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Aldeyra Therapeutics Achieves Goals In Crossover Clinical Trial Of 0.25% Reproxalap Solution
(RTTNews) - Aldeyra Therapeutics, Inc. (ALDX) announced Tuesday the achievement of the primary endpoints in a sequence-randomized, double-masked, vehicle-controlled crossover clinical trial of 0.25% reproxalap ophthalmic solution, an investigational new drug candidate, for the treatment of dry eye disease.
Reproxalap was statistically superior to vehicle for each of the two prespecified primary endpoints, ocular redness in a dry eye chamber and Schirmer test, a measure of tear production, after a single day of dosing.
The secondary endpoint of Schirmer test =10 mm responder analysis, which was multiplicity-controlled, was also achieved.
A pre-NDA meeting with the FDA has been scheduled for the third quarter of 2022.
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Aldeyra Therapeutics Gets CRL From FDA For NDA Of ADX-2191 To Treat Primary Vitreoretinal Lymphoma
Biotechnology company Aldeyra Therapeutics, Inc. (ALDX) announced Wednesday the receipt of a Complete Response Letter from the U.S. Food and Drug Administration (FDA) for the 505(b)(2) New Drug Application (NDA) of ADX-2191 (methotrexate for injection, USP), an investigational drug candidate, for the treatment of primary vitreoretinal lymphoma (PVRL).
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800 วันที่ผ่านมา
U.S. Consumer Sentiment Deteriorates Slightly More Than Initially Estimated In August
The University of Michigan released a report on Friday showing consumer sentiment in the U.S. deteriorated by slightly more than previously estimated in the month of August. The report said the consumer sentiment index for August was downwardly revised to 58.2 from the preliminary reading of 58.6.
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2 ชม. 5 นาทีที่ผ่านมา
Chicago Business Barometer Slumps Much More Than Expected In August
MNI Indicators released a report on Friday showing a sharp pullback by its reading on Chicago-area business activity in the month of August. The report said the Chicago business barometer tumbled to 41.5 in August after jumping to 47.1 in July, with a reading below 50 indicating contraction. Economists had expected the business barometer to edge down to 46.0.
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2 ชม. 23 นาทีที่ผ่านมา
U.S. Consumer Prices Increase In Line With Estimates In July
Consumer prices in the U.S. increased in line with economist estimates in the month of July, according to closely watched data released by the Commerce Department on Friday. The Commerce Department said its personal consumption expenditures (PCE) price index rose by 0.2 percent in July after climbing 0.3 percent in June. The uptick matched expectations.
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3 ชม. 7 นาทีที่ผ่านมา
German Unemployment Exceeds 3 Mln
Germany's unemployment exceeded the three million-mark for the first time in a decade in August as the prolonged period of subdued economic activity weighed on the labor market. The number of unemployed persons increased by 46,000 from the previous year to 3.025 million in August. However, unemployment fell by adjusted 9,000 compared to the previous month, while it was forecast to increase by 1
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3 ชม. 36 นาทีที่ผ่านมา
U.S. PCE Price Index Increased In Line With Estimates In July
Consumer prices in the U.S. increased in line with economist estimates in the month of July, according to closely watched data released by the Commerce Department on Friday.
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3 ชม. 49 นาทีที่ผ่านมา
Slightly Weak Start Seen For U.S. Stocks; PCE Data In Focus
Lower U.S. futures point to a slightly negative start on Wall Street Friday morning.
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4 ชม. 5 นาทีที่ผ่านมา
Lower Futures Pointing To Weak Start On Bay Street; Canadian GDP, US PCE Data In Focus
Lower Canadian and U.S. futures ahead of Canadian GDP data and U.S. personal consumption expenditure report, point to a weak start on Bay Street Friday morning.
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4 ชม. 43 นาทีที่ผ่านมา
