Veru Inc (VERU) Quote

$1.03 + 19% Veru to Deliver Keynote Presentation on the Scientific Support for Enobosarm in Combination with GLP-1 Receptor Agonist to Preserve Muscle for Higher Quality Weight Loss at the 4th Edition of the World Obesity and Weight Management Congress

Source: GlobeNewswire Inc.

Veru Inc. (NASDAQ: VERU), a late clinical stage biopharmaceutical company focused on developing innovative medicines for preserving muscle for high quality weight loss, oncology, and viral induced acute respiratory distress syndrome, today announced that the Company will present at the World Obesity and Weight Management Congress, taking place October 24-26, 2024, in Baltimore, Maryland.
Keynote Presentation Name: Advancing enobosarm, an oral novel Selective Androgen Receptor Modulator (SARM), to avoid muscle loss and augment fat loss when combined with a Glucagon-Like Peptide-1 Receptor Agonist (GLP-1 RA) drugs for potentially higher quality weight loss
Date: October 25, 2024
Start and end time: 9:40 AM – 10:20 AM Eastern Daylight Time
Location: Best Western Plus Hotel & Conference Center, Baltimore, MD

Additional information on the meeting can be found on the following website: https://obesityworldconference.com/

About the Enobosarm Phase 2b clinical trial
The Phase 2b, multicenter, double-blind, placebo-controlled, randomized, dose-finding clinical trial is designed to evaluate the safety and efficacy of enobosarm 3mg, enobosarm 6mg, or placebo as a treatment to preserve muscle and augment fat loss in 168 patients with sarcopenic obesity or overweight elderly (>60 years of age) patients receiving semaglutide (Wegovy®). The primary endpoint is total lean body mass, and the key secondary endpoints are total body fat mass and physical function as measured by stair climb test at 16 weeks. The Phase 2b clinical trial is actively enrolling patients from up to 15 clinical sites in the United States. Topline clinical results from the trial are expected in January of 2025.

After completing the efficacy dose-finding portion of the Phase 2b clinical trial, it is expected that participants will then continue in blinded fashion into a Phase 2b extension clinical trial where all patients will stop receiving a GLP-1 RA, but will continue taking placebo, enobosarm 3mg, or enobosarm 6mg for an additional 12 weeks. The Phase 2b extension clinical trial will evaluate whether enobosarm can maintain muscle and prevent the fat and weight gain that occurs after discontinuing a GLP-1 RA. The topline results of the separate blinded Phase 2b extension clinical study are expected in calendar Q2 2025.

About Sarcopenic Obesity
According to the CDC, 41.5% of older adults have obesity in the United States and could benefit from a weight loss medication. Up to 34.4% of these obese patients over the age of 60 have sarcopenic obesity. This large subpopulation of sarcopenic obese patients is especially at risk for taking GLP-1 drugs for weight loss as they already have critically low amount of muscle due to age-related muscle loss. Further loss of muscle mass when taking a GLP-1 RA medication may lead to muscle weakness leading to poor balance, decreased gait speed, mobility disability, loss of independence, falls, bone fractures and increased mortality which is a condition like age-related frailty. Because of the magnitude and speed of muscle loss while on GLP-1 RA therapy for weight loss, GLP-1 RA drugs may accelerate the development of frailty in older obese or overweight elderly patients.

About Enobosarm
Enobosarm (aka ostarine, MK-2866, GTx-024, and VERU-024), a novel oral daily selective androgen receptor modulator (SARM), has been previously studied in 5 clinical studies involving 968 older normal men and postmenopausal women as well as older patients who have muscle wasting because of advanced cancer. Advanced cancer causes the loss of appetite where there is significant unintentional loss or wasting of both muscle and fat mass which is similar to what is observed with in patients taking GLP-1 RA drugs. We believe the totality of the clinical data from these previous five clinical trials demonstrates that enobosarm treatment leads to dose-dependent increases in muscle mass with improvements in physical function as well as significant dose-dependent reductions in fat mass. The patient data that were generated from these five enobosarm clinical trials in both elderly patients and in patients with a cancer induced appetite suppression provide strong clinical rationale for enobosarm. The expectation is that enobosarm in combination with a GLP-1 RA would potentially augment the fat reduction and total weight loss while preserving muscle mass.

