-- アーカス・バイオサイエンス（RCUS）は月曜日、転移性非小細胞肺がんを対象とした第3相臨床試験STAR-121を中止したと発表した。独立データモニタリング委員会が、有効性が見込めないとして試験中止を勧告したためだ。 同社によると、ギリアド・サイエンシズ（GILD）との共同研究で実施されたこの試験は、ドムバナリマブ＋ジンベレリマブ＋化学療法とペムブロリズマブ＋化学療法を一次治療として比較評価するものだった。 今回の決定は、事前に計画された有効性分析の結果、この治療法が主要評価項目を達成する可能性が低いと判断されたことを受けてのものだ。 アーカス・バイオサイエンスの株価は月曜日の取引で5%下落した。
Price: $23.05, Change: $-1.20, Percent Change: -4.95%
Clinuvel Pharmaceuticals (ASX:CUV) is unlikely to seek regulatory approval for Scenesse in vitiligo until the Phase 3 CUV105 and CUV107 clinical trials are completed, according to a Friday Jefferies note.The company said on Friday that the European Medicines Agency (EMA) has proposed evaluating the company's Scenesse drug for the treatment of systemic vitiligo based on a "totality of evidence" regulatory approach.Jefferies said that the EMA's decision is a positive for the company because of the high unmet medical need for Vitiligo treatment.The investment firm has pushed back its revenue expectations from Scenesse in vitiligo, which is now expected to begin in the second half of fiscal 2029 rather than fiscal 2028.Jefferies kept a buy rating on Clinuvel and cut its price target to AU$39.20 from AU$40.50.
Australian shares are set to open flat on Monday, as oil prices climbed almost 2% following stalled US-Iran peace negotiations and restricted flows through the Strait of Hormuz, tightening global supply and pushing Brent crude above $107 a barrel.On April 25, the S&P 500 and the Nasdaq Composite rose 0.8% and 1.6%, respectively, while the Dow Jones Industrial Average fell 0.2%.In the macroeconomy, investors are eyeing the release of Australia's consumer price index report on Wednesday.In corporate news, Origin Energy (ASX:ORG) reported March quarter production of 164.5 petajoules, down from 167.1 petajoules a year earlier, according to a Monday filing with the Australian bourse.IperionX's (ASX:IPX) titanium powder production operations in Virginia, US, transitioned to an around-the-clock production schedule during the March quarter, advancing from commissioning to continuous operations, according to a Monday filing with the Australian bourse.Australia's benchmark index fell 0.1% or 6.9 points to close at 8,786.50 on April 24.
Cobre (ASX:CBE) has appointed Kaveen Bachoo as chief financial officer, effective April 28, according to a Monday filing with the Australian bourse.Bachoo has over 20 years of finance leadership experience in the mining sector, including executive positions at Glencore.