PRISM Mid-Day Movers: Trial Results and FDA Fast Tracks Drive Indices Higher

2025-05-05 14:00:34 ET

Immutep Surges 28% on Keytruda Combo Trial Result Driving Gains in PRISM Emerging Pharmaceuticals

Immutep Limited ( IMMP ) soared 27.54% to lead the PRISM Emerging Pharmaceuticals Index after reporting impressive median overall survival (OS) results from its Phase IIb TACTI-003 trial in head and neck squamous cell carcinoma (HNSCC) patients with PD-L1 CPS <1 . The study showed a 17.6-month median OS in this hard-to-treat subgroup--well above historical benchmarks ranging from 7.9 to 11.3 months for current immunotherapy and chemo-based options.

The trial combines Immutep's lead asset eftilagimod alfa (efti), a first-in-class APC activator, with Merck's KEYTRUDA(R) (pembrolizumab). Importantly, the combination has remained well-tolerated while producing multiple complete responses, a strong safety signal that further boosts its potential as a chemotherapy-free frontline treatment. Immutep has now requested a meeting with the FDA to discuss possible regulatory pathways, bolstered by the existing Fast Track designation for efti in this indication.

Alterity Therapeutics Rallies 31% on Fast Track Status for Parkinsonian Disorder Drug

Alterity Therapeutics ( ATHE ) jumped 30.93% in midday action, lifting the PRISM Emerging Global Health Index , after announcing the U.S. FDA granted Fast Track designation for its lead candidate ATH434 to treat Multiple System Atrophy (MSA)-- a rare and debilitating neurodegenerative disease with no approved treatments.

The designation follows positive Phase 2 results showing statistically significant improvements in patient function as measured by the UMSARS I scale, as well as favorable trends in motor function and biomarker response. ATH434, an oral iron chaperone designed to inhibit the aggregation of -synuclein, has also been granted Orphan Drug status by both the FDA and European Commission. The company highlighted that the Fast Track status will enable more frequent interactions with regulators and could accelerate time to market.

Other PRISM Mid-Day Movers:

• SciSparc Ltd. ( SPRC ): +38.24%
• WeightWatchers ( WW ): +23.92%
• Sunnova Energy International Inc. ( NOVA ): +20.02%
• Psyence Biomedical ( PBM ): +13.60%

The post PRISM Mid-Day Movers: Trial Results and FDA Fast Tracks Drive Indices Higher appeared first on PRISM MarketView .

COMTEX_465239809/2927/2025-05-05T13:00:34