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  1. Shilpa Medicare shares hit 52-week high on prospects of a huge order; check details

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Shilpa Medicare shares hit 52-week high on prospects of a huge order; check details

Upstox

2 min read | Updated on July 05, 2024, 12:07 IST

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SUMMARY

The company’s CDMO customer, Unicycive Therapeutics Inc., has reported positive results from pivotal clinical trials of Oxylanthanum Carbonate (OLC), used in the treatment of hyperphosphatemia in chronic kidney disease patients. Shilpa Medicare is most likely to receive a supply order for these tablets and $10 million as milestone income upon product launch.

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Shilpa Medicare up over 15% as CDMO customer places binding purchase order on positive results from clinical trials

Shilpa Medicare up over 15% as CDMO customer places binding purchase order on positive results from clinical trials

Shilpa Medicare Ltd shares surged over 15% in trade on Friday, July 5, to hit their 52-week high on prospects of a significant order for its CDMO (contract development and manufacturing organization) business from a US-based biotechnology company.

In a stock exchange notification on Thursday, Shilpa Medicare said that one of its customers has reported positive results from a pivotal clinical trial and has placed a binding purchase order.

The company’s CDMO customer, Unicycive Therapeutics Inc., has reported positive results from pivotal clinical trials of Oxylanthanum Carbonate (OLC), an NCE (new chemical entity) molecule with potential treatment for hyperphosphatemia in chronic kidney disease patients.

Unicycive is expected to file the new drug application for OLC by mid-2024 with potential approval by mid-2025.

Shilpa Medicare said that it has partnered with Unicycive to provide end-to-end CDMO services, from the development and supply of APIs to the finished dosage form. Based on the outcome of the pivotal clinical studies, Unicycive has entered into a long-term manufacturing and supply agreement with the company and agreed to place a binding purchase order for the supply of OLC tablets by June 30, 2025.

Unicycive has agreed to place orders for additional tablets to be delivered between December 31, 2025, and June 30, 2026. Shilpa Medicare will receive income from these supply agreements.

Apart from the supply arrangement, Shilpa Medicare is expected to receive $10 million as milestone income for filing, approval, and launch of the product.

Additionally, in anticipation of increased product demand, Unicycive will also fund the establishment of a new manufacturing block at Shilpa Medicare’s site.

Post the announcement, shares of Shilpa Medicare skyrocketed by as much as 15.4% to hit their 52-week high of ₹669 apiece on the NSE. The stock has already more than doubled on a year-to-date basis in 2024.

Shilpa Medicare share traded at ₹665 per share on NSE at 11:45 am.

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