This section highlights FDA-related milestones and regulatory updates for drugs developed by BioAtla (BCAB).
Over the past two years, BioAtla has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Ozuriftamab, BA3182, BA3011, CAB-AXL-ADC, and BA3021. 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.
Ozuriftamab Vedotin FDA Regulatory Timeline and Events
Ozuriftamab Vedotin is a drug developed by BioAtla for the following indication: For Treatment of Patients with Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck.
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:
- Ozuriftamab Vedotin
- Announced Date:
- December 31, 2025
- Indication:
- For Treatment of Patients with Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
Announcement
BioAtla, Inc. announced a SPV transaction to advance ozuriftamab vedotin (Oz-V) (CAB-ROR2-ADC) in a Phase 3 Study in 2L+ oropharyngeal squamous cell carcinoma (OPSCC).
AI Summary
BioAtla announced a special purpose vehicle (SPV) transaction to advance ozuriftamab vedotin (Oz‑V) (CAB‑ROR2‑ADC) into a Phase 3 study for patients with second‑line and later (2L+) oropharyngeal squamous cell carcinoma (OPSCC). Under the deal, BioAtla will receive an initial $5 million from Inversagen AI, LLC for general operations and Phase 3 expenses, with an additional $35 million expected to close in Q1 2026 when the registrational study is planned to begin. Inversagen AI was formed by GATC Health and Inversagen LLC.
After the transaction, BioAtla will retain 65% ownership of Oz‑V across solid tumor indications and Inversagen AI will hold 35%. BioAtla will lead Phase 3 trial execution and expects enrollment to start in early 2026 and continue through a key data readout. Oz‑V targets ROR2, a receptor that drives tumor progression and helps regulate cellular senescence, and the program could be expanded to other HPV‑associated cancers.Read Announcement
- Drug:
- Ozuriftamab Vedotin
- Announced Date:
- October 23, 2025
- Indication:
- For Treatment of Patients with Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
Announcement
BioAtla, Inc announced presentation of a poster entitled "Targeting HPV E6/E7 Upregulation of the Transmembrane Receptor Tyrosine Kinase ROR2 with the ADC Ozuriftamab Vedotin in Patients with Advanced HPV+ Oropharyngeal Squamous Cell Carcinoma" which details clinical data from its investigational antibody-drug conjugate (ADC), ozuriftamab vedotin (Oz-V), at the International Papillomavirus Society (IPVS) Conference, taking place October 23–26, 2025, in Bangkok, Thailand.
AI Summary
BioAtla, Inc. announced it will present a poster titled “Targeting HPV E6/E7 Upregulation of the Transmembrane Receptor Tyrosine Kinase ROR2 with the ADC Ozuriftamab Vedotin in Patients with Advanced HPV+ Oropharyngeal Squamous Cell Carcinoma” at the International Papillomavirus Society (IPVS) Conference, October 23–26, 2025, in Bangkok, Thailand.
The poster offers a detailed molecular analysis of Ozuriftamab vedotin (Oz-V), a conditionally active antibody-drug conjugate aimed at the ROR2 receptor. It explores how HPV oncoproteins E6 and E7 drive ROR2 overexpression, creating a cancer-promoting signaling axis in oropharyngeal tumors.
In addition to new mechanistic insights, the poster highlights clinical data previously shared at other medical meetings. Attendees can view it on October 25 during the E-Poster 02 session from 6:30 to 8:00 p.m. ICT.
After the presentation, related materials will be available in the Publications section of BioAtla’s website.
Read Announcement- Drug:
- Ozuriftamab Vedotin
- Announced Date:
- September 8, 2025
- Indication:
- For Treatment of Patients with Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
Announcement
BioAtla, Inc announced outcomes from its Type B meeting with the United States Food and Drug Administration (FDA).
AI Summary
BioAtla announced that its Type B meeting with the FDA produced agreement on the design of the Phase 3 trial for ozuriftamab vedotin (Oz-V), a conditionally active ADC targeting ROR2 in HPV-positive oropharyngeal cancer.
About 300 OPSCC patients will be randomized equally between two open-label arms. The Oz-V arm will receive 1.8 mg/kg every other week, and the control arm will get cetuximab, docetaxel, or methotrexate. For accelerated approval, the FDA will look at interim overall response rate confirmed by blinded review plus duration of response without harming overall survival. Full approval requires a significant overall survival benefit.
This alignment lets BioAtla prepare for Phase 3 initiation and supports plans to partner on Oz-V early next year. The company maintains guidance to finalize a strategic collaboration this year, highlighting the CAB platform’s potential for safer, more effective cancer treatments.
