Amryt Pharma To Submit Formal Dispute Resolution Request For Oleogel-S10 NDA

RTTNews | hace 1046
Amryt Pharma To Submit Formal Dispute Resolution Request For Oleogel-S10 NDA

(RTTNews) - Biopharmaceutical company Amryt Pharma plc (AMYT) announced Friday that the company plans to submit a Formal Dispute Resolution Request (FDRR) for the company's New Drug Application (NDA) for Oleogel-S10 (Filsuvez), for the treatment of the cutaneous manifestations of Dystrophic and Junctional Epidermolysis Bullosa (EB).

EB is a rare, genetic skin disease characterized by extremely fragile skin that blisters and tears from minor friction or trauma and for which there are no approved treatment options in the US.

Amryt recently had a Type A meeting with the US Food and Drug Administration (FDA) to discuss the issues raised in the Complete Response Letter (CRL) received in February 2022 relating to Amryt's NDA for Oleogel-S10.

Following this meeting, Amryt plans to proceed to the Formal Dispute Resolution pathway in the FDA's Center for Drug Evaluation and Research (CDER) by which NDA applicants can seek to resolve scientific and/or medical disputes that cannot be resolved at the division level.

read more
Australian Market Modestly Lower

Australian Market Modestly Lower

The Australian stock market is trading modestly lower on Tuesday, extending the losses in the previous session, following the broadly negative cues from Wall Street overnight. The benchmark S&P/ASX 200 is staying below the 8,200 level, with weakness in iron ore miners, financial and some technology stocks partially offset by strong gains in gold miners.
RTTNews | hace 15 minutos
Hong Kong Bourse May Spin Its Wheels On Tuesday

Hong Kong Bourse May Spin Its Wheels On Tuesday

Ahead of Monday's holiday for the buddha's birthday, the Hong Kong stock market had finished higher in three straight sessions, collecting almost 550 points or 2.4 percent along the way. The Hang Seng Index now sits just above the 22,500-point plateau although the rally may stall on Tuesday.
RTTNews | hace 30 minutos
China Shares May Return To The Downside

China Shares May Return To The Downside

Ahead of the long holiday weekend, the China stock market had finished lower in four straight sessions, sliding more than 20 points or 0.7 percent along the way. The Shanghai Composite Index now sits just beneath the 3,280-point plateau and it may open under pressure again on Tuesday.
RTTNews | hace 1h 0min
Continued Consolidation Called For Taiwan Stock Market

Continued Consolidation Called For Taiwan Stock Market

The Taiwan stock market on Monday snapped the five-day winning streak in which it had surged more than 1,300 points or 6.4 percent. The Taiwan Stock Exchange now sits just above the 20,530-point plateau and it may take further damage on Tuesday.
RTTNews | hace 1h 30min
Rally May Stall For Singapore Stock Market

Rally May Stall For Singapore Stock Market

The Singapore stock market has moved higher in three straight sessions, advancing almost 50 points or 1.3 percent along the way. The Straits Times Index now sits just above the 3,850-point plateau although it may run out of steam on Tuesday.
RTTNews | hace 2h 0min
Malaysia Bourse May Extend Monday's Losses

Malaysia Bourse May Extend Monday's Losses

The Malaysia stock market on Monday snapped the two-day winning streak in which it had collected more than 25 points or 1.6 percent. The Kuala Lumpur Composite Index now sits just beneath the 1,540-point plateau and the losses may accelerate on Tuesday.
RTTNews | hace 2h 30min