Shares of Bangalore-based Biocon Biologics slumped 2.4 percent to record a new 52-week low on Wednesday, January 11, after the US FDA disapproved its Insulin application, with a complete response letter (CRL), citing the need for further data as well as corrective measures at its Bangalore facilities.
During Wednesday’s trade, the stock opened on a positive note at a price of Rs. 258 per share closely against the previous close of Rs. 257.90 per share. However, during the morning session, the stock cracked and declined to touch an intraday low of Rs. 251.90.
It was trading at ₹251.80, down by 2.33 percent, at 12:10 p.m. on the NSE.
The stock touched a 52-week high of Rs. 410.70 on February 8, 2022, indicating that at the current level, it is trading 38 percent below its 52-week high.
In the past six months, the stock has recorded a decline of 23 percent. Furthermore, it has declined nearly 30 percent in the last one year and was one of the biggest wealth destroyers of 2022. In the last five years, the stock has fallen by almost 7 percent.
On Saturday, Biocon informed that the United States Food and Drugs Administration (USFDA) has issued a Complete Response Letter (CRL) for the Biologics License Application (BLA) for its Insulin-R product.
USFDA's letter cites additional data required in the submission of the license application. It further states that there is an expectation of satisfactory implementation of a Corrective and Preventive Action Plan (CAPA) pertaining to the Pre-Approval Inspection (PAI) of the company's Bengaluru facilities in August last year, the official statement reported.
The purpose of the Corrective and Preventive Action plan is to collect information, analyze information, identify and investigate product and quality problems, and take appropriate and effective corrective and/or preventive action to prevent their recurrence.
For the two sites inspected by the USFDA in August last year, Biocon was issued 11 observations each. In response, Biocon Biologics said that it is in the process of comprehensively addressing the CRL from the drug regulator.
Biocon Ltd., established in 1978, is a large-cap company with a market capitalization of ₹30,963.47 crore engaged in the pharmaceutical industry. It is an India-based biopharmaceutical company that focuses to treat diabetes, cancer and autoimmune diseases. The company is also focused on developing novel therapies for diabetes, oncology and immunology.
According to a Mintgenie poll, 21 analysts on average have a ‘HOLD’ call on the stock.