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We are sitting on a potentially a gold mine for the following reasons.
1. There is only one other product (fluconazole) & it is grossly & materially inferior to ibrexafungerp!
•NOTEWORTHY: Vaginal yeast infections are very common in women. It's estimated that 75% of all women will have at least one in their lifetime, and 40%-45% will have multiple cases.
2. Other successful pipeline uses for multiple serious fungal infections may make SCYX the gold standard for Hospital & Outpatient uses.
GLTAL & HAPPY NEW YEAR
SCYNEXIS Announces FDA Acceptance and Priority Review of New Drug Application for Oral Ibrexafungerp for the Treatment of Vaginal Yeast Infections 8:00 AM ET 12/7/20 | GlobeNewswire
SCYNEXIS Announces FDA Acceptance and Priority Review of New Drug Application for Oral Ibrexafungerp for the Treatment of Vaginal Yeast Infections
-- 6-month Priority Review granted for ibrexafungerp with PDUFA target
action date set for June 1, 2021
-- FDA indicated that it is not currently planning to hold an advisory
committee meeting for the application
-- SCYNEXIS is continuing preparations for a U.S. commercial launch of
ibrexafungerp in 2nd half 2021
JERSEY CITY, N.J., Dec. 07, 2020 (GLOBE NEWSWIRE) -- SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant infections, today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the SCYNEXIS's New Drug Application (NDA) for ibrexafungerp for the treatment of vulvovaginal candidiasis (VVC), also known as vaginal yeast infections. The FDA has granted this application Priority Review, a designation which is granted to applications for potential drugs that, if approved, would be significant improvements in the safety or effectiveness of the treatment of serious conditions when compared to standard applications.
Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target action date of June 1, 2021. Additionally, the FDA has communicated that it is not currently planning to hold an advisory committee meeting to discuss the application.
The NDA is supported by positive results from two Phase 3, randomized, double-blind, placebo-controlled, multi-center studies (VANISH-303 and VANISH-306), in which oral ibrexafungerp demonstrated statistically superior efficacy and a favorable tolerability profile in women with VVC.
"The acceptance of this NDA marks a major milestone toward our goal of bringing to market the first new class of antifungals in over 20 years and the first new oral treatment in more than 25 years to the millions of women suffering from vaginal yeast infections," said Marco Taglietti, M.D., President and Chief Executive Officer of SCYNEXIS. "As the first oral, non-azole treatment for this particularly symptomatic condition, we believe ibrexafungerp has the potential to change the antifungal treatment landscape."
Ibrexafungerp benefits from both Qualified Infectious Disease Product (QIDP) and Fast Track designations granted by the FDA for the treatment of VVC and prevention of recurrent VVC. Under QIDP designation, ibrexafungerp will receive five years of market exclusivity in addition to the five years of exclusivity as a new chemical entity.
Dr. Taglietti added, "We expect to benefit from almost 15 years of market exclusivity, which includes 10 years of regulatory exclusivity as a QIDP product and composition-of-matter patent protection until 2035. We believe this time on the market will allow us to establish ibrexafungerp as a major antifungal franchise and a key treatment option across several indications, which may help the brand attain blockbuster status."
"In VVC alone we believe ibrexafungerp has the potential to achieve significant sales in the U.S., given the large market and the limited treatment options," said Jim Maffezzoli, Vice President of Marketing and Sales. "With over 16 million prescriptions written each year and only one oral product to treat this condition, we believe our novel antifungal treatment has significant potential to address the needs of women and healthcare providers who are not satisfied with the standard of care. Based on ibrexafungerp's unique collection of attributes, including its differentiated mechanism of action, we are confident that, if approved, ibrexafungerp can capture a meaningful percentage of the VVC addressable market with the potential for label expansion in the hospital setting."