Enobosarm has a large safety database, which includes 27 clinical trials involving 1581 men and women, some of which included patients dosed for up to 3 years. In this large safety database, enobosarm was generally well tolerated with no increases in gastrointestinal side effects. This is important as there are already significant and frequent gastrointestinal side effects with a GLP-1 RA treatment alone.

About Veru Inc.
Veru is a late clinical stage biopharmaceutical company focused on developing novel medicines for the treatment of metabolic diseases, oncology, and ARDS. The Company’s drug development program includes two late-stage novel small molecules, enobosarm and sabizabulin.

Enobosarm, a selective androgen receptor modulator (SARM), is being developed for two indications: (i) Phase 2b clinical study of enobosarm as a treatment to augment fat loss and to prevent muscle loss in sarcopenic obese or overweight elderly patients receiving a GLP-1 RA who are at-risk for developing muscle atrophy and muscle weakness and (ii) subject to the availability of sufficient funding, Phase 3 ENABLAR-2 clinical trial of enobosarm and abemaciclib for the treatment of androgen receptor positive (AR+), estrogen receptor positive (ER+) and human epidermal growth factor receptor 2 negative (HER2-) metastatic breast cancer in the 2nd line setting.

Sabizabulin, a microtubule disruptor, is being developed as a Phase 3 clinical trial for the treatment of hospitalized patients with viral-induced ARDS. The Company does not intend to undertake further development of sabizabulin for the treatment of viral-induced ARDS until we obtain funding from government grants, pharmaceutical company partnerships, or other similar third-party external sources.

I've slept on this for a long time. I woke back up over the weekend. Bought some tickets today. Now I just need it to take off.

Yes more than viking

Is it Monday yet???

Could VERU be the next Viking Therapeutics????

Reason I ask and think an announcement might be incoming on Monday is due to their closing of the Open Market Stock Sale agreement with Jeffries while being involved in current clinical trials which will require cash!!!

Could there be a HUGE announcement incoming on Monday involving
Novo Nordisk A/S?????

I have a sneaky suspicion that VERU has cancelled the Sales Agreement to sell shares on the open market due to an impending deal with a Big Pharma or
Buy-Out announcement. Just my op and Wishful Thinking as a longtime investor and shareholder in here!

Can’t wait to see what VERU announces on Monday!!!!

VERU.............................https://stockcharts.com/h-sc/ui?s=VERU&p=W&b=5&g=0&id=p86431144783

VERU...........................................https://stockcharts.com/h-sc/ui?s=VERU&p=W&b=5&g=0&id=p86431144783

VERU......................................https://stockcharts.com/h-sc/ui?s=VERU&p=W&b=5&g=0&id=p86431144783

VERU................................https://stockcharts.com/h-sc/ui?s=VERU&p=W&b=5&g=0&id=p86431144783

VERU new 52 hi

Squeeeeeeeeeeeeeeeeeeeeeeeeeeeeeze baby squeeeeeeeeeeeeeeeeeeeeeeeeeeze!

VERU............................https://stockcharts.com/h-sc/ui?s=VERU&p=W&b=5&g=0&id=p86431144783

Developing a weight loss novel drug

I believe Regeneron announced yesterday they were pursuing something to this effect. Wonder if they would be interested in collaborating with VERU with this drug?

