Mesoblast (NASDAQ:MESO) Stock, Quote.Headers.trade-ideas

Mesoblast

Mesoblast Ltd is a biotechnology company. It uses its proprietary technology platform to develop and commercialize allogeneic cellular medicines to treat complex diseases resistant to conventional standards of care and where inflammation plays a central role. The company's product candidates include; Ryoncil (remestemcel-L) for the treatment of steroid refractory acute graft versus host disease as well as for the treatment of moderate to severe acute respiratory distress syndrome; Revascor (rexlemestrocel-L) for the treatment of chronic heart failure; and Rexlemestrocel-L for chronic low back pain. The company is managed as one operating segment, being the development of cell technology platform for commercialization.

movers image

News

Pre-Market Outlook

Markets

Movers

Trading Ideas

ABIO

AFRM

APLD

BCDA

BSLK

FIVE

JBDI

MESO

NTNX

OKTA

PSTG

QNTM

SPRC

TCBP

TOVX

Why Affirm Shares Are Trading Higher By Around 18%; Here Are 20 Stocks Moving Premarket

Intraday Update

AVXL

BMRC

CERO

CGTX

COMM

COUR

CPTN

CTRI

IART

ITRG

LGVN

LIPO

LUXH

NIPG

NISN

NLSP

NOVA

NUWE

OPTT

PGHL

PHIO

PYPD

RNLX

SERV

TIVC

TNDM

TSLA

TWOU

VERO

VTVT

VTYX

YIBO

Why Bank of Marin Bancorp Shares Are Trading Lower? Here Are Other Stocks Moving In Monday&#39;s Mid-Day Session

xr:d:DAFp1nJl8vk:2,j:4184241900145690738,t:23072714

ADIL

AEVA

AROC

ATPC

AZTR

CGBS

CLRB

CMAX

CMCSA

DRMA

EFSH

FEIM

FLYE

FTEL

ICLK

JAGX

KNSA

MEDP

MIRA

MLSS

MMYT

MSCI

NCPL

NUKK

NXPI

PCAR

PSIG

RNAZ

SLNA

SLRX

SMFL

SOAR

SPOT

STAF

TUSK

WBTN

XCUR

ZION

Why Comcast Shares Are Trading Lower By 6%? Here Are Other Stocks Moving In Tuesday&#39;s Mid-Day Session

Mesoblast Limited - American Depositary Shares

Mesoblast Ltd

MESO NUMISMATICS INC by Meso Numismatics, Inc.

Meso Numismatics Inc

Democratic Party candidate Kamala Harris <a href="https://www.benzinga.com/news/24/09/40974653/trump-vs-harris-vice-president-leads-in-2-more-new-polls-but-pollster-says-undecided-republicans-can">may be riding on the high of the strong impact</a> she has created among voters ever since she replaced President Joe Biden on the Democratic ticket in late July. But she can&#8217;t count on the support of Sen. Joe Manchin (I-W.Va.), who was a Democrat until May this year and has since then registered as an independent, refused to endorse her.
What Happened: Manchin&#8217;s stance against Harris comes as the Vice President said in an interview with Wisconsin Public Radio that she was in favor of bypassing the Senate&#8217;s filibuster rule if it was needed to protect abortion rights. A Senate filibuster is an attempt to delay or block a vote on a piece of legislation
In an interview with CNN, Manchin, who is a conservative in ideology, <a href="https://edition.cnn.com/2024/09/24/politics/joe-manchin-not-endorse-harris-filibuster/index.html">said</a>, &#8220;She knows the filibuster is the holy grail of democracy. It's the only thing that keeps us talking and working together. If she gets rid of that, then this would be the House on steroids.&#8221;
Manchin said he would not endorse Harris as he was of the view that the elimination of filibusters would destroy the country. &#8220;My country is more important for me than any one person or any one person&#8217;s ideology,&#8221; he said.
<a href="https://benzinga.grsm.io/register174">Benzinga </a>has reached out to the senator&#8217;s press team and Harris&#8217; campaign for clarification and will update the story on receipt of a response from them.
See Also: <a href="https://www.benzinga.com/government/24/05/38779387/joe-manchin-expresses-disappointment-in-congress-inaction-over-nations-rising-35-trillion-debt-its-a">Joe Manchin Expresses Disappointment In Congress&#8217; Inaction Over Nation&#8217;s Rising $35 Trillion Debt: &#8216;It&#8217;s A Shame &#8230; No One Cares About It&#8217;</a>
Why It&#8217;s Important: An earlier attempt by Biden in 2022 to restore abortion as a constitutional right by making an exception to the filibuster fell through due to a lack of support from Manchin and Sen. Kyrsten Sinema (I-Ariz.).
The Senate has already dropped the 60-vote threshold for confirming judicial and executive branch nominees.
Manchin is set to retire after his current term. Although an independent, he continues to caucus with Democrats. He had previously expressed his willingness to endorse Harris contingent on her stance on filibustering aligns with his.
Read Next:
<ul>
<li>Did You Know? Congress Is Making Huge Investments.&nbsp;<a href="https://www.benzinga.com/gov-trades" target="_blank" rel="noreferrer noopener">Get Tips On What They Bought And Sold Ahead Of The 2024 Election With Our Easy-to-Use Tool</a></li>
</ul>
Image Via Shutterstock