About Vulvovaginal Candidiasis (VVC)
VVC, commonly known as a vaginal yeast infection due to Candida, is the second most common cause of vaginitis. Although these infections are frequently caused by Candida albicans, fluconazole-resistant Candida strains, such as Candida glabrata, have been reported to become increasingly more common. VVC can be associated with substantial morbidity, including significant genital discomfort, reduced sexual pleasure, psychological distress and loss of productivity. Typical VVC symptoms include pruritus, vaginal soreness, irritation, excoriation of vaginal mucosa and abnormal vaginal discharge. An estimated 70-75% of women worldwide will have at least one episode of VVC in their lifetime, and 40-50% of them will experience two or more episodes. Approximately 6-8% of women with VVC suffer from recurrent disease, defined as experiencing at least three episodes within a 12-month period.
Current treatments for VVC include several topical azole antifungals (clotrimazole, miconazole, and others) and fluconazole, the only orally-administered antifungal currently approved for the treatment of VVC in the U.S. Fluconazole reported a 55% therapeutic cure rate in its label, which now also includes warnings of potential for fetal harm, illustrating the need for new oral alternatives. The needs of women with moderate-to-severe VVC, recurrent VVC, VVC caused by fluconazole-resistant Candida spp. or VVC during child-bearing age are not fully addressed by oral fluconazole or topical products. In addition, there are no oral alternatives for VVC patients who do not respond to or do not tolerate fluconazole, and there are no FDA-approved products for the prevention of recurrent VVC.
Average price target $31.25 - "In the last 3 months, 4 ranked analysts set 12-month price targets for SCYX. The average price target among the analysts is $31.25. Analysts compare their price target to the current market price of the stock to determine how much potential upside or downside movement there could be in the stock price.
From Etrade 11/23/20
:))
It should pop of shortly. Picking up shares while getting in is cheap.
I closed the books on this pile of dog
$H1T at the open today and I wish anyone else luck in their decision. I just couldn't stand the smell of management after the last 3 years. GLT All.
SCYX plans on holding an investor event on Tues, July 14 from ?from 10-12? . Please see the weblink below DCYX information. You can ask about the effecting the Reverse Split during the Q&A period if this event.
The https://www.scynexis.com/news-media/press-releases/detail/213/scynexis-to-host-a-key-opinion-leader-discussion-on-the
SCYX plans on holding an investor event on Tues, July 14 from from 10-12 . Please see the weblink below for further information. You can ask about the effecting the Reverse Split during the Q&A period of this event.
My understanding from SCYX Investor Relations is that the Company has not finally decided if & when a Reverse Split will be implemented.
Note: The majority voted FOR the Reverse Split via the Proxy results at the Annual Meeting.
I received a thank you & was also advised that my opinion was appreciated for their consideration.
IMO but not to Advise:
The reverse stock split seems to be a very good idea based on the following reasons, especially given SCYX’s very anemic share price.
• SCYX’s niche science to date has proven very good results for treating difficult conditions. This typically can bode well for a future robust investment once FDA approval is finalized.
• Reverse stock splits increase the share price to avoid delisting, and to meet the threshold required for listing on a major exchange. This is important for attracting equity investors especially institutional types. A reverse split might also be done to boost the company's image if the stock price has dropped dramatically. All of these typical reasons may apply to SCYX!
• SCYX’s anemic share price is seemingly the direct result of toxic financing e.g. the 1-for-1 for Ordinary Shares (@ $.90) + Options (& $1.10). There has been continuous massive selling & possibly rebuying which has suppressed the share price throughout the delivery of periodic good news.
And your response was......
6
? ?
Approval of an amendment to our Amended and Restated Certificate of Incorporation, as amended, to implement a 1-for-10 reverse stock split of our common stock and decrease the number of authorized shares
? ?
20
? ?
For
During the AM today, i sent the message below to Dr Marco Taglietti & Mr Eric Francois.
*******Message*******
Title: Hopefully the Sabotage of the PPS stops:
The SCYX current Price Per Share (PPS) may be unfortunately going down below $.87.
