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FibroGen's (FGEN) Drug for Anemia of CKD Gets CRL From FDA
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FibroGen, Inc. (FGEN - Free Report) announced that the FDA has refused to approve its new drug application (“NDA”) for roxadustat. The NDA is seeking approval of the candidate for the treatment of anemia of chronic kidney disease (“CKD”) in both non-dialysis-dependent (“NDD”) and dialysis-dependent (“DD”) adult patients.
The FDA issued a complete response letter (“CRL”) indicating that it will not approve roxadustat’s NDA in its present form. The letter also asked the company to conduct additional clinical studies on the candidate, prior to resubmission of NDA.
We remind investors that in the last month, the FDA’s Advisory Committee had voted majorly against roxadustat stating that the candidate’s benefit-risk profile does not support approval of the given indication. The Committee voted one in favor and 13 against for NDD patients, and voted two in favor and 12 against for DD patients.
Shares of the company fell 5.7% on Aug 11, following the above-mentioned news. In fact, the stock has plunged 66.5% so far this year in comparison with the industry’s decline of 12.4%.
Image Source: Zacks Investment Research
The company has partnered with Astrazeneca (AZN - Free Report) for development and commercialization of roxadustat across the United States. Both the companies will discuss the next steps to be taken in the United States, following FDA’s response.
Please note that roxadustat has already been approved in China, Japan, Chile and South Korea for a similar indication. In Europe, the Committee for Medicinal Products for Human Use has recommended the approval of roxadustatfor symptomatic anemia of CKD.
Anemia of CKD is a serious medical condition in which patients have insufficient red blood cells and low levels of hemoglobin. It is a common early complication of CKD, a progressive disease characterized by gradual loss of kidney function that may eventually lead to kidney failure or end stage renal disease, requiring dialysis or kidney transplant.
FibroGen currently carries a Zacks Rank #4 (Sell). A couple of better-ranked stocks in the biotech/drug sector are Ironwood Pharmaceuticals (IRWD - Free Report) and Repligen (RGEN - Free Report) . While Ironwood sports a Zacks Rank #1 (Strong Buy), Repligen currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Ironwood’s earnings per share estimates for 2021 have increased from $1.05 to $2.04 in the past 30 days. The same for 2022 has risen from $1.18 to $1.72 over the same period. The stock has rallied 22.2% in the year so far.
Repligen’s earnings per share estimates for 2021 have increased from $2.26 to $2.69 in the past 30 days. The same for 2022 has risen from $2.56 to $2.94 over the same period. The stock has rallied 30.3% in the year so far.
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FibroGen's (FGEN) Drug for Anemia of CKD Gets CRL From FDA
FibroGen, Inc. (FGEN - Free Report) announced that the FDA has refused to approve its new drug application (“NDA”) for roxadustat. The NDA is seeking approval of the candidate for the treatment of anemia of chronic kidney disease (“CKD”) in both non-dialysis-dependent (“NDD”) and dialysis-dependent (“DD”) adult patients.
The FDA issued a complete response letter (“CRL”) indicating that it will not approve roxadustat’s NDA in its present form. The letter also asked the company to conduct additional clinical studies on the candidate, prior to resubmission of NDA.
We remind investors that in the last month, the FDA’s Advisory Committee had voted majorly against roxadustat stating that the candidate’s benefit-risk profile does not support approval of the given indication. The Committee voted one in favor and 13 against for NDD patients, and voted two in favor and 12 against for DD patients.
Shares of the company fell 5.7% on Aug 11, following the above-mentioned news. In fact, the stock has plunged 66.5% so far this year in comparison with the industry’s decline of 12.4%.
Image Source: Zacks Investment Research
The company has partnered with Astrazeneca (AZN - Free Report) for development and commercialization of roxadustat across the United States. Both the companies will discuss the next steps to be taken in the United States, following FDA’s response.
Please note that roxadustat has already been approved in China, Japan, Chile and South Korea for a similar indication. In Europe, the Committee for Medicinal Products for Human Use has recommended the approval of roxadustatfor symptomatic anemia of CKD.
Anemia of CKD is a serious medical condition in which patients have insufficient red blood cells and low levels of hemoglobin. It is a common early complication of CKD, a progressive disease characterized by gradual loss of kidney function that may eventually lead to kidney failure or end stage renal disease, requiring dialysis or kidney transplant.
FibroGen, Inc Price
FibroGen, Inc price | FibroGen, Inc Quote
Zacks Rank & Stocks to Consider
FibroGen currently carries a Zacks Rank #4 (Sell). A couple of better-ranked stocks in the biotech/drug sector are Ironwood Pharmaceuticals (IRWD - Free Report) and Repligen (RGEN - Free Report) . While Ironwood sports a Zacks Rank #1 (Strong Buy), Repligen currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Ironwood’s earnings per share estimates for 2021 have increased from $1.05 to $2.04 in the past 30 days. The same for 2022 has risen from $1.18 to $1.72 over the same period. The stock has rallied 22.2% in the year so far.
Repligen’s earnings per share estimates for 2021 have increased from $2.26 to $2.69 in the past 30 days. The same for 2022 has risen from $2.56 to $2.94 over the same period. The stock has rallied 30.3% in the year so far.