Government

Regulations

Politics

Media

Long-Time Democrat Turned Independent Joe Manchin Withholds Endorsement For Kamala Harris: 'This Would Be House On Steroids' Says Senator, If Vice President Gets Rid Of Filibuster

SPGI

Platts, Part Of S&P Global Commodity Insights, Announced The Upcoming Launch Of First Daily Carbon-accounted Iron Ore Price Assessments And Related Carbon Intensity Estimates To Bring Greater Transparency To The Industry's Decarbonization Efforts

Global financial services company The Bank of New York Mellon Corp. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/BK#NYSE">BK</a>) secured an exception from the U.S. Securities and Exchange Commission&#8217;s (SEC) contentious SAB 121 rule, paving the way for its entry into the lucrative but largely untapped cryptocurrency custody market.
What Happened: The regulator did not raise any objections to BNY&#8217;s plan to safeguard cryptocurrency assets for its exchange-traded product clients, without reflecting these assets on the bank&#8217;s balance sheet, Bloomberg <a href="https://www.bloomberg.com/news/articles/2024-09-24/bny-plans-to-custody-crypto-for-etfs-after-sec-review">reported</a> Tuesday.
This is a significant development considering the ongoing debate around the SEC&#8217;s SAB 121 rule, which mandates that companies holding customers' cryptocurrencies <a href="https://www.benzinga.com/markets/cryptocurrency/24/05/38880951/senate-votes-to-overturn-controversial-sec-crypto-rule-but-will-biden-veto-it">must record them on their balance sheets</a>. Banks have been critical of this rule, arguing that it hampers their ability to custody digital assets.
See Also: <a href="https://www.benzinga.com/markets/cryptocurrency/24/09/41017645/elon-musk-applauds-pro-bitcoin-el-salvador-president-nayib-bukele-for-un-address-we-do-not">Elon Musk Applauds Pro-Bitcoin El Salvador President Nayib Bukele For UN Address</a>
BNY clarified that the SEC&#8217;s non-objection is limited to its ETP use case and does not address the broader issue of SAB 121 restricting bank custody of digital assets. The bank intends to continue its engagement with the Office of the Chief Accountant (OCA) on additional use cases through the OCA&#8217;s &#8216;facts and circumstances&#8217; process.
Why It Matters: A TradFi giant, BNY holds more than $50 trillion in assets as of June 30. Its decision to step into the digital custodian market could be influenced by the successful launch of spot Bitcoin (CRYPTO: <a class="ticker" href="https://www.benzinga.com/quote/btc/usd">BTC</a>) and Ethereum (CRYPTO: <a class="ticker" href="https://www.benzinga.com/quote/eth/usd">ETH</a>) exchange-traded funds (ETFs) earlier this year.
Currently, the market is lop-sided, with Coinbase being the primary custodian for most ETFs. Its hegemony was challenged somewhat after Anchorage Digital Bank <a href="https://www.benzinga.com/markets/cryptocurrency/24/09/40835527/crypto-bank-anchorage-digital-challenges-coinbases-etf-custody-dominance">secured a role as custodian</a> for the&nbsp;ARK 21Shares Bitcoin ETF (BATS:<a class="ticker" href="https://www.benzinga.com/stock/ARKB#BATS">ARKB</a>).
This development comes amidst a broader debate around the SEC&#8217;s SAB 121 rule. Republican lawmakers from both the Senate and House <a href="https://www.benzinga.com/markets/cryptocurrency/24/09/41007125/caitlin-long-says-progressives-are-actually-big-bank-corporatists-as-republican-lawmakers-">urged the SEC to retract this controversial accounting rule</a> for cryptocurrency assets.
It is the only cryptocurrency-related legislation to pass through the House and Senate, although it was vetoed by the White House in May.
Price Action: Shares of BNY closed 0.27% lower at $71.87 during Tuesday&#8217;s regular trading session, according to <a href="https://pro.benzinga.com/dashboard?_gl=1&#x2A;380nj0&#x2A;_ga&#x2A;MTEyOTAyOTcxMy4xNzEzMzY0NTYy&#x2A;_ga_V7ZK73W7N0&#x2A;MTcxNDk4MzIzMi42LjEuMTcxNDk4OTE0Ni4wLjAuMA..">data from Benzinga Pro</a>.
Read Next:
<ul>
<li><a href="https://www.benzinga.com/markets/cryptocurrency/24/09/41008797/core-emerges-as-leading-bitcoin-sidechain-by-total-value-locked">Core Emerges As Leading Bitcoin Sidechain By Total Value Locked</a></li>
</ul>
Photo courtesy: Shutterstock

