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Home Breaking News

FDA Reservations on Geron Corporations Imetelstat Application for Anemia in LowerRisk MDS Patients

Elaine Mendonca by Elaine Mendonca
March 12, 2024
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The FDA has expressed reservations regarding Geron Corporation‘s imetelstat application for anemia in lower-risk MDS patients, specifically questioning the balance of benefits and risks associated with the drug. While the Phase 3 trial met its statistical goals for primary and secondary endpoints, the FDA has raised doubts about the long-term effectiveness of achieving red blood cell transfusion independence (RBC-TI) compared to the potential risks of imetelstat treatment. Certain findings did not indicate a significant impact on the disease and concerns were raised about patient-reported outcomes.

The FDA’s Oncologic Drugs Advisory Committee is scheduled to convene virtually on March 14, 2024, to evaluate Geron Corporation’s application for approval in adult patients with transfusion-dependent anemia and lower-risk MDS. Despite these challenges, experts anticipate a positive vote from the AdComm and the possibility of full FDA approval by the PDUFA date on June 16, 2024.

GERN Stock Price Plummets by 18.22% on March 12, 2024 – What Investors Need to Know

On March 12, 2024, Geron Corporation (GERN) experienced a significant drop in its stock price, with shares falling by $0.39, representing an 18.22% decrease from the previous day’s closing price. The stock opened at $1.91, which was $0.23 lower than its previous close.

Investors may be concerned about the recent drop in GERN’s stock price and the fact that it is trading below its 200-day moving average. This could be a sign of weakening momentum and potential further declines in the stock price.

It is important for investors to carefully consider the factors driving the stock’s performance and to conduct thorough research before making any investment decisions. Market conditions, company news, and industry trends can all impact a stock’s performance, so it is essential to stay informed and stay ahead of any potential risks.

Overall, GERN’s performance on March 12, 2024, reflects a significant decline in its stock price, which may raise concerns among investors. It will be important to monitor the stock’s performance in the coming days to see if this trend continues or if there are any signs of a potential rebound.

GERN Stock Performance Declines on Decrease in Revenue and Net Income

On March 12, 2024, Geron Corporation (GERN) experienced a decline in its stock performance as the company reported a decrease in total revenue and net income compared to the previous year and the last quarter. According to data from CNN Money, GERN’s total revenue for the past year was $237.00K, which was a significant decrease of 60.23% compared to the previous year. In the last quarter, the total revenue further decreased to $23.00K, marking an 85.98% decline since the previous quarter. Similarly, GERN’s net income also saw a decline over the past year and the last quarter. The net income for the past year was reported as -$184.13M, which was a decrease of 29.76% compared to the previous year. In the last quarter, the net income further decreased to -$51.97M, marking a 16.0% decline since the previous quarter. In terms of earnings per share (EPS), GERN reported a negative EPS of -$0.32 for the past year, which was an increase of 13.39% compared to the previous year. However, in the last quarter, the EPS decreased to -$0.09, marking a 13.07% decline since the previous quarter. Overall, GERN’s stock performance on March 12, 2024, was impacted by the company’s decline in total revenue, net income, and EPS compared to the previous year and the last quarter. Investors and analysts will closely monitor GERN’s financial performance in the coming quarters to assess the company’s ability to improve its revenue and profitability.

Tags: GERN
Elaine Mendonca

Elaine Mendonca

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