FibroGEn Inc. - der Neue Star am Biotech Himmel?

SAN FRANCISCO--(BUSINESS WIRE)-- FibroGen, Inc. (Nasdaq:FGEN), a research-based biopharmaceutical company, today provided a corporate update and reported financial results for the year-ended December 31, 2014.

"FibroGen made excellent progress in 2014 on our lead clinical programs in anemia, fibrosis, and cancer," said Thomas Neff, chief executive officer of FibroGen. "We and our partners in the global development of roxadustat reached agreement on final protocols and are enrolling seven Phase 3 clinical trials of roxadustat for anemia in chronic kidney disease (CKD) in the US, Europe, and Asia Pacific, excluding Japan and China. Clinical trials of idiopathic pulmonary fibrosis and Stage 3 pancreatic cancer are on track, and we are now expanding our fibrosis program to include Duchenne muscular dystrophy."

"We ended 2014 with cash, cash equivalents, investments, and receivables of $346.8 million. As part of this amount, we received net proceeds of $171.8 million from our November 2014 initial public offering."

"In 2015, we expect to reach the cap on shared costs agreed upon with AstraZeneca for roxadustat CKD anemia development costs for the territories outside of China, after which, the costs we incur are reimbursed by our partners, as is described elsewhere in this press release."

"In addition, we expect non-contingent license and milestone payments of nearly $200 million in the next 15 months. We remain confident that our roxadustat CKD anemia program is fully funded through the planned Phase 3 clinical development program."

Recent Development Update

Roxadustat in Anemia of Chronic Kidney Disease

   Program remains on schedule to submit regulatory filings in 2016 for China and 2018 for U.S.
   Launch of seven Phase 3 studies for U.S. and European filing through collective efforts of FibroGen and its partners, AstraZeneca and Astellas.
   Phase 3 program expected to enroll approximately 7,300 dialysis and pre-dialysis patients.
   Completion of two carcinogenicity studies, one in rats and one in mice, and two independent pathology reviews of these studies. Final reports were audited and approved by all parties. The reports showed no carcinogenic effect of roxadustat.

FG-3019 in Idiopathic Pulmonary Fibrosis

   Study 067 - Ongoing Phase 2b randomized, placebo-controlled study of FG-3019 in patients with idiopathic pulmonary fibrosis.
   Protocol was amended to include subjects previously treated with recently approved IPF therapies.
   Study has been expanded to include certain European and former Commonwealth countries.

FG-3019 in Pancreatic Cancer

   Study 069 - Commenced enrollment in Phase 2a randomized open label study of FG-3019 in patients with Stage 3 unresectable pancreatic cancer.
   The endpoint of this randomized trial is complete surgical tumor removal in stage 3 pancreatic cancer patients who had inoperable tumors at study entry, thereby improving the prognosis for survival.

FG-3019 in Duchenne Muscular Dystrophy (DMD)

   Supportive review by TREAT-NMD Advisory Committee for Therapeutics (TACT) of proposed FG-3019 clinical plan was completed in December 2014. A summary of this review is available on their website.
   A DMD advisory board, comprising US and EU key opinion leaders, expressed support for investigational studies of FG-3019 as a potential treatment of DMD during its March 2015 meeting. Based on the CTGF mechanism of action on muscle differentiation and fibrosis, they suggested we evaluate the effect of FG-3019 on decline of lung capacity (due to decline in diaphragm function) and on progression of upper body muscle pathology and functional loss.
   FibroGen plans to commence patient enrollment in the second half of 2015.

China Manufacturing Certification

   In August 2014, the Beijing CFDA completed inspections and issued the Pharmaceutical Production Permit (PPP) to FibroGen China. The permit certifies that the facility was built and validated to GMP standards, and is a regulatory pre-requisite to starting the GMP NDA registration campaign for FG-4592 (roxadustat) in China.

Financial Results (unaudited)

Revenue, Operating Expenses, Net Loss, and EPS for the year ended December 31, 2014

   Total revenue was $137.6 million.
   Total operating expenses were $187.7 million, which includes $23.3 million of non-cash items.
   Net loss was $59.5 million.
   Pro forma loss per share was $1.01 based on 59.0 million shares outstanding at December 31, 2014.

Cost-Sharing Arrangements: FibroGen has two cost sharing arrangements with its collaboration partners, Astellas and AstraZeneca, for roxadustat.

