This section highlights FDA-related milestones and regulatory updates for drugs developed by Xencor (XNCR).
Over the past two years, Xencor has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
XmAb819 and XmAb942. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
XmAb819 FDA Regulatory Timeline and Events
XmAb819 is a drug developed by Xencor for the following indication: patients with clear cell renal cell carcinoma.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- XmAb819
- Announced Date:
- October 19, 2026
- Indication:
- patients with clear cell renal cell carcinoma
Announcement
Xencor, Inc. a clinical-stage biopharmaceutical company developing engineered antibodies for the treatment of cancer and autoimmune diseases, will host a webcast on Monday, October 26 at 7:00 a.m. EDT (4:00 a.m. PDT) to discuss results from the Phase 1 Study of XmAb819, an ENPP3 x CD3 T-cell engaging bispecific antibody, in development for patients with advanced clear cell renal cell carcinoma (ccRCC).
Read Announcement- Drug:
- XmAb819
- Announced Date:
- October 24, 2025
- Indication:
- patients with clear cell renal cell carcinoma
Announcement
Xencor, Inc announced initial results from the ongoing Phase 1 dose-escalation study of XmAb819, a ENPP3 x CD3 T-cell engaging bispecific antibody, in patients with advanced clear cell renal cell carcinoma (ccRCC).
AI Summary
Xencor announced Phase 1 dose-escalation results of XmAb819, an ENPP3 x CD3 T-cell engager, in heavily pretreated patients with advanced clear cell renal cell carcinoma. In the target dose range, 25% of evaluable patients achieved partial responses and the disease control rate was 70%. All responders remain on treatment, and half are still being treated.
XmAb819 was generally well tolerated. The most common side effects were mild to moderate cytokine release syndrome, rash, and gastrointestinal symptoms. Grade 3 events included rash (16%), elevated liver enzymes (7%), and CRS (4%), while one Grade 4 liver enzyme elevation was dose-limiting. No treatment-related neurotoxicity or deaths occurred.
The first dose-expansion cohort has been selected, and dose escalation continues to identify a Phase 3 dose in 2026. Xencor will host a webcast today at 1:30 p.m. ET to review these data.
Read Announcement- Drug:
- XmAb819
- Announced Date:
- October 21, 2025
- Indication:
- patients with clear cell renal cell carcinoma
Announcement
Xencor, Inc. will host a conference call and webcast on Friday, October 24 at 1:30 p.m. ET (10:30 a.m. PT) to discuss initial results from the ongoing Phase 1 dose-escalation study of XmAb819, an ENPP3 x CD3 T-cell engaging bispecific antibody, in development for patients with advanced clear cell renal cell carcinoma.
Read Announcement- Drug:
- XmAb819
- Announced Date:
- October 14, 2025
- Indication:
- patients with clear cell renal cell carcinoma
Announcement
Xencor, Inc. announced the upcoming presentation of initial results from the ongoing Phase 1 dose-escalation study of XmAb819, a bispecific ENPP3 x CD3 T-cell engaging bispecific antibody, in patients with clear cell renal cell carcinoma (ccRCC) in a poster at the AACR-NCI-EORTC Conference on Molecular Targets and Cancer Therapeutics, being held October 22-26, 2025 in Boston, Massachusetts.
AI Summary
Xencor, Inc. will present initial results from its Phase 1 dose-escalation study of XmAb819 at the AACR-NCI-EORTC Conference on Molecular Targets and Cancer Therapeutics in Boston, October 22–26, 2025. The data will appear as a poster on Friday, October 24, alongside other early-stage cancer therapy updates.
XmAb819 is a first-in-class bispecific antibody that links the tumor antigen ENPP3, often found on clear cell renal cell carcinoma (ccRCC) cells, to CD3 on T cells. The ongoing trial (NCT05433142) tests safety at different dose levels and looks for signs the treatment can shrink tumors. The placeholder abstract shared a basic safety summary but did not include new efficacy details.
At the conference, Xencor will reveal an updated data cut showing detailed safety analyses and preliminary antitumor activity in the target dose range. Management plans to host a webcast and conference call after the embargo lifts to discuss these findings in depth.
Read Announcement
XmAb942 FDA Regulatory Events
XmAb942 is a drug developed by Xencor for the following indication: For the treatment of cancer and other serious diseases.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- XmAb942
- Announced Date:
- April 29, 2025
- Indication:
- For the treatment of cancer and other serious diseases
Announcement
Xencor, Inc announced positive interim results from its first-in-human study of XmAb942, a high-potency, extended half-life, investigational anti-TL1A antibody in clinical development for patients with inflammatory bowel disease (IBD), such as ulcerative colitis (UC) and Crohn's disease (CD).
AI Summary
Xencor, Inc. announced encouraging interim results from its first-in-human study of XmAb942, an investigational anti-TL1A antibody designed for patients with inflammatory bowel disease (IBD), including ulcerative colitis (UC) and Crohn’s disease (CD). The Phase 1 study in healthy volunteers showed that single and multiple doses of XmAb942 are well tolerated, with no serious side effects. Pharmacokinetic analysis revealed a human half-life of over 71 days, supporting a 12-week dosing schedule during maintenance treatment. Based on these promising findings, Xencor plans to begin the Phase 2b trial, XENITH-UC, in patients with moderate-to-severe UC in the second half of 2025. These results validate the design goals for a high-potency drug that may improve clinical outcomes and convenience for patients, marking an important step forward in the treatment of IBD.
Read Announcement
