The Food and Drug Administration (FDA) notified Moderna Inc (NASDAQ:MRNA) on Friday that its review of a new vaccine has been delayed.
The agency, citing administrative constraints, does not expect to complete its review of the Biologics License Application (BLA) for mRNA-1345, Moderna's investigational respiratory syncytial virus (RSV) vaccine, by the Prescription Drug User Fee Act date of May 12, 2024.
The FDA has informed Moderna that it is working to conclude the review by the end of May 2024.
The FDA has not informed Moderna of any issues related to vaccine safety, efficacy, or quality that would prevent the approval of mRNA-1345.
Moderna remains on track for mRNA-1345 to be reviewed at the CDC's Advisory Committee on Immunization Practices June 26-27, 2024, meeting, which is necessary before commercial launch.
In February, Moderna released a longer-term trial analysis that showed a faster decline in the effectiveness of its experimental RSV vaccine.
Follow-up data from the Phase 3 mRNA-1345 Trial At ReSViNET suggests the vaccine efficacy is declining faster than RSV vaccines from GSK Plc (NYSE:GSK) and Pfizer Inc (NYSE:PFE).
The data showed that the efficacy of the mRNA-1345 vaccine was about 63% after 8.6 months, from 84% at 3.3 months.
Top-line data released a year ago showed that mRNA-1345 demonstrated vaccine efficacy of 83.7% against RSV lower respiratory tract disease.
William Blair writes that although regulatory delays are disappointing and usually create noise around the probability of approval, the update on Moderna's RSV vaccine does not alter the expectation that mRNA-1345 will receive approval under the current review cycle.
Management has pinned the RSV vaccination target addressable market at about $10 billion.
The analyst models $1.46 billion in peak U.S. sales for mRNA-1345.
"The product remains an important contributor to Moderna's return to growth in 2025 and 2026 breakeven story," William Blair writes.
The analyst reiterates the Market Perform rating on Moderna shares.
Price Action: MRNA shares are down 2.20% at $119.99 during the premarket session at last check Friday.
美国食品药品监督管理局（FDA）周五通知Moderna Inc（纳斯达克股票代码：MRNA），其对新疫苗的审查已推迟。
该机构以管理限制为由，预计不会在《处方药使用者费用法》（2024年5月12日）之前完成对Moderna在研呼吸道合胞病毒（RSV）疫苗mRNA-1345的生物制剂许可申请（BLA）的审查。
美国食品药品管理局已通知Moderna，它正在努力在2024年5月底之前完成审查。
美国食品药品管理局尚未向Moderna通报任何可能阻碍mRNA-1345批准的与疫苗安全性、有效性或质量有关的问题。
相关信息：Moderna报告第一季度亏损小于预期，为呼吸道合胞病毒疫苗和Spikevax 2024-2025年配方奶粉做准备，股票飙升。
Moderna仍有望在2024年6月26日至27日的疾病预防控制中心免疫实践咨询委员会会议上对mRNA-1345进行审查，这在商业发布之前是必要的。
2月，Moderna发布了一项长期试验分析，显示其实验性呼吸道合胞病毒疫苗的有效性下降得更快。
ResviNet的3期mRNA-1345试验的后续数据表明，该疫苗疗效的下降速度快于葛兰素史克公司（纽约证券交易所代码：GSK）和辉瑞公司（纽约证券交易所代码：PFE）的呼吸道合胞病毒疫苗。
数据显示，mRNA-1345疫苗的疗效在8.6个月后约为63％，而3.3个月时的疗效为84％。
一年前发布的主要数据显示，mRNA-1345对呼吸道合胞病毒下呼吸道疾病的疫苗疗效为83.7％。
威廉·布莱尔写道，尽管监管延误令人失望，而且通常会围绕批准的可能性产生噪音，但Moderna呼吸道合胞病毒疫苗的最新情况并未改变人们对mRNA-1345将在当前审查周期中获得批准的预期。
管理层已将呼吸道合胞病毒疫苗的目标目标市场定为约100亿美元。
该分析师估计，mRNA-1345的美国峰值销售额为14.6亿美元。
威廉·布莱尔写道：“该产品仍然是Moderna在2025年和2026年恢复增长的重要贡献者，” 威廉·布莱尔写道。
分析师重申了对Moderna股票的市场表现评级。
价格走势：在周五最后一次盘前交易中，MRNA股价下跌2.20％，至119.99美元。
