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Soligenix Says FDA Grants Type A Meeting Regarding New Drug Application For HyBryte
(RTTNews) - Biopharmaceutical company Soligenix, Inc. (SNGX) announced Monday that the U.S. Food and Drug Administration (FDA) has granted a Type A meeting to discuss the contents of a refusal to file (RTF) letter previously issued regarding the Company's new drug application (NDA) for HyBryte (synthetic hypericin) in the treatment of early stage cutaneous T-cell lymphoma (CTCL), a rare cancer.
The company has successfully demonstrated statistically significant results in a Phase 3 clinical trial.
The company said it intends to provide a further update once it receives the minutes from the meeting or when it has more clarity on next steps, which is anticipated by or before the end of April.
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Indian Market Likely To Open On Cautious Note
Subdued GIFT Nifty, weak Asian stocks and the overnight mixed close on Wall Street point to a slightly negative start for Indian shares Thursday morning.
Investors are likely to react to a slew of quarterly earnings announcements.
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2分前
Asian Markets Mixed Amid Cautious Trades
Asian stock markets are trading mixed on Thursday, following the mixed cues from Wall Street overnight, as traders remain cautious amid continued uncertainty surrounding US President Donald Trump's trade policies, despite reaching trade deals between the U.S. and China as well as the U.S. and the U.K. Asian Markets closed mostly higher on Wednesday.
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1時20分前
Japanese Market Significantly Lower
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Oversold Hang Seng Nonetheless Called Higher Again
The Hong Kong stock market bounced higher again on Wednesday, one day after snapping the eight-day winning streak in which it had surged almost 1,600 points or 7.1 percent. The Hang Seng Index now sits just above the 23,640-point plateau although it may tick higher again on Thursday.
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2時5分前
Australian Market Slightly Lower
The Australian market is trading slightly lower on Thursday, snapping a six-session winning streak, following the mixed cues from Wall Street overnight. The benchmark S&P/ASX 200 is staying well below the 8,300 level, with weakness across most sectors led by gold miners and energy stocks.
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2時6分前
China Bourse May Add To Its Winnings On Thursday
The China stock market has moved higher in three straight sessions, improving almost 65 points or 1.9 percent along the way. The Shanghai Composite Index now rests just above the 3,400-point plateau and it's looking at a higher open again on Thursday.
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