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Hot Stocks
Scynexis announces presentations on pooled data from Phase 3 VANISH program » 08:21
07/29/21
07/29
08:21
07/29/21
08:21
SCYX

Scynexis

$7.32 /

+0.42 (+6.09%)

SCYNEXIS announced two…

SCYNEXIS announced two oral presentations of oral ibrexafungerp from its Phase 3 VANISH Program at the Infectious Diseases Society for Obstetrics & Gynecology 2021 Virtual Annual Meeting, held on July 29 and July 30, 2021. The data presented demonstrate oral ibrexafungerp's safety and efficacy as a treatment for vulvovaginal candidiasis, also known as vaginal yeast infection. "The data from our Phase 3 VANISH program demonstrated strong efficacy and a favorable tolerability profile in women with vaginal yeast infections and supported the recent FDA approval of BREXAFEMME, which represents the first approved drug in a novel antifungal class in more than 20 years, offering the first and only oral non-azole treatment option for VVC patients," said Marco Taglietti, M.D., President and Chief Executive Officer of SCYNEXIS. "We believe that we can continue to build on this momentum in this category with our ongoing Phase 3 CANDLE study investigating ibrexafungerp for the prevention of recurrent VVC and expect to report topline data in the first half of 2022." Selected Important Safety Information Most common adverse reactions observed in clinical trials (incidence greater than or equal to2%) were diarrhea, nausea, abdominal pain, dizziness, and vomiting See below for complete Important Safety Information Oral presentation details: Title Efficacy and Safety of Oral Ibrexafungerp in Subjects with Vulvovaginal Candidiasis: Pooled Data from Two Phase 3, Randomized, Blinded, Studies vs. Placeb: The Phase 3 VANISH-303 and VANISH-306 trials evaluated the safety and efficacy of oral ibrexafungerp as a treatment for patients with VVC. A pooled analysis of 376 patients receiving oral ibrexafungerp and 182 patients receiving placebo found that 94% of ibrexafungerp patients had severe disease. Clinical Cure Rate, defined as complete resolution of all Vaginal Signs and Symptoms at the Day-10 Test-of-Cure visit, was reported as 56.9% in the treatment arm vs. 35.7% in the placebo arm. Overall, ibrexafungerp was well tolerated, with the most common treatment-related adverse events being gastrointestinal in nature. Outcomes in Subpopulations from Pooled Phase 3 Clinical Studies of Oral Ibrexafungerp versus Placebo in Patients with Vulvovaginal Candidiasis: The study outlines a sub-population analysis of different patient demographics from the Phase 3 VANISH-303 and VANISH-306 trials evaluating efficacy of oral ibrexafungerp as a treatment for patients with VVC. Clinical Cure, defined as complete resolution of all Vaginal Signs and Symptoms at the Day-10 Test-of-Cure visit, was 57.0% in patients aged less than65 years, 52.3% in Black patients, 54.7% in Hispanic or Latino patients, and 46.2% in patients with BMI greater than35. These results are largely consistent with the overall clinical cure rate reported by the study and support ibrexafungerp's potential to treat all important populations impacted by VVC infections.

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SCYX Scynexis
$7.32 /

+0.42 (+6.09%)

SCYX Scynexis
$7.32 /

+0.42 (+6.09%)

02/17/21 Maxim
Scynexis price target raised to $22 from $17 at Maxim
01/22/21 Guggenheim
Scynexis initiated with a Buy at Guggenheim
01/05/21 Cantor Fitzgerald
Scynexis initiated with an Overweight at Cantor Fitzgerald
12/28/20 H.C. Wainwright
Scynexis price target lowered to $20 from $35 at H.C. Wainwright
SCYX Scynexis
$7.32 /

+0.42 (+6.09%)

  • 17
    Dec
Over a week ago
Hot Stocks
Scynexis announces three oral presentations on ibrexafungerp » 08:09
07/12/21
07/12
08:09
07/12/21
08:09
SCYX

Scynexis

$7.32 /

+0.05 (+0.69%)