Coverage of Bitcoin, Etherum, Ripple and all the latest digital currencies.

Cryptocurrency

$BTC

$ETH

ARK 21Shares Bitcoin ETF ARK 21Shares Bitcoin ETF

ARKB

BNY Mellon Gets Exemption From SEC's Controversial Crypto Custody Rule: Will It Challenge Coinbase's Hegemony In Holding Assets For Bitcoin And Ethereum ETFs?

Ukrainian President Volodymyr Zelenskyy has called on Western leaders to take decisive action to compel Russia into ending the war, which he says cannot be resolved through dialogue alone. This plea comes amid accusations from the Kremlin that the United Nations is ignoring Ukraine&#8217;s alleged incursion into Russia&#8217;s Kursk region.
What Happened: Speaking at the United Nations Security Council, Zelenskyy emphasized the need for &#8220;forcing Russia into peace,&#8221; reported Reuters on Wednesday.
&#8220;This war can&#8217;t be calmed by talks. Action is needed,&#8221; Zelenskyy urged.
Zelenskyy&#8217;s <a href="https://www.benzinga.com/news/24/09/40975071/ukraines-zelenskyy-heads-to-us-to-present-victory-plan-against-russia-to-biden-as-war-drags-for-over">&#8220;victory plan&#8221; to end the war</a>, which he has been advocating to Western leaders, does not involve ceding any territory to Russia. He also accused North Korea and Iran of being &#8220;de facto accomplices&#8221; of Moscow by providing arms for the war.
Meanwhile, Russian Foreign Minister Sergei Lavrov slammed the U.N. of ignoring alleged atrocities committed by Ukrainian forces during an incursion into Russia&#8217;s Kursk region last month. 
&#8220;I have not heard any voices from U.N. representatives responsible for human rights, including, of course, the secretary general,&#8221; he said, referring to U.N. Secretary Antonio Guterres.
See Also: <a href="https://www.benzinga.com/government/24/09/40971374/elon-musk-responds-to-venture-capitalists-claim-on-government-subsidies-for-spacex-tesla-do-some-res?itm_source=parsely-api" target="_blank" rel="noreferrer noopener">Elon Musk Responds to Venture Capitalist&#8217;s Claim On Government Subsidies For SpaceX, Tesla: &#8216;Do Some Research Before You Display Your Utter Ignorance&#8217;</a>
Why It Matters: Zelenskyy&#8217;s call for Western support to force Russia into peace comes after a series of escalating tensions. Earlier this month, Russian President Vladimir Putin warned that Ukraine&#8217;s use of Western-made <a href="https://www.benzinga.com/news/24/09/40851131/russian-president-says-ukraines-use-of-long-range-missiles-would-signal-that-us-and-nato-are-at-war">long-range missiles</a> against Russia could lead to a direct military confrontation between Russia and the West. Zelenskyy had been lobbying for Western allies to permit Ukraine to deploy these missiles as a means to limit Moscow&#8217;s attack capabilities, a move that Putin argued would implicate the countries providing the missiles in the conflict.
Additionally, former U.S. President Donald Trump recently claimed that <a href="https://www.benzinga.com/news/24/09/40998738/trump-says-ukrainian-president-backs-kamala-harris-for-white-house-zelenskyy-is-the-greatest-salesma">Zelenskyy favors a Democratic win </a>in the upcoming 2024 U.S. election. This assertion contrasts with some of Trump&#8217;s allies who believe Ukraine would welcome his return, claiming he has the skills to negotiate peace with Putin.
Did You Know?
<ul>
<li>Congress Is Making Huge Investments. <a href="https://www.benzinga.com/gov-trades" target="_blank" rel="noreferrer noopener">Get Tips On What They Bought And Sold Ahead Of The 2024 Election With Our Easy-to-Use Tool</a></li>
</ul>
Disclaimer: This content was partially produced with the help of <a href="https://www.benzinga.com/author/benzinga-neuro" target="_blank" rel="noreferrer noopener">Benzinga Neuro</a> and was reviewed and published by Benzinga editors.
Photo by evan_huang on Shutterstock

