Another milestone from Immunome, Inc.! The New Drug Application (NDA) for varegacestat has officially been submitted to the FDA. This marks an important step forward for the desmoid tumor community and reflects the dedication of researchers, clinicians, trial participants, and patients whose commitment made this possible. Now begins the FDA review process: over the next 60 days, the agency will determine whether to file the application for formal review. If accepted, a multidisciplinary evaluation of safety, efficacy, and manufacturing quality typically follows over the next 6-10 months, with the potential for inspections and advisory committee review along the way. We are deeply grateful to everyone who helped bring this moment closer and look forward to the progress ahead for people living with desmoid tumors.

Today marks a significant milestone for Immunome and for the desmoid tumor community. We are proud to announce the submission of a New Drug Application (NDA) to the U.S. FDA for varegacestat — an investigational, once daily, oral, gamma-secretase inhibitor. The results from the phase 3 RINGSIDE trial highlight the progress we are making toward our mission to redefine the standard of care for desmoid tumors. To the RINGSIDE trial patients, families, investigators, study site teams, and patient advocacy partners — thank you for making this possible. Read more here: https://lnkd.in/giZHBa_9

Exciting news - the first patient has been dosed with Kestrel’s pan-KRAS inhibitor, KST-6051. It’s been an honor to be part of the team that advanced this molecule from discovery to the clinic, and I'm hopeful about what this may mean for patients moving forward.

We’re pleased to announce that the first patient has been dosed in our Phase 1 clinical trial (FALCON) evaluating KST-6051, our investigational oral pan-KRAS inhibitor, in patients with advanced or metastatic KRAS-driven solid tumors.   In parallel, we have entered into a strategic agreement with AbbVie, which includes an exclusive option for AbbVie to acquire Kestrel based on defined development milestones—further supporting the advancement of our lead program.    KST-6051 is designed with a differentiated mechanism of action, binding directly to KRAS in both its active and inactive states. This approach aims to provide broad pathway coverage while selectively sparing HRAS and NRAS, with the potential to improve tolerability and deliver durable pathway suppression.    The Phase 1 study will evaluate safety, tolerability, pharmacokinetics, and preliminary antitumor activity in patients with KRAS-mutant cancers, including #PancreaticCancer, #ColorectalCancer, and #NonSmallCellLungCancer (#NSCLC).    Read more in our press release: https://lnkd.in/eeEXyg6d

As the global oncology community gathers for #ASCO26 to discuss "The Science and Practice of Translation," the speed of early-phase development remains a critical bottleneck. For sponsors running Oncology PoC Phase I/II programs, every day of regulatory delay is a day lost for patients. China’s NMPA now offers a 30-day fast-track review pathway—slashing timelines by 50% for innovative drugs. At Emerald Clinical, we help you master this "translation" from IND to first-patient-in: ✅ Proven Velocity: We have successfully secured NMPA approvals in under 30 days. ✅ Strategic Readiness: We ensure your program meets the rigorous 12-week trial initiation commitment required for the fast-track. ✅ Local Depth: Our China-based teams de-risk recruitment by leveraging top-tier medical institutions. Heading to Chicago? Let’s discuss how to fastrack your global development timeline. 👉 Secure a meeting with our ASCO team today - https://lnkd.in/e3Pf-7VK #Oncology #ClinicalTrials #ASCO26 #DrugDevelopment #EmeraldClinical

Meet the Predicine team at AUA 2026 and explore how blood- and urine-based molecular insights are advancing precision oncology for patients with bladder, prostate, and kidney cancers.

1 in 2 men. 1 in 3 women. Those are the odds of a cancer diagnosis in a lifetime. Domestic production of the medical isotopes that will diagnose and treat them isn't close to meeting what's coming. Theranostics — precision therapies pairing diagnostics with treatment using medical isotopes — are advancing rapidly through pipelines at Novartis, Bristol Myers Squibb, AstraZeneca, Bayer, and Eli Lilly. The FDA has approved multiple radioligand therapies. More are coming. The pipeline spans the cancers Americans face most: → Prostate: Lu-177 PSMA therapy is already a cornerstone of treatment → Breast: HER2-targeted Lu-177 and Cu-64 programs in active clinical trials → Lung: Lu-177, Cu-64, and alpha-emitter programs in clinical development → Pancreatic, ovarian, melanoma, multiple myeloma: all next in line Domestic supply can't keep pace. The U.S. still relies on foreign reactors for virtually all of its Mo-99, the workhorse isotope behind 40 million diagnostic scans every year. Projected Lu-177 demand will outstrip current domestic capacity within years, not decades. Eden is being built to close that gap—reactor infrastructure designed for commercial-scale, multi-isotope production aligned with pharmaceutical timelines. Precision science. Human impact. #NuclearMedicine #Theranostics #Radiopharmaceuticals #CancerCare #DomesticManufacturing

Earlier this morning, Medsolve Dynamics founder Yoel Bakas posted on the capital question that gets skipped on most theranostics service-line decisions. Most programs evaluating theranostics in 2026 answer which radiopharmaceutical first. The capital form decision, build or partner, gets defaulted to whatever the vendor sized in the original proforma. Kenneth Brooks and Christine Stone at Wellstar Health System recently published the cleanest build-form case study in community radiation oncology. Three-year phased rollout. Six months to first patient treatment. 340B drug pricing as the financial wedge that made early adoption viable for a community system. The form sets the next ten years of operating posture. The product follows. Full piece on Yoel’s feed in the comments. #RadiationOncology #Theranostics #CapitalStrategy #OncologyLeadership #MedsolveDynamics Kenneth B.

A new drug class earned its first label on May 1.   The FDA approved Veppanu (vepdegestrant) for ESR1-mutated breast cancer — the first PROTAC ever approved.   Median PFS: 5.0 months vs. 2.1 on fulvestrant. HR 0.57. Approved 35 days early.   Three things that just changed:   1. Targeted protein degradation is no longer a platform thesis. It's a marketed mechanism.   2. Every degrader peer behind it — Kymera, C4, Foghorn, Nurix — re-rates on regulatory precedent, not on its own data.   3. Pfizer's pipeline story flips from defending a patent cliff to leading a class.   In our four-loci read: MoA validated, clinical utility confirmed, regulatory path cleared. The only loci still evolving is commercial — and the prize there isn't this label, it's the 1L combo and the pipeline behind it.   First-of-class approvals are rare. They reward conviction, not consensus.   #Biopharma #PROTAC #FDA #EventDriven

According to OncoLiv, the FDA has granted Fast Track designation to iSCIB1+, a potential promising oncolytic vaccine for advanced melanoma that demonstrated a 77% 20-month progression-free survival rate in recent clinical trials: https://lnkd.in/dQHwGcuX