NY-VIFOR
27.10.2021 07:02:10 CEST | Business Wire | Press release
Regulatory News:
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20211026006150/en/
AD HOC ANNOUNCEMENT PURSUANT TO ART. 53 LR
Vifor Pharma and Angion Biomedica Corp. (NASDAQ: ANGN) today announced that the phase-III trial of Angion’s ANG-3777 did not demonstrate a statistically significant difference from placebo on the primary endpoint (eGFR at 12 months) in the population of deceased donor kidney transplant patients who were at risk for developing DGF.
ANG-3777 showed a modest but not statistically significant difference in eGFR of 53.3mL/min/1.73m2 versus 50.4mL/min/1.73m2 for placebo (2.9 mL/min/1.73m2 (p=0.33)). In addition, ANG-3777 demonstrated an inconsistent benefit on key secondary endpoints. Based upon these data, it is not expected there is sufficient evidence to support an indication in the studied DGF population.
The statistical analysis plan also included an analysis of only those people who completed the trial, without using a multiple imputation method to account for missing data and intercurrent events. Under this analysis, ANG-3777 showed a difference on 12 month eGFR of 57.1mL/min/1.73m2 versus 52.2mL/min/1.73m2 (4.9mL/min/1.73m2 , p=0.06) for placebo. These data are potentially indicative of biologic activity of ANG-3777.
The overall safety profile of ANG-3777 in this trial was consistent with the overall experience in its clinical development program and consistent with the published literature in this patient population.
“Unfortunately, the results of the phase-III registrational trial did not confirm as strong of an effect as we hoped for in the interests of patients experiencing DGF after kidney transplantation”, said Dr. Klaus Henning Jensen, Chief Medical Officer of Vifor Pharma. “These kinds of challenges are part of clinical development activities. Our collaboration with Angion and the development of ANG-3777 in cardiac-surgery associated acute kidney injury (CSA-AKI) continues unchanged, with topline data expected later this year.”
“We are disappointed in the outcome of this trial. While we saw signals of activity for ANG‑3777, we hoped ANG-3777 would robustly demonstrate a benefit for transplant recipients who have no treatment options when their transplants have DGF,” stated Jay Venkatesan, M.D., Angion’s President and CEO. “The totality of the DGF data, together with the CSA-AKI data expected later this year, will inform our clinical strategy with respect to ANG-3777 going forward. I want to extend my special thanks to the patients, their families, and the investigators and their staff members who participated and worked diligently on this trial.”
This multi-center, double-blinded, and placebo-controlled phase-III trial randomized 253 patients 1:1 to receive ANG-3777 or a placebo treatment dosed once per day for three days. Eligible patients received a deceased donor transplant and were determined to be at risk for delayed graft function by having low urine output (oliguria) for more than 8 consecutive hours post-transplant, reflecting potential graft injury. Twenty-five transplant centers in the U.S. enrolled patients in this phase-III registration trial. The primary endpoint was renal function assessed by estimated glomerular filtration rate (eGFR) with a primary analysis time point of eGFR at twelve months using a pre-specified multiple imputation method.
About Vifor Pharma Group
Vifor Pharma Group is a global pharmaceuticals company. It aims to become the global leader in iron deficiency, nephrology and cardio-renal therapies. The company is a partner of choice for pharmaceuticals and innovative patient-focused solutions. Vifor Pharma Group strives to help patients around the world with severe and chronic diseases lead better, healthier lives. The company develops, manufactures and markets pharmaceutical products for precision patient care. Vifor Pharma Group holds a leading position in all its core business activities and consists of the following companies: Vifor Pharma and Vifor Fresenius Medical Care Renal Pharma (a joint company with Fresenius Medical Care). Vifor Pharma Group is headquartered in Switzerland, and listed on the Swiss Stock Exchange (SIX Swiss Exchange, VIFN, ISIN: CH0364749348).
For more information, please visit viforpharma.com .
