- The shares of Xeris Pharmaceuticals Inc (NASDAQ: XERS) increased by over 20% pre-market. This is why it happened.
The shares of Xeris Pharmaceuticals Inc (NASDAQ: XERS) – a pharmaceutical company leveraging its novel formulation technology platforms to develop and commercialize ready-to-use injectable and infusible drug formulations – increased by over 20% pre-market. Investors are responding positively to Xeris Pharmaceuticals announcing that the Food and Drug Administration (FDA) has allowed the Investigational New Drug Application (IND) for its XeriSol levothyroxine for hypothyroidism to proceed.
The active IND enables Xeris to initiate a Phase 1 clinical study for XP-8121 using its novel formulation of levothyroxine in a subcutaneous injection for the treatment of hypothyroidism. This Phase 1 study will characterize Pharmacokinetics (PK) and evaluate the safety and tolerability of XP-8121 in healthy participants.
“Levothyroxine is one of the most widely prescribed drug products in the United States. However, due to the many challenges associated with oral formulations there remains an area of significant unmet need. We believe that a potentially weekly subcutaneous injection of XeriSol levothyroxine can mitigate many of these challenges and improve compliance. The Phase 1 study is the first step toward addressing this unmet need.”
— Kenneth E. Johnson, PharmD, Xeris’ Senior Vice President of Global Development and Medical Affairs
“The FDA acceptance of our XP-8121 further underscores the applicability of our XeriSol technology and progress of our pipeline. We will continue to invest in our pipeline in therapeutic areas where we have an established commercial footprint,” said
— Paul R. Edick, Chairman and CEO of Xeris
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