This section highlights FDA-related milestones and regulatory updates for drugs developed by Corbus Pharmaceuticals (CRBP).
Over the past two years, Corbus Pharmaceuticals has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
CRB-701, CRB-913, and CRB-601. 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.
CRB-701 FDA Regulatory Timeline and Events
CRB-701 is a drug developed by Corbus Pharmaceuticals for the following indication: Targets the expression of Nectin-4 on cancer cells.
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:
- CRB-701
- Announced Date:
- May 21, 2026
- Indication:
- Targets the expression of Nectin-4 on cancer cells
Announcement
Corbus Pharmaceuticals Holdings, Inc announced that the Company's management team will host a conference call and webcast on Tuesday, May 26 at 8:00 a.m. EDT to discuss updated data for its Phase 1/2 study of CRB-701, a next-generation Nectin-4 antibody drug candidate (ADC), in both head and neck squamous cell carcinoma (HNSCC) as well as cervical cancer.
AI Summary
Corbus Pharmaceuticals said its management team will hold a conference call and webcast on Tuesday, May 26 at 8:00 a.m. EDT to share updated data from its Phase 1/2 study of CRB-701, a next-generation Nectin-4 antibody-drug conjugate. The company is evaluating the drug in two cancers: head and neck squamous cell carcinoma (HNSCC) and cervical cancer.
Corbus also said it is moving toward two major pipeline milestones this summer: starting a registrational study of CRB-701 in second-line HNSCC and finishing the CANYON-1 Phase 1b dose-ranging study for CRB-913, its oral CB1 inverse agonist. In addition, the company named Nishant Saxena, a former Evercore managing director, as its first Chief Business Officer. Updated CRB-701 data will also be presented at ASCO in oral and poster sessions.
Read Announcement- Drug:
- CRB-701
- Announced Date:
- April 7, 2026
- Indication:
- Targets the expression of Nectin-4 on cancer cells
Announcement
Corbus Pharmaceuticals announced broad alignment with the U.S. Food and Drug Administration (FDA) on the registration path for CRB-701, the Company's next-generation, highly stable Nectin-4 targeting ADC, in head and neck squamous cell carcinoma (HNSCC) and cervical cancer.
AI Summary
Corbus Pharmaceuticals announced broad alignment with the U.S. Food and Drug Administration on the registration path for CRB-701, its next-generation, highly stable Nectin-4 targeting antibody-drug conjugate (ADC). The FDA feedback enables Corbus to proceed with the proposed registrational study designs and endpoints aimed at supporting potential accelerated approval in second-line head and neck squamous cell carcinoma (HNSCC) and cervical cancer.
The agreed-upon second-line registrational designs define the key endpoints and overall approach needed to evaluate CRB-701 as monotherapy in these tumor types. Corbus plans to initiate the registrational study in second-line HNSCC in mid-2026. Updated monotherapy data for CRB-701 has been accepted for presentation at ASCO 2026, which the company says will inform ongoing development.
Company leadership called the FDA alignment an important regulatory milestone that clears a path toward late-stage development and potential accelerated approval as Corbus prepares to advance CRB-701 into registrational testing.
Read Announcement- Drug:
- CRB-701
- Announced Date:
- October 18, 2025
- Indication:
- Targets the expression of Nectin-4 on cancer cells
Announcement
Corbus Pharmaceuticals announced data from its Phase 1/2 clinical study of CRB-701 (SYS6002) will be presented as a poster at the 2025 European Society for Medical Oncology (ESMO25) Congress being held in Berlin, Germany.
AI Summary
Corbus Pharmaceuticals announced that data from its Phase 1/2 study of CRB-701 (SYS6002) will be presented as a poster at the 2025 European Society for Medical Oncology (ESMO25) Congress in Berlin. The poster, titled “Phase 1/2 study of the next-generation Nectin-4-targeting antibody–drug conjugate CRB-701 (SYS6002) in patients with urothelial and non-urothelial solid tumors,” will be shown on October 19, 2025, from 12:00 to 12:45 CEST (Poster #967P).
