Latest news with #Roxadustat
Yahoo
12-05-2025
- Sport
- Yahoo
After Simona Halep Another Romanian Player Suspended for Prohibited Substance
Romanian tennis player Irina Fetecau has been suspended by the International Tennis Integrity Agency (ITIA) for 10 months after testing positive for a banned substance. The 28-year-old was found to have 4-Methylpentan-2-amine, an illegal stimulant, in her body when she consumed a contaminated pre-training supplement. Fetecau, who has competed for Romania in many ITF and WTA tournaments, returned a positive after consuming "Gorillalpha Yeti Juice," one of those sports foods later found to include the prohibited stimulant but one that was not marked as containing any. The violation was deemed by the ITIA to have been accidental and the product of an adulterated product and a circumstance leading to the reduction of the ban. The positive test report adds to the emphasis on supplement use by elite athletes, and follows a recent string of doping scandal outbreaks among Romanian tennis players—in particular the high-profile suspension of two-time Grand Slam title winner Simona Halep. While Halep's was over the banned drug Roxadustat, Fetecau's case adds to the risks to sportspersons who take unregulated nutritional supplements. Simona Halep (ROU) hits a forehand against Paula Badosa© Geoff Burke-Imagn Images The ITIA stated that Fetecau co-operated throughout the investigation and submitted evidence of accidental ingestion. The 10-month ineligibility is served from the sample date, so she is free to return to compete later in the year. This latest trend is an eye-opener to sportsmen in general, reminding them to be careful about the supplements they use, as the consequences of even accidental violations can prove calamitous for their career as professional athletes. The ITIA is still calling upon the athletes to consult experts and only use authorized supplements so that incidents like this one can be avoided.
Yahoo
05-05-2025
- Business
- Yahoo
FibroGen to Report First Quarter 2025 Financial Results
SAN FRANCISCO, May 05, 2025 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) will announce first quarter 2025 financial results on Monday, May 12 after the markets close. FibroGen will also conduct a conference call on that day at 5:00 PM Eastern Time with the investment community to further detail the company's corporate and financial performance. Conference Call and Webcast PresentationThe FibroGen management team will host a conference call and webcast presentation to discuss the financial results and provide a business update. A live Q&A session will follow the brief presentation. Interested parties may access a live audio webcast of the conference call here. To access the call by phone, please register here, and you will be provided with dial in details. A replay of the webcast will also be available for a limited time on the Events & Presentations page on FibroGen's website. About FibroGenFibroGen, Inc. is a biopharmaceutical company focused on development of novel therapies at the frontiers of cancer biology and anemia. Roxadustat (爱瑞卓®, EVRENZO™) is currently approved in China, Europe, Japan, and numerous other countries for the treatment of anemia in chronic kidney disease (CKD) patients on dialysis and not on dialysis. The Company continues to evaluate a development plan for roxadustat in anemia associated with lower-risk myelodysplastic syndrome (LR-MDS) in the U.S. FG-3246 (also known as FOR46), a first-in-class antibody-drug conjugate (ADC) targeting CD46 is in development for the treatment of metastatic castration-resistant prostate cancer. This program also includes the development of FG-3180, an associated CD46-targeted PET biomarker. For more information, please visit For Investor Inquiries:David DeLucia, CFASenior Vice President and Chief Financial Officerir@ in to access your portfolio
Associated Press
20-02-2025
- Business
- Associated Press
FibroGen Announces the Sale of FibroGen China to AstraZeneca for Approximately $160 Million
