Jun 22, 2026
Eledon Pharmaceuticals reported positive long-term Phase 2 BESTOW trial results for tegoprubart in kidney transplant, showing sustained kidney function benefits and improved patient outcomes versus tacrolimus. The company outlined plans for a Phase 3 registrational trial and seeks an FDA meeting in early 2027. Safety data indicated lower adverse event rates with tegoprubart.
Jun 08, 2026
Sangamo Therapeutics has retained Raymond James to evaluate strategic alternatives to advance its pipeline and maximize stakeholder value. Key assets include the BLA-ready Fabry disease gene therapy ST-920, the STAC-BBB capsid platform generating $88M in fees to date, and multiple neurology programs. No transaction has been agreed and no timetable has been set.
Jun 05, 2026
New research presented at the ERA Congress found DCCB blood pressure medications were associated with a 33% increased risk of major adverse kidney events in Type 2 diabetes patients also receiving RAS and SGLT2 inhibitors. A separate study revealed that diabetic nephropathy patients exhibit the most severe biochemical disturbances, including markedly elevated glycemic indices and significantly impaired renal function compared to other groups.
Jun 02, 2026
Vera Therapeutics and the FDA aligned on an earlier ORIGIN 3 eGFR analysis plan to support potential full approval of atacicept for IgA Nephropathy, with results now expected in Q3 2026. The company plans to submit a supplemental BLA in Q4 2026 following positive results. The pivotal trial previously met its primary endpoint with a 46% reduction in proteinuria.
May 30, 2026
Tempus has launched "Preview," an AI-powered tool that provides early cancer insights within one day of sample receipt to inform treatment planning. The tool focuses on high-impact biomarkers including MSI-H, EGFR mutations, and FGFR fusions across several cancer types. The launch aligns with expert emphasis on the critical role of early biomarker testing in personalizing therapy for EGFR-mutated NSCLC.
May 22, 2026
FDA approves AstraZeneca and Daiichi Sankyo's Datroway for first-line TNBC patients not eligible for PD-1/L1 inhibitors, based on Phase III TROPION-Breast02 data showing a 21% reduction in risk of death versus chemotherapy.
May 18, 2026
Nurix reported new oncology preclinical data at AACR 2026 and outlined progress in its immunology degrader pipeline. The company said NX-3911 could enter an IND this year and Phase 1 data for bexobrutideg are planned this year.
May 13, 2026
NewAmsterdam Pharma said regulatory decisions on obicetrapib in Europe, the UK and Switzerland remain expected in 2H26. PREVAIL interim analysis is planned for 4Q2026, with a result expected in 1Q2027.
May 11, 2026
Sino Biopharmaceutical won Chinese approval for a new indication for benmelstobart as maintenance therapy in unresectable stage III NSCLC after chemoradiotherapy. Phase III R-ALPS data showed significantly prolonged progression-free survival versus placebo and a manageable safety profile.
May 05, 2026
ORIC selected rinzimetostat 400 mg plus darolutamide for the Himalayas-1 Phase 3 trial in post-abiraterone mCRPC, expected to start in 1H 2026. The company reported early efficacy and safety data and said cash runway extends into 2H 2028.
May 01, 2026
European biotechs are exploring new immunotherapy targets beyond PD-1/PD-L1, including BTLA, TIGIT, and SLAMF6. Lund University researchers discovered a SLAMF6-mediated immune evasion mechanism. BioNTech and GenMab are advancing next-generation ICIs and bispecific antibodies through strategic partnerships.
Apr 23, 2026
The FDA accepted Hansa Biopharma’s BLA for imlifidase and set a PDUFA action date of Dec. 19, 2026. The filing is backed by Phase 3 ConfIdeS data showing statistically significant efficacy.
Apr 16, 2026
The FDA approved once-monthly subcutaneous amivantamab with lazertinib for first-line EGFR-mutated advanced NSCLC. PALOMA-2 showed high response rates and no new safety signals.
Apr 14, 2026
The FDA granted full approval to Filspari to reduce proteinuria in patients aged eight and older with FSGS without nephrotic syndrome. The decision was based on Phase III DUPLEX data versus irbesartan.
Apr 14, 2026
Vir Biotechnology has dosed the first patient in a Phase I VIR-5500 expansion cohort for metastatic prostate cancer. The trial is evaluating VIR-5500 as monotherapy and in combination settings across mCRPC and mHSPC.
Apr 08, 2026
ALX Oncology has multiple 2026 catalysts for Evorpacept and ALX2004. Interim ASPEN-09 data are expected in Q3 2026, while an initial safety update from the phase 1 ALX2004 trial is expected in 1H 2026.
Apr 03, 2026
Final phase 3 trial results show atrasentan (Vanrafia®) provides significant long-term kidney function benefits in IgA nephropathy patients, with a 2.59 mL/min/1.73m² eGFR improvement versus placebo. Earlier phase 2 data demonstrated the drug reduces proteinuria by 30.7% when added to standard background therapy. The drug's manufacturer plans to seek traditional FDA approval in 2026 based on these findings.
Apr 02, 2026
The antibody-drug conjugate sacituzumab tirumotecan demonstrated significant survival benefits in pretreated EGFR-mutated NSCLC, with median overall survival of 20.0 months versus 13.5 months for docetaxel. The treatment also showed superior progression-free survival and objective response rates with a favorable safety profile compared to chemotherapy.
Apr 02, 2026
FDA has cleared a robotic nipple-sparing mastectomy platform after clinical trials showed excellent results with preserved breast sensation. Researchers are advancing immunotherapy combinations for breast cancer and novel strategies to overcome drug resistance in EGFR-mutated lung cancer, including protein degraders and dual-binding inhibitors.
Apr 01, 2026
Multiple phase 3 breast cancer trials reported significant findings in early 2026, including positive results for novel therapies across different subtypes. Key data includes progression-free survival benefits for palbociclib in HR-positive, HER2-positive advanced breast cancer and investigations of antibody-drug conjugates and combination therapies. Full trial findings are expected to be presented at upcoming medical meetings.