As of September 1, 2025, 167 patients were enrolled across the U.S. and Europe, with 122 evaluable for efficacy. At the 3.6 mg/kg dose, objective response rates reached 47.6% in head and neck squamous cell carcinoma, 37.5% in cervical cancer, and 55.6% in metastatic urothelial cancer. CRB-701 showed no dose-limiting toxicities and a manageable safety profile, with common side effects such as fatigue, anemia, alopecia, and keratitis.
Registrational studies are planned to begin in mid-2026. During ESMO25, Corbus will host a head and neck cancer expert event featuring leading physicians to discuss the findings and answer questions.
Read Announcement- Drug:
- CRB-701
- Announced Date:
- October 14, 2025
- Indication:
- Targets the expression of Nectin-4 on cancer cells
Announcement
Corbus Pharmaceuticals announced today the European Society for Medical Oncology (ESMO) Congress 2025 abstract for its Phase 1/2 clinical study has been released.
AI Summary
Corbus Pharmaceuticals announced that its European Society for Medical Oncology (ESMO) Congress 2025 abstract for a Phase 1/2 clinical study has been released. The abstract includes safety data from an April 2025 data cut on 70 participants. Updated results from a September 1, 2025 data cut will be presented as a poster during ESMO, covering 167 enrolled patients of whom 122 were evaluable for efficacy. Tumor types include head and neck squamous cell carcinoma (n=41), cervical cancer (n=37), metastatic urothelial tumors (n=23), and other solid tumors (n=21).
The poster, titled “Phase 1/2 study of the next-generation Nectin-4-targeting antibody–drug conjugate CRB-701 (SYS6002) in patients with urothelial and non-urothelial solid tumours,” will be presented on Sunday, October 19, from 12:00–12:45 CEST (Poster #967P).
Corbus will also host an in-person and virtual head and neck cancer event for KOLs at the Berlin Marriott on October 19 at 10:00 AM CEST. Experts Ari Rosenberg, MD; Glenn Hanna, MD; and Cesar Augusto Perez Batista, MD, will review and discuss the data, followed by a live Q&A session.
Read Announcement- Drug:
- CRB-701
- Announced Date:
- September 16, 2025
- Indication:
- Targets the expression of Nectin-4 on cancer cells
Announcement
Corbus Pharmaceuticals announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to CRB-701 for the treatment of recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) previously treated with platinum-based chemotherapy and an anti-PD(L)-1 therapy.
Read Announcement- Drug:
- CRB-701
- Announced Date:
- July 30, 2025
- Indication:
- Targets the expression of Nectin-4 on cancer cells
Announcement
Corbus Pharmaceuticals announced that an abstract on updated clinical data from its Phase 1/2 clinical study conducted in the United States and Europe of CRB-701 (SYS6002) has been accepted for presentation as a poster at the European Society for Medical Oncology (ESMO) Congress 2025, to be held October 17-21, 2025 in Berlin, Germany.
AI Summary
Corbus Pharmaceuticals Holdings announced that an abstract featuring updated clinical data from its Phase 1/2 study of CRB-701 (SYS6002) has been accepted for poster presentation at the European Society for Medical Oncology (ESMO) Congress 2025. The study is being conducted in both the United States and Europe, and focuses on safety, tolerability and early signs of anti-tumor activity in patients with advanced solid tumors.
CRB-701 is a next-generation antibody–drug conjugate designed to target Nectin-4, a protein overexpressed on many types of cancer cells. By delivering a potent cytotoxic payload directly to tumor cells, it aims to improve treatment precision and reduce off-target effects compared to standard therapies.
The poster presentation is scheduled for October 17–21, 2025, in Berlin, Germany. Corbus expects to share detailed safety and efficacy results, which may help guide further development of CRB-701 in upcoming clinical trials.
