Aptevo Therapeutics Inc Stock Price, News & Analysis

Aptevo Therapeutics announced a poster presentation during the 64th ASH Annual Meeting on December 11, 2022, focusing on its lead candidate APVO436 for treating acute myeloid leukemia.

The presentation will include updated results from a Phase 1 study evaluating the efficacy of this novel bispecific molecule designed for relapsed and refractory cases. The session will be led by Dr. Justin M. Watts from the University of Miami's Sylvester Comprehensive Cancer Center.

Alligator Bioscience and Aptevo Therapeutics announced that the FDA has issued a "may proceed" notification for ALG.APV-527, an investigational drug for treating 5T4-expressing tumors. This allows the initiation of a Phase 1 clinical trial in the U.S. ALG.APV-527 is designed to stimulate antitumor immune responses, aiming to address a significant unmet medical need in solid tumors. This marks a significant milestone for both companies, adding to Aptevo’s therapeutic pipeline alongside APVO436, which is currently in a Phase 1b trial.

Aptevo Therapeutics has released new preliminary data for its clinical trial of APVO436 targeting acute myeloid leukemia (AML). The latest results indicate a 36% remission rate among response-evaluable patients in Cohort 1, which includes combination therapy with standard chemotherapy. Additionally, a patient in Cohort 3 achieved bone marrow complete remission. One patient in the myelodysplastic syndrome (MDS) cohort remains stable after 18 months on treatment. The company remains optimistic about the potential of APVO436 as a therapeutic agent.

Aptevo Therapeutics reported its Q1 2022 financial results, revealing a net loss of $7.7 million or $1.55 per share, slightly higher than the $7.3 million loss reported in Q1 2021. The company earned a $10 million non-dilutive milestone payment from RUXIENCE sales and anticipates $22.5 million in additional milestones over the next two years. Royalty revenue increased by 29% to $3.1 million, while R&D expenses decreased to $4.9 million. Key clinical advancements include two patients achieving transplant eligibility in the APVO436 trial for acute myeloid leukemia.

Preclinical Data Supports APVO442 for Prostate Cancer

Aptevo Therapeutics (NASDAQ:APVO) announced promising preclinical findings for its bispecific candidate APVO442, targeting prostate-specific membrane antigen (PSMA) and CD3. Presented at the AACR Annual Meeting, this candidate aims to enhance tumor-fighting immune responses while reducing side effects, specifically cytokine release syndrome. The company is advancing toward clinical trials, aiming for better treatment options for challenging cases of metastatic castration-resistant prostate cancer.

Aptevo Therapeutics has reported encouraging outcomes from its ongoing Phase 1b trial of APVO436, a therapy for patients with relapsed/refractory acute myeloid leukemia (AML). A patient treated with APVO436 as monotherapy has achieved transplant eligibility after a significant reduction in bone marrow blasts. This follows another patient in a combination therapy arm also progressing to transplant. The treatment has demonstrated a favorable safety profile and showed clinical activity in previous dose escalation studies, raising hopes for its role in AML treatment.

Aptevo Therapeutics reported its 2021 financial results, revealing a net loss of $28.5 million or $6.07 per share, up from a loss of $17.8 million in 2020. The company achieved significant progress in its clinical trials, particularly with APVO436 for acute myeloid leukemia, showing a 27.5% clinical activity in 40 patients. Aptevo plans to submit an IND for ALG.APV-527 in late 2022 and reported a 185% increase in royalty revenue to $12.3 million, driven by Pfizer's RUXIENCE. Cash reserves stood at $46.3 million, sufficient for the next 12 months.

Aptevo Therapeutics (NASDAQ: APVO) announced a $10 million non-dilutive milestone payment related to RUXIENCE sales in 2021. The company anticipates additional milestones totaling $22.5 million over the next two years, based on optimistic sales forecasts. The Phase 1b trial for its lead candidate, APVO436, for acute myeloid leukemia (AML) continues to progress, enrolling new sites including MD Anderson Cancer Center. A patient in complete remission is set to advance to transplant, indicating positive clinical outcomes.

Aptevo Therapeutics announces the retirement of its founding chairman, Fuad El-Hibri, effective April 1, 2022. Vice Chairman John E. Niederhuber, M.D., will succeed him. Under El-Hibri's leadership, the company advanced its clinical-stage immuno-oncology platform, developing drug candidates like APVO436, currently in Phase 1b trials for acute myeloid leukemia. The transition is viewed positively by the company, expecting to build upon the foundation laid during El-Hibri's tenure.