This section highlights FDA-related milestones and regulatory updates for drugs developed by Aptevo Therapeutics (APVO).
Over the past two years, Aptevo Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
mipletamig, APVO442, ADAPTIR, APVO603, ALG.APV-527, and APVO436. 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.
Mipletamig FDA Regulatory Timeline and Events
Mipletamig is a drug developed by Aptevo Therapeutics for the following indication: acute myeloid leukemia.
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:
- mipletamig
- Announced Date:
- May 6, 2026
- Indication:
- acute myeloid leukemia
Announcement
Aptevo Therapeutics Inc today reported new clinical results from its RAINIER frontline acute myeloid leukemia (AML) trial..
AI Summary
Aptevo Therapeutics reported new results from its RAINIER frontline AML trial evaluating mipletamig with venetoclax and azacitidine. Among 31 evaluable frontline patients (27 from RAINIER Cohort 5 plus 4 from a prior dose-expansion), the combination produced an 87% clinical benefit rate (CR/CRi/PR) and an 81% remission rate (CR/CRi). Aptevo said the data show consistent clinical activity and a favorable safety profile as the dataset grows.
The trial has completed dosing through earlier mipletamig levels and entered a final stage with two highest-dose cohorts (Cohorts 6 and 7); enrollment in Cohort 6 is nearly complete. Two additional groups of six patients each will be enrolled at selected dose levels, with the first group enrolling alongside Cohort 6. These steps will finish the dataset needed to select the recommended Phase 2 dose (RP2D) and support a planned Phase 2 regulatory interaction, with trial completion expected this year.
Read Announcement- Drug:
- mipletamig
- Announced Date:
- March 10, 2026
- Indication:
- acute myeloid leukemia
Announcement
Aptevo Therapeutics Inc. announced new interim data for mipletamig in combination with venetoclax and azacitidine in newly diagnosed acute myeloid leukemia (AML) patients who are either elderly or unfit for intensive chemotherapy.
AI Summary
Aptevo reported interim data for mipletamig given with venetoclax and azacitidine in newly diagnosed acute myeloid leukemia (AML) patients who are elderly or unfit for intensive chemotherapy. Among 28 evaluable frontline patients (24 from the RAINIER trial and 4 from a dose‑expansion study), the combination showed promising efficacy while not materially increasing toxicity. Notably, four patients were able to move on to allogeneic stem cell transplant, which is considered the best possible outcome in AML and is rare in this older or unfit group. No cytokine release syndrome (CRS) has been observed so far, supporting a consistent safety and tolerability profile that is important for frontline treatment in patients with comorbidities.
These findings support further study of mipletamig in the RAINIER Phase 1b/2 dose‑optimization trial, which is testing 28‑day cycles in adults newly diagnosed with AML who are ineligible for intensive induction chemotherapy. The data suggest mipletamig may enhance current standard‑of‑care therapy.
Read Announcement- Drug:
- mipletamig
- Announced Date:
- September 16, 2025
- Indication:
- acute myeloid leukemia
Announcement
Aptevo Therapeutics announced a 100% remission rate in Cohort 3 of its Phase 1b/2 RAINIER trial evaluating mipletamig, the Company's first-in-class CD123 x CD3 bispecific antibody, in combination with venetoclax + azacitidine for newly diagnosed patients with acute myeloid leukemia (AML) unfit for intensive chemotherapy.
AI Summary
In its Phase 1b/2 RAINIER trial, Aptevo Therapeutics reported a 100% complete remission rate (CR/CRi) in Cohort 3 among newly diagnosed acute myeloid leukemia patients unfit for intensive chemotherapy. Patients received mipletamig, a first-in-class CD123 x CD3 bispecific antibody, combined with venetoclax and azacitidine. At the highest dose level to date, all patients achieved remission, and 40% reached minimal residual disease–negative status, a key indicator for long-term outcomes.
No dose-limiting toxicities or cases of cytokine release syndrome were observed, demonstrating a favorable safety and tolerability profile even at escalating doses. These safety findings align with results from the trial’s earlier cohorts, reinforcing mipletamig’s potential for smooth integration into frontline AML therapy.
RAINIER is advancing efficiently, with Cohort 4 now open for enrollment. Aptevo expects to present updated data at a major medical conference in the fourth quarter.