Read Announcement- Drug:
- CRB-701
- Announced Date:
- June 25, 2025
- Indication:
- Targets the expression of Nectin-4 on cancer cells
Announcement
Corbus Pharmaceuticals announced the dosing of the first participant in the PD-1 combination arm of its Phase 1 study investigating CRB-701 in solid tumors (the Phase 1 Western study).
AI Summary
Corbus Pharmaceuticals has reached an important milestone in its Phase 1 Western study of CRB-701 for solid tumors. The company announced that the first participant in the PD-1 combination arm has been dosed. In this part of the study, patients are receiving CRB-701 alongside Keytruda® (pembrolizumab). Test subjects are randomly assigned to one of two dosing groups, either 2.7 mg/kg or 3.6 mg/kg. This trial aims to evaluate the safety and effectiveness of combining these treatments, specifically targeting cancers with high Nectin-4 expression.
The study focuses on patients with advanced solid tumors, including those with Head and Neck Squamous Cell Carcinoma (HNSCC) and cervical cancer. With over 100 participants already dosed in the monotherapy cohort, the initiation of the PD-1 combination arm marks a significant development as the researchers work to determine the best dose for future trials.
Read Announcement- Drug:
- CRB-701
- Announced Date:
- March 11, 2025
- Indication:
- Targets the expression of Nectin-4 on cancer cells
Announcement
Corbus Pharmaceuticals provided a corporate update
AI Summary
Corbus Pharmaceuticals provided a corporate update that highlighted significant progress in its clinical pipeline. The update focused on CRB-701, a next-generation antibody drug conjugate that targets Nectin-4 on cancer cells. Early clinical data from a Phase 1 study in Western patients showed a promising safety profile with low levels of peripheral neuropathy and skin toxicity, as well as encouraging signs of effectiveness in multiple advanced tumor types, including urothelial, cervical, and head and neck cancers. The company is currently optimizing the dosing in cohorts of 2.7 mg/kg and 3.6 mg/kg, aiming to establish a recommended Phase 2 dose under Project Optimus by the end of 2025. Additionally, the FDA granted Fast Track designation to CRB-701 for the treatment of relapsed or refractory metastatic cervical cancer, underlining its potential as a valuable treatment option.
Read Announcement- Drug:
- CRB-701
- Announced Date:
- February 11, 2025
- Indication:
- Targets the expression of Nectin-4 on cancer cells
Announcement
Corbus Pharmaceuticals announced that the abstract for its first-in-human dose escalation clinical study conducted in the United States and Europe ("Western study") of CRB-701 (SYS6002) has been released.
AI Summary
Corbus Pharmaceuticals announced that the abstract for its first-in-human dose escalation clinical study, called the Western study, has been released. The study evaluates CRB-701 (SYS6002), a next-generation antibody-drug conjugate targeting Nectin-4, in patients with urothelial cancer and other advanced solid tumors.
The trial, conducted in the United States and Europe, is divided into three parts. Part A focuses on dose escalation and tests four predetermined doses to assess safety, pharmacokinetics, and initial efficacy signals. Updated results from 38 patients, expanding on earlier data from 31 patients, will be presented as a poster at the 2025 American Society of Clinical Oncology Genitourinary Cancers Symposium.
This study represents a significant step in optimizing the dosing of CRB-701 and further exploring its potential as an innovative treatment option for cancer patients.
Read Announcement - Drug:
- CRB-701
- Announced Date:
- December 3, 2024
- Indication:
- Targets the expression of Nectin-4 on cancer cells
Announcement
Corbus Pharmaceuticals announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to CRB-701 for the treatment of relapsed or refractory metastatic cervical cancer.
AI Summary
Corbus Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation to its drug CRB-701, aimed at treating relapsed or refractory metastatic cervical cancer. This special FDA designation is designed to speed up the development and review process for drugs that show promise in addressing serious conditions with unmet medical needs. CRB-701 is a next-generation antibody drug conjugate that targets the Nectin-4 protein on cancer cells, using a precise formulation that includes a cleavable linker and MMAE as its cytotoxic payload.