WHY —> The Market has learned that (shortly after the PPS continues to rise above low-mid $.90) the holders of the $.90 select Public Offerings Shares will sell enough Shares to drive the PPS down to mid $.80+. Then, they buy back (again) to repeat the process in the future. They also have the 1.10 (1-for-1) Offering Warrants to bolster their war chest for future big cash-ins.
We ALL (includes SCYX) loose any well deserved gains until SCYX receives a FDA approval to go-to-market on a pipeline drug. Then, hopefully the aforementioned .90 Shares when sold can’t logically go down to the mid $.80s. But then, the 1.10 Warrants can kick-in for the games played, using the .90 Offering Shares.
The well deserved increases to the PPS & related financing, at higher PPS, are both burdened for the foreseeable future. Hopefully, SCYX will never do another Offering as summarized herein.
Sorry to say that the recent very well deserved PPS run-up, unfortunately, is about to be ruined by the holders of the Stock Warrants via the last “selective” Public Offering.
The Offering Warrants are poorly structured because they (obviously) prevent any well deserved material PPS growth. The Offering Common Share holders sell massive amounts of their $.90 Offering Common Shares at the $1.05+/- to $1.10+ PPS levels and then, buy back shares at $.70s-$.80s, when the PPS sinks because of above massive selling.
The Offering should have had a provision that the $1.10 Offering Warrants get reduced 1-for-1 when Offering Common Shares are sold higher than the $.90 but below the $1.10 Offering Warrants. This could have substantially reduced the above described round-trip trading.
All of the above is frustrating to the non “selective” Public Offering shareholders and also, seemingly keeps future SCYX funding levels artificially low because of the continuous aforementioned round-trip trading.
I contacted SCYX & recommended that they have a good-will type Corporate update. Perhaps, you will join-in on this effort because us Shareholders need healing!
It's the ole "buy on rumor"price over a dollar"sell on the news" back in the 80 cent ...
I'm always afraid I'll miss the big run,,,,but should always do it,,
The following was just sent to SCYX investor relations.
Thanks for getting back to me. I recommend that SCYX issue a good-will corporate update ASAP, to calm your plunging PPS.
I also recommend that for future Warrants, to the extent there are remaining issued Warrants, they be reduced 1-for-1 when the related Common Shares are sold.
Your press release on Apr 21 reported very exciting news. This typically would attract new buyers & rewards existing Shareholders. However, the PPS has dropped around -28% since Apr 21. WHY is this?
Going forward, SCYX really needs to craft a better 1-for-1 warrants policy. The long term investors are getting severely punished by your last “selective” Public Offering Warrants.
There appears to be a strategic round trip strategy in-play at the $1.05+ to $1.10+ PPS levels. The Offering purchasers sell massive amounts of the Offering $.90 Common Shares because the 1.10 Warrants can, in the future, replenish shares sold. Also, If desirable, these same purchasers buy/increase the Common Shares when the PPS subsequently seems to bottom.
The aforementioned Warrant Holders are making huge profits by selling Common Shares (per above) while maintaining all of their Warrants. This massive selling precipitates anger & or panic selling to further plunge the PPS. To add insult to injury, at the bottoming of the PPS, Common Shares can be bought back by the selective Public Offering purchasers.
It should be noted that your future funding needs are compromised by lower (than justifiable) PPS because of the above matters.
Please forward this email to your Management.
The following was just sent to SCYX investor relations.
Thanks for getting back to me. I recommend that SCYX issue a good-will corporate update ASAP, to calm your plunging PPS.
I also recommend that for future Warrants, to the extent there are remaining issued Warrants, they be reduced 1-for-1 when the related Common Shares are sold.
Your press release on Apr 21 reported very exciting news. This typically would attract new buyers & rewards existing Shareholders. However, the PPS has dropped around -28% since Apr 21. WHY is this?
