Iterum Therapeutics PLC (NASDAQ:ITRM) Stock Soars 61% After Approval of ORLYNVAH™

This morning investors are going to look into those stocks that may have clocked strong gains last Friday, and one of the stocks that could be in focus is that of Iterum Therapeutics PLC (NASDAQ:ITRM). Following an announcement from the company, the stock soared by 61% for the day. 

Product Approval

On Friday, the company announced that its new drug ORLYNVAH had been approved by the United States Food and Drug Administration. The product is meant for treating UUTIs (uncomplicated urinary tract infections) in adult women, who may not have antibacterial treatment options of the oral variant. It was a particularly major milestone for the company since it was the first product from Iterum Therapeutics that got FDA approval.

Importance

In the news release, it was noted that the approval was a historic breakthrough for Iterum Therapeutics. The patients, investigators, the Iterum team, and its consultants were thanked for the development. The development of a product like ORLYNVAH was further described as a significant breakthrough since it provided a way of tackling antimicrobial resistance as opposed to the regular oral alternatives.

Following the approval, the company would work on its efforts to conclude a strategic transaction that would hopefully lead to the maximization of value for the esteemed shareholders of Iterum Therapeutics. It now remains to be seen if the stock can add to its gains today.

Key Quote

“The FDA approval of ORLYNVAH™ is tremendous news for those of us who have been hoping for a new option to treat appropriate at-risk patients suffering from UTIs,” said Marjorie Golden, MD, FIDSA, Site Chief, Infectious Disease, St. Raphael Campus Yale New Haven Hospital. “Based on the totality of clinical data generated, ORLYNVAH™ has the potential to be an important treatment alternative for use in the community.”

Technicals

+/- EMA(20)1.14 (+64.91%)
+/- SMA(50)1.11 (+69.37%)
+/- SMA(200)1.36 (+38.24%)
5-Day Perf.+60.68%
1-Month Perf.+75.7%
3-Month Perf.+50.4%
6-Month Perf.+19.75%
YTD Perf.-4.57%
1-Year Perf.+189.19%
RSI(14)83.6
ATR(14)0.17
ADX(14)26.46
Beta (5Y)0.87