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Last Post: 5/20/2022 2:30:03 PM - Followers: 45 - Board type: Free - Posts Today: 0



Veru Sets Another Quarterly Record in Both Net Revenues and in Gross Profit for Fiscal 2021 First Quarter 



VERU-111 for COVID-19

This past Monday we announced positive results from the Phase 2 clinical trial evaluating VERU-111 for the treatment of hospitalized patients with COVID-19 who were at high risk for acute respiratory distress syndrome (ARDS). VERU-111 is a novel once a day orally dosed small molecule that has both broad antiviral and anti-inflammatory activities which may serve a two-pronged approach to the treatment of COVID-19 virus infection and the subsequent debilitating inflammatory effects that lead to ARDS and death. We conducted a double-blind, randomized, placebo-controlled Phase 2 clinical trial evaluating daily oral once a day dosing of VERU-111 18mg versus placebo in approximately 40 hospitalized COVID-19 patients who were at high risk for ARDS. This trial was conducted in 5 sites across the United States. Patients that were hospitalized with documented evidence of COVID-19 infection with symptoms and who were at high risk for ARDS were enrolled. Subjects received either VERU-111 18mg or placebo as well as standard of care for 21 days or until released from hospital. The primary efficacy endpoint was the proportion of patients that were alive without respiratory failure at Day 29.

For the primary endpoint in hospitalized patients that had >1 dose of study drug, VERU-111 for COVID-19 treatment compared to placebo had a statistically significant and clinically meaningful 81% relative reduction in death or respiratory failure at Day 29. With respect to secondary endpoints, VERU-111 had a statistically significant 82% relative reduction in patient mortality and statistically significant reduction in days in ICU; there was also a decrease in days on mechanical ventilation versus placebo. Furthermore, VERU-111 was well tolerated with a good safety profile.

The Company has been granted an expedited End of Phase 2 meeting with the FDA to discuss next steps including a Phase 3 clinical registration trial design for the VERU-111 COVID-19 program. The Company expects that this confirmatory study will have a similar trial design as the Phase 2 study to evaluate daily oral doses of VERU-111 versus placebo with the primary efficacy endpoint of proportion of patients that are alive without respiratory failure at Day 29. We expect the Phase 3 clinical trial will be conducted in approximately 200 hospitalized patients who have COVID-19 and are at high risk for ARDS. The Biomedical Advanced Research and Development Authority of the US Department of Health and Human Services (BARDA) has granted Veru a meeting to discuss possible grant funding for the Phase 3 study and manufacturing scale up. We plan to commence the VERU-111 for COVID-19 Phase 3 study in April 2021.

Doctor Dean Presentation

VERU Pharma CEO, Dr. Mitchell Steiner Discusses Clinical Trials and COVID-19 on CEORoadshow

Edited Transcript of VERU.OQ earnings conference call or presentation 10-Feb-21 1:00pm GMT