About Angion
Angion is committed to transforming the treatment paradigm for patients suffering from acute organ injuries and fibrotic diseases for which there are no approved medicines or where existing approved medicines have limitations. Angion’s lead product candidate, ANG-3777, is a hepatocyte growth factor (HGF) mimetic. An exploratory Phase 2 trial of ANG-3777 for the treatment of acute kidney injury associated with cardiac surgery involving cardiopulmonary bypass surgery is ongoing with data expected in the fourth quarter of 2021. Angion is scheduled to begin a Phase 2 trial evaluating ANG-3070, an oral tyrosine kinase receptor inhibitor for the treatment of fibrotic disease, in patients with primary proteinuric kidney diseases. Additionally, Angion has preclinical programs for a rho kinase 2 (ROCK2) inhibitor and a CYP11B2 (aldosterone synthase) inhibitor. For more information, please visit www.angion.com .
Angion expects to report cash and cash equivalents as of 30 September 2021 totaling approximately $100 million, when it reports quarterly earnings in November 2021.
About ANG-3777
ANG-3777 is a small molecule designed to mimic the biological activity of hepatocyte growth factor (HGF), which activates the c-Met cascade of pathways involved in tissue repair and organ repair. ANG-3777 has a substantially longer half-life than HGF. An exploratory phase-II trial for the treatment of acute kidney injury associated with cardiac surgery involving cardiopulmonary bypass (CSA-AKI) is ongoing with data expected in the fourth quarter of 2021. In November 2020, Vifor Pharma and Angion signed a license agreement for global rights outside Greater China to commercialize ANG-3777 in nephrology indications only.
Forward Looking Statements
Statements contained in this press release regarding matters that may occur in the future are “forward looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including but not limited to statements in this press release regarding Angion’s expectations that release of topline data from the ANG-3777 Phase 2 exploratory trial for the treatment of acute kidney injury associated with cardiac surgery involving cardiopulmonary bypass surgery will be in the fourth quarter of 2021, a global Phase 2 trial of ANG-3070 in patients with primary proteinuric kidney diseases will begin enrolling patients this year, and Angion expects to report cash and cash equivalents as of September 30, 2021 totaling approximately $100 million. Such statements are subject to risks and uncertainties and actual results may differ materially from those expressed or implied by such forward-looking statements. In particular, the following factors, among others, could cause results to differ materially from those expressed or implied by such forward-looking statements: reporting of trial results or commencing enrollment in clinical trials could be delayed for reasons outside of Angion’s control, including the effects of COVID-19 on Angion’s clinical programs and business operations; and Angion’s September 30, 2021 estimated cash is preliminary and is subject to review and adjustment during the financial review process. For a description of risks and uncertainties that could cause actual results to differ from those expressed in forward-looking statements, see Angion’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2021, filed with the Securities and Exchange Commission on August 12, 2021, particularly the information under the caption “Risk Factors,” as well as other documents that may be filed by Angion from time to time with the Securities and Exchange Commission. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. Angion undertakes no obligation to update any forward-looking statement in this press release, except as required by law.
