Ibrexafungerp

Vulvovaginal Candidiasis Treatment Research Report 2023 - ResearchAndMarkets.com

Retrieved on: 
Tuesday, October 10, 2023
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The increasing demand for vulvovaginal candidiasis treatment can be attributed to several key factors driving its growth.

Key Points: 
  • The increasing demand for vulvovaginal candidiasis treatment can be attributed to several key factors driving its growth.
  • Furthermore, the global population's growing awareness of the need for effective yet cost-efficient treatment options, particularly among the elderly demographic, has led to a surge in demand for vulvovaginal candidiasis treatment on a global scale.
  • The market's growth is further driven by the rising prevalence of acute vulvovaginal candidiasis infections among the global population, with an increasing number of research initiatives aimed at understanding the prevalence of conditions like recurrent vulvovaginal candidiasis (RVVC).
  • Company Profiles: Detailed analysis of the major companies present in Global Vulvovaginal Candidiasis Treatment Market.

Kirby McInerney LLP Announces Investigation of Shareholder Claims Against Scynexis, Inc. (SCYX)

Retrieved on: 
Friday, September 29, 2023
Class Action Lawsuit, Professional Services, Legal, Hypersensitivity, LLP, GSK, Kirby, Tablet, Allergy, FDA, Ibrexafungerp, News, Private investigator, Pharmaceutical industry

The law firm of Kirby McInerney LLP is investigating potential claims against Scynexis, Inc. (“Scynexis” or the “Company”) (NASDAQ: SCYX).

Key Points: 
  • The law firm of Kirby McInerney LLP is investigating potential claims against Scynexis, Inc. (“Scynexis” or the “Company”) (NASDAQ: SCYX).
  • The investigation concerns whether Scynexis and/or certain of its officers have violated the federal securities laws and/or engaged in other unlawful business practices.
  • Scynexis, Inc. develops and distributes intravenous drug for the treatment of serious and life-threatening invasive fungal infections.
  • Kirby McInerney LLP is a New York-based plaintiffs’ law firm concentrating in securities, antitrust, whistleblower, and consumer litigation.

SCYNEXIS Issues a Voluntary Nationwide Recall of BREXAFEMME® (ibrexafungerp tablets) due to potential for cross contamination with a non-antibacterial ß-lactam drug substance

Retrieved on: 
Thursday, September 28, 2023
Online, Completeness, Ibrexafungerp, Biconvex, Blister, Hives, Rash, NDC, Tablet, Swelling, Anaphylaxis, Knowledge, SCY, FDA, Letter, Sedgwick, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Pharmaceutical industry, Dietary supplement

During a review of manufacturing equipment and cleaning activities at a supplier, SCYNEXIS was made aware of potential cross-contamination risk with a non-antibacterial beta-lactam drug substance.

Key Points: 
  • During a review of manufacturing equipment and cleaning activities at a supplier, SCYNEXIS was made aware of potential cross-contamination risk with a non-antibacterial beta-lactam drug substance.
  • This press release provides additional details on the voluntary product recall recently disclosed by SCYNEXIS.
  • Risk Statement: The potential cross contamination with a non-antibacterial beta-lactam drug substance could lead to hypersensitivity reactions such as swelling, rash, urticaria and anaphylaxis, a potentially life-threatening adverse reaction.
  • To date, SCYNEXIS has not received any reports of adverse events established to be due to the possible beta-lactam cross contamination.

SCYNEXIS Reports Second Quarter 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Monday, August 14, 2023
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JERSEY CITY, N.J., Aug. 14, 2023 (GLOBE NEWSWIRE) -- SCYNEXIS, Inc. (NASDAQ: SCYX ), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant infections, today reported financial results for the second quarter ended June 30, 2023.

Key Points: 
  • JERSEY CITY, N.J., Aug. 14, 2023 (GLOBE NEWSWIRE) -- SCYNEXIS, Inc. (NASDAQ: SCYX ), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant infections, today reported financial results for the second quarter ended June 30, 2023.
  • On June 21, 2023, SCYNEXIS announced the achievement of a $25 million performance-based development milestone under its exclusive license agreement with GSK for ibrexafungerp.
  • Selling, general & administrative (SG&A) expense for Q2 2023 decreased to $7.5 million from $15.8 million for Q2 2022.
  • Total other income was $5.7 million for Q2 2023, versus total other income of $8.4 million for Q2 2022.

