Latest news with #FDAapproval
Yahoo
5 hours ago
- Business
- Yahoo
Sanofi (ENXTPA:SAN) Gains FDA Approval For Dupixent To Address Rare Skin Disease
Sanofi experienced a 4% decline over the past week despite a largely unchanged market. The recent events, including the FDA approval of Dupixent for a rare skin condition and the signing of a memorandum with the Department of Health - Abu Dhabi, signal positive developments for its collaborative efforts with Regeneron and internal growth strategies. Although these announcements are significant, they were not sufficient to counteract the broader move, which might have been influenced by other factors specific to Sanofi, such as its recent €1.5 billion notes offering aimed at supporting corporate purposes. Buy, Hold or Sell Sanofi? View our complete analysis and fair value estimate and you decide. Explore 26 top quantum computing companies leading the revolution in next-gen technology and shaping the future with breakthroughs in quantum algorithms, superconducting qubits, and cutting-edge research. The recent developments for Sanofi, including FDA approval of Dupixent for a rare skin condition and the memorandum with the Department of Health - Abu Dhabi, highlight efforts to enhance revenue growth through expanded market reach and innovation. Despite these positive updates, Sanofi shares experienced a 4% decline over the past week, influenced by factors such as the recent €1.5 billion notes offering. Over a longer-term period, Sanofi achieved a total shareholder return of 11.29% over five years. Comparatively, over the past year, Sanofi's performance matched the French Pharmaceuticals industry, which reported a similar decline of 5.9%. In contrast, the broader French Market fared slightly better, returning 2.2%. The recent news related to Dupixent and international partnerships could potentially boost Sanofi's revenue and earnings forecasts, providing a catalyst for future growth given the innovative pipeline and market penetration opportunities. Considering the current share price of €95.9 and the analyst consensus price target of €117.7, there is potential for an 18.5% increase, according to market projections. These developments need to be weighed against existing market conditions and company fundamentals, as analysts remain divided on future earnings prospects and valuations. Click here to discover the nuances of Sanofi with our detailed analytical financial health report. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Companies discussed in this article include ENXTPA:SAN. This article was originally published by Simply Wall St. Have feedback on this article? Concerned about the content? with us directly. Alternatively, email editorial-team@
Medscape
a day ago
- Business
- Medscape
FDA Approves Dupilumab for Bullous Pemphigoid
Dupilumab has been approved by the FDA for the treatment bullous pemphigoid in adults, the manufacturer Regeneron announced. Dupilumab (Dupixent), a human monoclonal antibody that inhibits interleukin (IL)-4 and IL-13 signaling, is now approved in the United States for eight diseases, including atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis, and prurigo nodularis. Dupilumab, administered by subcutaneous injection, is the first targeted treatment to be approved in the United States for bullous pemphigoid, according to the company's press release. The approval follows a supplemental New Drug Application filed with the FDA in February 2025 and is based on data from ADEPT, a pivotal phase 2/3 study in more than 100 adults with moderate-to-severe bullous pemphigoid known as, according to Regeneron. The study's design was published in Advances in Therapy. In the study, 106 patients were randomized to 300 mg of subcutaneous dupilumab or a placebo injection every 2 weeks, added to standard-of-care oral corticosteroids. At 36 weeks, 18.3% of patients in the dupilumab group achieved the primary endpoint of sustained disease remission compared with 6.1% of those in the placebo group. The study defined sustained remission as a combination of complete clinical remission and no relapse after an oral corticosteroid taper by 16 weeks, with no use of rescue therapy during the study period. More patients treated with dupilumab achieved a clinically meaningful reduction in itching (38.3% vs 10.5%), and the median cumulative oral corticosteroid dose in the dupilumab-treated group was 2.8 g vs 4.1 g in the placebo group, according to the company release. The most common adverse events among patients receiving dupilumab (affecting 2% or more) compared with those receiving placebo were arthralgia, conjunctivitis, blurred vision, herpes viral infections, and keratitis. One patient receiving dupilumab also developed acute generalized exanthematous pustulosis; no cases were reported among those receiving placebo. The dupilumab study was funded by Sanofi and Regeneron, the companies co-developing dupilumab.
