There’s no doubt Fulcrum Therapeutics (NASDAQ:FULC) is committed to advancing its proposed treatment for sickle cell disease. However, there’s a regulatory holdup. Fulcrum Therapeutics will attempt to work with regulators to address any issues, but FULC stock is still heading south today.
Fulcrum Therapeutics is a clinical-stage biopharmaceutical company that targets genetically defined rare diseases. The company’s investigational drug, FTX-6058, is being evaluated in a Phase 1b study in people with sickle cell disease.
According to Fulcrum Therapeutics, “Initial data demonstrated proof-of-concept and achieved absolute levels of [fetal hemoglobin] increases associated with potential overall patient benefit.” Furthermore, it was generally found to be well-tolerated.
Nevertheless, the U.S. Food and Drug Administration (FDA) has issued a clinical hold on the Investigational New Drug (IND) application for FTX-6058 in the potential treatment of sickle-cell disease. This, of course, represents a major setback in Fulcrum Therapeutics’ advancement of the drug.
What’s Happening With FULC Stock?
As you might expect, FULC stock dropped after financial traders caught wind of the clinical hold on FTX-6058. The market’s response was immediate and harsh as shares fell 55% this morning.
The press release didn’t provide very specific details as to the reason for the clinical hold. Apparently, the FDA initiated the clinical hold “due to previously reported preclinical data.”
However, Fulcrum Therapeutics interim President and CEO Robert J. Gould may have provided a clue. He said, “Patient safety remains paramount to me.” It’s possible, then, the clinical hold pertained to safety-related concerns.
Moreover, Fulcrum Therapeutics “intends to work diligently with [the FDA] to resolve the hold as soon as possible.” So, there may be a resolution at some point and Fulcrum Therapeutics might be able to continue advancing FTX-6058. Many of today’s FULC stock traders aren’t particularly optimistic right now, however, as they’re selling shares quickly.
On the date of publication, David Moadel did not have (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.