   Under the Astellas arrangement, Astellas pays 50% of European and U.S. development costs, and 100% of Japan development costs incurred.
   Under the AstraZeneca arrangement, FibroGen's total funding obligations for roxadustat outside China are limited to $116.5 million. FibroGen and AstraZeneca are each responsible for 50% of roxadustat development costs not reimbursed by Astellas, until the cap is reached.
   Of the $116.5 million cap under the AstraZeneca arrangement, $46.8 million has been incurred and $69.7 million remained as of December 31, 2014.
   Based on current internal and partner projections, FibroGen expects to reach this $116.5 million cap in the fourth quarter of 2015.
   After the cap is reached, Astellas and AstraZeneca will be responsible for funding roxadustat development in CKD through launch for all territories outside of China.

Cash, Cash Equivalents, Investments, and Receivables

   At December 31, 2014, FibroGen's total cash balances were $346.8 million.
   Cash balance includes $171.8 million in net proceeds from the Company's initial public offering and side by side private placement of common stock to AstraZeneca.
 

aus meiner Sicht ein riesiges Potenzial drin.
Riesige Pipeline, einige vielversprechende Medikamente in Phase 3.
Starke Partner in Asien insbesondere in China.
Durchfinanziert
 

http://www.fibrogen.com/  

wurden alle Erwartungen übertroffen........:

Fibrogen earnings beat all estimates

A net loss of $1.01 for the whole year blew the estimates away which were a loss of $1.06 at best and $1.68 at worst. They hit the revenue estimates right on the head. The loss figure is confused by the computation of share count which uses a weighted average formula number of shares for the whole... More

Sentiment: Strong Buy
 

heute knapp 6 %. bei geringem Volumen.  

There were no additions to the IPO calendar last week; few companies launch before a shortened holiday week. Blueprint Medicines (BPMC) was the most notable new filer, given the biotech's $100 million proposed deal size and its lead bookrunner Goldman Sachs, as the underwriter has led just two biotech IPOs since 2013: FibroGen (FGEN; +66%) and Atara Biotherapeutics (ATRA; +233%).
http://seekingalpha.com/article/...its-domains-up-to-4-ipos-this-week  

Danke  

 

 

Quelle http://www.nasdaq.com/symbol/fgen  

http://charts.stocktwits.com/production/...al_38588361.jpg?1434978538
 

ist die abgegangen ! Freu  

weitergehen  

Da bin ich deiner Meinung !  

http://www.finanzen.net/analyse/...y-Stifel_Nicolaus__Co__Inc__619219  

 

deckt sich ca. mit dem im Aktionär ... aktueller Hot Stock der Woche mit 66 € Ziel  

in der aktuellen Ausgabe:
- Fibrogen könnte neue Maßstäbe in der Medizin setzen ("Gamechanger in der Entwicklung")
- gleich zwei aussichtsreiche Produktionskandidaten mit Milliardenpotenzial
- Spekulation auf Verpartnerung von Pamrevlumab
- Roxadustat könnte sich schon bald als Standardtherapie gegen Anämien etablieren
- Einreichung des Zulassungsantrags könnte bald in China erfolgen, Vertriebsstart dann bereits im kommenden Jahr
- Gerüchten zufolge steht ein Börsengang in China bei erfolgreicher Einführung zur Debatte
- Übernahmephantasie on top
- Der Aktionär geht davon aus, dass FGEN Pamrevlumab schon bald (!) einen einen "großen Pharma-/Biotech-Player" auslizensieren wird
- Kurstechnisch sei das Ende der Fahnenstange noch nicht erreicht (Zitat "in diesem Jahr Start einer möglichen Mega-Rallye")
- Fibrogen profitiert logischerweise vom Know-How Astrazenecas  

Passiert hier noch was ?  

"safety data" der  Phase 3 Studie für roxadustat kommen am Markt nicht gut an

• neues 52 Wochen-Tief
  

https://www.fiercebiotech.com/biotech/...ty-results-confuse-investors

 

Phase3 Studienergebnisse für Roxadustat

https://fibrogen.gcs-web.com/news-releases/...fety-results-roxadustat

 

Bin überrascht, dass sich in DE anscheinend keine "S*a" mehr für FibroGen interessiert.

Die NDA Entscheidung für Roxadusat sollte noch im Q1 veröffentlicht werden und ich persönlich erwarte mir hier (im Falle einer positiven Entscheidung) Kurse von $50+. Angesichts der zeitnahen Entscheidung durch die FDA wäre dies m.E. eine äußerst attraktive Rendite.

Naja, aber da keiner hier mitliest, ... ;-)

 

Schaun mer nun mal, was der Kurs die kommenden Tage macht.  

schaue hier regelmässig.Einstieg jetzt??  

schröd, dass kann ich dir nicht sagen.

Ich habe meine Posi zu 100% noch. Gebe aber auch zu, dass ich ob der bisherigen, kurzfristigen Entwicklung seit des NDA Approvals enttäuscht bin. Werde dennoch bis auf weiteres und vermutlich bis PDUFA halten.....

Was auch immer du machst: Good luck!