Alembic Pharma Shares Surge After US FDA Nod For Ovarian Cancer Drug

Alembic Pharmaceuticals share price jumped 12.40 per cent to Rs 1,089 apiece, notching its highest level since early January after securing the final US Food and Drug Administration (FDA) approval for a critical oncology drug. The company received final approval from the US FDA for its generic version of Doxorubicin Hydrochloride Liposome Injection, a cancer therapy used to treat ovarian cancer, multiple myeloma, and AIDS-related Kaposi’s sarcoma.

“This approval enhances our oncology portfolio and underlines our commitment to bringing affordable and high-quality generics to global markets,” the company said in its filing on June 29.

Alembic Share Price Trend

As of 10:51 am, the stock was trading at Rs 1,082.20 on the NSE, up nearly 11.35 per cent. Alembic shares are now up 16.50 per cent over the past 12 months. The company enjoys a market capitalisation of Rs 6,028.94 crore. Alembic Pharma share price is currently down over 17 per cent from its 52-week high of Rs 1,303.90 on October 9, 2024. Additionally, it has given a return of over 8 per cent in a period of six months. 

Why Is This Drug Significant?

According to IQVIA, the US market for the drug is worth around $29 million. But for Alembic, the win is less about size and more about presence. Oncology is tough terrain, and approval isn’t handed out lightly. This is a space dominated by high manufacturing standards and stringent inspections. Alembic, which traces its origins back to 1907, has built credibility with regulators, which helps it move faster than smaller players with less history and infrastructure.

The newly-approved drug is bioequivalent to Doxil, originally marketed by Baxter Healthcare. Alembic will manufacture it in 20 mg/10 mL and 50 mg/25 mL single-dose vials. The company now has a cumulative 224 Abbreviated New Drug Application (ANDA) approvals under its belt – 201 final and 23 tentative from the US FDA. This latest nod puts it on firmer ground in the specialty generics segment.