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 moved above its 50-day moving average on April 22, 2024 date and that indicates a change from a downward trend to an upward trend. In of 38 similar past instances, the stock price increased further within the following month. The odds of a continued upward trend are .
The Stochastic Oscillator suggests the stock price trend may be in a reversal from a downward trend to an upward trend. of 60 cases where ITRM's Stochastic Oscillator exited the oversold zone resulted in an increase in price. Tickeron's analysis proposes that the odds of a continued upward trend are .
The 10-day moving average for ITRM crossed bullishly above the 50-day moving average on March 27, 2024. This indicates that the trend has shifted higher and could be considered a buy signal. In of 14 past instances when the 10-day crossed above the 50-day, the stock continued to move higher over the following month. 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 247 cases, the price rose further within the following month. The odds of a continued upward trend are .
The Aroon Indicator entered an Uptrend today. In of 115 cases where ITRM Aroon's Indicator entered an Uptrend, the price rose further within the following month. The odds of a continued Uptrend are .
The Momentum Indicator moved below the 0 level on April 15, 2024. You may want to consider selling the stock, shorting the stock, or exploring put options on ITRM as a result. In of 83 cases where the Momentum Indicator fell below 0, the stock fell further within the subsequent month. The odds of a continued downward trend are .
The Moving Average Convergence Divergence Histogram (MACD) for ITRM turned negative on April 12, 2024. This could be a sign that the stock is set to turn lower in the coming weeks. Traders may want to sell the stock or buy put options. Tickeron's A.I.dvisor looked at 46 similar instances when the indicator turned negative. In of the 46 cases the stock turned lower in the days that followed. This puts the odds of success at .
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 April 04, 2024. 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 steady price growth. ITRM’s price grows at a higher 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 (10.207). P/E Ratio (0.000) is within average values for comparable stocks, (115.519). ITRM's Projected Growth (PEG Ratio) (0.000) is slightly lower than the industry average of (1.463). ITRM has a moderately low Dividend Yield (0.000) as compared to the industry average of (0.015). P/S Ratio (0.000) is also within normal values, averaging (210.351).
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 94, placing this stock worse than average.
The average fundamental analysis ratings, where 1 is best and 100 is worst, are as follows
an operator, which engages in the healthcare industry focusing on biotechnology business
Industry Biotechnology