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Hot Stocks
Scynexis reports completion of pre-NDA meetings with FDA on ibrexafungerp » 08:03
07/29/20
07/29
08:03
07/29/20
08:03
SCYX

Scynexis

$6.46 /

-0.28 (-4.15%)

SCYNEXIS announced the…

SCYNEXIS announced the successful completion of pre-NDA meetings with U.S. Food and Drug Administration regarding ibrexafungerp for the treatment of VVC, a common fungal infection that affects millions of women in the U.S. every year. The purpose of the meetings was to discuss and confirm the clinical, non-clinical and chemistry, manufacturing and controls content and requirements for the Company's planned NDA submission and ensure that all elements of submission are met. Ahead of the meetings, SCYNEXIS submitted a pre-NDA briefing document to the FDA that outlined the Company's preliminary data package, including clinical safety and efficacy, non-clinical results, CMC and other regulatory elements. Based on FDA feedback, the Company believes its regulatory package will be sufficient to support a submission of ibrexafungerp for the treatment of VVC. The Company remains on track to submit its NDA in Q4 2020. SCYNEXIS previously announced positive top-line results from its Phase 3, randomized, double-blind, placebo-controlled, multi-center studies investigating the safety and efficacy of oral ibrexafungerp as a treatment for women with VVC. In both studies, ibrexafungerp consistently showed statistical superiority over placebo for the key endpoints required to support the NDA filing for this indication. Additionally, ibrexafungerp had a favorable tolerability profile throughout its Phase 3 program in VVC. Enrollment is ongoing in the Phase 3 CANDLE study, investigating the safety and efficacy of oral ibrexafungerp for the prevention of recurrent VVC, for which there is no approved therapy in the U.S. Pending successful completion of this trial, SCYNEXIS anticipates top-line results and the submission of a supplemental NDA for this indication in the second half of 2021.

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SCYX Scynexis
$6.46 /

-0.28 (-4.15%)

SCYX Scynexis
$6.46 /

-0.28 (-4.15%)

07/31/19 Aegis
Scynexis initiated with a Buy at Aegis
SCYX Scynexis
$6.46 /

-0.28 (-4.15%)

  • 10
    Dec
Hot Stocks
Scynexis presents four posters highlighting clinical utility of ibrexafungerp » 08:07
07/22/20
07/22
08:07
07/22/20
08:07
SCYX

Scynexis

$6.96 /

+0.035 (+0.51%)

SCYNEXIS announced the…

SCYNEXIS announced the presentation of four posters at the American Society for Microbiology Microbe 2020 held virtually from June through August. The posters, presented as part of the ASM Microbe Online 2020 Summer of Science program, now available online, highlight the potential clinical utility of ibrexafungerp. Ibrexafungerp is the first representative of a new class of antifungal agents called triterpenoids, which are broad-spectrum, fungicidal, and designated by the suffix "-fungerp". Following the successful completion of its VANISH Phase 3 program, the Company plans to submit a new drug application for ibrexafungerp as a treatment for vaginal yeast infections in the second half of this year, while advancing several late-stage programs for the treatment of life-threatening fungal infections in hospitalized patients. Poster Details: Title Treatment Outcomes of Oral Ibrexafungerp in Patients with Severe Fungal Infections, Refractory to or Intolerant of Standard of Care Antifungals: Results from the Phase 3 FURI Study Second Interim Analysis: Highlights An interim analysis of 21 patients from the Phase 3 clinical study evaluating ibrexafungerp for the treatment of patients intolerant to the standard of care treatment for Candida infections found that treatment with oral ibrexafungerp showed significant clinical benefit in 81% of patients, with 12 patients achieving a complete or partial response and 5 patients with stable disease. Title Delayed Initiation of the Novel Glucan Synthase Inhibitor, Ibrexafungerp, is Effective in a Murine Model of Invasive Candidiasis Caused by Candida Auris: Highlights An in vivo delayed initiation study of Candida auris in a murine model found that treatment with ibrexafungerp significantly improved survival and reduced fungal burden. These data further support the potential utility of ibrexafungerp as a treatment for invasive infections caused by Candida auris. Title Determination of Antifungal Activity of SCY-078, a Novel Glucan Synthase Inhibitor, against a Broad Panel of Rare Pathogenic Fungi: Highlights An in vitro study found that ibrexafungerp demonstrated potent activity against 13 different genera of rare fungal pathogens and effectiveness against 7 more, supporting its broad-spectrum activity and potential to treat a range of fungal pathogens. Title Ibrexafungerp or Caspofungin in Combination with Azoles against Clinical Isolates of Aspergillus, Including Those Resistant to Azoles: Highlights An in vitro study evaluating the efficacy of ibrexafungerp and caspofungin alone or in combination with azole treatments against 50 Aspergillus clinical isolates found that the combination of IBX or CAS with azole treatment yielded synergistic activity. These results support further investigations evaluating the potential for the use of ibrexafungerp and azoles in combination for the treatment of infections caused by Aspergillus.

