Alzheon Inc.’s oral treatment for people in the early stages of Alzheimer’s disease missed its phase III primary endpoint. The endpoint was slowing cognitive decline as measured by the 13-item assessment Alzheimer’s Disease Assessment Scale Cognitive subscale. The top-line data came from the phase III Apolloe4 study of valiltramiprosate, which is designed to block formation of neurotoxic soluble beta-amyloid oligomer instead of targeting mature plaques. Patients each carried two copies of the ε4 allele of the apolipoprotein E gene, which is tied to the increased risk of developing dementia and to quickly fall into advanced stages. Privately held Alzheon raised $100 million in a series E financing round in June 2024.

Loss of experience at US FDA raises concerns as impact felt

“We’ve lost 1,000 person-years of expertise in a few weeks,” former U.S. FDA Commissioner David Kessler said in a House Oversight and Government Reform hearing yesterday as he discussed the impact of the termination of 3,500 FDA employees last week, on top of the 1,000 who were let go or offered retirement in February. If this goes on much longer, Kessler said, it “may not be fixable. This may affect us for decades.” That concern is shared by companies that are already feeling the impact as product reviews are delayed, dispute resolutions suspended and critical guidance not available.

Dems petition White House to ensure drug supply chains stay intact

The Trump administration has applied a 90-day hold on nation-specific tariffs, but lawmakers on Capitol Hill are nonetheless concerned that the threat of tariffs on drugs could crimp supply chains for essential pharmaceuticals. A group of 26 House Democrats penned an April 9 letter pressing the administration to ensure that any tariffs applied on active pharmaceutical ingredients and finished drug products don’t impede patient access lest patients be forced to rely on inferior alternatives.

IL-2 drawing more developers’ attention in eczema

As developers cast their nets wide for new approaches in atopic dermatitis (AD, or eczema), players are increasingly focused on strategies that include targeting IL-2. The most-popular AD approaches thus far involve IL-4, IL-13, thymic stromal lymphopoietin, and JAK, but IL-2 could hold special value. Among the players who think so are names such as Nektar Therapeutics Inc. and Corvus Pharmaceuticals Inc.

ADPD 2025: Novel treatment modalities in neurodegenerative disorders

The current treatment strategies for neurodegenerative diseases focus on targeting Aβ in Alzheimer’s disease (AD), α-synuclein aggregates in Parkinson’s disease (PD) and anti-tau therapies, which are primarily used in AD but are also being explored for PD. At the 2025 International Conference of Alzheimer’s & Parkinson’s Disease and Related Neurological Disorders, Aditya Iyer, senior RD scientist from Amyl Therapeutics Srl, presented data on an option which could potentially serve as a pan-amyloid therapeutic.

UK government invests £500M in health data research service

The U.K. government is to invest £500 million (US$645 million) in a health data research service that will provide a single point of access to national-scale anonymized patient records, ending the need to navigate different systems or make multiple applications to use information. The new service will get a further £100 million from the research charity Wellcome Trust, which will house the center at its Genome Campus in Cambridge.

Tryptamine to test injectable psilocybin for binge eating disorder

Tryptamine Therapeutics Ltd. (Tryp) is gearing up to enter the clinic with lead compound TRP-8803, an intravenous-infused psilocybin therapy, in patients with binge eating disorder in conjunction with psychotherapy. TRP-8802 is the predecessor to Tryp’s lead psilocybin-based drug candidate, and the I.V. formulation is designed to alleviate numerous shortcomings of oral psilocybin, including significantly reducing the time to onset of the psychedelic state, controlling the depth and duration of the psychedelic experience, and reducing the overall duration of the intervention to a commercially feasible timeframe.

Also in the news

Acrivon, Advaxis, Annexon, Artiva, Assembly, Augustine, Aviceda, Ayala, Biosymetrics, BMS, Cerevance, Cytora, Diakonos, GC Biopharma, Idorsia, Immunic, ITM, Kymera, Makana, Neurona, Novavax, OS Therapies, QumulusAI, Ractigen, Remegen, Renovaro, Revalesio, Sanofi, Serina, Solu, Taurx, Terray, Tirmed, Tonix, Valo, Vincerx.