conix
3 years ago
FibroGen Kidney-Disease Drug Set Back as FDA Panel Urges Rejection
Dan Weil
FibroGen shares slumped on Friday after an FDA advisory committee recommended against approval for roxadustat, the company's drug for anemia stemming from chronic kidney disease.
a person sitting on a table: FibroGen Kidney-Disease Drug Set Back as FDA Panel Urges Rejection© TheStreet FibroGen Kidney-Disease Drug Set Back as FDA Panel Urges Rejection
Shares of the San Francisco company recently traded at $15.89, down 36%. It had dropped 43% in the six months through Thursday.
The Food and Drug Administration isn't required to follow an advisory committee's vote, but it generally does.
"While we are disappointed with today's outcome, we believe the scientific evidence supports roxadustat approval in the U.S. and will work with the FDA as it completes its review of the new drug application," FibroGen Chief Executive Enrique Conterno said in a statement.
Roxadustat has been approved in China, Japan, Chile, and South Korea.
In other health news this week, the Centers for Medicare and Medicaid Services proposed reimbursement rules that include a 20% cut in physician payments for the Urolift service of medical device company Teleflex .
UroLift is Teleflex's system to treat enlarged prostate. The reimbursement guideline applies to procedures performed in doctors' offices.
The news was a "negative surprise," said Wells Fargo analyst Shagun Singh, according to Bloomberg. He said 30% of UroLift sales come from doctors' offices.
To be sure, Piper Sandler analyst Matt O'Brien said, according to Bloomberg, that while the reimbursement move on UroLift is sizable and will hurt doctors' profitability, it shouldn't greatly curb Teleflex's revenue and growth rate. He affirmed his overweight rating on the stock.
conix
3 years ago
Is Fibrogen Still a Buy Following Data Analysis Faux Pas? Analyst Weighs In
Marty Shtrubel
Apr 08, 2021
No one likes being given the wrong information. Investors reacted in dismay and sent Fibrogen (FGEN) shares deep into the red following the company’s embarrassing announcement. The biotech company said it had gotten the analysis for its therapy for sufferers of anemia related to chronic kidney disease, well, wrong.
The company said that the data from the late-stage study of roxadustat had “included post-hoc changes to the stratification factors.” The data was used instead of the original stratification plan, in presentations and several press releases last year. Leerink analyst Geoff Porges says it was also “presumably” used in the submission to the FDA.
Management said it was carrying out an “internal review to ensure such issues do not occur in the future.”
The major “oops,” says Porges, is nothing less than stunning.
“The re-statement reduced the benefit from roxa vs controls in every case, erased the appearance of superiority over ESAs in incident dialysis patients, and increased the apparent risk of a negative effect of roxa on CV safety in non-dialysis patients,” the analyst said. “It’s not clear to us whether the company previously mis-presented, or mis-represented, the results of the analysis, but either way this disclosure, long after the NDA had been submitted, and after both PDUFA dates have passed, raises questions about the reception that the company will get when they appear at the newly announced FDA Cardio Renal Advisory Committee meeting on July 15.”
The disclosure is also sure to raise several questions amongst investors. Does roxadustat still have any chance of approval? Will it affect the company’s partnership with AstraZeneca? Will management survive?
As far as Roxadustat is concerned, Porges anticipates one of two likely outcomes. If, as management has suggested, the FDA was informed of the issue and already aware of the “different statistical analyses,” then it “could approach the review without prejudice.” The drug could then even be granted approval by the end of the summer.
On the other hand, if the FDA has only recently been notified of the issue, then Porges says, there is the “real possibility that the agency will require a complete audit of all of the trial results, endpoints and analyses in the database, which could require many months.”
Porges takes the prudent approach and now does not expect approval until 1Q22.
