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Harmony Biotech jumps 8% on USFDA nod for Mycophenolate Mofetil oral suspension

by Vegas Valley News
June 3, 2026
in Business
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Harmony Biotech jumps 8% on USFDA nod for Mycophenolate Mofetil oral suspension
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Shares of Harmony Biotech surged as a lot as 8.46% on Wednesday, hitting an intraday excessive of Rs 1,264.90, after the corporate introduced that it had obtained approval from the U.S. Meals and Drug Administration (USFDA) for its Abbreviated New Drug Utility (ANDA) for Mycophenolate Mofetil for Oral Suspension USP, 200 mg/mL.

Based on the corporate’s regulatory submitting, the accepted product is an antimetabolite immunosuppressant used for the prophylaxis of organ rejection in grownup and pediatric sufferers aged three months and older present process kidney, coronary heart, or liver transplants. The medicine is run together with different immunosuppressive therapies.

The corporate highlighted that the approval aligns with its long-term progress technique and is predicted to strengthen its presence within the U.S. pharmaceutical market. Trade estimates recommend that the U.S. marketplace for Mycophenolate Mofetil is valued at roughly US$30 million, offering Harmony Biotech with a major industrial alternative.

In its disclosure, Harmony Biotech acknowledged that the approval was granted by the U.S. Meals and Drug Administration (USFDA) and pertains particularly to Mycophenolate Mofetil for Oral Suspension USP, 200 mg/mL. The corporate famous that the approval will improve its product portfolio and help growth throughout each U.S. and worldwide markets. There have been no cases of withdrawal, cancellation, or suspension of the approval, and subsequently no related penalties or antagonistic monetary impression.

Inventory Efficiency and Valuation

Regardless of Tuesday’s rally, Harmony Biotech’s inventory stays considerably beneath its 52-week excessive of Rs 2,150. The inventory’s 52-week low stands at Rs 987. The corporate presently instructions a market capitalization of roughly Rs 12,200 crore.

On the valuation entrance, the inventory is buying and selling at a price-to-earnings (P/E) ratio of 42.56 and a price-to-book (P/B) ratio of 6.13.

Technical Indicators

The inventory’s Relative Power Index (RSI-14) stands at 56.2, indicating neutral-to-positive momentum. An RSI studying beneath 30 is mostly thought of oversold, whereas a studying above 70 indicators overbought circumstances.

ET logo

Reside Occasions


From a pattern perspective, Harmony Biotech is buying and selling above six of its eight key easy transferring averages (SMAs), reflecting a broadly optimistic technical setup.

Shareholding Sample

Institutional investor exercise remained combined throughout the March 2026 quarter. International Institutional Buyers (FIIs) marginally elevated their stake in Harmony Biotech to 7.79% from 7.58% within the earlier quarter, reflecting continued investor curiosity. In distinction, mutual funds trimmed their holdings, lowering their stake from 4.44% to 4.30% throughout the identical interval.

(Disclaimer: Suggestions, solutions, views and opinions given by the consultants are their very own. These don’t signify the views of The Financial Instances)

Tags: BiotechConcordjumpsMofetilMycophenolatenodOralSuspensionUSFDA
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