

"We remain laser-focused on advancing the Phase 1 study and anticipate releasing additional data that will support the therapeutic potential of RAD204 to treat PD-L1 associated malignancies. The totality of data across our multiple dose cohorts supports our confidence in this program and are expected to inform the recommended dose for our planned Phase 2 clinical trial," concluded Mr. Canevari.

Initial Clinical Results from Cohort 3 of the Phase 1 Trial of RAD204

Thus far, two patients have been dosed with RAD204 in the third cohort of the Phase 1 treatment study, with the third patient under screening evaluation. Both patients remain on treatment, and initial clinical observations from the ongoing study support the potential of repeated administration of RAD204.

Patient 1

Patient 1 has achieved a RECIST-confirmed Partial Response after the second treatment cycle, which has been maintained during continued therapy:
19% reduction in target lesions from baseline, observed after Dose 1.
43% reduction after Dose 2, which meets the RECIST criteria for a Partial Response.
43% reduction maintained after Dose 3, i.e., a confirmed Partial response per RECIST
35% reduction after Dose 4, while continuing to meet RECIST criteria for a Partial Response.
The patient remains progression-free beyond seven months with continued follow-up.
Patient 2

Patient 2 has demonstrated an early 7% reduction in target lesions following the first treatment cycle. The patient remains on treatment and is progression-free with continued follow up for additional efficacy and safety assessments.
Safety and Tolerability

In all patients dosed to date across dose levels 1 to 3, RAD204 has continued to demonstrate a favorable safety and tolerability profile. There have been no dose-limiting toxicities observed in any of the cohorts thus far. Kidney uptake has been limited (cumulative 8.1 Gy across the four cycles, in Patient 1) and does not represent a potential obstacle for escalation to the next higher dose level (Dose level #4).
About the Phase 1 Study

The ongoing first-in-human Phase 1 study is evaluating the safety, tolerability, dosimetry, pharmacokinetics and preliminary anti-tumor activity of RAD204 in patients with advanced solid tumors following progression on standard therapies. The primary objectives are to establish the recommended Phase 2 dose and characterize safety, while secondary endpoints include anti-tumor activity, eg., tumor responses and duration of responses.

About RAD204

RAD204 is a single-domain monoclonal antibody (sdAb) that targets PD-L1, a protein that regulates the immune system’s response to malignant tumors and is overexpressed in many cancers, making it an attractive therapeutic target in multiple tumor types, including NSCLC, SCLC, TNBC, Cutaneous Melanoma, HNSCC, and Endometrial Cancer. Previously published Phase I imaging data of 16 NSCLC patients with 99Tc-RAD204 demonstrated positive tumor targeting, favorable biodistribution and image characteristics correlating with PD-L1 immunohistochemistry results in cancer patients2. Tumor targeting with radioimmunotherapies such as 177Lu-RAD204 has the potential to address resistance mechanisms to current standard-of-care treatment options. The platform is designed to provide hidden epitope access, exceptional stability, rapid tumor penetration, favorable pharmacokinetics and the potential for repeat dosing.

(Press release, Radiopharm Theranostics, JUL 22, 2026, View Source [SID1234669381])

Revolution Medicines’ New Drug Application for Daraxonrasib Accepted for Review by U.S. FDA for Previously Treated Metastatic Pancreatic Cancer

On July 22, 2026 Revolution Medicines, Inc. (Nasdaq: RVMD), a late-stage clinical oncology company developing targeted therapies for patients with RAS-addicted cancers, reported that the U.S. Food and Drug Administration (FDA) accepted for review the company’s New Drug Application (NDA) for daraxonrasib, an oral RAS(ON) multi-selective inhibitor, for previously treated metastatic pancreatic ductal adenocarcinoma (PDAC).

"The FDA’s acceptance of the daraxonrasib NDA is an important step in the regulatory review process and brings us closer to the possibility of offering patients a new targeted medicine for previously treated metastatic pancreatic cancer," said Mark A. Goldsmith, M.D., Ph.D., chief executive officer and chairman of Revolution Medicines. "Daraxonrasib is an oral targeted medicine designed to inhibit RAS, the main cause of pancreatic cancer, and the application is supported by unprecedented results from the Phase 3 RASolute 302 trial. These findings underscore the potential for daraxonrasib to become a new standard of care and to help define a new class of RAS‑targeted medicines for this disease. We look forward to continuing to work closely with the FDA as the agency reviews the application, and with other global regulatory authorities as we advance our efforts to bring daraxonrasib to patients as quickly as possible."

