Provention Bio Stock Craters After FDA Flags Deficiencies In PK Profiles From Teplizumab Trials For Diabetes
Provention Bio Stock Craters After FDA Flags Deficiencies In PK Profiles From Teplizumab Trials For Diabetes
預防FDA標記替普利珠單抗糖尿病試驗中PK圖譜缺陷後的生物堆積凹陷
- Provention Bio Inc (NASDAQ: PRVB) revealed it had received a notification on April 2 from the FDA stating that the agency has identified deficiencies that preclude discussion of labeling and post-marketing requirements/commitments at this time.
- Notably, the FDA expressed concerns over teplizumab pharmacokinetics data and comparability when Lilly first put teplizumab into clinical trials.
- Regulators assert the PK profiles from Provention’s studies and Lilly’s trials are not the same and asked for more data on April 2.
- According to the regulators, such concerns mean that the candidate cannot start post-marketing and label discussions.
- Investors responded sourly to the news after Thursday’s bell, with the stock crashing almost 40%.
- Provention responded, noting it is “willing to discuss these issues.” Regulators had scheduled a May 27 AdCom to discuss the experimental drug, which will continue as planned.
- The drug has a long history. In 2007, Eli Lilly And Co’s (NYSE: LLY) and MacroGenics Inc (NASDAQ: MGNX) partnered to develop and commercialize teplizumab.
- In 2010, teplizumab failed a pivotal late-stage diabetes study undertaken by Eli Lilly, and it handed the rights back to MacroGenics.
- In 2018, Provention Bio stepped in and in-licensed the drug from MacroGenics, hoping to bring the experimental drug back from the dead.
- PRVB used teplizumab as their lead drug for a $56 million IPO filing.
- Teplizumab is an investigational anti-CD3 monoclonal antibody for the delay or prevention of clinical type 1 diabetes (T1D) in at-risk individuals.
- Price Action: PRVB shares plunged 40.7% at $5.77 in the premarket session on the last check Friday.
- Provention Bio Inc (NASDAQ: PRVB) revealed it had received a notification on April 2 from the FDA stating that the agency has identified deficiencies that preclude discussion of labeling and post-marketing requirements/commitments at this time.
- Notably, the FDA expressed concerns over teplizumab pharmacokinetics data and comparability when Lilly first put teplizumab into clinical trials.
- Regulators assert the PK profiles from Provention’s studies and Lilly’s trials are not the same and asked for more data on April 2.
- According to the regulators, such concerns mean that the candidate cannot start post-marketing and label discussions.
- Investors responded sourly to the news after Thursday’s bell, with the stock crashing almost 40%.
- Provention responded, noting it is “willing to discuss these issues.” Regulators had scheduled a May 27 AdCom to discuss the experimental drug, which will continue as planned.
- The drug has a long history. In 2007, Eli Lilly And Co’s (NYSE: LLY) and MacroGenics Inc (NASDAQ: MGNX) partnered to develop and commercialize teplizumab.
- In 2010, teplizumab failed a pivotal late-stage diabetes study undertaken by Eli Lilly, and it handed the rights back to MacroGenics.
- In 2018, Provention Bio stepped in and in-licensed the drug from MacroGenics, hoping to bring the experimental drug back from the dead.
- PRVB used teplizumab as their lead drug for a $56 million IPO filing.
- Teplizumab is an investigational anti-CD3 monoclonal antibody for the delay or prevention of clinical type 1 diabetes (T1D) in at-risk individuals.
- Price Action: PRVB shares plunged 40.7% at $5.77 in the premarket session on the last check Friday.
- Proventive Bio Inc.(納斯達克市場代碼：PRVB)透露，它已於4月2日收到FDA的通知，稱FDA發現了目前無法討論標籤和上市後要求/承諾的不足之處。
- 值得注意的是，當禮來公司首次將teplizumab投入臨牀試驗時，FDA對teplizumab的藥代動力學數據和可比性表示了擔憂。
- 監管機構斷言，Provention的研究和禮來公司的試驗的PK資料並不相同，並要求在4月2日提供更多數據。
- 根據監管機構的説法，這種擔憂意味着候選人不能開始上市後和標籤方面的討論。
- 週四開盤後，投資者對這一消息反應冷淡，該股暴跌近40%。
- 該公司迴應稱，它“願意討論這些問題”。監管機構已安排在5月27日召開ADCOM會議，討論這種實驗藥物，並將按計劃繼續進行。
- 這種藥有很長的歷史。二零零七年，禮來公司(紐約證券交易所股票代碼：LLY)和MacroGenics Inc.(納斯達克市場代碼：MGNX)合作開發teplizumab並將其商業化。
- 2010年，teplizumab未能通過禮來公司(Eli Lilly)進行的一項關鍵的晚期糖尿病研究，並將權利交還給了MacroGenics。
- 2018年，Provention Bio介入並從MacroGenics獲得了這種藥物的許可，希望讓這種實驗藥物起死回生。
- PRVB使用teplizumab作為他們的主導藥物，提交了5600萬美元的IPO申請。
- 替普利單抗是一種研究中的抗CD3單克隆抗體，用於延遲或預防高危個體的臨牀1型糖尿病(T1D)。
- 價格行動：在週五的最後一次檢查中，PRVB的股價在盤前交易時段暴跌40.7%，至5.77美元。
譯文內容由第三人軟體翻譯。
以上內容僅用作資訊或教育之目的，不構成與富途相關的任何投資建議。富途竭力但無法保證上述全部內容的真實性、準確性和原創性。
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以上內容僅用作資訊或教育之目的，不構成與富途相關的任何投資建議。富途竭力但無法保證上述全部內容的真實性、準確性和原創性。
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風險及免責聲明
以上內容僅用作資訊或教育之目的，不構成與富途相關的任何投資建議。富途竭力但無法保證上述全部內容的真實性、準確性和原創性。
我知道了
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