Read Announcement
APVO442 FDA Regulatory Events
APVO442 is a drug developed by Aptevo Therapeutics 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:
- APVO442
- Announced Date:
- August 13, 2025
- Indication:
- Solid Tumors
Announcement
Aptevo Therapeutics Inc. today reinforced the strategic importance of its preclinical asset APVO442-an investigational CD3-engaging bispecific antibody designed to treat prostate cancer.
AI Summary
Aptevo Therapeutics Inc. today reaffirmed the strategic importance of its preclinical asset APVO442, an investigational CD3-engaging bispecific antibody designed to treat prostate cancer. Built on Aptevo’s next-generation ADAPTIR-FLEX platform, APVO442 uses a CRIS-7-derived anti-CD3 binding domain similar to mipletamig but adapted for solid tumors.
This antibody is engineered to activate T cells only within PSMA-expressing tumor sites. Its lower CD3 binding affinity and monovalent format reduce the risk of systemic immune activation, targeting the tumor microenvironment precisely. Preclinical studies demonstrate that APVO442 effectively localizes to prostate tumors, triggers a focused immune response, and spares healthy tissues.
The same solid tumor-optimized design underpins the new pipeline candidate APVO455. APVO442 strengthens Aptevo’s growing CD3-based bispecific portfolio, opening a promising path into solid tumors. It supports the company’s goal to expand its clinical pipeline and bring precise, scalable immunotherapies to patients.
Read Announcement- Drug:
- APVO442
- Announced Date:
- December 4, 2024
- Indication:
- Solid Tumors
Announcement
Aptevo Therapeutics Inc. announced additional details about the Company's preclinical bispecific antibody, APVO442, differentiated to target prostate cancer with enhanced precision and minimized safety risk
AI Summary
Aptevo Therapeutics Inc. recently shared more details about its latest preclinical bispecific antibody, APVO442. Built on the company’s ADAPTIR-FLEX® platform, APVO442 is designed to target prostate cancer with high precision while reducing safety risks. The antibody works by binding to the Prostate-Specific Membrane Antigen (PSMA) on prostate cancer cells and activating T cells directly within the tumor. This dual-target approach boosts the immune attack on cancer cells while limiting the impact on healthy cells. Early studies show that APVO442 can specifically home in on solid tumors, avoiding unwanted interactions with circulating immune cells. This precision could help improve therapy outcomes for advanced prostate cancer, where current treatments face challenges. Aptevo’s innovative design aims to transform treatment options by enhancing safety and effectiveness in the fight against prostate cancer.
Read Announcement
ADAPTIR FDA Regulatory Timeline and Events
ADAPTIR is a drug developed by Aptevo Therapeutics for the following indication: for patients unfit for intensive chemotherapy.
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:
- ADAPTIR
- Announced Date:
- June 18, 2025
- Indication:
- for patients unfit for intensive chemotherapy.
Announcement
Aptevo Therapeutics announced new clinical data from its ongoing Phase 1b/2 RAINIER trial evaluating mipletamig, its first-in-class CD123 x CD3 bispecific antibody, in combination with standard-of-care venetoclax and azacitidine (ven/aza) for newly diagnosed patients with acute myeloid leukemia (AML) who are unfit for intensive chemotherapy.
AI Summary
Aptevo Therapeutics recently shared promising results from its Phase 1b/2 RAINIER trial for mipletamig, a first-in-class CD123 x CD3 bispecific antibody. In the study, mipletamig was combined with the standard-of-care drugs venetoclax and azacitidine to treat newly diagnosed acute myeloid leukemia patients who are unfit for intensive chemotherapy. The trial showed that 85% of evaluable frontline patients achieved remission, surpassing the results seen with the venetoclax/azacitidine doublet therapy. Furthermore, the safety profile of the combination was strong, with no dose-limiting toxicities or cases of cytokine release syndrome observed. Enrollment is nearing completion in the highest dose level cohort, highlighting the trial’s momentum. These encouraging findings underscore mipletamig’s potential to improve treatment outcomes and offer a new, targeted immunotherapy option for a challenging patient population.
Read Announcement- Drug:
- ADAPTIR
- Announced Date:
- May 8, 2025
- Indication:
- for patients unfit for intensive chemotherapy.
