FIBROGEN WKN: A12EZ0 ISIN: US31572Q8087 Kürzel: 1FG Forum: Aktien Thema: Hauptdiskussion

FibroGen slides after FDA posted documents ahead of AdCom meeting on Roxadustat https://seekingalpha.com/news/3714766-fibrogen-slides-after-fda-posted-documents-ahead-of-adcom-meeting-on-roxadustat FibroGen (FGEN -6.3%) is trading lower after the FDA posted a report on Roxadustat ahead of a decision by its advisory committee this week. Roxadustat, an oral agent developed by the company in partnership with AstraZeneca (AZN -0.1%) for anemia of chronic kidney disease is set to undergo the review of FDA’s Cardiovascular and Renal Drugs Advisory Committee (CRDAC) on Thursday. The treatment that belongs to the category of Erythropoiesis Stimulating Agents (ESA) could face safety risks, the briefing documents filed by the FDA indicated. “You will discover that roxadustat’s efficacy is comparable to that of ESAs; however, there are important risks of serious thromboembolic events, as well as other risks, with Roxadustat,” the staff mentioned in the report. “The principal issue before the Committee is the drug’s safety, and safety with respect to the specific CKD patient populations,” they added. Last month, Fibrogen shares surged after the company announced that the European Medicines Agency (EMA) endorsed the therapy for the treatment of anemia symptoms in patients with chronic kidney disease.

https://www.reuters.com/article/brief-eu-drug-regulator-posts-human-medi-idUSFWN2O70C0 EMA-EVRENZO (ROXADUSTAT) ERHÄLT EINE POSITIVE STELLUNGNAHME ZUR BEHANDLUNG VON ANÄMIE-SYMPTOMEN BEI PATIENTEN MIT CHRONISCHER NIERENKRANKHEIT On 24 June 2021, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Evrenzo, intended for the treatment of anaemia symptoms in patients with chronic kidney disease. ... https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-evrenzo_en.pdf

FibroGen is facing a milestone this week: Mizuho https://seekingalpha.com/news/3708878-fibrogen-is-facing-a-milestone-this-week-mizuho • Fibrogen (FGEN -0.5%) is awaiting a key decision on its oral small molecule inhibitor Roxadustat as the European Medicines Agency (EMA) is set to decide on its approval for the treatment of anemia in adults with chronic kidney disease. • The decision expected this week will lead Fibrogen shares to move, Mizuho analysts led by Difei Yang note adding that the investors will consider the opinion of EMA’s Committee for Medicinal Products for Human Use ("CHMP") as a read through to an upcoming FDA Adcom meeting. • “A positive CHMP opinion in both the dialysis-dependent and non-dialysis-dependent settings would help de-risk next month's AdCom, in our opinion,” the analysts wrote. • In connection with the company’s New Drug Application (NDA) for roxadustat, the FDA has tentatively scheduled a meeting of its expert panel on July 15, Fibrogen announced last month.

FibroGen and HiFiBiO Announce Transformative Partnership to Advance Next-Generation Therapies for Patients with Cancer and Autoimmune Disease https://www.globenewswire.com/news-release/2021/06/17/2248801/33525/en/FibroGen-and-HiFiBiO-Announce-Transformative-Partnership-to-Advance-Next-Generation-Therapies-for-Patients-with-Cancer-and-Autoimmune-Disease.html • FibroGen Exclusively Licenses HiFiBiO’s Galectin-9 Program, and Obtains an Exclusive Option to their CXCR5 and CCR8 Programs • Transformative Transaction for FibroGen’s Early-stage Pipeline • HiFiBiO to Receive $25 Million Upfront, and Up to a Total of $1.1B in Additional Milestone Payments Across All Three Programs, Plus Royalties ...

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Pancreatic Cancer Action Network Partners With FibroGen To Bring New Experimental Treatment Arm To Adaptive Clinical Trial, Precision Promise(SM) https://www.prnewswire.com/news-releases/pancreatic-cancer-action-network-partners-with-fibrogen-to-bring-new-experimental-treatment-arm-to-adaptive-clinical-trial-precision-promisesm-301313531.html Addition Marks First Experimental Therapy Offered as Either First- or Second-Line Option for Pancreatic Cancer Patients Enrolled in Novel Trial Platform

Wieso geht's weiter nach unten, Leute, wo ist der Boden?

FibroGen Reports First Quarter 2021 Financial Results https://www.globenewswire.com/news-release/2021/05/10/2226627/0/en/FibroGen-Reports-First-Quarter-2021-Financial-Results.html • Roxadustat net product revenue in China of $15.4 million, on a US GAAP basis • Total roxadustat net sales in China of $43.5 million1 by FibroGen and the distribution entity jointly owned by FibroGen and AstraZeneca, compared to $29.2 million last quarter • FDA to hold Advisory Committee Meeting on Roxadustat NDA - tentative date July 15, 2021 ...

FibroGen Receives Rare Pediatric Disease Designation from the U.S. FDA for Pamrevlumab for the Treatment of Duchenne Muscular Dystrophy https://www.globenewswire.com/news-release/2021/04/15/2210640/33525/en/FibroGen-Receives-Rare-Pediatric-Disease-Designation-from-the-U-S-FDA-for-Pamrevlumab-for-the-Treatment-of-Duchenne-Muscular-Dystrophy.html

FibroGen Receives Fast Track Designation from the U.S. FDA for Pamrevlumab for the Treatment of Duchenne Muscular Dystrophy https://www.globenewswire.com/news-release/2021/04/12/2208102/33525/en/FibroGen-Receives-Fast-Track-Designation-from-the-U-S-FDA-for-Pamrevlumab-for-the-Treatment-of-Duchenne-Muscular-Dystrophy.html

Anschnallen oder guter Einstiegskurs?

https://de.investing.com/news/stock-market-news/fibrogenaktie-crasht-unstimmigkeiten-bei-sicherheitsdaten-2122890 Fibrogen-Aktie crasht: Unstimmigkeiten bei Sicherheitsdaten

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