In what has turned out to be an important day for the atopic dermatitis community, shares of two biopharma companies surged on phase II data showing statistically significant and sustained outcomes for new biologics that could address the 40% of patients whose disease is not adequately controlled. Evommune Inc.’s shares (NYSE:EVMN) rose by 45% to $24.62 midday Feb. 10 on news that EVO-301, its long-acting fusion protein consisting of an IL-18 binding protein and an anti-serum albumin Fab-associated (SAFA) domain, achieved statistical significance in a phase IIa trial with a 33% improvement of the Eczema Area and Severity Index (EASI) over placebo at week 12. Nektar Therapeutics Inc.’s shares (NASDAQ:NKTR) jumped 45% as well, to $53.62, with 71% and 83% of patients receiving IL-2-targeting rezpegaldesleukin every four weeks and every 12 weeks, respectively, maintaining EASI-75 responses at the 36-week timepoint in the Rezolve-AD phase IIb study.

Relaxin prospects shaken by Astrazeneca move in HF

Astrazeneca plc’s halt of phase II work with long-acting relaxin-2 analogue AZD-3427 because of less than ideal efficacy shook up the space. Shares of competitor Tectonic Therapeutics Inc. (NASDAQ:TECX) were trading at $17.69, down $7.14, or 28%, having dipped as low as $16.77. Astrazeneca disclosed the move as part of full-year 2025 results. Tectonic has TX-45 undergoing the Apex phase II study in patients with group 2 pulmonary hypertension in heart failure with preserved ejection fraction, and top-line data are expected this year. Astrazeneca continues to develop phase IIb-stage oral relaxin candidate AZD-5462, which in the firm’s 2024 annual report was declared “the first and only small molecule targeting relaxin biology to enter clinical trials.”

Genentech plans NDA for multiple sclerosis pill with study win

Genentech Inc. is covering more bases in multiple sclerosis (MS), with its latest swing on fenebrutinib hitting a rare phase III noninferiority win against Ocrevus (ocrelizumab) in primary progressive multiple sclerosis (PPMS). The Ocrevus developer said it is planning a regulatory submission for the oral Bruton’s tyrosine kinase inhibitor in PPMS based on the Fentrepid study results. Genentech is also eyeing fenebrutinib’s approval in relapsing MS patients, contingent on an upcoming readout from its phase III Fenhance 1 study. Fenhance results are expected in the mid-first half of 2026.

Regenxbio’s MPS II gene therapy gets CRL

As many had predicted following news of a clinical hold on the gene therapy last month, Regenxbio Inc. disclosed receipt of a complete response letter (CRL) regarding its BLA for RGX-121 (clemidsogene lanparvovec) in mucopolysaccharidosis II, an ultra-rare neurodegenerative disease in dire need of new therapies. According to the company, the U.S. FDA noted in the CRL reasons for the rejection, namely uncertainty regarding eligibility criteria in clinical study and the comparability of natural history external control data to the study population. The agency also raised questions as to the appropriateness of the cerebrospinal fluid levels of heparan sulfate D2S6, a biomarker of brain disease activity that was used as a surrogate endpoint to predict clinical benefit.

Sava sees positive data on microsensing tech

Sava Technologies Ltd. reported positive clinical data which showed that its multi-molecule biosensor technology can reliably monitor glucose levels beneath the skin in real time. In a head-to-head comparison with a leading commercial continuous glucose monitor, Sava’s device demonstrated comparable performance over a full 10-day wear period, with a mean absolute relative difference only around 0.8 percentage points apart.

ATF6 shapes liver cancer: from ER stress to inflammation

Hepatocellular carcinoma (HCC) is the most common form of primary liver cancer, representing approximately 75%-85% of all cases. Often considered preventable, primary liver cancer ranks as the sixth most frequently diagnosed cancer and the third leading cause of cancer deaths worldwide. Through a multi-institutional effort, researchers have identified activated ATF6α as a driver of HCC that suppresses immune defenses, predicts response to immune checkpoint therapy, and represents a potential target for intervention.

Also in the news

Aerska, Anixa, Ascletis, Atraverse, BD, Bioaffinity, Biofrontera, Biogen, Breye, Cala, Clearmind, Conexeu, CSL, Entera, Ernexa, Estrella, Evogene, Hemex, Human Longevity, Johnson & Johnson, Krystal, Lumosa, Median Technologies, Memo, Nervgen, Ocugen, Peijia, Quantx, Rapid, Roche, Sanofi, Trained Therapeutix, Vesalic, Waters, Zenas

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