Read Announcement- Drug:
- Ozuriftamab Vedotin
- Announced Date:
- June 2, 2025
- Indication:
- For Treatment of Patients with Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
Announcement
BioAtla, Inc. announced data in a poster titled, "Phase 2 Trial of Ozuriftamab Vedotin (Oz-V), a Conditionally Binding CAB-ROR2-ADC, in Patients with Heavily Pretreated Squamous Cell Carcinoma of the Head and Neck."
AI Summary
BioAtla, Inc. presented encouraging Phase 2 trial data at the 2025 ASCO Annual Meeting with a poster titled “Phase 2 Trial of Ozuriftamab Vedotin (Oz-V), a Conditionally Binding CAB-ROR2-ADC, in Patients with Heavily Pretreated Squamous Cell Carcinoma of the Head and Neck.” In this study, patients with advanced head and neck cancer received a dose of 1.8 mg/kg of Oz-V using two treatment schedules. These patients had already undergone several lines of therapy, including anti–PD-1 and platinum treatments.
For the subset of HPV+ OPSCC patients, the results were notable with a 45% overall response rate and a 100% disease control rate. The median duration of response was nearly 10 months, suggesting that Oz-V has strong antitumor activity. This data provides hope for a potential new treatment option for patients with limited alternatives in this challenging patient population.
Read Announcement- Drug:
- Ozuriftamab Vedotin
- Announced Date:
- July 23, 2024
- Target Action Date:
- H2 2024
- Estimated Target Date Range:
- July 1, 2024 - December 31, 2024
- Indication:
- For Treatment of Patients with Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
Announcement
BioAtla, Inc announced that The Company is on track to meet with the FDA for guidance on a potentially registrational trial in 2H 2024
AI Summary
BioAtla, Inc. announced that the company is on track to meet with the U.S. Food and Drug Administration (FDA) in the second half of 2024 to seek guidance on a potentially registrational trial. The focus of this meeting is ozuriftamab vedotin, a conditionally active antibody drug conjugate that targets the ROR2 receptor in several solid tumors, including squamous cell carcinoma of the head and neck (SCCHN). Clinical studies have shown that this promising drug has encouraging activity and a manageable safety profile in patients who have exhausted prior therapies. The upcoming FDA discussion is expected to provide valuable input on the trial design and key requirements for progressing ozuriftamab vedotin toward regulatory approval, marking an important step in BioAtla’s efforts to offer new treatment options for patients with limited alternatives.
Read Announcement- Drug:
- Ozuriftamab Vedotin
- Announced Date:
- July 23, 2024
- Indication:
- For Treatment of Patients with Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
Announcement
BioAtla, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to ozuriftamab vedotin, the Company's conditionally and reversibly active ROR2 antibody drug conjugate directed for the treatment of patients with recurrent or metastatic SCCHN with disease progression on or after platinum-based chemotherapy and anti-PD-1/L1 antibody therapy.
AI Summary
BioAtla, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to its drug ozuriftamab vedotin. This conditionally and reversibly active antibody drug conjugate is designed to target ROR2, a protein found on many solid tumors, including squamous cell carcinoma of the head and neck (SCCHN). The Fast Track status recognizes the drug’s potential to address a serious unmet need for patients whose disease has progressed after platinum-based chemotherapy and anti-PD-1/L1 treatments.
The designation may help expedite the drug’s development and review process by providing opportunities for more frequent interactions with the FDA and potentially a priority review when the data is ready for submission. Early clinical trials have shown promising activity in patients with treatment-refractory SCCHN while maintaining a manageable safety profile.
Read Announcement
BA3182 FDA Regulatory Timeline and Events
BA3182 is a drug developed by BioAtla for the following indication: In Patients with Treatment Refractory Metastatic Adenocarcinoma.
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:
- BA3182
- Announced Date:
- October 20, 2025
- Indication:
- In Patients with Treatment Refractory Metastatic Adenocarcinoma
Announcement
BioAtla, Inc announced preliminary clinical data from a Phase 1 study of BA3182 during a poster presentation titled "Preliminary Results from a First-in-Human Phase 1 Study of BA3182, a Dual-Conditionally Binding Biologic (CAB) EpCAM x CD3 Bispecific T-cell Engager in Patients with Treatment Refractory Metastatic Adenocarcinoma" at the European Society for Medical Oncology (ESMO) Congress 2025, held in Berlin, Germany.
Read Announcement- Drug:
- BA3182
- Announced Date:
- July 17, 2025
- Indication:
- In Patients with Treatment Refractory Metastatic Adenocarcinoma
Announcement
BioAtla, Inc. announced an oral presentation at the upcoming 2025 European Society for Medical Oncology (ESMO) TAT Asia Meeting to be held in Hong Kong Sar, China from July 18–20, 2025.