Global

General

Ukraine's Zelenskyy Urges West For Forcing Russia To Peace While Kremlin Slams UN For Turning A Blind Eye To Kyiv's Incursion Into Kursk

NKTR

Nektar Therapeutics Announced Several Presentations For Rezpegaldesleukin At The 2024 European Academy Of Dermatology And Venereology Congress

CLVT

Clarivate Announced The Development Of A Comprehensive Framework For Evaluating The Societal Impact Of Research

Broadridge Financial Announced That Skandinaviska Enskilda Banken Ab Is Leveraging Broadridge's International Post-trade Processing Solution To Simplify And Streamline Its Securities Business Across International And Domestic Markets

HII (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/HII#NYSE">HII</a>) announced today that its Ingalls Shipbuilding division was awarded a $9.6 billion multi-ship procurement contract for the construction of three San Antonio-class (LPD 17) amphibious ships and a contract modification for the next America-class (LHA 6) large-deck amphibious ship. This combined procurement — the first of its kind for amphibious ships — begins the journey for the construction of LPDs 33, 34, 35 and LHA 10 for the U.S. Navy. &nbsp;
"We greatly appreciate the stability that this award provides to all Ingalls shipbuilders and our surrounding communities," Ingalls President Kari Wilkinson said. "It is an honor to continue our support of the joint Navy and Marine Corps mission to meet the minimum 31-amphibious-ship requirement."
Approximately half of all Ingalls shipbuilders build amphibious ships today, with another 650 supplier partners in 39 states across the country that provide components for the construction of amphibious ships.

Reported Earlier, HII Secures $9.6B Contract to Build Amphibious Ships for US Navy

VTNR

Reported Earlier, Vertex Energy Announced It Entered Into A Restructuring Support Agreement With Term Loan Lenders And Commenced Chapter 11 Cases In The United States Bankruptcy Court For The Southern District Of Texas

At&nbsp;a special briefing for policymakers on Capitol Hill today, Centrus said that the $3.4 billion that Congress has made available for domestic nuclear fuel production should be focused on deploying American uranium enrichment technology that is manufactured in the United States, by American workers, as opposed to foreign-origin centrifuge technologies that are manufactured overseas.&nbsp;
&nbsp;
&nbsp;
"The need to transition away from Russian nuclear fuel, coupled with a historic investment in U.S. nuclear fuel production approved by Congress, has created a once-in-a-generation opportunity to restore America's domestic supply chain for enriched uranium," said Amir Vexler, President and CEO of Centrus. "We should not be content to trade dependence on Russia for dependence on China, or Europe, or anywhere else. The time has come to invest in American enrichment technology, built by American workers, with an American supply chain."&nbsp;
Vexler was joined at the briefing by leaders of approximately 14 large and small businesses with work locations in 13 states, representing Centrus' nationwide supply chain. These American-owned companies and many others would provide critical components and other support to Centrus if the federal government decides to support deployment of Centrus' American Centrifuge technology, which is manufactured in Oak Ridge, Tennessee and operated in Piketon, Ohio.&nbsp;
Under contract with the U.S. Department of Energy, Centrus has deployed a cascade of sixteen centrifuges at the American Centrifuge Plant in Piketon, Ohio, and is pioneering production of an advanced reactor fuel called High-Assay, Low-Enriched Uranium (HALEU). Centrus' goal is to expand the capacity of the plant with thousands of additional centrifuges to accommodate large-scale production of Low-Enriched Uranium (LEU) for existing reactors and HALEU for next generation reactors. This will require a public private partnership including robust federal investment alongside private capital and purchase agreements from customers.&nbsp;
Centrus is competing for federal funding under a series of Requests for Proposals (RFPs) issued by the U.S. Department of Energy. These RFPs are backed by more than $3.4 billion in Congressional appropriations that were approved as part of the Inflation Reduction Act in 2022 and the bipartisan government funding bill in March 2024.&nbsp;

