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Palisade Bio's (PALI) LB1148 Gets FDA Fast-Track Designation
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Shares of Palisade Bio (PALI - Free Report) were up 81.08% during market hours after the company announced that its lead asset, LB1148, a protease inhibitor has been granted Fast Track designation by the FDA for accelerated return of bowel function following gastrointestinal (GI) surgery.
However, the stock has plunged 100% in the year-to-date period compared with the industry’s fall of 17.8%.
Image Source: Zacks Investment Research
LB1148 is an oral liquid formation of the well-characterized digestive enzyme inhibitor tranexamic acid (“TXA”). It has the potential to reduce abdominal adhesions and accelerate the return of bowel function following surgery.
The candidate is currently being developed for administration before surgeries that are at risk of disrupting the intestinal epithelial barrier.
The FDA’s Fast Track designation accelerates the development and review of new drugs or biologics developed to treat serious or life-threatening conditions and demonstrate the potential to address unmet medical needs. The designation will allow Palisade to engage in frequent communications with the FDA to discuss the development plan of LB1148 and if relevant criteria is met, eligibility for accelerated approval and priority review.
Palisade in August 2022 announced that it had enrolled the first patient in a phase III study evaluating LB1148 to accelerate the return of bowel function in adult patients undergoing gastrointestinal surgery. The phase III double-blind, placebo-controlled study is designed similarly to the positive phase II study of the candidate, where it demonstrated a statistically significant improvement in the time of the return of bowel function. The primary endpoint of the phase III study is the time for recovery of the upper and lower gastrointestinal tract following surgery, defined as the time from the end of surgery to the toleration of food and first bowel movement.
Per the company, if LB1148 is successfully developed and approved, it might have the ability to become a suitable treatment option across a broad range of chronic and acute conditions of GI barrier dysfunction.
Immunocore’s loss per share estimates for 2022 have narrowed from $1.25 to 97 cents over the past 30 days. The loss per share for 2023 has narrowed from $1.69 to $1.10 in the same time frame.
Earnings of Immunocore beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion. The average earnings surprise for IMCR is 68.34%.
AVEO Pharmaceuticals’ loss per share estimates for 2022 have narrowed down from 94 cents to 68 cents over the past 30 days. The earnings estimate for 2023 remained steady at improved from 41 cents to 52 cents in the same time frame.
Earnings of AVEO beat estimates in three of the trailing four quarters, while missing the same in the reaming occasion. The average earnings surprise for AVEO is 19.87%.
Eton Pharmaceuticals’ loss per share estimates for 2022 remained steady at 44 cents in the past 30 days. The earnings per share for 2023 have remained steady at a cent in the same time frame.
Earnings of Eton missed estimates in three of the trailing four quarters, while beating the same on the remaining occasion. The average earnings surprise for ETON is 115.63%.
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Palisade Bio's (PALI) LB1148 Gets FDA Fast-Track Designation
Shares of Palisade Bio (PALI - Free Report) were up 81.08% during market hours after the company announced that its lead asset, LB1148, a protease inhibitor has been granted Fast Track designation by the FDA for accelerated return of bowel function following gastrointestinal (GI) surgery.
However, the stock has plunged 100% in the year-to-date period compared with the industry’s fall of 17.8%.
Image Source: Zacks Investment Research
LB1148 is an oral liquid formation of the well-characterized digestive enzyme inhibitor tranexamic acid (“TXA”). It has the potential to reduce abdominal adhesions and accelerate the return of bowel function following surgery.
The candidate is currently being developed for administration before surgeries that are at risk of disrupting the intestinal epithelial barrier.
The FDA’s Fast Track designation accelerates the development and review of new drugs or biologics developed to treat serious or life-threatening conditions and demonstrate the potential to address unmet medical needs. The designation will allow Palisade to engage in frequent communications with the FDA to discuss the development plan of LB1148 and if relevant criteria is met, eligibility for accelerated approval and priority review.
Palisade in August 2022 announced that it had enrolled the first patient in a phase III study evaluating LB1148 to accelerate the return of bowel function in adult patients undergoing gastrointestinal surgery. The phase III double-blind, placebo-controlled study is designed similarly to the positive phase II study of the candidate, where it demonstrated a statistically significant improvement in the time of the return of bowel function. The primary endpoint of the phase III study is the time for recovery of the upper and lower gastrointestinal tract following surgery, defined as the time from the end of surgery to the toleration of food and first bowel movement.
Per the company, if LB1148 is successfully developed and approved, it might have the ability to become a suitable treatment option across a broad range of chronic and acute conditions of GI barrier dysfunction.
Palisade Bio, Inc. Price
Palisade Bio, Inc. price | Palisade Bio, Inc. Quote
Zacks Rank and Stocks to Consider
Palisae Bio currently has a Zacks Rank #3 (Hold).
Some better-ranked stocks in the same sector include Immunocore (IMCR - Free Report) , AVEO Pharmaceuticals and Eton Pharmaceuticals (ETON - Free Report) , each carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 (Strong Buy) Rank stocks here.
Immunocore’s loss per share estimates for 2022 have narrowed from $1.25 to 97 cents over the past 30 days. The loss per share for 2023 has narrowed from $1.69 to $1.10 in the same time frame.
Earnings of Immunocore beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion. The average earnings surprise for IMCR is 68.34%.
AVEO Pharmaceuticals’ loss per share estimates for 2022 have narrowed down from 94 cents to 68 cents over the past 30 days. The earnings estimate for 2023 remained steady at improved from 41 cents to 52 cents in the same time frame.
Earnings of AVEO beat estimates in three of the trailing four quarters, while missing the same in the reaming occasion. The average earnings surprise for AVEO is 19.87%.
Eton Pharmaceuticals’ loss per share estimates for 2022 remained steady at 44 cents in the past 30 days. The earnings per share for 2023 have remained steady at a cent in the same time frame.
Earnings of Eton missed estimates in three of the trailing four quarters, while beating the same on the remaining occasion. The average earnings surprise for ETON is 115.63%.