Tag: Regulatory

Basel, June 12, 2026 – Novartis today presented data from the RemIND trial at the European Academy of Allergy and Clinical Immunology (EAACI) Congress showing that Rhapsido^®  (remibrutinib) met its primary endpoints across the three most common chronic inducible urticaria (CIndU) subtypes, becoming the first-ever treatment to demonstrate efficacy in a global Phase III CIndU clinical trial⁷. In the RemIND trial, higher rates of complete responses were observed at week 12, with responses seen as early as week 2 in two subtypes. These results demonstrate that Rhapsido may provide sustained relief for patients whose disease remains inadequately controlled after treatment with second-generation H1-antihistamines⁷.

“Chronic inducible urticaria (CIndU) is a form of chronic hives in which everyday triggers—such as pressure, heat, cold, or sunlight—can lead to itchy wheals, and there are currently no approved targeted treatment options,” said Prof. Dr. med. Martin Metz, Deputy Director, Institute of Allergology, Charité–Universitätsmedizin Berlin, Germany. “The RemIND results across the three most common CIndU subtypes highlight the potential of Rhapsido as an important new treatment option for patients with significant unmet need.”

The three most prevalent CIndU subtypes are symptomatic dermographism (SD), cold urticaria, and cholinergic urticaria, with SD being the most common⁸. Novartis has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) seeking approval of Rhapsido for the treatment of SD subtype and will continue additional filings to health authorities globally throughout 2026. Rhapsido is approved for use in the U.S., European Union, China and several other countries for the treatment of chronic spontaneous urticaria (CSU), in adult patients with inadequate response to H1-antihistamines.

“Rhapsido significantly improves symptom control for patients living with the three most common subtypes of chronic inducible urticaria, and it has the potential to become the first approved targeted therapy. This is a major step forward for CIndU patients who have limited options,” said Angelika Jahreis, Global Head, Immunology Development, Novartis. “The CIndU data presented today are consistent with Rhapsido’s proven efficacy and favorable safety profile in chronic spontaneous urticaria and demonstrate Novartis’ commitment to developing truly meaningful innovation for patients with complex immune-mediated diseases.”

Primary endpoint results at Week 12 in the RemIND trial¹

— Sovleplenib demonstrated rapid and durable hemoglobin response with favorable safety profile —

New York, New York, June 11, 2026 (GLOBE NEWSWIRE) -- Ocean Capital Acquisition Corporation, a blank check company incorporated in the British Virgin Islands as an exempted company with limited liability (the “Company”), today announced the closing of its previously announced initial public offering (the “IPO” or this “Offering”) of 10,000,000 units (the “Units”) at an offering price of $10.00 per Unit. Each Unit consists of one ordinary share, one redeemable warrant, and one right to receive one ordinary share upon the consummation of an initial business combination. Each redeemable warrant entitles the holder thereof to purchase one ordinary share of the Company at a price of $11.50 per share, subject to certain adjustments.

FAIR LAWN, N.J. and WOODBRIDGE, N.J., June 11, 2026 (GLOBE NEWSWIRE) -- Columbia Financial, Inc. (“Columbia”) (NASDAQ: CLBK), a Delaware corporation and the mid-tier holding company for Columbia Bank (the “Bank”), and Northfield Bancorp, Inc. (“Northfield”) (NASDAQ: NFBK), the holding company for Northfield Bank, jointly announced today that Columbia has provided an election form and letter of transmittal (together with the related instructions, the “Election Materials”) to the holders of Northfield common stock so that Northfield stockholders may elect to receive, upon the completion of the previously announced merger of the Holding Company and Northfield, either (i) shares of common stock of Columbia Financial, Inc., a newly formed Maryland corporation (the “Holding Company”) that will become the holding company for the Bank following the completion of Columbia’s pending second-step conversion transaction, (ii) cash, or (iii) a combination of both. The deadline for holders of Northfield common stock to elect their preferred form of merger consideration and to return their completed Election Materials is 5:00 p.m., Eastern time, on July 10, 2026.