Centrus Urges Congress to Prioritize US-Made Nuclear Fuel Technology Amid $3.4B Funding to Cut Russian Dependency

Offerings

OCCI

Reported Earlier, OFS Credit Company Announced The Pricing Of An Underwritten Public Offering Of 1,040,000 Shares Of 7.875% Series F Term Preferred Stock Due 2029 At A Price Of $25.00 Per Share, Raising $26.0M In Gross Proceeds

Wayfair Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/W#NYSE">W</a>) (the "Company," "we" or "Wayfair") today announced the pricing by its subsidiary, Wayfair LLC (the "Issuer"), of its private offering of $800 million in aggregate principal amount of 7.250% senior secured notes due 2029 (the "Notes"). The&nbsp;offering size was increased to $800 million from the previously announced offering size of $700 million in aggregate principal&nbsp;amount&nbsp;of&nbsp;Notes. The Notes&nbsp;will mature on October 31, 2029, unless earlier repurchased or redeemed in accordance with their terms. The Notes oﬀering is expected to close on October 8, 2024, subject to customary closing conditions.
&nbsp;
We intend to use the net proceeds from the Notes oﬀering, together with cash on hand, for the repayment of certain of Wayfair's existing convertible senior notes and general corporate purposes.

Reported Earlier, Wayfair Raised $800M (Prior $700M) Via Upsized Secondary Senior Secured Notes Offering For Debt Repayment

BNZI

Reported Earlier, Banzai International Announced Agreements To Issue And Sell 1,176,471 Class A Common Shares, Along With Series A And Short-term Series B Warrants To Purchase Up To 1,176,471 Shares Each, At $4.25 Per Share

Nuvve Holding Corp. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NVVE#NASDAQ">NVVE</a>), a leader in vehicle-to-grid (V2G) technology, has issued a letter to shareholders regarding actions taken to regain compliance with Nasdaq's Bid Price Rule.&nbsp;
&nbsp;
Nuvve recently executed a 1-for-10 reverse stock split, resulting in 652,727 shares outstanding. The Company encourages shareholders to protect their shares against market manipulation through actions such as holding shares in cash accounts and requesting "no loan" status.&nbsp;

Stock Split

NVVE

Reported Earlier, Nuvve Holding Executes Reverse Stock Split to Regain Nasdaq Compliance

Rithm Capital Corp. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/RITM#NYSE">RITM</a>, "Rithm" or the "Company")))) announced today that it priced its underwritten public offering of 30,000,000 shares of its common stock for gross proceeds of approximately $342.9 million, before deducting estimated underwriting discounts and commissions and estimated offering expenses. In connection with the offering, the Company has granted the underwriters an option for a period of 30 days to purchase up to an additional 4,500,000 shares of common stock. The underwriters may offer the shares from time to time for sale in negotiated transactions or otherwise, at market prices prevailing at the time of sale, at prices related to such prevailing market prices or at negotiated prices. The offering is expected to close on September 26, 2024, subject to customary closing conditions. The Company intends to use the net proceeds from this offering for general corporate purposes.

RITM

Reported Earlier, Rithm Capital Raised $342.9M Via Secondary Stock Offering Of 30M Shares

SMTC

Semtech Announced Its Collaboration With Traxmate To Offer A Seamless Indoor And Outdoor Asset Tracking Solution

Verizon Business and SK Shieldus have agreed to collaborate to deliver cybersecurity solutions to South Korean and Asian enterprises operating on a global scale. This strategic relationship will leverage Verizon Business' extensive global reach and SK Shieldus' deep-rooted expertise to provide comprehensive, world-class protection addressing the unique needs of Asian businesses. &nbsp;
By combining their strengths in real-time threat intelligence, vulnerability assessment, incident response, and managed security services, Verizon Business and SK Shieldus aim to empower enterprises to confidently navigate the complex global threat landscape, safeguarding their operations and assets worldwide.
Verizon Business works with 99% of Fortune 500 companies and governments worldwide and offers a suite of management and data security services. The company operates nine Security Operations Centers, six forensics labs and one of the largest IP networks in the world, monitoring 61 billion security events annually. In addition, Verizon's investigative response team boasts more than 400 security experts and conducted 500+ IT investigations in 2023.