Purchase price represents enterprise value of $85 million plus FibroGen net cash held in China at closing, currently estimated to be approximately $75 million Upon close, FibroGen will repay its term loan to Morgan Stanley Tactical Value, further simplifying the Company's capital structure Company's cash runway extended into 2027 Company to continue to advance its oncology pipeline, with the initiation of the Phase 2 monotherapy trial of FG-3246 in metastatic castration-resistant prostate cancer (mCRPC) in 2Q 2025 Preliminary unaudited cash, cash equivalents, and accounts receivable of $121.1 million as of December 31, 2024 FibroGen to host conference call and webcast presentation today at 8:30 AM ET SAN FRANCISCO, Feb. 20, 2025 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) today announced the sale of its China subsidiary to AstraZeneca for approximately $160 million. 'Today, we announced the sale of FibroGen China to AstraZeneca, our long-time strategic partner for roxadustat in China, bolstering our company on several fronts. It strengthens our financial position, meaningfully extending our cash runway into 2027, and enables us to continue progressing the clinical development program for FG-3246, our first-in-class, CD46 targeting antibody drug conjugate, and FG-3180, our companion PET imaging agent, in mCRPC,' said Thane Wettig, Chief Executive Officer of FibroGen. 'After a thorough evaluation of alternatives, we believe selling our China operations and repaying our term loan is in the best interest of FibroGen's stakeholders. We are grateful for our China colleagues, and in particular Christine Chung, our Head of China Operations, for their unwavering commitment to patients and successful commercialization of roxadustat in China. Now, we turn the page to the next exciting chapter for FibroGen.' Under the terms of the agreement, FibroGen will receive an enterprise value of $85 million plus FibroGen net cash held in China at closing, currently estimated to be approximately $75 million, totaling approximately $160 million. The transaction is expected to close by mid-2025, pending customary closing conditions, including regulatory review in China. Following the close of the transaction, FibroGen will repay its term loan facility to investment funds managed by Morgan Stanley Tactical Value, further simplifying the Company's capital structure. The combined transactions are expected to extend the Company's cash runway into 2027. Upon closing, AstraZeneca will obtain all rights to roxadustat in China. Roxadustat is the category leader in brand value share for the treatment of anemia in chronic kidney disease with a pending regulatory decision for chemotherapy-induced anemia. FibroGen maintains its rights to roxadustat in the U.S. and in all markets not licensed to Astellas. The Company continues to evaluate a development plan for roxadustat in anemia associated with lower-risk myelodysplastic syndrome (LR-MDS), a high-value indication with significant unmet medical need. The Company is planning for an FDA meeting in the second quarter of 2025 to determine the potential next steps for the development program for roxadustat in the U.S. In addition, FibroGen continues to advance the clinical development of its lead asset, FG-3246, and its companion PET imaging agent, FG-3180, with the initiation of the Phase 2 monotherapy trial of FG-3246 in patients with mCRPC expected in the second quarter of 2025. BofA Securities, Inc. is acting as exclusive financial advisor and Ropes & Gray LLP is acting as legal advisor to FibroGen on this transaction. Conference Call and Webcast Presentation FibroGen management team will host a conference call and webcast presentation today, February 20, 2025 at 8:30 a.m. ET to discuss the sale of FibroGen China. A live Q&A session will follow the brief presentation. Interested parties may access a live audio webcast of the conference call here. To access the call by phone, please register here, and you will be provided with dial in details. A replay of the webcast will also be available for a limited time on the Events & Presentations page on FibroGen's website. About FibroGen FibroGen, Inc. is a biopharmaceutical company focused on development of novel therapies at the frontiers of cancer biology and anemia. Roxadustat (爱瑞卓®, EVRENZO™) is currently approved in China, Europe, Japan, and numerous other countries for the treatment of anemia in chronic kidney disease (CKD) patients on dialysis and not on dialysis. The Company continues to evaluate a development plan for roxadustat in anemia associated with lower-risk myelodysplastic syndrome (LR-MDS) in the U.S. FG-3246 (also known as FOR46), a first-in-class antibody-drug conjugate (ADC) targeting CD46 is in development for the treatment of metastatic castration-resistant prostate cancer. This program also includes the development of FG-3180, an associated CD46-targeted PET biomarker. For more information, please visit Forward-Looking Statements This release contains forward-looking statements regarding FibroGen's strategy, future plans and prospects, including statements regarding its commercial products and clinical