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Sutro Biopharma (NASDAQ: STRO) is a clinical-stage biopharmaceutical company pioneering next-generation oncology therapeutics through its proprietary cell-free XpressCF® platform. This page provides centralized access to official news, including clinical trial updates, strategic partnerships, and financial developments.
Investors and researchers will find timely updates on the company’s innovative antibody drug conjugates (ADCs) and bispecific antibody programs. Content categories include clinical milestones, regulatory filings, collaboration announcements, and manufacturing advancements.
Bookmark this page to stay informed about Sutro’s progress in developing precision oncology treatments and its role in advancing cell-free therapeutic innovation. Check regularly for verified updates directly from the company and trusted sources.
Sutro Biopharma (NASDAQ: STRO) presented expanded data from the dose-optimization portion of the REFRαME-O1 trial for luveltamab tazevibulin (luvelta) in platinum resistant ovarian cancer at SGO 2025. The study demonstrated:
At the optimized dose of 5.2 mg/kg + G-CSF (followed by 4.3 mg/kg), luvelta achieved:
- 32% overall response rate (ORR) and 96% disease control rate (DCR), compared to 13.8% ORR and 69% DCR at 4.3 mg/kg
- Consistent clinical activity across FRα expression levels ≥25%
- 30.8% ORR and 100% DCR for positive staining 2+ ≥75%
- 33.3% ORR and 91.7% DCR for PS2+ <75%
The safety profile remained consistent across dosing groups, with manageable neutropenia. However, Sutro announced it is deprioritizing luvelta's development across all indications and is seeking out-licensing opportunities.
Sutro Biopharma (NASDAQ: STRO) has reported its full year 2024 financial results, announcing a strategic portfolio review that prioritizes wholly-owned next-generation ADC programs. The company's financial position shows $316.9 million in cash, cash equivalents, and marketable securities as of December 31, 2024, projecting a cash runway into at least Q4 2026.
Key financial metrics include:
- Revenue decreased to $62.0 million in 2024 from $153.7 million in 2023
- Total operating expenses increased to $300.5 million in 2024 from $243.0 million in 2023
- Research and development expenses were $252.0 million
- General and administrative expenses totaled $48.5 million
The restructuring plan is expected to require $40 to $45 million in cash payments, but subsequent cost reductions and refocused clinical development priorities are anticipated to support the company's operations through Q4 2026.
Sutro Biopharma (NASDAQ: STRO) has announced a major strategic portfolio restructuring, focusing on its next-generation ADC pipeline development. The company will prioritize three wholly-owned preclinical programs, with STRO-004, a Tissue Factor ADC, expected to enter clinical trials in H2 2025.
Key changes include:
- Deprioritizing luveltamab tazevibulin development while seeking partnership opportunities
- Reducing workforce by nearly 50%
- Exiting internal GMP manufacturing facility by year-end 2025
- Leadership transition: Jane Chung replacing Bill Newell as CEO
The company reported $316.9 million in cash and equivalents as of December 31, 2024, with runway expected into Q4 2026. Restructuring costs are estimated at $40-45 million. The pipeline includes three planned INDs over the next three years: STRO-004 (H2 2025), STRO-006 (2026), and a dual-payload ADC (2027).
Sutro Biopharma (NASDAQ: STRO), a clinical-stage oncology company specializing in site-specific and novel-format antibody drug conjugates (ADCs), has announced its participation in the TD Cowen 45th Annual Health Care Conference. The conference is scheduled for March 3-5, 2025, in Boston, MA.
The company's management will deliver a presentation, which will be made available through the News & Events page in the Investor Relations section of Sutro's website (www.sutrobio.com). Interested parties can access an archived replay of the presentation for a minimum of 30 days following the event.
Sutro Biopharma (NASDAQ: STRO), a clinical-stage oncology company specializing in antibody drug conjugates (ADCs), has announced its participation in the 43rd Annual J.P. Morgan Healthcare Conference. Bill Newell, the company's Chief Executive Officer, will deliver a presentation on Wednesday, January 15, 2025, at 2:15 p.m. PT / 5:15 p.m. ET in San Francisco, CA.
The presentation will be available to view through the News & Events page in the Investor Relations section of Sutro's website at www.sutrobio.com. An archived version of the presentation will remain accessible for a minimum of 30 days following the event.
Sutro Biopharma (STRO) and Boehringer Ingelheim BioXcellence™ have successfully scaled up Sutro's proprietary cell-free expression technology to commercial scale manufacturing. The collaboration achieved production of luveltamab tazevibulin (luvelta), Sutro's antibody-drug conjugate (ADC) for ovarian cancer treatment, at 4,500L scale in Boehringer's Vienna facility.
The breakthrough represents an industry milestone, marking the first successful transition from small-scale to large-scale GMP production using Sutro's cell-free protein synthesis platform. All manufactured batches met the required quality criteria for clinical studies. The platform's unique advantage lies in its modular approach, utilizing non-natural amino acids for site-specific protein conjugation, potentially offering improved safety and efficacy profiles compared to traditional ADC production methods.
This achievement validates the commercial viability of Sutro's technology and can be applied to their pipeline of next-generation ADCs targeting various cancers. Sutro is actively seeking business development partners to advance their technology platform and product pipeline.
Sutro Biopharma announced positive results from the dose-optimization portion of the REFRαME-O1 trial for luvelta in platinum-resistant ovarian cancer. The selected 5.2 mg/kg starting dose achieved a 32% objective response rate in evaluable patients, with a disease control rate of 96%. The trial included patients with ≥25% FRα expression levels, potentially benefiting 8 out of 10 PROC patients.
The study demonstrated manageable safety profiles with 32% of patients experiencing Grade 3 or higher neutropenia, but no febrile neutropenia. The ongoing registrational trial (Part 2) will enroll approximately 500 patients, randomized between luvelta and standard chemotherapy. The company is targeting an Accelerated Approval application in mid-2027.
Sutro Biopharma (NASDAQ: STRO) reported Q3 2024 financial results and business updates. The company plans three IND applications in the next three years based on next-generation ADC technology. Two new clinical trials are underway: REFRαME-P1 for pediatric leukemia and REFRαME-L1 for non-small cell lung cancer. Recent data showed a 56% response rate for luvelta in combination with bevacizumab. Financial highlights include $388.3 million in cash and equivalents, revenue of $8.5 million (down from $16.9 million in Q3 2023), and operating expenses of $76.4 million. The company realized a $32.1 million gain from selling Vaxcyte shares.
Sutro Biopharma (NASDAQ: STRO) announced five presentations at the 15th Annual World ADC Conference in San Diego, November 4-6, 2024. The presentations cover various aspects of ADC innovation, including: dual-payload ADCs development, clinical updates on Luvelta targeting folate receptor, preclinical development of STRO-004, cell-free protein synthesis for site-specific conjugation, and optimization of high DAR and dual payload ADCs. The presentations will be available on Sutro's website after the event.
Sutro Biopharma has initiated REFRαME-P1, a registration-enabling trial of luveltamab tazevibulin (luvelta) for pediatric patients with CBF/GLIS AML. The study follows encouraging compassionate use data presented in December 2023, showing 42% complete remission in patients with ≥5% blasts. CBF/GLIS AML is a rare, aggressive leukemia affecting infants and young children, with an average onset age of 18 months and over 80% chemotherapy resistance rate. The global trial will evaluate luvelta's efficacy and safety in children under 12 years with CBF/GLIS AML, with most sites planned to open by year-end.