PRISM Biotech in Motion: FDA Approval for Panbela Therapeutics Pediatric Cancer Drug; Shares Jump 120%

PRISM Biotech in Motion: FDA Approval for Panbela Therapeutics Pediatric Cancer Drug; Shares Jump 120%

New York, N.Y., December 20, 2023 – – PRISM MarketView, a leading provider of unbiased market insight and company news, today highlights Panbela Therapeutics, Inc. which 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

 

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”.

 

About PRISM MarketView:

Established in 2020, PRISM MarketView is dedicated to the monitoring and analysis of small cap stocks in burgeoning sectors. We deliver up-to-the-minute financial market news, provide comprehensive investor tools and foster a dynamic investor community. Central to our offerings are proprietary indexes that observe emerging sectors, including biotech, clean energy, next-generation tech, medical devices and beyond. Visit us at prismmarketview.com and follow us on Twitter.

 

PRISM MarketView does not provide investment advice.

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