A month away from the PDUFA decision date for a Leqembi (lecanemab) subcutaneous autoinjector to be used for maintenance dosing for those with early Alzheimer’s disease, Eisai Co. Ltd. and Biogen Inc. presented clinical data at the Alzheimer's Association International Conference (AAIC) 2025 in Toronto, showing comparable efficacy and safety to the FDA-approved intravenous formulation. If the subcutaneous (subq) autoinjector is approved by the Aug. 31 set date, the new formulation “could materially accelerate use” of anti-amyloid antibody Leqembi, noted analyst Brian Abrahams, of RBC Capital Markets. It also would enable patients to receive the drug through their caregivers at home. The positive findings came alongside interim real-world study data indicating that, of 178 people living with early Alzheimer’s disease (AD), 83.6% remained at the same clinical stage or improved from mild dementia to mild cognitive impairment over a mean duration of treatment of 375.4 days. It is welcome news for the AD community, which has seen few advances in decades, with the only promising prospects in recent years receiving a fair amount of pushback from regulatory agencies.

Soligenix has phase IIa success in rare disease Behçet's

Soligenix Inc.’s phase IIa study of SGX-945 (dusquetide) for treating oral ulcers in those with Behçet's disease showed biological efficacy in the proof-of-concept study. The positive results had propelled the company’s stock (NASDAQ:SNGX) 440% higher at midday, when shares were going for $4.40 each. Behçet's, a rare disease also known as vasculitis, is an inflammatory issue in blood vessels and is most often found in young adults. The open-label study was designed to be highly comparable to the phase III trial of Otezla (apremilast), the blockbuster from Amgen Inc. that is already approved in the indication.

Alterity develops novel MRI biomarker to track disease progression in MSA

Alterity Therapeutics Ltd. helped develop a new neuroimaging biomarker called the multiple system atrophy index (MSA-AI), which looks to be a more reliable biomarker for tracking disease progression of MSA. Developed using deep learning methods, the MSA-AI offers a superior, objective and quantifiable measure of brain atrophy in MSA patients. MSA is a rare, neurodegenerative disease characterized by failure of the autonomic nervous system and impaired movement. Alterity CEO David Stamler told BioWorld that the imaging tool will be used in its upcoming phase III trial for lead asset ATH-434, either as a tool to select patients or as a tool to monitor drug effect or disease progression.

Australian researchers identify world-first treatments to prevent HTLV-1 infection

Around 10 million people globally live with the life-threatening human T-cell lymphotropic virus type-1 (HTLV-1), yet it remains a poorly understood disease that currently has no preventative treatments and no cure. That could soon change after Australian researchers discovered that existing HIV drugs can suppress transmission of the HTLV-1 virus in mice.

Allergens attack by way of pores in epithelial cell membrane

Chinese scientists have discovered a common mechanism by which certain allergens elicit an immune reaction, showing they cause the formation of pores in the membrane of epithelial airway cells. That allows calcium ions to enter and trigger a type II immune cascade, which results in the release of histamine from mast cells. This could fill one of the major gaps in the understanding of allergies, which is why some of the many proteins humans encounter cause an allergic reaction and others do not.

NIH to receive a $400M boost under Senate spending bill

The Senate Appropriations Committee met July 31 to mark up legislation that would fund the Department of Health and Human Services, which includes an additional $400 million for the National Institutes of Health. The increase in NIH funding would repudiate the Trump administration’s efforts to drastically cut those appropriations, an outcome that marks a clear win for companies in the life sciences.

Nektar soars on atopic dermatitis data, leads drug developer gainers in Q2

The BioWorld Drug Developers Index (BDDI) rebounded in the second quarter, ending the first half of 2025 (H1) up 1.23% after being down 7.36% at the end of March. Nektar Therapeutics Inc. led the BDDI over May and June, driven by strong phase IIb data for its atopic dermatitis candidate. Acadia Pharmaceuticals Inc. was bolstered by a key patent win for Nuplazid and solid Q1 earnings. Atai Life Sciences NV advanced on the back of its acquisition of Beckley Psytech Ltd., while Blueprint Medicines Corp. climbed on news of a buyout offer from Sanofi SA.

Also in the news

Abbvie, Aclaris, Actio, Aerorx, Allianthera, Biogen, Cardiff, Celcuity, Dr. Falk, Dxvx, Eisai, Eli Lilly, Evotec, Hansa, Kane, Kedrion, Kissei, Larimar, Neuvivo, Newamsterdam, Poxel, Rein, Sandoz, Sanofi, Tenaya, Viridian, Vivace, Vyne