4 - SCYNEXIS INC (0001178253) (Issuer)

4 - SCYNEXIS INC (0001178253) (Issuer)

4 - SCYNEXIS INC (0001178253) (Issuer)

4 - SCYNEXIS INC (0001178253) (Issuer)

4 - SCYNEXIS INC (0001178253) (Issuer)

4 - SCYNEXIS INC (0001178253) (Issuer)

4 - SCYNEXIS INC (0001178253) (Issuer)

4 - SCYNEXIS INC (0001178253) (Issuer)

4 - SCYNEXIS INC (0001178253) (Issuer)

4 - SCYNEXIS INC (0001178253) (Issuer)

4 - SCYNEXIS INC (0001178253) (Issuer)

Submission status for SCYNEXIS, INC's drug BREXAFEMME (ORIG-1) with active ingredient IBREXAFUNGERP has changed to 'Approval' on 06/01/2021. Application Category: NDA, Application Number: 214900, Application Classification: Type 1 - New Molecular Entity

Submission status for SCYNEXIS, INC's drug BREXAFEMME (SUPPL-1) with active ingredient IBREXAFUNGERP has changed to 'Approval' on 06/01/2021. Application Category: NDA, Application Number: 214900, Application Classification: Type 1 - New Molecular Entity

JERSEY CITY, N.J., April 08, 2025 (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 the presentation of preclinical efficacy data on its second-generation fungerp candidate SCY-247 at the European Society of Clinical Microbiology and Infectious Diseases (ESCMID Global) in Vienna, Austria being held from April 11-15, 2025. SCY-247 is being developed to address systemic fungal diseases, with a key focus on invasive fungal infections where resistance to current limited treatment options is a significant concern. These presentations at ESCMID Global

The Phase 1 trial of the second-generation triterpenoid antifungal SCY-247, initiated in December of 2024, continues and results are expected in Q3 of 2025.Four presentations for SCY-247 were accepted by the European Society of Clinical Microbiology and Infectious Diseases (ESCMID Global) congress, April 11-15, 2025 in Vienna, Austria.SCYNEXIS continues to make progress towards the restart of the Phase 3 MARIO study in invasive candidiasis. The Company anticipates the restart, pending the FDA's lifting of the clinical hold, in the second quarter of 2025.SCYNEXIS ended 2024 with cash, cash equivalents and investments of $75.1 million, and projects a cash runway into Q3 2026. JERSEY CITY, N.J

JERSEY CITY, N.J., Dec. 18, 2024 (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 it has completed the dosing of the first cohort of subjects in its Phase 1 trial of SCY-247, the Company's second-generation triterpenoid antifungal in development for the treatment of severe invasive fungal infections.   "We are pleased to advance our potent, second-generation fungerp candidate SCY-247 into the clinic in a Phase 1 study," said David Angulo, M.D., President and Chief Executive Officer. "SCY-247 has consistently shown promising results in prec

Clinical study reports for the FURI, CARES and NATURE trials in refractory or resistant invasive fungal infections were delivered to GSK, triggering a $10 million development milestone payment to SCYNEXIS, received in Q3 2024. SCY-247 preclinical studies were presented at medical conferences and continue to show potent and broad antifungal activity. Phase 1 study initiation is anticipated in Q4 2024. SCYNEXIS ended Q3 2024 with cash, cash equivalents and investments of $84.9 million, including the recently earned $10.0 million development milestone, and projects a cash runway into Q3 2026. SCYNEXIS will attend Guggenheim's Inaugural Global Healthcare Conference in Boston on November 12tha

JERSEY CITY, N.J., Oct. 10, 2024 (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 David Angulo, M.D., President and Chief Executive Officer, will participate in a fireside chat at the 2024 Maxim Healthcare Virtual Summit on Thursday, October 17, at 11:30 A.M. ET. Maxim Healthcare Virtual Summit Details:  Format:Fireside chatDate:Thursday, October 17, 2024Time:11:30 A.M. ETLocation:Virtual   To sign up to view the presentation, click here. 1x1 investor meetings will be available after the event upon request through the following link or by conta

JERSEY CITY, N.J., Oct. 03, 2024 (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 upcoming presentations of preclinical efficacy and pharmacokinetic data on its second-generation fungerp candidate SCY-247 at IDWeek 2024 taking place in Los Angeles, CA from October 16-19, 2024. Presentation details can be found below: Oral Presentation: Title:Efficacy of SCY-247, a Second-generation Triterpenoid Antifungal, in Three Murine Models of Invasive Fungal InfectionsSession:Mycology Matters: Insights into Fungal InfectionsDate/Time:Thursday October 17,

JERSEY CITY, N.J., Aug. 27, 2024 (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 David Angulo, M.D., President and Chief Executive Officer, will make a corporate presentation as well as host 1x1 meetings at the H. C. Wainwright 26th Annual Global Investment Conference on Wednesday, September 11 at 10:00 A.M. ET. H. C. Wainwright 26th Annual Global Investment Conference Format:Live presentation and one-on-one meetingsDate:Wednesday, September 11, 2024Time:10:00 A.M. ETLocation:New York, NYWebcast:Link To request a one-on-one m

