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
BA3021, BA3071, BA3182, BA3361, CAB-AXL-ADC, and Ozuriftamab. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
BA3021 (Ozuriftamab Vedotin) - FDA Regulatory Timeline and 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
- 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- Drug:
- BA3021 (Ozuriftamab Vedotin)
- Announced Date:
- September 16, 2024
- Estimated Event Date Range:
- July 1, 2024 - December 31, 2024
- Target Action Date:
- 2024-H2
- 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.
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BA3071 - FDA Regulatory Timeline and Events
BA3071 is a drug developed by BioAtla for the following indication: Multiple solid tumor indications.
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:
- BA3071
- Announced Date:
- May 23, 2024
- Estimated Event Date Range:
- July 1, 2024 - December 31, 2024
- Target Action Date:
- 2024-H2
- Indication:
- Multiple solid tumor indications
Announcement
BioAtla, Inc announced that anticipated to initiate in 2H of 2024 following planned FDA meeting
AI Summary
BioAtla, Inc. recently announced that it is on track to begin a Phase 3 trial of evalstotug in first-line metastatic or unresectable BRAF-mutated melanoma. The trial is anticipated to start in the second half of 2024, following a planned meeting with the FDA. This upcoming study will further evaluate evalstotug as a potential best-in-class CTLA-4 antibody, especially used in combination with PD-1 inhibitors. The company’s innovative approach uses Conditionally Active Biologics (CAB) technology, which aims to provide effective cancer treatment with reduced systemic toxicity. BioAtla’s announcement highlights the promising potential of evalstotug in producing durable clinical responses and a manageable safety profile, which could expand treatment options for patients with challenging solid tumors.
Read Announcement- Drug:
- BA3071
- Announced Date:
- May 23, 2024
- Indication:
- Multiple solid tumor indications
Announcement
BioAtla, Inc announced expanded data at an upcoming presentation entitled, "Phase 1 study of evalstotug (BA3071), an anti-CTLA-4 Conditionally Active Biologic, in combination with nivolumab in advanced solid tumors", demonstrating confirmed responses with a potentially differentiated tolerability profile with the Company's novel, conditionally active anti-CTLA-4 agent, evalstotug, in combination with anti-PD-1 therapy.
AI Summary
BioAtla, Inc. announced expanded data for its novel anti-CTLA-4 agent, evalstotug (BA3071), at an upcoming presentation titled “Phase 1 study of evalstotug in combination with nivolumab in advanced solid tumors.” In the Phase 1 study, evalstotug was combined with the anti-PD-1 drug nivolumab to treat advanced solid tumors in patients who had previously failed PD-1 therapy. The study showed confirmed responses, including prolonged progression-free survival—with some patients remaining progression-free for over 10 months—suggesting that higher doses of evalstotug may drive significant clinical benefit. Notably, the therapy demonstrated a differentiated and manageable safety profile, with a relatively low incidence and severity of immune-mediated adverse events. These positive findings support evalstotug’s potential to become a best-in-class CTLA-4 antibody when combined with PD-1 inhibitors for treating various cancers.
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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:
- 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.
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BA3361 - FDA Regulatory Timeline and Events
BA3361 is a drug developed by BioAtla for the following indication: for the Treatment of Multiple 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:
- BA3361
- Announced Date:
- May 6, 2024
- Indication:
- for the Treatment of Multiple Tumors
Announcement
BioAtla, Inc. announced that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application to evaluate BA3361 (CAB-Nectin-4) antibody drug conjugate (ADC) for the treatment of multiple tumor types.
AI Summary
BioAtla, Inc. received significant news from the U.S. Food and Drug Administration (FDA). The agency has cleared the company's investigational new drug (IND) application, allowing BioAtla to begin evaluating its innovative therapy, BA3361 (CAB-Nectin-4) antibody drug conjugate (ADC). This decision marks an important step for the company as it paves the way to study the drug’s effectiveness in treating multiple tumor types.
This clearance means that the FDA has reviewed the initial data and design of BioAtla’s planned clinical trials. The company now has the opportunity to further investigate if BA3361 can become a beneficial treatment option for patients with various cancers. BioAtla’s advancement represents a promising stride in cancer research and shows the growing interest in targeting multiple tumor types through novel therapies like antibody drug conjugates.
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CAB-AXL-ADC - FDA Regulatory Timeline and 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.
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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:
- 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
- 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- Drug:
- Ozuriftamab Vedotin
- Announced Date:
- July 23, 2024
- Estimated Event Date Range:
- July 1, 2024 - December 31, 2024
- Target Action Date:
- 2024-H2
- 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