Interestingly, though, Porges sticks to an Outperform (i.e. Buy) rating, and while the price target is reduced from $64 to $56, the revised figure still implies upside of a hefty 198%. (To watch Porges’ track record, click here)
Overall, TipRanks analysis of 9 analyst ratings shows an indecision between the bulls and the naysayers on FGEN: 4 suggest Buy, 4 say Hold, and only one recommends Sell. Importantly, the 12-month average price target stands at $47.17, marking nearly 151% in upside potential from where the stock is currently trading. (See FGEN stock analysis on TipRanks)
stocktrademan
9 years ago
$FGEN recent news/filings
bullish 30.28
resistance breakout
## source: finance.yahoo.com
Sat, 28 Nov 2015 15:49:56 GMT ~ Is Caleres Inc (CAL) Going to Burn These Hedge Funds?
read full: http://www.insidermonkey.com/blog/is-caleres-inc-cal-going-to-burn-these-hedge-funds-392549/
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Wed, 25 Nov 2015 16:39:20 GMT ~ Is Scholastic Corp (SCHL) Going to Burn These Hedge Funds?
read full: http://www.insidermonkey.com/blog/is-scholastic-corp-schl-going-to-burn-these-hedge-funds-2-388951/
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Thu, 19 Nov 2015 18:04:23 GMT ~ FIBROGEN INC Financials
read full: http://finance.yahoo.com/q/is?s=fgen
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Wed, 18 Nov 2015 13:00:01 GMT ~ Strength Seen in FibroGen (FGEN): Stock Rises 6.3%
read full: http://finance.yahoo.com/news/strength-seen-fibrogen-fgen-stock-130001890.html
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Mon, 16 Nov 2015 04:11:01 GMT ~ PRESS STATEMENT: First Gen reports 3Q2015 attributable net income at USD120 million
[at noodls] - November 13, 2015 First Gen Corporation (First Gen) reported net income attributable to equity holders of the parent of USD120 million for the first nine months of 2015. This was a 26%, or a USD43 million, ...
read full: http://www.noodls.com/view/035BC97E307BCF7E5C5D2A58253B68DF89395482
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$FGEN charts
basic chart ## source: stockcharts.com
basic chart ## source: stockscores.com
big daily chart ## source: stockcharts.com
big weekly chart ## source: stockcharts.com
$FGEN company information
## source: otcmarkets.com
Link: http://www.otcmarkets.com/stock/FGEN/company-info
Ticker: $FGEN
OTC Market Place: Not Available
CIK code: not found
Company name: FibroGen, Inc.
Incorporated In:
$FGEN share structure
## source: otcmarkets.com
Market Value: Not Available
Shares Outstanding: Not Available
Float: Not Available
Authorized Shares: Not Available
Par Value: Not Available
$FGEN extra dd links
Company name: FibroGen, Inc.
## STOCK DETAILS ##
After Hours Quote (nasdaq.com): http://www.nasdaq.com/symbol/FGEN/after-hours
Option Chain (nasdaq.com): http://www.nasdaq.com/symbol/FGEN/option-chain
Historical Prices (yahoo.com): http://finance.yahoo.com/q/hp?s=FGEN+Historical+Prices
Company Profile (yahoo.com): http://finance.yahoo.com/q/pr?s=FGEN+Profile
Industry (yahoo.com): http://finance.yahoo.com/q/in?s=FGEN+Industry
## COMPANY NEWS ##
Market Stream (nasdaq.com): http://www.nasdaq.com/symbol/FGEN/stream
Latest news (otcmarkets.com): http://www.otcmarkets.com/stock/FGEN/news - http://finance.yahoo.com/q/h?s=FGEN+Headlines
## STOCK ANALYSIS ##
Analyst Research (nasdaq.com): http://www.nasdaq.com/symbol/FGEN/analyst-research
Guru Analysis (nasdaq.com): http://www.nasdaq.com/symbol/FGEN/guru-analysis
Stock Report (nasdaq.com): http://www.nasdaq.com/symbol/FGEN/stock-report
Competitors (nasdaq.com): http://www.nasdaq.com/symbol/FGEN/competitors
Stock Consultant (nasdaq.com): http://www.nasdaq.com/symbol/FGEN/stock-consultant
Stock Comparison (nasdaq.com): http://www.nasdaq.com/symbol/FGEN/stock-comparison
Investopedia (investopedia.com): http://www.investopedia.com/markets/stocks/FGEN/?wa=0
Research Reports (otcmarkets.com): http://www.otcmarkets.com/stock/FGEN/research
Basic Tech. Analysis (yahoo.com): http://finance.yahoo.com/q/ta?s=FGEN+Basic+Tech.+Analysis
Barchart (barchart.com): http://www.barchart.com/quotes/stocks/FGEN
DTCC (dtcc.com): http://search2.dtcc.com/?q=FibroGen%2C+Inc.&x=10&y=8&sp_p=all&sp_f=ISO-8859-1
Spoke company information (spoke.com): http://www.spoke.com/search?utf8=%E2%9C%93&q=FibroGen%2C+Inc.