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VERU News: Veru to Participate in Fireside Chat at the Jefferies Healthcare Conference on June 8, 2022 05/25/2022 04:30:00 AM
VERU News: Veru Announces Appointment of Joel Batten to Lead U.S. Infectious Disease Franchise to Focus on Hospitalized COVID-19 Patients 05/18/2022 04:30:00 AM
VERU News: Analysts Are Bullish on These Healthcare Stocks: Veru (VERU), Moderna (MRNA) 05/17/2022 02:35:12 PM
VERU News: Veru to Present at the H.C. Wainwright Global Investment Conference on May 24th 2022 05/17/2022 04:30:00 AM
VERU News: Veru: EUA for Covid-19 Treatment Could Be Granted by Q3, Says Oppenheimer 05/16/2022 09:26:03 AM
#539  Sticky Note CAN THIS HAPPEN AGAIN? nonsequetor 04/26/22 04:30:15 PM
#465  Sticky Note Just Google VERU'S drug and see all the tomj1 04/14/22 09:06:12 AM
#380  Sticky Note The Independent Data Safety Monitoring Committee unanimously recommended crudeoil24 04/13/22 02:46:41 PM
#608   Totally. With such a low float, I’m buying Here Today 05/20/22 02:30:03 PM
#607   Creating another buying opportunity!!! idccwin 05/20/22 02:08:52 PM
#606   This is what happens to Short Cabal Fudders....... They Here Today 05/19/22 03:56:43 PM
#605   Shorts are winning today idccwin 05/19/22 03:30:00 PM
#604   The shorts are giving us another buying opportunity!!! idccwin 05/18/22 10:51:23 AM
#603   Outstanding news said the new investor. BostonSportsNut 05/17/22 09:45:08 PM
#602   Come on.... Your pulling my leg.... Mike Burry. Google Here Today 05/17/22 07:48:13 PM
#601   Alleyba says........... Alleyba1 05/17/22 07:08:19 PM
#600   Alleyba says............. Alleyba1 05/17/22 04:32:43 PM
#599   A lot going for this company besides the Here Today 05/17/22 04:13:56 PM
#598   Nice accumulation last hour of trading session. crudeoil24 05/17/22 04:10:30 PM
#597   I can’t drive 55 but I’ll take 55. idccwin 05/17/22 04:08:12 PM
#596   2 gaps 9.70 & 4.54 nonsequetor 05/16/22 09:16:05 AM
#595   Veru Shares Spike, Jefferies Reiterates Buy Rating And crudeoil24 05/16/22 07:42:34 AM
#594   I think to get cash to pay for idccwin 05/14/22 12:56:06 PM
#593   Alleyba says to tomj 1............... Alleyba1 05/13/22 06:09:24 PM
#592   I’m long…. And I like that too!!!! SQUEEZE !! Xunefox 05/13/22 05:07:48 PM
#591   Alleyba says............. Alleyba1 05/13/22 03:51:22 PM
#590   Considering the type of company that they are, Here Today 05/13/22 01:48:25 PM
#589   Already traded 1x through the float and almost Here Today 05/13/22 01:47:41 PM
#588   I want to and need to see 17.50$ EOD! Xunefox 05/13/22 01:05:52 PM
#587   Alleyba says: Alleyba1 05/13/22 12:15:30 PM
#586   Coming close to that $16 / 65 million Here Today 05/13/22 11:03:52 AM
#585   Anyone who was short premarket and is still Here Today 05/13/22 11:02:58 AM
#584   Looking to break 52 week high today Imarket13 05/13/22 11:00:07 AM
#583   She’s gonna BLOW!!!!!! Here Today 05/13/22 10:59:20 AM
#582   Phase 3 trial of its sabizabulin treatment for crudeoil24 05/13/22 10:52:00 AM
#581   PT To $55 crudeoil24 05/13/22 10:41:24 AM
#580   Possibly! > Regardless, what a rocket ship! crudeoil24 05/13/22 10:40:39 AM
#579   In my opinion, once snd if she hits Here Today 05/13/22 10:39:53 AM
#578   So how many times does the Float turn Here Today 05/13/22 10:38:37 AM
#577   Oh Yeah..... Fun times accumulating when shortie was Here Today 05/13/22 10:37:04 AM
#576   Veru Shares Spike, Jefferies Reiterates Buy Rating And crudeoil24 05/13/22 10:28:19 AM
#575   Run Forest RUUUUUUUUUUUUN!!!!!! Here Today 05/13/22 10:23:35 AM
#574   Shorts are TOAST!!!!! “Veru price target raised at Jefferies Here Today 05/13/22 10:17:38 AM
#573   I don't expect an offering but in this frankyahoo 05/13/22 09:58:00 AM
#572   Why an offering if they are ripe with Glider549 05/13/22 09:54:03 AM
#571   I agree 100%!!!! Glider549 05/13/22 09:52:56 AM
#570   That is exactly what Dr. Steiner told Cramer nonsequetor 05/12/22 06:52:41 PM
#569   True, as they did when they issued the nonsequetor 05/12/22 06:50:07 PM
#568   100% Hopefully the payback is coming! idccwin 05/12/22 03:18:01 PM
#567   I agree 100%. That article was total shyt. Gman3343 05/12/22 08:22:03 AM
#566   Xurefox, Whatever was done was in the past. Apparently Alleyba1 05/11/22 10:36:06 PM
#565   ALLEYBA SAYS........ Alleyba1 05/11/22 04:45:21 PM
#564   Seems like $VERU would have done an offering frankyahoo 05/11/22 12:28:21 PM
#563   Earnings report tomorrow. Just another catalyst for $VERU. frankyahoo 05/11/22 12:09:25 PM
#562   Yes, this will be moving higher in the Milo1 05/11/22 12:06:51 PM
#561   Company has plenty of cash on hand. Trials Milo1 05/11/22 12:05:59 PM
#560   *SNIFF* *SNIFF* This smells just like another Dr. nonsequetor 05/11/22 09:55:35 AM
#559   55% relative reduction in deaths (p=0.0029) FooBarAndGrill 05/11/22 09:55:18 AM
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