에 대한 최신 뉴스 J-Long Group (NASDAQ:JL) 주식

J-Long Group

J-Long Group Ltd is an established distributor in Hong Kong of reflective and non-reflective garment trims including, among others, heat transfers, fabrics, woven labels and tapes, sewing badges, piping, zipper pullers and drawcords. It also offers a wide range of apparel solution services to cater to its customers' needs for reflective and non-reflective garment trims, ranging from market trend analysis, product design and development and production to quality control.

J-Long Group Ltd

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JOLIMARK HOLDINGS LTD ORD by Jolimark Holdings Ltd.

Jolimark Holdings Ltd

Jupiter Perpetuals Liquidity Provider Token - United States Dollar

Janus Henderson Corporate Bond ETF

SOUTH ATLANTIC GOLD INC by South Atlantic Gold Inc.

South Atlantic Gold Inc

Nuveen Mortgage And Income Fund

Biotech

General

RDHL

RedHill Biopharma Announces The China National Intellectual Property Administration Formally Allowed A Critical Use Of Composition-Of-Matter Patent For RHB-107, A Potential COVID-19 Treatment

Opera (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/OPRA#NASDAQ">OPRA</a>) sees Q2 sales of $134.000 million-$138.000 million vs $134.12 million analyst estimate.

News

Guidance

OPRA

Opera Sees Q2 Sales $134.000M-$138.000M vs $134.12M Est

<ul>
<li>Approval-in-Principle Received For Up To $900,000 in Government Funding to&nbsp;</li>
<li>Directly Support Globavend's Expansion into the China Market</li>
</ul>

Globavend Gains Government Approval To Expand Into China, Securing Potential $900,000 Non-Dilutive Grant

VYJUVEK approved for the treatment of DEB from birth in Europe
Approval allows for dosing at home or in a healthcare setting, as well as patient or caregiver administration if deemed appropriate by a healthcare professional
PITTSBURGH, April 28, 2025 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the "Company") (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/KRYS#NASDAQ">KRYS</a>) announced today that on April 23, 2025, the European Commission (EC) granted marketing authorization to VYJUVEK&#xAE; (beremagene geperpavec-svdt) for the treatment of wounds in patients with dystrophic epidermolysis bullosa (DEB) who have mutations in the collagen type VII alpha 1 chain (COL7A1) gene, starting from birth. VYJUVEK is designed to address the genetic root cause of DEB by delivering functional copies of the human COL7A1 gene to provide wound healing and sustained functional type VII collagen protein expression with redosing. VYJUVEK is the first corrective medicine approved in Europe for the treatment of DEB. The approval granted by the EC allows for flexible VYJUVEK dosing either at home or in healthcare setting, with the option for patient or caregiver administration if deemed appropriate by a healthcare professional.
This EC decision authorizes the marketing of VYJUVEK in all European Union member states, as well as Iceland, Norway and Liechtenstein. The timing for availability of VYJUVEK in individual countries will depend on multiple factors, including the completion of reimbursement procedures. The Company is planning for its first European launch in Germany in mid-2025.

KRYS

EC Grants Marketing Authorization To Krystal Biotech's VYJUVEK For Treatment Of Wounds In Patients With DEB Who Have Mutations In COL7A1 Gene, Starting From Birth

Opera (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/OPRA#NASDAQ">OPRA</a>) raises FY2025 sales outlook from $555.00 million-$570.00 million to $567.00 million-$582.00 million vs $565.46 million estimate.

Opera Raises FY2025 Sales Guidance from $555.00M-$570.00M to $567.00M-$582.00M vs $565.46M Est

