Veru Inc. (VERU), an oncology biopharmaceutical company, has gained an increase of 5.99% in aftermarket trading session. As a result, VERU stock is trading at $5.66 at the time of the writing. The increase could be attributed to the FDA grant of fast track designation for one of Veru’s products. On Monday, VERU closed the day at $5.34 after declining 2.20% during the regular trading session.
Why VERU Increasing?
On Monday, VERU announced that the US Food and Drug Administration (FDA) has granted Fast Track designation to the Phase 3 registration program for the investigation of enobosarm. Enobosarm is a selective androgen receptor targeting agonist and is used for the treatment of metastatic breast cancer patients which are androgen receptor-positive, estrogen receptor-positive, human epidermal growth factor receptor 2 negatives (AR+ER+HER2-). The receptor is used for the treatment of breast cancer patients who have shown previous disease progression on a nonsteroidal AI, fulvestrant, and CDK 4/6 inhibitor therapy. Alongside that, they should also have AR% nuclei staining ≥40% in breast cancer tissue.
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FY2021 Operational Results
In early December, VERU released the operational results for the full fiscal year 2021. The year ended on 30th September 2021. The company generated net revenue of $61.25 million during the year against $42.59 million for the fiscal year 2020. The gross profit for the 12 months was $47.92 million against $30.78 million for the fiscal year 2020. The net income generated by the company during the fiscal year 2021 stood at $7.39 million (or $0.10 and $0.09 per basic and diluted share) against the net loss of $18.97 million (or $0.28 per basic and diluted share) for the fiscal year 2020.
Mitchell Steiner, M.D., Chairman, President, and Chief Executive Officer of VERU, while commenting on the results said that once again the company has had historical highs for full fiscal year net revenues and gross profit based on the robust growth of its US FC2 prescription business. The strong results have enabled the company to continue to advance its deep late clinical-stage drug pipeline portfolio. Looking ahead, the company will have substantial resources to invest in its premium oncology drug pipeline line.
Future Outlook for VERU
The last three months have seen VERU stock declined by more than 30%, primarily owing to the negative developments related to the company’s ongoing trials, which have forced investors to sell their stock. However, in the longer run, the stock appears to provide investors with the best returns. Hence, investors should look out for long-term investment in VERU stock.