Clinical study reports for the FURI, CARES and NATURE trials in refractory or resistant invasive fungal infections were delivered to GSK, triggering a $10 million development milestone payment to SCYNEXIS which we expect to receive in Q3 2024. SCY-247's IND-enabling activities continue to progress. Pre-clinical in vitro and in vivo studies, presented at several medical conferences, have shown potent and broad antifungal activity. Phase 1 study initiation is planned for Q4 2024. SCYNEXIS ended Q2 2024 with cash, cash equivalents and investments of $83.7 million, not including the recently earned $10 million development milestone, and projects a cash runway of more than two years. JERSEY CI

JERSEY CITY, N.J., July 23, 2024 (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 it will receive a $10 million development milestone payment under its exclusive license agreement with GSK for ibrexafungerp. The milestone payment is triggered by the delivery of final clinical study reports for the completed FURI, CARES, and NATURE clinical studies. "We are pleased to have completed these important studies in refractory invasive fungal infections, for which there remains an urgent need to deliver new solutions and combat growing resistance,

SCY-247's IND-enabling activities continue to progress, with initiation of Phase I anticipated in the second half of 2024Clinical study reports for the FURI, CARES and NATURE trials in refractory invasive fungal infections remain on track for delivery to GSK in mid 2024, which would trigger a $10 million development milestone payment to SCYNEXISSCYNEXIS ended Q1 2024 with cash, cash equivalents and investments of $94.2 million and projects a cash runway of more than two years JERSEY CITY, N.J., May 08, 2024 (GLOBE NEWSWIRE) -- SCYNEXIS, Inc. (NASDAQ:SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant infections, toda

Lyon - France, July 24, 2023 (GLOBE NEWSWIRE) -- AUROBAC THERAPEUTICS WELCOMES TWO NEW INDEPENDENT MEMBERS TO ITS BOARD: MANOS PERROS, AS CHAIRMAN, AND MARCO TAGLIETTI Dr Manos Perros and Dr Marco Taglietti are appointed new Independent Members of the Board of AUROBAC THERAPEUTICSDr Perros becomes Chairman of the Board These new appointments bring extensive US and international experience in company leadership and development of anti-infectives from R&D to commercialization Lyon (France), Thursday July 24, 2023 AUROBAC THERAPEUTICS SAS, a biopharmaceutical company developing the next generation of products to fight antimicrobial resistance (AMR), is delighted to announce th

Secured non-dilutive funding of approximately $35 million thus far in 2021, including licensing payments from Hansoh Pharma, the first tranche from a term loan agreement with Hercules and Silicon Valley Bank, and the monetization of the 2020 New Jersey NOLsAppointed Christine Coyne as Chief Commercial Officer to lead the launch of ibrexafungerp (Brexafemme®) for the treatment of vaginal yeast infections, following expected approval by June 1st Began dosing patients in a Phase 1 trial of the IV formulation of ibrexafungerpFurther strengthened balance sheet and projected cash runway into 2023 JERSEY CITY, N.J., May 17, 2021 (GLOBE NEWSWIRE) -- SCYNEXIS, Inc. (NASDAQ:SCYX), a biotechnology c

Strengthening the management team with deep anti-infective commercial expertise across hospital and community settings ahead of anticipated approval of Brexafemme (ibrexafungerp) in June 2021 and H2:2021 launch JERSEY CITY, N.J., May 11, 2021 (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 the appointment of Christine Coyne as Chief Commercial Officer, effective May 10, 2021. Ms. Coyne will play a significant role in the anticipated U.S. launch and commercialization of Brexafemme, the expected trade name for ibrexafungerp, an oral antifungal p

WARREN, N.J., Feb. 09, 2021 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST), a pharmaceutical company focused on developing and commercializing differentiated products that address patients’ unmet needs and solve therapeutic problems, today announced the appointment of Julie Krop, M.D., Chief Medical Officer of Freeline Therapeutics (NASDAQ: FRLN), and Marco Taglietti, M.D., Director, President and Chief Executive Officer of SCYNEXIS (NASDAQ: SCYX), to the Board of Directors of the Company effective February 10, 2021. Aquestive also announced the resignation of Douglas K. Bratton from the Board of Directors after more than 17 years of service. Aquestive’s Board of Directors

Brexafemme complements GSK's industry-leading infectious disease portfolio with an FDA approved treatment for vulvovaginal candidiasisSCYNEXIS will receive an upfront payment of $90 million with future performance-based milestone payments and tiered royaltiesSCYNEXIS retains rights to all other assets derived from enfumafungin, with GSK having a right of first negotiation to these pre-clinical and discovery stage assetsSCYNEXIS to host an investor call and webcast at 8:30 a.m. EDT today LONDON and JERSEY CITY, N.J., March 30, 2023 (GLOBE NEWSWIRE) -- GSK plc (NYSE:GSK) and SCYNEXIS, Inc. (NASDAQ:SCYX), today announced they have entered into an exclusive licence agreement for Brexafemme (i

