Xeris Biopharma Holdings Inc. (XERS) became bullish on the news of its Recorlev® receiving FDA approval for Cushing’s syndrome patients. Consequently, the stock was trading at $3.15 apiece with a huge increase of 29.63% in the after-hours.
During the regular session, the stock fluctuated between a high of $2.63 and a low of $2.42 at 9.28 million shares. XERS closed the session with a decrease of 3.19% at $2.43 on December 30. Following the news, the stock saw a reversal as it became bullish after hours, gaining big at 6.01M shares.
Xeris Biopharma Holdings Inc. has a market capitalization of $313.02 million. Currently, the company has 124.71 million shares outstanding in the market.
XERS’ FDA Approval of Recorlev
Recorlev® or Levoketoconzaole is a new therapeutic option for the management of endogenous Cushing’s syndrome patients. It is a severe and potentially life-threatening rare disease. It is caused by chronic elevated cortisol exposure, usually due to a pituitary gland benign tumor. Moreover, it causes multisystem complications like diabetes, high cholesterol, and B.P, the fragility of multiple tissues including blood vessels, skin, muscle, and bone, and psychological disorders as well.
On Thursday, XERS disclosed that the U.S FDA has approved Recorlev® (levokeyoconazole). Further, it is approved for treating endogenous hypercortisolemia in Cushing’s syndrome’s adult patients with no option of surgery or noncurative surgery.
In addition, the basis of the approval was the safety and efficacy data of Recorlev® from two Phase 3 studies of a total of 166 patients. Both the studies achieved their primary as well as key secondary endpoints. Moreover, the studies also resulted in a significant decrease in the mean urinary free cortisol concentrations without a dose increase. Hence, treatment with Recorlev® causes reduction and normalization of cortisol levels.
Financial Analysis
On November 10, the company announced its financial results for the third quarter of 2021, which ended on September 30.
In the third quarter of 2021, XERS’s net sales of Gvoke HypoPen® and Gvoke pre-filled syringe were $11.0 million. This compares to $9.4 million in the third quarter of 2020.
Moreover, the cost of goods sold in the third quarter of 2021, was $3.2 million.
Furthermore, the company incurred a net loss of $26.0 million in the third quarter of 2021. Consequently, the net loss per basic and diluted shares in the third quarter of 2021, was $0.39. This includes transaction-related expenses of $2.3 million or $0.03 per share.