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SCYX Scynexis
$6.96 /

+0.035 (+0.51%)

SCYX Scynexis
$6.96 /

+0.035 (+0.51%)

07/31/19 Aegis
Scynexis initiated with a Buy at Aegis
SCYX Scynexis
$6.96 /

+0.035 (+0.51%)

  • 10
    Dec
Hot Stocks
Scynexis announces one-for-ten reverse stock split » 09:07
07/16/20
07/16
09:07
07/16/20
09:07
SCYX

Scynexis

$0.69 /

+0.0192 (+2.87%)

SCYNEXIS announced that…

SCYNEXIS announced that it has filed a Certificate of Amendment to its Amended and Restated Certificate of Incorporation to effect a reverse stock split of its issued and outstanding common stock, at a ratio of 1-for-10. The effective time of the reverse stock split will be 12:01 a.m. ET on July 17, 2020. SCYNEXIS common stock will begin trading on a split-adjusted basis commencing upon market open on July 17, 2020. At SCYNEXIS's annual meeting of stockholders held on July 2, 2020, stockholders voted to approve a proposal to effect a reverse stock split and reduce the number of authorized shares of SCYNEXIS's common stock from 250 million shares to 100 million shares. Accordingly, on July 17, 2020, the number of authorized shares of SCYNEXIS's common stock will be 100 million shares. As a result of the reverse split, every 10 shares of SCYNEXIS's issued and outstanding common stock will be automatically combined and converted into one issued and outstanding share of common stock, par value $0.001 per share. SCYNEXIS's common stock will continue to trade on the Nasdaq Global Market under the symbol "SCYX," but will be assigned a new CUSIP number, 811292 200. The reverse stock split reduces the number of shares of common stock issuable upon the conversion of SCYNEXIS's outstanding convertible notes and the exercise or vesting of its outstanding stock options, restricted stock units and warrants in proportion to the ratio of the reverse stock split and causes a proportionate increase in the conversion and exercise prices of such convertible notes, stock options and warrants.

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SCYX Scynexis
$0.69 /

+0.0192 (+2.87%)

SCYX Scynexis
$0.69 /

+0.0192 (+2.87%)

07/31/19 Aegis
Scynexis initiated with a Buy at Aegis
SCYX Scynexis
$0.69 /

+0.0192 (+2.87%)

  • 10
    Dec
Conference/Events
Scynexis to hold a Key Opinion Leader conference call » 09:50
07/14/20
07/14
09:50
07/14/20
09:50
SCYX

Scynexis

$0.68 /

+0.001 (+0.15%)

Management holds a Key…

Management holds a Key Opinion Leader conference call with Dr. Caroline Mitchell to discuss the potential commercial opportunity for Ibrexafungerp, Scynexis' novel antifungal drug candidate, on July 14 at 10 am. Webcast Link

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SCYX Scynexis
$0.68 /

+0.001 (+0.15%)

SCYX Scynexis
$0.68 /

+0.001 (+0.15%)

07/31/19 Aegis
Scynexis initiated with a Buy at Aegis
SCYX Scynexis
$0.68 /

+0.001 (+0.15%)

