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Panbela (PBLA) Regains Flynpovi Rights to Treat FAP
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Panbela Therapeutics (PBLA - Free Report) , a clinical stage biopharmaceutical company, gained almost 37.5% in pre-market hours on Apr 12. This occurred after the company regained its rights to develop and commercialize Flynpovi — a combination of CPP-1X (eflornithine) and sulindac to treat patients with familial adenomatous polyposis (FAP) — in North America.
The announcement came after the termination of the licensing agreement between Cancer Prevention Pharmaceuticals and One-Two Therapeutics Assets Limited.
FAP is a rare genetic condition that causes the development of numerous polyps in the colon and rectum, leading to an increased risk of colorectal cancer. Flynpovi has shown promising results in clinical studies, with a 100% risk reduction in the need for surgery in patients with intact lower gastrointestinal anatomy compared to CPP-1X or sulindac alone.
Since there are currently no approved drug therapies for the treatment of FAP, Flynpovi has become a potentially life-changing therapeutic option for patients with this rare genetic disease.
Shares of Panbela have plunged 99.4% in the past year compared with the industry's 15% decline.
Image Source: Zacks Investment Research
With its regained rights to Flynpovi in North America, PBLA is now poised to take the lead in designing the global trial protocol. It is also responsible for presenting the protocol to the Federal Drug Administration and European Medicines Agency for agreement on the registration pathway.
The new registration trial will focus on FAP patients with intact lower gastrointestinal anatomy. It will also build upon the positive results from the FAP-310 trial, which showed compelling evidence for product approval.
Panbela's pipeline includes assets in clinical trials for FAP, pancreatic cancer, colorectal cancer prevention and ovarian cancer. The company is committed to bringing innovative treatments for urgent unmet medical needs, and Flynpovi has the potential to make a meaningful difference for FAP patients globally. PBLA’s lead candidates include Ivospemin (SBP-101) and Flynpovi.
Flynpovi has received Fast Track designation in the United States, and Orphan Drug designation status for FAP in Europe and the United States.
Loss per share estimates for CRISPR have narrowed from $8.21 to $7.35 for 2023 in the past 60 days.
The company's earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, the average surprise being 3.19%. CRSP's shares have plunged 31.1% in the past year
Loss per share estimates for Kala have narrowed from $18.34 to $16.54 for 2023 and from $14.41 to $13.12 for 2024 in the past 60 days. The company's shares have plunged 60.4% in the past year.
KALA's earnings beat estimates in two of the last four quarters and missed the mark in the other two, the average surprise being 11.56%.
Loss per share estimates for Allogene Therapeutics have narrowed from $2.83 to $2.44 for 2023 and from $2.69 to $2.46 for 2024 in the past 60 days.
The company's earnings beat estimates in each of the trailing four quarters, the average surprise being 8.33%. ALLO's shares have plunged 46.9% in the past year.
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Panbela (PBLA) Regains Flynpovi Rights to Treat FAP
Panbela Therapeutics (PBLA - Free Report) , a clinical stage biopharmaceutical company, gained almost 37.5% in pre-market hours on Apr 12. This occurred after the company regained its rights to develop and commercialize Flynpovi — a combination of CPP-1X (eflornithine) and sulindac to treat patients with familial adenomatous polyposis (FAP) — in North America.
The announcement came after the termination of the licensing agreement between Cancer Prevention Pharmaceuticals and One-Two Therapeutics Assets Limited.
FAP is a rare genetic condition that causes the development of numerous polyps in the colon and rectum, leading to an increased risk of colorectal cancer. Flynpovi has shown promising results in clinical studies, with a 100% risk reduction in the need for surgery in patients with intact lower gastrointestinal anatomy compared to CPP-1X or sulindac alone.
Since there are currently no approved drug therapies for the treatment of FAP, Flynpovi has become a potentially life-changing therapeutic option for patients with this rare genetic disease.
Shares of Panbela have plunged 99.4% in the past year compared with the industry's 15% decline.
Image Source: Zacks Investment Research
With its regained rights to Flynpovi in North America, PBLA is now poised to take the lead in designing the global trial protocol. It is also responsible for presenting the protocol to the Federal Drug Administration and European Medicines Agency for agreement on the registration pathway.
The new registration trial will focus on FAP patients with intact lower gastrointestinal anatomy. It will also build upon the positive results from the FAP-310 trial, which showed compelling evidence for product approval.
Panbela's pipeline includes assets in clinical trials for FAP, pancreatic cancer, colorectal cancer prevention and ovarian cancer. The company is committed to bringing innovative treatments for urgent unmet medical needs, and Flynpovi has the potential to make a meaningful difference for FAP patients globally. PBLA’s lead candidates include Ivospemin (SBP-101) and Flynpovi.
Flynpovi has received Fast Track designation in the United States, and Orphan Drug designation status for FAP in Europe and the United States.
Panbela Therapeutics Inc. Price and Consensus
Panbela Therapeutics Inc. price-consensus-chart | Panbela Therapeutics Inc. Quote
Zacks Rank & Stocks to Consider
Currently, Panbela has a Zacks Rank #3 (Hold).
Some better-ranked stocks for investors interested in the same sector are CRISPR Therapeutics (CRSP - Free Report) , Kala Pharmaceuticals (KALA - Free Report) and Allogene Therapeutics (ALLO - Free Report) , each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here.
Loss per share estimates for CRISPR have narrowed from $8.21 to $7.35 for 2023 in the past 60 days.
The company's earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, the average surprise being 3.19%. CRSP's shares have plunged 31.1% in the past year
Loss per share estimates for Kala have narrowed from $18.34 to $16.54 for 2023 and from $14.41 to $13.12 for 2024 in the past 60 days. The company's shares have plunged 60.4% in the past year.
KALA's earnings beat estimates in two of the last four quarters and missed the mark in the other two, the average surprise being 11.56%.
Loss per share estimates for Allogene Therapeutics have narrowed from $2.83 to $2.44 for 2023 and from $2.69 to $2.46 for 2024 in the past 60 days.
The company's earnings beat estimates in each of the trailing four quarters, the average surprise being 8.33%. ALLO's shares have plunged 46.9% in the past year.