What's Going On With FibroGen Stock Tuesday?
What's Going On With FibroGen Stock Tuesday?
FibroGen Inc (NASDAQ:FGEN) shares initially traded higher Tuesday morning after the company said the FDA cleared its Investigational New Drug (IND) of FG-3165. FibroGen also announced a new clinical trial supply agreement with Regeneron.
FibroGen Inc（納斯達克：FGEN）股票週二上午最初交易高漲，原因是該公司表示FDA已批准其FG-3165新藥申請。FibroGen還宣佈與再生元製藥公司（Regeneron）簽訂了一項新的臨床試驗供應協議。
The Details: FibroGen announced that the FDA cleared its IND of FG-3165, allowing the company to initiate a Phase 1 clinical trial.
詳情：FibroGen宣佈，FDA已批准其FG-3165新藥申請，使公司能夠啓動第一階段臨床試驗。
FG-3165 is a galectin-9 targeted monoclonal antibody under development for treatment of solid tumors characterized by high Gal9 levels of expression. Phase 1 trials evaluating the safety and efficacy of FG-3165 in patients with select solid tumors are expected to begin enrollment in the second half of 2024.
FG-3165是一種靶向galactin-9單克隆抗體，可用於治療固體腫瘤，這些腫瘤表達出高水平的Gal9。預計在2024年下半年開始招募選擇性固體腫瘤患者，開展對FG-3165安全性和療效的第一階段試驗。
"To date, FG-3165 has demonstrated anti-tumor activity with improved survival in combination with other immune modulatory therapies in mouse cancer models and has shown excellent tolerability in nonclinical safety studies," said Thane Wettig, CEO of FibroGen.
FibroGen的首席執行官Thane Wettig表示：“到目前爲止，FG-3165在小鼠癌症模型中已經證明了抗腫瘤活性，並在非臨床安全性研究中表現出極佳的耐受性。同時FG-3165與其他免疫調節療法聯合使用也能提高患者的生存率。”
FibroGen also announced a clinical trial supply agreement with Regeneron Pharmaceuticals Inc (NASDAQ:REGN) to evaluate FibroGen's immuno-oncology assets FG-3165 and FG-3175 with Reneneron's anti-PD-1 therapy LIBTAYO (cemiplimab) in patients with solid tumors.
FibroGen還與再生元製藥公司簽訂了一項臨床試驗供應協議，以評估FibroGen的免疫腫瘤學資產FG-3165和FG-3175與Regeneron的anti-PD-1療法LIBTAYO（Cemiplimab）在固體腫瘤患者中的協同作用。FibroGen的首席醫學官Deyaa Adib表示：“我們相信FG-3165抑制Gal9和FG-3175抑制CCR8的作用機制與Cemiplimab是協同的，這提供了患者臨床結果改善的可能性。我們期待與再生元製藥公司建立合作關係。”
FibroGen will be the sponsor of each Phase 1 monotherapy and combination trial. Regeneron will provide drug supply to FibroGen. Each company will retain all rights to their respective compounds.
FibroGen將是每個單獨臨床試驗和聯合試驗的贊助方。再生元製藥公司將向FibroGen提供藥物供應。每家公司將保留其各自化合物的所有權。
"We believe that the mechanisms of action for both FG-3165 (anti-Gal9) and FG-3175 (anti-CCR8) have the potential to be synergistic with cemiplimab, providing the possibility for an improvement in clinical outcomes for patients. We look forward to building a collaborative relationship with Regeneron," said Deyaa Adib, chief medical officer of FibroGen.
FibroGen股價走勢：股價在開盤早期上漲約14%，隨後再回落。根據Benzinga Pro的數據，該股價爲1.21美元，下跌了1.63%。
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FGEN Price Action: FibroGen shares were up around 14% in early trading before pulling back. The stock was down 1.63% at $1.21 at the time of publication, according to Benzinga Pro.
FGEN股價走勢：FibroGen股價在開盤早期上漲約14%，隨後再回落。根據Benzinga Pro的數據，該股價爲1.21美元，下跌了1.63%。
Photo: Shutterstock.
照片：shutterstock。
譯文內容由第三人軟體翻譯。