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Veru Files US Application For TADFIN Combo For Prostate Enlargement

  • Veru Inc (NASDAQ: VERU) has submitted a 505(b)(2) New Drug Application with the FDA for TADFIN (tadalafil 5mg and finasteride 5mg) capsules, daily oral dosing combination formulation, for the treatment of benign prostatic hyperplasia (BPH), also called prostate gland enlargement.
  • The agency’s goal date is expected in December 2021.
  • TADFIN revenues will be part of Veru’s sexual health commercial business.
  • Eli Lily and Co’s (NYSE: LLY) CIALIS (tadalafil) is currently approved for the treatment of BPH and erectile dysfunction, and Merck & Co Inc’s (NYSE: MRK) MPROSCAR (finasteride) is approved for male pattern hair loss (androgenic alopecia).
  • The company’s stock rallied after it announced positive efficacy and safety results from a Phase 2 trial evaluating VERU-111 versus placebo in approximately 40 hospitalized patients at high risk for Acute Respiratory Distress Syndrome from SARS-CoV-2.
  • Price Action: VERU is down 6.9% at $15.3 on the last check Tuesday.

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