This section highlights FDA-related milestones and regulatory updates for drugs developed by NextCure (NXTC).
Over the past two years, NextCure has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
SIM0505, LNCB74, and NC410. 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.
SIM0505 FDA Regulatory Timeline and Events
SIM0505 is a drug developed by NextCure for the following indication: in patients with advanced solid tumors.
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:
- SIM0505
- Announced Date:
- May 4, 2026
- Indication:
- in patients with advanced solid tumors.
Announcement
NextCure, Inc. announced initiation of the dose optimization portion of the Phase 1 study of SIM0505, focusing on patients with platinum-resistant ovarian cancer.
AI Summary
NextCure, Inc. announced it has begun the dose optimization portion of its Phase 1 study of SIM0505. This stage will initially focus on patients with platinum-resistant ovarian cancer (PROC), a form of ovarian cancer that no longer responds to standard platinum chemotherapy. Dose optimization aims to find the safest and most effective dose by testing different dose levels and schedules, monitoring safety, side effects, drug behavior in the body, and early signs of clinical activity in these patients.
SIM0505 is an investigational therapy developed by NextCure, a clinical-stage biopharmaceutical company that advances targeted cancer medicines, including antibody-drug conjugates. The company plans to present Phase 1 data from the study at ASCO 2026. Results from dose optimization will help determine the recommended dose for later trials and guide further development for patients with PROC.
Read Announcement- Drug:
- SIM0505
- Announced Date:
- April 7, 2026
- Indication:
- in patients with advanced solid tumors.
Announcement
NextCure, Inc. announced that the U.S. Food And Drug Administration (FDA) has granted Fast Track Designation for SIM0505 for the treatment of platinum-resistant ovarian cancer. SIM0505 is an investigational antibody drug conjugate (ADC) comprised of an antibody that targets Cadherin-6 (CDH6) and a proprietary topoisomerase 1 inhibitor (TOPOi) payload.
AI Summary
The U.S. Food and Drug Administration has granted Fast Track designation to SIM0505 for the treatment of women with platinum‑resistant ovarian cancer. SIM0505 is an investigational antibody‑drug conjugate that pairs an antibody targeting Cadherin‑6 (CDH6) with a proprietary topoisomerase‑1 inhibitor payload. NextCure, a clinical‑stage biopharmaceutical company focused on targeted cancer therapies, is developing the candidate to address an unmet need in this hard‑to‑treat disease.
Fast Track status is intended to speed development and review for therapies treating serious conditions, making SIM0505 eligible for more frequent FDA meetings, rolling review, and potential priority review. NextCure plans to present Phase 1 data for SIM0505 at ASCO 2026, with dose optimization in ovarian cancer expected to begin in the second quarter of 2026.Read Announcement
- Drug:
- SIM0505
- Announced Date:
- January 23, 2026
- Indication:
- in patients with advanced solid tumors.
Announcement
NextCure, Inc. today provided updates for its two antibody drug conjugate (ADC) programs and reported a preliminary year-end 2025 cash position.
AI Summary
NextCure reported updates on two antibody-drug conjugate (ADC) programs. SIM0505, an ADC targeting cadherin-6 (CDH6) with a topoisomerase I inhibitor payload, is in an open-label Phase 1 dose-escalation trial (NCT06792552) for advanced solid tumors, focusing on gynecologic cancers and platinum-resistant ovarian cancer. The company expects to present dose-escalation data in Q2 2026, is adding clinical sites, increasing drug supply, and plans to start dose optimization in the first half of 2026. LNCB74, an ADC targeting B7-H4 with an MMAE payload, has begun dosing higher dose cohorts after a November 2025 protocol amendment. Those cohorts will prioritize patients with high B7-H4 expression in breast and gynecologic cancers and now include adenoid cystic carcinoma type 1. Proof-of-concept data timing was pushed back, with a trial progress update expected in the second half of 2026.
NextCure reported preliminary, unaudited cash, cash equivalents and marketable securities of approximately $41.8 million as of December 31, 2025, and expects current resources to fund operations into the first half of 2027.
Read Announcement- Drug:
- SIM0505
- Announced Date:
- October 16, 2025
- Indication:
- in patients with advanced solid tumors.
Announcement
NextCure, announced that the first patient in the U.S. has been dosed with SIM0505 in the ongoing Phase 1 trial (NCT06792552), which is evaluating safety, tolerability, pharmacokinetics and efficacy in patients with advanced solid tumors.
AI Summary
NextCure and Simcere Zaiming announced the first U.S. patient has been dosed with SIM0505 in the ongoing Phase 1 trial (NCT06792552). This study is evaluating safety, tolerability, pharmacokinetics and early signs of effectiveness in patients with advanced solid tumors.
SIM0505 is an antibody-drug conjugate targeting cadherin-6, equipped with a proprietary topoisomerase I inhibitor payload. It is designed for broad anti-tumor activity, rapid systemic clearance and a wider therapeutic window. After observing multiple responses at mid-tier dose levels in China, NextCure expanded enrollment in the U.S. at those same doses while dose escalation continues overseas. NextCure holds an exclusive global license (outside Greater China) for the asset.