Yahoo
4 days ago
- Business
- Yahoo
Vistagen Therapeutics Inc (VTGN) Q4 2025 Earnings Call Highlights: Strategic Advancements Amid ...
Research and Development Expenses: $39.4 million for the fiscal year ended March 31, 2025, up from $20 million the previous year. General and Administrative Expenses: $17.1 million for the fiscal year ended March 31, 2025, compared to $14.1 million the previous year. Net Loss: $51.4 million for the fiscal year ended March 31, 2025, compared to $29.4 million the previous year. Cash, Cash Equivalents, and Marketable Securities: $80.5 million as of March 31, 2025. Warning! GuruFocus has detected 3 Warning Signs with VTGN. Release Date: June 17, 2025 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Vistagen Therapeutics Inc (NASDAQ:VTGN) has five clinical-stage pherine product candidates with differentiated mechanisms of action, showing positive results in controlled trials. The company's lead product candidate, Fasedienol, is in Phase III development for social anxiety disorder (SAD), aiming to become the first FDA-approved acute treatment for SAD. Vistagen is advancing Itruvone for major depressive disorder (MDD), showing promise without common side effects of traditional antidepressants. PH80, a pherine product candidate for women's health, is progressing as a potential hormone-free treatment for menopausal hot flashes and premenstrual dysphoric disorder (PMDD). The company has $80.5 million in cash, cash equivalents, and marketable securities as of March 31, 2025, providing a solid financial position to support ongoing development. Research and development expenses increased significantly to $39.4 million for the fiscal year ended March 31, 2025, compared to $20 million the previous year. General and administrative expenses rose to $17.1 million, up from $14.1 million, due to increased headcount and professional fees. The net loss attributable to common shareholders was $51.4 million, a substantial increase from $29.4 million the previous year. The timeline for PALISADE-4 trial results has been modestly delayed due to stringent subject eligibility requirements and operational adjustments. There is uncertainty regarding the FDA's evolving regulatory landscape and its impact on Vistagen's product approvals, despite positive interactions with the agency. Q: Have you noticed any changes in FDA interactions due to leadership turnover, and what caused the timing adjustment for PALISADE-4? A: Shawn Singh, CEO, noted that no FDA reviewers were affected by the recent staff changes, and they are hiring more experts. The timing adjustment for PALISADE-4 was due to stringent subject eligibility requirements and enhanced study execution, which are now showing positive results in screening visits. Q: Will you announce enrollment completion for PALISADE-3, and how long until top-line data is reported? A: Shawn Singh, CEO, confirmed they will announce when the last patient completes the study. It typically takes about six to eight weeks from database lock to report top-line data. Q: Can we expect placebo effects in PALISADE-3 and 4 to be similar to PALISADE-2? A: Shawn Singh, CEO, stated that PALISADE-3 and 4 are designed to replicate PALISADE-2's success by limiting variability and enhancing study execution, although actual results will depend on study outcomes. Q: How are you ensuring proper patient disqualification and scoring consistency in the trials? A: Shawn Singh, CEO, explained that they have an internal secondary eligibility review team to ensure proper execution and scoring, focusing on stringent eligibility criteria and site conduct. Q: Is there alignment with the FDA on the unmet need for social anxiety disorder treatments like Fasedienol? A: Shawn Singh, CEO, mentioned that while specific program discussions were not allowed at the FDA forum, they have Fast Track designation, indicating FDA's recognition of the unmet need and potential benefits of Fasedienol. For the complete transcript of the earnings call, please refer to the full earnings call transcript. This article first appeared on GuruFocus.