AI Summary
BioAtla, Inc. announced an upcoming oral presentation at the 2025 European Society for Medical Oncology (ESMO) TAT Asia Meeting, scheduled for July 18–20, 2025 in Hong Kong SAR, China. The presentation, titled "First-in-human phase I study of a dual-Conditionally Active Biologic (CAB) EpCAM x CD3 bispecific T-cell engager (TCE), BA3182, in patients with treatment refractory metastatic adenocarcinoma," will be delivered by Jennifer B. Brooke Valerin. The talk is set for July 18, 2025, from 15:59 to 16:06 GMT+8 and is identified as presentation number 36O during the meeting.
Following the session, the presentation materials will be available on BioAtla’s website under the "Publication" section, allowing interested parties to review the details of their clinical study and innovative approach in treating solid tumors.
Read Announcement- Drug:
- BA3182
- Announced Date:
- July 3, 2025
- Indication:
- In Patients with Treatment Refractory Metastatic Adenocarcinoma
Announcement
BioAtla, Inc today presented first-in-human data in a poster titled "Preliminary Results from a First-in-Human Phase 1 Study of a Dual-Conditionally Binding CAB-EpCAM x CAB-CD3 Bispecific T-cell Engager, BA3182, in Patients with Treatment Refractory Metastatic Adenocarcinoma" at the European Society for Medical Oncology (ESMO) Gastrointestinal Cancers Congress being held in Barcelona, Spain from July 2–5, 2025.
AI Summary
BioAtla, Inc. presented its first-in-human data during the ESMO Gastrointestinal Cancers Congress in Barcelona, Spain from July 2–5, 2025. The data came from a Phase 1 study of BA3182, a dual-conditionally binding bispecific T-cell engager designed to target EpCAM and CD3 in patients with treatment refractory metastatic adenocarcinoma. The poster, titled “Preliminary Results from a First-in-Human Phase 1 Study of a Dual-Conditionally Binding CAB-EpCAM x CAB-CD3 Bispecific T-cell Engager, BA3182,” highlighted early signs of tumor reduction and prolonged tumor control in heavily pretreated patients. The ongoing trial uses a dose-escalation approach, now advancing to 1.2 mg administered weekly via subcutaneous dosing. Overall, the safety profile was encouraging with low-grade adverse events that were transient and manageable, supporting further development of BA3182 as a potential therapy for multiple adenocarcinoma types.
Read Announcement
BA3011 (Mecbotamab Vedotin) FDA Regulatory Events
BA3011 (Mecbotamab Vedotin) is a drug developed by BioAtla for the following indication: 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:
- BA3011 (Mecbotamab Vedotin)
- Announced Date:
- October 3, 2025
- Indication:
- Solid Tumors
Announcement
BioAtla, Inc. announced that clinical data for its investigational AXL-targeting antibody-drug conjugate (ADC), mecbotamab vedotin (BA3011), will be presented at the upcoming Society for Immunotherapy of Cancer (SITC) 2025 Annual Meeting to be held at National Harbor, MD from November 5-9, 2025.
AI Summary
BioAtla, Inc., a clinical-stage biotech developing CAB antibody therapeutics, announced that clinical data for its investigational AXL-targeting antibody-drug conjugate (ADC), mecbotamab vedotin (BA3011), will be presented at the Society for Immunotherapy of Cancer (SITC) 2025 Annual Meeting. The meeting takes place at National Harbor, Maryland, from November 5–9, 2025.
The presentation, titled “Median OS of 21.5 months among 44 patients with treatment-refractory leiomyosarcoma, liposarcoma, and undifferentiated pleomorphic sarcoma treated with mecbotamab vedotin, an AXL-targeting ADC,” will be delivered by Dr. Mihaela Druta of Moffitt Cancer Center on Friday, November 7, 2025. The abstract (#523) will be featured in a poster session, with the exact time to be announced.
After the presentation, the materials will be available on the “Publication” section of BioAtla’s website at www.bioatla.com. Researchers and attendees can review the data once the meeting concludes.
Read Announcement
CAB-AXL-ADC FDA Regulatory Events
CAB-AXL-ADC is a drug developed by BioAtla for the following indication: In Patients with Advanced NSCLC.
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:
- CAB-AXL-ADC
- Announced Date:
- March 20, 2025
- Indication:
- In Patients with Advanced NSCLC
Announcement
BioAtla, Inc announced two abstracts accepted for poster presentations at the upcoming European Lung Cancer Congress (ELCC) 2025 Scientific Committee and Mayo Clinic Multidisciplinary Head and Neck Cancer Symposium 2025, to be held in Paris, France from March 26–29, 2025 and in Scottsdale, AZ from March 27–29, 2025, respectively.
