MRK Deadline: MRK Purchasers with Losses in Excess of $100K Have Opportunity to Lead Merck & Co., Inc. Securities Fraud Lawsuit

PR Newswire


NEW YORK
, April 2, 2025 /PRNewswire/ — Rosen Law Firm, a global investor rights law firm, announces the filing of a class action lawsuit on behalf of purchasers of securities of Merck & Co., Inc. (NYSE: MRK) between February 3, 2022 and February 3, 2025, both dates inclusive (the “Class Period”). A class action lawsuit has already been filed. If you wish to serve as lead plaintiff, you must move the Court no later than April 14, 2025.

So what: If you purchased Merck securities during the Class Period you may be entitled to compensation without payment of any out of pocket fees or costs through a contingency fee arrangement.

What to do next: To join the Merck class action, go to https://rosenlegal.com/submit-form/?case_id=34975 or call Phillip Kim, Esq. toll-free at 866-767-3653 or email [email protected] for information on the class action. A class action lawsuit has already been filed. If you wish to serve as lead plaintiff, you must move the Court no later than April 14, 2025. A lead plaintiff is a representative party acting on behalf of other class members in directing the litigation.

Why Rosen Law: We encourage investors to select qualified counsel with a track record of success in leadership roles. Often, firms issuing notices do not have comparable experience, resources, or any meaningful peer recognition. Many of these firms do not actually litigate securities class actions, but are merely middlemen that refer clients or partner with law firms that actually litigate the cases. Be wise in selecting counsel. The Rosen Law Firm represents investors throughout the globe, concentrating its practice in securities class actions and shareholder derivative litigation. Rosen Law Firm achieved the largest ever securities class action settlement against a Chinese Company at the time. Rosen Law Firm was Ranked No. 1 by ISS Securities Class Action Services for number of securities class action settlements in 2017. The firm has been ranked in the top 4 each year since 2013 and has recovered hundreds of millions of dollars for investors. In 2019 alone the firm secured over $438 million for investors. In 2020, founding partner Laurence Rosen was named by law360 as a Titan of Plaintiffs’ Bar. Many of the firm’s attorneys have been recognized by Lawdragon and Super Lawyers.

Details of the case: According to the lawsuit, throughout the Class Period, defendants provided investors with material information concerning Merck’s expected revenue of $11 billion from sales of Gardasil by 2030. Defendants’ statements included, among other things, confidence in Merck’s purported ability to utilize successful consumer activation and education efforts on the benefits of Gardasil in order to drive demand and capitalize on eligible populations for vaccination, resulting in confidently optimistic reports and forecasts of Gardasil’s growth in China. Defendants provided these overwhelmingly positive statements to investors while, at the same time, disseminating materially false and misleading statements and/or concealing material adverse facts concerning the true state of Gardasil’s demand in China; notably, that Merck lacked visibility into demand for Gardasil in China among eligible and otherwise targeted populations, resulting in the inflated inventory of its distributor, Zhifei. When the true details entered the market, the lawsuit claims that investors suffered damages.

To join the Merck class action, go to https://rosenlegal.com/submit-form/?case_id=34975 call Phillip Kim, Esq. toll-free at 866-767-3653 or email [email protected] for information on the class action.

No Class Has Been Certified. Until a class is certified, you are not represented by counsel unless you retain one. You may select counsel of your choice. You may also remain an absent class member and do nothing at this point. An investor’s ability to share in any potential future recovery is not dependent upon serving as lead plaintiff.

Follow us for updates on LinkedIn: https://www.linkedin.com/company/the-rosen-law-firm or on Twitter: https://twitter.com/rosen_firm or on Facebook: https://www.facebook.com/rosenlawfirm.

Attorney Advertising. Prior results do not guarantee a similar outcome.

Contact Information:

      Laurence Rosen, Esq.
      Phillip Kim, Esq.
      The Rosen Law Firm, P.A.
      275 Madison Avenue, 40th Floor
      New York, NY 10016
      Tel: (212) 686-1060
      Toll Free: (866) 767-3653
      Fax: (212) 202-3827
      [email protected]
      www.rosenlegal.com

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SOURCE THE ROSEN LAW FIRM, P. A.

Enliven Therapeutics Announces Poster Presentations at the 2025 AACR Annual Meeting

PR Newswire


BOULDER, Colo.
, April 2, 2025 /PRNewswire/ — Enliven Therapeutics, Inc. (Enliven or the Company) (Nasdaq: ELVN), a clinical-stage biopharmaceutical company focused on the discovery and development of small molecule therapeutics, today announced the Company will present five posters at the upcoming American Association for Cancer Research (AACR) Annual Meeting, taking place April 25-30, 2025, in Chicago, Illinois.

