Weekly Rundown: Threat of pharma tariffs causes markets to swing

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Threat of pharma tariffs causes markets to swing

Earlier this week, President Trump said that pharmaceutical imports would no longer be exempt from tariffs and he would soon announce “major” tariffs. The Wall Street Journal reported that as of midday Wednesday, Big Pharma stocks were down at least two percent across AbbVie, Bristol Myers Squibb, Eli Lilly, Johnson & Johnson, and Merck, with others faring even worse, such as Sanofi which was down by 6.4 percent in Europe. Pharma stocks soon rebounded across many companies by Thursday morning after President Trump reversed course on Wednesday afternoon and announced a 90-day pause on higher reciprocal tariffs for dozens of countries except China (which received an increased tariff rate of 125 percent). But, the seesaw effect continued, with stocks from many companies dipping again by Thursday afternoon.

The future of pharmaceutical tariffs remains uncertain. On Monday, David Risinger, who works on Wall Street covering the biopharma industry, told Endpoints News, “They’ve said that they plan to follow through on pharmaceutical tariffs. … So I’m fearing that things will get worse before they get better.” If pharmaceutical tariffs do go into effect, ABC News reported that they could lead to higher costs and drug shortages. Ernie Tedeschi, who directs the Budget Lab at Yale University, told ABC News, “Based on our assessment … costs for prescription drugs would rise by an average of around $600 per year per household in the United States.” – Allison Whitten

Highlights from the AD/PD 2025 symposium

An incredible week at the AD/PD Alzheimer's Disease (AD) and Parkinson's Disease (PD) International Conference 2025 has come to an end. The conference featured the latest advancements in drug development, research, and clinical trials for AD, PD, and other related neurological disorders. Here are a few highlights from the meeting:

In a Phase 3 trial, researchers at Alzheon evaluated the effect of valiltramiprosate — an oral small-molecule inhibitor of beta amyloid aggregation — in a large cohort of APOE4 homozygous individuals with mild AD. APOE4 homozygous individuals have the highest genetic risk for sporadic AD (1). Valiltramiprosate did not meet the study’s primary endpoint as measured by the Alzheimer’s Disease Assessment-Cognitive (ADAS-Cog13) subscale which evaluates cognitive function. However, the drug led to significant improvements in ADAS-Cog13 scores in patients with mild cognitive impairment, suggesting that it may be more effective when used earlier in the disease course.
Cognito Therapeutics, a late-stage clinical neurotechnology company, presented data from their Phase 2 trial on Spectris, a noninvasive gamma sensory stimulation device, in mild-to-moderate AD patients. Spectris uses auditory and visual neuromodulation to boost gamma brain activity, with the aim of slowing brain atrophy and functional decline in AD. After 6 months of treatment, the device induced 40 Hz steady-state oscillation and significantly preserved corpus callosum (CC) structure in patients compared to controls. As the CC typically deteriorates in AD, Spectris may help restore brain resilience and function in the disease.
In a Phase 2/3 study, researchers at Annovis Bio assessed the efficacy of buntanetap, an oral small molecule, in 340 mild-to-moderate AD patients, including APOE4 homozygotes, heterozygotes, and non-carriers. Buntanetap works by inhibiting the formation of neurotoxic proteins like amyloid-beta, alpha-synuclein, and TDP-43. Treatment with buntanetap significantly improved ADAS-Cog11 scores in individuals with mild AD compared to placebo and baseline. However, while APOE4 carriers did not show significant improvements compared to placebo, treatment with the drug led to significant improvements over baseline scores in this cohort. Buntanetap was also safe and effective in both APOE4 carriers and non-carriers. Annovis Bio plans to begin a Phase 3 study to evaluate the drug's efficacy and potential for disease modification in a larger AD patient population.
Researchers at remynd, a clinical-stage biotechnology company, shared their Phase 2a results for REM0046127, their lead small molecule drug for mild-to-moderate AD. REM0046127 works by restoring the integrity of the cytoskeletal protein septin, which is disrupted by pathological tau proteins during the course of AD. Results from the Phase 2a trial showed that the drug resulted in significant liver injury in treated patients, leading the researchers to terminate the study early. Despite this, REM0046127 treatment led to improved memory retrieval, normalized EEG activity, and increased dopamine levels in the cerebrospinal fluid. The compound also reduced total tau levels, indicating its potential disease-modifying effects. These findings suggest that REM0046127 could offer symptomatic and disease-modifying benefits in AD patients, pointing to the need to conduct further studies with a better optimized compound. –Dika Ojiakor

Lower risk of Alzheimer’s disease linked to GLP-1 drugs and SGLT2is

University of Florida researchers published a study in JAMA Neurology where they reported that GLP-1 receptor agonist drugs and sodium-glucose cotransporter-2 inhibitors (SGLT2is) are associated with a lower risk of AD and related dementias in patients with type 2 diabetes (2). By comparing the electronic health records of nearly 34,000 patients over age 50 with type 2 diabetes, the researchers showed that the incidence rate of AD and related dementias was significantly lower in patients taking GLP-1 drugs and SGLT2is compared to patients taking other glucose-lowering drugs. The results support a possible neuroprotective effect of both GLP-1 drugs and SGLT2is and could signal a positive sign for Novo Nordisk’s Phase 3 trials testing the GLP-1 drug semaglutide in patients with early onset AD. Their results are expected to be released later this year. – Allison Whitten

How FDA firings will affect drug approvals and user fees

The effects of the massive layoffs at HHS last week will reverberate for some time. Of particular concern for drug developers are how the cuts may affect the FDA’s User Fee programs. To ensure drugs, devices, and diagnostic tests get approved in a timely manner, biotech and pharma companies pay user fees to the FDA. These fees — which make up a little less than half of the FDA’s overall budget — allow the FDA to hire additional staff to aid in quick but thorough drug reviews. The publication AgencyIQ by Politico recently reported that many FDA staff who helped negotiate these user fees were laid off last week, endangering the existence of this program. Regulatory policy expert, Alexander Gaffney wrote in the piece, “The loss of FDA’s user fee funding would be catastrophic for FDA and the life sciences industry. The evaporation of $3.3 billion in funding would likely halt all medical product reviews.” – Stephanie DeMarco

A new gene editing tool for multi-mutation diseases

Researchers have developed STITCHR — an RNA-based gene editing tool that can insert therapeutic genes into precise locations within the genome without causing unwanted mutations (3). STITCHR makes use of enzymes from retrotransposons — mobile DNA elements also known as "jumping genes" that can move and insert themselves from one location in the genome to another — to insert genes at specific sites. The research team initially screened for thousands of retrotransposons, after which they selected one that was suited to the new technology and combined it with a CRISPR nickase enzyme to create STITCHR. The tool can insert gene edits ranging from 1 bp to 12.6 kb, far surpassing CRISPR’s 500 bp limit. Researchers could also potentially use STITCHR to target the thousands of mutations that are present in diseases like cystic fibrosis, all by using a single editing construct. – Dika Ojiakor

A quick, portable test for TB

Tuberculosis (TB) is the deadliest infectious disease in the world, but a quick way to diagnose people and get them drugs to treat the infection will help block its spread. Reporting in Science Translational Medicine, scientists at Tulane University have developed a smartphone-sized TB diagnostic test that’s portable and can give people results in under one hour (4). The test detected Mycobacterium tuberculosis DNA in saliva, sputum, and blood samples with higher sensitivity and similar specificity to currently available tests. The low cost and portable nature of this test would increase access to people in rural resource-limited areas where the majority of TB cases occur. – Stephanie DeMarco

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