VERU......................................https://stockcharts.com/h-sc/ui?s=VERU&p=W&b=5&g=0&id=p86431144783

struggling to get off the mat, had a good thing going but no staying power... and certainly no interest in it on IHUB.... LOL LOL

VERU new 52 week low

VERU new 52 week low

Looks like it’s come up off the mat

Life today?
H.mmmm

VERU new 52 week low

VERU new 52 week low

It surely doesn't look good for him. Now we just wait. However you can all check out xrp on Coinbase. That's my biggest holding out of all my investments. Xrp just got clarity from a federal judge, xrp is not a security.
I'm still holding Veru, long term I like it, but short term not much going on, still many clinicals.
Good luck to all.

VERU...............................https://stockcharts.com/h-sc/ui?s=VERU&p=W&b=5&g=0&id=p86431144783

Ther meme stock..good nws

https://www.prnewswire.com/news-releases/theralink-acquires-exclusive-landmark-immunotherapy-patent-including-biomarker-from-vanderbilt-university-301787847.html

I still say in my opinion the shareholders should thank Dr. Eisenbarger for the demise of the Veru share price. I wonder when he found out and knew they would not get FDA approval in my opinion. My opinion is when he sold all of his stock the stock tanked shortly thereafter. That is my opinion.

I believe in the latest VERU filing Blackrock took a 5% or more interest in the company. News can't be all that bad

VERU.................................https://stockcharts.com/h-sc/ui?s=VERU&p=W&b=5&g=0&id=p86431144783

I still say in my opinion the shareholders should thank Dr. Eisenbarger for the demise of the Veru share price. I wonder when he found out and knew they would not get FDA approval in my opinion. My opinion is when he sold all of his stock the stock tanked shortly thereafter. That is my opinion.

Never mess with the FDA. They only approve when influenced with Cash imo. Look at IMGN. Sick approval. Market drops it cause they think they can’t market there own drug. They have another approval coming in less then 3 months

No, just investors fed up with the games.

Yea, that didn't help. And it looks shady that he sold all.

I still say in my opinion the shareholders should thank Dr. Eisenbarger for the demise of the Veru share price. I wonder when he found out and knew they would not get FDA approval in my opinion. My opinion is when he sold all of his stock the stock tanked shortly thereafter. That is my opinion.

Very sad, they could be helping people. But because of money not going their way, it won't happen. It's disgusting.

G-Man,
I totally agree with you. The FDA was most likely paid to not approve the Sabi drug in my opinion.

Is this just another frivolous lawsuit by a typical bottom feeding law firm?

It's ridiculous, that drug should have gotten approved. Probably was a pay off, who knows.
That's our government for you.

I totally agree with your comments. If this application was made by PFIZER or another BIG PHARMA COMPANY the vote would have been 13-0 in favor. Who knows, in my opinion maybe someone got paid off

So, what are we saying ~ all is lost ?

I totally agree with you. Statistically the numbers may have been better if the FDA had no concerns about the efficacy of the drug and did not ask VERU to stop the trials. I am afraid the FDA screwed us and wonder who paid them off to give us the denial. Every drug I see on TV indicates the side effects can be death, suicide thoughts, kidney failure, liver disease, COPD , etc. etc. We have a safe drug and it gets shoved up our rear ends.

No, why would that happen ? Drug was not approved yet. FDA f-,cked Veru with it's shytty slides show of the drug.
Our government is a bunch of back door dealing scumbags.

A good chance that VERU will force some shorts to cover today?

Yes, that is very suspicious.

Here Today,
I hope you are somehow correct.

I agree with you, but I think, in my opinion, it all goes back to Dr. Eisenbager when he dumped his entire position. In my opinion he must have known the drug would not get approved. He was an insider . This of course is just my opinion.

Accumulate here.

