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ORGANON!
It should be an interesting day!
VERU had leased new office space. Have they moved?
https://www.bizjournals.com/southflorida/news/2021/07/08/biopharma-company-veru-inks-lease-wynwood-miami.html
Back to what?
2 more days...
Some playing for pennies will get burned soon.
Is this the week...?
Not even Cramer can help now!
$1.89 *OUCH!!!*
No argument with you here as I have no dog in the fight.
Biotechs and energy are the play now.
Biotechs appear to be the safe haven in this situation.
Loading up in a biotech with a strong pipeline and pending partnership is a no brainer.
Welcome new investors!
OHHHHHHHHHHHH CRAMERRRRRRRRRRRRRRRRRR
Ya think?
Kinda going against your prognostication...
Bucking the trend.
Many see the opportunity here...
Frustration abounds in Dr. Steiner's fantasy land...
"Cramer", "Cramer" he shouts out...
I need more juice...
The way back up (if ever) is traveling on a long and winding road...
HMMMMMMMM... not a good response from the market...
could it be Dr. Steiner cannot be trusted...
maybe his buddy Cramer can put in another good word...
perhaps another NO NO NOOOOOOOOOOOOOOOOOOO (offering) moment on national TV.
Daré Bioscience to Participate in Upcoming Conferences
https://ir.darebioscience.com/news-releases/news-release-details/dare-bioscience-participate-upcoming-conferences
SAN DIEGO, Feb. 07, 2022 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s health innovation, today announced that Sabrina Martucci Johnson, its President and Chief Executive Officer, will participate in the following upcoming conferences:
2022 BIO CEO & Investor Conference
February 14-17, 2022, New York Marriott Marquis and Virtual
In-person Presentation Monday, February 14, 2022 at 2:15 p.m. EST
SVB Leerink Virtual 11th Annual Global Healthcare Conference
February 14-18, 2022, Virtual
Presentation Thursday, February 17, 2022 at 1:00 p.m. EST
Webcast link: https://wsw.com/webcast/svbleerink67/dare/2615800
An archived webcast of Ms. Johnson’s presentation at the SVB Leerink Virtual 11th Annual Global Healthcare Conference will be available until March 3, 2022 under “Presentations, Events & Webcasts" in the Investors section of the company's website at http://ir.darebioscience.com.
About Daré Bioscience
Daré Bioscience is a biopharmaceutical company committed to advancing innovative products for women’s health. The company’s mission is to identify, develop and bring to market a diverse portfolio of differentiated therapies that prioritize women's health and well-being, expand treatment options, and improve outcomes, primarily in the areas of contraception, fertility, and vaginal and sexual health.
Daré’s first FDA-approved product, XACIATOTM (clindamycin phosphate), is a lincosamide antibacterial indicated for the treatment of bacterial vaginosis in female patients 12 years of age and older. XACIATO is a clear, colorless, viscous gel, to be administered once intravaginally as a single dose. Daré’s product portfolio also includes potential first-in-category candidates in clinical development: Ovaprene®, a novel, hormone-free monthly contraceptive whose U.S. commercial rights are under a license agreement with Bayer; Sildenafil Cream, 3.6%, a novel cream formulation of sildenafil to treat female sexual arousal disorder utilizing the active ingredient in Viagra®; and DARE-HRT1, a combination bio-identical estradiol and progesterone intravaginal ring for hormone therapy following menopause. To learn more about XACIATOTM, Daré’s full portfolio of women’s health product candidates, and Daré’s mission to deliver differentiated therapies for women, please visit www.darebioscience.com.
Daré may announce material information about its finances, product and product candidates, clinical trials and other matters using the Investors section of its website (http://ir.darebioscience.com), SEC filings, press releases, public conference calls and webcasts. Daré will use these channels to distribute material information about the company, and may also use social media to communicate important information about the company, its finances, product and product candidates, clinical trials and other matters. The information Daré posts on its investor relations website or through social media channels may be deemed to be material information. Daré encourages investors, the media, and others interested in the company to review the information Daré posts in the Investors section of its website and to follow these Twitter accounts: @SabrinaDareCEO and @DareBioscience. Any updates to the list of social media channels the company may use to communicate information will be posted in the Investors section of Daré’s website.