Going forward, SCYX really needs to craft a better 1-for-1 warrants policy. The long term investors are getting severely punished by your last “selective” Public Offering Warrants.
There appears to be a strategic round trip strategy in-play at the $1.05+ to $1.10+ PPS levels. The Offering purchasers sell massive amounts of the Offering $.90 Common Shares because the 1.10 Warrants can, in the future, replenish shares sold. Also, If desirable, these same purchasers buy/increase the Common Shares when the PPS subsequently seems to bottom.
The aforementioned Warrant Holders are making huge profits by selling Common Shares (per above) while maintaining all of their Warrants. This massive selling precipitates anger & or panic selling to further plunge the PPS. To add insult to injury, at the bottoming of the PPS, Common Shares can be bought back by the selective Public Offering purchasers.
It should be noted that your future funding needs are compromised by lower (than justifiable) PPS because of the above matters.
Please forward this email to your Management.
Please contact SCYX via their website and request that they change their future stock warrants policy. The Long investors are getting destroyed by the Warrants that were issued on the last selective Public Offering. The strategic round trips to sell the ordinary shares & buy back, exercising the Warrants, makes the Warrant holders a 10-15%+ profit but this stunts any future justified increase to the share price.
Those warrants included in the last (selected) Public Offering financing, are really killing the PPS. They can sell now & buy back at .90 for booking a profit without reducing their core holdings!
$SCYX SCYNEXIS Announces Positive Top-Line Results from its Second Pivotal Phase 3 Study (VANISH-306) of Oral Ibrexafungerp for the Treatment of Vulvovaginal Candidiasis (Vaginal Yeast Infection) GlobeNewswire "Press Releases"
Ibrexafungerp achieved highly statistically significant superiority over placebo for the primary and key secondary study endpoints
Ibrexafungerp was generally safe and well-tolerated
Positive results consistent with previously reported VANISH-303 study support anticipated NDA submission for the treatment of vulvovaginal candidiasis (VVC) in the second half of 2020
Enrollment is ongoing in the CANDLE Phase 3 study of oral ibrexafungerp for the prevention of recurrent VVC, with supplemental NDA submission planned for the second half of 2021
Conference call to be held April 21 st, 2020 at 8:30 a.m. E
SCYX...$1.02...SCYNEXIS Announces Positive Top-Line Results from its Second Pivotal Phase 3 Study (VANISH-306) of Oral Ibrexafungerp for the Treatment of Vulvovaginal Candidiasis (Vaginal Yeast Infection)
https://www.otcmarkets.com/stock/SCYX/news/story?e&id=1580383
Yeah, I'm fully loaded as well.
Time to load up shares - I did yesterday just before the Close & earlier today.
Currently climbing up the wall for a breakout to much higher PPS. Recent very friendly financing as required / needed is truly a dream come true.
NCT03987620: Efficacy and Safety of Oral Ibrexafungerp (SCY-078) vs. Placebo in Subjects With Acute Vulvovaginal Candidiasis
*Primary Completion Date: March 2020
*Study Completion Date: April 2020
*Last Update Submitted: February 19, 2020
*Last Update Posted: February 20, 2020
https://clinicaltrials.gov/ct2/history/NCT03987620?A=6&B=7&C=merged#StudyPageTop
* * $SCYX Video Chart 01-09-2020 * *
Link to Video - click here to watch the technical chart video
* * $SCYX Video Chart 01-08-2020 * *
Link to Video - click here to watch the technical chart video
Massive level 2 battle market is bad but this ticker is battling it out
Zero value in his charting
* * $SCYX Video Chart 12-10-2019 * *
Link to Video - click here to watch the technical chart video
Candida auris is now a CDC urgent threat https://www.cdc.gov/drugresistance/biggest-threats.html
3 Penny Stocks To Watch Ahead Of Key Biotech Data
$SELB $CLDX $SCYX
https://www.transparenttraders.me/2019/11/3-penny-stocks-to-watch-ahead-of-key.html
Here's what you need to know about SCYX msmoneymoves.com/2019/10/13/in-a-tough-environment-for-biotechs-can-the-science-at-scynexis-win/
I should also add that it also has an IV preparation as well. Both IV and Oral has significant application and broader market use
It’s Not truly a competitor since cidaras’s product is an IV only preparation( as far as I can tell ). SCYNEXIS’s product is an oral preparation which provides significant advantages in availability to treatment. This IV prep will be used mainly in hospital settings. Scynexis product will and can be used as out patient in your regular family doctors office or urgent care. Much broader and bigger market!!