View source version on businesswire.com: https://www.businesswire.com/news/home/20211026006150/en/
Link:
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
IFF Reports Fourth Quarter and Full Year 2025 Results11.2.2026 22:36:00 CET | Press release
Delivered solid top and bottom-line performance & advanced strategic priorities in 2025Launched sale process for the Food Ingredients segmentContinuing to drive financial performance in 2026 International Flavors & Fragrances Inc. (NYSE: IFF) reported financial results for the fourth quarter and full year ended December 31, 2025. Full year 2025 Consolidated Summary: Management Commentary “IFF delivered a solid 2025 performance, meeting the full-year financial commitments we set at the start of the year, despite a challenging operating environment,” said Erik Fyrwald, CEO of IFF. “It was also a year of continued strategic progress. We invested in R&D, commercial capabilities, and capacity expansion to better serve customers, advance our innovation pipeline, and support future profitable growth.” “We also took steps to optimize our portfolio. Through several divestitures and the recent launch of a sale process for our Food Ingredients segment, we sharpened our strategic focus and improve
Grid Dynamics Accelerates AI Transformation Momentum11.2.2026 22:05:00 CET | Press release
Earns Preferred Vendor Status at a Top-Tier Hyperscaler; 2025 AI Revenue Grew 30% Year-Over-YearKey Takeaways: Achieved Preferred Vendor status with a top-tier hyperscaler, opening up a significantly larger revenue opportunity for Grid Dynamics. In 2025, Grid Dynamics achieved 30% year-over-year AI revenue growth. Partners increasingly rely on Grid Dynamics to deliver next-generation AI capabilities to global clients, supporting continued AI revenue growth. Grid Dynamics Holdings, Inc. (Nasdaq: GDYN) (“Grid Dynamics”), a premier AI transformation partner for the Fortune 1000, today announced it has achieved Preferred Vendor status with one of the major hyperscale cloud providers. This milestone follows a strategic, exhaustive two-year vendor consolidation initiative by the hyperscaler that reduced its service provider ecosystem to a small group. This designation establishes the contractual framework for Grid Dynamics to significantly increase business with this hyperscaler, boosting Gr
Altasciences Announces Chris Perkin Appointed Executive Chairman; Marie-Hélène Raigneau Appointed Chief Executive Officer11.2.2026 21:14:00 CET | Press release
Altasciences announced today that Chris Perkin has been appointed Executive Chairman of the company’s Board of Directors, effective Tuesday, February 24, 2026. Following a leadership transition that has been underway for the past 12 months, Marie-Hélène Raigneau, President of the company since April 2025, has been appointed Chief Executive Officer, also effective Tuesday, February 24, 2026. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260211203073/en/ From left to right: Chris Perkin, Executive Chairman of the Board (Altasciences), and Marie-Hélène Raigneau, Chief Executive Officer (Altasciences). “Having worked alongside Marie-Hélène for over two decades, I am fully confident in her readiness to guide Altasciences forward with clarity and purpose,” said Chris. “I am happy to be stepping aside after 50 years in drug development, knowing that Altasciences is well-positioned for the future.” Chris joined Altasciences as CEO
Sodali & Co Hires BlackRock Investment Stewardship AI and Data Lead11.2.2026 20:20:00 CET | Press release
Brett Miller to lead the firm’s global AI, data and insight offering Sodali & Co, the leading global capital markets-centric stakeholder advisory firm, is pleased to announce that Brett Miller has joined the firm as Global Head of Data Analytics based in New York. Miller joins from BlackRock where he served as Head of Data Analytics for its Investment Stewardship team. In his new role, Miller will lead Sodali’s global AI and data analytics strategy and embed data-driven insight across the firm’s integrated Shareholder Services, Sustainability, and Strategic Communications offering to help support clients navigate the increasingly complex and interconnected governance, investor, and stakeholder landscape. Miller joins Sodali & Co. at a time when investors are rapidly leveraging data and AI to drive investment and voting decisions. He will lead the buildout of an advanced analytics and technology platform to give clients actionable insight into how their narrative is driving capital flow
Andersen Consulting tilføjer Lighthouse Consultants11.2.2026 20:16:00 CET | Pressemeddelelse
Andersen Consulting indgår en samarbejdsaftale med Lighthouse Consultants, et London-baseret konsulentfirma med speciale i retsmedicinsk regnskab og finansielle undersøgelser. Lighthouse Consultants blev stiftet af administrerende direktør Kingsley Bye og leverer ydelser, der omfatter efterforskning af svindel og økonomisk kriminalitet, undersøgelser af bestikkelse og korruption, analyse af retssager og forsikringskrav, finansiel analyse, risikovurderinger, interne revisioner og compliance-gennemgange samt bæredygtighedsrevisioner. Virksomhedens team af erfarne statsautoriserede revisorer arbejder sammen med advokatfirmaer, formuende privatpersoner, virksomheder og velgørende organisationer med henblik på at løse komplekse tvister, mindske risici og øge gennemsigtigheden i finansielle og operationelle processer. "Ved at integrere vores retsmedicinske og efterforskningsmæssige ekspertise med Andersens globale platform kan vi levere en mere omfattende pakke af ydelser, der imødekommer ku
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom
