Why Capricor Therapeutics Stock Is Soaring Tuesday
Why Capricor Therapeutics Stock Is Soaring Tuesday
The company noted that the filing will be based on existing cardiac data from the Phase 2 HOPE-2 and HOPE-2 Open Label Extension trials. Capricor said it plans to combine Cohorts A and B of the Phase 3 clinical trial to serve as a post-approval study. Capricor Therapeutics Inc (NASDAQ:CAPR) shares are trading higher Tuesday after the company announced intent to file a biologics license application (BLA) for the full approval of Deramiocel for the treatment of Duchenne muscular dystrophy cardiomyopathy.
capricor therapeutics公司（納斯達克：CAPR）股價週二上漲，因該公司宣佈擬就 Duchenne 肌營養不良型心肌病的治療提交生物製品許可申請（BLA）以獲得全面批准。
What To Know: Capricor said it determined its intent to file a BLA following recent meetings with the U.S. Food and Drug Administration.
了解到：Capricor 表示，經過最近與美國食品藥品監督管理局的會議，決定擬定意向提交 BLA。
Based on those meetings, Capricor plans to commence the filling in October, seeking full approval of deramiocel for the treatment of DMD-cardiomyopathy with full submission expected by the end of the year.
根據這些會議，Capricor 計劃於十月開始填寫申請，尋求批准用於 DMD-心肌病的 Deramiocel 的全面批准，預計年底前將提交申請。
The company noted that the filing will be based on existing cardiac data from the Phase 2 HOPE-2 and HOPE-2 Open Label Extension trials. Capricor said it plans to combine Cohorts A and B of the Phase 3 clinical trial to serve as a post-approval study.
公司指出，申請將基於第 2 期 HOPE-2 和 HOPE-2 開放式延長試驗的現有心臟數據。Capricor 表示，計劃合併第 3 期臨床試驗 A 和 B 組，以用作後續批准研究。
"There are currently no approved therapies for DMD cardiomyopathy, which is the leading cause of death in those with Duchenne. Based on the strength of our cardiac data, combined with the FDA's commitment to advancing therapeutics for the treatment of rare diseases, we are seeking approval for the cardiomyopathy associated with DMD and will look to expand the label for skeletal muscle myopathy post-approval," said Linda Marbán, CEO of Capricor Therapeutics.
「目前尚無可批准用於 DMD 心肌病的療法，這是導致 Duchenne 患者死亡的主要原因。基於我們心臟數據的強大性，再加上 FDA 致力於推動治療罕見疾病的承諾，我們正在尋求批准用於 DMD 相關心肌病，後續將考慮在批准後擴大標籤以涉及骨骼肌肌病。」Capricor Therapeutics 首席執行官 Linda Marbán 表示。
"Deramiocel has shown in multiple clinical trials attenuation of the cardiac implications of DMD. Based on the totality of evidence of the safety and efficacy data deramiocel has shown, we believe this is the best path forward to potential approval."
「Deramiocel 在多項臨床試驗中顯示了對 DMD 心臟影響的減輕。基於 deramiocel 顯示的安全性和有效性數據的全部證據，我們相信這是潛在批准的最佳途徑。」
Capricor shares are now up more than 55% over the past week. The stock has been in the spotlight since the company signed a European expansion deal with Nippon Shinyaku. Several analysts have raised price targets on the stock since. Here's a look at all of the analyst updates over the past week.
Capricor 的股價在過去一週已上漲逾 55%。自該公司與日本新藥擴張合作協議簽署以來，該股備受關注。自此以來，多位分析師已調高了該股的價格目標。以下是過去一週內所有分析師的更新。
- HC Wainwright & Co. analyst Joseph Pantginis reiterated Capricor Therapeutics with a Buy and maintained a price target of $40.
- HC Wainwright & Co. 分析師 Joseph Pantginis 重申對 Capricor Therapeutics 的買入評級，並維持目標股價在 40 美元。
- Maxim Group analyst Jason McCarthy reiterates Capricor Therapeutics with a Buy and maintained a price target of $12.
- Maxim Group分析師Jason McCarthy重申買入capricor therapeutics，並維持12美元的目標價。
- Oppenheimer analyst Leland Gershell maintained Capricor Therapeutics with an Outperform and raised the price target from $14 to $15.
- Oppenheimer分析師Leland Gershell維持Capricor Therapeutics的表現優異，並將目標價從14美元上調至15美元。
- Cantor Fitzgerald analyst Kristen Kluska reiterated Capricor Therapeutics with an Overweight and maintained a price target of $8.
- Cantor Fitzgerald分析師Kristen Kluska重申超重籌碼期權，並維持8美元的目標價。
Don't Miss: EXCLUSIVE: Capricor Therapeutics Inks European Expansion, Commercialization Pact For Lead Asset With Japanese Pharma Firm
別錯過：獨家：Capricor Therapeutics與日本製藥公司簽署歐洲拓展、商業化協議，推動旗艦資產。
CAPR Price Action: Capricor shares were up 27.1% at $7.63 at the time of publication, according to Benzinga Pro.
CAPR價格走勢：根據Benzinga Pro，Capricor股價在發表時上漲27.1%，報7.63美元。
Photo: 3844328 from Pixabay.
照片來自Pixabay（ID：3844328）。
譯文內容由第三人軟體翻譯。