Medscape
13-06-2025
- Health
- Medscape
FDA Bucks Advisors to Approve Mitomycin for NMIBC
The FDA has approved mitomycin intravesical solution (Zusduri, UroGen Pharma) for recurrent low-grade intermediate-risk non-muscle invasive bladder cancer. The intravesical mitomycin formulation is meant to be an alternative to the current standard of care for recurrent disease: Transurethral resection of bladder tumor (TURBT). The surgical procedure is usually done under general anesthesia, while Zusduri can be instilled by a catheter in a urologist's office. Treatment is once a week for 6 weeks. The approval came shortly after the FDA's Oncologic Drugs Advisory Committee met to consider the agency's concern that UroGen's approval study — ENVISION — was a single-arm trial with no direct comparison to TURBT. The agency had concerns about comparative safety because TURBT's side effects are generally limited to the day of the procedure, while Zusduri's side effects span the full 6 weeks of administration. There were also concerns about comparative efficacy. One panelist commented that without a randomized trial, 'it's very hard to determine the true benefit of this, and there is toxicity.' Plus, 'this is a $140,000 treatment that might not change how many follow-up TURBTs you need after 3 months.' The panel voted 5 to 4 that the risk/benefit of Zusduri wasn't favorable based on the available data, but in the end, the FDA apparently decided it was. The multicenter ENVISION trial included 240 adults who had recurred after TURBT and who had multiple tumors, a solitary tumor > 3 cm, and/or a recurrence within 1 year of TURBT. Patients in the trial were treated with 75 mg once a week for 6 consecutive weeks, the approved mitomycin dosage. Among 223 evaluable patients, 78% had a complete response, meaning no detectable disease; 12 months after a complete response, 79% of patients remained recurrence free. As for adverse events, 10% or more patients had increased creatinine, increased potassium, dysuria, decreased hemoglobin, increased aspartate aminotransferase, increased alanine aminotransferase, increased eosinophils, decreased lymphocytes, urinary tract infection, decreased neutrophils, and hematuria. Serious adverse events occurred in 12% of patients and included urinary retention (0.8%) and urethral stenosis (0.4%). One patient died of heart failure.
Yahoo
12-06-2025
- Health
- Yahoo
US FDA approves UroGen's bladder cancer drug
By Padmanabhan Ananthan and Kamal Choudhury (Reuters) -The U.S. Food and Drug Administration on Thursday approved UroGen Pharma's drug to treat a type of bladder cancer, providing an alternative treatment as opposed to traditional surgical procedures. U.S.-listed shares of the Israel-based company were up about 50% in afternoon trading. The approval follows a late-stage trial with 223 patients, in which 78% of the participants showed a complete response, meaning all signs of cancer disappeared in response to the treatment. The drug, branded Zusduri, will be the first to get approval to treat a type of bladder cancer that has not spread beyond the inner layers of the organ. The disease primarily affects older population. Scotiabank analyst George Farmer called the decision a "major positive outcome," noting that regulators were "moved by the quality of the clinical trial results, despite lack of solid randomized data". The FDA appreciated the non-surgical treatment option, describing it as "a huge win for patients with recurrent low-grade tumors" as it involves "a simple drug instillation in a doctor's office," Farmer added. Zusduri is a gel-based formulation that keeps chemotherapy in the bladder for a longer duration, aiming to reduce tumor recurrence and avoid repeated surgeries. UroGen said it expects the treatment to be available in the U.S. on or around July 1. Last month, an FDA advisory panel narrowly opposed approval of the drug citing concerns that a single arm study for efficacy might not be enough to indicate sustained benefits. The panel warned that such precedents could be problematic given existing surgical alternatives. The disease, a type of non-muscle invasive bladder cancer, affects about 82,000 people in the U.S. each year, with around 59,000 experiencing a recurrence, according to UroGen. Current standard-of-care treatments include surgical procedures such as transurethral resection of bladder tumor, in which doctors insert a thin tube through the urethra to remove the tumor.
