Acumen Pharmaceuticals

In 2024, pharma saw breakthroughs like Amtagvi for solid tumors and Cobenfy for schizophrenia. Challenges include the Inflation Reduction Act's price negotiations and R&D financial pressures. Innovations expected in 2025 include SERDs for breast cancer, bispecific antibodies in immuno-oncology, and the first tri-specific antibody approval. Clinical trials will evolve with external control arms and adaptive designs, while policy shifts may impact rare disease R&D and obesity care coverage.

Acumen Pharmaceuticals is advancing ACU193, a novel therapeutic targeting toxic soluble amyloid-β oligomers (AβOs) for Alzheimer’s disease (AD), aiming for improved safety and efficacy. With positive phase 1 trial results, ACU193 shows promise in reducing amyloid plaques and minimizing adverse effects, marking a significant step towards effective AD treatment.

Opdivo Qvantig, the first subcutaneously administered PD-1 inhibitor, received FDA approval for treating adult solid tumors. Co-formulated with Halozyme's ENHANZE technology, it offers faster administration and comparable efficacy and safety to IV Opdivo, as shown in the Phase 3 CheckMate-67T trial.

Halozyme Therapeutics announced Takeda's HYQVIA® received Japanese regulatory approval for treating agammaglobulinemia or hypogammaglobulinemia, offering reduced dosing frequency with Halozyme's ENHANZE® technology.

Halozyme Therapeutics announced Japan's MHLW approved argenx's VYVDURA, co-formulated with Halozyme's ENHANZE® technology, for CIDP treatment. VYVDURA, a once-weekly subcutaneous injection, is the first FcRn blocker for CIDP, following its approval for gMG in Japan. The approval is based on the ADHERE Study, showing significant clinical improvement in patients.

Halozyme announced argenx's VYVDURA, co-formulated with ENHANZE®, received Japan's MHLW approval for CIDP treatment, marking the first FcRn blocker for CIDP. Approved for weekly self-administered subcutaneous injection, it follows ADHERE Study's positive outcomes, offering a new treatment option in Japan.

The Cancer Immunotherapy Market 2025-2029 report forecasts significant growth in immuno-oncology therapeutics, highlighting technologies like CAR-T Cells and Checkpoint Inhibitors. It offers insights into market opportunities, key players, and the impact on healthcare, aiming to guide investment and strategic decisions.

Halozyme proposes to acquire Evotec for €11.00 per share, creating a leading global pharma services company with capabilities in drug discovery, biologic manufacturing, and drug delivery technologies, diversifying and scaling Halozyme's revenue and EBITDA into the next decade. The all-cash transaction would be funded by cash on hand and new debt, with expected net leverage less than 2x two years post-close.

Acumen Pharmaceuticals' Q3 2024 Form 10-Q reports a net loss of $(29.8) million, up from $(13.0) million in Q3 2023, due to higher R&D expenses. The company is advancing sabirnetug in the Phase 2 ALTITUDE-AD trial, with expected enrollment completion in H1 2025. Acumen expects its cash and equivalents to fund operations into H1 2027, despite anticipating increased expenses and operating losses.