SCYNEXIS recently announced new strategic direction to refocus its resources on the clinical development of ibrexafungerp for severe, hospital-based indications.Ivor Macleod, a 30-year biopharma veteran, joined SCYNEXIS as Chief Financial Officer.Marco Taglietti, M.D., to retire as President and Chief Executive Officer of SCYNEXIS and step down from the Board of Directors on December 31, 2022. David Angulo, M.D., Chief Medical Officer of SCYNEXIS will become President and Chief Executive Officer and join the Board effective January 1, 2023.BREXAFEMME® (ibrexafungerp tablets) prescriptions continued to grow in Q3 2022, increasing 13% over Q2 2022, generating net revenues of $1.6 million in Q3

JERSEY CITY, N.J., Nov. 01, 2022 (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 it will host a conference call and live webcast at 8:30 a.m. EDT on Wednesday, November 9, 2022, to provide a corporate update and discuss the Company's financial results for the third quarter ended September 30, 2022. Conference call and webcast details: Investors (domestic): (844) 826-3033Investors (international): (412) 317-5185Webcast:  LinkConference ID: 10172836 A live audio webcast can be accessed by visiting the Investor Relations section of the Company'

SCYNEXIS is announcing a new strategic direction to refocus its resources on the clinical development of ibrexafungerp for severe, hospital-based indications in which higher long-term returns are expected, given the promising data generated to date in refractory fungal infections, including Candida auris, and the anticipated first approval in the hospital setting in 2024.Company intends to out-license BREXAFEMME® (ibrexafungerp tablets) for vulvovaginal candidiasis (VVC) and is actively pursuing a U.S. commercialization partner that can build on the positive momentum to date and maximize its commercial value. During this process, SCYNEXIS will wind down its promotional activities, while keep

JERSEY CITY, N.J., Aug. 09, 2022 (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 it will host a conference call and live webcast at 8:30 a.m. EDT on Monday, August 15, 2022 to provide a corporate update and discuss the Company's financial results for the second quarter ended June 30, 2022. Conference call and webcast details: Investors (domestic): (877) 704-4453Investors (international): (201) 389-0920Webcast:  https://viavid.webcasts.com/starthere.jsp?ei=1555622&tp_key=54aa49f539 Conference ID: 13730704 A live audio webcast can be accessed

JERSEY CITY, N.J., May 05, 2022 (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 it will host a conference call and live webcast at 8:30 a.m. ET on Thursday, May 12, 2022 to provide a corporate update and discuss the Company's financial results for the first quarter ended March 31, 2022. Conference call and webcast details: Investors (domestic): (877) 704-4453Investors (international): (201) 389-0920Webcast:  https://viavid.webcasts.com/starthere.jsp?ei=1543196&tp_key=e943d8c4f4 Conference ID: 13729053 A live audio webcast can be accessed by

BREXAFEMME® (ibrexafungerp tablets), launched in August 2021, achieved net revenues of $1.1 million in 2021. Fourth quarter 2021 net revenues were $0.6 million.As of the end of 2021, BREXAFEMME was covered by commercial insurance plans representing 81 million or 48% of commercially insured lives.Ibrexafungerp successfully achieved statistically significant superiority over placebo for the primary and key secondary study endpoints in the CANDLE Phase 3 trial for recurrent vulvovaginal candidiasis (rVVC) with a supplemental New Drug Application (sNDA) to be filed in the second quarter of 2022 and potential approval by year end.SCYNEXIS is initiating MARIO, a global Phase 3 study to evaluate ib

JERSEY CITY, N.J., March 24, 2022 (GLOBE NEWSWIRE) -- SCYNEXIS, Inc. (NASDAQ:SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant infections, will announce fourth quarter and full year 2021 financial results and provide a business update on Tuesday, March 29, 2022. The company will host a conference call and webcast at 8:30 a.m. Eastern Daylight Time on the same day. Investors (domestic): (877) 705-6003Investors (international): (201) 493-6725Webcast: https://viavid.webcasts.com/starthere.jsp?ei=1531381&tp_key=627476145dConference ID: 13727358 A recording of the webcast will be posted on the Company's website

Ibrexafungerp, the only fungicidal oral treatment for vaginal yeast infections, successfully achieved statistically significant superiority over placebo for the primary and key secondary study endpoints.SCYNEXIS will submit a supplemental New Drug Application (sNDA) for BREXAFEMME® (ibrexafungerp tablets) for the prevention of recurrent vaginal yeast infections (rVVC) in the first half of 2022 with anticipated approval by the end of the year.Additionally, a one day treatment of ibrexafungerp achieved a substantial reduction or complete elimination of symptoms in a subset of study patients who failed to respond to a three-day regimen of fluconazole. In the study, ibrexafungerp was generally s

JERSEY CITY, N.J., Nov. 03, 2021 (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 it will host a conference call and live webcast at 8:30 a.m. ET on Wednesday, November 10, 2021, to provide a corporate update and discuss the Company's financial results for the third quarter ended September 30, 2021. Conference call and webcast details: Investors (domestic): (877) 705-6003Investors (international): (201) 493-6725Conference ID: 13724235Webcast: https://viavid.webcasts.com/starthere.jsp?ei=1504710&tp_key=3a6a6b5742 A live audio webcast can be ac