Latest news with #VVC
Yahoo
30-05-2025
- Business
- Yahoo
SCYNEXIS, Inc. (SCYX) Resumes Phase III Dosing for Brexafemme After 19-Month FDA Hold
SCYNEXIS, Inc. (NASDAQ:SCYX) has officially restarted patient dosing in its Phase III MARIO trial for Brexafemme (ibrexafungerp) after the FDA lifted a nearly two-year clinical hold. The hold, initiated over concerns of beta-lactam contamination at the original manufacturing facility, was removed once new drug batches were produced at a separate location. With trial sites now reactivated, patient enrollment has resumed, reaching about 25% of its 220-participant goal. A pharmacist technician sorting pills in a drug pharmacy. The MARIO trial explores Brexafemme's use as an oral follow-up treatment to IV echinocandins for invasive candidiasis, a life-threatening fungal infection. SCYNEXIS, Inc. (NASDAQ:SCYX) received a $10 million milestone payment from GSK after the first new patient was dosed, though disagreements over further payments and trial duties have sparked tension between the two partners. Previously recalled in 2023 due to contamination risks, Brexafemme had FDA approval for treating VVC. While its commercial progress has faced setbacks, projected global revenue could reach $139 million by 2031 if development succeeds. While we acknowledge the potential of SCYX to grow, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns and have limited downside risk. If you are looking for an AI stock that is more promising than SCYX and that has 100x upside potential, check out our report about this READ NEXT: and Disclosure: None. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
29-05-2025
- Business
- Yahoo
SCYNEXIS, Inc. (SCYX) Resumes Phase III Dosing for Brexafemme After 19-Month FDA Hold
SCYNEXIS, Inc. (NASDAQ:SCYX) has officially restarted patient dosing in its Phase III MARIO trial for Brexafemme (ibrexafungerp) after the FDA lifted a nearly two-year clinical hold. The hold, initiated over concerns of beta-lactam contamination at the original manufacturing facility, was removed once new drug batches were produced at a separate location. With trial sites now reactivated, patient enrollment has resumed, reaching about 25% of its 220-participant goal. A pharmacist technician sorting pills in a drug pharmacy. The MARIO trial explores Brexafemme's use as an oral follow-up treatment to IV echinocandins for invasive candidiasis, a life-threatening fungal infection. SCYNEXIS, Inc. (NASDAQ:SCYX) received a $10 million milestone payment from GSK after the first new patient was dosed, though disagreements over further payments and trial duties have sparked tension between the two partners. Previously recalled in 2023 due to contamination risks, Brexafemme had FDA approval for treating VVC. While its commercial progress has faced setbacks, projected global revenue could reach $139 million by 2031 if development succeeds. While we acknowledge the potential of SCYX to grow, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns and have limited downside risk. If you are looking for an AI stock that is more promising than SCYX and that has 100x upside potential, check out our report about this READ NEXT: and Disclosure: None. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
28-05-2025
- Business
- Yahoo
Scynexis resumes dosing in Phase III MARIO study after lengthy delay
Scynexis has resumed dosing of its vaginal yeast infection drug Brexafemme (ibrexafungerp) in a Phase III trial after a 19-month clinical hold by the US Food and Drug Administration (FDA). The resumption of dosing in the MARIO study (NCT05178862) comes after the FDA lifted the clinical hold last month, originally in place due to concerns about cross-contamination. Scynexis said the investigational sites were reactivated a few days ago, as per a 28 May press release. The issue was highlighted after a review from GSK, which signed a licensing deal for the drug with Scynexis in 2023. The British big pharma noted that the manufacturing site for Brexafemme also produced a non-antibiotic beta-lactam substance. This drug, which can cause allergic reactions in some patients, has been the subject of an FDA draft guidance that details the separation of manufacturing processes for these compounds. In September 2023, Scynexis issued a voluntary recall of Brexafemme, an FDA-approved treatment for vulvovaginal candidiasis (VVC), due to the potential for cross-contamination. Scynexis said the study has resumed following the manufacture of new clinical supplies at another site. The Phase III MARIO study is investigating oral Brexafemme as a potential step-down antifungal therapy following intravenous (IV) echinocandin for invasive candidiasis, a potentially life-threatening infection. The trial has enrolled around 25% of its 220-patient target. 'We are pleased to announce the dosing of the first new patient in the Phase III MARIO study following the lifting of the clinical hold by the FDA in April,' said Scynexis CEO David Angulo. 'The rapid resumption of patient enrolment, just a few days after the investigational sites were reactivated in the study, reflects the eagerness of the scientific community to have new treatment options for this life-threatening infection.' MARIO being back on track comes amid a saga between Scynexis and GSK, with the companies pointing fingers at each other with regard to trial duties. During its Q1 earnings report, Scynexis said that GSK had tried to terminate the study, with Angulo affirming plans to move forward with Brexafemme in this new indication. There used to be substantial cash on the line. The partnership in 2023 included not just a $90m upfront payment, but up to $503m in milestone payments. However, after the commercial delays, millstone payments were cut in a revised deal in December 2023. Approval-based milestones were slashed from $70m to $49m, whilst commercial counterparts were halved from $115m to a potential $57.5m. Milestone payments based on sales were also downwardly revised. By dosing the first new patient, Scynexis believes it has now triggered a $10m payment, with another $20m to arrive by the six-month anniversary of dosing. 'As previously disclosed, there is a disagreement between Scynexis and GSK regarding the resumption of the MARIO Study and GSK's responsibility for paying these milestones. Scynexis is working to resolve the disagreement,' Scynexis said in a statement. GSK did not immediately respond to Clinical Trials Arena's request for comment. Scynexis reported $3.7m in revenue for 2024, which primarily consisted of the licence agreement with GSK. Brexafemme generated sales of $5m in 2022 before the recall. GlobalData's Pharma Intelligence Center forecasts global sales of $139m by 2031, a valuation that hinges on the outcome of the MARIO study and a subsequent label expansion. GlobalData is the parent company of Clinical Trials Arena. "Scynexis resumes dosing in Phase III MARIO study after lengthy delay" was originally created and published by Clinical Trials Arena, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Time of India
