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IFUS is strong and about to move higher
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
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 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.
G-Man,
I totally agree with you. The FDA was most likely paid to not approve the Sabi drug in my opinion.
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
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.
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.
Alleyba1
In my opinion, Dr. Mario Eisenbarger, who was an insider of the company (I believe), sold his entire stake in this company which amounted to $20 million at a time when there may have been a material event pending (before they pushed back ADCOM). In my opinion, the SEC should be looking at this sale of stock. He had owned the stock 5-7 years so why did he sell unless he knew the or heard that the company would not be successful at the meeting and why did Steiner allow the sale at the time? This, in my opinion, is looking very suspicious to me and I was wondering what the thoughts of the other shareholders are?
The FDA does not have to follow what the ADCOM says. They can still give EAU based on conditions. I have 2,000 writtten calls that expire November 18th so I am screwed there, I has 3,000 free trading shares, woke up this morning, read report which did not look good and sold 1,000 shares at $14.75.; however, we do not know what FDA will do tomorrow, but I think we got screwed and I wonder if there is any recourse against Dr. Eisenbarger for dumping his whole position. He must have know something in my opinion.
Panther
Until they got the tax lien on the property paid their hands were tied. Now the lien is paid off and operations are about to commence.
Because it is good for other things. Why not take the grant money if ir is available?
He cost everyone big bucks non-sequitor.; however, the real drugs are the cancer drugs.
No not for me. How about you non-sequitor?
Just read Ad-com for stock has been pushed back 1 month until November.
Just read on Stocktwits the following:
rumor is Israel approved VERU as emergency use for critical cases
"The discussion also approved the purchase of a medicine called Sabizabulin, intended for corona patients in serious condition." This is in regard to what the doctors are saying in Israel, perhaps the next country to approve the use of the drug.
Here Today,
Thank you. I happened to find it afterwards. What is you opinion of the upcoming Ad-Com review. As I understand it Steiner said there was nothing wrong with the drug manufacturing facilities and the FDA stopped the clinical trial because the efficacy was sound. So is there any reason in your mind to think we will not get EAU approval, particularly since the drug works and has reduced COVID deaths?
Here Today,
Do you have a copy of that news that you can reprint? So that adds another country interested in the drug. With the plants having no deficiencies and the previous report that they were satisfied with the efficacy, do you think this will happen on October 6th?
I guess there is no chart to see that is revealing
Here today.....what makes you think institutional investors are shorting the stock to accumulate additional shares. I thought for sure Dr. Eisenbarger would be in some type of quiet period and not allowed to sell stock as he was an insider. I could have sworn that Mitchell said the decision on the treatment that is under EAU preliminary approval would have been out already. I would like to hear your thoughts.
Additionally I would like to see the chart AD-2 keeps referring to.
AD2,
What did Mario Esienbarger sell his stake and stop the momentum of the stock in it's tracks? The optics, in my opinion looked very bad, particularly if they do not get the EAU designation which the CEO said on the conference call they would know the decision by the end of the month. So on the assumption that they do get it, no harm no foul. If they do not get it I feel certain with this news expected , out there would have been a blackout period and he would have been unable to do anything with his stock, much less sell it.
What is your take on this . Same question for here today.
Here Today,
Here is my opinion. Blackrock increased their holdings, Morgan Stanley also increased their holdings as well as Goldman Sachs. I think the optics of Eisenbarger were terrible in his selling all shares owned by him. I thought while the EAU decision was pending that this stock was in a black out period. If they DO NOT get EAU approval I think VERU is open to a class action lawsuit. He stopped the momentum of this stock right in it's tracks. We are supposed to get a decision according to Steiner by the end of the month. This I view as a major buying opportunity. Who knows why Dr. Eisenbarger sold? Again, the optics were bad and I will look into filing a lawsuit against VERU if they do not get EAU approval.
HerecToday,
The call is still on for a week, but that is what I gleaned from the report.
I agree, but these guys are professionals. They shorted and probably covered with options.
On TD I am seeing 34% short interest. Am I reading that wrong
Here Today,
I listened to the conference call today. Looks like they anticipate EAU approval in 9-14 days. I am looking for it to happen when my August 18 options expire because I have the 21's which I have the right to buy back prior to them hitting 21. The facilities visited by the FDA passed with flying colors. The efficacy is good and they have already made arrangements with distribution centers for the pills to go to the hospitals. I was very encouraged by the report.