AUROBAC THERAPEUTICS welcomes two new independent members to its Board: Manos Perros, as Chairman, and Marco Taglietti

Retrieved on: 
Monday, July 24, 2023
GSK, AS, Fungal infection, D, Independent, Ceftazidime, AND, Global health, Research, AMR, Acinetobacter baumannii, Boehringer Ingelheim, Acquisition, Medicine, Knowledge, Growth, FDA, Therapy, Health, Independent Board for Presbyterian Foreign Missions, Pneumonia, Avibactam, Management, Pharmaceutical industry, Ibrexafungerp

"We are thrilled to welcome Dr Manos Perros as our new Chairman of the Board and Dr Marco Taglietti as an Independent Member” said Frank Kalkbrenner, former Chairman of the Board, representing Boehringer Ingelheim, main shareholder of AUROBAC THERAPEUTICS.

Key Points: 
  • "We are thrilled to welcome Dr Manos Perros as our new Chairman of the Board and Dr Marco Taglietti as an Independent Member” said Frank Kalkbrenner, former Chairman of the Board, representing Boehringer Ingelheim, main shareholder of AUROBAC THERAPEUTICS.
  • His strategic insights and wealth of knowledge in anti-infective drug development will undoubtedly play a pivotal role in steering AUROBAC THERAPEUTICS towards achieving its goals.
  • AUROBAC THERAPEUTICS’ Board now comprises Frank Kalkbrenner and Karl Penz, representing Boehringer Ingelheim, Philippe Archinard, representing bioMérieux, Antonio Felici, representing Evotec SE, Marco Taglietti as Independent Member and Manos Perros as Independent Member and Chairman.
  • With this Board working in collaboration with AUROBAC’s leadership team, AUROBAC THERAPEUTICS is well-positioned to drive innovation, improve patient outcomes, and address the critical global health challenge of antibiotic resistance.

SCYNEXIS and Hansoh Pharma Announce NMPA Acceptance of the New Drug Application for Ibrexafungerp in China

Retrieved on: 
Thursday, July 20, 2023
Biotechnology, NDA, Candidiasis, Tablet, Antimalarial medication, VVC, Patient, National Medical Products Administration, NMPA, Pharmaceutical industry, Ibrexafungerp

In February 2021, SCYNEXIS entered into an agreement for the development and commercialization rights for oral ibrexafungerp in the greater China region with Hansoh Pharma.

Key Points: 
  • In February 2021, SCYNEXIS entered into an agreement for the development and commercialization rights for oral ibrexafungerp in the greater China region with Hansoh Pharma.
  • Under the terms of the agreement, Hansoh is responsible for the development, regulatory approval and commercialization of ibrexafungerp in Greater China.
  • Ibrexafungerp, once approved, is expected to become a new, first in class anti-fungal treatment for Chinese patients with vulvovaginal candidiasis (VVC).
  • The acceptance of the NDA brings us one more step closer to making this novel and differentiated antifungal available to patients in Greater China.”

SCYNEXIS Announces Achievement of First Development Milestone of $25 Million Under Exclusive License Agreement with GSK

Retrieved on: 
Wednesday, June 21, 2023
Biotechnology, Tablet, GSK, Antimalarial medication, VVC, Ibrexafungerp, Pharmaceutical industry

JERSEY CITY, N.J., June 21, 2023 (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 achievement of a $25 million performance-based development milestone under its exclusive license agreement with GSK for ibrexafungerp.

Key Points: 
  • JERSEY CITY, N.J., June 21, 2023 (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 achievement of a $25 million performance-based development milestone under its exclusive license agreement with GSK for ibrexafungerp.
  • The milestone payment follows a development goal for the Phase 3 MARIO study for ibrexafungerp in invasive candidiasis as SCYNEXIS continues executing ongoing ibrexafungerp trials.
  • Under the agreement, SCYNEXIS received a $90 million upfront payment and is eligible for additional potential milestone-based payments totaling up to $503 million.
  • Including the payment announced above, SCYNEXIS has achieved $115 million in upfront and milestone payments during the exclusive license agreement thus far.

