This section highlights FDA-related milestones and regulatory updates for drugs developed by Sutro Biopharma (STRO).
Over the past two years, Sutro Biopharma has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
STRO-004 and luvelta. 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.
STRO-004 FDA Regulatory Timeline and Events
STRO-004 is a drug developed by Sutro Biopharma for the following indication: Next-Generation Tissue Factor ADC, in TF-Expressing 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:
- STRO-004
- Announced Date:
- April 19, 2026
- Indication:
- Next-Generation Tissue Factor ADC, in TF-Expressing Solid Tumors
Announcement
Sutro Biopharma, Inc announced promising preclinical data across its pipeline of next- generation ADCs in five posters and one oral presentation at the American Association for Cancer Research (AACR) Annual Meeting 2026.
AI Summary
Sutro Biopharma reported promising preclinical data across its next-generation antibody-drug conjugate (ADC) pipeline in five posters and one oral presentation at the AACR Annual Meeting 2026. STRO-004 showed robust and consistent antitumor activity in multiple TF-expressing solid tumor PDX models and demonstrated improved efficacy versus benchmark ADCs. STRO-006 and STRO-227 produced meaningful, dose-dependent tumor control across several solid tumor models, supporting their continued development.
The company also presented a TROP2-targeted immunostimulatory ADC program, developed with Astellas, which highlights Sutro’s platform capability to create dual-payload ADCs that combine direct tumor killing with immune stimulation. Multiple posters covered advances across Sutro’s ADC pipeline and discovery platforms. Full presentation details will be posted in the Scientific Publications section of Sutro’s website for further review. These preclinical results support the potential of Sutro’s technology to advance targeted cancer therapies.
Read Announcement- Drug:
- STRO-004
- Announced Date:
- March 23, 2026
- Indication:
- Next-Generation Tissue Factor ADC, in TF-Expressing Solid Tumors
Announcement
Sutro Biopharma, announced recent business highlights.
AI Summary
Sutro Biopharma, a clinical-stage company developing site-specific and novel-format antibody-drug conjugates (ADCs), reported several recent business highlights. The company has dosed three cohorts in its Phase 1 STRO-004 trial, a potential best-in-class Tissue Factor ADC, and remains on track to report initial clinical data in mid-2026. Sutro also advanced its wholly owned PTK7 dual-payload ADC, STRO-227, targeting an IND submission in 2026, and expects STRO-006, a Topo1 ADC against integrin β6, to enter clinical development in 2026. Separately, an Astellas-partnered dual-payload immunostimulatory ADC program targeting TROP2 has entered the clinic and is dosing patients, triggering a $10 million milestone expected in Q2 2026; a second partnered program reached IND-enabling toxicology, triggering a $7.5 million milestone.
As of December 31, 2025, Sutro held $141.4 million in cash and marketable securities. After a recent financing that raised about $110 million, the company says its cash runway extends into at least the second quarter of 2028.
Read Announcement- Drug:
- STRO-004
- Announced Date:
- December 3, 2025
- Indication:
- Next-Generation Tissue Factor ADC, in TF-Expressing Solid Tumors
Announcement
Sutro Biopharma, Inc nnounced that the patients in the first cohort have been dosed in its Phase 1 trial evaluating STRO-004 in a range of Tissue Factor (TF) expressing solid tumors.
AI Summary
Sutro Biopharma announced that patients in the first cohort have been dosed in a Phase 1 trial of STRO-004, an antibody‑drug conjugate (ADC) targeting tissue factor (TF) in solid tumors. STRO-004 is built using Sutro’s cell‑free platform and is designed for greater stability, potency and tumor selectivity. The molecule includes an Fc‑silent, high‑affinity antibody, a site‑specific β‑glucuronidase‑cleavable linker, and an exatecan payload at a drug‑to‑antibody ratio of 8 (DAR8).
The open‑label, multicenter dose‑escalation study will assess safety, pharmacokinetics and early anti‑tumor activity in patients with advanced TF‑expressing cancers such as non‑small cell lung, head and neck, cervical, colorectal, pancreatic and bladder cancers. Strong preclinical tolerability in non‑human primates at doses up to 50 mg/kg supports higher entry doses to help find a Phase 2 dose more quickly. Sutro expects initial clinical data in mid‑2026 and thanked the patients and investigators participating in the study.
Read Announcement
Luvelta FDA Regulatory Timeline and Events
Luvelta is a drug developed by Sutro Biopharma for the following indication: Treatment of endometrial cancer.
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:
- luvelta
- Announced Date:
- March 15, 2025
- Indication:
- Treatment of endometrial cancer
Announcement
Sutro Biopharma, Inc announced expanded data in a late-breaking oral presentation from the dose-optimization portion of the REFRαME-O1 trial with luveltamab tazevibulin (luvelta) in patients with platinum resistant ovarian cancer (PROC) at the Society of Gynecologic Oncology (SGO) Annual Meeting on Women's Cancer®.