Announcement
Aptevo Therapeutics Inc. provided a program update for APVO711, a dual mechanism bispecific utilizing the PD-L1 arm to block the PD-1/PD-L1 pathway and the CD40 arm to enhance T cell priming through activation of the stimulatory receptor CD40 on antigen presenting cells.
AI Summary
Aptevo Therapeutics recently provided an update on APVO711, a promising dual mechanism bispecific antibody currently in preclinical development. APVO711 is designed with two active components: one arm targets PD-L1 to block the PD-1/PD-L1 signaling pathway, which helps reduce tumor-induced immune suppression, while the other arm targets CD40. Activation of CD40 on antigen presenting cells enhances T cell priming, fostering a more robust immune response against cancer cells. This innovative design aims to generate deeper and more durable anti-tumor activity, particularly for patients with cancers that have been resistant to standard checkpoint inhibitors. The approach underscores the potential of Aptevo’s proprietary ADAPTIR® platform in creating novel immunotherapy candidates that address significant unmet needs in the treatment of solid tumors.
Read Announcement- Drug:
- ADAPTIR
- Announced Date:
- March 20, 2025
- Indication:
- for patients unfit for intensive chemotherapy.
Announcement
Aptevo Therapeutics announced two additional frontline AML patients have achieved remission* within 30 days of treatment in the Company's RAINIER dose optimization trial evaluating mipletamig in combination with standard of care for patients unfit for intensive chemotherapy.
AI Summary
Aptevo Therapeutics announced that two additional frontline AML patients achieved remission within 30 days of treatment in the RAINIER dose optimization trial. This trial is evaluating mipletamig in combination with standard of care therapy, which includes venetoclax and azacitidine, for patients who are not fit for intensive chemotherapy. The new results add to the strong outcomes in this trial, where 9 out of 10 frontline patients across two studies reached remission. Notably, no cases of cytokine release syndrome (CRS) have been observed, underlining the safety profile of mipletamig. These encouraging results support the potential of this triplet combination to improve treatment outcomes for elderly AML patients who have limited options, highlighting the impact of mipletamig’s unique mechanism of action when combined with standard therapies.
Read Announcement
APVO603 FDA Regulatory Events
APVO603 is a drug developed by Aptevo Therapeutics 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:
- APVO603
- Announced Date:
- March 18, 2025
- Indication:
- Solid Tumors
Announcement
Aptevo Therapeutics a leader in the development of novel bispecific antibodies for cancer treatment, based on its proprietary ADAPTIR® and ADAPTIR-FLEX® platform technologies provided an overview of solid tumor anti-cancer compound APVO603, currently in preclinical development for the treatment of solid tumors.
AI Summary
Aptevo Therapeutics is advancing its research on bispecific antibodies for cancer treatment with its novel solid tumor compound, APVO603. This preclinical candidate is designed using the company’s proprietary ADAPTIR® and ADAPTIR-FLEX® platforms. APVO603 works by simultaneously targeting the co-stimulatory receptors 4-1BB (CD137) and OX40 (CD134) to boost T cell and natural killer cell activity in the tumor microenvironment. By activating these pathways, APVO603 aims to enhance immune responses against solid tumors while reducing systemic toxicity, a common challenge with current immunotherapies. Preclinical studies have shown promising results, including increased immune cell proliferation, improved tumor cell lysis, and a favorable safety profile, suggesting that APVO603 could overcome tumor-induced immune suppression. This development marks a significant step forward as Aptevo continues to innovate new therapies to improve cancer patient outcomes.
Read Announcement
ALG.APV-527 FDA Regulatory Timeline and Events
ALG.APV-527 is a drug developed by Aptevo Therapeutics for the following indication: 5T4-expressing tumor antigens in multiple solid tumor types.
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:
- ALG.APV-527
- Announced Date:
- November 22, 2024
- Indication:
- 5T4-expressing tumor antigens in multiple solid tumor types
Announcement
Aptevo Therapeutics provided additional details about its robust oncology pipeline which is poised to potentially address some of the most challenging and aggressive forms of cancer in both blood and solid tumors.