Poster Presentation Details 

Abstract 4712 – ELVN-002, a potent, selective HER2 inhibitor with a differentiated binding mode conferring the potential for enhanced efficacy in combination with HER2-targeting antibody-drug conjugates

Date/Time:
Tuesday, April 29, 2025, 9:00 a.m.12:00 p.m. CDT
Session: Targeted Therapies and Combinations 2
Location: Poster Section 34

Abstract 4361 – Development and application of a mechanistic pharmacokinetic pharmacodynamic (PKPD) model to predict anti-chronic myeloid leukemia (CML) effects of tyrosine kinase inhibitors

Date/Time:
Tuesday, April 29, 2025, 9:00 a.m.12:00 p.m. CDT
Session: Pharmacokinetics and Pharmacodynamics of Cancer Therapeutics
Location: Poster Section 20

Abstract LB295 – ELV-3111, a type 1 pan-RAF inhibitor, that safely combines with MEK inhibitors for enhanced anti-tumor activity in NRAS and BRAF mutant cancers including the most common mechanisms of BRAF inhibitor clinical resistance

Date/Time:
Tuesday, April 29, 2025, 9:00 a.m.12:00 p.m. CDT
Session: Late-Breaking Research: Experimental and Molecular Therapeutics 3
Location: Poster Section 52

Abstract LB294 – Mechanism of tumor-selective inhibition of dimeric RAF by a Type 1 RAF inhibitor

Date/Time:
Tuesday, April 29, 2025, 9:00 a.m.12:00 p.m. CDT
Session: Late-Breaking Research: Experimental and Molecular Therapeutics 3
Location: Poster Section 52

Abstract 5515 – ELVN-001, a highly selective ATP-competitive ABL1 tyrosine kinase inhibitor for the treatment of chronic myeloid leukemia alone or in combination with asciminib

Date/Time:
Tuesday, April 29, 2025, 2:00 p.m.5:00 p.m. CDT
Session: Drug Resistance in Molecular Targeted Therapies 3
Location: Poster Section 17

Abstracts are currently available on the AACR website. Following the presentations, copies will be available on the “Program Presentations & Publications” section of the Company’s website at www.enliventherapeutics.com.

About Enliven Therapeutics
Enliven is a clinical-stage biopharmaceutical company focused on the discovery and development of small molecule therapeutics to help people not only live longer, but live better. Enliven aims to address existing and emerging unmet needs with a precision oncology approach that improves survival and enhances overall well-being. Enliven’s discovery process combines deep insights in clinically validated biological targets and differentiated chemistry to design potentially first-in-class or best-in-class therapies. Enliven is based in Boulder, Colorado.

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SOURCE Enliven Therapeutics, Inc.

Light & Wonder Provides Update on Dragon Train Litigation

Light & Wonder Provides Update on Dragon Train Litigation

Reaffirms 2025 $1.4 Billion Targeted Consolidated AEBITDA(1) and Targeted Adjusted NPATA Range(1) between $565 million and $635 million(2)

Company to Host Conference Call at 4:30 PM Eastern Time

LAS VEGAS–(BUSINESS WIRE)–Light & Wonder, Inc. (NASDAQ and ASX: LNW) (together with its subsidiaries, “we,” “Light & Wonder,” “L&W” or the “Company”) today provided an update regarding its ongoing litigation with Aristocrat in the U.S. District Court of Nevada.

On March 14, 2025, Aristocrat filed a second amended complaint with the District Court of Nevada, adding a trade secret misappropriation claim against Jewel of the Dragon. The initial claims concerning Jewel of the Dragon did not include a claim for trade secret misappropriation. We intend to respond to the second amended complaint by April 11, 2025.

In the latest complaint, Aristocrat has also raised new issues, which we intend to vigorously defend against.

First, Aristocrat asserts that replacement games for Dragon Train, including Dragon Train Grand Central, a social game we have released, would “reap the benefits” of trade secret misappropriation even if none of the claimed trade secrets are used in such games.

  • There are many elements of Dragon Train that made it successful and that are not contested by Aristocrat. We have structured development of new games to solve the issue raised by Emma Charles’ use of certain math in the design of Dragon Train.
  • We have been and will continue to be transparent with the courts and Aristocrat on the process to ensure that new games do not contain any of Aristocrat’s claimed trade secrets or confidential information. We followed that process with our new social game, Dragon Train Grand Central. We provided the math to Aristocrat in advance of the launch of the game.
  • Aristocrat has made no claim with respect to the Dragon Train Grand Central math, and we are confident the same will be true for our Dragon Train replacement land-based game that is in development.

Second, Aristocrat’s complaint also refers to emails sent by Emma Charles, the game designer of Dragon Train, to other team members at L&W that were provided to Aristocrat as part of the discovery process.

__________

(1)

Represents a non-GAAP financial measure. Additional information on non-GAAP financial measures presented herein is available at the end of this release. 

(2)

Targets reaffirmation does not include any contribution from the proposed acquisition of Grover Charitable Gaming business.
  •  We have investigated the circumstances surrounding these e-mails and have not identified any evidence of similar issues affecting games of other studios related to these e-mails.

Third, Aristocrat references an unreleased game in its latest amended complaint.

  • The game in question was part of our pipeline of products. Our internal review processes identified that an early version of this game’s math model potentially presented issues relating to Aristocrat. While these issues had been removed in later versions, we took a conservative position and acted promptly prior to this amended complaint to stop further development of the game and will not be releasing it.

Finally, Aristocrat has for the first time made a trade secret misappropriation claim on Jewel of the Dragon.

