As of September 29, 2024, Iterum Therapeutics (ITRM) has a closing price of $1.061, with a MACD of 0.012, an RSI of 43.833, a KDJ of 38.974, a resistance level at $1.075, and a support level at $1.026. The stock is trading below its 5-day moving average of $1.077 and 10-day moving average of $1.078, indicating a potential downward trend.
The company's recent developments and financial performance as of September 29, 2024, are as follows:
- FDA Advisory Committee Discussion: The FDA's Antimicrobial Drugs Advisory Committee (AMDAC) discussed ITRM's NDA for oral sulopenem for the treatment of uUTIs in adult women. The committee acknowledged oral sulopenem as an important treatment option and emphasized the importance of appropriate physician use to limit antimicrobial resistance. The FDA is expected to make a decision on sulopenem's approval by October 25, 20249.
- Financial Performance: ITRM has reported negative net income for the past year, with significant losses in Q2 2024 amounting to $12.36 million. The company's total revenue for the past year is not available, but it is important to note that ITRM has reduced its net loss and extended its cash runway into 2025 through a successful rights offering10.
- Strategic Developments: ITRM has been focusing on the FDA advisory committee meeting and the potential approval of sulopenem. The company has also expanded its intellectual property estate with new patents in the US and Canada. The upcoming FDA decision on sulopenem's approval is a critical milestone for ITRM, as it would be the first oral penem approved in the US1112.
- Market Sentiment: Despite the potential approval of sulopenem, ITRM's stock has experienced a significant drop of 51.8% so far this year, compared to the industry's decrease of 0.8%. This could be attributed to concerns over the drug's off-label use and potential limitations in its approval. However, a buy rating has been reaffirmed by HC Wainwright with a price target of $5.00, indicating confidence in the company's prospects1213.
- Breakeven Expectations: Analysts expect ITRM to post a final loss in 2025 before turning a profit of $73k in 2026, suggesting a breakeven point approximately 2 years from now. Achieving profitability will be crucial for ITRM's long-term sustainability and market valuation14.
In conclusion, as of September 29, 2024, ITRM is awaiting a critical FDA decision on the approval of its lead product, sulopenem. The company's financial performance and strategic developments are critical factors in its path to profitability. Investors will closely monitor the FDA's decision and the company's ability to capitalize on the potential approval of its lead product.
9/29/2024 01:02pm
