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Month: December 2022

MediWound Announces FDA Approval of NexoBrid® for the Treatment of Severe Thermal Burns in Adults

Potential to become the new standard of care for eschar removal in patients with deep partial- and/or full- thickness thermal burns Triggers $7.5 million milestone payment from Vericel Corporation; NexoBrid is anticipated to be commercially available in the U.S. in the second quarter of 2023 YAVNE, Israel, Dec. 29, 2022 (GLOBE NEWSWIRE) — MediWound Ltd. (Nasdaq: MDWD) (the “Company”), a fully-integrated biopharmaceutical company focused on next-generation biotherapeutic solutions for tissue repair and regeneration, today announced that the U.S. Food and Drug Administration (FDA) has approved NexoBrid® (anacaulase-bcdb) for the removal of eschar in adults with deep partial-thickness and/or full-thickness thermal burns. “We are pleased and excited that the FDA has approved NexoBrid, an innovative, non-surgical alternative for the...

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Vericel Announces FDA Approval of NexoBrid for the Treatment of Severe Thermal Burns in Adults

Potential to become the new standard of care for eschar removal in patients with deep partial- and/or full- thickness thermal burns Label supported by robust clinical data demonstrating significantly higher incidence of complete eschar removal in patients treated with NexoBrid compared to placebo  CAMBRIDGE, Mass., Dec. 29, 2022 (GLOBE NEWSWIRE) — Vericel Corporation (NASDAQ:VCEL), a leader in advanced therapies for the sports medicine and severe burn care markets, today announced that the U.S. Food and Drug Administration (FDA) has approved NexoBrid® (anacaulase-bcdb) for the removal of eschar in adults with deep partial-thickness and/or full-thickness thermal burns. “There is a considerable unmet need for non-surgical eschar removal for patients with severe thermal burns, and the FDA’s approval of NexoBrid marks an important...

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SeaStar Medical and Nuwellis Enter into a U.S. License and Distribution Agreement for SeaStar Medical’s Selective Cytopheretic Device (SCD) for Pediatric Acute Kidney Injury (AKI)

Approximately 4,000 children in the U.S. with AKI require Continuous Kidney Replacement Therapy (CKRT) DENVER and MINNEAPOLIS, Dec. 29, 2022 (GLOBE NEWSWIRE) — SeaStar Medical Holding Corporation (Nasdaq: ICU) (SeaStar Medical) and Nuwellis, Inc. (Nasdaq: NUWE) (Nuwellis) announce an exclusive U.S. license and distribution agreement by Nuwellis of SeaStar Medical’s Selective Cytopheretic Device (SCD) for the treatment of acute kidney injury (AKI) in children. Nuwellis will market and distribute the SCD through its direct salesforce to nephrologists and intensive care physicians who are trained in pediatric extracorporeal therapy. SeaStar Medical expects the U.S. Food and Drug Administration (FDA) to complete a substantive review of a Humanitarian Device Exemption (HDE) for the use of SCD in children (>20 kg.) with AKI during the...

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Admirals Expands Licenses in Africa

The Capital Markets Authority (CMA) has licenced Admirals Kenya Limited as a non-dealing online forex trading broker under the Capital Markets Regulations. Admirals hopes the achieving of this license shall assist further growth in Africa and grant access to a stringently regulated market. Also, Admiral Markets Cyprus and Admirals South Africa jointly entered into a takeover agreement of Aglobe Investments Ltd, incorporated in the Republic of Seychelles and licensed as a securities dealer by the Seychelles Financial Services Authority.  Further information:  Kaia Gil Communication Manager of Admirals Group AS kaia.gil@admiralmarkets.com +372 53 413 764  

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Delta Drone SA confirms partial sale of DLT Shares

Delta Drone SA confirms partial sale of DLT Shares Dardilly, 29 December 2022 – 6.30 pm Delta Drone International Limited (“Company” or “DLT”) (ASX: DLT), a Global drones-as-a-service provider, has confirmed that its major shareholder Delta Drone Société Anonyme (Delta Drone SA), has disposed of part of its shareholding in DLT. Delta Drone SA engaged the services of Baker Young Advisory to sell 85,812,067 fully paid ordinary shares it held in DLT, which was executed as a special crossing/block trade, equating to 16.77% of ordinary issued shares in DLT. Baker Young Advisory has confirmed that the trade was placed with several independent institutional and professional investors at a price of $0.005 per share. About Delta Drone: Delta Drone Group is a recognized international player in the field of civilian drones for professional use....