  • In light of this claim, we made the decision to voluntarily stop commercializing and offer to replace Jewel of the Dragon to minimize any confusion and potential disruption to our customers. We are seeking to ensure our customers are not affected by the ongoing legal process. The success we had in rapidly replacing the Dragon Train units, and the strong game performance of our broader portfolio, give us confidence that this is the best course of action for our customers at this point as we continue to build great games. For context, Jewel of the Dragon’s Premium installed base footprint is less than one percent (1%) of the total Premium installed base in North America, with approximately 150 premium leased units.
  • After Aristocrat added the trade secret claim on Jewel of the Dragon, we identified certain Aristocrat PAR sheets dated 2015 that appear to have been available to certain members of the Jewel of the Dragon development team. PAR sheets are used by suppliers to describe the performance characteristics and settings of a slot machine and contain information about the game’s payout structure and odds and some of the mechanics of how the machine operates. These PAR sheets have been historically provided to customers to allow them to meet regulatory requirements and to understand their own exposure as it relates to the likelihood of large but infrequent award amounts. Because PAR sheets have been so widely distributed, it has historically been common for PAR sheets from industry players, including L&W, to end up in the hands of competitors.
  • Given our identification of these historical Aristocrat PAR sheets, we are expanding the scope of the review we conducted following the preliminary injunction to include all hold and spin games released before mid-2021. We have no reason to believe that the expanded review covering all hold and spin games released before mid-2021 will identify evidence of similar issues. The scope of our initial review included a number of later versions of games first released before mid-2021. None of those later versions had evidence of similar issues making it unlikely that earlier versions would. Furthermore, all of these games have been on the market for a minimum of three years. Separately, no one has made a claim that any of these games incorporate confidential trade secrets of any other party. We plan to give an update to the market on this review as part of our Q1 2025 results briefing.

We remain steadfast in our commitment to continued R&D investment to further develop our catalog of proven, evergreen franchises. The broad uplift in game performance we’ve experienced across our portfolio is a testament to the quality of the talent and culture in our organization. We are extremely proud to have a robust and diversified portfolio of the best products in the market that gives us a competitive advantage not tied to any one game or franchise. We are grateful to our customers and stakeholders for their unwavering support as we continue to execute to strategy.

Reaffirms 2025 Financial Targets

Most importantly, our decision to stop commercializing and offer to remove Jewel of the Dragon is not expected to have a material effect on our revenue, nor our commitment to delivering our $1.4 billion Targeted Consolidated AEBITDA(1) and Targeted Adjusted NPATA range(1) between $565 million and $635 million for 2025 and is not expected to affect our future growth. These financial targets are affirmed without any contribution from the proposed acquisition of Grover Gaming’s Charitable business, which we expect to close during Q2 this year. We look forward to sharing new strategic objectives at our upcoming 2025 Investor Day.

Additional Background Regarding the Litigation

Aristocrat originally made claims with respect to two Light &Wonder games in its complaint filed on February 26, 2024, a trade secret misappropriation claim on Dragon Train and trade dress, copyright infringement and related claims on Jewel of the Dragon. In its first amended complaint filed in July 2024, Aristocrat added references to trade dress issues relating to Dragon Unleashed Link.

__________

(1)

Represents a non-GAAP financial measure. Additional information on non-GAAP financial measures presented herein is available at the end of this release. 

On September 23, 2024, the Nevada court granted a preliminary injunction on Dragon Train games. We complied with that order on a global basis, including converting out approximately 95% of the 2,200 units from our North American gaming operations fleet within the 30-day time period for compliance. Following our own internal review, we also found that Emma Charles, the game designer responsible for Dragon Train, had breached her employment obligations and we swiftly terminated her employment.

Following the Nevada court preliminary injunction ruling and our internal review, we decided to undertake a broad third-party audit by Mark Nicely, a gaming expert and former game mathematician with deep experience in the industry. He has been involved in design, development and analysis of casino games since 1997. From 2005-2014, he was an employee of IGT working on a wide range of game design and development projects and analysis of IP portfolios. He has been named as a lead or co-inventor on more than 250 issued patents. For the last four years, Mark has worked as a freelance game designer, mathematician and analyst and as an expert witness on matters involving casino game design, gaming IP, casino operations and gaming contracts. Mark earned a Bachelor of Science in Computer and System Engineering from Rensselaer Polytechnic Institute in 1983 and worked in various computer engineering roles until 1997.

That review has not identified any evidence of similar issues for hold and spin games released from mid-2021, when Emma Charles joined Light & Wonder, through to the present.

As previously announced, we are hosting an investor conference call and simultaneous webcast with the event details listed below.

Investor Conference Call

April 2, 2025

4:30 p.m. U.S. Eastern Time / 1:30 p.m. U.S. Pacific Time

April 3, 2025

7:30 a.m. Australian Eastern Daylight Time

To pre-register, click here: Light & Wonder Litigation Update Conference Call

Callers who pre-register will be given a conference passcode and unique PIN to gain immediate access to the call and bypass the live operator. Participants may pre-register at any time, including up to the call start time.

Webcast

To access the live webcast of the call, please visit the Company’s website at https://explore.investors.lnw.com and click on the webcast link. A replay of the webcast will be available approximately one hour after the webcast and will be archived on the Company’s website.