SCYNEXIS announced three…

SCYNEXIS announced three oral presentations demonstrating the potential clinical utility of ibrexafungerp at the 31st European Congress of Clinical Microbiology and Infectious Diseases. "Fungal infections worldwide are becoming increasingly drug-resistant and more deadly, leaving patients with limited treatment options. However, we believe that ibrexafungerp has the potential to be effective against many drug-resistant fungal pathogens, like Candida auris, which has capitalized on the crowded hospital conditions created by the COVID-19 pandemic," said Marco Taglietti, M.D., President and Chief Executive Officer of SCYNEXIS. "These presentations continue to build on the positive responses we've seen in both the CARES and FURI studies and support ibrexafungerp's potential to be the treatment option that patients need. We continue to actively enroll patients in both studies." Presentation titled, "EUCAST Ibrexafungerp MICs for contemporary Danish Yeast Isolates" found an in vitro susceptibility analysis of 967 unique yeast isolates from 794 patients found that ibrexafungerp displayed broad activity. Additional analysis demonstrated that ibrexafungerp was active in most strains harboring mutations in the fks gene, commonly associated with echinocandin resistance. The second presentation is titled, "Outcomes of Oral Ibrexafungerp in 33 Patients with Refractory Fungal Diseases, Interim Analysis of a Phase 3 Open-label Study." In an interim analysis by an independent data review committee of 33 patients from the Phase 3 FURI study evaluating ibrexafungerp for the treatment of patients with refractory fungal disease found that 23 patients achieved clinical improvement, defined as complete or partial response. 7 patients maintained stable disease and 0 patients progressed. 3 patients were considered as indeterminate. Overall, ibrexafungerp was well-tolerated, with the most common treatment-related adverse events being gastrointestinal in nature. The third presentation is titled, "Outcomes of Oral Ibrexafungerp in the Treatment of Ten Patients with Candida auris Infections, from the CARES Study." This reviews an interim analysis by an independent data review committee of 10 patients from the global Phase 3 CARES study evaluating ibrexafungerp for the treatment of patients with invasive candidiasis or candidemia due to Candida auris found that 8 patients had a complete response. One patient was considered indeterminate, and one patient died of other causes.

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SCYX Scynexis
$7.32 /

+0.05 (+0.69%)

SCYX Scynexis
$7.32 /

+0.05 (+0.69%)

02/17/21 Maxim
Scynexis price target raised to $22 from $17 at Maxim
01/22/21 Guggenheim
Scynexis initiated with a Buy at Guggenheim
01/05/21 Cantor Fitzgerald
Scynexis initiated with an Overweight at Cantor Fitzgerald
12/28/20 H.C. Wainwright
Scynexis price target lowered to $20 from $35 at H.C. Wainwright
SCYX Scynexis
$7.32 /

+0.05 (+0.69%)

  • 17
    Dec
Over a month ago
Conference/Events
Scynexis to host conference call » 11:25
06/29/21
06/29
11:25
06/29/21
11:25
SCYX

Scynexis

$7.98 /

-0.1 (-1.24%)

Management, along with…

Management, along with KOL Michael L. Krychman, M.D.C.M., Southern California Center, discuss the 2H21 commercial plan for BREXAFEMME on a conference call to be held on June 29 at 12 pm. Webcast Link

ShowHide Related Items >><<
SCYX Scynexis
$7.98 /

-0.1 (-1.24%)

SCYX Scynexis
$7.98 /

-0.1 (-1.24%)

02/17/21 Maxim
Scynexis price target raised to $22 from $17 at Maxim
01/22/21 Guggenheim
Scynexis initiated with a Buy at Guggenheim
01/05/21 Cantor Fitzgerald
Scynexis initiated with an Overweight at Cantor Fitzgerald
12/28/20 H.C. Wainwright
Scynexis price target lowered to $20 from $35 at H.C. Wainwright
SCYX Scynexis
$7.98 /

-0.1 (-1.24%)

  • 17
    Dec
SCYX Scynexis
$7.98 /

-0.1 (-1.24%)

Conference/Events
Scynexis to host conference call » 04:55
06/29/21
06/29
04:55
06/29/21
04:55
SCYX

Scynexis

$8.08 /

+0.14 (+1.76%)

Management, along with…

Management, along with KOL Michael L. Krychman, M.D.C.M., Southern California Center, discuss the 2H21 commercial plan for BREXAFEMME on a conference call to be held on June 29 at 12 pm. Webcast Link

ShowHide Related Items >><<
SCYX Scynexis
$8.08 /

+0.14 (+1.76%)

SCYX Scynexis
$8.08 /

+0.14 (+1.76%)

