Single infusion of CARVYKTI® (ciltacabtagene autoleucel) delivered lasting treatment-free remissions for at least five years in patients with relapsed or refractory multiple myeloma
Prnewswire· 2025-06-03 14:45
Core Insights - Johnson & Johnson announced long-term follow-up data from the CARTITUDE-1 study, showing that 33% of patients with relapsed or refractory multiple myeloma treated with CARVYKTI® achieved progression-free survival of five years or more with a single infusion [1][3][4] - The CARTITUDE-4 analysis demonstrated significant overall survival and progression-free survival benefits across various patient subgroups, including those with standard and high-risk cytogenetics [1][5] Group 1: CARTITUDE-1 Study Findings - In the CARTITUDE-1 study, 32 out of 97 patients (33%) achieved progression-free survival for at least five years after receiving CARVYKTI® [1][3] - The median overall survival for patients in the study was reported at 60.7 months, indicating a durable response to the treatment [3] - Among the patients who remained progression-free, the majority had undergone a median of six prior lines of therapy, with 90.6% being triple-class refractory [3][7] Group 2: Safety Profile - The safety profile of CARVYKTI® in the CARTITUDE-1 study remained consistent with previous findings, with no new safety signals identified [4] - Two new cases of second primary malignancies were reported, but no new cases of Parkinsonism or cranial nerve palsies were observed [4] - The incidence of cytokine release syndrome (CRS) was noted in 84% of patients, with 4% experiencing Grade 3 or higher CRS [21] Group 3: CARTITUDE-4 Study Insights - The CARTITUDE-4 study, presented at the ASCO Annual Meeting, showed that CARVYKTI® improved progression-free survival and overall survival compared to standard care in various patient subgroups [5][9] - The study included patients with relapsed and lenalidomide-refractory multiple myeloma who had received one to three prior lines of therapy [9] Group 4: Future Directions - Johnson & Johnson is focusing on shifting treatment strategies from managing progression to aiming for a cure in multiple myeloma [6] - Upcoming presentations at the European Hematology Association (EHA) 2025 Congress will further discuss the findings from the CARTITUDE studies [6]
Early results from Johnson & Johnson's trispecific antibody show promising response in heavily pretreated multiple myeloma patients
Prnewswire· 2025-06-03 14:45
Core Insights - Johnson & Johnson announced promising initial Phase 1 results for JNJ-79635322 (JNJ-5322), a novel trispecific antibody targeting relapsed or refractory multiple myeloma, showing an overall response rate (ORR) of 86.1% among 36 patients at the recommended phase 2 dose (RP2D) [1][2] - The study highlighted that the ORR was 100% in 27 patients who had not previously received BCMA and GPRC5D directed therapies, indicating strong efficacy in treatment-naive patients [1][2] - JNJ-5322 is designed to bind simultaneously to three targets, aiming to address tumor heterogeneity and resistance, which is a significant advancement over existing bispecific antibodies [1][3] Clinical Trial Details - The Phase 1 study involved 126 heavily pretreated patients with a median follow-up of 8.2 months, with a recommended RP2D of 100 mg administered every four weeks [2] - The trial's findings were presented at the 2025 ASCO Annual Meeting and will also be featured at the 2025 EHA Congress [1] Safety Profile - The most common adverse event reported was cytokine release syndrome (CRS), occurring in 59% of patients, with no Grade 3 or higher events noted [3][4] - Grade 3 or higher infections were reported in 28% of patients, and there were four treatment-emergent deaths, including one related to adenoviral encephalitis [3][4] Industry Context - Multiple myeloma is the second most common blood cancer globally, with over 35,000 new diagnoses expected in the U.S. in 2024, highlighting the need for effective treatment options [5] - The five-year survival rate for multiple myeloma patients is approximately 59.8%, indicating a significant unmet medical need in this area [5] Company Vision - Johnson & Johnson aims to transform oncology outcomes through next-generation immunotherapies, leveraging its portfolio of therapies to provide clinicians with effective treatment options for multiple myeloma [3][6]
Science Applications Stock Plunges 13% as Q1 Earnings Miss Estimates
ZACKS· 2025-06-03 14:42
Core Insights - Science Applications International (SAIC) reported its first-quarter fiscal 2026 results, with non-GAAP earnings of $1.92 per share, missing the Zacks Consensus Estimate of $2.14 by 10.28% and showing flat year-over-year profits [1][9] - Revenues for the fiscal first quarter rose 2% year over year to $1.877 billion, slightly surpassing the Zacks Consensus Estimate of $1.864 billion by 0.71%, driven by increased contract volumes [2][9] - Despite the revenue growth, SAIC shares fell 13% following the earnings miss, contributing to a year-to-date decline of 9.8%, underperforming the Computers – IT Services industry [3] Financial Performance - Defence and Intelligence segment revenues, accounting for 76.3% of total revenues, decreased 0.2% year over year to $1.43 billion, while Civilian revenues rose 8% year over year to $444 million, constituting 23.7% of total revenues [4] - Net bookings for the quarter were approximately $2.4 billion, resulting in a book-to-bill ratio of 1.3, with an estimated backlog of $22.3 billion at the end of the quarter [5] - Selling, general and administrative (SG&A) expenses decreased 4.7% to $89 million, while non-GAAP operating income fell to $158 million from $165 million year over year, leading to a non-GAAP operating margin contraction of 50 basis points to 8.4% [6] EBITDA and Cash Flow - Adjusted EBITDA declined 5.42% to $157 million, with an adjusted EBITDA margin of 8.4%, down from 9% in the prior-year quarter, impacted by seasonal investment costs [7] - The company ended the fiscal first quarter with cash and cash equivalents of $47 million, down from $56 million in the previous quarter, and long-term debt decreased to $1.876 billion [8] Guidance and Outlook - SAIC reaffirmed its fiscal 2026 guidance, projecting revenues in the range of $7.60-$7.75 billion and adjusted earnings between $9.10-$9.30 per share, with adjusted EBITDA expected to be approximately $715-$735 million [11]
Hilton Fuels Luxury Growth With New Brands and 500 Hotels Pipeline
ZACKS· 2025-06-03 14:42
Key Takeaways Hilton has reached 1,000 luxury and lifestyle hotels and plans more than 150 openings in 2025. New brands like NoMad and Graduate by Hilton, plus the SLH partnership, fuel the expansion. Hilton aims to open three luxury or lifestyle hotels weekly amid strong global brand momentum.Hilton Worldwide Holdings Inc. (HLT) recently celebrated a significant milestone with the opening of its 1,000th luxury and lifestyle hotel globally. The achievement comes amid a period of robust growth driven by a ...
Is Aisin Seiki (ASEKY) Stock Outpacing Its Auto-Tires-Trucks Peers This Year?
ZACKS· 2025-06-03 14:42
For those looking to find strong Auto-Tires-Trucks stocks, it is prudent to search for companies in the group that are outperforming their peers. Aisin Seiki Co. Ltd. Unsponsored ADR (ASEKY) is a stock that can certainly grab the attention of many investors, but do its recent returns compare favorably to the sector as a whole? Let's take a closer look at the stock's year-to-date performance to find out.Aisin Seiki Co. Ltd. Unsponsored ADR is one of 102 individual stocks in the Auto-Tires-Trucks sector. Coll ...
Wall Street Analysts Think MINISO Group Holding Limited (MNSO) Is a Good Investment: Is It?
ZACKS· 2025-06-03 14:36
When deciding whether to buy, sell, or hold a stock, investors often rely on analyst recommendations. Media reports about rating changes by these brokerage-firm-employed (or sell-side) analysts often influence a stock's price, but are they really important?Let's take a look at what these Wall Street heavyweights have to say about MINISO Group Holding Limited Unsponsored ADR (MNSO) before we discuss the reliability of brokerage recommendations and how to use them to your advantage.MINISO Group Holding Limite ...
Wall Street Analysts See Allegheny Technologies (ATI) as a Buy: Should You Invest?
ZACKS· 2025-06-03 14:36
The recommendations of Wall Street analysts are often relied on by investors when deciding whether to buy, sell, or hold a stock. Media reports about these brokerage-firm-employed (or sell-side) analysts changing their ratings often affect a stock's price. Do they really matter, though?Before we discuss the reliability of brokerage recommendations and how to use them to your advantage, let's see what these Wall Street heavyweights think about Allegheny Technologies (ATI) .Allegheny Technologies currently ha ...
Lam Research (LRCX) Just Overtook the 20-Day Moving Average
ZACKS· 2025-06-03 14:36
After reaching an important support level, Lam Research (LRCX) could be a good stock pick from a technical perspective. LRCX surpassed resistance at the 20-day moving average, suggesting a short-term bullish trend.The 20-day simple moving average is a popular trading tool. It provides a look back at a stock's price over a 20-day period, and is beneficial to short-term traders since it smooths out price fluctuations and provides more trend reversal signals than longer-term moving averages.Like other SMAs, if ...
Down 54.8% in 4 Weeks, Here's Why You Should You Buy the Dip in Omeros (OMER)
ZACKS· 2025-06-03 14:36
Omeros (OMER) has been on a downward spiral lately with significant selling pressure. After declining 54.8% over the past four weeks, the stock looks well positioned for a trend reversal as it is now in oversold territory and there is strong agreement among Wall Street analysts that the company will report better earnings than they predicted earlier.Guide to Identifying Oversold StocksWe use Relative Strength Index (RSI), one of the most commonly used technical indicators, for spotting whether a stock is ov ...
Down 36.7% in 4 Weeks, Here's Why Summit Therapeutics (SMMT) Looks Ripe for a Turnaround
ZACKS· 2025-06-03 14:36
A downtrend has been apparent in Summit Therapeutics PLC (SMMT) lately with too much selling pressure. The stock has declined 36.7% over the past four weeks. However, given the fact that it is now in oversold territory and Wall Street analysts are majorly in agreement about the company's ability to report better earnings than they predicted earlier, the stock could be due for a turnaround.How to Determine if a Stock is OversoldWe use Relative Strength Index (RSI), one of the most commonly used technical ind ...