Following the announcement of receiving Fast Track designation from the FDA, Veru Inc. (VERU) stock became bullish after hours. On January 10, the company announced that its Phase 3 registration program in breast cancer patients has received Fast Track designation.
During regular trading, the stock fluctuated between a high of $5.81 and a low of $5.11 at 3.43 million shares. VERU closed the session at $5.34, with a loss of 2.20%. After the emergence of the news, the stock gained 5.99% to reach $5.66 in the after hours.
The oncology biopharmaceutical company, Veru Inc. has a market capitalization of $436.96 million. Currently, the company has 80.03 million shares outstanding in the market. Furthermore, VERU has lost 14.01% in the past five days and 45.29% last year.
Fast Track Designation
VERU has been working on a Phase 3 registration program for evaluating Enobosarm in (AR+ER+HER2) metastatic breast cancer patients. These patients have previously demonstrated disease progression on nonsteroidal AI, fulvestrant, and CDK 4/6 inhibitor therapy and have a third-line metastatic setting.
Enobosarm is the company’s selective androgen receptor agonist. It targets the androgen receptor in AR+ER+HER2 metastatic breast cancer without causing any masculinizing side effects. Currently, Enobosarm is under investigation in VERU’s three studies in various types of breast cancer. Moreover, breast cancer is one of the most common types of cancer in women. According to data, in the U.S. almost 284,200 news cases of breast cancer and 44,130 deaths from it are expected for 2021.
On Monday, the company announced that the Phase 3 program of Enobosarm has been awarded Fast Track designation by the U.S. FDA. Hence, the development of Enobosarm has been expedited for review.
VERU’s Upcoming Participation
On January 03, the company announced its upcoming participation at the H.C. Wainwright BioConnect Conference. Further, the conference will take place from January 10 to January 13, 2022. VERU’s management will present corporate updates of the company at the conference.
VERU’s Financials
On December 02, the company disclosed its financial results for Q4 and the full fiscal year 2021.
Q4 Financial Highlights
In the fiscal fourth quarter of 2021, VERU had a net loss of $4.3 million ($0.05/share) on revenues of $15.6 million. This compares to a net loss of $11.8 million on revenues of $11.7 million in the year-ago quarter.
Fiscal 2021
In fiscal 2021, the company had a net income of $7.4 million ($0.09/diluted share) on revenues of $61.3 million. Comparatively, VERU had a net loss of $19.0 million ($0.28/diluted share) on revenues of $42.6 million.