AI Summary
Aptevo Therapeutics is advancing a strong oncology pipeline using innovative bispecific antibodies aimed at tackling some of the most challenging and aggressive cancers in both blood and solid tumors. The company’s approach uses its ADAPTIR® and ADAPTIR-FLEX® platforms to develop therapies that engage multiple targets, potentially offering more effective and safer treatment options. The pipeline includes both clinical candidates, such as mipletamig for acute myeloid leukemia and ALG.APV-527 for various solid tumors, and promising preclinical assets. Early data suggests these antibodies not only activate the immune system but also show targeted action against cancer cells. Aptevo’s plans to add a new targeted asset soon highlights its commitment to transforming cancer care, especially for patients with limited treatment options in aggressive cancer types.
Read Announcement- Drug:
- ALG.APV-527
- Announced Date:
- September 16, 2024
- Indication:
- 5T4-expressing tumor antigens in multiple solid tumor types
Announcement
Aptevo Therapeutics and Alligator Bioscience AB announced positive interim data from the dose escalation phase of their Phase 1 trial evaluating ALG.APV-527 for the treatment of solid tumors likely to express the tumor antigen 5T4.
AI Summary
Aptevo Therapeutics and Alligator Bioscience announced positive interim results from the dose escalation phase of their Phase 1 trial for ALG.APV-527, a new bispecific antibody designed to treat solid tumors that likely express the 5T4 antigen. The drug works by engaging both the tumor antigen 5T4 and the immune cell receptor 4-1BB, potentially boosting the body’s anti-tumor response. Early results showed that 60% of patients in the trial experienced stable disease, with one breast cancer patient maintaining stability for more than 11 months, despite prior disease progression. The trial, which included patients with advanced solid tumors who had received multiple preceding therapies, also demonstrated favorable safety, tolerability, and pharmacokinetic profiles. These early findings support the potential of ALG.APV-527 as a promising treatment option for patients with various solid tumors and warrant further clinical evaluation.
Read Announcement- Drug:
- ALG.APV-527
- Announced Date:
- September 13, 2024
- Indication:
- 5T4-expressing tumor antigens in multiple solid tumor types
Announcement
Aptevo Therapeutics announced that positive interim data from the dose escalation phase of their Phase 1 trial evaluating ALG.APV-527 will be presented in a poster session on Saturday, September 14, 2024, at the European Society for Medical Oncology (ESMO) Annual Congress 2024, taking place September 13 th - 17 th , 2024 in Barcelona, Spain.
AI Summary
Aptevo Therapeutics announced that positive interim data from the dose escalation phase of their Phase 1 trial for ALG.APV-527 will be presented at the upcoming European Society for Medical Oncology (ESMO) Annual Congress 2024. The poster session, scheduled for Saturday, September 14, 2024, in Barcelona, Spain, will highlight early results from the study, which looks at the safety and potential anti-tumor effects of the novel bispecific antibody targeting the 5T4 tumor antigen and activating 4-1BB. This first-in-human trial is being conducted at multiple sites in the U.S. and includes patients with various advanced solid tumors. The data indicate promising safety findings and initial signs of biological activity, setting the stage for further investigation into the treatment’s ability to stabilize disease and stimulate immune responses against cancer.
Read Announcement
APVO436 FDA Regulatory Events
APVO436 is a drug developed by Aptevo Therapeutics for the following indication: Relapsed Acute Myeloid Leukemia.
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:
- APVO436
- Announced Date:
- August 13, 2024
- Indication:
- Relapsed Acute Myeloid Leukemia
Announcement
Aptevo Therapeutics announced initiation of the Company's Phase 1b/2 dose optimization trial, "RAINIER," as part of its ongoing program to evaluate APVO436 in combination with venetoclax + azacitidine for frontline patients with acute myeloid leukemia (AML).
AI Summary
Aptevo Therapeutics has launched its Phase 1b/2 dose optimization trial, “RAINIER,” to evaluate its lead candidate APVO436—now renamed mipletamig—in combination with standard treatments venetoclax and azacitidine for frontline patients with acute myeloid leukemia (AML). The trial will enroll up to 39 patients across five dosing levels in a multi-center, open-label setting to identify the recommended Phase 2 dose. Researchers will assess the safety, tolerability, and overall effectiveness of this triplet therapy in adults who are not eligible for intensive chemotherapy. Early results from previous studies have shown mipletamig to have an excellent safety profile coupled with promising efficacy outcomes. With the RAINIER trial, Aptevo aims to confirm these encouraging findings and further demonstrate mipletamig’s potential to improve treatment outcomes in AML, offering a new avenue for patients facing limited options.
Read Announcement