We have a competitor in Phase 3 https://www.cidara.com/rezafungin/
Clinical Trial Study: https://clinicaltrials.gov/ct2/show/NCT03667690
Reminder: $SCYX at Ladenburg Thalmann Healthcare Conference tomorrow http://wsw.com/webcast/ladenburg5/scyx/index.aspx
With Claytrader posting will come his band of shorts to try and knock it lower.
The good thing is, it usually doesn't last to long. IMO
He usually posts when there is a move on volume in a lower priced stock.
NCT03734991 Study updated today and completed early https://clinicaltrials.gov/ct2/show/NCT03734991
* * $SCYX Video Chart 09-18-2019 * *
Link to Video - click here to watch the technical chart video
News: $SCYX SCYNEXIS Completes Last-Patient/Last-Visit Ahead of Schedule in the First Phase 3 Study (VANISH 303) of Oral Ibrexafungerp for the Treatment of Vulvovaginal Candidiasis (VVC)
JERSEY CITY, N.J. , Sept. 18, 2019 /PRNewswire/ -- SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company delivering innovative therapies for difficult-to-treat and often life-threatening infections, today announced completion of the last-patient/last-visit in its Phase 3 VANISH...
Got this from SCYX - SCYNEXIS Completes Last-Patient/Last-Visit Ahead of Schedule in the First Phase 3 Study (VANISH 303) of Oral Ibrexafungerp for the Treatment of Vulvovaginal Candidiasis (VVC)
Nevermind. That's for antibiotics rather than antifungal.
Good for $SCYX if true, but not great in general:
""
Johnson & Johnson, Sanofi, Pfizer, AstraZeneca, Novartis, Otsuka and many others have all gutted their antibiotic development teams and moved those budgets elsewhere. This is despite a 2016 pledge signed by over 100 companies, including Johnson & Johnson and Novartis, saying they would help prevent the next epidemic by investing in ways to combat the rise of antibiotic-resistant "superbugs."
""
https://www.dw.com/en/big-pharma-nixes-new-drugs-despite-impending-antibiotic-apocalypse/a-50432213
NCT03059992 Primary Completion Date: September 2019 https://clinicaltrials.gov/ct2/show/NCT03059992
SCYNEXIS, Inc. to Participate in Two Upcoming Investor Conferences
BY PR Newswire
— 7:00 AM ET 09/04/2019
JERSEY CITY, N.J., Sept. 4, 2019 /PRNewswire/ -- SCYNEXIS, Inc. ( SCYX ) , a biotechnology company delivering innovative therapies for difficult-to-treat and often life-threatening infections, today announced that the Company will present in the following investor conferences:
The H.C. Wainwright Global Investment Conference at the Lotte New York Palace Hotel in New York City on Monday, September 9, 2019 at 2:10 p.m. ET.
The Ladenburg Thalmann Healthcare Conference at the Sofitel New York in New York City on Tuesday, September 24, 2019 at 1:30 p.m. ET.
Live webcasts of the presentations will be available on the Investors section of the Company's website: www.scynexis.com. Replays of the presentations will be available approximately two hours after each event and will be available for two weeks following each presentation.
Update to NCT03987620 posted 8/6. Looks like they added locations and contacts. https://clinicaltrials.gov/ct2/history/NCT03987620?A=2&B=3&C=merged#StudyPageTop
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