programs and those of its collaboration partners Fortis and UCSF. These forward-looking statements include, but are not limited to, statements regarding the net cash portion of the purchase price and closing of the sale of FibroGen China as well as the payoff of the Morgan Stanley Tactical Value term loan, use of proceeds, and statements regarding the expectation that cash, cash equivalents and accounts receivable will be sufficient to fund FibroGen's operating plans into 2027, and statements about FibroGen's plans and objectives. These forward-looking statements are typically identified by use of terms such as 'may,' 'will', 'should,' 'on track,' 'could,' 'expect,' 'plan,' 'anticipate,' 'believe,' 'estimate,' 'predict,' 'potential,' 'continue' and similar words, although some forward-looking statements are expressed differently. FibroGen's actual results may differ materially from those indicated in these forward-looking statements due to risks and uncertainties related to the continued progress and timing of its various programs, including the enrollment and results from ongoing and potential future clinical trials, and other matters that are described in FibroGen's Annual Report on Form 10-K for the fiscal year ended December 31, 2023, and our Quarterly Report on Form 10-Q for the quarter ended September 30, 2024, each as filed with the Securities and Exchange Commission (SEC), 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 FibroGen undertakes no obligation to update any forward-looking statement in this press release, except as required by law.
The Independent
05-02-2025
- Sport
- The Independent
Simona Halep hit extraordinary highs but leaves tennis with a complicated legacy
After the best hour of tennis she ever played, Simona Halep dropped to her knees and beamed at her box in disbelief. The Romanian had just bamboozled and outclassed the greatest female tennis player in the modern game in the 2019 Wimbledon final, in doing so claiming her second Grand Slam title. She hit just three unforced errors in the entire match and a sentence rarely uttered came to mind: Serena Williams was powerless. It felt like a seismic moment, not just for Halep but for women's tennis and the next generation behind the Williams sisters. In her prime years at 27, Halep reclaimed her world No 1 ranking and her ceiling seemed limitless. But five years on, as Halep waved goodbye to professional tennis on Tuesday after a 6-1, 6-1 thrashing by world No 72 Lucia Bronzetti at her home tournament, her legacy is a complicated one. 'I don't know if it's with joy or sadness, I think both feelings are trying me but I'm making this decision with my soul,' Halep said, as she announced her decision to retire on court at the Transylvania Open. 'Where I probably was, it's very hard to get there and I know what it means to get there. It's a beautiful thing. I became world number one, I won grand slams, it's all I wanted. Life goes on, there is life after tennis and I hope that we will see each other again.' Halep is speaking after a tempestuous two-and-a-half years which was spent mostly away from the tennis court. In October 2022, the Romanian was provisionally suspended by the International Tennis Integrity Agency (ITIA) after testing positive for the banned substance Roxadustat, the blood-boosting anaemia drug, at the 2022 US Open. Irregularities were also found in her biological passport – the testing system used to establish an athlete's blood profile over several years – with 'suspicious' results in the 2022 season. Nearly a year later, Halep was banned for four years but an appeal last February in the Court of Arbitration for Sport (CAS) reduced the ban to nine months, as CAS ruled Halep 'on the balance of probabilities' had not taken Roxadustat on purpose. The Romanian has always insisted she did not take the drug intentionally, with her former coach Patrick Mouratoglou taking the blame for adding a collagen supplement to her nutrition plan in the summer of 2022. 'This collagen happened to be contaminated,' he said, in November 2023. 