The Unicycive Therapeutics Inc (NASDAQ: UNCY) stock price soared 163.4% after signing a securities purchase deal with certain funds that invest in healthcare companies. The deal could yield gross proceeds of up to $130 million for the company after receiving a $30 million initial payment.
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The funding package was led by Vivo Capital, a healthcare investment fund, along with RA Capital, Logos Capital and BVF Partners. In addition, the company’s existing investors Rosalind Advisors Inc. and Nantahala Capital Partners also participated in the funding round. Additionally, Gaurav Aggarwal, M.D., Vivo Capital’s Managing Director, will join Unicycive’s Board of Directors.
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The clinical-stage pharmaceutical company confirmed that it would use the funds raised to file a New Drug Application (NDA) for Renazorb to get marketing approval from the U.S. Food and Drug Administration (FDA) by mid-year.
Unicycive had announced positive results from its pivotal bioequivalence (BE) study comparing Renazorb to Fosrenol®, with the study meeting its primary endpoints. The study’s topline results showing the pharmacodynamic (PD) BE of Renazorb to Fosrenol was established and met FDA’s regulatory criteria for PD BE in the healthy volunteer study.
The company had received confirmation from the FDA that the single BE study in healthy volunteers would satisfy all clinical and regulatory requirements and that no other clinical studies would be required for an NDA filing through the 505(b)(2) pathway.
Shalabh Gupta, M.D., Unicycive Therapeutics’ CEO, said: “We are delighted to have the financial backing of both existing and new investors from these high profile, healthcare-focused funds as it provides strong validation of the best-in-class potential for Renazorb® and provides funding for its potential commercial launch if approved. We remain on track to file a New Drug Application (NDA) for Renazorb marketing approval with the U.S. Food and Drug Administration (FDA) in mid-year.”
Unicycive Therapeutics noted that if approved, Renazorb may dramatically reduce the pill burden patients endure with the currently available medications.
*This is not investment advice.
Unicycive Therapeutics (UNCY) stock price.
The Unicycive Therapeutics (UNCY) stock soared $163.3% to trade at $1.29, from Friday’s closing price of $0.49.
YOUR CAPITAL IS AT RISK. 76% OF RETAIL CFD ACCOUNTS LOSE MONEY.