[Featured Stock] Nivek Rises on News of Expanded US FDA Approval for 'Sarepta' Roche Co-Developed Treatment

Naivek is showing strength. It is interpreted that this is influenced by the news that Sarepta Therapeutics, a U.S. new drug developer, received FDA expanded approval for ELEVIDYS, a treatment for Duchenne Muscular Dystrophy (DMD) for patients aged 4 and older.

As of 9:56 AM on the 21st, Naivek is trading at 19,350 KRW, up 9.08% compared to the previous day.

According to the industry, the FDA expanded Sarepta's ELEVIDYS indication to include DMD patients aged 4 and older with confirmed mutations in the DMD gene, granting approval on this day. The FDA granted full approval for ambulatory patients and accelerated approval for non-ambulatory patients.

Last June, Sarepta obtained accelerated approval from the U.S. FDA for ‘SRP-9001,’ a DMD treatment co-developed with Roche. This was the first case of a gene therapy for DMD. DMD is a rare muscle disease caused by abnormalities in the dystrophin gene on the X chromosome. It occurs in approximately 1 out of every 3,500 boys and currently has no effective treatment, with most patients dying around the age of 20.

Meanwhile, Naivek has signed a Material Transfer Agreement (MTA) and material evaluation contract with Sarepta for applying the drug delivery platform ‘NIPEP-TPP.’ Naivek is known to supply Sarepta with a nano-complex fused with messenger RNA (mRNA) based on NIPEP-TPP.