Shilpa Medicare share price on Friday's trading session surged 17% to hit a 52-week high following the release of encouraging results from a key clinical study of oxylanthanum carbonate by Unicyctive Therapeutics, Inc, one of the company's contract development and manufacturing organisation (CDMO) customers.
According to the company's exchange filing, oxylanthanum carbonate is an NCE molecule that has the ability to cure hyperphosphatemia in individuals with persistent kidney disease. It also offers multiple advantages for different people with this chronic condition.
Shilpa Medicare share price today opened at an intraday low of ₹598.05 apiece, and the stock touched an intraday high of ₹677 apiece.
“Shilpa Medicare share price has been forming a higher-top, higher-bottom structure and is thus in an uptrend. However, as per historical data, the resistance is around ₹700. It needs to be seen if the stock surpasses and continues its upmove. Fresh buying is not advisable, but investors can hold existing positions,” said Ruchit Jain, Lead Research Analyst at 5paisa.
According to Trendlyne data, Shilpa Medicare share pricehas shot up by 120.69% during the last year, outperforming its sector by 62.66%.
Rajesh Bhosale, Equity Technical and Derivative Analyst at Angel One highlighted that Shilpa Medicare share prices have seen a strong gap up opening, and follow-up traction is seen with prices up more than 14% backed by strong volumes. We can expect further upside towards 750 in the coming week.
As stated in the filing, Unicycive plans to submit the New Drug Application for oxylanthanum carbonate by the middle of 2024, with a possible approval date of the middle of 2025.
Unicycive and the company have signed into a long-term manufacturing and supply agreement based on the results of the pivotal clinical trials. Unicycive has also committed to placing a legally binding purchase order for the delivery of OLC tablets by June 30, 2025. Furthermore, Unicycive has committed to ordering extra tablets, with delivery scheduled for December 31, 2025, to June 30, 2026.
In addition to the supply agreement, the business anticipates milestone income of US$ 10 million covering the product's filing, approval, and launch. Additionally, Unicycive will provide funding for the construction of a new manufacturing block at Shilpa's location in preparation of rising product demand.
As per company's recent filing, the US Food & Drug Administration (US FDA) conducted an inspection of Shilpa Medicare's Nacharam, Hyderabad, Telangana facility from February 26 to March 1, 2024.
At the end of the inspection, there were no discussion issues and only zero 483 observations. With the release of the establishment inspection report (EIR), this inspection is now concluded. The facility has a No Action Indicated (NAI) classification.
Shilpa is a comprehensive pharmaceutical organisation with commercial interests in polymers, peptides, and specialty oncology and non-oncology APIs. It also offers highly curated biological portfolio and unique final dosage formulations, such as transdermal patches and oral dispersible films.
Encompassing all business divisions, Shilpa offers comprehensive CDMO services to multinational pharmaceutical corporations by virtue of its robust R&D and production capacities, which are reinforced by four R&D units and seven manufacturing sites.
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