ARS Pharmaceuticals Says FDA Schedules Type A Meeting For Neffy By The End Of October

RTTNews | 675日前
ARS Pharmaceuticals Says FDA Schedules Type A Meeting For Neffy By The End Of October

(RTTNews) - Biopharmaceutical company ARS Pharmaceuticals, Inc. (SPRY) announced Friday that the U.S. Food and Drug Administration (FDA) has scheduled a Type A meeting to discuss the contents of a Complete Response Letter (CRL) previously issued regarding its new drug application (NDA) for neffy (epinephrine nasal spray) for the treatment of allergic reactions (Type I), including anaphylaxis.

The Type A meeting with FDA will be held by the end of October. The company said it intends to work with FDA to meet the critical need for a needle-free epinephrine treatment as quickly as possible.

In May 2023, an FDA Advisory Committee (the Pulmonary-Allergy Drugs Advisory Committee (PADAC) concluded a favorable benefit-risk profile and recommended approval of neffy.

Clinical data from a rigorous registration program of more than 600 subjects demonstrated that neffy achieved both a pharmacokinetic (PK) and pharmacodynamic (PD) profile that is comparable to approved injection products as well as a safety profile that is well-tolerated, but without needle-related risks.

The company plans to complete a repeat dose study with neffy in allergen-induced allergic rhinitis and file its NDA resubmission to the FDA in the first half of 2024, with an anticipated launch of neffy, if approved, in the second half of 2024.

read more
Singapore Q2 GDP Climbs 4.4% On Year

Singapore Q2 GDP Climbs 4.4% On Year

Singapore's gross domestic product expanded 4.4 percent on year in the second quarter of 2025, the Ministry of Trade and Industry said on Tuesday - beating forecasts for 4.3 percent, which would have been unchanged.
RTTNews | 2分前
Singapore Bourse May Give Up Support At 4,200 Points

Singapore Bourse May Give Up Support At 4,200 Points

The Singapore stock market has finished lower in two straight sessions, slipping more than 25 points or 0.6 percent along the way. The Straits Times Index now sits just above the 4,230-point plateau and it may extend its losses on Tuesday. The global forecast for the Asian markets is soft ahead of key U.S. inflation data. The European markets were mixed and the U.S. bourses were down and the Asian markets also figure to track into the red.
RTTNews | 25分前
Rally May Stall For Malaysia Stock Market

Rally May Stall For Malaysia Stock Market

The Malaysia stock market has moved higher in five straight sessions, collecting more than 35 points or 2.4 percent along the way. The Kuala Lumpur Composite Index now sits just above the 1,560-point plateau although it's due for consolidation on Tuesday. The global forecast for the Asian markets is soft ahead of key U.S. inflation data. The European markets were mixed and the U.S. bourses were down and the Asian markets also figure to track into the red.
RTTNews | 55分前
Win Streak May End For Japan Stock Market

Win Streak May End For Japan Stock Market

Ahead of Monday's holiday for Mountain Day, the Japan stock market had moved higher in four consecutive sessions, advancing more than 1,580 points or 3.8 percent along the way. The Nikkei 225 now sits just above the 41,820-point plateau although investors are likely to lock in gains on Tuesday. The global forecast for the Asian markets is soft ahead of key U.S. inflation data. The European markets were mixed and the U.S. bourses were down and the Asian markets also figure to track into the red. The Nikkei finished sharply higher on Friday with gains cross the board, especially among the finance, automobile and technology sectors. For the day, the index surged 761.38 points or 1.85 percent to finish at 41,820.48 after trading between 41,248.05 and 42,033.92. Among the actives, Nissan Motor accelerated 2.75 percent, while Mazda Motor spiked 4.91 percent, Toyota Motor jumped 3.47 percent, Honda Motor rallied 3.95 percent, Softbank Group skyrocketed 10.39 percent, Mitsubishi UFJ Financial collected 0.64 percent, Mizuho Financial advanced 1.02 percent, Sumitomo Mitsui Financial added 0.71 percent, Mitsubishi Electric fell 0.28 percent, Sony Group soared 3.50 percent, Panasonic Holdings climbed 1.16 percent and Hitachi rose 0.50 percent. The lead from Wall Street is negative as the major averages opened mixed on Monday, rallied midday but then slumped in the afternoon and finished under water.
RTTNews | 1時10分前
Continued Consolidation Called For South Korea Shares

Continued Consolidation Called For South Korea Shares

The South Korea stock market has finished lower in back-to-back sessions, sinking more than 20 points or 0.6 percent along the way. The KOSPI now sits just above the 3,200-point plateau and it may take further damage again on Tuesday. The global forecast for the Asian markets is soft ahead of key U.S. inflation data. The European markets were mixed and the U.S. bourses were down and the Asian markets also figure to track into the red.
RTTNews | 1時25分前
Australia Interest Rate Decision On Tap For Tuesday

Australia Interest Rate Decision On Tap For Tuesday

The Reserve Bank of Australia will wrap up its monetary policy meeting this morning and then announce its decision on interest rates, highlighting a light day for Asia-Pacific economic activity. The RBA is expected lower its benchmark lending rate by 25 basis points, to 3.60 percent from 3.85 percent.
RTTNews | 2時25分前