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Johnson & Johnson (JNJ) Exceeds Market Returns: Some Facts to Consider
ZACKS· 2024-09-16 22:51
Johnson & Johnson (JNJ) closed the most recent trading day at $166.99, moving +0.89% from the previous trading session. The stock's performance was ahead of the S&P 500's daily gain of 0.13%. On the other hand, the Dow registered a gain of 0.55%, and the technology-centric Nasdaq decreased by 0.52%.Coming into today, shares of the world's biggest maker of health care products had gained 3.85% in the past month. In that same time, the Medical sector gained 3.34%, while the S&P 500 gained 3.67%.Market partici ...
Neoadjuvant TAR-200 plus cetrelimab nearly doubles the pathological complete response rate compared to cetrelimab alone in patients with muscle-invasive bladder cancer
Prnewswire· 2024-09-16 06:50
TAR-200 plus cetrelimab effective in reducing tumor size in those with muscle-invasive disease, potentially improving surgical outcomes and lowering risk of recurrenceBARCELONA, Spain, Sept. 16, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) announced today interim data from the ongoing Phase 2 SunRISe-4 study showing neoadjuvant treatment with investigational TAR-200 plus cetrelimab (CET) achieved nearly double the pathological complete response (pCR) rate compared to CET alone in patients with muscle- ...
RYBREVANT® (amivantamab-vmjw) plus chemotherapy show 49 percent overall response rate in metastatic colorectal cancer
Prnewswire· 2024-09-14 13:45
Clinical Trial Results - RYBREVANT® combined with chemotherapy (mFOLFOX6 or FOLFIRI) demonstrated promising antitumor activity in patients with RAS/BRAF wild-type metastatic colorectal cancer (mCRC) who had not previously received anti-EGFR therapy, with a median duration of response of 7.4 months and a median progression-free survival of 7.5 months [1] - The overall response rate (ORR) was 49%, with disease control observed in 88% of patients, and 21% of patients proceeded to curative-intent surgery due to strong antitumor activity [1] - The safety profile of RYBREVANT® plus chemotherapy was manageable, with no new safety signals observed, and the most frequent adverse events were neutropenia, rash, stomatitis, infusion-related reactions, and diarrhea [1] Study Design and Patient Population - OrigAMI-1 is an open-label Phase 1b/2 study assessing the efficacy and safety of RYBREVANT® plus mFOLFOX6 or FOLFIRI in anti-EGFR-naïve RAS/BRAF WT mCRC patients, with 43 patients treated in the study [2][3] - Patients were either in their first (26%) or second line (74%) of treatment for mCRC and had not been treated with specific anti-EGFR therapies [1] RYBREVANT® Overview - RYBREVANT® is a fully-human bispecific antibody targeting EGFR and MET, approved for the treatment of NSCLC with EGFR exon 20 insertion mutations in the U.S., Europe, and other markets [4] - It is also approved in combination with chemotherapy for first-line treatment of NSCLC with EGFR exon 20 insertion mutations and in combination with LAZCLUZE™ for NSCLC with EGFR exon 19 deletions or L858R substitution mutations [4][5] Regulatory Submissions and Approvals - Johnson & Johnson submitted a supplemental Biologics License Application (sBLA) to the U.S. FDA for RYBREVANT® in combination with chemotherapy for EGFR-mutated NSCLC patients who progressed on or after osimertinib, with this indication approved in Europe in August 2024 [5] - A BLA was submitted to the U.S. FDA for the subcutaneous formulation of RYBREVANT® in combination with LAZCLUZE™ for NSCLC indications, with a similar submission made to the EMA [6] Colorectal Cancer Background - Colorectal cancer is the third most common cancer globally, accounting for approximately 10% of all cancer cases and is the second leading cause of cancer-related deaths worldwide [8] - Left-sided colorectal cancer represents approximately 65% of cases, with around half of patients having mutations in the RAS genes, particularly KRAS, which influences treatment strategies [8] Ongoing Clinical Trials - RYBREVANT® is being studied in multiple clinical trials, including Phase 3 studies like MARIPOSA, MARIPOSA-2, PAPILLON, and PALOMA-3, evaluating its efficacy in various NSCLC settings [6][7] - Other trials include Phase 1/2 studies like METalmark, PolyDamas, and swalloWTail, exploring combination therapies and new formulations for NSCLC and other solid tumors [7]
RYBREVANT® (amivantamab-vmjw) plus chemotherapy shows positive overall survival trend versus chemotherapy in patients with previously treated EGFR-mutated lung cancer
Prnewswire· 2024-09-14 07:10
Post-progression outcomes showed significant and sustained improvement for RYBREVANT® plus standard of care versus chemotherapy aloneBARCELONA, Sept. 14, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ) today announced updated results from the Phase 3 MARIPOSA-2 study which showed RYBREVANT® (amivantamab-vmjw) combined with chemotherapy led to consistent benefit across post-progression outcomes in adult patients with previously treated non-small cell lung cancer (NSCLC) with epidermal growth factor recepto ...