Corporation WIKI (corporationwiki.com): http://www.corporationwiki.com/search/results?term=FibroGen%2C+Inc.&x=0&y=0
## FUNDAMENTALS ##
Call Transcripts (nasdaq.com): http://www.nasdaq.com/symbol/FGEN/call-transcripts
Annual Report (companyspotlight.com): http://www.companyspotlight.com/library/companies/keyword/FGEN
Income Statement (nasdaq.com): http://www.nasdaq.com/symbol/FGEN/financials?query=income-statement
Revenue/EPS (nasdaq.com): http://www.nasdaq.com/symbol/FGEN/revenue-eps
SEC Filings (nasdaq.com): http://www.nasdaq.com/symbol/FGEN/sec-filings
Latest filings (otcmarkets.com): http://www.otcmarkets.com/stock/FGEN/filings
Latest financials (otcmarkets.com): http://www.otcmarkets.com/stock/FGEN/financials
Short Interest (nasdaq.com): http://www.nasdaq.com/symbol/FGEN/short-interest
Dividend History (nasdaq.com): http://www.nasdaq.com/symbol/FGEN/dividend-history
RegSho (regsho.com): http://www.regsho.com/tools/symbol_stats.php?sym=FGEN&search=search
OTC Short Report (otcshortreport.com): http://otcshortreport.com/index.php?index=FGEN
Short Sales (otcmarkets.com): http://www.otcmarkets.com/stock/FGEN/short-sales
Key Statistics (yahoo.com): http://finance.yahoo.com/q/ks?s=FGEN+Key+Statistics
Insider Roster (yahoo.com): http://finance.yahoo.com/q/ir?s=FGEN+Insider+Roster
Income Statement (yahoo.com): http://finance.yahoo.com/q/is?s=FGEN
Balance Sheet (yahoo.com): http://finance.yahoo.com/q/bs?s=FGEN
Cash Flow (yahoo.com): http://finance.yahoo.com/q/cf?s=FGEN+Cash+Flow&annual
## HOLDINGS ##
Major holdings (cnbc.com): http://data.cnbc.com/quotes/FGEN/tab/8.1
Insider transactions (yahoo.com): http://finance.yahoo.com/q/it?s=FGEN+Insider+Transactions
Insider transactions (secform4.com): http://www.secform4.com/insider-trading/FGEN.htm
Insider transactions (insidercrow.com): http://www.insidercow.com/history/company.jsp?company=FGEN
Ownership Summary (nasdaq.com): http://www.nasdaq.com/symbol/FGEN/ownership-summary
Institutional Holdings (nasdaq.com): http://www.nasdaq.com/symbol/FGEN/institutional-holdings
Insiders (SEC Form 4) (nasdaq.com): http://www.nasdaq.com/symbol/FGEN/insider-trades
Insider Disclosure (otcmarkets.com): http://www.otcmarkets.com/stock/FGEN/insider-transactions
## SOCIAL MEDIA AND OTHER VARIOUS SOURCES ##
PST (pennystocktweets.com): http://www.pennystocktweets.com/stocks/profile/FGEN
Market Watch (marketwatch.com): http://www.marketwatch.com/investing/stock/FGEN
Bloomberg (bloomberg.com): http://www.bloomberg.com/quote/FGEN:US
Morningstar (morningstar.com): http://quotes.morningstar.com/stock/s?t=FGEN
Bussinessweek (businessweek.com): http://investing.businessweek.com/research/stocks/snapshot/snapshot_article.asp?ticker=FGEN
$FGEN DD Notes ~ http://www.ddnotesmaker.com/FGEN
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