  • 10
    Dec
Conference/Events
Scynexis to hold a Key Opinion Leader conference call » 04:55
07/14/20
07/14
04:55
07/14/20
04:55
SCYX

Scynexis

$0.68 /

-0.03 (-4.23%)

Management holds a Key…

Management holds a Key Opinion Leader conference call with Dr. Caroline Mitchell to discuss the potential commercial opportunity for Ibrexafungerp, Scynexis' novel antifungal drug candidate, on July 14 at 10 am. Webcast Link

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SCYX Scynexis
$0.68 /

-0.03 (-4.23%)

SCYX Scynexis
$0.68 /

-0.03 (-4.23%)

07/31/19 Aegis
Scynexis initiated with a Buy at Aegis
SCYX Scynexis
$0.68 /

-0.03 (-4.23%)

  • 10
    Dec
Conference/Events
Scynexis to hold a Key Opinion Leader conference call » 17:01
07/13/20
07/13
17:01
07/13/20
17:01
SCYX

Scynexis

$0.68 /

-0.03 (-4.23%)

Management holds a Key…

Management holds a Key Opinion Leader conference call with Dr. Caroline Mitchell to discuss the potential commercial opportunity for Ibrexafungerp, Scynexis' novel antifungal drug candidate, on July 14 at 10 am. Webcast Link

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SCYX Scynexis
$0.68 /

-0.03 (-4.23%)

SCYX Scynexis
$0.68 /

-0.03 (-4.23%)

07/31/19 Aegis
Scynexis initiated with a Buy at Aegis
SCYX Scynexis
$0.68 /

-0.03 (-4.23%)

  • 10
    Dec
Over a month ago
Hot Stocks
Scynexis appoints Jim Maffezzoli as VP of marketing, sales » 08:23
06/02/20
06/02
08:23
06/02/20
08:23
SCYX

Scynexis

$0.82 /

+0.0755 (+10.17%)

SCYNEXIS announced the…

SCYNEXIS announced the appointment of Jim Maffezzoli as Vice President of Marketing and Sales, effective June 1, 2020. Mr. Maffezzoli will lead marketing and commercialization of SCYNEXIS's lead clinical asset, ibrexafungerp, pending regulatory approval, for the treatment of vulvovaginal candidiasis, more commonly known as vaginal yeast infection. Most recently, Mr. Maffezzoli served as Senior Vice President of Marketing at women's health company Viveve Medical.

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SCYX Scynexis
$0.82 /

+0.0755 (+10.17%)

SCYX Scynexis
$0.82 /

+0.0755 (+10.17%)

07/31/19 Aegis
Scynexis initiated with a Buy at Aegis
SCYX Scynexis
$0.82 /

+0.0755 (+10.17%)

Earnings
Scynexis reports Q1 EPS (7c), consensus (15c) » 09:22
05/11/20
05/11
09:22
05/11/20
09:22
SCYX

Scynexis

$0.87 /

-0.0206 (-2.31%)

"The past several…

"The past several months have seen major accomplishments by SCYNEXIS, as we continued to generate positive clinical data from both our vaginal yeast infection and hospital-based programs, while also enhancing both our current cash position and our financial flexibility going forward," said Marco Taglietti, M.D., President and Chief Executive Officer of SCYNEXIS. "With the successful completion of our Phase 3 VANISH program, we remain on track to submit an NDA for ibrexafungerp as a treatment for vaginal yeast infections in the second half of this year, as we continue SCYNEXIS's transition to a fully-integrated research and commercial entity. If approved, ibrexafungerp could represent the first new class of antifungals in over 20 years - a particularly significant achievement at a time when the need for novel anti-infectives has become devastatingly clear."