Not over yet since the FDA May allow with some provisions. Adcom an advisory and not a final decision. Let’s see what happens since I believe as the Wednesday company PR states:



Veru Provides Update on FDA Advisory Committee Meeting Regarding Emergency Use Authorization of Sabizabulin to Treat Hospitalized COVID-19 Patients at High Risk for Acute Respiratory Distress Syndrome

MIAMI, FL, Nov. 09, 2022 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), a biopharmaceutical company focused on developing novel medicines for COVID-19 and other viral ARDS-related diseases and for oncology, announces the results of today’s meeting of the U.S. Food and Drug Administration’s (FDA) Pulmonary-Allergy Drugs Advisory Committee (PADAC), which reviewed sabizabulin for Emergency Use Authorization (EUA) in hospitalized moderate to severe COVID-19 patients who are at high risk for acute respiratory distress syndrome (ARDS). The advisory committee voted 8-5 that the known and potential benefits of sabizabulin when used for the treatment of adult patients hospitalized with COVID-19 at high risk of ARDS do not outweigh the known and potential risks of sabizabulin. However, there was additional discussion around the clinical trial design aspects of an additional clinical trial as a potential post authorization requirement. FDA will consider the input of the advisory committee as part of their review of the EUA and render a decision on the Emergency Use Authorization.
“We look forward to continuing to work with the FDA as we continue our efforts to ensure that this product is available to patients in a timely manner,” said Mitchell Steiner, M.D., Chairman, President, and Chief Executive Officer of Veru.
“In a still evolving COVID-19 pandemic taking the lives of over 300 U.S. citizens a day and with the threat of new virus variants looming that may not be as easily treated with the limited array of presently used therapies, there is an urgent need for newer therapies with much greater effectiveness than what is available. Sabizabulin with its unique action as a microtubular disruptor, both reducing inflammation and viral replication independent of virus variant, shows compelling promise,” said Erik Swenson, M.D. Professor of Medicine, Physiology, and Biophysics, University of Washington, and former Chairman of PADAC. “In a recently published well-executed double-blind placebo-controlled trial of patients with respiratory compromise and at high risk of developing ARDS, sabizabulin reduced absolute mortality at 60 days by 20.5%, compared to 0-6% for all other available drugs. In the long history of drug trials for patients with severe respiratory failure over many decades, there has never been a drug to show such dramatic protection.”
“Adding sabizabulin to the cadre of therapies among hospitalized patients with COVID-19 is crucial in the effort to reduce mortality among a group of patients who have seen the least reduction in death despite newer treatments and approaches,” said Christian Sandrock, M.D. Division Vice Chief of Internal Medicine and Director of Critical Care University of California, Davis, School of Medicine.
Phase 3 sabizabulin clinical study:
A double-blind, randomized, placebo-controlled Phase 3 COVID-19 clinical trial was conducted in 204 hospitalized COVID-19 patients with moderate to severe COVID-19 at high risk for ARDS and death. The primary endpoint was the proportion of deaths by Day 60. Based on a planned interim analysis of the first 150 patients randomized, the Independent Data Monitoring Committee unanimously halted the study for clear clinical efficacy and no safety concerns were identified. Treatment with sabizabulin 9 mg once daily, an oral, first-in-class, new chemical entity, microtubule disruptor that has dual anti-inflammatory and antiviral properties, resulted in a clinically meaningful and statistically significant 55.2% relative reduction in deaths compared to placebo. In the full study, there were 204 patients enrolled, and for the primary endpoint, there was a clinically meaningful and statistically significant 20.5% absolute reduction and 51.6% relative reduction in mortality at Day 60. In June, the Company submitted a request for Emergency Use Authorization to FDA. On July 6, 2022, the Company announced the publication of the Phase 3 COVID-19 trial results evaluating the efficacy and safety of oral sabizabulin in The New England Journal of Medicine Evidence®.
Global regulatory activities:
The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) informed the Company on July 25, 2022, that the sabizabulin marketing authorization application will receive expedited review. On July 27, 2022, The European Medicines Agency’s Emergency Task Force initiated the review of sabizabulin treatment for hospitalized COVID-19 patients for emergency use in European Union countries. On August 22, 2022, Australia’s Therapeutic Goods Administration (TGA) determined that sabizabulin treatment in hospitalized COVID-19 patients at high risk for ARDS qualifies for an expedited, provisional registration regulatory pathway.