Fulcrum Therapeutics (NASDAQ:FULC) stock is on the rise Tuesday as investors react to positive news from the U.S. Food and Drug Administration.
The big news here is that the FDA lifted its clinical hold on the Investigational New Drug (IND) application for FTX-6058. This is a drug in testing for the potential treatment of patients suffering from sickle-cell disease (SCD).
The FDA initially placed the IND for FTX-6058 on hold on Feb. 23, 2023. The FDA took issue with preclinical data, as well as “evidence of hematological malignancies observed with other inhibitors of polycomb repressive complex 2 (PRC2).” That resulted in Fulcrum pausing its clinical trial to alleviate the concerns of the FDA.
Alex Sapir, President and CEO of Fulcrum Therapeutics, said the following about the potential of FTX-6058 in a news release:
“Based on the initial data from the Phase 1b trial, which showed increasing levels of HbF with each dose escalation, we believe in the potential of FTX-6058 to not only shift the current standard of care but importantly, offer these patients a differentiated oral option. We look forward to building on these results with plans to resume enrollment for patients with SCD.”
FULC Stock Movement Today
Following this update from the FDA, shares of FULC stock are seeing heavy trading. As of this writing, over 9 million shares have changed hands. That’s well above its daily average trading volume of about 691,000 shares.
FULC stock is up 43% as of Tuesday morning. However, shares are still down 29.5% year-to-date (YTD).
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On the date of publication, William White did not hold (either directly or indirectly) any positions in the securities mentioned in this article. The opinions expressed in this article are those of the writer, subject to the InvestorPlace.com Publishing Guidelines.
