Welcome to our dedicated page for Novartis SEC filings (Ticker: NVS), a comprehensive resource for investors and traders seeking official regulatory documents including 10-K annual reports, 10-Q quarterly earnings, 8-K material events, and insider trading forms.
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Novartis’ tender offer for Tourmaline Bio advances as its subsidiary Torino Merger Sub updates terms and regulatory status. The offer seeks to purchase all outstanding shares of Tourmaline Bio at $48.00 per share in cash, without interest and subject to applicable withholding taxes, on the terms set out in the Offer to Purchase and Letter of Transmittal.
Novartis and Tourmaline filed their Premerger Notification and Report Forms on October 6, 2025, and the HSR Act waiting period expired on October 21, 2025 at 11:59 p.m. ET, satisfying the antitrust condition to the offer. The offer remains subject to the other conditions described in Section 15 — Conditions to the Offer. An exhibit was added for a Novartis press release dated October 22, 2025.
Novartis announced FDA approval of Rhapsido (regibrutinib) as the first oral Brutons tyrosine kinase inhibitor (BTKi) for adult patients with chronic spontaneous urticaria (CSU) who remain symptomatic despite H1 antihistamine treatment. Rhapsido is taken twice daily, requires no injections or laboratory monitoring, and demonstrated onset of well-controlled disease (UAS7 ) as early as Week 2 and at Week 12, with about one-third of patients achieving complete absence of itch and hives at Week 12.
The prescribing information reports a safety profile that does not require lab monitoring; the most common adverse events (>=3%) were nasal congestion, nasopharyngitis, bleeding, headache, nausea, and abdominal pain. Novartis notes remibrutinib is also in development for chronic inducible urticaria, food allergy, and hidradenitis suppurativa.
Novartis announced positive top-line results from two global Phase III trials (NEPTUNUS-1 and NEPTUNUS-2) of ianalumab in adults with active Sjögren's disease. Both trials met the primary endpoint, demonstrating statistically significant improvements in systemic disease activity measured by reduction in ESSDAI versus placebo.
NEPTUNUS-1 enrolled 275 patients and NEPTUNUS-2 enrolled 504, evaluating ianalumab 300 mg subcutaneous monthly or every three months versus placebo for up to 52 weeks. Novartis reported ianalumab was well tolerated with a favorable safety profile, described the medicine as having dual B cell-directed activity, and said it plans to present the data and submit to health authorities globally. The program has FDA Fast Track designation, and the release notes there is no guarantee of approval or commercial success.