The Fast Track status reflects the potential of CRB-701 to offer new treatment options for patients with aggressive cervical cancer. The drug is currently under investigation in a Phase 1 clinical trial in the U.S. and Europe, with initial dosing data expected to be released in the first quarter of 2025.
Read Announcement
CRB-913 FDA Regulatory Timeline and Events
CRB-913 is a drug developed by Corbus Pharmaceuticals for the following indication: For Obesity.
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:
- CRB-913
- Announced Date:
- April 14, 2026
- Indication:
- For Obesity
Announcement
Corbus Pharmaceuticals announced the last patient has been enrolled and completed the first clinical visit (Last Patient First Visit) in the Company's CANYON-1 Phase 1b clinical trial of CRB-913 for the treatment of obesity.
AI Summary
Corbus Pharmaceuticals announced the Last Patient First Visit in its CANYON‑1 Phase 1b trial of CRB‑913 for obesity, meaning the final enrolled subject has completed their initial clinical visit. This milestone marks the start of full participant dosing and moves the study into its active treatment phase.
The randomized, dose‑finding Phase 1b will enroll about 240 people and runs for 16 weeks. Corbus says the study is on track for completion in summer 2026. Results from this stage are intended to build on Phase 1a data and help define safe and effective dosing.
CRB‑913 is a daily oral, non‑incretin small molecule being developed for weight loss and long‑term weight management. In Phase 1a, short‑term findings showed nearly a 3% average weight loss at 14 days, and Phase 1b aims to expand on those initial efficacy and safety signals.
Read Announcement- Drug:
- CRB-913
- Announced Date:
- December 11, 2025
- Indication:
- For Obesity
Announcement
Corbus Pharmaceuticals announced the completion of the single ascending dose (SAD) and multiple ascending dose (MAD) Phase 1a study of CRB-913 and the initiation of a Phase 1b dose-range finding study ("CANYON-1"), with completion expected in summer 2026.
AI Summary
Corbus Pharmaceuticals completed a double-blind, placebo-controlled Phase 1a study of CRB-913, including a single ascending dose (SAD, n=64 across eight cohorts) and a multiple ascending dose (MAD, n=48 across four cohorts). CRB-913, a peripherally restricted oral CB1 inverse agonist, was safe and well tolerated across all doses with no serious treatment-emergent adverse events and minimal gastrointestinal effects. Daily neuropsychiatric assessments (C-SSRS, PHQ-9, GAD-7) remained negative for all participants, and pharmacokinetics supported once-daily dosing. In the dedicated obese MAD cohort (150 mg QD), treated participants showed a placebo-adjusted mean weight loss of 2.9% at Day 14.
Building on these results, Corbus has initiated CANYON-1, a 12-week Phase 1b dose-ranging study in approximately 240 obese, non-diabetic participants with placebo and 20 mg, 40 mg, and 60 mg QD arms (with titration). The company expects CANYON-1 to complete in summer 2026.
Read Announcement- Drug:
- CRB-913
- Announced Date:
- December 10, 2025
- Target Action Date:
- December 11, 2025
- Indication:
- For Obesity
Announcement
Corbus Pharmaceuticals announced the Company's plan to release results of its Phase 1a single ascending dose (SAD) and multiple ascending dose (MAD) study of CRB-913 prior to the market open on Thursday, December 11, 2025.
AI Summary
Corbus Pharmaceuticals said it will release results from its Phase 1a single ascending dose (SAD) and multiple ascending dose (MAD) study of CRB-913 before the market opens on Thursday, December 11, 2025. The company will discuss the data the same day on a conference call and live webcast at 8:00 am ET. A replay will be available on Corbus’s website for those unable to attend.
CRB-913 is an oral small molecule inverse agonist of the CB1 G‑protein coupled receptor, a known target for weight loss. Earlier drugs in this class were stopped because of possible neuropsychiatric side effects. Corbus designed CRB-913 to be highly peripherally restricted so it has reduced penetration into the brain, which could lower central nervous system risks while retaining effects on body weight.
