Catalyst Pharma Says FIRDAPSE NDA Submitted In Japan By Partner DyDo Pharma

RTTNews | 615 dias atrás
Catalyst Pharma Says FIRDAPSE NDA Submitted In Japan By Partner DyDo Pharma

(RTTNews) - Biopharmaceutical company Catalyst Pharmaceuticals, Inc. (CPRX) announced Monday that its collaboration partner, Japan's DyDo Pharma, Inc., reported that it has submitted a New Drug Application (NDA) to the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan, seeking marketing approval for FIRDAPSE (amifampridine) Tablets 10 mg for the treatment of Lambert Eaton myasthenic syndrome (LEMS) in Japan.

The submission is based on preliminary favorable analysis results of interim data after six months into the safety phase of the registration study to evaluate the efficacy and safety of FIRDAPSE for the treatment of LEMS.

The review period is expected to be approximately a minimum of nine months from the submission date.

In June 2021, Catalyst entered into a license agreement with DyDo for the development and commercialization of FIRDAPSE in Japan.

Marcadores : CPRX
read more
Catalyst Pharma Appoints Richard Daly To Succeed Patrick McEnany As CEO

Catalyst Pharma Appoints Richard Daly To Succeed Patrick McEnany As CEO

Biopharmaceutical company Catalyst Pharmaceuticals, Inc. (CPRX) announced Thursday the appointment of Richard Daly as its new Chief Executive Officer, effective January 1, 2024. Daly is a seasoned pharmaceutical executive bringing more than three decades of experience to Catalyst.
RTTNews | 675 dias atrás
Thai Shares Tipped To Open To The Upside On Monday

Thai Shares Tipped To Open To The Upside On Monday

The Thai stock market has finished higher in two of three trading days since the end of the four-day losing streak in which it had slumped more than 40 points or 3.5 percent. The Stock Exchange of Thailand now sits just above the 1,250-point plateau and it's poised to extend its gains on Monday.
RTTNews | 24 minutos atrás
Japanese Market Notably Higher

Japanese Market Notably Higher

The Japanese stock market is trading notably higher on Monday, extending the gains in the previous session, following the broadly positive cues from Wall Street on Friday, with the Nikkei 225 moving well above the 42,850 level, with gains across most sectors led by index heavyweights and technology stocks.
RTTNews | 36 minutos atrás
Indonesia Stock Market May End Losing Streak On Monday

Indonesia Stock Market May End Losing Streak On Monday

The Indonesia stock market has moved lower in two straight sessions, slipping almost 85 points or 1.1 percent along the way. The Jakarta Composite Index now sits just shy of the 7,860-point plateau although it's likely to stop the bleeding on Monday.
RTTNews | 54 minutos atrás
Australian Market Notably Higher

Australian Market Notably Higher

The Australian stock market is notably higher on Monday, recouping the losses in the previous session, following the broadly positive cues from Wall Street on Friday. The benchmark S&P/ASX 200 index is moving well above the 9,000.00 mark, with gains across most sectors led by mining and technology stocks. Financial stocks were the only weal spot.
RTTNews | 55 minutos atrás
Hong Kong Shares Tipped To Open In The Green

Hong Kong Shares Tipped To Open In The Green

The Hong Kong stock market has moved higher in two of three trading days since the end of the four-day losing streak in which it had fallen more than 480 points or 1.7 percent. The Hang Seng Index now rests just beneath the 25,340-point plateau and it's expected to open higher again on Monday.
RTTNews | 1h 9min atrás
China Stock Market May Extend Winning Streak

China Stock Market May Extend Winning Streak

The China stock market has moved higher in three straight sessions, advancing almost 100 points or 2.9 percent along the way. The Shanghai Composite Index now sits just above the 3,825-point plateau and it's expected to add to its winnings again on Monday.
RTTNews | 1h 24min atrás
Rebound Anticipated For Taiwan Stock Market

Rebound Anticipated For Taiwan Stock Market

The Taiwan stock market on Friday snapped the two-day winning streak in which it had gained more than 600 points or 2.6 percent. The Taiwan Stock Exchange now rests just above the 23,760-point plateau, although it's likely to bounce higher again on Monday.
RTTNews | 1h 54min atrás