-- イムリコー・メディカル・システムズ（ASX:IMR）は、米国食品医薬品局（FDA）の承認を取得したことを受け、同社の3Dマッピング・ガイダンスシステム「NorthStar」の米国における初販売が第2四半期に開始される見込みであると、火曜日にオーストラリア証券取引所に提出した書類で明らかにした。 同社は、成人電気生理学分野および小児分野において、米国市場に大きな可能性を見出している。 また、中東地域における将来の販売拠点の開拓と地域拡大の機会についても検討している。
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Syntara Receives Positive US FDA Feedback for Clinical Trial of Bone Marrow Cancer Treatment
Syntara (ASX:SNT) received positive feedback from the US Food and Drug Administration following a type C meeting, supporting the design of its planned phase 2b clinical trial of amsulostat for the treatment of myelofibrosis, according to a Tuesday filing with the Australian bourse.The primary endpoint of the phase 2b study will be the achievement of a 50% reduction in the total symptom score following nine months of treatment, with about 100 patients expected to be enrolled, per the filing.The positive feedback from the US FDA allows for amsulostat's progression into late-stage clinical development and paves the way for further engagement with prospective commercial partners, the company said.Myelofibrosis is a type of bone marrow cancer where the accumulation of scar tissue leads to a loss of red and white blood cells and platelets.
$ASX:SNT
Asia
Market Chatter: Japan IPO Market Will Stay Subdued as AI Stocks Draw Investors
Japan's IPO market will remain under pressure despite strong debuts from a sake brewer and a pet food maker, as investors continue to favor AI-related stocks, Reuters reported Tuesday.Shares of Umenoyado Brewery (TYO:559A) rose about 75% on their first trading day, while Inuneko-Seikatsu (TYO:556A) gained more than 30% after listing. The gains contrast with broader weakness, with many new listings trading below their offer prices this year, the report said.Investor focus on AI leaders such as SoftBank Group (TYO:9984) and Advantest (TYO:6857) has diverted flows away from smaller, domestically focused IPO candidates. Stricter listing standards from the Tokyo Stock Exchange are also weighing on activity, with companies facing tougher valuation thresholds in coming years, according to the report.The number of IPOs in Tokyo will likely fall about 20% this year from 2025 levels, as retail investors prioritize short-term gains in large-cap technology stocks over new listings, the report said.(Market Chatter news is derived from conversations with market professionals globally. This information is believed to be from reliable sources but may include rumor and speculation. Accuracy is not guaranteed.)
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Asia
Magma Group Completes Private Placement of Shares
Magma Group (KLSE:MAGMA) completed the listing and quotation of 18.9 million shares on the Main Market of Bursa Securities, according to a Monday Malaysian bourse filing.Shares dropped about 2% in Tuesday's recent trade.The company had proposed a private placement of up to 10% of its total shares to third-party investors.
$KLSE:MAGMA