Preclinical tests show CRB-913 is about 15-fold less brain-penetrant than monlunabant and has a roughly 50-fold lower brain:plasma ratio than rimonabant. The upcoming Phase 1a SAD and MAD results will report initial safety, tolerability, and dose-ranging findings.
Read Announcement- Drug:
- CRB-913
- Announced Date:
- June 30, 2025
- Indication:
- For Obesity
Announcement
Corbus Pharmaceuticals Holdings Inc. announced the initiation of the multiple ascending dose (MAD) portion of its Phase 1 trial for CRB-913, a highly peripherally restricted CB1 inverse agonist for the treatment of obesity.
AI Summary
Corbus Pharmaceuticals Holdings Inc. has announced the launch of the multiple ascending dose (MAD) portion of its Phase 1 trial for CRB-913, a highly peripherally restricted CB1 inverse agonist designed to treat obesity. This next phase of the trial comes after favorable safety and pharmacokinetics data from the single ascending dose (SAD) study, where no treatment-related neuropsychiatric events were observed even at higher dosages. The MAD study will test once-daily dosing over 7 days in healthy volunteers, focusing on safety, tolerability, and pharmacokinetics as the doses increase.
With key data from both parts of the Phase 1 trial expected to be completed by the third quarter of 2025, the company is optimistic about CRB-913’s potential. Positive results from this study will help set the stage for a Phase 1b dose-range finding study in obese patients later in the year.
Read Announcement- Drug:
- CRB-913
- Announced Date:
- March 28, 2025
- Indication:
- For Obesity
Announcement
Corbus Pharmaceuticals Holdings, Inc announced today the dosing of the first subject in the single ascending dose / multiple ascending dose (SAD/MAD) portion of the Phase 1 trial of CRB-913 for the treatment of obesity.
AI Summary
Corbus Pharmaceuticals Holdings, Inc. announced a significant milestone in its obesity treatment program with the dosing of the first subject in the single ascending dose/multiple ascending dose (SAD/MAD) portion of its Phase 1 trial for CRB-913. This second-generation, highly peripherally restricted cannabinoid type-1 (CB1) receptor inverse agonist is designed to aid weight loss while reducing the risk of neuropsychiatric side effects seen in earlier drugs like rimonabant. Pre-clinical studies highlight that CRB-913 is markedly more peripherally restricted compared to other similar compounds.
The current SAD/MAD trial is scheduled for completion in Q3 2025, with plans to begin a Phase 1b dose-range finding study in Q4 2025, which is expected to conclude in the second half of 2026. This study marks an important step for Corbus in addressing unmet needs in obesity treatment.
Read Announcement
CRB-601 FDA Regulatory Events
CRB-601 is a drug developed by Corbus Pharmaceuticals for the following indication: Designed to block the activation of latent TGFβ in the tumor microenvironment.
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:
- CRB-601
- Announced Date:
- December 9, 2024
- Indication:
- Designed to block the activation of latent TGFβ in the tumor microenvironment
Announcement
Corbus Pharmaceuticals announced the dosing of the first patient in the Phase 1 portion of the clinical study of CRB-601 for the treatment of patients with advanced solid tumors (NCT06603844).
AI Summary
Corbus Pharmaceuticals has reached an important milestone by dosing the first patient in the Phase 1 part of its clinical study for CRB-601 in patients with advanced solid tumors (NCT06603844). CRB-601 is a monoclonal antibody that targets latent TGFβ by blocking the integrin αVβ8. This study is designed to explore new ways to mobilize the immune system against tumors and potentially improve the effects of existing immune therapies.
Pre-clinical data showed that CRB-601 may help overcome tumor immune exclusion, boosting the activity of immune checkpoint inhibitors. The early stage dose escalation study aims to gather valuable insights on the drug's safety and its potential to trigger an immune response. Researchers hope that these results could lead to advancements in immunotherapy for patients with advanced solid tumors.
Read Announcement