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SCYX Scynexis
$0.87 /

-0.0206 (-2.31%)

07/31/19 Aegis
Scynexis initiated with a Buy at Aegis
05/28/19 Canaccord
Scynexis weakness a buying opportunity, says Canaccord
Over a quarter ago
Hot Stocks
Scynexis announces publication of six abstracts » 08:50
05/06/20
05/06
08:50
05/06/20
08:50
SCYX

Scynexis

$0.91 /

+0.0109 (+1.21%)

SCYNEXIS announced the…

SCYNEXIS announced the publication of six abstracts in the 30th European Congress of Clinical Microbiology and Infectious Diseases abstract book, now available online. Title: Efficacy and Safety of Oral Ibrexafungerp in 41 Patients with Refractory Fungal Diseases, Interim Analysis of a Phase 3 Open-label Study. Highlights: An interim analysis of 41 patients from the Phase 3 clinical study evaluating ibrexafungerp for the treatment of patients with refractory candidiasis or patients who were intolerant to the standard of care found that 83% of the patients achieved a clinical benefit, compared to 15% with disease progression. One patient was categorized as indeterminate. Ibrexafungerp was well-tolerated with the most common treatment-related adverse events being of gastrointestinal origin. Title: Clinical Experience of Oral Ibrexafungerp for Treatment of Four Patients with Invasive Candidiasis from the FURI Study: A case report of four patients from the Phase 3 FURI study treated at Medical University Hospital, Graz, Austria, evaluating ibrexafungerp for the treatment of patients with refractory candidiasis or patients who were intolerant to the standard of care. The four patients were diagnosed with the different Candida infections, including, femoro-tibial osteomyelitis, candidemia, intraabdominal abscess and oropharyngeal candidiasis. At the end of treatment, two patients had a complete response, one patient had a partial response and one patient had a stable response. Results suggest that the use of ibrexafungerp could be effective against invasive candidiasis and could significantly decrease in-hospital stays by reducing dependence on IV-administered antifungals. Title: Ibrexafungerp Demonstrates Potent and Consistent In Vitro Activity Against greater than400 Global Candida auris Isolates, Including Isolates with Elevated MIC's to Echinocandins. Highlights: A compilation of four independent in vitro studies testing the activity of ibrexafungerp against a total 445 Candida auris isolates. The ibrexafungerp MIC90 value against the 445 clinical isolates was 1 mg/mL; the modal and MIC50 values were 0.5 mg/mL each. Of the 445 isolates, 32 of the C. auris strains had elevated MIC's to echinocandins. Only 1 of the 32 isolates had elevated MIC's to ibrexafungerp. The result highlights ibrexafungerp's potential to combat the growing global health threat posed by Candida auris. Title: Prevention of Pneumocystis Pneumonia by Ibrexafungerp in a Murine Prophylaxis Model: A preclinical study demonstrated that a 30 mg/kg B.I.D. dose of ibrexafungerp prevented Pneumocystis Pneumonia in a murine model, suggesting that it warrants further testing for preventing PCP in immunocompromised patients. Title: In Vitro Activity of Ibrexafungerp in pH 7.0 and pH 4.5 Testing Environments Against 187 Fluconazole-susceptible and -resistant Candida Species from Vulvovaginal Candidiasis: Ibrexafungerp exhibited significant in vitro activity against fluconazole-resistant and fluconazole-sensitive vaginal Candida isolates at normal and low pH environments and, unlike, fluconazole, ibrexafungerp retained its activity at lower pH These results suggest that ibrexafungerp may be an effective antifungal agent in a lower pH environment such as that found in the vagina of patients with vulvovaginal candidiasis. Title: CANDIMAD study: a prospective, -multicenter, laboratory-based survey of antifungal resistance in Candida spp. causing invasive candidiasis in Madrid: An active surveillance study evaluating 312 clinical isolates from 292 patients from 15 hospitals in Madrid, Spain. Ibrexafungerp showed consistent high activity against all strains of Candida and, in particular, ibrexafungerp was more active against C. parapsilosis than the echinocandins, including micafungin and anidulafungin.