Verizon and SK Shieldus Team Up to Strengthen Cybersecurity for Asian Enterprises

SNOW

Snowflake Announced The Pricing Of $1.0 Billion Aggregate Principal Amount Of Its 0% Convertible Senior Notes Due 2027 And $1.0 Billion Aggregate Principal Amount Of Its 0% Convertible Senior Notes Due 2029

<a href="https://www.globenewswire.com/Tracker?data=DAo_2_u9_oQEIldgL6aKaJ5v7MvqaO48kWVdUQQPXNb1GYG1p-QfkU9Lg-F2xWAYXFnDoFntLXxCpA_cu4IO3uZxxBBb4khM6taIcweI0Ng=">Arcutis Biotherapeutics, Inc.</a>&nbsp;(NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ARQT#NASDAQ">ARQT</a>), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology and immunology, today announced new pooled subgroup analysis results from the Phase 3 INTEGUMENT-1 and -2 trials showing that ZORYVE cream 0.15% provided consistent and meaningful improvements in signs and symptoms of AD in individuals regardless of race, ethnicity, and Fitzpatrick skin types. The results will be presented in a poster at the European Academy of Dermatology &amp; Venereology Congress held September 25-28, 2024, in Amsterdam.
At Week 4, higher percentages of Validated Investigator Global Assessment for AD (vIGA-AD) Success for ZORYVE- vs. vehicle-treated patients were observed regardless of race (White: 32.3% vs. 13.3%; Black or African American: 25.8% vs 11.5%; Asian: 33.7% vs. 21.8%; Others: 33.2% vs. 13.7%), ethnicity (Hispanic or Latino: 32.9% vs. 16.5%; Not Hispanic or Latino: 31.1% vs 13.8%), or Fitzpatrick score (I–III: 33.0% vs. 13.4%; IV–VI: 29.2% vs. 14.8%). The Fitzpatrick skin type is a scale of I to VI that classifies the skin by its reaction to exposure to sunlight, with skin type I being pale white skin that always burns, does not tan, to VI being dark brown or black skin that never burns, always tans darkly. vIGA-AD Success was defined as vIGA-AD value of 0 or 1 plus a 2-grade improvement from baseline.
"Given that the clinical presentation of AD may differ among patients by race, ethnicity, and Fitzpatrick skin type, it is reassuring to see the consistency of efficacy, safety, and tolerability of a treatment across these various subgroups," said Vimal H. Prajapati MD, FRCPC, DABD, clinical associate professor at the University of Calgary and co-founder/co-director of the Skin Health &amp; Wellness Centre, Dermphi Centre, Dermphi Shop, and Dermatology Research Institute. "ZORYVE cream 0.15% consistently achieved meaningful and significant improvements in disease clearance and itch reduction, in all subgroups. This analysis can give confidence to clinicians that ZORYVE provides effective and well-tolerated relief of atopic dermatitis signs and symptoms across individuals with diverse skin types."
ZORYVE-treated patients also achieved a greater improvement in itch as measured by reductions in Worst Itch-Numeric Rating Scale (WI-NRS) Success, defined as ≥4-point improvement in patients 12 years of age and older with baseline WI-NRS score ≥4, at Week 4 with consistent results regardless of subgroup (White: 33.5% vs. 16.5%; Black or African American: 30.6% vs. 21.0%; Asian: 25.4% vs. 7.9%; Others: 34.3% vs. 22.7%), ethnicity (Hispanic or Latino: 37.4% vs. 30.5%; Not Hispanic or Latino: 30.9% vs. 13.8%), or Fitzpatrick score (I–III: 35.5% vs. 15.0%; IV–VI: 27.3% vs. 18.2%). Similar findings were observed for additional endpoints including achievement of vIGA-AD score of ‘Clear (0)' or ‘Almost Clear (1)' and 75% improvement in the Eczema Area and Severity Index (EASI-75).
"We formulated ZORYVE cream with all AD patients in mind, and we are pleased to present these data from our Phase 3 INTEGUMENT studies, which demonstrated ZORYVE's ability to significantly, consistently, and safely improve AD symptoms regardless of race, ethnicity, or skin type," said Patrick Burnett, MD, PhD, FAAD, chief medical officer of Arcutis. "It is critical that our clinical data represent the diversity in the world around us, and these results further reinforce our commitment to providing meaningful innovation for immune-mediated skin diseases."
The Incidence of Treatment Emergent Adverse Events (TEAEs) was low in both ZORYVE- and vehicle-treated patients. The incidence of TEAEs in ZORYVE-treated patients was generally similar across subgroups. Local tolerability was also favorable. The most common adverse reactions were headache, nausea, application site pain, diarrhea, and vomiting.
INTEGUMENT-1 and INTEGUMENT-2 (The INterventional Trial EvaluatinG roflUMilast cream for the treatmENt of aTopic dermatitis) were two identical Phase 3, parallel group, double blind, vehicle-controlled trials evaluating the safety and efficacy of ZORYVE cream 0.15% in AD.