Contacts:
Investors on behalf of Daré Bioscience, Inc.:
Lee Roth
Burns McClellan
lroth@burnsmc.com
212.213.0006
OR
Media on behalf of Daré Bioscience, Inc.:
Jake Robison
Canale Communications
jake.robison@canalecomm.com
619.849.5383
Source: Daré Bioscience, Inc.
It appears the new CEO announcement did not produce the bump up in SP as many expected.
It did, though, produce a filing announcing buckets more shares being doled out to management.
Veru Announces FDA Grant of Fast Track Designation for Sabizabulin for the Treatment of Hospitalized COVID-19 Patients at High Risk for Acute Respiratory Distress Syndrome
https://ih.advfn.com/stock-market/NASDAQ/veru-VERU/stock-news/87140444/veru-announces-fda-grant-of-fast-track-designation
Veru Inc. (NASDAQ: VERU) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the Phase 3 registration program for the investigation of sabizabulin, a novel, proprietary, oral cytoskeleton disruptor with both anti-viral and anti-inflammatory properties, to combat COVID-19 infection and the cytokine storm that is responsible for Acute Respiratory Distress Syndrome (ARDS) and death. FDA Fast Track Designation is intended to expedite the development and review of new drugs to treat serious medical conditions that fill unmet medical needs. The global pandemic disease caused by the novel coronavirus SARS-CoV-2 is entering its 3rd year, and there remains an unmet medical need for new effective treatments for hospitalized patients with moderate to severe COVID-19 symptoms at high risk for ARDS and death.
“We are very pleased that the sabizabulin therapeutic for COVID-19 clinical program has received Fast Track designation from the FDA, a distinction that underscores the urgent need for new, novel, effective therapies to be used along with vaccinations to combat this COVID-19 pandemic,” said Mitchell Steiner, MD, Chairman, President and Chief Executive Officer of Veru Inc.
Dr. Steiner added: “COVID-19 global cases, hospitalizations, and deaths are at the highest levels since the start of the pandemic. Some of the antibody drugs are not effective against the omicron variant. It is clear that an effective and safe oral therapeutic that prevents deaths in hospitalized patients with moderate to severe COVID-19 disease who are at high risk for ARDS is desperately needed. We strongly believe that sabizabulin with its anti-viral and anti-inflammatory properties and a favorable safety profile can be that greatly needed oral therapy for hospitalized COVID-19 patients with serious illness. We look forward to ongoing, productive regulatory interactions with the FDA, which are further enabled with this designation.”
About Fast Track Designation
Fast Track designation aims to expedite the development and review of new drugs that are intended to treat serious or life-threatening conditions and demonstrate the potential to fill unmet medical needs. The purpose is to get important new drugs to patients faster. Filling an unmet medical need is defined as providing a therapy where none exists or providing a therapy which may be potentially better than available therapy. Drugs that are granted this designation are given the opportunity for more frequent meetings with FDA to discuss the drug's development plan and ensure collection of appropriate data needed to support drug approval: more frequent written communication with FDA about such things as the design of the proposed clinical trials and use of biomarker; Eligibility for Accelerated Approval and Priority Review, if relevant criteria are met; and, Rolling Review, which means that a drug company can submit completed sections of its New Drug Application (NDA) for review by FDA, rather than waiting until every section of the NDA is completed before the entire application can be reviewed. NDA review usually does not begin until the drug company has submitted the entire application to the FDA.
About Sabizabulin for COVID-19
Microtubule trafficking is critical for viruses to be transported, replicated, assembled, and released from the cell. Microtubules also play a role in the inflammatory process including the cytokine release syndrome (cytokine storm). Sabizabulin is a cytoskeleton disruptor which blocks microtubule trafficking and has the potential to treat both the SARS-CoV-2 viral infection and the cytokine storm and septic shock that leads to ARDS and the high COVID-19 mortality rates.