Gman,
It has not been under 10 for quite a while now. I think you could have bought it in the high 11's all day long last week.
Here Today,
Here is what I did. I bought 900 shares and rounded my position to 5,000 shares. I then sold 10 covered calls for 21 which expires in 8 days and then sold 10 more at 25 that expires next month. I then cashed in 500 shares so I banked some money, but have a core position of 2500. I have heard very positive things are coming out and this drug they kind of stumbled on, but this IS NOT the drug they are waiting for. It is their cancer drug that is the big one.
I probably own a heck of less stock than you, but that is how I decided to play it after letting the last move get away from me. What is you opinion as to how I played it? At the very least I have banked 2 premiums and cashed 500 shares.
It’s not a done deal. But so far, all indications point to the probability of Veru, a small biotech, winning the latest Emergency Use Authorization from the FDA for a COVID-19 treatment. And if all goes well, the approval would be the first of its kind for a company of its size — potentially catapulting Veru from relative obscurity into a blockbuster drugmaker.
Here’s how it happened.
The company announced in April that it was halting a late-stage trial for sabizabulin, an antiviral and anti-inflammatory treatment in hospitalized COVID-19 patients, because the drug was so successful in reducing deaths, it would not have been ethical to continue giving other patients a placebo.
On May 10, Veru was then granted a pre-EUA meeting with the FDA to discuss filing for the approval. According to Veru’s CEO, Mitchell Steiner, the tone of the meeting was unlike others he’s had with the agency.
“They’ve seen the data. The safety is there, the efficacy is there,” he explains. “So this was more like they were saying ‘Tell us about your drug supply because we have to get this going.’ It was very process-oriented.”
The reason for the rush is that although vaccines have made an enormous impact on the fight against COVID-19, and other therapies have been shown to reduce symptoms or speed recovery, the death rate for hospitalized patients has remained stubbornly high. But in the trial of severely ill patients with COVID-19 at high risk for acute respiratory distress syndrome (ARDS), sabizabulin reduced the chance of death to about 20%, compared to 45% on a placebo.
And of course, the pandemic hasn’t been “behaving,” Steiner notes. Despite the many mitigation efforts, COVID-19 has continued to mutate and spread — presenting an ongoing challenge made all the more apparent recently when the U.S. passed the grim milestone of 1 million COVID-related deaths.
“If our drug would have been available at the start of the pandemic, 500,000 patients would be home right now,” Steiner says.
Veru plans to submit its materials for the EUA by the end of this quarter and expects to hear back from the FDA within two months of submission.
Now, Veru is hustling to quickly scale up for widespread distribution.
Alleyba says:
bout Veru Inc.
Veru is a biopharmaceutical company focused on developing novel medicines for COVID-19 and other viral and ARDS-related diseases and for the management of breast and prostate cancers.
Infectious disease program:
The Company has completed a positive Phase 3 COVID-19 study in hospitalized moderate to severe COVID-19 patients at high risk for ARDS.
A double-blind, randomized, placebo-controlled Phase 3 COVID-19 clinical trial was conducted in approximately 210 hospitalized COVID-19 patients with moderate to severe COVID (≥ WHO 4-supplemental oxygen) 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 overwhelming efficacy and safety. Treatment with sabizabulin 9mg 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. On June 7, 2022, 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®.
Oncology program:
The Company's late-stage breast cancer development portfolio comprises enobosarm, a selective androgen receptor targeting agonist, and sabizabulin.
Current studies on the two drugs include:
Enrolling Phase 3 ARTEST study of enobosarm in androgen receptor positive, estrogen receptor positive, and human epidermal growth factor receptor two negative (AR+ ER+ HER2-) metastatic breast cancer with AR ≥ 40% expression (third-line metastatic setting), and which has been granted Fast Track designation by the FDA.
Enrolling Phase 3 ENABLAR-2 study of enobosarm + abemaciclib (a CDK 4/6 inhibitor) combination in AR+ ER+ HER2- metastatic breast cancer with AR ≥ 40% expression (second-line metastatic setting). The Company and Eli Lilly and Company have entered into a clinical study collaboration and supply agreement for the ENABLAR-2 study. Lilly will supply Verzenio® (abemaciclib).
Planned Phase 2b study of sabizabulin in AR+ ER+ HER2- metastatic breast cancer with AR < 40% expression (third-line metastatic setting).
Veru's late-stage prostate cancer portfolio comprises sabizabulin, VERU-100, a long-acting GnRH antagonist, and zuclomiphene citrate, an oral nonsteroidal estrogen receptor agonist.
