FDA Approval for Panbela Therapeutics Pediatric Cancer Drug; Shares Jump 120%
Panbela Therapeutics, Inc. (Nasdaq: PBLA) has announced that US WorldMeds®1 (USWM) has received FDA approval of its New Drug Application (NDA) for the use of eflornithine as a maintenance therapy for high-risk neuroblastoma patients who have achieved at least a partial response to certain prior therapies.
In July 2023, Panbela divested its pediatric neuroblastoma program to USWM in an arrangement entitling Panbela to up to approximately $9.5 million of non-dilutive funding, including payments upon USWM’s successful completion of milestones related to eflornithine’s clinical development, regulatory approval, and commercial sales.
Jennifer K. Simpson, PhD, MSN, CRNP, President & Chief Executive Officer of Panbela, said, “The FDA’s approval of USWM’s eflornithine NDA for high-risk neuroblastoma is an exciting milestone in our partnership. This demonstrates the potential for polyamine targeted therapies in cancer. This approval is a prerequisite for considerable development milestone payments for Panbela as US WorldMeds continues its efforts to bring eflornithine to the market.”
Panbela’s share price rose more than 120% on Monday and surged 82% in early morning trading on Tuesday.
Highlights
The decision is the first FDA approval of an NDA for any polyamine targeted therapy in a cancer indication, highlighting the role polyamines can play in cancer therapy.
Elizabeth Bruckheimer, Ph.D., Vice President & Chief Scientific Officer of Panbela, said, “After many years investigating the role of polyamines and the therapeutic potential of eflornithine in neuroblastoma, it is rewarding to see USWM’s success with the FDA’s positive review of its NDA for eflornithine. We are excited about how the USWM NDA approval of eflornithine should help address this high unmet need in patients with neuroblastoma.”
Neuroblastoma, a rare cancer originating from immature nerve cells, contributes to nearly 15% of pediatric cancer deaths.
About Panbela Therapeutics
Panbela Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing disruptive therapeutics for patients with urgent unmet medical needs. Panbela’s lead assets are Ivospemin (SBP-101) and Flynpovi. Further information can be found at www.panbela.com . Panbela’s common stock is listed on The Nasdaq Stock Market LLC under the symbol “PBLA”.
