Evaxion Biotech Gets FDA Approval To Proceed With Clinical Phase 2b Study For EVX-01

RTTNews | 1042 days ago
Evaxion Biotech Gets FDA Approval To Proceed With Clinical Phase 2b Study For EVX-01

(RTTNews) - Biotech company Evaxion Biotech A/S (EVAX) announced Tuesday that the U.S. Food and Drug Administration or FDA, determined that the Company may proceed with its Phase 2b clinical trial of EVX-01.

In November 2022, the Company submitted an Investigational New Drug Application along with a Fast Track designation application to the FDA for a Phase 2b clinical trial of EVX-01 in combination with KEYTRUDA for the treatment of patients with metastatic melanoma.

On December 22, 2022, the FDA issued approval for the Company to proceed with its Phase 2b trial. The Company anticipates a response to the Fast Track designation submission in the first quarter of 2023.

EVX-01 is already actively enrolling patients in Australia, and the FDA approval expands our ability to move forward quickly with our lead program in malignant melanoma.

The Phase 2b study will be conducted at clinical sites across the United States, Europe, and Australia. It is carried out in collaboration with Merck, supplying its PD-1 inhibitor KEYTRUDA. The trial was first initiated in Australia with the enrollment of the first patient in September 2022.

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Additional Support Likely For China Stock Market

Additional Support Likely For China Stock Market

The China stock market bounced higher again on Monday, one session after halting the two-day winning streak in which it had advanced more than 45 points or 1.1 percent. The Shanghai Composite Index now sits just beneath the 4,020-point plateau The global forecast for the Asian markets is broadly positive on optimism that the end of the U.S. government shutdown in near. The European and U.S. markets were sharply higher and the Asian bourses are expected to follow that lead. The SCI finished modestly higher on Monday following gains from the financial shares, property stocks and resource companies. For the day, the index gained 21.04 points or 0.53 percent to finish at 4,018.60 after trading between 3,990.84 and 4,018.70. The Shenzhen Composite Index added 10.15 points or 0.40 percent to end at 2,529.44. Among the actives, Industrial and Commercial Bank of China advanced 0.87 percent, while Bank of China rose 0.35 percent, Agricultural Bank of China rallied 2.12 percent, China Merchants Bank added 0.49 percent, Bank of Communications collected 0.82 percent, China Life Insurance jumped 1.95 percent, Jiangxi Copper improved 0.95 percent, Aluminum Corp of China (Chalco) soared 3.26 percent, Yankuang Energy vaulted 1.88 percent, PetroChina strengthened 1.65 percent, China Petroleum and Chemical (Sinopec) fell 0.27 percent, Huaneng Power perked 0.24 percent, China Shenhua Energy gained 0.94 percent, Gemdale spiked 2.33 percent, Poly Developments increased 1.25 percent and China Vanke climbed 1.29 percent.
RTTNews | 1h 12min ago
Taiwan Bourse Expected To Open In The Green On Tuesday

Taiwan Bourse Expected To Open In The Green On Tuesday

The Taiwan stock market has moved higher in two of three trading days since the end of the two-day losing streak in which it had given up more than 640 points or 2.3 percent. The Taiwan Stock Exchange now sits just beneath the 27,870-point plateau and it's likely to extend its gains on Tuesday. The global forecast for the Asian markets is broadly positive on optimism that the end of the U.S. government shutdown in near. The European and U.S. markets were sharply higher and the Asian bourses are expected to follow that lead.
RTTNews | 1h 42min ago
Renewed Support Anticipated For Singapore Stock Market

Renewed Support Anticipated For Singapore Stock Market

The Singapore stock market on Monday snapped the two-day winning streak in which it had climbed more than 75 points or 1.7 percent. The Straits Times Index now sits just beneath the 4,490-point plateau although it's expected to bounce higher again on Tuesday. The global forecast for the Asian markets is broadly positive on optimism that the end of the U.S. government shutdown in near. The European and U.S. markets were sharply higher and the Asian bourses are expected to follow that lead. The STI finished slightly lower following mixed performances from the financial shares, property stocks and industrial issues. For the day, the index slipped 4.11 points or 0.09 percent to finish at 4,488.13 after trading between 4,457.14 and 4,490.55. Among the actives, CapitaLand Ascendas REIT slipped 0.35 percent, while CapitaLand Integrated Commercial Trust added 0.43 percent, DBS Group stumbled 1.29 percent, DFI Retail Group and Yangzijiang Shipbuilding both gained 0.30 percent, Genting Singapore surged 3.36 percent, Hongkong Land shed 0.50 percent, Keppel DC REIT fell 0.42 percent, Keppel Ltd lost 0.49 percent, Mapletree Industrial Trust spiked 0.99 percent, Oversea-Chinese Banking Corporation soared 2.31 percent, SATS rallied 0.86 percent, Seatrium Limited jumped 0.93 percent, SembCorp Industries rose 0.16 percent, Singapore Technologies Engineering plunged 1.33 percent, SingTel slumped 0.65 percent, United Overseas Bank skidded 0.53 percent, Wilmar International advanced 0.61 percent, Yangzijiang Financial plummeted 51.42 percent and CapitaLand Investment, City Developments, Comfort DelGro, Thai Beverage, Mapletree Pan Asia Commercial Trust, Mapletree Logistics Trust, UOL Group and Frasers Centrepoint Trust were unchanged.
RTTNews | 2h 12min ago
Win Streak May Continue For Malaysia Stock Market

