Geron Corp. (GERN)

Geron Corp (GERN) stock declined by 12.15% following concerns raised by U.S. Food and Drug Administration (FDA) staff regarding the company's blood disorder drug, imetelstat. The FDA staff reviewers expressed uncertainty about the drug's clear benefit to patients in a late-stage trial and raised multiple safety concerns.

• FDA's Concerns: Geron is seeking approval for imetelstat as a treatment for transfusion-dependent anemia in patients with myelodysplastic syndromes (MDS). While the drug met its main goal of increasing independence from transfusion at eight weeks in a late-stage study, the FDA staff questioned the "clinical meaningfulness" of the data, noting that experts generally consider only a 16-week or longer period of transfusion independence to be clinically meaningful.
• Competition and Market Potential: If approved, imetelstat will compete with Bristol Myers Squibb's (BMY.N) Reblozyl, which was approved by the FDA last year for the same indication. Geron's CEO previously anticipated a peak market potential of $1.2 billion for the treatment in the United States and some key EU countries by 2030.
• Analyst and Regulatory Outlook: Wedbush analyst Robert Driscoll noted that it was expected for the briefing documents to lean negative but believes Geron will be able to provide a strong case against the FDA's concerns. The FDA is expected to make a decision on the drug by June 16, following a meeting of its independent advisers scheduled for Thursday.

Shares of Geron Corp. (GERN) dropped by 6.76% from $2.07 to $1.93 in the trading on Monday, December 11, 2023. The reason why GERN down today is due to growing concerns about the approval status of the company's key drug, imetelstat. These concerns have created uncertainty among investors, leading to the drop in GERN shares. Investors are closely watching for updates and announcements related to imetelstat's approval, as it plays a pivotal role in Geron's portfolio. Regulatory decisions and clinical developments often have a significant impact on the stock performance of biopharmaceutical companies, and this uncertainty is affecting GERN's stock.

Shares of Geron Corp. (GERN) dropped by 6.53% from $1.99 to $1.86 in the trading on Monday, December 04, 2023. The reason why GERN is down today is due to the announcement of the publication of results from the IMerge Phase 3 Clinical Trial evaluating Imetelstat in Lower Risk Myelodysplastic Syndromes (MDS) in The Lancet. The market's reaction to these trial results may have contributed to the decrease in GERN's share price.

Geron Corporation (GERN) experienced a 13.31% decline, reaching $2.28. The FDA has scheduled a regular review and set the action date for Geron's new drug application for Imetelstat, designed to treat transfusion-dependent anemia in patients with lower-risk myelodysplastic syndromes, to be on June 16, 2024.

https://finance.yahoo.com/news/geron-announces-pdufa-date-imetelstat-120000799.html