FDA Approves Phase II Clinical Trial for Ruxoprubart in ANCA Associated Vasculitis (AAV) – a Chronic Rare Disease in Nephrology [Yahoo! Finance]
Amgen Inc. (AMGN)
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Source: Yahoo! Finance
A Phase II, Efficacy Trial in adult AAV patients has been approved by the FDA. Ruxoprubart is a first-in-class treatment for sustaining remission in AAV patients as a conjunctive therapy along with Standard of Care (SOC) which includes corticosteroids plus Cyclophosphamide/Azathioprine or Rituximab. Ruxoprubart demonstrated an anticipated safety profile in Phase I trial in healthy subjects in 2022. TAVNEOS ® (avacopan) was approved by the FDA in 2022 for treating AAV. Ruxoprubart is being positioned as the next-generation AAV treatment based on its mechanism of action. NovelMed's Ruxoprubart drug blocks the alternative pathway (AP) without blocking the complement classical pathway (CP), an important advantage in maintaining a healthy lifestyle. Recent commencement of Ruxoprubart proof-of-concept Phase II trial through intravenous (IV) administration in naïve PNH patients shows promising results with a clean safety and efficacy profile. The Subcutaneous (SC) route of administr
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News
- Regeneron Pharmaceuticals Suffers Worst Month in Two Years After Legal Setback [Yahoo! Finance]Yahoo! Finance
- Amgen Inc. (NASDAQ: AMGN) is now covered by analysts at Cantor Fitzgerald. They set an "overweight" rating and a $405.00 price target on the stock.MarketBeat
- AMGN Stock Falls Despite Upbeat Data on Immunology Drugs: Here's Why [Yahoo! Finance]Yahoo! Finance
- Amgen Inc. (NASDAQ: AMGN) had its "outperform" rating re-affirmed by analysts at Royal Bank of Canada. They now have a $362.00 price target on the stock.MarketBeat
- Amgen Inc. (NASDAQ: AMGN) had its "underperform" rating re-affirmed by analysts at Robert W. Baird. They now have a $215.00 price target on the stock.MarketBeat
AMGN
Earnings
- 8/6/24 - Beat
AMGN
Sec Filings
- 8/13/24 - Form 4
- 8/13/24 - Form 4
- 8/13/24 - Form 4
- AMGN's page on the SEC website