Johnson & Johnson Stock Price, News & Analysis

Johnson & Johnson (NYSE:JNJ) has submitted a supplemental Biologics License Application (sBLA) to the FDA for a new indication of DARZALEX FASPRO® in combination with bortezomib, lenalidomide, and dexamethasone (D-VRd) for newly diagnosed multiple myeloma patients ineligible for or deferring autologous stem cell transplant. The submission is based on the Phase 3 CEPHEUS study, which showed:

• 60.9% of patients achieved minimal residual disease (MRD)-negativity with D-VRd
• 43% reduction in risk of progression or death
• Overall MRD-negativity rate of 60.9% vs 39.4% for VRd alone
• Sustained MRD-negativity rate of 48.7% vs 26.3% for VRd
• Complete response rate of 81.2% vs 61.6% for VRd

The safety profile was consistent with known profiles for DARZALEX FASPRO® and VRd. This could potentially be the first FDA-approved treatment regimen for newly diagnosed multiple myeloma based on MRD-negativity as the primary endpoint.

Johnson & Johnson has expanded the rollout of its latest TECNIS Odyssey intraocular lens (IOL) in the U.S. This new full visual range IOL offers cataract patients precise vision at every distance in any lighting. Key features include:

- Exceptional distance vision and 14% smaller readable print size compared to PanOptix
- 93% of patients become glasses-free at all distances
- Higher tolerance to residual refractive errors
- Two-times better contrast in low lighting than PanOptix
- 93% of patients reported no or mild halos, glare, or starbursts one month after surgery

The TECNIS Odyssey IOL aims to provide continuous, uninterrupted vision at all distances, minimizing the need for glasses. It has already benefited over 14,000 eyes and has received regulatory approval in several countries.

Johnson & Johnson announced long-term results from the Phase 3 CARTITUDE-4 study, showing that CARVYKTI® (ciltacabtagene autoleucel) significantly extended overall survival in patients with relapsed or lenalidomide-refractory multiple myeloma. The study demonstrated a 45 percent reduction in risk of death with CARVYKTI® compared to standard therapies after three years of follow-up.

Key findings include:

• Median overall survival was not reached for both CARVYKTI® and standard therapies arms
• 30-month overall survival rates were 76% for CARVYKTI® vs 64% for standard therapies
• Median progression-free survival was not reached for CARVYKTI® vs 11.79 months for standard therapies
• CARVYKTI® showed higher complete response rates (77%) and overall response rates (85%) compared to standard therapies

The safety profile was consistent with previous analyses, with cytopenia being the most common grade 3/4 treatment-emergent adverse event in both arms.

Johnson & Johnson (NYSE: JNJ) announced data from three studies highlighting the clinical efficacy of DARZALEX® and DARZALEX FASPRO® in maintenance regimens for multiple myeloma patients. The Phase 3 AURIGA study showed that DARZALEX FASPRO® plus lenalidomide (D-R) maintenance therapy significantly increased minimal residual disease (MRD)-negative conversion rates compared to lenalidomide alone after autologous stem cell transplant. The D-R arm demonstrated a higher MRD-negative conversion rate (50.5% vs 18.8%) and superior sustained MRD-negative rate (35.4% vs 13.9%) at 12 months. This resulted in improved progression-free survival, with an estimated 30-month rate of 82.7% for D-R compared to 66.4% for lenalidomide alone.

Additional data from the Phase 3 PERSEUS and CASSIOPEIA studies further supported the efficacy of DARZALEX®-based regimens across different patient populations and treatment stages. The studies demonstrated deep and sustained MRD-negativity, improved response rates, and reduced risk of progression or death with DARZALEX®-containing regimens.

Johnson & Johnson (NYSE:JNJ) announced significant results from the Phase 3 CEPHEUS study, evaluating DARZALEX FASPRO® in combination with bortezomib, lenalidomide, and dexamethasone (D-VRd) for newly diagnosed multiple myeloma patients ineligible for transplant or with deferred transplant. The study showed:

- 60.9% improvement in minimal residual disease (MRD) negativity rate
- 43% reduction in the risk of progression or death
- Significantly increased depth of response with higher rates of complete response or better

At a median follow-up of 58.7 months, D-VRd demonstrated superior efficacy compared to VRd alone, with an overall MRD-negativity rate of 60.9% vs 39.4%. The study also showed a significant reduction in the risk of progression or death, with median progression-free survival not reached for D-VRd vs 52.6 months for VRd.

Johnson & Johnson (NYSE: JNJ) announced updated results from the Phase 1b RedirecTT-1 study evaluating the combination of TALVEY® (talquetamab-tgvs) and TECVAYLI® (teclistamab-cqyv) in patients with relapsed or refractory multiple myeloma (RRMM). The study showed:

- Overall response rate (ORR) of 79.5% and complete response or better (CR+) rate of 52.3%
- 18-month duration of response (DOR) of 85.9%
- 18-month progression-free survival (PFS) rate of 69.8%

In patients with extramedullary disease (EMD), the combination demonstrated an ORR of 61.1% and CR+ rate of 33.3%. The safety profile was consistent with known profiles of each agent as monotherapy, with manageable side effects.

Johnson & Johnson announced updated results from the Phase 1b TRIMM-2 study evaluating TALVEY® (talquetamab-tgvs) combined with DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) and pomalidomide in relapsed or refractory multiple myeloma patients. The study showed an overall response rate (ORR) of 82 percent. In the weekly dosing arm, the ORR was 100 percent, with 56 percent achieving complete response or better. The biweekly arm achieved 76 percent ORR. The median duration of response in the biweekly arm was 26.4 months, with median progression-free survival of 20.3 months. The safety profile reflected known profiles of the individual therapies, with manageable side effects. These results support further investigation of TALVEY® in combination with DARZALEX FASPRO®, currently being studied in the Phase 3 MonumenTAL-3 study.

Johnson & Johnson (NYSE:JNJ) has filed a pre-packaged bankruptcy in Texas, claiming 83% of surveyed plaintiffs agree to the plan's terms. Attorneys representing ovarian cancer victims linked to J&J's talc products vow to seek dismissal, calling it a fraudulent effort to manipulate the bankruptcy process. They argue that the proposed compensation is inadequate, with average medical costs for treating ovarian cancer exceeding $220,000 and lost wages averaging over $230,000.

Lawyers question the integrity of the voting process and cite the recent U.S. Supreme Court ruling in Harrington v. Purdue Pharma as a reason why J&J's plan should not succeed. They also criticize J&J's choice of filing in Texas as forum shopping. Previous bankruptcy attempts by J&J were found to be in bad faith by courts in New Jersey and the Third Circuit.

Johnson & Johnson announced that its subsidiary, Red River Talc , has filed a voluntary prepackaged Chapter 11 bankruptcy case to resolve all current and future ovarian cancer claims related to cosmetic talc litigation in the United States. The proposed bankruptcy plan has received support from approximately 83% of current claimants, exceeding the 75% approval threshold required by the U.S. Bankruptcy Code.

Red River has increased its settlement commitment by $1.75 billion to approximately $8 billion. The plan represents a present value of about $8 billion to be paid over 25 years, totaling approximately $10 billion nominal. This settlement is one of the largest ever reached in a mass tort bankruptcy case.

The company maintains that none of the talc-related claims have merit, citing rejections by independent experts and regulatory bodies. The plan would resolve 99.75% of all pending talc lawsuits against Johnson & Johnson and its affiliates in the United States.