Telephone Dial-in

US Toll Free: +1 (833) 470-1428

Australia: +61 2 7908 3093

International: +1 (404) 975-4839

Access Code: 604986

About Light & Wonder

Light & Wonder, Inc. is the leading cross-platform global games company. Through our three unique, yet highly complementary businesses, we deliver unforgettable experiences by combining the exceptional talents of our 6,500+ member team, with a deep understanding of our customers and players. We create immersive content that forges lasting connections with players, wherever they choose to engage. At Light & Wonder, it’s all about the games. The Company is committed to the highest standards of integrity, from promoting player responsibility to implementing sustainable practices. To learn more visit www.lnw.com.

You can access our filings with the Securities Exchange Commission (“SEC”) through the SEC website at www.sec.gov, with the Australian Securities Exchange (“ASX”) through the ASX website at www.asx.com.au or through our website, and we strongly encourage you to do so. We routinely post information that may be important to investors on our website at explore.investors.lnw.com, and we use our website as a means of disclosing material information to the public in a broad, non-exclusionary manner for purposes of the SEC’s Regulation Fair Disclosure.

The information contained on, or that may be accessed through, our website is not incorporated by reference into, and is not a part of, this document, and shall not be deemed “filed” under the Securities Exchange Act of 1934, as amended.

All ® notices signify marks registered in the United States. © 2025 Light & Wonder, Inc. All Rights Reserved.

Forward-Looking Statements

In this press release, Light & Wonder makes “forward-looking statements” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements about 2025 financial targets; statements regarding the proposed Grover Charitable Gaming transaction and statements that describe future expectations, plans, results or strategies and can often by identified by the use of terminology such as “will,” “may,” “estimate,” “intend,” “plan,” “continue,” “believe,” “expect,” “anticipate,” “target,” “should,” “could,” “potential,” “opportunity,” “goal,” or similar terminology. These statements are based upon current Company management expectations, assumptions and estimates and are not guarantees of timing, future results, or performance. Therefore, you should not rely on any of these forward-looking statements as predictions of future events. Actual results may differ materially from those contemplated in these statements due to a variety of risks, uncertainties and other factors, including (i) the risk that the conditions to the closing of the proposed Grover Charitable Gaming transaction, including the receipt of regulatory and gaming approvals, may not be satisfied, (ii) the risk that a material adverse change, event or occurrence may affect the Company and Grover Charitable Gaming prior to the closing of the proposed Grover Charitable Gaming transaction and may delay the proposed transaction or cause the companies to abandon the proposed transaction, (iii) the risk that the proposed Grover Charitable Gaming transaction may involve unexpected costs, liabilities or delays, (iv) the risk that the businesses of the companies may suffer as a result of uncertainty surrounding the proposed transaction, (v) the risk that disruptions from the proposed transaction will harm relationships with customers, employees and suppliers or (vi) the risk that the Company may be unable to achieve expected financial, operational and strategic benefits of the proposed transaction and may not be able to successfully integrate Grover Charitable Gaming into the Company’s operation and those factors described in our filings with the Securities and Exchange Commission (the “SEC”) and the Australian Securities Exchange (“ASX”). Additional information regarding risks and uncertainties and factors that could cause results to differ materially from those contemplated in forward-looking statements is included from time to time in our filings with the SEC and ASX, including the Company’s current reports on Form 8-K, quarterly reports on Form 10-Q and its latest annual report on Form 10-K filed with the SEC and ASX for the year ended December 31, 2024 on February 25, 2025 (including under the headings “Forward-Looking Statements” and “Risk Factors”). Forward-looking statements speak only as of the date they are made and, except for our ongoing obligations under the U.S. federal securities laws, we undertake no and expressly disclaim any obligation to publicly update any forward-looking statements whether as a result of new information, future events or otherwise.

Non-GAAP Financial Measures

Consolidated AEBITDA

Consolidated AEBITDA, as used herein, is a non-GAAP financial measure that is presented as a supplemental disclosure of the Company’s operations and is reconciled to net income as the most directly comparable GAAP measure. Consolidated AEBITDA should not be considered in isolation of, as a substitute for, or superior to, the consolidated financial information prepared in accordance with GAAP, and should be read in conjunction with the Company’s financial statements filed with the SEC. Consolidated AEBITDA may differ from similarly titled measures presented by other companies.

Consolidated AEBITDA is reconciled to Net income attributable to L&W and includes the following adjustments, as applicable: (1) Net income attributable to noncontrolling interest; (2) Restructuring and other, which includes charges or expenses attributable to: (i) employee severance; (ii) Management restructuring and related costs; (iii) restructuring and integration (including costs associated with strategic review, rebranding, divestitures, SciPlay acquisition and ongoing separation activities and related activities); (iv) cost savings initiatives; (v) major litigation; and (vi) acquisition- and disposition-related costs and other unusual items; (3) Depreciation, amortization and impairment charges and Goodwill impairments; (4) Loss on debt financing transactions; (5) Change in fair value of investments and Gain on remeasurement of debt and other; (6) Interest expense; (7) Income tax expense (benefit); (8) Stock-based compensation; and (9) Other (income) expense, net, including foreign currency gains or losses and earnings from equity investments.