AI Summary
Sutro Biopharma, Inc. presented expanded data from the dose-optimization portion of the REFRαME-O1 trial at the Society of Gynecologic Oncology Annual Meeting on Women’s Cancer. The trial focused on luveltamab tazevibulin (luvelta) for patients with platinum-resistant ovarian cancer. Findings showed that at the optimized dose of 5.2 mg/kg (with G-CSF support for two cycles, then 4.3 mg/kg), luvelta achieved an overall response rate (ORR) of 32% and a disease control rate (DCR) of 96%. The data revealed encouraging antitumor activity across patients with varying levels of Folate Receptor-α (FRα) expression (25% or greater), demonstrating consistent safety and low discontinuation rates across all dosages. These results suggest that luvelta may offer improved patient responses compared to standard chemotherapy for a key group with unmet medical needs.
Read Announcement- Drug:
- luvelta
- Announced Date:
- December 10, 2024
- Indication:
- Treatment of endometrial cancer
Announcement
Sutro Biopharma, Inc. announced the selected dose from the dose-optimization portion (Part 1) of REFRαME-O1, the registration-directed trial of luveltamab tazevibulin (luvelta) in platinum-resistant ovarian cancer (PROC), following a meeting with the U.S. Food and Drug Administration (FDA).
AI Summary
Sutro Biopharma announced that the 5.2 mg/kg starting dose from the dose-optimization stage of its REFRαME-O1 trial has been selected for the randomized, registration-directed study of luveltamab tazevibulin (luvelta) in platinum-resistant ovarian cancer. This decision was made after a meeting with the U.S. Food and Drug Administration (FDA), which supported the safety and efficacy seen at this dose. In the trial’s dose-optimization phase, the 5.2 mg/kg group, which included prophylactic pegfilgrastim for the first two cycles followed by a reduction to 4.3 mg/kg, showed an objective response rate of 32%. The results suggest luvelta could be an effective treatment for patients with varying levels of folate receptor alpha expression, offering a promising new option compared to chemotherapy for this challenging patient population.
Read Announcement- Drug:
- luvelta
- Announced Date:
- September 14, 2024
- Indication:
- Treatment of endometrial cancer
Announcement
Sutro Biopharma, Inc announced updated data from the ongoing Phase 1b study of luveltamab tazevibulin (luvelta) in combination with bevacizumab for patients with epithelial ovarian cancer (EOC) in a poster presentation at the 2024 European Society For Medical Oncology (ESMO) Congress in Barcelona, Spain.
AI Summary
Sutro Biopharma recently presented updated data from its ongoing Phase 1b study of luveltamab tazevibulin (luvelta) in combination with bevacizumab for patients with epithelial ovarian cancer at the 2024 ESMO Congress in Barcelona. The study highlighted that at the recommended Phase 2 dose (RP2D) of 4.3 mg/kg of luvelta with a standard bevacizumab dose (15 mg/kg) administered every three weeks, an objective response rate of 56% was observed among patients. Overall, the combination showed encouraging antitumor activity with a 35% response rate across all dose groups. Importantly, the treatment demonstrated promising effects regardless of Folate Receptor-α expression or previous bevacizumab exposure. An expansion phase is currently underway with an additional 23 patients enrolled, and early expansion data are expected in the first half of 2025.
Read Announcement- Drug:
- luvelta
- Announced Date:
- August 22, 2024
- Target Action Date:
- H1 2025
- Estimated Target Date Range:
- January 1, 2025 - June 30, 2025
- Indication:
- Treatment of endometrial cancer
Announcement
Sutro Biopharma, Inc announced that Initial data from this study is expected in the first half of 2025
AI Summary
Sutro Biopharma, Inc. recently announced the global Phase 2 REFRαME-L1 study for their investigational treatment luveltamab tazevibulin (luvelta). The trial focuses on patients with non-small cell lung cancer (NSCLC) that express the Folate Receptor-α (FRα), an important target in many cancers. This study is designed to evaluate the safety and potential benefits of luvelta for patients who have seen few treatment options for their advanced disease.
A major highlight of the announcement is that the initial data from this study is expected in the first half of 2025. This anticipated milestone marks a significant step for Sutro as they work to expand treatment opportunities for patients with FRα-expressing cancers, offering hope for improved outcomes in NSCLC.
Read Announcement- Drug:
- luvelta
- Announced Date:
- August 22, 2024
- Indication:
- Treatment of endometrial cancer
Announcement
Sutro Biopharma, Inc. announced that REFRαME-L1, the global Phase 2 study of luveltamab tazevibulin (luvelta) for patients with non-small cell lung cancer (NSCLC) whose tumor expresses Folate Receptor-α (FRα), has been initiated and is open for enrollment.
AI Summary
Sutro Biopharma, Inc. has initiated the REFRαME-L1 global Phase 2 study, which is now open for enrollment. This clinical trial will evaluate luveltamab tazevibulin (luvelta) in adult patients with advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors express Folate Receptor-α (FRα) at levels equal to or higher than 25% Tumor Proportion Score. The study plans to dose patients with 4.3 mg/kg of luvelta every three weeks. Researchers hope that the treatment’s precise design and wide therapeutic window will provide a new option for patients, including those with lower FRα expression who may not have many alternatives. The study represents a significant step forward in expanding treatment options for NSCLC, particularly for cases where the tumors display elevated levels of FRα, and initial data is anticipated in the first half of 2025.
Read Announcement
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