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 saw its Momentum Indicator move above the 0 level on May 30, 2023. This is an indication that the stock could be shifting in to a new upward move. Traders may want to consider buying the stock or buying call options. Tickeron's A.I.dvisor looked at 84 similar instances where the indicator turned positive. In of the 84 cases, the stock moved higher in the following days. The odds of a move higher are at .
The Stochastic Oscillator demonstrated that the ticker has stayed in the oversold zone for 2 days, which means it's wise to expect a price bounce in the near future.
ITRM moved above its 50-day moving average on April 28, 2023 date and that indicates a change from a downward trend to an upward trend.
Following a 3-day Advance, the price is estimated to grow further. Considering data from situations where ITRM advanced for three days, in of 246 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 117 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 10-day RSI Indicator for ITRM moved out of overbought territory on May 25, 2023. This could be a bearish sign for the stock. Traders may want to consider selling the stock or buying put options. Tickeron's A.I.dvisor looked at 24 similar instances where the indicator moved out of overbought territory. In of the 24 cases, the stock moved lower in the following days. This puts the odds of a move lower at .
The Moving Average Convergence Divergence Histogram (MACD) for ITRM turned negative on May 31, 2023. 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 43 similar instances when the indicator turned negative. In of the 43 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 May 23, 2023. 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 (0.812) is normal, around the industry mean (24.947). P/E Ratio (9.533) is within average values for comparable stocks, (122.964). Projected Growth (PEG Ratio) (0.000) is also within normal values, averaging (4.308). Dividend Yield (0.000) settles around the average of (0.031) among similar stocks. P/S Ratio (0.000) is also within normal values, averaging (307.036).
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
A.I.dvisor indicates that over the last year, ITRM has been loosely correlated with PLRX. These tickers have moved in lockstep 41% of the time. This A.I.-generated data suggests there is some statistical probability that if ITRM jumps, then PLRX could also see price increases.
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