“SIM0505 has been well tolerated with a favorable safety profile,” said Udayan Guha, M.D., Ph.D., NextCure’s Chief Medical Officer. The company plans to accelerate this multi-regional trial and present proof-of-concept data in the first half of 2026.
This milestone underscores NextCure’s commitment to advancing innovative cancer therapies worldwide and speeding the path to clinical proof of concept.
Read Announcement
LNCB74 FDA Regulatory Timeline and Events
LNCB74 is a drug developed by NextCure for the following indication: For treating multiple cancers.
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:
- LNCB74
- Announced Date:
- March 6, 2025
- Indication:
- For treating multiple cancers.
Announcement
NextCure, Inc. provided a business update
AI Summary
NextCure, Inc. provided a business update alongside its full year 2024 financial results. The company highlighted significant progress in its antibody-drug conjugate (ADC) program, focusing on LNCB74 (B7-H4 ADC) as a potential treatment for multiple cancers. They successfully completed cohort 1 of the Phase 1 trial in February 2025 and plan to start additional backfill cohorts in the latter half of 2025. CEO Michael Richman explained that in 2024 the company reallocated resources to fast-track the ADC program, emphasizing the importance of these milestones in their development strategy.
NextCure also noted that its current cash resources, totaling approximately $68.6 million, are expected to fund operations into the second half of 2026. This update underscores the company’s commitment to advancing innovative cancer treatments through continued clinical progress.
Read Announcement - Drug:
- LNCB74
- Announced Date:
- January 10, 2025
- Indication:
- For treating multiple cancers.
Announcement
NextCure, Inc. announced the first patient has been dosed in its Phase 1 study of LNCB74, a B7-H4-targeting antibody-drug conjugate (ADC) as a therapeutic for treating multiple cancers.
AI Summary
NextCure, Inc. announced a major milestone in its cancer treatment research by dosing the first patient in its Phase 1 study of LNCB74. This new therapy is an antibody-drug conjugate (ADC) that specifically targets the B7-H4 protein found in various cancers. The Phase 1 trial is designed to evaluate the safety and tolerability of LNCB74, as well as its early signs of anti-tumor activity in patients with multiple cancer types.
The dosing marks the beginning of a crucial phase in the development of LNCB74, where researchers hope to demonstrate that this novel treatment option may improve outcomes for cancer patients. NextCure is excited about the potential of this ADC to pave the way for more effective therapies and to bring new hope to patients with limited treatment options.
Read Announcement- Drug:
- LNCB74
- Announced Date:
- December 10, 2024
- Indication:
- For treating multiple cancers.
Announcement
NextCure, Inc. announced that the U.S. Food and Drug Administration (FDA) accepted an Investigational New Drug (IND) application for initiation of a Phase 1 clinical trial to evaluate LNCB74, a B7-H4-targeting antibody-drug conjugate (ADC) as a therapeutic for treating multiple cancers.
AI Summary
NextCure, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application to begin a Phase 1 clinical trial for LNCB74. This new treatment is a B7-H4-targeting antibody‐drug conjugate (ADC) being developed to address multiple cancers. The trial will focus on evaluating the safety and potential effectiveness of LNCB74, following promising preclinical data that distinguishes it from other ADCs targeting B7-H4.
The acceptance of the IND marks an important milestone for NextCure, highlighting their commitment to advancing innovative cancer therapies. By launching this Phase 1 study, the company aims to improve treatment options for patients and strengthen its ADC program. The progress of LNCB74 into clinical development brings renewed hope for more effective cancer care in the future.
Read Announcement
NC410 FDA Regulatory Events
NC410 is a drug developed by NextCure for the following indication: In Combination with Pembrolizumab.
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:
- NC410
- Announced Date:
- September 16, 2024
- Indication:
- In Combination with Pembrolizumab
Announcement
NextCure, Inc. announced that clinical data from the Phase 1b portion of a Phase 1b/2 study evaluating NC410, a LAIR-2 fusion protein, in combination with pembrolizumab was presented at ESMO 2024.
AI Summary
NextCure, Inc. announced new clinical data at ESMO 2024 from the Phase 1b portion of its Phase 1b/2 study. The study evaluated NC410, a LAIR-2 fusion protein, in combination with pembrolizumab for treatment of ovarian cancer and colorectal cancer (CRC) patients. These patients included individuals who had not previously received immune checkpoint inhibitors as well as those with refractory disease.
The clinical results showed promising activity with durable responses in these hard-to-treat cancers. Trial investigators, including Emese Zsiros, M.D., Ph.D., and Eric S. Christenson, M.D., presented the Phase 1b data, noting partial responses and stable disease in the treated patients. NextCure plans to continue monitoring the patients and expects to provide further updates later this year.
Read Announcement
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