Consolidated AEBITDA Target denotes a non-GAAP financial measure. We are not providing a forward-looking quantitative reconciliation of targeted Consolidated AEBITDA to the most directly comparable GAAP measure because we are unable to do so without unreasonable efforts or to reasonably estimate the projected outcome of certain significant items. These items are uncertain, depend on various factors out of our control and could have a material impact on the corresponding measures calculated in accordance with GAAP.

Adjusted NPATA

Adjusted NPATA, as used herein, is a non-GAAP financial measure that is presented as a supplemental disclosure of the Company’s operations and is reconciled to net income as the most directly comparable GAAP measure. Adjusted NPATA should not be considered in isolation of, as a substitute for, or superior to, the consolidated financial information prepared in accordance with GAAP, and should be read in conjunction with the Company’s financial statements filed with the SEC. Adjusted NPATA may differ from similarly titled measures presented by other companies.

Adjusted NPATA is reconciled to Net income attributable to L&W and includes the following adjustments, as applicable: (1) Net income attributable to noncontrolling interest; (2) Amortization of acquired intangible assets; (3) Non-cash asset and goodwill impairments; (4) Restructuring and other, which includes charges or expenses attributable to: (i) employee severance; (ii) Management restructuring and related costs; (iii) restructuring and integration (including costs associated with strategic review, rebranding, divestitures, SciPlay acquisition and ongoing separation activities and related activities); (iv) cost savings initiatives; (v) major litigation; and (vi) acquisition- and disposition-related costs and other unusual items; (5) Loss on debt financing transactions; (6) Change in fair value of investments and Gain on remeasurement of debt and other; (7) Income tax impact on adjustments; and (8) Other expense (income), net, including foreign currency gains or losses and earnings from equity investments.

Adjusted NPATA targeted range for fiscal year 2025 denotes a non-GAAP financial measure. We are not providing a forward-looking quantitative reconciliation of Adjusted NPATA targeted range to the most directly comparable GAAP measure because we are unable to do so without unreasonable efforts or to reasonably estimate the projected outcome of certain significant items. These items are uncertain, depend on various factors out of our control and could have a material impact on the corresponding measures calculated in accordance with GAAP.

Company Contacts

Media Relations

Andy Fouché +1 206-697-3678

Vice President, Corporate Affairs and Communications

[email protected]

Investor Relations

Nick Zangari +1 702-301-4378

Senior Vice President, Investor Relations and Treasury

[email protected]

KEYWORDS: United States North America Nevada

INDUSTRY KEYWORDS: Electronic Games Casino/Gaming Entertainment

MEDIA:

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BioCryst to Present at Upcoming Investor Conference

RESEARCH TRIANGLE PARK, N.C., April 02, 2025 (GLOBE NEWSWIRE) — BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that the company plans to present at the 24th Annual Needham Virtual Healthcare Conference on Wednesday, April 9, 2025, at 9:30 a.m. ET.

Link to the live audio webcast and replay of the presentation may be accessed in the Investors & Media section of BioCryst’s website at http://www.biocryst.com.

About BioCryst Pharmaceuticals

BioCryst Pharmaceuticals is a global biotechnology company with a deep commitment to improving the lives of people living with hereditary angioedema and other rare diseases. BioCryst leverages its expertise in structure-guided drug design to develop first-in-class or best-in-class oral small-molecule and protein therapeutics to target difficult-to-treat diseases. BioCryst has commercialized ORLADEYO® (berotralstat), the first oral, once-daily plasma kallikrein inhibitor, and is advancing a pipeline of small-molecule and protein therapies. For more information, please visit www.biocryst.com or follow us on LinkedIn.

BCRXW


Contact

:

John Bluth
+1 919 859 7910
[email protected]



Fate Therapeutics Reports New Employee Inducement Awards Under Nasdaq Listing Rule 5635(c)(4)

SAN DIEGO, April 02, 2025 (GLOBE NEWSWIRE) — Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to bringing a first-in-class pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients with cancer and autoimmune diseases, today announced that on April 1, 2025 the Company granted restricted stock units (RSUs) representing 32,200 shares of its common stock to two newly-hired non-executive employees. The grants were approved by the Compensation Committee of the Company’s Board of Directors and granted under the Company’s Amended and Restated Inducement Equity Plan as an inducement material to the new employees entering into employment with the Company in accordance with Nasdaq Listing Rule 5635(c)(4). The RSUs will vest over four years, with 25% of the shares underlying each RSU award vesting on each anniversary of the grant date, subject to the employees being continuously employed by the Company through each vesting date.

About Fate Therapeutics, Inc.

Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to bringing a first-in-class pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients with cancer and autoimmune diseases. Using its proprietary iPSC product platform, the Company has established a leadership position in creating multiplexed-engineered iPSC lines and in the manufacture and clinical development of off-the-shelf, iPSC-derived cell products. The Company’s pipeline includes iPSC-derived natural killer (NK) cell and T-cell product candidates, which are selectively designed, incorporate novel synthetic controls of cell function, and are intended to deliver multiple therapeutic mechanisms to patients. Fate Therapeutics is headquartered in San Diego, CA. For more information, please visit www.fatetherapeutics.com.

