Key Takeaways J&J said nipocalimab met the primary endpoint in the phase IIb JASMINE study in SLE.The study also hit key secondary and exploratory endpoints, including signals for steroid sparing.Nipocalimab is approved under the brand name Imaavy for treating generalized myasthenia gravis.Johnson & Johnson (JNJ) announced that the phase IIb JASMINE study, which evaluated its pipeline candidate, nipocalimab, for treating adult patients with systemic lupus erythematosus (SLE), has met the primary endpoint.Th ...

Core Insights - Halozyme Therapeutics, Inc. (NASDAQ:HALO) is recognized as one of the best small-cap stocks with significant upside potential according to Reddit discussions [2] - The company focuses on oncology therapies targeting the tumor microenvironment and has recently acquired Elektrofi to enhance its drug delivery capabilities [2] - The stock has appreciated approximately 54% year-to-date [2] Financial Performance - Halozyme reported a revenue growth of 22% year-over-year in its latest quarterly results, with royalty revenue increasing by 52% [3] - The company raised its full-year guidance in May, indicating strong earnings performance [4] Product Developments - The FDA approved Darzalex Faspro, an injectable version of the multiple myeloma therapy daratumumab, developed by Johnson & Johnson and Halozyme, as a front-line treatment for light chain amyloidosis [3] Market Sentiment - Artisan Small Cap Fund noted that despite strong earnings and raised guidance, Halozyme's shares faced pressure due to uncertainty regarding new draft guidance from the Centers for Medicare and Medicaid Services (CMS) on drug pricing [4] - The fund expressed a belief that while Halozyme has investment potential, some AI stocks may offer greater returns with limited downside risk [4]

Core Insights - The FDA approved Johnson & Johnson's Darzalex Faspro for high-risk smoldering multiple myeloma, marking it as the first approved treatment for this condition [1] - The approval is based on the AQUILA study, which showed a 51% reduction in the risk of disease progression compared to active monitoring [2] - Johnson & Johnson's Caplyta was also approved as an adjunctive therapy for major depressive disorder, marking its fourth indication [4][5] Group 1: Darzalex Faspro Approval - Darzalex Faspro is the first and only approved treatment for high-risk smoldering multiple myeloma, allowing for earlier intervention [1] - The AQUILA study demonstrated a significant improvement in progression-free survival (PFS), with a 51% reduction in the risk of progression to active myeloma or death [2] - After a median follow-up of 65.2 months, 63.1% of patients on Darzalex Faspro had not progressed to active myeloma at five years, compared to 40.7% in the active monitoring group [3] Group 2: Caplyta Approval - Caplyta received FDA approval as an adjunctive therapy for major depressive disorder, marking its fourth indication [4][5] - The approval is based on two Phase 3 trials that met primary and key secondary endpoints, showing significant improvement in depression symptoms compared to an oral antidepressant plus placebo [5] Group 3: Treatment Timing - Patients receiving Darzalex Faspro experienced a delay in the median time to first-line multiple myeloma treatment, with a median time of not reached (NR) compared to 50.2 months for the active monitoring group [4]