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Month: May 2024

Update on FDA Priority Review of Dupixent® (dupilumab) for the Treatment of COPD Patients with Type 2 Inflammation

TARRYTOWN, N.Y. and PARIS, May 31, 2024 (GLOBE NEWSWIRE) — Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced the U.S. Food and Drug Administration (FDA) has extended by three months the target action date of its priority review of the supplemental Biologics License Application (sBLA) for Dupixent® (dupilumab) as an add-on maintenance treatment in certain adult patients with uncontrolled chronic obstructive pulmonary disease (COPD). The revised target action date is September 27, 2024. The FDA did not raise any concerns regarding the approvability of Dupixent for this indication. The FDA had requested additional analyses on the efficacy of Dupixent in the BOREAS and NOTUS pivotal trials. Based on the submission of these analyses earlier in May, the agency has now determined that this additional information...

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VEON discloses April YTD trading update at its AGM

VEON discloses April YTD trading update at its AGM Amsterdam, 31 May 2024 07:00 CEST – VEON April YTD 2024 HighlightsTotal revenue of USD 1,278 million, +8.6% YoY (+12.9% YoY in local currency) Service revenue of USD 1,226 million, +7.5% YoY (+11.7% YoY in local currency) EBITDA of USD 528 million, +2.1% YoY (+6.4% YoY in local currency) VEON appoints UHY LLP as auditors for VEON Group’s 2023 PCAOB auditVEON Ltd. (NASDAQ: VEON, Euronext Amsterdam: VEON), a global digital operator that provides converged connectivity and online services (“VEON or, together with its subsidiaries, the “Group”) will report its key financial highlights for the first four months of 2024 (“4M24”) at the Annual General Meeting of shareholders (“AGM”) being held today. During the first four months of 2024, the Group demonstrated accelerated growth....

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Dividend payment ex-date of AS Merko Ehitus is 7 June 2024

AS Merko Ehitus (trading code MRK1T, ISIN code EE3100098328) will fix the list of shareholders for dividend payment as of the close of the business of the settlement system on 10 June 2024. Proceeding from the above, the ex-date is 7 June 2024. From that date onwards, the person acquiring the shares is not entitled to receive dividends for the financial year 2023. AS Merko Ehitus will pay dividend 1.30 euro per share on 21 June 2024. Urmas SomelarHead of FinanceAS Merko Ehitus+372 650 1250urmas.somelar@merko.ee AS Merko Ehitus (group.merko.ee) group companies develop real estate and construct buildings and infrastructure. We create a better living environment and build the future. We operate in Estonia, Latvia, Lithuania and Norway. As at the end of 2023, the group employed 635 people, and the group’s revenue for 2023 was EUR 466 mill...

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Net asset value of the EfTEN United Property Fund as of 30.04.2024

The net asset value (NAV) of EfTEN United Property Fund unit was 10.70 euros at the end of April, increasing by 0.9% over the month. The jump in NAV was related to the investment of the listed fund EfTEN Real Estate Fund AS, whose shares closed on the Tallinn stock exchange at 4% higher than a month ago. The fund’s return on unlisted investments was on average 0,4% in April. In May, EfTEN United Property Fund invested 255 thousand euros in the EfTEN Residential Fund, which was used to complete the construction of a rental house with 145 apartments in Vilnius. This was the fund’s last investment in the rental apartments segment. The completion of the Vilnius rental house is planned for the coming summer, after which the building will start generating cash flow for the fund. In the Uus-Järveküla residential development May was...

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Dupixent® (dupilumab) Recommended for EU Approval by the CHMP to Treat Patients with COPD

Recommendation for adults with uncontrolled COPD with raised blood eosinophils based on data from two landmark Phase 3 trials demonstrating Dupixent significantly reduced exacerbations and improved lung function If approved, Dupixent would be the first-ever targeted therapy for COPD in the EU and the first new treatment approach for this disease in more than a decade TARRYTOWN, N.Y. and PARIS, May 31, 2024 (GLOBE NEWSWIRE) — Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the approval of Dupixent® (dupilumab) in the European Union (EU) as an add-on maintenance treatment in adults with uncontrolled chronic obstructive pulmonary disease (COPD) characterized by raised blood eosinophils....

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Press Release: Dupixent recommended for EU approval by the CHMP to treat patients with COPD

Dupixent recommended for EU approval by the CHMP to treat patients with COPDRecommendation for adults with uncontrolled COPD with raised blood eosinophils based on data from two landmark Phase 3 trials demonstrating Dupixent significantly reduced exacerbations and improved lung function If approved, Dupixent would be the first-ever targeted therapy for COPD in the EU and the first new treatment approach for this disease in more than a decadeParis and Tarrytown, N.Y. May 31, 2024. The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the approval of Dupixent (dupilumab) in the European Union (EU) as an add-on maintenance treatment in adults with uncontrolled chronic obstructive pulmonary disease (COPD) characterized by raised blood eosinophils. The European Commission...

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Renault Group: Renault Group and Geely announce the creation of leading Powertrain Technology Company, “HORSE Powertrain Limited”

Renault Group and Geely announce the creation of leading Powertrain Technology Company, “HORSE Powertrain Limited”Following the agreements signed on July 11, 2023 by Renault Group and Geely, and after having obtained the approval of the relevant authorities, HORSE Powertrain Limited has been officially created on May 31, 2024 with each group holding 50% stake in the new company. The new company will lead the market for hybrid and combustion powertrain components and systems. Matias Giannini is appointed CEO of HORSE Powertrain limited. The Board of directors of HORSE Powertrain Limited will be chaired by Daniel Li and will have 6 directors with equal representation from its shareholders. HORSE Powertrain Limited expects to reach c. €15 billion in annual revenues and a production of c. 5 million powertrain units per year and will have...

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Clip Money Inc. Reports First Quarter 2024 Results

TORONTO, May 30, 2024 (GLOBE NEWSWIRE) — Clip Money, Inc. (“Clip” or “Company”) (TSXV:CLIP) (OTCQB:CLPMF), a company that operates a multi-bank self-service deposit system for businesses, is pleased to announce its financial results for the three months ended March 31, 2024. First Quarter 2024 HighlightsRevenue for Q1 2024 was $299,176, compared to $31,465 in Q1 2023, representing a more than 850% year-over-year (“YoY”) growth. This growth was fueled by a more than 821% increase in new users making deposits, combined with revenue from new products. Conversely, Cost of Goods Sold (“COGS”) increased by 32% YoY, demonstrating the ability for the solution to scale with customer and revenue growth. Customer retention and expansion of new stores from existing customers has been a consistent theme for the Company following a record-breaking...

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CloudMD Reports First Quarter 2024 Results

First Quarter HighlightsQ1 Revenue of $22.8 million compared to $22.6 million in Q4 2023 and $22.9 million in the prior year. Q1 2024 gross profit margin of 37.0% increased from 36.9% in the prior year. Q1 Adjusted EBITDA gain of $0.1 million compared to a loss of $0.4 million in the previous quarter, annual improvement of $1.5 million compared to prior year. Net loss from continuing operations of $4.2 million in Q1 2024. Cash and cash equivalents, including restricted cash of $7.7 million at the end of Q1 2024. Multi-year contract signings of $1.8 million in annual recurring revenue in the quarter. Additional cost reductions of $1.6 million annualized actioned in Q1 2024.TORONTO, May 30, 2024 (GLOBE NEWSWIRE) — CloudMD Software & Services Inc. (TSXV: DOC, Frankfurt: 6PH) (the “Company” or “CloudMD”), an innovative health...

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