Johnson & Johnson - JNJ STOCK NEWS

Johnson & Johnson (NYSE: JNJ) has completed the acquisition of Yellow Jersey Therapeutics, a subsidiary of Numab Therapeutics, for $1.25 billion. This acquisition secures JNJ the global rights to NM26, a novel, investigational bispecific antibody targeting IL-4Rα and IL-31 pathways in atopic dermatitis (AD). NM26 is ready for Phase 2 clinical trials and aims to provide better treatment for AD by addressing multiple disease-driving pathways. The investment aligns with JNJ's mission to improve care for immune-mediated diseases.

Johnson & Johnson (NYSE: JNJ) announced positive results from an interim analysis of the Phase 3 CARTITUDE-4 study, which evaluated CARVYKTI® (ciltacabtagene autoleucel; cilta-cel) against standard therapies for treating multiple myeloma in patients who have had one prior line of therapy. The study showed that CARVYKTI® achieved a statistically significant and clinically meaningful improvement in overall survival (OS) compared to standard treatments like PVd and DPd. The safety profile was consistent with the approved label. These results will be shared at an upcoming medical meeting and submitted to regulatory authorities.

Johnson & Johnson announced positive results from the Phase 3 Vivacity-MG3 trial of nipocalimab in patients with generalized myasthenia gravis (gMG). The study showed that patients treated with nipocalimab plus standard of care (SOC) improved significantly more than those on placebo plus SOC in the MG-ADL score over 24 weeks. The trial included a broad range of gMG patients, representing 95% of the population. Key secondary endpoints, including muscle strength and function, also showed significant improvements. Safety and tolerability were consistent with prior studies. These findings will be presented at the EAN 2024 Congress and submitted to regulatory authorities.

The U.S. Supreme Court has denied Purdue Pharmaceuticals' $7 billion bankruptcy plan, which sought to grant the Sackler family immunity from further liability for their role in the opioid crisis. This decision has significant implications for Johnson & Johnson (NYSE:JNJ), which is attempting to use bankruptcy protection to resolve tens of thousands of ovarian cancer claims related to its talc-based products.

The Beasley Allen Law Firm, representing the plaintiffs in the talc/ovarian cancer multidistrict litigation (MDL), believes this ruling undermines J&J's similar attempts to use bankruptcy as a shield. The court's decision reinforces that financially solvent entities cannot use bankruptcy to escape liability for marketing and manufacturing dangerous products.

This ruling could derail J&J's efforts to return the talc litigation to bankruptcy courts, potentially moving forward with trials that support the plaintiffs' constitutional rights and address the substantial financial and emotional toll suffered by J&J’s victims.

Johnson & Johnson (NYSE: JNJ) has completed the acquisition of Proteologix, a biotech firm specializing in bispecific antibodies for immune-mediated diseases, for $850 million in cash with potential milestone payments. This acquisition, announced on May 16, 2024, brings two pre-clinical bispecific antibodies, PX-128 and PX-130, into J&J's portfolio. These antibodies target multiple disease pathways and could transform treatments for atopic dermatitis and asthma. Additionally, J&J gains eight other bispecific antibody programs, enhancing its capabilities in innovative immunology therapeutics.

Johnson & Johnson submitted a supplemental Biologics License Application to the U.S. FDA for TREMFYA® (guselkumab) to treat moderately to severely active Crohn's disease.

The application is based on 48-week results from Phase 3 GALAXI and GRAVITI programs.

Data show TREMFYA®, an IL-23 inhibitor, achieved superior endoscopic outcomes with subcutaneous (SC) and intravenous (IV) induction therapies.

GALAXI demonstrated TREMFYA®'s superiority over STELARA® (ustekinumab) in Crohn's disease.

Both GALAXI and GRAVITI studies met multiple co-primary endpoints, showing significant clinical remission and endoscopic response at various weeks.

If approved, TREMFYA® will be the first IL-23 inhibitor offering both SC and IV induction therapy options for Crohn's disease.

This is Johnson & Johnson's second FDA submission for inflammatory bowel disease this year, after a March submission for ulcerative colitis.

Johnson & Johnson announced positive topline results from the Phase 3 GRAVITI study of TREMFYA® (guselkumab) for treating moderately to severely active Crohn's disease. The study met all primary and secondary endpoints, demonstrating significant clinical remission and endoscopic response at Week 12, with continued efficacy at Weeks 24 and 48 compared to placebo. The results highlight TREMFYA® as potentially the only IL-23 inhibitor offering both subcutaneous (SC) and intravenous (IV) induction options. Safety data aligned with the known profile of TREMFYA®. These findings, along with results from the GALAXI studies where TREMFYA® outperformed STELARA® in key endoscopic endpoints, underscore its potential in treating Crohn's disease. A separate study on ulcerative colitis is ongoing.

Johnson & Johnson (NYSE: JNJ) has submitted a Biologics License Application to the U.S. FDA for subcutaneous amivantamab for patients with EGFR-mutated non-small cell lung cancer (NSCLC), based on promising Phase 3 PALOMA-3 study results. These results showed a five-fold reduction in infusion-related reactions and comparable overall response rates to intravenous administration. Additionally, subcutaneous amivantamab demonstrated longer overall survival, progression-free survival, and duration of response. The BLA includes data from the Phase 2 PALOMA-2 study, supporting dosing schedules of every two and every three weeks. This submission follows recent milestones for the intravenous formulation, including FDA approval and a positive CHMP opinion for use in combination with chemotherapy for first-line treatment of NSCLC with EGFR exon 20 insertion mutations.

Johnson & Johnson (NYSE: JNJ) announced significant findings from the Phase 2 DAHLIAS study of nipocalimab, demonstrating over 70% relative average improvement in Sjögren's disease (SjD) activity compared to placebo. The study involved patients treated with 15 mg/kg of nipocalimab, showing a statistically significant (P=0.002) and clinically meaningful improvement on the primary endpoint, ClinESSDAI, at 24 weeks.

Improvements were noted as early as Week 4, with continued progress throughout the 24-week period. Secondary endpoints also showed clinically meaningful improvements in multiple organ assessments, physician assessments, and composite tools for clinical trial endpoints. Additionally, the treatment led to reductions in total IgG and autoantibodies associated with SjD.

This breakthrough in SjD therapy was highlighted among 30 abstracts presented by the company at the EULAR 2024 Congress, signifying potential advancement in treatment options for the approximately four million people affected globally.