Johnson & Johnson Stock Price, News & Analysis

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.

Johnson & Johnson's (NYSE: JNJ) TALVEY® (talquetamab-tgvs) demonstrated durable, long-term responses in patients with relapsed or refractory multiple myeloma (RRMM) in the Phase 1/2 MonumenTAL-1 study.

The study revealed a 24-month overall survival rate of 67% with biweekly dosing. Patients continued to show high response rates regardless of prior T-cell therapy exposure. At 23.4 months median follow-up, the median duration of response (DOR) was 17.5 months for biweekly dosed patients and 9.5 months for weekly dosed patients, increasing to 28.6 months in those with complete response or better. TALVEY® also exhibited low infection rates and manageable safety profiles.

The Phase 1b MonumenTAL-2 study with TALVEY® and pomalidomide showed an 88.6% overall response rate at a median follow-up of 16.8 months. The progression-free survival (PFS) rate at 12 months was 72.6%.

TALVEY® received FDA approval in August 2023 for treating RRMM in patients with at least four prior therapies.

A group of ovarian cancer victims has filed a motion in federal court to prevent Johnson & Johnson (NYSE: JNJ) from pursuing a third bankruptcy filing outside New Jersey. The company aims to resolve talc claims through a prepackaged bankruptcy plan in Texas, but the plaintiffs see this as a delay tactic to limit compensation. Past bankruptcy attempts by J&J in New Jersey were denied. The motion also seeks to prevent J&J from amending agreements without notifying the plaintiffs. The case, Rebecca Love, et al. v LLT Management et al., is filed in the U.S. District Court for the District of New Jersey.

Johnson & Johnson (NYSE: JNJ) will host an investor conference call on July 17th at 8:30 a.m. Eastern Time to discuss its second-quarter results. The call will be led by CEO Joaquin Duato, CFO Joseph J. Wolk, and VP of Investor Relations Jessica Moore, with other executive team members participating in the Q&A session. The webcast and presentation materials will be accessible on J&J's investor website, with a replay available three hours post-conference. U.S. participants can dial in at 877-869-3847, while international participants can use 201-689-8261. The replay will be available until August 14th, using the ID 13746915.

Johnson & Johnson (NYSE: JNJ) has completed its acquisition of Shockwave Medical, integrating it as a business unit within Johnson & Johnson MedTech. This strategic move aims to enhance Johnson & Johnson's position in the cardiovascular intervention sector. Shockwave Medical is renowned for its intravascular lithotripsy (IVL) platform, used to treat coronary and peripheral artery diseases. The acquisition is projected to support revenue growth and strengthen Johnson & Johnson MedTech’s market leadership. However, the transaction will likely dilute adjusted earnings per share by $0.10 in 2024 and $0.17 in 2025 due to financing costs. Shockwave's common stock has ceased trading on NASDAQ.

Johnson & Johnson (NYSE: JNJ) announced a definitive agreement to acquire Numab Therapeutics' subsidiary for global rights to NM26, a Phase 2-ready bispecific antibody.

This $1.25 billion all-cash deal focuses on NM26, which targets IL-4Rα and IL-31 pathways in atopic dermatitis (AD). NM26 aims to address unmet needs in AD by offering a unique treatment for inflammation and itch.

The transaction is expected to close in the second half of 2024, pending regulatory clearance. Johnson & Johnson plans to develop more bispecific antibodies for AD and other immune-mediated diseases.