Resmed Corp. has agreed to acquire Noctrix Health Inc. for $340 million, boosting its sleep health portfolio. Noctrix has developed Nidra, a wearable neuromodulation device which treats restless legs syndrome (RLS) without disrupting sleep. With RLS impacting approximately 7% of adults globally, including about 17 million people in the U.S., the technology offers a non-drug option that could potentially treat a significant proportion of this patient population.

In its first substantial M&A transaction since 2021, Bayer AG is buying Perfuse Therapeutics Inc., a firm that has operated quietly, though it reported positive midstage data last year for PER-001, an endothelin antagonist, in glaucoma and diabetic retinopathy.

Three years after Johnson & Johnson handed back rights to an siRNA candidate targeting a genetic driver of metabolic dysfunction-associated steatohepatitis (MASH), Arrowhead Pharmaceuticals Inc. found a new partner in Madrigal Pharmaceuticals Inc., a firm that markets the first U.S. FDA-approved MASH drug, Rezdiffra (resmetirom), and has been building a pipeline in the space.

Amid calls for transparency on the most-favored nation (MFN) pricing deals U.S. President Donald Trump has reached with 17 biopharma companies, the White House Council of Economic Advisers released a report May 5 detailing how the volunteer MFN policy works and touting the $530 billion-plus in savings it’s projected to deliver over the next 10 years.

Medical Microinstruments Inc.’s (MMI) Symani surgical system was used to treat a patient with Alzheimer’s disease as part of a study evaluating robotic-enabled microsurgery for the condition. The procedure investigated whether restoring lymphatic drainage pathways in the deep cervical lymph nodes could improve the clearance of harmful neurotoxins believed to contribute to the progression of Alzheimer’s.

Thanks to a trial design that, according to Evercore ISI analyst Cory Kasimov, “played out exactly as drawn up,” Cytokinetics Inc. hit both of the phase III co-primary endpoints with aficamten in symptomatic non-obstructive hypertrophic cardiomyopathy (nHCM).

Top-line data from the Reveal-2 phase III trial of elegrobart to treat chronic thyroid eye disease (TED) drove Viridian Therapeutics Inc.’s stock up by 33.6%, positioning the company for a BLA filing in the first quarter of 2027. The trial met both primary endpoints at week 24: proptosis responder rate, as measured by exophthalmometry, required for a filing with the U.S. FDA; and the overall responder rate, required for an EMA filing. Doses every four weeks or every eight weeks achieved 50% and 54% PRR, respectively, compared to 15% for placebo. The doses also achieved 47% and 54% ORR vs. 15% for placebo. ORR included those with both proptosis and Clinical Activity Score response, defined as no worsening from baseline in the study eye, without deterioration in the fellow eye.

Regulatory uncertainty that dominated the life science sector in 2025 is transitioning into an execution framework for biotechnology companies, provided companies can tailor regulatory strategies early, and across the entire development cycle.

As Celcuity Inc. awaits a U.S. FDA approval decision for gedatolisib in HER-positive, HER2-negative, PIK3CA wild-type advanced breast cancer, the company already is setting its sights on a supplemental NDA filing, based on a top-line readout of the multi-target PAM inhibitor in a PIK3CA-mutant breast cancer cohort.

For the first time in 13 years, the U.S. Trade Representative (USTR) singled out one of the U.S. trading partners as the worst of the worst when it named Vietnam as a Priority Foreign Country (PFC) in its newly released Special 301 Report.