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SCYX Scynexis
$0.91 /

+0.0109 (+1.21%)

07/31/19 Aegis
Scynexis initiated with a Buy at Aegis
05/28/19 Canaccord
Scynexis weakness a buying opportunity, says Canaccord
Conference/Events
Maxim Group to hold a virtual conference » 08:58
05/05/20
05/05
08:58
05/05/20
08:58
APM

Aptorum Group

$3.25 /

+ (+0.00%)

, ARDS

Aridis Pharmaceuticals

$7.29 /

+0.885 (+13.83%)

, ARMP

Armata Pharmaceuticals

$3.49 /

-0.01 (-0.29%)

, CDTX

Cidara Therapeutics

$2.91 /

+0.15 (+5.43%)

, CFRX

ContraFect

$6.71 /

+0.3 (+4.68%)

, INO

Inovio

$11.26 /

+1.01 (+9.85%)

, MTNB

Matinas BioPharma

$0.71 /

-0.0345 (-4.63%)

, SCYX

Scynexis

$0.90 /

-0.0509 (-5.36%)

Maxim Group Infectious…

Maxim Group Infectious Disease Virtual Conference will be held on May 5 at 10 am. Webcast Link

ShowHide Related Items >><<
APM Aptorum Group
$3.25 /

+ (+0.00%)

ARDS Aridis Pharmaceuticals
$7.29 /

+0.885 (+13.83%)

02/19/20 Roth Capital
Aridis Pharmaceuticals initiated with a Buy at Roth Capital
01/27/20 Cantor Fitzgerald
Cantor sees 'meaningful' coronavirus opportunity for Aridis Pharmaceuticals
12/30/19
Fly Intel: Top five analyst actions
12/30/19 H.C. Wainwright
Aridis Pharmaceuticals initiated with a Buy at H.C. Wainwright
ARMP Armata Pharmaceuticals
$3.49 /

-0.01 (-0.29%)

02/06/20 Maxim
Armata Pharmaceuticals initiated with a Buy at Maxim
02/06/20 Maxim
Armata Pharmaceuticals initiated with a Buy at Maxim
01/29/20 H.C. Wainwright
Armata investment removes significant overhang, says H.C. Wainwright
10/31/19 H.C. Wainwright
Armata Pharmaceuticals price target raised to $9.50 from $7 at H.C. Wainwright
CDTX Cidara Therapeutics
$2.91 /

+0.15 (+5.43%)

03/10/20 Maxim
Cidara Therapeutics initiated with a Buy at Maxim
03/10/20 Maxim
Cidara Therapeutics initiated with a Buy at Maxim
01/27/20 Cantor Fitzgerald
Street underappreciates Cidara's Cloudbreak AVCs, says Cantor Fitzgerald
12/04/19 WBB Securities
Cidara Therapeutics upgraded to Buy from Speculative Buy at WBB Securities
CFRX ContraFect
$6.71 /

+0.3 (+4.68%)

10/02/19 Piper Sandler
Piper says design differentiates ContraFect trial from other antibiotic studies
06/11/19 Maxim
ContraFect initiated with a Buy at Maxim
INO Inovio
$11.26 /

+1.01 (+9.85%)

04/30/20 Roth Capital
Inovio downgraded to Neutral from Buy at Roth Capital
04/29/20 Cantor Fitzgerald
Inovio price target raised to $17 from $13 at Cantor Fitzgerald
04/29/20 H.C. Wainwright
Inovio COVID-19 vaccine could be used across globe, says H.C. Wainwright
04/29/20 Stifel
Stifel more than doubles Inovio target to $19, sees favorable setup
MTNB Matinas BioPharma
$0.71 /

-0.0345 (-4.63%)

03/31/20 Piper Sandler
Matinas BioPharma price target lowered to $1.50 from $3.00 at Piper Sandler
01/27/20
Fly Intel: Top five analyst initiations
01/26/20 Piper Sandler
Matinas BioPharma initiated with an Overweight at Piper Sandler
01/24/20
Fly Intel: Top five analyst initiations
SCYX Scynexis
$0.90 /

-0.0509 (-5.36%)

07/31/19 Aegis
Scynexis initiated with a Buy at Aegis
05/28/19 Canaccord
Scynexis weakness a buying opportunity, says Canaccord

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