Iterum (ITRM, $0.63) denied approval by FDA for UTI Treatment
Iterum Therapeutics plc said that it will not get approval for the current form of its new drug application for oral sulopenem.
According to the Food and Drug Administration (FDA), additional data are required and the company should conduct at least one more well-controlled clinical trial for its treatment of adult women with uncomplicated urinary tract infections. FDA mentioned that it is willing to work with Iterum on the design of clinical trials in order to address the issues the FDA identified.
However, Iterum CEO Corey Fishman said the company is “disappointed in this outcome and believe that the data package submitted was adequate for the approval of oral sulopenem,” . Fishman added that they will still assess the points raised in the CRL for discussion with the FDA to determine an “expeditious path forward."
ITRM's MACD Histogram crosses above signal line
The Moving Average Convergence Divergence (MACD) for ITRM turned positive on May 27, 2025. Looking at past instances where ITRM's MACD turned positive, the stock continued to rise in of 50 cases over the following month. The odds of a continued upward trend are .
Technical Analysis (Indicators)
Bullish Trend Analysis
The Stochastic Oscillator is in the oversold zone. Keep an eye out for a move up in the foreseeable future.
The Momentum Indicator moved above the 0 level on June 16, 2025. You may want to consider a long position or call options on ITRM as a result. In of 80 past instances where the momentum indicator moved above 0, the stock continued to climb. The odds of a continued upward trend are .
Following a 3-day Advance, the price is estimated to grow further. Considering data from situations where ITRM advanced for three days, in of 251 cases, the price rose further within the following month. The odds of a continued upward trend are .
Bearish Trend Analysis
Following a 3-day decline, the stock is projected to fall further. Considering past instances where ITRM declined for three days, the price rose further in of 62 cases within the following month. The odds of a continued downward trend are .
ITRM broke above its upper Bollinger Band on June 09, 2025. This could be a sign that the stock is set to drop as the stock moves back below the upper band and toward the middle band. You may want to consider selling the stock or exploring put options.
The Tickeron PE Growth Rating for this company is (best 1 - 100 worst), pointing to outstanding earnings growth. The PE Growth rating is based on a comparative analysis of stock PE ratio increase over the last 12 months compared against S&P 500 index constituents.
The Tickeron Price Growth Rating for this company is (best 1 - 100 worst), indicating fairly steady price growth. ITRM’s price grows at a lower rate over the last 12 months as compared to S&P 500 index constituents.
The Tickeron Valuation Rating of (best 1 - 100 worst) indicates that the company is significantly overvalued in the industry. This rating compares market capitalization estimated by our proprietary formula with the current market capitalization. This rating is based on the following metrics, as compared to industry averages: P/B Ratio (0.000) is normal, around the industry mean (17.006). P/E Ratio (0.000) is within average values for comparable stocks, (59.274). ITRM's Projected Growth (PEG Ratio) (0.000) is slightly lower than the industry average of (2.273). Dividend Yield (0.000) settles around the average of (0.041) among similar stocks. P/S Ratio (0.000) is also within normal values, averaging (256.503).
The Tickeron SMR rating for this company is (best 1 - 100 worst), indicating weak sales and an unprofitable business model. SMR (Sales, Margin, Return on Equity) rating is based on comparative analysis of weighted Sales, Income Margin and Return on Equity values compared against S&P 500 index constituents. The weighted SMR value is a proprietary formula developed by Tickeron and represents an overall profitability measure for a stock.
The Tickeron Profit vs. Risk Rating rating for this company is (best 1 - 100 worst), indicating that the returns do not compensate for the risks. ITRM’s unstable profits reported over time resulted in significant Drawdowns within these last five years. A stable profit reduces stock drawdown and volatility. The average Profit vs. Risk Rating rating for the industry is 95, placing this stock worse than average.
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General Information
an operator, which engages in the healthcare industry focusing on biotechnology business
Industry Biotechnology
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