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VERU

Veru

$4.01

0.13 (3.35%)

08:10
01/13/20
01/13
08:10
01/13/20
08:10

Veru announces interim data from Phase 2 trial of Zuclomiphene

Veru announced positive top line data interim results from its Phase 2 clinical study of Zuclomiphene citrate, a nonsteroidal oral estrogen receptor agonist, for the treatment of androgen deprivation hormone therapy induced hot flashes, also known as vasomotor symptoms, in men who have advanced prostate cancer. The Phase 2 clinical study is a double-blind randomized placebo-controlled dose finding study evaluating daily oral doses of Zuclomiphene in men with advanced prostate cancer who have ADT induced moderate to severe hot flashes. The clinical study has a treatment duration of 12 weeks and is being conducted in 24 clinical centers in the United States. A topline interim analysis was performed in which 93 men with ADT-induced hot flashes were enrolled. The objectives of the study were to evaluate the estrogenic activity of Zuclomiphene on hot flashes, to confirm a no-effect dose and to evaluate the effect of a higher dose of Zuclomiphene on the frequency of moderate to severe hot flashes at Day 42. The topline interim clinical results demonstrate that a statistically significant decrease in moderate to severe hot flashes from baseline was observed in the 50mg treatment group. The 10mg treatment group, as expected, did not show a statistically significant reduction in hot flashes from baseline. Based on this result, the 10mg dose group is established as a no-effect dose as was planned for in the study. Furthermore, when comparing the 50mg treatment group versus the 10mg treatment group, a statistically significant reduction in the frequency of moderate to severe hot flashes at Day 42 is observed. Moreover, the observed estrogenic activity of the 50mg group was statistically different from 10mg and placebo group. Zuclomiphene appears to be well tolerated as there have been no reports of drug related serious adverse events nor drug related severe adverse events and no observations of adverse events of special interest, such as breast enlargement or pain, or venothromboembolic events in the safety database for the Phase 2 clinical study. Adverse events of special interest are side effects commonly seen with off label use of steroidal estrogens and progestins for hot flashes. The 50mg treatment group shows statistical and clinically meaningful reductions in moderate to severe hot flashes from baseline without any clinically relevant safety findings. The Company plans to meet with FDA for an End of Phase 2 meeting and following this discussion with FDA, advance Zuclomiphene into a pivotal Phase 3 clinical trial for the treatment of ADT-induced moderate to severe hot flashes in men with prostate cancer in the first half of 2020.

VERU Veru
$4.01

0.13 (3.35%)

07/01/19
CANT
07/01/19
INITIATION
Target $6
CANT
Overweight
Veru initiated with an Overweight at Cantor Fitzgerald
Cantor Fitzgerald analyst Brandon Folkes initiated Veru with an Overweight rating and $6 price target.
07/02/19
CANT
07/02/19
INITIATION
Target $6
CANT
Overweight
Cantor starts Veru at Overweight, sees multiple near-term catalysts
Cantor Fitzgerald analyst Brandon Folkes last night initiated coverage of Veru with an Overweight rating and $6 price target. The company has built a pipeline of "compelling" assets, Folkes tells investors in a research note. He believes Veru's female condom business and Preboost have the potential to provide non-dilutive funding for the company to support continued investment in its pipeline. Further, at current share levels, little value is being ascribed to VERU-111, VERU-100, or Zuclomiphene citrate, which, if any are successful, could generate revenue in excess of $100M-plus each, Folkes contends. He believes "multiple near-term catalysts could transform" Veru.
07/02/19
07/02/19
INITIATION

Fly Intel: Top five analyst initiations
Catch up on today's top five analyst initiations with this list compiled by The Fly: 1. Veru (VERU) initiated with an Overweight at Cantor Fitzgerald. 2. Uber (UBER) initiated with a Hold at Stifel. 3. Wyndham Hotels & Resorts (WH) initiated with an Overweight at Barclays. 4. Veracyte (VCYT) initiated with a Buy at Needham. 5. Paysign (PAYS) initiated with a Buy at Canaccord. This list is just a portion of The Fly's analyst coverage. To see The Fly's full Street Research coverage, click here.
07/29/19
BRKL
07/29/19
INITIATION
Target $12
BRKL
Buy
Veru initiated with a Buy at Brookline
Brookline Capital Markets analyst Kumaraguru Raja initiated Veru with a Buy and $12 price target.

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