AI Summary
BioAtla, Inc., a global clinical-stage biotechnology company, announced that two of its abstracts have been accepted for poster presentations at major upcoming cancer conferences. The first abstract, presented by Karen Reckamp, focuses on an exploratory analysis of overall survival among non-small cell lung cancer (NSCLC) patients with mutated KRAS in a Phase 2 trial of mecbotamab vedotin (CAB‐AXL‐ADC). This presentation is scheduled for the European Lung Cancer Congress (ELCC) 2025 in Paris, France, from March 26–29, 2025.
The second abstract, presented by Winston Wong, details findings from the Phase 2 experience using ozuriftamab vedotin (BA3021) in patients with heavily pretreated squamous cell carcinoma of the head and neck. This poster will be showcased at the Mayo Clinic Multidisciplinary Head and Neck Cancer Symposium 2025 in Scottsdale, Arizona, from March 27–29, 2025.
Read Announcement- Drug:
- CAB-AXL-ADC
- Announced Date:
- December 16, 2024
- Indication:
- In Patients with Advanced NSCLC
Announcement
BioAtla, Inc presented a poster entitled "Characterization of Mutated KRAS Genotype and Clinical Outcomes in Patients With Advanced NSCLC Treated With Mecbotamab Vedotin, a CAB-AXL-ADC" at the IASLC 2024 Hot Topic in Basic & Translational Science Meeting on December 14, 2024.
AI Summary
BioAtla, Inc. presented a poster titled "Characterization of Mutated KRAS Genotype and Clinical Outcomes in Patients With Advanced NSCLC Treated With Mecbotamab Vedotin, a CAB-AXL-ADC" at the IASLC 2024 Hot Topic in Basic & Translational Science Meeting on December 14, 2024. The study focused on patients with advanced non‐small cell lung cancer (NSCLC) and found that those with mutated KRAS had much better outcomes when treated with Mecbotamab Vedotin. Specifically, 58% of patients with mutated KRAS were alive after one year compared to only 23% of patients with wild-type KRAS.
The poster also highlighted antitumor activity across nine different mutated KRAS variants and confirmed that high AXL expression is strongly associated with mutated KRAS tumors. These promising results suggest that Mecbotamab Vedotin may offer a new treatment option for patients with advanced NSCLC, with further trials planned for 2025.
Read Announcement
BA3021 (Ozuriftamab Vedotin) FDA Regulatory Events
BA3021 (Ozuriftamab Vedotin) is a drug developed by BioAtla for the following indication: 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:
- BA3021 (Ozuriftamab Vedotin)
- Announced Date:
- September 16, 2024
- Target Action Date:
- H2 2024
- Estimated Target Date Range:
- July 1, 2024 - December 31, 2024
- Indication:
- Solid Tumors
Announcement
BioAtla, Inc. announced that The Company intends to meet with the FDA to discuss a SCCHN potential registrational trial in 2H 2024
AI Summary
BioAtla, Inc. announced plans to meet with the FDA in the second half of 2024 to discuss a potential registrational trial for squamous cell carcinoma of the head and neck (SCCHN). The proposed randomized trial would compare treatment using ozuriftamab vedotin monotherapy against the investigator's choice in patients who have previously received platinum/PD-1 inhibitor therapies. This step is part of the company’s ongoing effort to evaluate the effectiveness of their conditionally active antibody drug conjugate targeting ROR2, which has shown promising activity in heavily pretreated patients with SCCHN. BioAtla’s decision to meet with the FDA reflects its commitment to advancing smarter, more focused treatments for patients facing difficult-to-treat cancers, and it hopes that this trial will provide supporting evidence for potential approval in this challenging and high unmet need area.
Read Announcement- Drug:
- BA3021 (Ozuriftamab Vedotin)
- Announced Date:
- September 16, 2024
- Indication:
- Solid Tumors
Announcement
BioAtla, Inc. today presented a poster of promising Phase 2 trial data at the European Society for Medical Oncology (ESMO) Annual Meeting. The poster presentation entitled, "Phase 2 trial of ozuriftamab vedotin (BA3021), a conditionally active biologic (CAB)-ROR2-ADC, in patients with recurrent or metastatic squamous cell carcinoma of the head and neck," reported multiple confirmed responses among heavily pretreated patients who tolerated treatment well.
AI Summary
BioAtla, Inc. shared promising Phase 2 trial results at the European Society for Medical Oncology Annual Meeting. The study focused on ozuriftamab vedotin (BA3021), a novel conditionally active biologic targeting ROR2 in patients with recurrent or metastatic squamous cell carcinoma of the head and neck. The poster presented data showing an overall response rate of 32% among heavily pretreated patients, with one complete response and several partial responses. Importantly, patients also experienced a 77% disease control rate. The treatment was well tolerated, and most side effects were low-grade. These early signs of anti-tumor activity highlight the potential of this targeted therapy for a patient group with limited treatment options. BioAtla plans to meet with the FDA later this year to further explore a potential registrational trial for this promising new treatment option.
Read Announcement