Contact:

Christina Tartaglia
Precision AQ
212.362.1200
[email protected]



Seacoast Banking Corporation of Florida to Announce First Quarter Earnings Results April 24, 2025

Seacoast Banking Corporation of Florida to Announce First Quarter Earnings Results April 24, 2025

Investors May Listen to Live Webcast

STUART, Fla.–(BUSINESS WIRE)–
Seacoast Banking Corporation of Florida (NASDAQ: SBCF), a bank holding company whose operating entity is Seacoast Bank, today announced it will release first quarter 2025 results on April 24th, after the market closes. Upon release, investors may access a copy of Seacoast’s earnings results at the company’s website www.SeacoastBanking.com on the home page by selecting “Press Releases” under the heading “News/Events.”

Seacoast will host a conference call April 25th at 10:00 a.m. Eastern Time, to discuss the first quarter 2025 earnings results and business trends. Investors may call in (toll-free) by dialing (800) 715-9871 (Conference ID: 4944599). Charts will be used during the conference call and may be accessed at Seacoast’s website at www.SeacoastBanking.com by selecting “Presentations” under the heading “News/Events.” Additionally, a recording of the call will be made available to individuals shortly after the conference call and can be accessed via a link at www.SeacoastBanking.com under the heading “Corporate Information.” The recording will be available for one year.

About Seacoast Banking Corporation of Florida (NASDAQ: SBCF)

Seacoast Banking Corporation of Florida is one of the largest community banks headquartered in Florida with $15.2 billion in assets and $12.2 billion in deposits as of December 31, 2024. Seacoast provides integrated financial services including commercial and consumer banking, wealth management, and mortgage services to customers at 79 full-service branches across Florida, and through advanced mobile and online banking solutions. Seacoast National Bank is the wholly-owned subsidiary bank of Seacoast Banking Corporation of Florida. For more information about the Seacoast, visit www.SeacoastBanking.com.

Tracey Dexter

Chief Financial Officer

Seacoast Banking Corporation of Florida

(772) 403-0461

KEYWORDS: United States North America Florida

INDUSTRY KEYWORDS: Banking Professional Services Finance

MEDIA:

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Fluor to Provide EPCM Services for a Second Multi-Billion-Dollar Pharmaceutical Facility in Indiana

Fluor to Provide EPCM Services for a Second Multi-Billion-Dollar Pharmaceutical Facility in Indiana

IRVING, Texas–(BUSINESS WIRE)–Fluor Corporation (NYSE: FLR) announced today that it has received a letter of intent from one of the world’s leading pharmaceutical makers to provide engineering, procurement and construction management (EPCM) services for its Lebanon, Indiana, mega-project. Fluor will recognize the multi-billion-dollar reimbursable contract as a new award in the first quarter of 2025.

This investment is in addition to its first multi-billion-dollar project that was awarded to Fluor in 2023.

The facility will manufacture groundbreaking peptide-based drugs for Type 2 diabetes and weight control and represents the largest investment in an active pharmaceutical ingredient facility in U.S. history.

“This monumental project stands as one of the largest life science endeavors ever undertaken in a single initiative and demonstrates Fluor’s EPCM leadership position in the sector,” said Richard Meserole, President of Fluor’s Advanced Technologies & Life Sciences business. “The products this facility manufactures have the ability to enhance the overall wellbeing of its users globally. Fluor is honored to be delivering it.”

About Fluor Corporation:

Fluor Corporation (NYSE: FLR) is building a better world by applying world-class expertise to solve its clients’ greatest challenges. Fluor’s nearly 27,000 employees provide professional and technical solutions that deliver safe, well-executed, capital-efficient projects to clients around the world. Fluor had revenue of $16.3 billion in 2024 and is ranked 265 among the Fortune 500 companies. With headquarters in Irving, Texas, Fluor has provided engineering, procurement and construction services for more than a century. For more information, please visit www.fluor.com or follow Fluor on Facebook, Instagram, LinkedIn, X and YouTube.

#ATLS

Brett Turner

Media Relations

864.281.6976

Jason Landkamer

Investor Relations

469.398.7222

KEYWORDS: United States North America Indiana Texas

INDUSTRY KEYWORDS: Research Architecture Pharmaceutical Other Construction & Property Commercial Building & Real Estate Construction & Property Science Engineering Building Systems Health Diabetes Other Science Manufacturing

MEDIA:

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Expedia Group to Webcast First Quarter 2025 Results on May 8, 2025

Expedia Group to Webcast First Quarter 2025 Results on May 8, 2025

SEATTLE–(BUSINESS WIRE)–
Expedia Group (NASDAQ: EXPE) will report its first quarter 2025 results for the period ended March 31, 2025, on Thursday, May 8, 2025 via an earnings release and accompanying webcast. These items will be available in the Investor Relations section of the company’s corporate website at http://ir.expediagroup.com. The earnings release will post after market close and the webcast will begin at 1:30 PM Pacific Time / 4:30 PM Eastern Time. A replay of the call is expected to be available for approximately twelve months.

