Earnings summaries and quarterly performance for Pyxis Oncology.
Executive leadership at Pyxis Oncology.
Board of directors at Pyxis Oncology.
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Recent press releases and 8-K filings for PYXS.
Pyxis Oncology announces Interim CEO appointment and leadership transition
PYXS
CEO Change
Management Change
Executive Compensation
- Dr. Lara Sullivan, M.D. ceased serving as President, Chief Executive Officer, and Chief Medical Officer of Pyxis Oncology, Inc. effective February 2, 2026.
- Tom Civik, a current director, has been appointed Interim Chief Executive Officer and principal executive officer, effective February 2, 2026.
- Mr. Civik's compensation includes an annualized base salary of $710,000 and eligibility for a target bonus of 60% of his base salary, along with stock option grants representing 1.1% and 0.4% of the Company's outstanding common stock.
- The Board of Directors has initiated a search for a permanent Chief Executive Officer.
5 hours ago
Pyxis Oncology Appoints Interim CEO Amid Leadership Transition
PYXS
CEO Change
Management Change
- Pyxis Oncology announced a leadership transition, appointing Thomas Civik as Interim Chief Executive Officer, effective immediately.
- Lara S. Sullivan, M.D., has stepped down from her roles as President, Chief Executive Officer, and Chief Medical Officer.
- The Board of Directors has initiated a structured search for a permanent Chief Executive Officer.
- The company's clinical development leadership team will continue to execute ongoing trials, and its lead program, micvotabart pelidotin (MICVO), continues to advance in Phase 1 and Phase 1/2 studies.
4 days ago
Pyxis Oncology Reports Promising MCVO Clinical Data in Head and Neck Squamous Cell Carcinoma
PYXS
New Projects/Investments
- Pyxis Oncology announced preliminary clinical data for MCVO in recurrent metastatic head and neck squamous cell carcinoma, demonstrating a 46% confirmed objective response rate (ORR) and 92% disease control rate (DCR) in monotherapy (N=13 at 5.4 mg/kg) and a 71% confirmed ORR and 100% DCR in combination with Keytruda/Pembro (N=7 at 3.6 mg/kg and 4.4 mg/kg).
- The monotherapy study at 5.4 mg/kg observed some grade 3 adverse events, while the combination study at lower doses (3.6 and 4.4 mg/kg) reported no grade 3, 4, or 5 adverse events. The company will implement an adjusted ideal body weight (AIBW) dosing approach for MCVO across all clinical trials to manage safety, with FDA alignment.
- Pyxis Oncology anticipates providing mature data from the monotherapy dose expansion study in mid-2026 (targeting ~40 patients) and additional data from the combination dose escalation study in the second half of 2026 (targeting ~20 patients). The company is evaluating paths for potential pivotal studies in head and neck cancer, seeing a significant market opportunity in second/third-line and underserved front-line settings.
Dec 18, 2025, 1:30 PM
Pyxis Oncology Provides MICVO Clinical Study Update for R/M HNSCC
PYXS
New Projects/Investments
- Pyxis Oncology's MICVO monotherapy demonstrated a 46% Confirmed Overall Response Rate (ORR) and 92% Disease Control Rate (DCR) in 13 patients with 2L+ R/M HNSCC at 5.4 mg/kg, based on data as of November 3, 2025.
- The MICVO + KEYTRUDA combination showed a 71% Confirmed ORR and 100% DCR in 7 patients with 1L/2L+ R/M HNSCC at 3.6 mg/kg and 4.4 mg/kg, with data as of November 3, 2025.
- The FDA has aligned on the 2L+ monotherapy pivotal trial design for MICVO.
- Safety data as of November 3, 2025, indicated no Grade 4 or Grade 5 ADC payload TRAEs of interest for MICVO monotherapy at 5.4 mg/kg or for the MICVO + KEYTRUDA combination at 3.6 mg/kg and 4.4 mg/kg in R/M HNSCC.
- MICVO is positioned as the first-in-concept extracellular targeting ADC in clinical development, designed to target EDB+FN, a splice variant of fibronectin.
Dec 18, 2025, 1:30 PM
Pyxis Oncology Provides Positive Clinical Update for MCVO in Head and Neck Squamous Cell Carcinoma
PYXS
New Projects/Investments
Product Launch
- Pyxis Oncology announced preliminary data for MCVO in recurrent metastatic head and neck squamous cell carcinoma (HNSCC), reporting a 46% confirmed objective response rate (ORR) and 92% disease control rate (DCR) in monotherapy at the 5.4 mg/kg dose.
- In an ongoing combination study with Keytruda (Pembro), MCVO demonstrated a 71% confirmed ORR and 100% disease control rate (DCR) in seven first and second-line plus HNSCC patients at 3.6 mg/kg and 4.4 mg/kg doses.
- The company has FDA alignment on the trial design for a planned monotherapy pivotal study in second-line plus HNSCC and is evaluating paths forward for potential pivotal studies for both monotherapy and combination programs.
- Safety profiles indicate no grade 4 or 5 events in monotherapy at 5.4 mg/kg, with grade 3 neuropathy and neutropenia observed. The combination study at 3.6 and 4.4 mg/kg doses with Pembro reported no grade 3, 4, or 5 events, with all adverse events being grade 1 or 2.
- Pyxis is migrating its dosing approach for MCVO from milligrams per kilogram to an adjusted ideal body weight method to mitigate adverse events, a strategy supported by dialogue with the FDA.