Approval of Lynozyfic is based on data showing deep and durable responses in relapsed/refractory multiple myeloma
Lynozyfic will provide a new option with&nbsp;convenient dosing and administration to patients who face cycles of relapse and remission
&nbsp;Regeneron Pharmaceuticals, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/REGN#NASDAQ">REGN</a>) today announced that the European Commission (EC) has granted conditional marketing approval of Lynozyfic&#x2122; (linvoseltamab) to treat adults with relapsed and refractory (R/R) multiple myeloma (MM). The indication is specific to those who have received at least three prior therapies, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody, and have demonstrated disease progression on the last therapy. Lynozyfic is a bispecific antibody designed to bridge B-cell maturation antigen (BCMA) on MM cells with CD3-expressing T cells to facilitate T-cell activation and cancer-cell killing.
Lynozyfic is the first BCMAxCD3 therapy approved that can be dosed every four weeks due to a response-adapted regimen if a very good partial response (VGPR) or better is achieved following completion of at least 24 weeks of therapy. The regimen includes monitoring in close proximity of a qualified treatment center for safety during the step-up dosing period (one 24-hour period after the first step-up dose and another 24-hour period after the second step-up dose, if certain safety events occur).
"Despite treatment advances, patients with multiple myeloma inevitably endure relapses, reduced responses to subsequent therapies, and increasingly shorter remissions. For those who develop relapsed and refractory disease after having been exposed to the three major drug classes, it's important to have new therapies with different mechanisms of action like linvoseltamab," said Paula Rodriguez-Otero, M.D., Department of Hematology, Cancer Center Clínica Universidad de Navarra, Pamplona, Navarra, Spain. "In a clinical trial, linvoseltamab demonstrated compelling and impressive efficacy with the potential for complete remission in this patient population, including those with high disease burden. Furthermore, its response-adapted schedule will provide patients a convenient treatment option."
The EC approval is based on results from the pivotal LINKER-MM1 trial (n=117 at the 200 mg dose of Lynozyfic), which demonstrated robust and durable responses in patients with R/R MM. Results showed a 71% objective response rate (ORR), with 50% of patients achieving a complete response (CR) or better, as determined by an independent review committee. The minimal residual disease (MRD) negativity rate in patients achieving a CR or stringent CR was 41% (24 of 58 patients; 95% confidence interval [CI]: 29 to 55). The median duration of response (DOR) was 29 months (95% CI: 19 to not estimable).
The most frequent adverse reactions were musculoskeletal pain (52%), cytokine release syndrome (CRS; 46%), neutropenia (43%), cough (42%), diarrhea&nbsp;(39%), anemia (38%), fatigue (36%), pneumonia (32%), and upper respiratory tract infection (30%).&nbsp;The majority of CRS cases were Grade 1 (35%) or Grade 2 (10%), and there was one case of Grade 3 CRS (0.9%) and no cases of ≥Grade 4 CRS. The median time to first CRS onset was 11 hours (range: -1.1 to 184 hours), with the median time to resolution within 1 day (16 hours; range: 1-96 hours). Grade 3 immune effector cell-associated neurotoxicity syndrome (ICANS; 2.6%) and infections that were Grade 3 or 4 (36%) or fatal (4%) also occurred.
"Lynozyfic is our second approved bispecific antibody – in this case for relapsed/refractory multiple myeloma patients – reinforcing our relentless commitment to transforming cancer care for those who need it most," said George D. Yancopoulos, M.D., Ph.D., Board co-Chair, President and Chief Scientific Officer of Regeneron. "We are excited by the potential of Lynozyfic and its differentiated clinical profile, dosing and administration. Given the strength of the data, we are pursuing a robust clinical development program exploring its use – in earlier lines of therapy as monotherapy and in novel combinations – with the hope of further advancing care for patients."

REGN

Regeneron Pharmaceuticals Announces That The European Commission  Has Granted Conditional Marketing Approval Of Lynozyfic To Treat Adults With Relapsed And Refractory Multiple Myeloma

INMD

InMode Lowers FY2025 Adj EPS Guidance from $1.95-$1.99 to $1.64-$1.68 vs $1.93 Est

Kandi Technologies Gr (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/KNDI#NASDAQ">KNDI</a>) reported quarterly losses of $(0.57) per share. This is a 850 percent decrease over losses of $(0.06) per share from the same period last year. The company reported $37.80 million in sales this quarter. This is a 33.29 percent increase over sales of $28.36 million the same period last year.

Earnings

KNDI

Kandi Technologies Gr Q4 EPS $(0.57) Down From $(0.06) YoY, Sales $37.80M Up From $28.36M YoY

RNTX

Rein Therapeutics To Present New Data On Caveolin Scaffolding Peptides In IPF And Normal Lung Samples At ATS 2025

JP Morgan analyst Michael Mueller initiates coverage on Smartstop Self Storage (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/SMA#NYSE">SMA</a>) with a Overweight rating and announces Price Target of $36.

