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First Wave (FWBI) IND Filing Under FDA's Review, Stock Up
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First Wave BioPharma, Inc.’s (FWBI - Free Report) shares rose 20.02% in after-market trading hours after the company announced that the FDA is reviewing the investigational new drug (IND) amendment for the planned phase II study of an enhanced enteric microgranule delivery formulation for adrulipase as a treatment for exocrine pancreatic insufficiency (EPI) associated with cystic fibrosis (CF) and chronic pancreatitis (CP) as an IND protocol amendment.
Adrulipase is a recombinant lipase enzyme administered as an oral, non-systemic biologic capsule for the treatment of exocrine EPI associated with CF and CP.
The FDA tries to complete its review of phase II protocols within 60 days as per the guidelines, but that is contingent on available resources.
On Nov 30, First Wave submitted the IND amendment to the FDA. It expects a forthcoming response around the end of this month.
The company is engaged in the research and development of targeted, non-systemic therapies for the treatment of patients with gastrointestinal (“GI”) diseases and is developing a pipeline of gut-restricted GI clinical drug candidates, including adrulipase and niclosamide, an oral small molecule with anti-viral and anti-inflammatory properties.
Last month, First Wave selected the initial clinical trial sites for its planned phase II study evaluating an enhanced enteric microgranule delivery formulation of adrulipase as a treatment for exocrine EPI associated with CF and CP.
Shares of First Wave have plunged 98.5% in the past year compared with the industry’s decline of 12.9%.
Image Source: Zacks Investment Research
First Wave is advancing two phase II programs built around adrulipase for the treatment of exocrine pancreatic insufficiency (FW-EPI) in patients with CF and CP.
First Wave is also advancing multiple programs involving niclosamide, including FW-UP for ulcerative proctitis and ulcerative proctosigmoiditis, FW-UC for ulcerative colitis, and FW-CD for Crohn’s disease.
The successful development of its pipeline holds the key for this clinical-stage company.
Zacks Rank & Other Stocks to Consider
First Wave currently carries a Zacks Rank #2 (Buy). Some other top-ranked stocks in the biotech sector are Syndax Pharmaceuticals, Inc. (SNDX - Free Report) and Inovio Pharmaceuticals (INO - Free Report) . Both companies currently sport carry a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Loss per share estimates for Syndax Pharmaceuticals for 2022 and 2023 have narrowed by 5 cents and 18 cents, respectively, over the past 60 days. Earnings of Syndax Pharmaceuticals surpassed estimates in three of the trailing four quarters and met the same on the other occasion. SNDX witnessed an earnings surprise of 95.39% on average.
Loss per share estimates for INO have narrowed by 29 cents and 44 cents for 2022 and 2023, respectively, in the past 60 days.
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First Wave (FWBI) IND Filing Under FDA's Review, Stock Up
First Wave BioPharma, Inc.’s (FWBI - Free Report) shares rose 20.02% in after-market trading hours after the company announced that the FDA is reviewing the investigational new drug (IND) amendment for the planned phase II study of an enhanced enteric microgranule delivery formulation for adrulipase as a treatment for exocrine pancreatic insufficiency (EPI) associated with cystic fibrosis (CF) and chronic pancreatitis (CP) as an IND protocol amendment.
Adrulipase is a recombinant lipase enzyme administered as an oral, non-systemic biologic capsule for the treatment of exocrine EPI associated with CF and CP.
The FDA tries to complete its review of phase II protocols within 60 days as per the guidelines, but that is contingent on available resources.
On Nov 30, First Wave submitted the IND amendment to the FDA. It expects a forthcoming response around the end of this month.
The company is engaged in the research and development of targeted, non-systemic therapies for the treatment of patients with gastrointestinal (“GI”) diseases and is developing a pipeline of gut-restricted GI clinical drug candidates, including adrulipase and niclosamide, an oral small molecule with anti-viral and anti-inflammatory properties.
Last month, First Wave selected the initial clinical trial sites for its planned phase II study evaluating an enhanced enteric microgranule delivery formulation of adrulipase as a treatment for exocrine EPI associated with CF and CP.
Shares of First Wave have plunged 98.5% in the past year compared with the industry’s decline of 12.9%.
Image Source: Zacks Investment Research
First Wave is advancing two phase II programs built around adrulipase for the treatment of exocrine pancreatic insufficiency (FW-EPI) in patients with CF and CP.
First Wave is also advancing multiple programs involving niclosamide, including FW-UP for ulcerative proctitis and ulcerative proctosigmoiditis, FW-UC for ulcerative colitis, and FW-CD for Crohn’s disease.
The successful development of its pipeline holds the key for this clinical-stage company.
Zacks Rank & Other Stocks to Consider
First Wave currently carries a Zacks Rank #2 (Buy). Some other top-ranked stocks in the biotech sector are Syndax Pharmaceuticals, Inc. (SNDX - Free Report) and Inovio Pharmaceuticals (INO - Free Report) . Both companies currently sport carry a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Loss per share estimates for Syndax Pharmaceuticals for 2022 and 2023 have narrowed by 5 cents and 18 cents, respectively, over the past 60 days. Earnings of Syndax Pharmaceuticals surpassed estimates in three of the trailing four quarters and met the same on the other occasion. SNDX witnessed an earnings surprise of 95.39% on average.
Loss per share estimates for INO have narrowed by 29 cents and 44 cents for 2022 and 2023, respectively, in the past 60 days.