The NDA is based on results from the global, randomized Phase 3 RASolute 302 trial, evaluating daraxonrasib versus standard of care cytotoxic chemotherapy in patients with previously treated metastatic PDAC, with or without an identified tumor RAS mutation. The trial met all primary and key secondary endpoints, including unprecedented improvements in overall survival and progression-free survival. In addition, daraxonrasib exhibited a manageable safety profile and patients treated with daraxonrasib reported significantly delayed deterioration in cancer-related pain, overall global health status and quality of life, compared to those treated with chemotherapy. Results from the RASolute 302 trial were presented at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting with simultaneous publication in The New England Journal of Medicine.

Daraxonrasib was selected for the FDA Commissioner’s National Priority Voucher pilot program, which is designed to accelerate the review of medicines that address key national health priorities. The FDA previously granted daraxonrasib Breakthrough Therapy Designation and Orphan Drug Designation for the treatment of patients with previously treated metastatic PDAC.

The Company recently announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use has begun a phased review of daraxonrasib, allowing data to be evaluated as they become available before submission of a full marketing authorization application. Daraxonrasib has also received orphan medicine designation for the treatment of pancreatic cancer, and high-priority status under EMA’s Cancer Medicines Pathfinder project based on its potential to address a significant unmet need.

About Pancreatic Cancer and Pancreatic Ductal Adenocarcinoma

Pancreatic cancer is one of the most lethal malignancies, characterized by its typically late-stage diagnosis, resistance to standard chemotherapy, and high mortality rate. In the U.S., recent estimates indicate that annually approximately 60,000 people will be diagnosed with pancreatic cancer, and about 50,000 people will die from this aggressive disease.1 Due to the lack of early symptoms and detection methods, most patients are diagnosed with pancreatic ductal adenocarcinoma (PDAC) at an advanced or metastatic stage. Metastatic PDAC remains one of the most common causes of cancer-related deaths in the U.S., with a five-year survival rate of approximately 3%.2,3

About Daraxonrasib

Daraxonrasib is an investigational, oral RAS(ON) multi-selective, noncovalent tri-complex inhibitor that works by suppressing RAS signaling through inhibition of the interaction between both wild-type and mutant RAS(ON) proteins and their downstream effectors. It is designed to target cancers driven by a broad range of common RAS genotypes, including pancreatic ductal adenocarcinoma (PDAC), non-small cell lung cancer (NSCLC), and colorectal cancer. Daraxonrasib is being advanced through a global Phase 3 registrational program comprising four trials, including the completed RASolute 302 trial and three additional trials in patients with PDAC and metastatic RAS mutant NSCLC.

About the RASolute 302 Clinical Trial

RASolute 302 (NCT06625320) is a global, randomized Phase 3 registrational clinical trial designed to evaluate the efficacy and safety of daraxonrasib as a monotherapy in patients with previously treated metastatic pancreatic ductal adenocarcinoma (PDAC). In the trial, patients were randomized to receive either an oral dose of 300 mg daraxonrasib once daily or investigator’s choice of four different cytotoxic chemotherapy regimens, which represent standard of care across the globe. The trial enrolled patients with metastatic PDAC harboring a wide range of RAS variants, including those with RAS G12 mutations (such as G12D, G12V, and G12R), as well as patients without an identified tumor RAS mutation (wild type).

The primary endpoints of the RASolute 302 trial were progression-free survival (PFS), as assessed by a Blinded Independent Central Review according to RECIST 1.1, and overall survival (OS) in patients with tumors harboring RAS G12 mutations. Secondary endpoints included PFS and OS in all enrolled patients (the intent-to-treat population) encompassing patients with and without identified tumor RAS mutations, as well as objective response rate, duration of response, and patient-reported quality of life.

(Press release, Revolution Medicines, JUL 22, 2026, View Source [SID1234669380])