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
预防FDA标记替普利珠单抗糖尿病试验中PK图谱缺陷后的生物堆积凹陷
- 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.(纳斯达克市场代码：PRVB)透露，它已于4月2日收到FDA的通知，称FDA发现了目前无法讨论标签和上市后要求/承诺的不足之处。
- 值得注意的是，当礼来公司首次将teplizumab投入临床试验时，FDA对teplizumab的药代动力学数据和可比性表示了担忧。
- 监管机构断言，Provention的研究和礼来公司的试验的PK资料并不相同，并要求在4月2日提供更多数据。
- 根据监管机构的说法，这种担忧意味着候选人不能开始上市后和标签方面的讨论。
- 周四开盘后，投资者对这一消息反应冷淡，该股暴跌近40%。
- 该公司回应称，它“愿意讨论这些问题”。监管机构已安排在5月27日召开ADCOM会议，讨论这种实验药物，并将按计划继续进行。
- 这种药有很长的历史。二零零七年，礼来公司(纽约证券交易所股票代码：LLY)和MacroGenics Inc.(纳斯达克市场代码：MGNX)合作开发teplizumab并将其商业化。
- 2010年，teplizumab未能通过礼来公司(Eli Lilly)进行的一项关键的晚期糖尿病研究，并将权利交还给了MacroGenics。
- 2018年，Provention Bio介入并从MacroGenics获得了这种药物的许可，希望让这种实验药物起死回生。
- PRVB使用teplizumab作为他们的主导药物，提交了5600万美元的IPO申请。
- 替普利单抗是一种研究中的抗CD3单克隆抗体，用于延迟或预防高危个体的临床1型糖尿病(T1D)。
- 价格行动：在周五的最后一次检查中，PRVB的股价在盘前交易时段暴跌40.7%，至5.77美元。
译文内容由第三方软件翻译。
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以上内容仅用作资讯或教育之目的，不构成与富途相关的任何投资建议。富途竭力但不能保证上述全部内容的真实性、准确性和原创性。
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