Current studies on these drugs include:
Enrolling Phase 3 VERACITY study in metastatic castration and androgen receptor targeting agent resistant prostate cancer prior to IV chemotherapy.
Enrolling Phase 2 dose-finding study of VERU-100 in advanced hormone sensitive prostate cancer.
Planned Phase 2b study of zuclomiphene citrate to treat hot flashes in men with advanced prostate cancer undergoing androgen deprivation therapy.
Commercial sexual health program, Urev, has 2 FDA approved products:
ENTADFI™ (finasteride and tadalafil) capsules for oral use, a new treatment for benign prostatic hyperplasia, for which commercialization launch plans are underway.
FC2 Female Condom® (internal condom), for the dual protection against unplanned pregnancy and the transmission of sexually transmitted infections which is sold in the U.S. and globally.
Alleyba says.......
That he just came across this. Click on and read the story:
Biotech poised for H2 recovery as stocks rise amid quarterly results, M&A activity
04:00 PM | (VERU) | By: Jonathan Block, SA News Editor
Read now »
Boiler Room,
You tell me. Here is latest news:
Oppenheimer said that a new analysis conducted by Veru (NASDAQ:VERU) on mortality rates in a phase 3 trial of its COVID-19 therapy sabizabulin assuages concerns and will lead to an Emergency Use Authorization from the U.S. FDA
Panther,
I read your reply. Would you kindly put on the board a copy of that report that speaks to the efficacy of the product. If you do not have it then in my view, it does not exist. If It does exist I would like to read it in it's entirety.
Panther,
Because of the tax lien on the property, they were unable to operate the company. The tax lien has been paid off in full and now the company has access to the building and will begin to immediately fill back orders to existing cattlemen. As there is a drought down there you know the CEO product is much cheaper than hay. I do not believe that the efficacy of this product has ever been questioned. I think we are in for an interesting ride on this stock in the coming weeks.
Alleyba says,
Latest news:
Veru to Report Fiscal 2022 Third Quarter Financial Results, Host Conference Call on August 11th
Print Article
MIAMI – July 28, 2022 – Veru Inc. (NASDAQ: VERU), a biopharmaceutical company focused on developing novel medicines for COVID-19 and other viral and ARDS-related diseases and for the management of breast and prostate cancers, today announced that it will report financial results for its fiscal 2022 third quarter, on Thursday, August 11, 2022, before the market opens. Veru’s management will host a conference call that same day at 8 a.m. ET to review the Company’s performance and to answer questions. The call will also be accessible via webcast.
Event Details
Interested parties may access the call by dialing 1-800-341-1602 from the U.S. or 1-412-902-6706 from outside the U.S. and asking to be joined into the Veru Inc. call. The call will also be available through a live, listen-only audio broadcast via the Internet at www.verupharma.com. Listeners are encouraged to visit the website at least 10 minutes prior to the start of the scheduled presentation to register, download and install any necessary software. A playback of the call will be archived and accessible on the same website for at least three months. A telephonic replay of the conference call will be available, beginning the same day at approximately 12 p.m. (noon) ET by dialing 1-877-344-7529 for U.S. callers, or 1-412-317-0088 from outside the U.S., passcode 1902173, for one week.
About Veru Inc.
Veru is a biopharmaceutical company focused on developing novel medicines for COVID-19 and other viral and ARDS-related diseases and for the management of breast and prostate cancers.
Infectious disease program:
The Company has completed a positive Phase 3 COVID-19 study in hospitalized moderate to severe COVID-19 patients at high risk for ARDS.
A double-blind, randomized, placebo-controlled Phase 3 COVID-19 clinical trial was conducted in approximately 210 hospitalized COVID-19 patients with moderate to severe COVID (≥ WHO 4-supplemental oxygen) 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 overwhelming efficacy and safety. Treatment with sabizabulin 9mg 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. On June 7, 2022, 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®.
Oncology program:
The Company’s late-stage breast cancer development portfolio comprises enobosarm, a selective androgen receptor targeting agonist, and sabizabulin.
Current studies on the two drugs include:
Enrolling Phase 3 ARTEST study of enobosarm in androgen receptor positive, estrogen receptor positive, and human epidermal growth factor receptor two negative (AR+ ER+ HER2-) metastatic breast cancer with AR ≥ 40% expression (third-line metastatic setting), and which has been granted Fast Track designation by the FDA.
