Tag: Securities and Exchange Commission

Responder rate of 57% at one year in open-label extension (OLE) comparable to 63% at 12 weeks in Phase 2 Avail™ trial

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

COPENHAGEN, Denmark, June 12, 2026 - Evaxion A/S (NASDAQ: EVAX) (“Evaxion”), a clinical-stage TechBio company developing novel vaccines with its pioneering AI-Immunology™ platform, has been awarded the 2026 Prix Galien UK Award for Best digital health solution for AI-Immunology™.

LAS VEGAS, June 11, 2026 (GLOBE NEWSWIRE) -- HF Foods Group Inc. (NASDAQ: HFFG), a leading distributor of international foodservice solutions to Asian restaurants and other businesses across the United States, announces that its Board of Directors (the “Board”) has approved a limited duration stockholder rights plan (the “Rights Plan”) and declared a dividend distribution of one right (“Right”) for each outstanding share of the Company’s common stock to stockholders of record as of the close of business on June 22, 2026.

NEW YORK, June 11, 2026 (GLOBE NEWSWIRE) --

WHY: Rosen Law Firm, a global investor rights law firm, continues to investigate potential securities claims on behalf of shareholders of PennyMac Financial Services, Inc. (NYSE: PFSI) resulting from allegations that PennyMac may have issued materially misleading business information to the investing public.

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

DALLAS, June 11, 2026 (GLOBE NEWSWIRE) -- Arcadia Biosciences, Inc.^® (Nasdaq: RKDA), a producer and marketer of innovative wellness products, announced today that it has entered into securities purchase agreements for the purchase and sale of 3,883,496 shares of its common stock (or pre-funded warrants in lieu thereof), Series A-1 preferred investment options to purchase up to an aggregate of 3,883,496 shares of common stock and Series A-2 preferred investment options to purchase up to an aggregate of 3,883,496 shares of common stock at a purchase price of $1.03 per share of common stock (or pre-funded warrant in lieu thereof) and associated preferred investment options in a private placement priced at-the-market under Nasdaq rules.

NEW YORK, June 11, 2026 (GLOBE NEWSWIRE) -- Nasdaq (Nasdaq: NDAQ) today announced the results of the June 2026 quarterly rebalance of the Nasdaq-100 Index^® (NDX^®), which will become effective prior to market open on Monday, June 22, 2026.