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)
LongRun8
9 years ago
Phase 2 Data for Investigational Orally Active HIF-PHI Roxadustat (FG-4592) Show Anemia Correction in Incident Dialysis Chronic Kidney Disease Patients Regardless of Iron Repletion Status, Iron Supplementation Regimen, or Dialysis Modality
October 22, 2015
SAN FRANCISCO, Oct. 22, 2015 (GLOBE NEWSWIRE) -- FibroGen, Inc. (Nasdaq:FGEN) (“FibroGen”), a research-based biopharmaceutical company, along with its partner, AstraZeneca (NYSE:AZN), today announced that the Journal of the American Society of Nephrology has published Phase 2 data showing roxadustat, an investigational therapy for the treatment of anemia in patients with chronic kidney disease (CKD), achieved 96 percent hemoglobin (Hb) response and increased mean Hb regardless of baseline iron repletion status, C-reactive protein level, iron regimen, or dialysis modality within 7 weeks.
The primary endpoint, the mean maximum Hb change from baseline (baseline Hb 8.3+1.0 g/dL), was 3.1 ±0.2 g/dL (SEM) among the efficacy evaluable subjects (n=55). Hb response, defined as Hb increase by ≥ 1.0 g/dL, was achieved in 96 percent of all roxadustat-treated subjects, with a median time to Hb response of 3 weeks in each cohort.
“This trial demonstrated that roxadustat may be able to correct anemia in an incident dialysis population, and to do so with either oral or IV iron supplementation even when the patient’s initial iron status does not meet broadly accepted clinical practice guidelines,” said Anatole Besarab, MD, executive director, clinical research, at FibroGen, and lead author. “The correction of anemia with roxadustat did not require prior iron repletion as is often the case with erythropoiesis-stimulating agents. This independence of hemoglobin response from iron regimen or basal iron status resulted from reduction in the hepcidin levels.”
The rates of increase in mean Hb over the 12-week treatment period and the mean Hb levels during the last four weeks were similar among patients receiving oral or intravenous (IV) iron (mean maximum Hb change of 3.4 to 3.5 g/dL). Roxadustat therapy in the absence of any form of iron supplementation still led to a mean maximum Hb increase of 2.8 g/dL.
“We designed this study to evaluate the ability of roxadustat to correct hemoglobin in what is widely regarded as the highest risk yet least frequently studied population of CKD patients,” said Thomas Neff, chief executive officer of FibroGen. “Our study showed that newly initiated dialysis patients with end stage renal disease had a robust hemoglobin response regardless of whether they received IV or oral iron supplementation. FibroGen and its partners are currently conducting a global Phase 3 clinical program evaluating the efficacy and safety of roxadustat in patients with anemia due to CKD, including incident and stable dialysis patients and patients not on dialysis.”
Current treatment of anemia in CKD requires erythropoiesis-stimulating agents (ESAs) with IV iron supplementation, particularly in end stage renal disease patients (ESRD). In standard clinical practice, ESRD patients who have recently started dialysis are a clinically challenging population. During the first four months of dialysis initiation, life-threatening cardiovascular complications and other adverse events generally occur more frequently than thereafter, leading to a higher mortality rate for incident dialysis patients than for stable dialysis patients.1 It is during this period of initiation that the highest doses of erythropoietin analog and IV iron use are required. In addition, a variety of factors, including the obligate need for IV iron with ESAs, inhibit optimal Hb correction during this initiation period.2
About the Study
This was a randomized, open-label, dose-titration study in incident dialysis subjects not receiving ESA treatment to evaluate the efficacy of roxadustat in the correction of anemia.
This study was conducted in 60 patients who received no iron, oral iron, or IV iron while treated with roxadustat for 12 weeks.
Eligible patients were erythropoietin analog-naïve, had initiated dialysis two weeks to four months before enrollment with baseline Hb values ≤10.0 g/dL, had ferritin levels of 50 to 300 ng/mL, had transferrin saturation levels of 10% to 30%, had normal liver function, and had not received IV iron therapy within four weeks prior to randomization. In this study, 24 hemodialysis (HD) subjects received no exogenous iron supplementation, 12 HD and 12 peritoneal dialysis (PD) subjects received oral iron, and 12 HD subjects were administered IV iron.
Roxadustat was dosed orally three times weekly for 12 weeks. Initial doses (1.0 - 1.7 mg/kg per dose) for the first four weeks were determined using three body weight tiers, followed by dose adjustment evaluations every four weeks based on Hb, to a maximum of 2.5 mg/kg.
Roxadustat was well tolerated in the safety population. Treatment-emergent adverse events were reported in 30 patients, 50 percent of all patients in the safety population. The nature and severity of the adverse events was typical for ESRD patients undergoing HD or PD. Adverse events characterized as severe (n=4), life-threatening (n=0), or fatal (n=2) were reported in six (10 percent) patients.
Detailed results and safety data from the trial were published in Journal of the American Society of Nephrology and can be viewed here: http://jasn.asnjournals.org/content/early/2015/10/22/ASN.2015030241.full.pdf+html.
