Lannett Company, Inc. (LCI) stock declined in the pre-market after the company announced that the FDA had completed their review for the application submitted earlier. LCI values at $1.52, declining more than 1.94% from the previously closed value. At the end of the last trading session, the stock closed at around $1.55. The stock traded volume in the previous trading session was approximately 456.84K shares.
Reason for LCI stock gain
Lannett Company, Inc. (LCI) announced that the FDA had notified them about completing its safety review application. FDA said that Lannett Company, Inc. (LCI) could proceed with the clinical investigation. The company submitted the Investigational New Drug (IND) application for biosimilar insulin glargine. LCI is co-developing the drug by partnering with the HEC Group of companies. The company expects the crucial clinical study to start in March 2022 and end in early 2023.
Lannett Company (LCI) expects to file the BLA in early 2023 once the study shows positive results. If authorized, they will commercialize the product in early 2024. Lannett Company, Inc. (LCI) is excited to deliver this critically important and more inexpensive biosimilar medicine to the enormous and rising number of patients living with diabetes.
The clinical study will be conducted in South Africa at the same site as the first human volunteer research. Following FDA approval of the IND, the study has acquired regulatory clearances in both the US and South Africa. The critical trial will use the final and will market the product as Lannett/HEC biosimilar insulin glargine formulation.
Effect on the stock gain
The stock value escalated slightly in the pre-market following the news of getting a green signal from the FDA. Investors are taking a considerable interest in its stock because the stock value might surge if the study is successful and the product is commercialized.
Conclusion
The FDA has permitted the company to proceed with the next stage of the study. It will be a crucial part of the trials. But the company seems optimistic and is expecting that the results will be successful. It will be a great relief for diabetic patients once it gets approved.
