Related coverage linked through entity extraction aliases.
Jun 01, 2026
The FDA has accepted for review a New Drug Application for tirabrutinib, a Bruton tyrosine kinase inhibitor, for relapsed or refractory primary central nervous system lymphoma. The application is based on phase 2 PROSPECT trial data showing an overall response rate of 67% and complete response rate of 44%. The target action date is December 18, 2026.
May 31, 2026
BioNTech presented phase 2 data for HER2-directed ADC Trastuzumab Pamirtecan showing 47.9% response rate in endometrial cancer, with FDA submission planned for 2026. BioLineRx dosed first patient in phase 1/2a GLIX1 trial for glioblastoma and reported new preclinical data. Both companies presented at ASCO 2026.
May 29, 2026
BMS's mezigdomide doubled progression-free survival in relapsed/refractory multiple myeloma at ASCO, while the FDA reviews iberdomide with a decision due by August 17. C4 Therapeutics has dosed the first patient in its Phase 2 MOMENTUM trial of cemsidomide.
May 26, 2026
BioNTech faces mixed analyst views as Bernstein initiates with a cautious Market Perform rating, while the company secures FDA Fast Track designation for BNT113 and prepares for a shareholder vote on capital restructuring and leadership transition.
May 19, 2026
The FDA has accepted the New Drug Application for giredestrant plus everolimus in ESR1-mutated, ER-positive, HER2-negative advanced breast cancer. The filing is based on Phase III evERA data showing reduced risk of disease progression or death versus standard-of-care endocrine therapy plus everolimus.
May 05, 2026
Topline phase 3 VIKTORIA-1 results showed gedatolisib combinations improved progression-free survival versus alpelisib plus fulvestrant in PIK3CA-mutant HR-positive/HER2-negative advanced breast cancer. Celcuity plans a supplemental FDA filing based on the data.
May 02, 2026
FDA has accepted the NDA for vepdegestrant (ARV-471), an oral PROTAC ER degrader from Arvinas and Pfizer, for ESR1-mutated ER+/HER2- advanced breast cancer. A PDUFA date of June 5, 2026 has been set. The submission is based on positive Phase 3 VERITAC-2 data.
May 01, 2026
Crescent Biopharma dosed the first patient in its ASCEND Phase 1/2 trial of CR-001, a PD-1 x VEGF bispecific antibody for solid tumors. The company also reported Q1 2026 results and outlined pipeline milestones including ADC combination trials expected in the second half of 2026.
Apr 29, 2026
Immunome submitted an NDA to the FDA for varegacestat in desmoid tumors after the Phase 3 RINGSIDE trial showed an 84% reduction in progression risk (HR=0.16) and a 56% objective response rate. The company plans to file in Q2 2026.
Apr 24, 2026
AstraZeneca will report pivotal first-half data on sonesitatug vedotin in Claudin18.2 gastric cancer. The phase 3 Clarity-Gastric01 study is enrolling patients with ≥25% expression.
Apr 24, 2026
A study in stage 3 dMMR colon cancer found that atezolizumab plus chemotherapy after surgery cut recurrence and death risk by 50%. The trial enrolled 712 patients and the regimen is now included in treatment guidelines.
Apr 22, 2026
Ascentage Pharma said six clinical abstracts were selected for ASCO 2026 and four preclinical studies will be presented at AACR 2026. The presentations feature olverembatinib and other pipeline candidates.
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 14, 2026
Daraxonrasib showed median overall survival of 13.2 months versus 6.7 months for chemotherapy in a Phase III trial in previously treated metastatic pancreatic adenocarcinoma. The once-daily pan-RAS(ON) inhibitor was generally well tolerated, and the company plans to seek FDA approval.
Apr 08, 2026
The FDA granted fast track designation to SIM0505, a CDH6-targeting antibody-drug conjugate, for platinum-resistant ovarian cancer based on preclinical and early clinical data. A phase 1 trial is currently evaluating the drug in advanced solid tumors, with initial data expected at the 2026 ASCO conference. The company plans to begin dose optimization studies in ovarian cancer patients in Q2 2026.
Apr 03, 2026
MacroGenics faces critical 2026 milestones for its ADC pipeline, including Phase 1 data for MGC026 and regulatory resolution for lorigerlimab. The company has financial runway through 2027 and plans IND submission for MGC030 in Q3 2026. Key investor events include ASCO abstract releases and financial results in Q2 2026.
Mar 02, 2026
The FDA has accepted New Drug Applications for rusfertide in polycythemia vera with Priority Review and tirabrutinib for relapsed/refractory primary CNS lymphoma under Accelerated Approval, with PDUFA dates set for Q3 2026 and December 2026 respectively.
Feb 28, 2026
A T-cell engager drug called VIR-5500 demonstrated tumor shrinkage or growth halt in 45% of evaluable patients with advanced prostate cancer in a phase 1 trial, with 88% experiencing only mild side-effects.
Feb 27, 2026
New research shows cancer survivors who exercise reduce their risk of cancer-related death, while expert panel recommends exercise as essential for older cancer patients during and after treatment.
Feb 24, 2026
Enhertu combined with pertuzumab received FDA approval for first-line treatment of HER2-positive metastatic breast cancer, marking the first new treatment in a decade. Real-world data show trastuzumab deruxtecan efficacy is consistent across patient subgroups.
