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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]
Can Oddity Tech (ODD) Climb 28.74% to Reach the Level Wall Street Analysts Expect?
ZACKS· 2024-11-20 16:01
Core Viewpoint - Oddity Tech (ODD) has shown a recent price increase and analysts suggest there is potential for further upside based on price targets and earnings estimates [1][9]. Price Targets - The mean price target for ODD is $52.14, indicating a potential upside of 28.7% from the current price of $40.50 [1]. - Price targets from analysts range from a low of $42 to a high of $66, with a standard deviation of $8.49, suggesting variability in estimates [2]. - The lowest estimate indicates a 3.7% increase, while the highest suggests a 63% upside [2]. Analyst Sentiment - Analysts have shown increasing optimism regarding ODD's earnings prospects, with a strong consensus on higher EPS estimates [9]. - Over the last 30 days, three estimates have been revised upward, leading to a 13.1% increase in the Zacks Consensus Estimate [10]. - ODD holds a Zacks Rank 1 (Strong Buy), placing it in the top 5% of over 4,000 ranked stocks based on earnings estimate factors [11]. Caution on Price Targets - Solely relying on price targets for investment decisions may not be wise, as analysts' ability to set unbiased targets has been questioned [3][5]. - Analysts often set optimistic price targets due to business incentives, which can lead to inflated estimates [6]. - A low standard deviation in price targets indicates a high degree of agreement among analysts, which can be a starting point for further research [7].
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
Core Points - ODDITY Tech Ltd. has announced a transaction to repurchase approximately 2.35 million Class A Ordinary Shares for about $100 million at a price of $42.501 per share, funded from existing cash resources [1][2] - The board of directors believes the repurchase is in the best interest of the company due to its strong balance sheet and current circumstances, and this transaction is separate from the ongoing share buyback plan [2][3] - Following the transaction, L Catterton will own around 4 million shares, equating to approximately 7% of the company's outstanding shares as of September 30, 2024 [3] Financial Position - As of September 30, 2024, ODDITY held $248 million in cash, cash equivalents, and investments, along with an undrawn credit facility of $100 million, and has no financial debt [4] - For the 12 months ending September 30, 2024, the company generated $127 million in free cash flow, with $130 million from operations and $3 million in capital expenditures [5][10] - The company has repurchased a total of $147 million of its shares year-to-date, including $47 million under the standing share buyback plan [3] Business Overview - ODDITY is a consumer tech company focused on building and scaling digital-first brands in the beauty and wellness sectors, serving approximately 50 million users through its AI-driven platform [12] - The company operates with headquarters in New York City, an R&D center in Tel Aviv, Israel, and a biotechnology lab in Boston [12]
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 ...
ODD DEADLINE TODAY: ROSEN, TRUSTED INVESTOR COUNSEL, Encourages Oddity Tech Ltd. Investors to Secure Counsel Before Important September 17 Deadline in Securities Class Action - ODD
Newsfile· 2024-09-17 19:01
● . . | --- | --- | |--------------------------------------------------------------------------------------------|-------| | | | | INVESTOR COUNSEL, Encourages Oddity Tech Ltd. Investors to Secure Counsel Before Important | | | September 17 Deadline in Securities Class Action - | | September 17, 2024 10:45 AM EDT | Source: The Rosen Law Firm PA New York, New York--(Newsfile Corp. - September 17, 2024) - WHY: Rosen Law Firm, a global investor rights law firm, reminds purchasers of securities of Oddity Tech L ...
FINAL REMINDER ODD DEADLINE: Bronstein, Gewirtz & Grossman LLC Alerts ODDITY Tech Ltd. Investors to Participate in the Class Action Lawsuit!
Newsfile· 2024-09-17 19:01
New York, New York--(Newsfile Corp. - September 17, 2024) - Bronstein, Gewirtz & Grossman, LLC, a nationally recognized law firm, notifies investors that a class action lawsuit has been filed against ODDITY Tech Ltd. ("ODDITY" or "the Company") (NASDAQ: ODD) and certain of its officers. Class Definition This lawsuit seeks to recover damages against Defendants for alleged violations of the federal securities laws on behalf of all persons and entities that purchased or otherwise acquired ODDITY securities bet ...