Win Streak May Continue For Malaysia Stock Market

The Malaysia stock market has moved higher in back-to-back sessions, collecting almost 10 points or 0.7 percent in that span. The Kuala Lumpur Composite Index now sits just beneath the 1,630-point plateau and it's expected to see additional support on Tuesday. The global forecast for the Asian markets is broadly positive on optimism that the end of the U.S. government shutdown in near. The European and U.S. markets were sharply higher and the Asian bourses are expected to follow that lead. The KLCI finished modestly higher on Monday following gains from the financial shares and telecoms and mixed performances from the plantations and industrials. For the day, the index added 8.25 points or 0.51 percent to finish at 1,627.38 after trading between 1,620.49 and 1,633.52. Among the actives, 99 Speed Mart Retail and CIMB Group both gained 0.66 percent, while AMMB Holdings increased 0.70 percent, Axiata surged 3.85 percent, Celcomdigi shed 0.27 percent, Gamuda advanced 0.79 percent, IHH Healthcare slumped 0.72 percent, IOI Corporation lost 0.25 percent, Kuala Lumpur Kepong perked 0.19 percent, Maxis soared 3.04 percent, Maybank collected 0.30 percent, MISC spiked 2.88 percent, MRDIY declined 1.23 percent, Nestle Malaysia sank 0.36 percent, Petronas Chemicals accelerated 2.82 percent, Petronas Dagangan rallied 1.69 percent, PPB Group added 0.69 percent, Press Metal strengthened 1.11 percent, QL Resources fell 0.24 percent, RHB Bank jumped 1.48 percent, SD Guthrie improved 0.74 percent, Sunway stumbled 1.65 percent, Telekom Malaysia rose 0.55 percent, Tenaga Nasional climbed 0.91 percent, YTL Corporation plunged 2.73 percent, YTL Power retreated 1.28 percent and Petronas Gas, Public Bank and Sime Darby were unchanged.
RTTNews | 2h 42min ago
Japan Shares May Extend Monday's Gains

Japan Shares May Extend Monday's Gains

The Japan stock market has moved higher in two of three trading days since the end of the two-day slide in which it had plunged nearly 2,200 points or 4.2 percent. The Nikkei 225 now rests just above the 50,900-point plateau and it may add to its winnings on Tuesday. The global forecast for the Asian markets is broadly positive on optimism that the end of the U.S. government shutdown in near. The European and U.S. markets were sharply higher and the Asian bourses are expected to follow that lead. The Nikkei finished sharply higher on Monday following gains from the financial shares and technology stocks, while the automobile producers were mixed. For the day, the index jumped 635.39 points or 1.26 percent to finish at 50,911.76 after trading between 50,392.44 and 50,969.50. Among the actives, Nissan Motor accelerated 2.11 percent, while Mazda Motor stumbled 2.06 percent, Toyota Motor rose 0.42 percent, Honda Motor plunged 4.67 percent, Softbank Group spiked 2.56 percent, Mitsubishi UFJ Financial and Mizuho Financial both collected 0.67 percent, Sumitomo Mitsui Financial added 0.65 percent, Mitsubishi Electric gathered 0.33 percent, Sony Group improved 0.59 percent, Panasonic Holdings perked 0.15 percent and Hitachi rallied 2.15 percent. The lead from Wall Street is solid as the major averages opened higher on Monday and largely spent most of the sessions firmly in positive territory.
RTTNews | 2h 57min ago
KOSPI May Break Through 4,100-Point Barrier

KOSPI May Break Through 4,100-Point Barrier

The South Korea stock market has tracked higher in two of three trading days since the end of the two-day slide in which it had plummeted almost 220 points or 5 percent. The KOSPI sits just beneath the 4,075-point plateau and it's tipped to open in the green again on Tuesday. The global forecast for the Asian markets is broadly positive on optimism that the end of the U.S. government shutdown in near. The European and U.S. markets were sharply higher and the Asian bourses are expected to follow that lead. The KOSPI finished sharply higher on Monday with gains across the board, especially among the financial shares, technology stocks and industrials. For the day, the index surged 119.48 points or 3.02 percent to finish at 4,073.24 after trading between 3,984.24 and 4,092.91. Volume was 334 million shares worth 16.5 trillion won. There were 804 gainers and 98 decliners. Among the actives, Shinhan Financial collected 1.81 percent, while KB Financial spiked 4.28 percent, Hana Financial vaulted 4.57 percent, Samsung Electronics jumped 2.76 percent, Samsung SDI strengthened 2.94 percent, LG Electronics climbed 1.47 percent, SK Hynix rallied 4.48 percent, LG Chem expanded 3.93 percent, Lotte Chemical skyrocketed 7.12 percent, SK Innovation accelerated 3.97 percent, POSCO Holdings improved 1.51 percent, SK Telecom added 0.94 percent, KEPCO soared 4.88 percent, Hyundai Mobis gained 3.62 percent, Hyundai Motor increased 2.46 percent, Kia Motors surged 3.27 percent and Naver was unchanged.
RTTNews | 3h 12min ago