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Ilkka Oyj – Acquisition of own shares on 29 December 2022

ILKKA OYJ, STOCK EXCHANGE RELEASE, 29 December 2022 at 19:00 EET Ilkka Oyj – Acquisition of own shares on 29 December 2022 At Nasdaq Helsinki Ltd:Date 29 December 2022Exchange transaction BuyShare trading code ILKKA2Amount, shares  1,400Average price/share, EUR 3.6089Total cost, EUR 5,052.46The company holds a total of 21,635 of its own shares (ILKKA2) including the shares acquired on 29 December 2022. Detailed information concerning the acquisition is attached to this stock exchange release. On behalf of Ilkka Oyj DANSKE BANK A/S, FINLAND BRANCH Jonathan Nyberg        Antti Väliaho Additional information Olli Pirhonen, CEO, Ilkka Oyj, tel. +358 40 766 5418 www.ilkka.comAttachmentIlkka buyback 29.12.2022

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The 30-Year Fixed-Rate Moves Higher

Primary Mortgage Market Survey® U.S. weekly average mortgage rates as of 12 29 2022MCLEAN, Va., Dec. 29, 2022 (GLOBE NEWSWIRE) — Freddie Mac (OTCQB: FMCC) today released the results of its Primary Mortgage Market Survey® (PMMS®), showing the 30-year fixed-rate mortgage (FRM) averaged 6.42 percent. “The housing market remains in the doldrums with declining sales, inventory and prices,” said Sam Khater, Freddie Mac’s Chief Economist. “The declines in sales and deceleration in home prices began swiftly earlier in 2022 but have moderated more recently. While the intensity of weakness is moderating, the market continues to decline and forward leading indicators suggest housing will remain weak throughout the winter.” News Facts30-year fixed-rate mortgage averaged 6.42 percent as of December 29, 2022, up from last week when it averaged...

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AB Science has received approval from the U.S. Food and Drug Administration (FDA) to initiate the confirmatory Phase 3 study with masitinib in the treatment of progressive multiple sclerosis

PRESS RELEASE AB SCIENCE HAS RECEIVED APPROVAL FROM THE U.S. FOOD AND DRUG ADMINISTRATION (FDA) TO INITIATE THE CONFIRMATORY PHASE 3 STUDY WITH MASITINIB IN THE TREATMENT OF PROGRESSIVE MULTIPLE SCLEROSIS Paris, December 29 2022, 6pm CET AB Science SA (Euronext – FR0010557264 – AB) announced today that its Phase III clinical trial (AB20009) in progressive forms of multiple sclerosis has been approved by the US Food and Drug Administration (FDA). This decision follows authorizations received from several European countries, including the French Agency (ANSM). This approval to initiate a confirmatory study in neurology is the third obtained from the FDA after studies in Amyotrophic Lateral Sclerosis (AB19001) and Alzheimer’s disease (AB21004). Study AB20009 is actively recruiting patients. This is a randomized, double-blind,...

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Nextensa sells the Titanium site in the Grand Duchy of Luxembourg to Codic, for 110 million euros

PRESS RELEASE Brussels, 29 December 2022, 5.40 PMNextensa sells the Titanium site in the Grand Duchy of Luxembourg to Codic, for 110 million eurosCodic is a Belgian real estate player operating in Belgium, Luxembourg, France, Spain and Hungary. In November 2021, Nextensa signed an agreement with Codic to sell 100% of the shares of the Luxembourg company GK5 Sàrl, owner of the Titanium site in the Cloche d’Or district, under conditions precedent. The effective transfer of the shares took place today. The total investment reaches 110 million euros. With this sale, the real estate investor and developer Nextensa realises a significant capital gain in the last quarter of 2022. Furthermore, the rental income from the Titanium building on the site – representing approximately 2.6 million euros in 2022 – is still contributing...

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