ODD DEADLINE TOMORROW: ROSEN, A LEADING LAW FIRM, Encourages Oddity Tech Ltd. Investors to Secure Counsel Before Important September 17 Deadline in Securities Class Action - ODD
GlobeNewswire News Room· 2024-09-16 17:00
Core Viewpoint - Rosen Law Firm is reminding investors who purchased securities of Oddity Tech Ltd. during the specified class period of the upcoming lead plaintiff deadline for a class action lawsuit [1]. Group 1: Class Action Details - The class period for the lawsuit is from July 19, 2023, to May 20, 2024, and the lead plaintiff deadline is September 17, 2024 [1]. - Investors may be entitled to compensation without any out-of-pocket fees through a contingency fee arrangement [1]. - A class action lawsuit has already been filed, and interested parties must move the Court by the specified deadline to serve as lead plaintiff [2]. Group 2: Law Firm Credentials - Rosen Law Firm has a strong track record in securities class actions, having achieved the largest settlement against a Chinese company and being ranked No. 1 for securities class action settlements in 2017 [3]. - The firm has recovered hundreds of millions of dollars for investors, including over $438 million in 2019 alone [3]. - Founding partner Laurence Rosen was recognized as a Titan of Plaintiffs' Bar by Law360 in 2020, and many attorneys at the firm have received accolades from Lawdragon and Super Lawyers [3]. Group 3: Allegations Against Oddity Tech - The lawsuit alleges that Oddity made false and misleading statements regarding its AI technology and sales capabilities [4]. - It is claimed that Oddity's revenue was partly derived from unsustainable and deceptive sales practices [4]. - The company allegedly downplayed the severity of ongoing civil litigation against itself and its subsidiaries, leading to materially false public statements [4].
The Gross Law Firm Reminds Shareholders of a Lead Plaintiff Deadline of September 17, 2024 in ODDITY Tech Lawsuit - ODD
Prnewswire· 2024-09-16 09:45
NEW YORK, Sept. 16, 2024 /PRNewswire/ -- The Gross Law Firm issues the following notice to shareholders of ODDITY Tech Ltd. (NASDAQ: ODD). Shareholders who purchased shares of ODD during the class period listed are encouraged to contact the firm regarding possible lead plaintiff appointment. Appointment as lead plaintiff is not required to partake in any recovery. CONTACT US HERE: https://securitiesclasslaw.com/securities/oddity-tech-loss-submission-form/?id=102411&from=4 CLASS PERIOD: July 19, 2023 to May ...
CLASS ACTION DEADLINE APPROACHING: Berger Montague Advises Oddity Tech (NASDAQ: ODD) Investors to Inquire About a Securities Fraud Class Action by September 17, 2024
GlobeNewswire News Room· 2024-09-13 21:53
Core Viewpoint - A class action lawsuit has been filed against Oddity Tech Ltd. for allegedly misleading investors regarding its business practices and financial health [1][4]. Company Overview - Oddity Tech Ltd. is headquartered in Tel Aviv, Israel, and operates as a consumer tech platform aimed at transforming the global beauty and wellness market through an AI-driven online platform [3]. Lawsuit Details - The lawsuit covers purchasers of Oddity securities from July 19, 2023, to May 20, 2024, with a deadline of September 17, 2024, for investors to seek lead plaintiff status [2]. - The lawsuit claims that a report by NINGI Research accused Oddity of misleading investors about critical aspects of its business, including the nature of its AI technology and undisclosed legal issues [4]. Financial Impact - Following the allegations, Oddity's share price dropped by $3.02, or 7.37%, closing at $37.97 on May 21, 2024, and continued to decline by an additional $1.30, or 3.42%, over the next two trading sessions [4].