About Expedia Group

Expedia Group, Inc. brands power travel for everyone, everywhere through our global platform. Driven by the core belief that travel is a force for good, we help people experience the world in new ways and build lasting connections. We provide industry-leading technology solutions to fuel partner growth and success, while facilitating memorable experiences for travelers. Our organization is made up of three pillars: Expedia Brands, housing all our consumer brands; Expedia Product & Technology, focused on the group’s product and technical strategy and offerings; and Expedia for Business, consisting of business-to-business solutions and relationships throughout the travel ecosystem. Expedia Group’s three flagship consumer brands includes: Expedia®, Hotels.com®, and Vrbo®.

For more information, visit www.expediagroup.com. Follow us on Twitter @expediagroup and check out our LinkedIn www.linkedin.com/company/expedia.

© 2025 Expedia, Inc., an Expedia Group company. All rights reserved. Trademarks and logos are the property of their respective owners. CST: 2029030-50

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INDUSTRY KEYWORDS: Software Internet Lodging Destinations Travel Vacation Cruise Technology

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Neurogene Announces Peer-Reviewed Publication Demonstrating Gene Therapy Candidate NGN-401 with EXACT™ Technology Regulates Transgene Expression in Preclinical Models of Rett Syndrome

Neurogene Announces Peer-Reviewed Publication Demonstrating Gene Therapy Candidate NGN-401 with EXACT™ Technology Regulates Transgene Expression in Preclinical Models of Rett Syndrome

Data demonstrate EXACT has potential to overcome limitations of conventional gene therapy for dosage-sensitive disorders

Findings published in Science Translational Medicine

NEW YORK–(BUSINESS WIRE)–
Neurogene Inc. (Nasdaq: NGNE), a clinical-stage company founded to bring life-changing genetic medicines to patients and families affected by rare neurological diseases, today announced a peer-reviewed publication on its EXACT™ transgene regulation technology. The preclinical studies demonstrate EXACT’s ability to regulate gene therapy expression to a tolerable and therapeutic level, including in preclinical models of Rett syndrome. These data, published in Science Translational Medicine, supported the initiation of Neurogene’s ongoing Phase 1/2 clinical trial with NGN-401 gene therapy for Rett syndrome.

“Neurogene was founded to extend the promise of gene therapy to rare neurological disorders, and EXACT was critical to enabling gene therapy treatment for Rett syndrome, a disorder with a narrow therapeutic window that requires transgene regulation,” said Rachel McMinn, Ph.D., Founder and Chief Executive Officer of Neurogene. “NGN-401 gene therapy for Rett syndrome is our first product candidate incorporating EXACT, which was intentionally developed to deliver therapeutic and tolerable MeCP2 levels. The preclinical data published today and the translation of the platform into the clinic support the proposition that EXACT has the potential to overcome the limitations of conventional gene therapy to address Rett syndrome and other devastating disorders.”

Rett syndrome is caused by loss of function variants in the MECP2 gene; however, high levels of MeCP2 can lead to toxicity. Conventional, unregulated gene therapy leads to variable cellular uptake that can result in toxic levels of transgene expression. EXACT is a self-regulating circuit contained within a gene therapy cassette and enables therapeutic and tolerable transgene expression on a cell-by-cell basis through regulation by microRNA.

“Gene therapy with transgene regulation holds the potential to treat a variety of dosage-sensitive disorders that currently have no disease-modifying options available,” said Stuart Cobb, Ph.D., Chief Scientific Officer of Neurogene, and Professor of Translational Neuroscience at Simons Initiative in the Developing Brain and Centre for Discovery Brain Sciences at the University of Edinburgh. “The development of a potential treatment option for Rett syndrome was the impetus for creating EXACT, and its translation to NGN-401 is a major advancement. I would like to thank my colleagues at the University of Edinburgh, Edinburgh Innovations and Neurogene for their support in the development of EXACT.”

Overview of Data

The publication today details a series of preclinical studies that led to the development of NGN-401 and demonstrate more promising safety and efficacy compared to conventional gene therapy:

  • To design a gene therapy to move forward into clinical testing for Rett syndrome, a series of constructs were designed by modifying individual regulatory elements. In the male knockout model of Rett syndrome that has no MeCP2 expression, NGN-401 was the most effective construct and extended median survival the longest.
  • In the female murine model of Rett syndrome that has mosaic MeCP2 expression, similar to human females with Rett syndrome, NGN-401 was well-tolerated across all doses evaluated; in comparison, conventional gene therapy resulted in severe toxicity.
  • In non-human primates, which express normal levels of MeCP2 in all cells and are therefore the most conservative model to evaluate tolerability, all doses of NGN-401 were well-tolerated. Conventional gene therapy resulted in more variable and several-fold higher MECP2 mRNA levels in key tissues compared to NGN-401.

Together, these data provide evidence that EXACT regulates expression across disease and large animal models. The peer-reviewed article, “Self-regulating Gene Therapy for Overcoming Gene Dosage Sensitivity in Rett Syndrome,” was published in Science Translational Medicine, a member of the Science family of journals. The article can be accessed from Neurogene’s website at https://ir.neurogene.com.