SCYNEXIS Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Corporate Update

Retrieved on: 
Friday, March 31, 2023
Candidiasis, Public, Food and Drug Administration, Prescription, Bangladesh Technical Education Board, Chemistry, Incidence, Journal, Candida auris, Investment, Patient, Body mass index, Medicines and Healthcare products Regulatory Agency, 3B, Infection, Research, VVC, Ibrexafungerp, Diagnosis, Fungal infection, FDA, NIH, Safety, Salvage therapy, Aspergillosis, GSK, General Administration of Sport of China, Biotechnology, Voriconazole, Tablet, Mortality, Hand, MHRA, Journal of Fungi, SG, CMC, IC, NDA, Medication, Case Western Reserve University, Fungemia, Antimalarial medication, United Kingdom, Poster, Trial of the century, Fluconazole, Food, Pharmaceutical industry, Drug, Self storage, Cryptocurrency, Reinsurance, Fungus, IQVIA, FURI

GSK will make an upfront payment to SCYNEXIS of $90 million, as well as potential future milestones and tiered royalties.

Key Points: 
  • GSK will make an upfront payment to SCYNEXIS of $90 million, as well as potential future milestones and tiered royalties.
  • JERSEY CITY, N.J., March 31, 2023 (GLOBE NEWSWIRE) -- SCYNEXIS, Inc. (NASDAQ: SCYX ), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant infections, today reported financial results for the fourth quarter and full year ended on December 31, 2022.
  • According to IQVIA data, there were 5,125 total prescriptions for BREXAFEMME written in Q4 2022, and more than 20,000 total prescriptions written in 2022.
  • The approval was based on positive results from the pivotal Phase 3 CANDLE study reported in February 2022.

GSK and SCYNEXIS Announce an Exclusive Agreement to Commercialise and Further Develop Brexafemme (ibrexafungerp), a Novel, First-in-Class Medicine to Treat Fungal Infection

Retrieved on: 
Thursday, March 30, 2023
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This exclusive licence agreement gives GSK rights to commercialise Brexafemme for VVC and RVVC while continuing to develop ibrexafungerp, which is in phase III clinical trials for the potential treatment of invasive candidiasis (IC), a life-threatening fungal infection.

Key Points: 
  • This exclusive licence agreement gives GSK rights to commercialise Brexafemme for VVC and RVVC while continuing to develop ibrexafungerp, which is in phase III clinical trials for the potential treatment of invasive candidiasis (IC), a life-threatening fungal infection.
  • Luke Miels, Chief Commercial Officer, GSK said: “The challenge of antimicrobial resistance includes increasing rates of multi-drug resistant fungal infections.
  • Brexafemme is a novel, approved antifungal medicine with a broad spectrum of activity against existing and emerging resistant strains of fungi.
  • Brexafemme has a distinct mechanism of action whereby it kills the fungus, as opposed to some antifungals which inhibit fungal growth.

Mycovia Pharmaceuticals Announces Presentation of Oteseconazole (VT-1161) Phase 3 Data Demonstrating Safety and Efficacy for Treatment of Recurrent Vulvovaginal Candidiasis (RVVC) at the 2021 IDSOG Annual Meeting

Retrieved on: 
Thursday, July 29, 2021
Women, Biotechnology, Pharmaceutical, General Health, Health, FDA, Consumer, Clinical trials, Health sciences, Life sciences, Drug discovery, Health policy, Medicinal chemistry, Therapy, Food and Drug Administration, Ibrexafungerp, Mycovia Pharmaceuticals, Oteseconazole, Recurrent Vulvovaginal Candidiasis, NovaQuest Capital Management, MYCOVIA PHARMACEUTICALS, OTESECONAZOLE, RECURRENT VULVOVAGINAL CANDIDIASIS, NOVAQUEST CAPITAL MANAGEMENT

Oteseconazole protected more than 90% of participants from having a recurrence during the 48-week maintenance phase, compared to approximately 40% of those in the control group.

Key Points: 
  • Oteseconazole protected more than 90% of participants from having a recurrence during the 48-week maintenance phase, compared to approximately 40% of those in the control group.
  • This meeting provides a chance to generate increased discussion with healthcare professionals about RVVC and the need for improved treatment options.
  • Oteseconazole (VT-1161) is a novel, investigational oral therapy for the treatment of recurrent vulvovaginal candidiasis (RVVC).
  • Oteseconazole received FDA Qualified Infectious Disease Product and Fast-Track designations and, if approved, could be the first FDA-approved treatment for RVVC.