02/17/21 Maxim
Scynexis price target raised to $22 from $17 at Maxim
01/22/21 Guggenheim
Scynexis initiated with a Buy at Guggenheim
01/05/21 Cantor Fitzgerald
Scynexis initiated with an Overweight at Cantor Fitzgerald
12/28/20 H.C. Wainwright
Scynexis price target lowered to $20 from $35 at H.C. Wainwright
SCYX Scynexis
$8.08 /

+0.14 (+1.76%)

  • 17
    Dec
SCYX Scynexis
$8.08 /

+0.14 (+1.76%)

Conference/Events
Scynexis to host conference call » 16:36
06/24/21
06/24
16:36
06/24/21
16:36
SCYX

Scynexis

$7.99 /

+0.39 (+5.13%)

Management, along with…

Management, along with KOL Michael L. Krychman, M.D.C.M., Southern California Center, discuss the 2H21 commercial plan for BREXAFEMME on a conference call to be held on June 29 at 12 pm. Webcast Link

ShowHide Related Items >><<
SCYX Scynexis
$7.99 /

+0.39 (+5.13%)

SCYX Scynexis
$7.99 /

+0.39 (+5.13%)

02/17/21 Maxim
Scynexis price target raised to $22 from $17 at Maxim
01/22/21 Guggenheim
Scynexis initiated with a Buy at Guggenheim
01/05/21 Cantor Fitzgerald
Scynexis initiated with an Overweight at Cantor Fitzgerald
12/28/20 H.C. Wainwright
Scynexis price target lowered to $20 from $35 at H.C. Wainwright
SCYX Scynexis
$7.99 /

+0.39 (+5.13%)

  • 17
    Dec
SCYX Scynexis
$7.99 /

+0.39 (+5.13%)

Hot Stocks
Scynexis to present commercial launch update for BREXAFEMME » 08:49
06/23/21
06/23
08:49
06/23/21
08:49
SCYX

Scynexis

$7.24 /

+0.13 (+1.83%)

SCYNEXIS announced that…

SCYNEXIS announced that it will present a commercial launch update for its recently FDA-approved drug, BREXAFEMME. BREXAFEMME is a triterpenoid antifungal indicated for the treatment of adult and postmenarchal pediatric females with vulvovaginal candidiasis, or vaginal yeast infections. It is contraindicated during pregnancy and in patients with a history of hypersensitivity to ibrexafungerp. The webcast on Tuesday, June 29, 2021 at 12pm Eastern Time will feature presentations by the SCYNEXIS management team who will discuss the second half 2021 commercial plan for BREXAFEMME, the first approved drug from a novel antifungal class in over 20 years. Also featured will be Key Opinion Leader, Michael L. Krychman, M.D.C.M., Southern California Center for Sexual Health and Survivorship Medicine, a renowned physician specializing in Obstetrics and Gynecology, who will discuss how BREXAFEMME fits into the yeast infection treatment landscape.

ShowHide Related Items >><<
SCYX Scynexis
$7.24 /

+0.13 (+1.83%)

SCYX Scynexis
$7.24 /

+0.13 (+1.83%)

02/17/21 Maxim
Scynexis price target raised to $22 from $17 at Maxim
01/22/21 Guggenheim
Scynexis initiated with a Buy at Guggenheim
01/05/21 Cantor Fitzgerald
Scynexis initiated with an Overweight at Cantor Fitzgerald
12/28/20 H.C. Wainwright
Scynexis price target lowered to $20 from $35 at H.C. Wainwright
SCYX Scynexis
$7.24 /

+0.13 (+1.83%)

  • 17
    Dec
SCYX Scynexis
$7.24 /

+0.13 (+1.83%)

Hot Stocks
Scynexis confirms Brexafemme qualifies for 10 years of regulatory exclusivity » 08:40
06/09/21
06/09
08:40
06/09/21
08:40
SCYX

Scynexis

$8.34 /

-0.125 (-1.48%)

SCYNEXIS announced that…

SCYNEXIS announced that the Food and Drug Administration granted BREXAFEMME, five years of exclusivity extension under the Generating Antibiotic Incentives Now Act. This exclusivity will be added to any other applicable exclusivity periods, such as the five years of new chemical entity exclusivity, for a combined ten-year period of regulatory exclusivity. BREXAFEMME is also protected by multiple patents, including a composition-of-matter patent covering the ibrexafungerp molecule. With patent term extension, this patent is expected to expire in 2035, providing 14 years of protection from generic competitors in the U.S.