'I feel responsible for what happened because it's my team – so me, basically – who brought her this collagen.' Throughout the whole saga, Halep had been incandescent, describing it as 'the hardest match' of her life. In the end, it was a situation where a route back to the top quickly became unfeasible. Whichever way you look at it, it has been a lamentable conclusion to a career Halep could only dream of when training as a teenager in the coastal town of Constanta, on the shores of the Black Sea. There was her first WTA title in 2013 on her favoured clay in Nuremberg, which was quickly followed by five more titles in the same year. Halep was in the top-10 for 373 consecutive weeks from 2014-2021, emerging as one of women's tennis' most consistent players, omnipresent in the latter stages of the world's biggest tournaments. Yet her early 20s did not come without heartbreak. After blowing a set and a break advantage in the 2017 French Open final to unseeded teenager Jelena Ostapenko – her third defeat in a Grand Slam final – there were question marks around whether Halep would ever reach the pinnacle of professional tennis. But a year later, in the same setting on Court Philippe-Chatrier, Halep this time came from a set and a break down to beat Sloane Stephens in the final to claim her first major. Her relief at reaching her Everest was felt across the game. That sensational 56-minute hot-streak of stunning athleticism and exceptional defensive skills on Centre Court in 2019 would follow for major No 2. But those highest of highs did not translate into all-court dominance standing the test of time. In fact, she would never reach another Grand Slam final. She was blighted by Covid in 2020 and then came the spate of injuries in 2021 which, ultimately, she has never recovered from. Her final title came in August 2022, with a WTA 1000 victory in Toronto. A few weeks later, she would test positive for Roxadustat. Despite being cleared to play a year ago – and returning to the tour with a wild card in Miami – constant pain in her knee would not disappear. An exhibition event in Abu Dhabi in December saw her experience shoulder pain, too, and the writing looked on the wall when she withdrew from Australian Open qualifying last month. However, she can take solace in that she managed to finish with one final appearance in her homeland, where she is revered as the greatest Romanian tennis player since Ilie Nastase in the 1970s. Halep's achievements, including 24 WTA titles and 64 weeks at world No 1, are awe-inspiring. Yet in a period where Grand Slam champions Jannik Sinner and Iga Swiatek have also tested positive for banned substances, the Romanian's own ordeal cannot be ignored when discussing her career and has been a bad look for the sport in general. Halep's highs were extraordinary – and none were better than that all-time Wimbledon final performance on the grass of SW19. But her legacy now is convoluted; tangled up in a murky final two years.
CNN
05-02-2025
- Sport
- CNN
Former world No. 1 Simona Halep retires from tennis with emotional speech
Two-time grand slam champion and former world No. 1 Simona Halep has retired from tennis. The Romanian announced her decision at the Transylvania Open in Cluj, Romania on Tuesday after losing her first-round match against Lucia Bronzetti 6-1, 6-1. 'It's very hard to reach that level, and I know what it takes to get there,' Halep said while addressing supporters after her defeat, per AP. 'That's why I wanted to be here today, in Cluj, to play in front of you and say goodbye on the tennis court, even if my performance wasn't great.' Halep has struggled with injuries since returning to the court last year after serving a doping ban. The 33-year-old was handed a four-year ban in September 2023 after testing positive for the banned substance Roxadustat at the 2022 US Open. Halep maintained the anti-doping violations were not intentional and, in March last year, the Court of Arbitration for Sport (CAS) agreed and reduced the backdated ban to nine months, clearing the two-time grand slam champion to return to the sport. At the same time Halep was handed her ban, the International Tennis Integrity Agency also announced she was being charged with having irregularities in her Athlete Biological Passport (ABP), which is designed to monitor an athlete's selected biological variables over time. CAS dismissed that charge. Before her ban, though, Halep enjoyed a successful career which included 24 WTA singles titles and 64 weeks as the women's world No. 1. She won her first grand slam at the French Open in 2018, before securing her second at Wimbledon in 2019. Her win at Wimbledon came after a dominant victory against Serena Williams in the final, where she made just three unforced errors before wrapping the match up in under an hour. At the time she considered it the best performance of her career. 'To be competitive again requires much more, and at this moment, it's no longer possible,' Halep added Tuesday. 'I don't want to cry. This is something beautiful. I reached world No. 1. I won grand slams; it's everything I ever wanted.'