ARQT

Arcutis Reports ZORYVE Cream Shows AD Relief Across Racial and Skin Type Groups: Study Findings

Elon Musk&#8216;s SpaceX on Tuesday slammed the Federal Aviation Administration (FAA) administrator Mike Whitaker for his <a href="https://www.benzinga.com/news/24/09/41016988/spacex-in-violation-of-texas-federal-law-on-some-matters-says-faa-agency-hits-back-at-elon-musks-roc">comments defending delays</a> in greenlighting the next launch of its Starship launch vehicle. 
What Happened: &#8220;&#8230;every statement he made was incorrect,&#8221; SpaceX wrote in a letter addressed to U.S. House of Representatives member Kevin Kiley  (R-Calif.). &#8220;It is deeply concerning that the Administrator does not appear to have accurate information immediately available to him with respect to SpaceX licensing matters.&#8221;
Whitaker told lawmakers on the House Transportation Committee on Tuesday that the decision to delay Starship launches is grounded in safety and also backed the $633,000 fine proposed on SpaceX earlier this month. He said that the fines were proposed against SpaceX for using plans not approved by the agency last year during certain Falcon launch missions.
<figure class="wp-block-embed is-type-rich is-provider-twitter wp-block-embed-twitter"> 
<div class="wp-block-embed__wrapper">
<blockquote class="twitter-tweet" data-width="500" data-dnt="true">FAA Administrator Whitaker made several incorrect statements today regarding SpaceX. In fact, every statement he made was incorrect. It is deeply concerning that the Administrator does not appear to have accurate information immediately available to him with respect to SpaceX… <a href="https://t.co/OrtMUvnCNI">pic.twitter.com/OrtMUvnCNI</a>
&mdash; SpaceX (@SpaceX) <a href="https://twitter.com/SpaceX/status/1838694004277547121?ref_src=twsrc%5Etfw">September 24, 2024</a></blockquote>
<script async src="https://platform.twitter.com/widgets.js" charset="utf-8"></script></div>
</figure>
SpaceX Disputes Claims: SpaceX shot back at Whitaker, disputing the claims made by the agency in proposing fines against the company.
&#8220;SpaceX was fully licensed to conduct these Falcon launches and FAA has not alleged otherwise. With respect to Starship, neither of the two items he referenced, including the sonic boom, are related to public safety, but to environmental considerations that had been previously evaluated as posing no risk to the environment,&#8221; the letter signed by Matt Dunn, Director of Government Affairs at SpaceX, read. &#8220;Additionally, his assertion that SpaceX violated state law is simply wrong,&#8221;
Why It Matters: &#8220;Flight 5 (of Starship) is built and ready to fly. Flight 6 will be ready to fly before Flight 5 even gets approved by FAA!&#8221; Musk said on Thursday, referring to the delay in receiving approvals for Starship flights. Starship last flew in June, and the next test flight is now expected in November. 
The CEO also accused the agency of favoritism towards Boeing after it&nbsp;<a href="https://www.benzinga.com/markets/equities/24/09/40912464/elon-musk-accuses-faa-of-fining-spacex-over-nonsense-that-doesnt-affect-safety-amazingly-no-star" target="_blank" rel="noreferrer noopener">proposed a fine of $633,009</a>&nbsp;on SpaceX for regulatory violations this month. 
"The FAA leadership spends their resources attacking SpaceX for petty matters that have nothing to do with safety, while neglecting real safety issues at Boeing. This is deeply wrong and puts human lives at risk," Musk wrote on Thursday.
SpaceX also<a href="https://www.benzinga.com/markets/equities/24/09/40951122/elon-musk-blasts-faa-for-targeting-spacex-over-petty-matters-while-ignoring-boeings-safety-issue" target="_blank" rel="noreferrer noopener">&nbsp;sent a letter addressed to key members&nbsp;</a>of the U.S. Congress, including Rep.&nbsp;Frank Lucas&nbsp;(R-Okla.) and Rep.&nbsp;Zoe Lofgren&nbsp;(D-Calif.), Sen.&nbsp;Ted Cruz&nbsp;(R-Texas) and Senate Commerce Committee Chair&nbsp;Maria Cantwell&nbsp;(D-Wash.) denying the FAA's allegations of regulatory violations while also countering that the federal agency lacks the resources to review licensing commercial spaceflight operations.
Check out more of Benzinga's Future Of Mobility coverage by&nbsp;<a href="https://www.benzinga.com/topic/mobility" target="_blank" rel="noreferrer noopener">following this link</a>.
Read More:
<ul>
<li><a href="https://www.benzinga.com/news/24/09/40999063/elon-musks-grok-ai-chatbot-has-no-clue-what-teslas-cybertruck-looks-like-senior-exec-calls-it-extra" target="_blank" rel="noreferrer noopener">Elon Musk's Grok AI Chatbot Has ‘No Clue' What Tesla's Cybertruck Looks Like: Senior Exec Calls It ‘Extra Disappointing'</a></li>
</ul>
Photo courtesy: Shutterstock

