Eli Lilly Highlights P-III (LIBRETTO-432) Trial Data on Retevmo for Early-Stage RET Fusion–Positive NSCLC at ASCO 2026
Eli Lilly presented data from its phase III LIBRETTO‑432 trial of selpercatinib (Retevmo) as adjuvant therapy in early‑stage RET‑fusion positive NSCLC. In 151 patients, the drug reduced the risk of disease recurrence or death by 83% versus placebo, with 24‑month event‑free survival (EFS) of 92% in stage II‑IIIA versus 61% on placebo. Overall, 24‑month EFS was 94% versus 70% in the full cohort, and median EFS was not reached. Results were published in NEJM and will be filed with regulators.
Akeso Presents the P-III (HARMONi-6) Trial Data on Ivonescimab + CT in 1L Squamous NSCLC at ASCO 2026
Akeso’s global Phase III HARMONi‑6 trial compared ivodescimab plus chemotherapy with Tevimbra plus chemotherapy in 532 patients with first‑line squamous non‑small cell lung cancer. The study met its primary overall‑survival endpoint, showing a 34% reduction in death risk (median OS 27.9 months...
Merck Secures the US FDA Breakthrough Therapy Designation for Calderasib to Treat Newly Diagnosed Metastatic KRAS G12C-Mutant NSCLC
The U.S. FDA granted Merck’s KRAS‑G12C inhibitor calderasib (MK‑1084) breakthrough therapy designation for first‑line treatment of newly diagnosed metastatic non‑small cell lung cancer (NSCLC) that harbors a KRAS G12C mutation and expresses PD‑L1 (TPS ≥ 1%). The designation is backed by Phase I...
Altimmune Reports the P-IIb (IMPACT) Trial Data on Pemvidutide for Metabolic Dysfunction-Associated Steatohepatitis (MASH)
Altimmune presented 48‑week Phase‑IIb (IMPACT) results for its GLP‑1‑GIP agonist pemvidutide in 212 patients with metabolic dysfunction‑associated steatohepatitis (MASH) and fibrosis stage F2‑F3. The 1.8 mg weekly dose cut triglycerides by 23.7%, total cholesterol by 15.4%, lowered BMI by 3 kg/m², reduced...
Samsung Bioepis Reports the EC Launch of Opuviz (Biosimilar, Eylea)
Samsung Bioepis announced the European commercial launch of Opuviz 40 mg/mL solution for injection, a biosimilar to aflibercept (Eylea). The product will be sold directly by the company across the EU for wet age‑related macular degeneration, diabetic macular oedema, retinal vein...
AstraZeneca Receives the US FDA Approval for Imfinzi Regimen to Treat High-Risk Non-Muscle-Invasive Bladder Cancer (NMIBC)
AstraZeneca’s Imfinzi (durvalumab) combined with Bacillus Calmette‑Guérin (BCG) therapy received U.S. FDA approval for treating adults with BCG‑naïve, high‑risk non‑muscle‑invasive bladder cancer (NMIBC). The decision rests on the phase‑III POTOMAC trial, which enrolled 1,018 patients post‑TURBT and compared Imfinzi + BCG induction...
Is Immune Priming the Missing Piece in Oncology? Oncolytics Biotech Thinks So
Oncolytics Biotech is positioning its oncolytic virus pelareorep as an "immune‑priming backbone" to boost the efficacy of existing cancer therapies. Recent combination trials have shown striking survival gains—median overall survival of 27 months in metastatic colorectal cancer and a two‑year...
Ironwood Pharmaceuticals Reports the US FDA Approval of Linzess to Treat Pediatric Patients (≥2yrs.) With Functional Constipation
U.S. FDA has approved an expanded label for Ironwood Pharmaceuticals’ Linzess (linaclotide) for children aged two years and older with functional constipation. The decision follows a 12‑week Phase III trial in 2‑ to 5‑year‑old patients, where the 72 µg dose significantly increased...
Apogee Therapeutics Reports Part B P-II (APEX) Data on Zumilokibart in Atopic Dermatitis (AD)
Apogee Therapeutics announced Phase II Part B (APEX) results for its IL‑4/13 inhibitor zumilokibart in moderate‑to‑severe atopic dermatitis. In a 346‑patient study, the mid‑ and high‑dose arms met the primary endpoint at week 16, with 65.9% and 61.6% of patients achieving EASI‑75 versus...
Sanofi’s Venglustat Secures the US FDA Priority Review for Type 3 Gaucher Disease
Sanofi’s oral glucosylceramide synthase inhibitor venglustat has received FDA acceptance of its New Drug Application and a priority‑review designation for treating the neurological manifestations of type 3 Gaucher disease (GD3). The decision follows the phase‑III LEAP2MONO trial, which enrolled 43 patients...
AbbVie Reports the US FDA Approval for Decnupaz to Treat Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)
AbbVie’s Decnupaz (pivekimab sunirine‑pvzy) received U.S. FDA approval for treating adult patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN), an ultra‑rare aggressive blood cancer. The decision was based on the global Phase I/II CADENZA trial that enrolled 84 CD123‑positive hematologic malignancy...
Roy Maute on Macrophage Checkpoint Inhibition: Pheast’s Vision for Advancing PHST001 in Solid Tumors
Pheast Therapeutics presented early Phase 1a data on PHST001, an anti‑CD24 macrophage checkpoint inhibitor, at AACR 2026. The drug demonstrated favorable tolerability, dose‑linear pharmacokinetics, robust CD24 receptor occupancy and signs of immune activation. Preliminary anti‑tumor activity was seen across heavily pretreated...
Apogee Therapeutics Secures Up to $1.3B Financing From Blackstone to Advance Zumilokibart
Apogee Therapeutics announced a financing package of up to $1.3 billion from Blackstone, comprising roughly $800 million in synthetic royalty funding and $500 million in senior debt. The synthetic royalty agreement spans 15 years, with tiered rates that decline as sales increase and...
D&D Pharmatech Reports P-II Trial Results on Zabopegdutide for Metabolic Dysfunction-Associated Steatohepatitis (MASH)
D&D Pharmatech disclosed topline Phase II data for its GLP‑1‑like agent zabopegdutide in 67 overweight or obese patients with metabolic dysfunction‑associated steatohepatitis (MASH). After a 2‑week titration to a 40 mg weekly maintenance dose, 48‑week histology showed a 50% fibrosis‑stage improvement versus...
Myriad Genetics Launches Prolaris + AI Test for Personalized Prostate Cancer Active Surveillance
Myriad Genetics is introducing the Prolaris + AI Test, the first prostate‑cancer assay that blends its long‑term Prolaris CCR genomic score with an artificial‑intelligence model (AI‑GUR) that predicts near‑term Gleason score upgrades. The AI metric will be available for all Prolaris Biopsy...