Enrolling Phase 3 ENABLAR-2 study of enobosarm + abemaciclib (a CDK 4/6 inhibitor) combination in AR+ ER+ HER2- metastatic breast cancer with AR ≥ 40% expression (second-line metastatic setting). The Company and Eli Lilly and Company have entered into a clinical study collaboration and supply agreement for the ENABLAR-2 study. Lilly will supply Verzenio® (abemaciclib).
Planned Phase 2b study of sabizabulin in AR+ ER+ HER2- metastatic breast cancer with AR < 40% expression (third-line metastatic setting).
Veru’s late-stage prostate cancer portfolio comprises sabizabulin, VERU-100, a long-acting GnRH antagonist, and zuclomiphene citrate, an oral nonsteroidal estrogen receptor agonist.
Current studies on these drugs include:
Enrolling Phase 3 VERACITY study in metastatic castration and androgen receptor targeting agent resistant prostate cancer prior to IV chemotherapy.
Enrolling Phase 2 dose-finding study of VERU-100 in advanced hormone sensitive prostate cancer.
Planned Phase 2b study of zuclomiphene citrate to treat hot flashes in men with advanced prostate cancer undergoing androgen deprivation therapy.
Commercial sexual health program, Urev, has 2 FDA approved products:
ENTADFI™ (finasteride and tadalafil) capsules for oral use, a new treatment for benign prostatic hyperplasia, for which commercialization launch plans are underway.
FC2 Female Condom® (internal condom), for the dual protection against unplanned pregnancy and the transmission of sexually transmitted infections which is sold in the U.S. and globally.
Forward-Looking Statements
Alleyba says,
That VERU released the following after the bell. This is the article in it's entirety. Can someone post it on Stocktwits because that is where all the shorts are posting and my credential are messed up on that board?
European Medicines Agency’s Emergency Task Force Has Initiated the Review of Veru’s Sabizabulin Treatment for Hospitalized COVID-19 Patients for Emergency Use in European Union Countries
Print Article
MIAMI – July 27, 2022 – Veru Inc. (NASDAQ: VERU), a biopharmaceutical company focused on developing novel medicines for COVID-19 and other viral and ARDS-related diseases and for the management of breast and prostate cancers, today announced that the European Medicines Agency’s (EMA) Emergency Task Force (ETF) has informed the Company that it has initiated the review of sabizabulin for the treatment of hospitalized COVID-19 patients at high risk for Acute Respiratory Distress Syndrome (ARDS).
ETF stated: “The review will look at all available data, including data from a study involving hospitalized patients with moderate-to-severe COVID-19 who are at high risk of acute respiratory distress syndrome (ARDS) and death [NEJM Evidence publication DOI:10.1056/EVIDoa2200145]. The results of this study would indicate that sabizabulin treatment reduces the number of deaths in these patients compared with placebo (a dummy treatment). . . .The review will assist EU Member States who may consider allowing use of the medicine before a possible authorisation. The review is the first to be triggered under Article 18 of the new EU regulation (Reg 2022/123) that expanded the role of EMA during public health emergencies. The ETF will conduct this review and send recommendations to the Agency’s human medicines committee (CHMP), which will issue the Agency’s opinion. EMA will communicate on the outcome of the review when it concludes.”
“COVID-19 infections are sharply rising in Europe. Unfortunately, the death rate in hospitalized patients with moderate to severe COVID-19 who are at risk for ARDS remains unacceptably high with current standard of care. By reducing deaths in hospitalized COVID-19 patients, sabizabulin has great potential to play a critical role in the battle against COVID-19 in the EU. We are excited with this development at the EMA by the Emergency Task Force. We were just notified yesterday that sabizabulin triggered Article 18,” said Mitchell Steiner, M.D., Chairman, President, and Chief Executive Officer of Veru. “This new emergency regulatory pathway may allow the availability of sabizabulin to EU member states prior to sabizabulin being approved by EMA. Separately, we were also informed by CHMP yesterday that the sabizabulin product is eligible for submission of an application for a centralized marketing authorization.”
About Veru Inc.
Veru is a biopharmaceutical company focused on developing novel medicines for COVID-19 and other viral and ARDS-related diseases and for the management of breast and prostate cancers.
Infectious disease program:
The Company has completed a positive Phase 3 COVID-19 study in hospitalized moderate to severe COVID-19 patients at high risk for ARDS.
