
French penny stock will no longer knock on FDA door for approval in a certain type of blood cancer
Things are not looking up for the French biotech Erytech Pharma.
The company is knocking off its plan to get FDA approval for its drug Graspa in hypersensitive acute lymphoblastic leukemia (ALL), following feedback from the regulators, it said in a press release Wednesday afternoon. ALL is the common type of childhood cancer diagnosed in approximately 5,000 new cases each year in the United States.
“We are obviously disappointed to stop the process of seeking approval for Graspa in ALL after all the work done and clinical promise observed in this indication,” Erytech CEO Gil Beyen said in a press statement.
The company’s stocks $ERYP plunged more than 20% following the news.
After positive results of a Phase II trial, Erytech had been in discussions with the FDA for the approval of Graspa to treat ALL patients who had previously experienced hypersensitivity reactions to pegylated asparaginase therapy.
However, the changing competitive landscape and the FDA’s request for more clinical data made it too difficult for Erytech, leading to its decision to withdraw its application, according to the company’s press statement.
In 2017, the FDA approved Kymriah (tisagenlecleucel) — a CAR-T therapy for certain pediatric and young adult patients with a form of ALL that has become one of the go-to therapies for the condition.
Nearly four years ago, Erytech celebrated its impressive Phase IIb data for second-line metastatic pancreatic cancer, but that hype died when the drug failed the Phase III pivotal trial. That led the stock to fall 28%.
Graspa is Erytech’s lead product candidate. It contains a chemotherapeutic agent L-asparaginase encapsulated inside a donor-derived red blood cell. By encapsulating the L-asparaginase into red blood cells, Graspa aims to enlarge its therapeutic window.
Meanwhile, the company has been undergoing a “strategic review” since at least April. Erytech sold its commercial-scale cell therapy manufacturing facility in Princeton, NJ to Catalent for $44.5 million, and 40 people from Erytech’s New Jersey location would be offered employment at Catalent.
For now, the company will focus on its other preclinical programs, “while pursuing strategic partnering options to maximize value for our shareholders and employees,” Beyen said.