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First Wave (FWBI) Down 32% on Cystic Fibrosis Study Setback
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Shares of First Wave BioPharma (FWBI - Free Report) plunged 32.46% on Jul 13, after management announced initial top-line results from the phase II SPAN study evaluating its investigational oral biologic capsule adrulipase to treat exocrine pancreatic insufficiency (“EPI”) associated with cystic fibrosis (“CF”). The study enrolled a total of 13 CF patients, aged 18 years and older.
Preliminary data from the SPAN study showed that treatment with adrulipase was safe and well-tolerated. The data also suggested that it is likely the primary efficacy endpoint — coefficient of fat absorption — was not achieved.
FWBI plans to assess this preliminary data and expects to report additional findings on the SPAN study’s primary and secondary endpoints in approximately eight weeks.
However, considering the initial data and safety profile of adrulipase, FWBI intends to conduct an End-of-Phase II meeting with the FDA before this year’s end to review the data and discuss the parameters for a registrational phase III study which would support a potential biologics license application (“BLA”) filing for adrulipase in CF-induced EPI.
Year to date, shares of First Wave have lost 85.2% compared with the industry‘s 10.0% fall.
Image Source: Zacks Investment Research
First Wave BioPharma is also evaluating adrulipase in a separate mid-stage study for treating EPI caused by chronic pancreatitis (“CP”).
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 that 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 evaluating another pipeline candidate, niclosamide, in multiple clinical studies targeting ulcerative proctitis and ulcerative proctosigmoiditis, ulcerative colitis and Crohn’s disease indications.
Estimates for Alkermes’ 2023 earnings have increased from 20 cents to 79 cents in the past 60 days. The earnings estimates for 2024 have also increased from $1.73 to $2.07 in the past 60 days. Shares of Alkermes have risen 14.9% in the year-to-date period.
Earnings of Alkermes beat estimates in three of the last four quarters and met the mark on the one occasion, the average surprise being 90.83%. In the last reported quarter, Alkermes delivered an earnings surprise of 133.33%.
Estimates for Axsome Therapeutics’ 2023 earnings have narrowed from $4.16 to $3.96 in the past 60 days. The loss estimates for 2024 have also improved from $1.65 to $1.63 in the past 60 days. Shares of Axsome have lost 5.4% in the year-to-date period.
Earnings of Axsome Therapeutics beat estimates in three of the last four quarters and missed the mark on one occasion, the average surprise being 22.34%. In the last reported quarter, Axsome delivered an earnings surprise of 80.53%.
In the past 60 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 2.5%.
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%.In the last reported quarter, Ligand delivered an earnings surprise of 121.36%.
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First Wave (FWBI) Down 32% on Cystic Fibrosis Study Setback
Shares of First Wave BioPharma (FWBI - Free Report) plunged 32.46% on Jul 13, after management announced initial top-line results from the phase II SPAN study evaluating its investigational oral biologic capsule adrulipase to treat exocrine pancreatic insufficiency (“EPI”) associated with cystic fibrosis (“CF”). The study enrolled a total of 13 CF patients, aged 18 years and older.
Preliminary data from the SPAN study showed that treatment with adrulipase was safe and well-tolerated. The data also suggested that it is likely the primary efficacy endpoint — coefficient of fat absorption — was not achieved.
FWBI plans to assess this preliminary data and expects to report additional findings on the SPAN study’s primary and secondary endpoints in approximately eight weeks.
However, considering the initial data and safety profile of adrulipase, FWBI intends to conduct an End-of-Phase II meeting with the FDA before this year’s end to review the data and discuss the parameters for a registrational phase III study which would support a potential biologics license application (“BLA”) filing for adrulipase in CF-induced EPI.
Year to date, shares of First Wave have lost 85.2% compared with the industry‘s 10.0% fall.
Image Source: Zacks Investment Research
First Wave BioPharma is also evaluating adrulipase in a separate mid-stage study for treating EPI caused by chronic pancreatitis (“CP”).
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 that 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 evaluating another pipeline candidate, niclosamide, in multiple clinical studies targeting ulcerative proctitis and ulcerative proctosigmoiditis, ulcerative colitis and Crohn’s disease indications.
First Wave BioPharma, Inc. Price
First Wave BioPharma, Inc. price | First Wave BioPharma, Inc. Quote
Zacks Rank & Stocks to Consider
First Wave BioPharma currently carries a Zacks Rank #4 (Sell).Some better-ranked stocks in the overall healthcare sector include Alkermes (ALKS - Free Report) , Axsome Therapeutics (AXSM - Free Report) and Ligand Pharmaceuticals (LGND - Free Report) , each sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Estimates for Alkermes’ 2023 earnings have increased from 20 cents to 79 cents in the past 60 days. The earnings estimates for 2024 have also increased from $1.73 to $2.07 in the past 60 days. Shares of Alkermes have risen 14.9% in the year-to-date period.
Earnings of Alkermes beat estimates in three of the last four quarters and met the mark on the one occasion, the average surprise being 90.83%. In the last reported quarter, Alkermes delivered an earnings surprise of 133.33%.
Estimates for Axsome Therapeutics’ 2023 earnings have narrowed from $4.16 to $3.96 in the past 60 days. The loss estimates for 2024 have also improved from $1.65 to $1.63 in the past 60 days. Shares of Axsome have lost 5.4% in the year-to-date period.
Earnings of Axsome Therapeutics beat estimates in three of the last four quarters and missed the mark on one occasion, the average surprise being 22.34%. In the last reported quarter, Axsome delivered an earnings surprise of 80.53%.
In the past 60 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 2.5%.
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%.In the last reported quarter, Ligand delivered an earnings surprise of 121.36%.