FDA Grants Label Expansion to J&J's Tremfya in Ulcerative Colitis
ZACKS· 2024-09-12 16:41
Johnson & Johnson (JNJ) announced that the FDA approved its blockbuster immunology medicine, Tremfya (guselkumab), for a third indication. The drug is approved to treat adults with moderately to severely active ulcerative colitis (UC).Tremfya is already approved for plaque psoriasis and active psoriatic arthritis (PsA) indications in several countries, including the United States and Europe.This latest approval is based on data from the phase IIb/III QUASAR study, which showed that a significantly greater p ...
How To Earn $500 A Month From Johnson & Johnson Stock
Benzinga· 2024-09-12 12:33
On Tuesday, Johnson & Johnson JNJ announced results from the open-label Phase 2 SKIPPirr study, which evaluated additional prophylactic strategies to reduce the incidence of infusion-related reactions (IRRs) with intravenous (IV) Rybrevant (amivantamab-vmjw) in patients with advanced non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions (ex19del) or L858R substitution mutations.The company, last month, agreed to acquire V-Wave for an upfront payment of $600 millio ...
Johnson & Johnson seeks first EU approval of nipocalimab to treat a broad population of patients living with antibody-positive generalised myasthenia gravis
GlobeNewswire News Room· 2024-09-12 12:25
Marks first EMA submission for nipocalimab, an investigational treatment that binds with high affinity and specificity to block FcRn and reduce levels of autoantibodies Filing based on the Phase 3 Vivacity-MG3 programme, the first registrational study results in the class demonstrating sustained disease control over 24 weeks in antibody-positive adult patients: anti-AChR+, anti-MuSK+, anti-LRP4+ BEERSE, BELGIUM, Sept. 12, 2024 (GLOBE NEWSWIRE) -- Janssen-Cilag International NV, a Johnson & Johnson company, ...
3 Safe Stocks with Safe Dividends for Your Portfolio
MarketBeat· 2024-09-11 12:10
The stock market can feel like a roller coaster, especially during economic uncertainty. As fears of a recession increase, investors seek stability and look for investments that can weather the storm and offer a sense of security. That's where defensive stocks start to shine. Defensive stocks are companies known for their resilience, often operating in sectors that are less vulnerable to economic downturns. They're like anchors during uncertain times, providing stability despite the volatility.Defensive sto ...
Dexamethasone reduces infusion-related reactions in patients with EGFR-mutated non-small cell lung cancer treated with intravenous RYBREVANT® (amivantamab-vmjw)
Prnewswire· 2024-09-10 21:15
Pre-medication regimen showed an infusion-related reaction rate of 22.5 percent with intravenous RYBREVANT®, a three-fold reduction from 67.4 percent historically seen with standard IRR managementSAN DIEGO, Sept. 10, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ) today announced results from the open-label Phase 2 SKIPPirr study, which evaluated additional prophylactic strategies to reduce the incidence of infusion-related reactions (IRRs) with intravenous (IV) RYBREVANT® (amivantamab-vmjw) in patients w ...
RYBREVANT® (amivantamab-vmjw) plus LAZCLUZE™ (lazertinib) show strong favorable overall survival trend versus osimertinib in EGFR-mutated advanced lung cancer
Prnewswire· 2024-09-08 17:47
New longer-term data from the MARIPOSA study confirm superior outcomes of chemotherapy-free RYBREVANT® plus LAZCLUZE™ regimen compared to osimertinib monotherapy as first-line therapyResults from an interim analysis featured in late-breaker oral presentation at WCLCSAN DIEGO, Sept. 8, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced longer follow-up data from the landmark Phase 3 MARIPOSA study which showed first-line treatment with RYBREVANT® (amivantamab-vmjw) combined with LAZCLUZE™ (la ...