28-04-2025
- Entertainment
- Time of India
Paresh Rawal didn't do 'Munnabhai MBBS' due to Vidhu Vinod Chopra's arrogance: 'He started ignoring the people he started off with'
Paresh Rawal who has been in the industry for around four decades is known for his unique characters that have left a mark in the hearts of the audience. He's also considered one of the best actors in Indian cinema. In a recent interview, Rawal revealed that he was supposed to be a part of ' Munnabhai MBBS ' and had almost signed Boman Irani 's role. Rawal spoke about it, as he was sharing details about how Rajkumar Hirani and Abhijaat Joshi came to see his play ' Kanji Virudh Kanji '. This particular Gujarati play was adapted into a film 'OMG: Oh My God' which also starred Rawal. Incidentally, Rajkumar Hirani was making 'PK' two years later which also dealt with the beliefs existing in India. Rawal revealed, "It was around the time PK was happening, Saumya Joshi, a brilliant Gujarati writer, was accompanied by his brother Abhijat and Raju Hirani. They were there f0r almost every show. You see, we used to incorporate newer angles in every show." He added that they came to Rawal to check for any new dialogue that they wrote. He added, "Any new dialogue, they came and checked. Both are very good people, despite staying with Vidhu Vinod Chopra for so long." With this sarcastic comment for Chopra, Paresh was asked about his equation with him. He revealed that VVC has forgotten the people who he started off with. He said, "He is someone who started ignoring the people he started off with, especially after becoming big in his career. I was supposed to do Munna Bhai. We were discussing remuneration, and in my head, I wanted Rs 15 lakhs. Vidhu also offered the same number, but the way he said 'I'll give you 15' miffed me. I asked for Rs 50 lakhs, and decided to not budge from my want just to not take arrogance from anyone." Interestingly, 'Munnabhai MBBS' was remade in Telugu with Chiranjeevi. It was titled ' Shankar Dada MBBS ' and Rawal played Boman Irani's role in that. Later, he played Sunil Dutt's role in Sanjay Dutt's biopic 'Sanju'. Paresh Rawal added that money is not important for him, but he didn't appreciate Chopra's attitude. 'Artistes are built differently. If you place a hand on my shoulders, and ask nicely, I will do a film for even one rupee. But, if you throw around attitude, I won't accept a role even if I'm paid in crores," he said.
Yahoo
23-04-2025
- Business
- Yahoo
Coologics Announces Oversubscribed Seed Funding Round
CLEVELAND, April 23, 2025 /PRNewswire/ -- Coologics Inc., a clinical-stage medical device company, today announced the successful closing of their Seed round. The round was oversubscribed, demonstrating strong investor confidence in Coologics' vision and technology around its initial product, Vlisse. The seed funding round secured over $3 million in investment, exceeding the initial target of $1.5 million. The funding was led by Prevail and Dream Ventures and saw material participation from two university alumni groups, Ohio State Early Investor Network and Illinois Ventures Illini Angels Program. The Company's CEO/founder, Dr. Kim Langdon and Chief Medical Officer, Dr. Nicole Williams are alumni of the Ohio State University and the University of Illinois, respectively. This significant capital injection will be instrumental in accelerating Coologics' key milestones, around the completion of their ongoing clinical trial, FDA submission and initial market release of their flagship product, Vlisse. "We are beyond excited about the investor commitment to Coologics," said Dr. Langdon, CEO/Founder. "The overwhelming interest in our seed round validates the critical need for a more effective treatment for vaginal infections. We are thrilled to welcome our new investors and leverage their expertise to accelerate our growth and deliver impactful solutions to female patients and their clinicians." "Dr. Langdon's vision and passion for this problem is what excited us the most about Coologics," said Kerry Lawing, Prevail Ventures CEO, "This market is ripe for innovative solutions like Vlisse. I look forward to watching our experienced teams at Prevail and Dream strategically support Coologics efforts in bringing Vlisse to market." Coologics Inc. is committed to supporting female health and treating the underlying issues affecting women daily. The successful completion of this seed round marks a significant step forward in realizing this vision and bringing its groundbreaking solution, Vlisse, to market. About Coologics Inc. Coologics aims to revolutionize women's health by providing innovative, drug-free solutions for vaginal infections. The company is committed to developing sustainable treatments that reduce the unnecessary use of antibiotics, addressing the growing concern of antibiotic resistance. Vlisse is an innovative, drug-free intravaginal cooling device designed to treat vaginal infections, including VVC, BV, and mixed infections by leveraging its patented cooling mechanism. This approach represents a paradigm shift from traditional antifungal drugs, focusing on restoring the vaginal environment to a healthy state without the use of chemicals. For more information visit Email: rich@ Inquiries contact Rich Mazzola, CFO, 216.376.7972 View original content to download multimedia: SOURCE Coologics, Inc. Sign in to access your portfolio