Dec 18, 2025, 1:30 PM
Pyxis Oncology Provides MCVO Clinical Update
PYXS
New Projects/Investments
Guidance Update
- Pyxis Oncology reported preliminary data for MCVO in recurrent metastatic head and neck squamous cell carcinoma (HNSCC), showing a 46% confirmed objective response rate (ORR) and 92% disease control rate (DCR) in monotherapy (N=13 at 5.4 mg/kg dose).
- In combination with Pembro, MCVO demonstrated a 71% confirmed ORR and 100% disease control rate in seven first and second-line plus patients at 3.6 mg/kg and 4.4 mg/kg doses.
- The company noted a manageable safety profile for MCVO, with no Grade 4 or 5 events in monotherapy at 5.4 mg/kg and no Grade 3, 4, or 5 events in combination therapy at the tested doses.
- Pyxis Oncology plans to implement an Adjusted Ideal Body Weight dosing approach to optimize the benefit-risk profile and reduce adverse events, and has FDA alignment on the trial design for a planned monotherapy pivotal study.
- Updates for the fully enrolled monotherapy study (approximately 40 patients) are expected in mid-next year, and for the combination study (approximately 20 patients) in the second half of next year.
Dec 18, 2025, 1:30 PM
Pyxis Oncology Announces Positive Preliminary Phase 1 Data for MICVO
PYXS
New Projects/Investments
Guidance Update
- Pyxis Oncology announced positive preliminary Phase 1 data for micvotabart pelidotin (MICVO) in recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) as of November 3, 2025.
- MICVO monotherapy demonstrated a 46% confirmed objective response rate (ORR) and 92% disease control rate (DCR) in 13 evaluable 2L+ R/M HNSCC patients at 5.4 mg/kg.
- In combination with KEYTRUDA®, MICVO achieved a 71% confirmed ORR and 100% DCR in 7 evaluable 1L/2L+ R/M HNSCC patients at 3.6 mg/kg and 4.4 mg/kg.
- The company has received FDA alignment on the pivotal trial design for MICVO monotherapy and expects updated clinical data in mid-2026 and 2H26.
- Pyxis Oncology's cash runway is projected to fund operations into the fourth quarter of 2026, partly due to an $11 million payment from a royalty sale.
Dec 18, 2025, 12:25 PM
Pyxis Oncology Announces Positive Preliminary Phase 1 Data for Micvotabart Pelidotin (MICVO)
PYXS
New Projects/Investments
Guidance Update
- Pyxis Oncology announced positive preliminary Phase 1 data for micvotabart pelidotin (MICVO) in recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC), with a data cutoff as of November 3, 2025.
- As monotherapy, MICVO demonstrated a 46% confirmed objective response rate (ORR) and 92% disease control rate (DCR) in 2L+ R/M HNSCC patients at 5.4 mg/kg.
- In combination with KEYTRUDA®, MICVO achieved a 71% confirmed ORR and 100% DCR in 1L/2L+ R/M HNSCC patients at 3.6 mg/kg and 4.4 mg/kg.
- The company anticipates presenting updated data from the monotherapy study in mid-2026 and from the combination study in 2H26.
- Pyxis Oncology also secured $11 million from the sale of royalty rights, which is expected to fund operations through data milestones and into the fourth quarter of 2026.
Dec 18, 2025, 12:00 PM
Pyxis Oncology Discusses MICVO Clinical Development and Financial Runway
PYXS
New Projects/Investments
Guidance Update
- Pyxis Oncology is an ADC-focused company developing MICVO, an extracellular cleaving ADC that targets extracellular domain B (EDB) in the tumor microenvironment.
- Initial clinical data from a basket trial showed a 50% confirmed Overall Response Rate (ORR) in head and neck cancer patients and broad tumor regression across six tumor types, with a well-tolerated safety profile at an efficacious dose range of 3.6-5.4 mg/kg.
- The company is currently conducting expansion trials for MICVO in monotherapy (targeting platinum/PD-1 resistant and EGFR/PD-1 resistant head and neck cancer patients) and in combination with Pembro for first and second-line patients.
- For the upcoming year-end data disclosure, Pyxis aims for a 35-45% ORR in monotherapy for platinum/PD-1 resistant patients, 60-65% ORR in combo therapy with PD-1, and approximately 20% ORR for post-EGFR monotherapy.
- Pyxis Oncology reported a $77 million cash balance, providing a runway into the second half of 2026.
Nov 11, 2025, 9:00 PM
Pyxis Oncology provides update on MICVO clinical development in head and neck cancer
PYXS
New Projects/Investments
Guidance Update
- Pyxis Oncology's lead asset, MICVO, is an antibody-drug conjugate (ADC) that targets EDB in the tumor microenvironment, utilizing a three-pronged mechanism involving direct tumor killing, bystander effect, and immunogenic cell death.
- Based on Phase 1, Part 1 data, MICVO's development is focused on head and neck cancer, where it demonstrated a 50% confirmed response rate in heavily pretreated patients and broad tolerability.
- Current clinical programs for MICVO in head and neck cancer include second/third-line monotherapy (for patients with prior platinum/PD-1 or EGFR/PD-1 treatment) and first/second-line combination therapy with Keytruda.
- Pyxis Oncology plans an upcoming data disclosure in Q4 (2025) that will include preliminary data from both monotherapy arms and the combination setting in head and neck cancer.
- The company believes MICVO, which is HPV agnostic, has the potential to be a credible competitor in the second/third-line setting, where the minimum expected objective response rate (ORR) is around 35%.
Nov 10, 2025, 7:30 PM
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