About Roxadustat (FG-4592)
Roxadustat is an orally administered small molecule inhibitor of hypoxia-inducible factor (HIF) prolyl hydroxylase activity, in development for the treatment of anemia in patients with chronic kidney disease. HIF is a protein transcription factor that induces the natural physiological response to conditions of low oxygen, "turning on" erythropoiesis (the process by which red blood cells are produced) and other protective pathways.
About Chronic Kidney Disease
CKD affects more than 200 million people worldwide and more than 30 million adults in the U.S. Although it can occur at any age, it becomes more common in aging populations and the prevalence is increasing. Currently, no curative treatment or ability to stop kidney deterioration in CKD exists with the exception of kidney transplantation, creating a significant unmet medical need.
About FibroGen
FibroGen is a research-based biopharmaceutical company focused on the discovery, development, and commercialization of novel therapeutics to treat serious unmet medical needs. The company utilizes its extensive experience in fibrosis and hypoxia-inducible factor (HIF) biology to generate development programs in multiple therapeutic areas. Its most advanced product candidate, roxadustat, or FG-4592, is an orally administered small molecule inhibitor of HIF prolyl hydroxylase (HIF-PH) activity in Phase 3 clinical development for the treatment of anemia in CKD. A second product candidate, FG-3019, is a monoclonal antibody in Phase 2 clinical development for the treatment of idiopathic pulmonary fibrosis (IPF), pancreatic cancer and liver fibrosis. For more information please visit:www.fibrogen.com.
Forward Looking Statements
This release contains forward-looking statements, including statements regarding the increasing prevalence of CKD and the potential for roxadustat to be able to correct anemia in an incident dialysis population regardless of baseline iron repletion status or method of iron supplementation. Actual prevalence of CKD and our actual results may differ materially from those indicated in these forward-looking statements due to risks and uncertainties that are described in our Annual Report on Form 10-K and our quarterly reports on Form 10-Q filed with the Securities and Exchange Commission, including the risk factors set forth therein. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release and we undertake no obligation to update any forward-looking statement in this press release, except as required by law.
References
United States Renal Data System. 2013 USRDS annual data report: Epidemiology of kidney disease in the United States, Volume 2, Chapter 5.National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, 2013.
United States Renal Data System. 2013 USRDS annual data report: Epidemiology of kidney disease in the United States, Volume 2, Chapter 2.National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MDContact Greg Mann FibroGen, Inc. 415-978-1433 gmann@fibrogen.com
FibroGen, Inc.
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stocktrademan
9 years ago
$FGEN DD Notes ~ http://www.ddnotesmaker.com/FGEN
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$FGEN recent news/filings
## source: finance.yahoo.com
Tue, 09 Dec 2014 11:32:05 GMT ~ Coverage initiated on FibroGen by RBC Capital Mkts and Stifel
read full: http://finance.yahoo.com/q/ud?s=FGEN
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Fri, 21 Nov 2014 11:03:07 GMT ~ FIBROGEN INC Files SEC form 8-K, Material Modification to Rights of Security Holders, Amendments to Articles of Inc.
read full: http://biz.yahoo.com/e/141121/fgen8-k.html
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Wed, 19 Nov 2014 15:08:21 GMT ~ FibroGen, Inc. Announces Pricing of Its Initial Public Offering
[at noodls] - SAN FRANCISCO--(BUSINESS WIRE)--Nov. 13, 2014-- FibroGen, Inc. (NASDAQ:FGEN), a research-based biopharmaceutical company focused on the discovery, development and commercialization of novel therapeutics ...
read full: http://www.noodls.com/view/965FFCACE045817F9253B5797D6172A5BC567FBE
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Wed, 19 Nov 2014 15:08:04 GMT ~ FibroGen, Inc. Announces Full Exercise of Greenshoe Option
[at noodls] - SAN FRANCISCO--(BUSINESS WIRE)--Nov. 17, 2014-- FibroGen, Inc. (NASDAQ:FGEN), a research-based biopharmaceutical company focused on the discovery, development and commercialization of novel therapeutics ...
read full: http://www.noodls.com/view/DC458B462335AEB1E408CE3A9299E8EADCFB7907
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Mon, 17 Nov 2014 12:05:00 GMT ~ FibroGen, Inc. Announces Full Exercise of Greenshoe Option
[Business Wire] - FibroGen, Inc. , a research-based biopharmaceutical company focused on the discovery, development and commercialization of novel therapeutics to treat serious unmet medical needs, today announced that the underwriters of its initial public offering exercised in full their option to purchase an additional 1,215,000 shares of common stock from FibroGen at the initial public offering price of $18.00 per ...
read full: http://finance.yahoo.com/news/fibrogen-inc-announces-full-exercise-120500087.html
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$FGEN charts
basic chart ## source: stockcharts.com
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$FGEN company information
## source: otcmarkets.com
Link: http://www.otcmarkets.com/stock/FGEN/company-info
Ticker: $FGEN
OTC Market Place: Not Available
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Company name: FibroGen, Inc.
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$FGEN share structure
## source: otcmarkets.com
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$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
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