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FDA Grants Revascor® (Rexlemestrocel-L) Regenerative Medicine Advanced Therapy (RMAT) Designation in Children with Congenital Heart Disease
GlobeNewswire News Room· 2024-12-04 23:32
Core Insights - Mesoblast Limited has received FDA's Regenerative Medicine Advanced Therapy (RMAT) designation for its stromal cell therapy Revascor® (rexlemestrocel-L) aimed at treating hypoplastic left heart syndrome (HLHS) in children, following positive results from a randomized controlled trial [1][2][3] Group 1: FDA Designations and Implications - The RMAT designation allows Mesoblast to expedite the development of Revascor, providing benefits such as rolling review and eligibility for priority review upon filing a Biologics License Application (BLA) [3] - Earlier in the year, Revascor was also granted Rare Pediatric Disease Designation (RPDD) and Orphan-Drug Designation (ODD) by the FDA, indicating the serious nature of HLHS and its rarity [2] Group 2: Clinical Trial Results - A blinded, randomized, placebo-controlled trial involving 19 children with HLHS demonstrated that a single administration of Revascor led to significantly larger increases in left ventricular end-systolic and end-diastolic volumes over 12 months compared to controls, with p-values of 0.009 and 0.020 respectively [4] - These results suggest clinically important growth of the left ventricle, which is crucial for successful surgical correction and reducing the risk of heart failure and other complications [5] Group 3: About HLHS and Revascor - HLHS is a severe congenital heart defect that can lead to high neonatal mortality rates, accounting for 25% to 40% of all neonatal cardiac deaths if not treated promptly [6] - Revascor is an allogeneic therapy derived from immunoselected mesenchymal precursor cells, which may provide multiple benefits including neovascularization and reduction of inflammation [7] Group 4: Company Overview - Mesoblast is a leader in developing allogeneic cellular medicines for severe inflammatory conditions, with a strong intellectual property portfolio extending to at least 2041 [8][9] - The company is also advancing other product candidates for various indications, including remestemcel-L for inflammatory diseases and rexlemestrocel-L for chronic heart failure [10]
Oddity Tech: Executing Well (Rating Upgrade)
Seeking Alpha· 2024-12-04 20:30
Group 1 - The article discusses the initiation of coverage on Oddity Tech Ltd., an Israeli-based consumer tech firm aiming to disrupt the beauty and wellness industry [1] - Oddity Tech Ltd. is listed on NASDAQ under the ticker ODD, indicating its presence in the public market [1] Group 2 - The firm has intriguing ambitions, suggesting a focus on innovation and potential market disruption within its sector [1]
Oddity Tech (ODD) Recently Broke Out Above the 20-Day Moving Average
ZACKS· 2024-11-22 15:35
From a technical perspective, Oddity Tech (ODD) is looking like an interesting pick, as it just reached a key level of support. ODD recently overtook the 20-day moving average, and this suggests a short-term bullish trend.A well-liked tool among traders, the 20-day simple moving average offers a look back at a stock's price over a 20-day period. This is very beneficial to short-term traders, as it smooths out short-term price trends and gives more trend reversal signals than longer-term moving averages.Simi ...
Can Oddity Tech (ODD) Climb 28.74% to Reach the Level Wall Street Analysts Expect?
ZACKS· 2024-11-20 16:01
Oddity Tech (ODD) closed the last trading session at $40.50, gaining 3.7% over the past four weeks, but there could be plenty of upside left in the stock if short-term price targets set by Wall Street analysts are any guide. The mean price target of $52.14 indicates a 28.7% upside potential.The average comprises seven short-term price targets ranging from a low of $42 to a high of $66, with a standard deviation of $8.49. While the lowest estimate indicates an increase of 3.7% from the current price level, t ...
What Makes Oddity Tech (ODD) a New Strong Buy Stock
ZACKS· 2024-11-15 18:05
Oddity Tech (ODD) appears an attractive pick, as it has been recently upgraded to a Zacks Rank #1 (Strong Buy). An upward trend in earnings estimates -- one of the most powerful forces impacting stock prices -- has triggered this rating change.The sole determinant of the Zacks rating is a company's changing earnings picture. The Zacks Consensus Estimate -- the consensus of EPS estimates from the sell-side analysts covering the stock -- for the current and following years is tracked by the system.Individual ...
L Catterton Agrees to Sell $100 Million of Shares Back to ODDITY
GlobeNewswire News Room· 2024-11-13 22:19
NEW YORK, Nov. 13, 2024 (GLOBE NEWSWIRE) -- ODDITY Tech Ltd. (NASDAQ: ODD) today announced that it has entered into a transaction with a fund managed by L Catterton (“L Catterton”) to repurchase approximately 2.35 million Class A Ordinary Shares (the “Shares”) of the Company for a total cash consideration of approximately $100 million, at a purchase price of $42.501 per share. The transaction will be funded from the Company’s existing cash resources. ODDITY’s board of directors determined that the repurchas ...
Oddity Tech .(ODD) - 2024 Q3 - Earnings Call Transcript
2024-11-09 15:34
Oddity Tech Ltd (NASDAQ:ODD) Q3 2024 Results Conference Call November 7, 2024 8:30 AM ET Company Participants Maria Lycouris - Investor Relations Oran Holtzman - Co-Founder and Chief Executive Officer Lindsay Drucker Mann - Global Chief Financial Officer Conference Call Participants Dara Mohsenian - Morgan Stanley Nick Cronin - Truist Securities Operator Good morning, and welcome to the ODDITY's Third Quarter 2024 Earnings Conference Call. Today's call is being recorded, and we have allocated time for prepa ...
Oddity Tech (ODD) Q3 Earnings and Revenues Surpass Estimates
ZACKS· 2024-11-07 00:26
Oddity Tech (ODD) came out with quarterly earnings of $0.32 per share, beating the Zacks Consensus Estimate of $0.22 per share. This compares to earnings of $0.21 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 45.45%. A quarter ago, it was expected that this online retailer of cosmetics and beauty products would post earnings of $0.67 per share when it actually produced earnings of $0.82, delivering a surprise of 22.39%.Over ...
Oddity Tech .(ODD) - 2024 Q3 - Quarterly Report
2024-11-06 21:10
Exhibit 99.1 ODDITY TECH REPORTS RECORD THIRD QUARTER RESULTS, RAISES OUTLOOK · Record third quarter net revenue of $119 million, up 26% year-over-year · Record third quarter adjusted EBITDA of $25 million · Record third quarter net income of $18 million, up 362% year-over-year, and record third quarter adjusted net income of $20 million, up 53% year-over-year · Record nine-month net revenue of $523 million, up 27% year-over-year · Record nine-month adjusted EBITDA of $135 million · Record nine-month net op ...
ODD or SMAR: Which Is the Better Value Stock Right Now?
ZACKS· 2024-09-30 16:46
Investors interested in stocks from the Internet - Software sector have probably already heard of Oddity Tech (ODD) and Smartsheet (SMAR) . But which of these two stocks is more attractive to value investors? We'll need to take a closer look to find out. The best way to find great value stocks is to pair a strong Zacks Rank with an impressive grade in the Value category of our Style Scores system. The proven Zacks Rank emphasizes companies with positive estimate revision trends, and our Style Scores highlig ...