About Neurogene

The mission of Neurogene is to treat devastating neurological diseases to improve the lives of patients and families impacted by these rare diseases. Neurogene is developing novel approaches and treatments to address the limitations of conventional gene therapy in central nervous system disorders. This includes selecting a delivery approach to maximize distribution to target tissues and designing products to maximize potency and purity for an optimized efficacy and safety profile. The Company’s novel and proprietary EXACT transgene regulation platform technology allows for the delivery of therapeutic levels while limiting transgene toxicity associated with conventional gene therapy. Neurogene has constructed a state-of-the-art gene therapy manufacturing facility in Houston, Texas. CGMP production of NGN-401 was conducted in this facility and will support pivotal clinical development activities. For more information, visit www.neurogene.com.

About NGN-401

NGN-401 is an investigational AAV9 gene therapy being developed as a one-time treatment for Rett syndrome. It is the first clinical candidate to deliver the full-length human MECP2 gene under the control of Neurogene’s EXACT™ transgene regulation technology. EXACT technology is an important advancement in gene therapy for Rett syndrome, specifically because the disorder requires a treatment approach that enables targeted levels of MECP2 transgene expression without causing overexpression-related toxic effects associated with conventional gene therapy.

NGN-401 was selected by the U.S. Food and Drug Administration (FDA) for its START Pilot Program and has also received Regenerative Medicine Advance Therapy (RMAT) designation, orphan drug designation, Fast Track designation and rare pediatric designation from the FDA. Neurogene was previously granted an INTERACT meeting with the FDA regarding the EXACT technology. NGN-401 also received Priority Medicines (PRIME) designation, orphan designation and advanced therapy medicinal product designation from the European Medicines Agency (EMA) and the Innovative Licensing and Application Pathway (ILAP) designation from the United Kingdom (UK) Medicines and Healthcare products Regulatory Agency (MHRA).

Cautionary Note Regarding Forward-Looking Statements

Statements in this press release which are not historical in nature are intended to be, and hereby are identified as, forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current expectations and beliefs of the management of Neurogene, as well as assumptions made by, and information currently available to, management of Neurogene, including, but not limited to, statements regarding: the therapeutic potential and utility, efficacy and clinical benefits of the EXACT transgene technology generally and specifically in NGN-401; the safety, tolerability and efficacy of NGN-401; and the potential applications of the EXACT transgene technology for future uses, including in potential additional preclinical product candidates. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” “on track,” and other similar expressions or the negative or plural of these words, or other similar expressions that are predictions or indicate future events or prospects, although not all forward-looking statements contain these words. Forward-looking statements are based on current beliefs and assumptions that are subject to risks, uncertainties and assumptions that are difficult to predict with regard to timing, extent, likelihood, and degree of occurrence, which could cause actual results to differ materially from anticipated results and many of which are outside of Neurogene’s control. Such risks, uncertainties and assumptions include, among other things: risk related to the Company’s ability to obtain regulatory approval for, and ultimately commercialize, its product candidates, including NGN-401; the Company’s ability to successfully create future product candidates using EXACT; the ability to successfully advance any product candidates using EXACT through pre-clinical and clinical development and obtain regulatory and marketing approvals of these product candidates; the potential for competitors to create other therapies that compete with EXACT; and other risks and uncertainties identified under the heading “Risk Factors” included in Neurogene’s Annual Report on Form 10-K for the year ended December 31, 2024, filed with the Securities and Exchange Commission (SEC) on March 24, 2025, and other filings that the Company has made and may make with the SEC in the future. Nothing in this communication should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that the contemplated results of any such forward-looking statements will be achieved. Forward-looking statements in this communication speak only as of the day they are made and are qualified in their entirety by reference to the cautionary statements herein. Except as required by applicable law, Neurogene undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.

This communication contains hyperlinks to information that is not deemed to be incorporated by reference into this communication.

Company Contact:

Cara Mayfield

Vice President, Corporate Affairs

[email protected]

Investor Contact:

Melissa Forst

Argot Partners

[email protected]

KEYWORDS: United States North America New York

INDUSTRY KEYWORDS: Science Other Science Biotechnology Research Pharmaceutical Health Genetics Clinical Trials

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Alkermes to Participate in the 24th Annual Needham Virtual Healthcare Conference

PR Newswire


DUBLIN
, April 2, 2025 /PRNewswire/ — Alkermes plc (Nasdaq: ALKS) announced today that management will participate in a webcast panel discussion “Development of Orexin Receptor Agonist in Sleep-Wake Disorders” at the upcoming 24th Annual Needham Virtual Healthcare Conference on Wednesday, April 9, 2025 at 11:45 a.m. EDT (4:45 p.m. BST). The live webcast may be accessed under the Investors tab on www.alkermes.com and will be archived for 14 days.


About Alkermes plc

Alkermes plc is a global biopharmaceutical company that seeks to develop innovative medicines in the field of neuroscience. The company has a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia and bipolar I disorder, and a pipeline of clinical and preclinical candidates in development for neurological disorders, including narcolepsy and idiopathic hypersomnia. Headquartered in Ireland, Alkermes also has a corporate office and research and development center in Massachusetts and a manufacturing facility in Ohio. For more information, please visit Alkermes‘ website at www.alkermes.com.

Alkermes Contact:
Jamie Constantine
Investor Relations
+1 781 873 2402

 

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SOURCE Alkermes plc