Very excited to expand #VIKTORIA-2 study and include a majority of potentially eligible patients with #HR+ #HER2- #ABC for #front-line treatment with #gedatolisib regimen #PAM. Patients with #HS (hormone-sensitive) and #HR (hormone-resistant) #ABC regardless of #PIK3CA mutation status are eligible for enrollment.

🧬 FDA NDA Filed for Varegacestat in Desmoid Tumors A new targeted therapy may soon expand options for patients with desmoid tumors. A new drug application (NDA) has been submitted to the FDA for varegacestat (AL102), an investigational, once-daily gamma secretase inhibitor. 📊 What’s driving the submission? • The NDA is supported by results from the phase 3 RINGSIDE trial, which met its primary end point of progression-free survival (PFS) • Varegacestat achieved an 84% reduction in the risk of disease progression or death vs placebo 🔗 Read more: https://lnkd.in/eEH_XsXW #Sarcoma #DesmoidTumors #TargetedTherapy #RareCancers #ClinicalTrials #DrugDevelopment #Oncology #CancerResearch

Cellectar Biosciences, Inc. has rolled out new #clinicaltrial data showing patients are responding well to one of its #cancer therapies. The drug development firm, which has roots in University of Wisconsin-Madison, recently announced 12-month follow-up results from Phase 2b of its CLOVER WaM clinical trial. It’s evaluating the use of its Iopofosine I-131 drug, which targets #tumorcells while limiting exposure to healthy tissues, in patients with certain forms of a rare #bloodcancer called Waldenström macroglobulinemia. Read on ➡️ https://lnkd.in/gK3H4Jdu

Initial clinical trial results from our Ajax Therapeutics AJX-101 trial of AJ1-11095 in patients with myelofibrosis will be presented at EHA2026 next month, and abstracts went live today; a link to the announcement is below. John Mascarenhas from Icahn School of Medicine at Mount Sinai will be presenting the data in an oral session on the afternoon of Saturday, June 13th. I'm grateful to the patients who are participating in the trial (most who enrolled in the dose escalation phase are still receiving the study drug!), a terrific group of investigators and site staff, our colleagues at Medpace and consultants who helped us get to this point, and the Ajax team. And of course Ajax principal founder Ross Levine, whose idea this was, and who I am sure is thrilled to see his lab's work translating into real benefit for patients - spleen reduction, improved symptoms, and reduction of mutant clones. https://lnkd.in/e8R4v4u5

We welcome three new leaders to our management team We are pleased to announce the appointment of Jeremy Fitch as Chief Business Officer, Michael Alrutz as General Counsel, and Guy Ruble, Pharm D., RAC-Drugs as Vice President of Regulatory Affairs.   With alnodesertib progressing toward potential registration and U.S. commercialization, initiation of a randomized Phase 2 study for ART6043 in metastatic breast cancer, and our DNA Damage Response antibody drug conjugate (ADC) platform advancing toward the clinic, their combined expertise will support disciplined execution across our pipeline to deliver first-in-class therapies as soon as possible to patients with no other treatment options.   Their full bios can be viewed on our website: https://lnkd.in/djEc63wX

We are excited to announce the further expansion of our leadership team with the addition of three more seasoned executives to Artios. The addition of Jeremy, Michael and Guy brings additional late-phase capability to our team and further enables our mission to deliver the next generation of DDR therapeutics to patients as soon as possible.

Cleo Diagnostics Commences Kit #Manufacturing Program ahead of #FDA Submission. ▪️Initial phase of staged manufacturing program now underway with Bio-Techne to support production of CLEO’s test kits. ▪ Follows completion of sample collection for CLEO’s pivotal #U.S. #clinicaltrial, marking transition to analytical validation and clinical sample testing. ▪ Staged approach designed to reduce technical and manufacturing risk ahead of full-scale test kit production and FDA 510(k) submission. Link to release: https://bit.ly/4sZ45Vy #CleoDX #ovarian #cancer #medtech #womenshealth ASX.COV #invest

New approach methodologies (NAMs) for preclinical drug testing are being pushed by the FDA and we’re here to help. We’re launching new tumoroid cell lines, built directly from primary patient tumor cells for stronger clinical relevance. Designed for long‑term culture and co‑culture with matched non‑tumor cells, these models are ideal for on‑target drug efficacy studies. ⚠️ Note: autologous matched cells are limited and move quickly once released. If you want early visibility across endometrial, CRC, and lung indications, now’s the time. Be the first to know and get early access 👇 https://lnkd.in/ekQCqsR2 #oncology #drugdevelopment #NAMs #preclinicalmodels

Oncology KOLs react to the exciting FDA approval based on the DESTINY-Breast11 (and DESTINY-Breast05) clinical trials. 👉AI-Native web page, Use as a source in NotebookLM! https://hubs.ly/Q04gTzS00