A double-blind, randomized, placebo-controlled Phase 3 COVID-19 clinical trial was conducted in approximately 210 hospitalized COVID-19 patients with moderate to severe COVID (≥ WHO 4-supplemental oxygen) 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 overwhelming efficacy and safety. Treatment with sabizabulin 9mg 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. On June 7, 2022, 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®.
Oncology program:
The Company’s late-stage breast cancer development portfolio comprises enobosarm, a selective androgen receptor targeting agonist, and sabizabulin.
Current studies on the two drugs include:
Enrolling Phase 3 ARTEST study of enobosarm in androgen receptor positive, estrogen receptor positive, and human epidermal growth factor receptor two negative (AR+ ER+ HER2-) metastatic breast cancer with AR ≥ 40% expression (third-line metastatic setting), and which has been granted Fast Track designation by the FDA.
Enrolling Phase 3 ENABLAR-2 study of enobosarm + abemaciclib (a CDK 4/6 inhibitor) combination in AR+ ER+ HER2- metastatic breast cancer with AR ≥ 40% expression (second-line metastatic setting). The Company and Eli Lilly and Company have entered into a clinical study collaboration and supply agreement for the ENABLAR-2 study. Lilly will supply Verzenio® (abemaciclib).
Planned Phase 2b study of sabizabulin in AR+ ER+ HER2- metastatic breast cancer with AR < 40% expression (third-line metastatic setting).
Veru’s late-stage prostate cancer portfolio comprises sabizabulin, VERU-100, a long-acting GnRH antagonist, and zuclomiphene citrate, an oral nonsteroidal estrogen receptor agonist.
Current studies on these drugs include:
Enrolling Phase 3 VERACITY study in metastatic castration and androgen receptor targeting agent resistant prostate cancer prior to IV chemotherapy.
Enrolling Phase 2 dose-finding study of VERU-100 in advanced hormone sensitive prostate cancer.
Planned Phase 2b study of zuclomiphene citrate to treat hot flashes in men with advanced prostate cancer undergoing androgen deprivation therapy.
Commercial sexual health program, Urev, has 2 FDA approved products:
ENTADFI™ (finasteride and tadalafil) capsules for oral use, a new treatment for benign prostatic hyperplasia, for which commercialization launch plans are underway.
FC2 Female Condom® (internal condom), for the dual protection against unplanned pregnancy and the transmission of sexually transmitted infections which is sold in the U.S. and globally.
Forward-Looking Statements
The statements in this release that are not historical facts are “forward-looking statements” as that term is defined in the Private Securities Litigation Reform Act of 1995. Forward-looking statements in this release include statements regarding: whether and when the Company will receive an emergency use authorization or any approval from FDA or EMA or EU member countries or from any other regulatory authority outside the U.S. for sabizabulin for certain COVID-19 patients; whether and when sabizabulin will become an available treatment option for certain COVID-19 patients in the U.S., EU or anywhere else outside the U.S.; whether and when the Company will submit any marketing authorization application or emergency application for sabizabulin to EMA or to any EU member state; whether the Company will have sufficient supply of sabizabulin to meet demand, if an emergency use authorization or other approval is granted in the U.S. or in any other country; whether the Company will secure any advance purchase agreement with the U.S. government or any foreign government; whether the current and future clinical development and results will demonstrate sufficient efficacy and safety and potential benefits to secure FDA approval of the Company’s drug candidates and companion diagnostic; whether the drug candidates will be approved for the targeted line of therapy; the anticipated design and scope of clinical studies and FDA acceptance of such design and scope; whether any regulatory pathways, including the accelerated Fast Track designations, to seek FDA approval for sabizabulin, enobosarm or any of the Company’s drug candidates are or continue to be available; whether the expected commencement and timing of the Company’s clinical studies, including the Phase 3 ARTEST study, the Phase 3 ENABLAR-2 study, the sabizabulin monotherapy Phase 2b clinical study for 3rd line treatment of metastatic breast cancer, the Phase 2 registration clinical study for VERU-100, and the development of the companion diagnostic will be met; when clinical results from the ongoing clinical studies will be available, whether sabizabulin, enobosarm, VERU-100, zuclomiphene, and ENTADFI will serve any unmet need or, what dosage, if any, might be approved for use in the U.S. or elsewhere, and also statements about the potential, timing and efficacy of the rest of the Company’s development pipeline, and the timing of the Company’s submissions to FDA and MHRA and FDA’s and MHRA’s review of all such submissions; whether the companion diagnostic for enobosarm will be developed successfully or be approved by the FDA for use; and whether and when ENTADFI will be commercialized successfully. These forward-looking statements are based on the Company’s current expectations and subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments in and risks related to: the development of the Company’s product portfolio and the results of clinical studies possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical studies and the ability to enroll subjects in accordance with planned schedules; the ability to fund planned clinical development; the timing of any submission to the FDA, MHRA or any other regulatory authority and any determinations made by the FDA, MHRA or any other regulatory authority; the possibility that as vaccines and other antiviral medicines become widely distributed the need for new COVID-19 treatment candidates may be reduced or eliminated; government entities possibly taking actions that directly or indirectly have the effect of limiting opportunities for sabizabulin as a COVID-19 treatment, including favoring other treatment alternatives or imposing price controls on COVID-19 treatments; the Company’s existing products and any future products, if approved, possibly not being commercially successful; the effects of the COVID-19 pandemic and measures to address the pandemic on the Company’s clinical studies, supply chain and other third-party providers, commercial efforts, and business development operations; the ability of the Company to obtain sufficient financing on acceptable terms when needed to fund development and operations; demand for, market acceptance of, and competition against any of the Company’s products or product candidates; new or existing competitors with greater resources and capabilities and new competitive product approvals and/or introductions; changes in regulatory practices or policies or government-driven healthcare reform efforts, including pricing pressures and insurance coverage and reimbursement changes; risks relating to the Company’s development of its own dedicated direct to patient telemedicine and telepharmacy services platform, including the Company’s lack of experience in developing such a platform, potential regulatory complexity, and development costs; the Company’s ability to protect and enforce its intellectual property; the potential that delays in orders or shipments under government tenders or the Company’s U.S. prescription business relating to the FC2 female condom could cause significant quarter-to-quarter variations in the Company’s operating results and adversely affect its net revenues and gross profit; the Company’s reliance on its international partners and on the level of spending by country governments, global donors and other public health organizations in the global public sector for its FC2 female condom; the concentration of accounts receivable with our largest customers and the collection of those receivables; the Company’s production capacity, efficiency and supply constraints and interruptions, including potential disruption of production at the Company’s and third party manufacturing facilities and/or of the Company’s ability to timely supply any of its product due to labor unrest or strikes, labor shortages, raw material shortages, physical damage to the Company’s and third party facilities, COVID-19 (including the impact of COVID-19 on suppliers of key raw materials), product testing, transportation delays or regulatory actions; costs and other effects of litigation, including product liability claims; the Company’s ability to identify, successfully negotiate and complete suitable acquisitions or other strategic initiatives; the Company’s ability to successfully integrate acquired businesses, technologies or products; and other risks detailed from time to time in the Company’s press releases, shareholder communications and Securities and Exchange Commission filings, including the Company’s Form 10-K for the fiscal year ended September 30, 2021 and subsequent quarterly reports on Form 10-Q. These documents are available on the “SEC Filings” section of our website at www.verupharma.com/investors. The Company disclaims any intent or obligation to update these forward-looking statements.
Verzenio® is a registered trademark of Eli Lilly and Company
NEJM Evidence® is a registered trademark of the Massachusetts Medical Society
Investor and Media Contact:
Samuel Fisch – Executive Director, Investor Relations and Corporate Communications
'Alleyba says,
That is looks like someone is looking to buy stock on the cheap. Hoping for big day today
AD-2,
Here is what I found yesterday:
Veru: The Signs Seem To Point To An EUA For Sabizabulin
Jul. 13, 2022 12:04 PM ETVeru Inc. (VERU)4 Comments7 Likes
Edmund Ingham profile picture
Edmund Ingham
Marketplace
Summary
Veru ought to find out very soon whether its lead asset, Sabizabulin, has been awarded an Emergency Use Authorization to treat hospitalized COVID patients.
The company's share price leapt >$20 when its COVID study data was published, showing a clinically and statistically meaningful 55% relative reduction in deaths.
There ought to be a blockbuster sales opportunity in play based on high unmet need, and that suggests Veru stock is still significantly undervalued.
The ex-COVID pipeline also offers hope for peak sales >$500m, while the Sexual Health Division revenues >$60m in FY21 ought to grow higher thanks to newly approved Entadfi in BPH.
As such, we can make a bull case for Veru stock - with the caveat that the market pushed shares as low as $2.5 when the Sabizabulin/COVID opportunity looked remote.
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