About the Sabizabulin for COVID-19 Phase 3 Trial
The Phase 3 clinical trial is a double-blind, multicenter, multinational, randomized (2:1), placebo-controlled trial evaluating daily oral doses of 9 mg sabizabulin for up to 21 days versus placebo in 300 hospitalized patients (200 subjects treated with sabizabulin and 100 subjects receive placebo/standard of care) who have SARS-CoV-2 virus infection and who are at high risk for ARDS. Subjects in the sabizabulin and placebo arms will also be allowed to receive standard of care. The primary efficacy endpoint will be the proportion of patients that die on study up to Day 60. Secondary endpoints will include the proportion of patients without respiratory failure, days in ICU, WHO Ordinal Scale for Clinical Improvement change from baseline, days on mechanical ventilation, days in the hospital, and viral load. The study is being conducted in the United States, Brazil, Argentina, Mexico, Colombia and Bulgaria. Clinical results are expected in the first half of calendar year 2022.
About Veru Inc.
Veru is an oncology biopharmaceutical company with a principal focus on developing novel medicines for the management of breast and prostate cancers.
The Company’s late-stage breast cancer development portfolio comprises enobosarm, a selective androgen receptor targeting agonist, and sabizabulin, a cytoskeleton disruptor.
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% (third-line metastatic setting), and which has been granted Fast Track designation by the FDA.
Planned Q1 2022 Phase 3 ENABLAR-2 study of enobosarm + abemaciclib (a CDK 4/6 inhibitor) in AR+ ER+ HER2- metastatic breast cancer with AR = 40% (second-line metastatic setting).
Planned Q1 2022 Phase 2b study of sabizabulin in AR+ ER+ HER2- metastatic breast cancer with AR < 40% (third-line metastatic setting).
The Company has determined that patients who have = 40% androgen receptor nuclei staining by immunohistochemistry in their breast cancer tissue, a measure of AR expression, are most likely to respond to enobosarm. Consequently, Veru is developing a companion diagnostic to determine a patient’s androgen receptor expression status, and has partnered with Roche/Ventana Diagnostics, a world leader in oncology companion diagnostics, which will develop and, if it is approved, commercialize the companion AR diagnostic.
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 and ongoing Phase 2 studies of sabizabulin 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 in men with advanced prostate cancer undergoing androgen deprivation therapy who suffer from hot flashes.
In addition, sabizabulin, which has dual anti-viral and anti-inflammatory effects, is currently enrolling in a Phase 3 study for the treatment of hospitalized COVID-19 patients at high risk for acute respiratory distress syndrome, also known as the cytokine storm.
Veru also has a commercial sexual health division, the proceeds of which help fund its drug development programs, comprised of:
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.
Did you just gulp up a half-mil?
ASK taken out up to 1.52 one hour ago
I was outside and missed all the action.
and there we go... 1.38 arghhhhhhhhhhhhhhhh
I hope everyone got their fill.
It should be only up from here.
I sincerely thought the bottom was in @1.59
Then, Biden, Putin, and the FED proved me wrong.
We shall see, but under 1.40 is a stretch...
heck
what do I know!
We opened up a dock for a limited time only.
Take advantage while you can.
*PLOP* Someone forgot to fill the pool with water...
We are on our way!
FDA already approved product, partner being considered, and pipeline loaded.
Did you DARE pursue some DD?
It's ready to pop!
Maxim Group, this morning, raised their PT to $4 from $3.
Indicators pointing to an interesting week.
It appears I did OK for today...
thanks for the lookee...
will do...
LOTSALUCKTOYATOO!
All in today @1.59
Time to roll!
I agree wholeheartedly.
Keeping a blind eye while hoping for the best did not prove to be a good method for financial gains in this stock/company.
They may pull it out yet, but I cannot stress out any longer while waiting.
I may reenter in 6-9 months or so when WISH should finally be profitable...
MAYBE
GLTA!
Maybe...
Sold @2.50
Couldn't take the heat anymore, rolled it all into DARE @1.59
Huge loss, but better chance of making it up with good prospects...
Lost a few teeth when it flopped over, but still coiled...
Coiled spring ready to release some energy?
2.69 looked twitchy...
You didn't buy that round?
*GRINZ*
At least you were honest there...
as you expected another track to have been taken...
I am clueless; is that not apparent?
Now preparing for the infamous Cramer Swan Dive
It appears WISH is attempting to grow a pair...