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SCYX Scynexis
$8.34 /

-0.125 (-1.48%)

SCYX Scynexis
$8.34 /

-0.125 (-1.48%)

02/17/21 Maxim
Scynexis price target raised to $22 from $17 at Maxim
01/22/21 Guggenheim
Scynexis initiated with a Buy at Guggenheim
01/05/21 Cantor Fitzgerald
Scynexis initiated with an Overweight at Cantor Fitzgerald
12/28/20 H.C. Wainwright
Scynexis price target lowered to $20 from $35 at H.C. Wainwright
SCYX Scynexis
$8.34 /

-0.125 (-1.48%)

  • 17
    Dec
SCYX Scynexis
$8.34 /

-0.125 (-1.48%)

Conference/Events
Scynexis to host conference call » 08:34
06/02/21
06/02
08:34
06/02/21
08:34
SCYX

Scynexis

$9.98 /

+0.435 (+4.56%)

Conference call to…

Conference call to discuss the FDA approval of BREXAFEMME will be held on June 2 at 8;30 am.

ShowHide Related Items >><<
SCYX Scynexis
$9.98 /

+0.435 (+4.56%)

SCYX Scynexis
$9.98 /

+0.435 (+4.56%)

02/17/21 Maxim
Scynexis price target raised to $22 from $17 at Maxim
01/22/21 Guggenheim
Scynexis initiated with a Buy at Guggenheim
01/05/21 Cantor Fitzgerald
Scynexis initiated with an Overweight at Cantor Fitzgerald
12/28/20 H.C. Wainwright
Scynexis price target lowered to $20 from $35 at H.C. Wainwright
SCYX Scynexis
$9.98 /

+0.435 (+4.56%)

  • 17
    Dec
SCYX Scynexis
$9.98 /

+0.435 (+4.56%)

Hot Stocks
Scynexis trading resumes  08:00
06/02/21
06/02
08:00
06/02/21
08:00
SCYX

Scynexis

$9.98 /

+0.435 (+4.56%)

 
ShowHide Related Items >><<
SCYX Scynexis
$9.98 /

+0.435 (+4.56%)

SCYX Scynexis
$9.98 /

+0.435 (+4.56%)

02/17/21 Maxim
Scynexis price target raised to $22 from $17 at Maxim
01/22/21 Guggenheim
Scynexis initiated with a Buy at Guggenheim
01/05/21 Cantor Fitzgerald
Scynexis initiated with an Overweight at Cantor Fitzgerald
12/28/20 H.C. Wainwright
Scynexis price target lowered to $20 from $35 at H.C. Wainwright
SCYX Scynexis
$9.98 /

+0.435 (+4.56%)

  • 17
    Dec
SCYX Scynexis
$9.98 /

+0.435 (+4.56%)

Hot Stocks
Scynexis announces FDA approval of BREXAFEMME for yeast infections » 07:32
06/02/21
06/02
07:32
06/02/21
07:32
SCYX

Scynexis

$9.98 /

+0.435 (+4.56%)

SCYNEXIS announced that…

SCYNEXIS announced that the U.S. Food and Drug Administration has approved BREXAFEMME, for oral use in patients with vulvovaginal candidiasis, also known as vaginal yeast infection. BREXAFEMME, which represents the first approved drug in a novel antifungal class in more than 20 years, was approved based on positive results from two Phase 3 studies in which oral ibrexafungerp demonstrated efficacy and a favorable tolerability profile in women with VVC. SCYNEXIS has partnered with Amplity Health to support U.S. commercialization of BREXAFEMME, with commercial launch scheduled in the second half of this year.

ShowHide Related Items >><<
SCYX Scynexis
$9.98 /

+0.435 (+4.56%)

SCYX Scynexis
$9.98 /

+0.435 (+4.56%)

02/17/21 Maxim
Scynexis price target raised to $22 from $17 at Maxim
01/22/21 Guggenheim
Scynexis initiated with a Buy at Guggenheim
01/05/21 Cantor Fitzgerald
Scynexis initiated with an Overweight at Cantor Fitzgerald
12/28/20 H.C. Wainwright
Scynexis price target lowered to $20 from $35 at H.C. Wainwright
SCYX Scynexis
$9.98 /

+0.435 (+4.56%)

  • 17
    Dec
SCYX Scynexis
$9.98 /

+0.435 (+4.56%)

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