SPACE

Tech

SpaceX Hits Back At FAA Chief For Pinning Starship Delays On Safety Concerns: 'Every Statement He Made Was Incorrect'

Mesoblast stock climbs 9% amid FDA update, Piper upgrade (update)

Mesoblast (MESO) has released an update. Mesoblast Limited, a global leader in allogeneic cellular medicines, has announced that the FDA has accept...

Mesoblast's Ryoncil® Awaits FDA Approval for SR-aGVHD

Mesoblast FY Earnings Preview

Here's the major earnings after the close today

Mesoblast Limited (MESO) Q4 2024 Earnings Call Transcript

Mesoblast Limited 2024 Q4 - Results - Earnings Call Presentation

Mesoblast GAAP EPS of -$0.09 beats by $0.63, revenue of $5.9M misses by $1.71M

In a report released today, Edward Tenthoff from Piper Sandler reiterated a Buy rating on Mesoblast (MESO – Research Report), with a price target o...

Mesoblast (MESO) Receives a Buy from Piper Sandler

Bell Potter analyst John Hester maintained a Buy rating on Mesoblast Limited (MEOBF – Research Report) today and set a price target of A$1.40. The ...

Bell Potter Sticks to Their Buy Rating for Mesoblast Limited (MEOBF)

In a report released today, David Stanton from Jefferies upgraded Mesoblast Limited (MEOBF – Research Report) to a Buy, with a price target of A$1....

Mesoblast Limited (MEOBF) was upgraded to a Buy Rating at Jefferies

CRWD

IREN

LFVN

MEOBF

NOAH

NTAP

NVDA

VEEV

VSCO

Analyst Ratings

Press Releases

Appendix 4c Quarterly Activity Report for Quarter Ended March 31, 2024

Mesoblast Corporate Presentation at Investor Conference

Health Care

Mesoblast to File Biologics License Application for Ryoncil® FDA Approval Next Week

Mesoblast Resubmits Biologics License Application (BLA) with United States Food & Drug Administration (FDA) for Approval of Ryoncil® in Children with Steroid-Refractory Acute Graft-Versus-Host Disease (SR-aGVHD)

Patient Enrollment Commenced in Pivotal Phase 3 Trial of Rexlemestrocel-L for Chronic Low Back Pain

FDA Accepts Mesoblast's Biologics License Application (BLA) for Ryoncil® in Children With Steroid-Refractory Acute Graft-Versus-Host Disease (SR-aGVHD)

Appendix 4C Quarterly Activity Report for Quarter Ended June 30, 2024

Mesoblast Financial Results and Corporate Update Webcast

Earnings

Mesoblast Reports Financial Results and Operational Update for Fiscal Year Ended June 30, 2024

KaliVir Immunotherapeutics Appoints Schond Greenway as Chief Financial Officer

AVTX

DRRX

Top Stock Ideas Sent Daily — Join and Gain Your Edge

Top Stock Ideas Sent Daily — Join and Gain Your Edge

Comments

Mesoblast

Mesoblast (MESO) Forecast

Mesoblast (NASDAQ:MESO) Stock, Quote.Headers.trade-ideas