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First Wave (FWBI) Surges 33% on Finishing Enrolment in CF Study
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Shares of First Wave BioPharma surged 33.3% on Jun 13 after management announced that it has achieved the enrolment target in the phase II SPAN study evaluating its investigational oral biologic capsule adrulipase for treating exocrine pancreatic insufficiency (“EPI”) associated with cystic fibrosis (“CF”).
The primary efficacy endpoint of the SPAN study is the coefficient of fat absorption, with secondary endpoints of stool weight, signs and symptoms of malabsorption, and coefficient of nitrogen absorption.
The study has enrolled a total of 13 CF patients, aged 18 years and older. Management claims that the majority of the patients have completed the study while the remaining patients are currently being dosed. Management expects to report topline results from the SPAN study next month.
First Wave BioPharma is also evaluating adrulipase in a separate mid-stage study for treating EPI caused by chronic pancreatitis (“CP”).
So far this year, shares of First Wave have plunged 75.2%, compared with the industry‘s 7.3% fall.
Image Source: Zacks Investment Research
EPI is a condition marked by deficiency of the exocrine pancreatic enzymes, resulting in a patient’s inability to digest food properly, or maldigestion. The deficiency is also responsible for greasy diarrhea, fecal urge and weight loss. Per management, there are around 40,000 patients with CF-induced EPI and 95,000 patients with CP-induced EPI living just in the United States.
The current standard of care treatment for CF and CP patients with EPI are commercially-available pancreatic enzyme replacement therapy (“PERT”) pills, which are made from the pancreas of pigs. However, PERT administration in a patient can go up as high as 40 pills per day with patients not achieving normal absorption of fat even after that.
With the development of adrulipase, First Wave BioPharma aims to provide a safe and effective therapy to control EPI which is not only non-animal derived but also reduces the patient’s burden of taking multiple pills in a day.
Apart from adrulipase, First Wave BioPharma is also evaluating another pipeline candidate, niclosamide, in multiple clinical studies targeting ulcerative proctitis and ulcerative proctosigmoiditis, ulcerative colitis and Crohn’s disease indications.
Zacks Rank & Stocks to Consider
First Wave BioPharma currently carries a Zacks Rank #4 (Sell).
Some better-ranked stocks in the overall healthcare sector are Akero Therapeutics (AKRO - Free Report) , Adaptimmune Therapeutics and Ligand Pharmaceuticals . While Ligand Pharmaceuticals sports a Zacks Rank #1 (Strong Buy) at present, Akero Therapeutics and Adaptimmune Therapeutics carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 30 days, the estimate for Ligand’s 2023 earnings per share has increased from $4.79 to $5.25. During the same period, the earnings per share estimate for 2024 has increased from $4.58 to $4.69. So far this year, the shares of Ligand have risen 15.1%.
Ligand Pharmaceuticals beat earnings estimates in two of the last four quarters and missed the mark on the other two occasions. On average, the company’s earnings witnessed an earnings surprise of 21.50%.
Estimates for Adaptive Biotechnologies’ 2023 loss per share have narrowed from 63 cents to 46 cents in the past 30 days. Shares of Adaptive Biotechnologies have declined 30.8% year to date.
Earnings of Adaptive Biotechnologies beat estimates in three of the last four quarters and met the mark on one occasion. On average, the company’s earnings witnessed an earnings surprise of36.89%.
Estimates for Akero Therapeutics’ 2023 loss per share have narrowed from $2.97 to $2.80 in the past 30 days. During the same period, the loss estimate per share for 2024 improved from $3.40 to $3.32. Shares of Akero Therapeutics have risen 3.8% year to date.
Earnings of Akero Therapeutics beat estimates in three of the last four quarters and missed the mark on one occasion. On average, the company’s earnings witnessed an earnings surprise of 7.96%.
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First Wave (FWBI) Surges 33% on Finishing Enrolment in CF Study
Shares of First Wave BioPharma surged 33.3% on Jun 13 after management announced that it has achieved the enrolment target in the phase II SPAN study evaluating its investigational oral biologic capsule adrulipase for treating exocrine pancreatic insufficiency (“EPI”) associated with cystic fibrosis (“CF”).
The primary efficacy endpoint of the SPAN study is the coefficient of fat absorption, with secondary endpoints of stool weight, signs and symptoms of malabsorption, and coefficient of nitrogen absorption.
The study has enrolled a total of 13 CF patients, aged 18 years and older. Management claims that the majority of the patients have completed the study while the remaining patients are currently being dosed. Management expects to report topline results from the SPAN study next month.
First Wave BioPharma is also evaluating adrulipase in a separate mid-stage study for treating EPI caused by chronic pancreatitis (“CP”).
So far this year, shares of First Wave have plunged 75.2%, compared with the industry‘s 7.3% fall.
Image Source: Zacks Investment Research
EPI is a condition marked by deficiency of the exocrine pancreatic enzymes, resulting in a patient’s inability to digest food properly, or maldigestion. The deficiency is also responsible for greasy diarrhea, fecal urge and weight loss. Per management, there are around 40,000 patients with CF-induced EPI and 95,000 patients with CP-induced EPI living just in the United States.
The current standard of care treatment for CF and CP patients with EPI are commercially-available pancreatic enzyme replacement therapy (“PERT”) pills, which are made from the pancreas of pigs. However, PERT administration in a patient can go up as high as 40 pills per day with patients not achieving normal absorption of fat even after that.
With the development of adrulipase, First Wave BioPharma aims to provide a safe and effective therapy to control EPI which is not only non-animal derived but also reduces the patient’s burden of taking multiple pills in a day.
Apart from adrulipase, First Wave BioPharma is also evaluating another pipeline candidate, niclosamide, in multiple clinical studies targeting ulcerative proctitis and ulcerative proctosigmoiditis, ulcerative colitis and Crohn’s disease indications.
Zacks Rank & Stocks to Consider
First Wave BioPharma currently carries a Zacks Rank #4 (Sell).
Some better-ranked stocks in the overall healthcare sector are Akero Therapeutics (AKRO - Free Report) , Adaptimmune Therapeutics and Ligand Pharmaceuticals . While Ligand Pharmaceuticals sports a Zacks Rank #1 (Strong Buy) at present, Akero Therapeutics and Adaptimmune Therapeutics carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 30 days, the estimate for Ligand’s 2023 earnings per share has increased from $4.79 to $5.25. During the same period, the earnings per share estimate for 2024 has increased from $4.58 to $4.69. So far this year, the shares of Ligand have risen 15.1%.
Ligand Pharmaceuticals beat earnings estimates in two of the last four quarters and missed the mark on the other two occasions. On average, the company’s earnings witnessed an earnings surprise of 21.50%.
Estimates for Adaptive Biotechnologies’ 2023 loss per share have narrowed from 63 cents to 46 cents in the past 30 days. Shares of Adaptive Biotechnologies have declined 30.8% year to date.
Earnings of Adaptive Biotechnologies beat estimates in three of the last four quarters and met the mark on one occasion. On average, the company’s earnings witnessed an earnings surprise of36.89%.
Estimates for Akero Therapeutics’ 2023 loss per share have narrowed from $2.97 to $2.80 in the past 30 days. During the same period, the loss estimate per share for 2024 improved from $3.40 to $3.32. Shares of Akero Therapeutics have risen 3.8% year to date.
Earnings of Akero Therapeutics beat estimates in three of the last four quarters and missed the mark on one occasion. On average, the company’s earnings witnessed an earnings surprise of 7.96%.