Shares of Xenon Pharmaceuticals Inc. soared as the company’s top-line readout of the phase III X-Tole2 study testing azetukalner in focal onset seizures (FOS) solidly bested expectations, positioning the K_V7 potassium channel opener for a regulatory filing later this year. If approved, azetukalner could offer a much-needed new mechanism of action in the epilepsy space, with Xenon executives touting the impressive efficacy along with the drug’s safety and ease of use as a once-daily oral treatment option. The company’s stock (NASDAQ:XENE) was trading up 48% at midday.

Forecast brighter for Uniqure with Prasad’s departure

The regulatory clouds that have been darkening the U.S. FDA landscape for Uniqure NV’s gene therapy AMT-130 in Huntington’s disease may be parting a bit with the announced departure of Vinay Prasad as director of the agency’s CBER. Seemingly reluctant to exercise regulatory flexibility in some rare diseases like Huntington’s, Prasad is thought to be one of the voices pushing for Uniqure to demonstrate the efficacy of its therapy via a randomized trial with a sham surgery serving as a control arm. That was a big shift from CBER’s stance pre-Prasad. Consequently, news of Prasad’s pending departure is being hailed as a positive for Uniqure, as it “is likely to open up a more balanced discussion on risk/reward” for Huntington’s, RBC Capital Markets analyst Luca Issi said today. The Street apparently agreed, pushing Uniqure (NASDAQ:QURE) up nearly 25% this morning in heavy trading nearly three times its average volume.

Dianthus rises on phase III data with claseprubart in CIDP

Shares of Dianthus Therapeutics Inc. (NASDAQ:DNTH) were trading at $81.10, up $15.90, or 24%, on an early “go” decision with regard to continued development of claseprubart in chronic inflammatory demyelinating polyneuropathy (CIDP). The move is based on an interim responder analysis in the phase III Captivate trial. A monoclonal antibody, claseprubart has been engineered to selectively target the classical pathway by inhibiting only the active form of the C1s protein. Claseprubart is enhanced with YTE half-life extension technology meant to allow for a subcutaneous, infrequently dosed, self-administered shot. Dianthus, of Waltham, Mass., faces competition in CIDP, a rare, acquired disorder in which the immune system attacks the myelin sheath of peripheral nerves.

Agilent buys Biocare for $950M

Agilent Technologies Inc. has agreed to buy Biocare Medical LLC for $950 million in cash, in a bid to strengthen its pathology portfolio. The deal adds Biocare’s complementary immunohistochemistry antibodies, reagents and instruments portfolio to Agilent’s existing offerings, and expands its ability to serve a wider range of pathology laboratories across clinical and research settings.

Ipsen pulls Tazverik from US market on secondary malignancies

Ipsen SA has withdrawn Tazverik (tazemetostat) from the U.S. market after evidence emerged of secondary hematological malignancies in an ongoing phase Ib/III study in follicular lymphoma. The orally available inhibitor of the histone methyltransferase EZH2 (enhancer of zeste homolog-2) was granted accelerated approval by the FDA for treating the rare soft tissue cancer epithelioid sarcoma, and also received accelerated approval as a treatment for relapsed/remitting follicular lymphoma in patients with an EZH2 gain of function mutation. Tazverik licensee Hutchmed Ltd. also announced it has taken steps to withdraw the product from the market in China.

Olema falls on Roche breast cancer failure with giredestrant

The failure of the Persevera study, sponsored by Roche Group AG’s Genentech unit, may delay advancement of giredestrant in combination with palbociclib (Ibrance) as a first-line treatment for ER-positive, HER2-negative, locally advanced or metastatic breast cancer, but the FDA recently accepted an NDA based on success with the phase III Evera trial for giredestrant with everolimus (Affinitor) as a second-line treatment. Genentech also hit endpoints with the Lidera trial as an adjuvant endocrine monotherapy, and those results will be submitted to the FDA shortly, the company said. But for competitor Olema Pharmaceuticals Inc., which has palazestrant, also a selective estrogen receptor degrader and complete estrogen receptor antagonist for the same indication, missing the phase III Persevera primary endpoint of progression-free survival translated to a 22% stock slide (NASDAQ:OLMA) to $16.79 midday on March 9.

Mixed phase II results still point to path forward for AISA-021

Although Aisa Pharma Inc’s cilnidipine (AISA-021) failed to meet the primary endpoint, multiple secondary endpoints showed statistically significant improvement in treating sclerosis-associated Raynaud's phenomenon, potentially positioning the drug for a phase III program in a disease with no approved oral therapies globally.

Taiwan to invest $752M in biopharma security over four years

Taiwan plans to invest NT$24 billion (US$752 million) over four years to bolster national biosecurity, expand domestic pharmaceutical production and safeguard against global supply chain volatility. Taiwan President Lai Ching-te announced the initiative at the seventh meeting of the Healthy Taiwan Promotion Committee March 5, emphasizing the need to strengthen national resilience across all levels.

Eli Lilly commits $500M to boost South Korea’s biomedical sector

Eli Lilly and Co. will invest $500 million to support South Korea’s biopharmaceutical industry over the next five years, following high-level talks March 9 between Prime Minister Kim Min-seok and Lilly Executive Vice President Patrik Jonsson. The memorandum of understanding, signed with the Ministry of Health and Welfare, aligns with the government’s goal of making Korea’s biomedical industry one of the top five globally and Lilly’s aim of delivering innovative medicines worldwide, according to the agency.

Med-tech fraud charges lead to prison time

The owner of three durable medical equipment companies was sentenced Friday to more than seven years in prison and ordered to pay more than $25 million in restitution and forfeiture after he pleaded guilty nearly two years ago to one count of health care fraud. Also last week, a former chief regulatory officer at the California-based med-tech company Exthera Medical Corp. agreed to plead guilty to one count of failure to report adverse events with the intent to defraud or mislead the FDA – a criminal charge that carries a maximum sentence of three years in prison. In addition, Exthera entered into a three-year deferred prosecution agreement with the U.S. Department of Justice.

Study ties gut and saliva microbes to peanut allergy defense

In an article published in Cell Host & Microbe on March 3, 2026, researchers at McMaster University in Canada and at the Hospital Universitario de La Princesa in Spain have shed some light on the impact of microbiota on peanut-driven allergy and anaphylaxis. Anaphylaxis is an acute, potentially life-threatening reaction that is often triggered by food and mainly mediated by immunoglobulin E (IgE) and mast cells.

Also in the news

Accord, Aisa, Alfasigma, Apozeal, Beam, Bio Palette, Calidi, Cellbox, Claritas, Eli Lilly, Foresee, GSK, Helus, Hutchmed, Inimmune, Johnson & Johnson, Lifevac, Medicus, Merck, Minnesota, Neuspera, Orexo, Rakovina, Rapport, Roche, Royal Philips, Salus, Sciwind, Shuttle, Solid, Soterix, Springworks, Sumitomo, Tenacia, Tersis, Tevogen, Tonix, Valcare, Vdyne, Venturemed, Zealand