Price Target

Initiation

Analyst Ratings

JP Morgan Initiates Coverage On Smartstop Self Storage with Overweight Rating, Announces Price Target of $36

YJUVEK approved for the treatment of DEB from birth in Europe
Approval allows for dosing at home or in a healthcare setting, as well as patient or caregiver administration if deemed appropriate by a healthcare professional
Krystal Biotech, Inc. (the "Company") (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/KRYS#NASDAQ">KRYS</a>) announced today that on April 23, 2025, the European Commission (EC) granted marketing authorization to VYJUVEK&#xAE; (beremagene geperpavec-svdt) for the treatment of wounds in patients with dystrophic epidermolysis bullosa (DEB) who have mutations in the collagen type VII alpha 1 chain (COL7A1) gene, starting from birth. VYJUVEK is designed to address the genetic root cause of DEB by delivering functional copies of the human COL7A1 gene to provide wound healing and sustained functional type VII collagen protein expression with redosing. VYJUVEK is the first corrective medicine approved in Europe for the treatment of DEB. The approval granted by the EC allows for flexible VYJUVEK dosing either at home or in healthcare setting, with the option for patient or caregiver administration if deemed appropriate by a healthcare professional.
This EC decision authorizes the marketing of VYJUVEK in all European Union member states, as well as Iceland, Norway and Liechtenstein. The timing for availability of VYJUVEK in individual countries will depend on multiple factors, including the completion of reimbursement procedures. The Company is planning for its first European launch in Germany in mid-2025.
"Today's approval is an exciting milestone for Krystal and the patients we aim to serve. After years of preparation in close coordination with leading DEB treatment centers, we are ready and excited to bring this urgently needed therapy to patients," said Laurent Goux, Senior Vice President and General Manager of Europe at Krystal Biotech. "With already 1,000 DEB patients identified in France and Germany, as well as many more across the continent, our goal is clear – to ensure as many patients as possible are able to benefit from sustainable access to VYJUVEK."

Krystal Biotech Receives European Commission Approval Of VYJUVEK For The Treatment Of Dystrophic Epidermolysis Bullosa

2025 Financial Outlook
Management provided an outlook for the full year of 2025 ending December 31, 2025. Based on our current estimates, management expects:
<ul>
<li>Revenues between $395 to $405 million</li>
<li>Non-GAAP gross margin between 78% and 80%, compared to previous guidance of 80% to 82%</li>
<li>Non-GAAP income from operations to be between $101 million and $106 million, compared to previous guidance of $130 million to $135 million</li>
</ul>

InMode Affirms FY2025 Sales Guidance of $395.00M-$405.00M vs $393.38M Est

CDK2 molecular glue degrader (MGD) in combination with CDK4/6 inhibition and anti-estrogen therapy achieved superior tumor regression in vivo compared to standard of care CDK4/6 inhibition and anti-estrogen therapy
CDK2 MGD delayed resistance to CDK4/6 inhibition in vitro and displayed superior selectivity versus clinical-stage CDK2 inhibitors

GLUE

Monte Rosa's MRT-51443 Demonstrates Potent CDK2 Degradation And Delays Resistance To CDK4/6 Inhibitors In Preclinical Studies

XRTX

XORTX Announces Receipt Of Patent For Xanthine Oxidase Inhibitor Formulations By European Patent Office

Opera (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/OPRA#NASDAQ">OPRA</a>) reported quarterly earnings of $0.27 per share which beat the analyst consensus estimate of $0.24 by 12.5 percent. This is a 58.82 percent increase over earnings of $0.17 per share from the same period last year. The company reported quarterly sales of $142.72 million which beat the analyst consensus estimate of $131.36 million by 8.65 percent. This is a 40.10 percent increase over sales of $101.87 million the same period last year.

Earnings Beats

Opera Q1 Adj. EPS $0.27 Beats $0.24 Estimate, Sales $142.72M Beat $131.36M Estimate

InMode Q1 2025 Adj. EPS $0.31 Misses $0.35 Estimate, Sales $77.87M Miss $78.21M Estimate

