Veru Announces Successful Bioavailability and Bioequivalence Clinical Trial for Tadalafil and Finasteride Combination Tablet for Benign Prostatic Hyperplasia
Veru Inc. (VERU)
Last veru inc. earnings: 2/12 06:30 am
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Source: GlobeNewswire
MIAMI, Jan. 14, 2019 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), an oncology and urology biopharmaceutical company, today announced that the clinical trial of the Company’s proprietary Tadalafil and Finasteride Combination tablet met the U.S. Food and Drug Administration’s (FDA) requirements for bioavailability and bioequivalence for the co-administration of tadalafil 5mg and finasteride 5mg dosed daily for benign prostatic hyperplasia (BPH) (Tad-Fin Combination Tablet). Stability testing of commercially manufactured batches (GMP) of the Tad-Fin Combination Tablet required for submission of a New Drug Application (NDA) is in progress. The Company has also requested a Pre-NDA meeting with FDA and anticipates submitting an NDA under the 505(b)(2) regulatory pathway in the second half of calendar year 2019. Tad-Fin Combination Tablet combines two of the most popular medicines, tadalafil and finasteride, that are currently prescribed separately to treat lower urinary tract symptoms
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- Veru to Present at the American Association of Clinical Endocrinology (AACE) 2024 Annual Meeting on May 9-11GlobeNewswire
- What Makes Veru (VERU) a New Buy Stock [Yahoo! Finance]Yahoo! Finance
- Veru Inc. (NASDAQ: VERU) had its "outperform" rating re-affirmed by analysts at Oppenheimer Holdings Inc.. They now have a $5.00 price target on the stock, down previously from $7.00.MarketBeat
- Veru Announces Date of 2024 Annual Meeting of Shareholders [Yahoo! Finance]Yahoo! Finance
VERU
Earnings
- 8/10/23 - Beat
VERU
Sec Filings
- 4/25/24 - Form 8-K
- 4/24/24 - Form SC
- 4/1/24 - Form DEFA14A
- VERU's page on the SEC website