Outlines strong operational and financial performance driven by the Company's transformative strategy
Warns that Elliott's high-risk proposals are misleading, based on flawed analysis and threaten long-term shareholder value
Underscores the valuable skills and experiences Phillips 66's Board and nominees have to drive shareholder value creation, superior to those of Elliott's nominees
Phillips 66 (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PSX#NYSE">PSX</a>) (the "Company") today filed an investor presentation with the U.S. Securities and Exchange Commission in connection with its upcoming Annual Meeting of Shareholders on May 21, 2025.
In conjunction with the presentation, Phillips 66 published two new videos that showcase the skills and experiences the Company's two new Board nominees, A. Nigel Hearne and Howard Ungerleider, would bring to the Board and how they would approach driving shareholder value as a potential Board member of Phillips 66.
The presentation and the videos are available at <a href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.phillips66delivers.com&amp;esheet=54244480&amp;newsitemid=20250427721989&amp;lan=en-US&amp;anchor=www.phillips66delivers.com&amp;index=1&amp;md5=da7ce40342b0431b228bfc94fbd4636d">www.phillips66delivers.com</a>.
Highlights of the investor presentation include:
Phillips 66's proven strategy has driven, and will drive, outperformance for shareholders
<ul>
<li>Since Mark Lashier became President and CEO in 2022, Phillips 66 has delivered total shareholder returns of 67%1, significantly outperforming the S&amp;P 500 Energy Index by 45%1 and the Company's synthetic proxy peer median2 by 42%1</li>
<li>In under three years, Phillips 66 has taken significant action, including returning over $14 billion to shareholders through share repurchases and dividends, rationalization of Refining assets, $3.5 billion in non-core asset divestitures, and opportunistic Midstream expansion through the Pinnacle and EPIC NGL acquisitions3</li>
<li>Reduced Refining Adjusted Controllable Costs from $6.98/bbl in 2022 to $5.90/bbl4 in 2024 with a clear plan in place to further reduce costs and achieve $5.50/bbl by 20275</li>
<li>Phillips 66's transformative strategy is in its early innings and has significant room to deliver further value. This proven strategy will continue to drive long-term competitiveness in Refining, grow the NGL value chain, maintain the Company's advantaged position in Chemicals, optimize profitability across all assets, and deliver consistent, compelling returns
<ul>
<li>Phillips 66 has delivered Refining profitability on par with peers on a like-for-like basis, while outperforming them in overall Refining cost improvements since 2022 6. The Company remains focused on cost improvements with a focus on further enhancing market capture.</li>
<li>Compared to 2021, our projected Midstream Adjusted EBITDA (post EPIC NGL) has grown by $1.9 billion, driven by an incremental 18% Cash Return on Capital Invested7, with additional organic growth opportunities in the future</li>
<li>CPChem's global scale and feedstock advantages result in a self-funding joint venture with stable, growing distributions that is constructing two world-scale projects coming online in late 2026</li>
</ul>
</li>
</ul>
The Company's integrated model creates consistent and compelling long-term value for shareholders
<ul>
<li>Compared to the weighted proxy peer average, the Company's integrated model delivers higher returns for shareholders and lower volatility across cycles</li>
<li>Phillips 66's integrated structure creates $500 million in annual operating synergies8, as the Midstream business ensures reliable supply and integrated logistics for refineries and CPChem, ultimately improving flow assurance, feedstock quality, blending efficiency, and market flexibility</li>
<li>Since the spinoff in 2012, we have grown our dividend at a 15% CAGR.9 Our annual dividend paid has increased every year – a rare achievement in the energy sector, especially through economic and commodity cycles</li>
</ul>

Phillips 66 Files Investor Presentation Highlighting Strategy, Board Strength, and Path For Shareholder Value Creation

JP Morgan analyst Jeffrey Zekaukas downgrades Eastman Chemical (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/EMN#NYSE">EMN</a>) from Overweight to Neutral and lowers the price target from $112 to $76.

Downgrades

JP Morgan Downgrades Eastman Chemical to Neutral, Lowers Price Target to $76

Alliance Res Partners (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ARLP#NASDAQ">ARLP</a>) reported quarterly earnings of $0.57 per share which beat the analyst consensus estimate of $0.50 by 14 percent. This is a 52.89 percent decrease over earnings of $1.21 per share from the same period last year. The company reported quarterly sales of $540.47 million which missed the analyst consensus estimate of $552.05 million by 2.10 percent. This is a 17.07 percent decrease over sales of $651.70 million the same period last year.

Earnings Misses

ARLP

Alliance Res Partners Q1 EPS $0.57 Beats $0.50 Estimate, Sales $540.47M Miss $552.05M Estimate

ADMA

ADMA Biologics Announces FDA Approval Of Its Yield Enhancement Production Process

Press Releases

J-Long Group Limited Receives Nasdaq Deficiency Notice Regarding Minimum Bid Price Requirement

J-Long Group Limited, Ltd Receives Notification Regarding Non-Compliance with Nasdaq Global Market Minimum Market Value of Publicly Held Shares Requirement

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