Latest news with #Zusduri
Business Insider
a day ago
- Business
- Business Insider
UroGen Pharma price target raised to $16 from $3 at Goldman Sachs
Goldman Sachs analyst Paul Choi raised the firm's price target on UroGen Pharma (URGN) to $16 from $3 and keeps a Neutral rating on the shares following yesterday's approval of Zusduri. The firm cites the stock being bid up (+22% following FDA approval of Zusduri in patients with low-grade intermediate-risk non muscle-invasive bladder cancer, which was surprising to most investor expectations given the negative ODAC advisory committee briefing document and vote that the drug's overall benefit-risk profile was not favorable, the analyst tells investors in a research note. Although the FDA is not obligated to follow the ODAC's recommendation, approvals following negative advisory committee meeting votes, particularly in oncology, are exceedingly rare, the firm adds. Confident Investing Starts Here:
Business Insider
a day ago
- Business
- Business Insider
UroGen Pharma price target raised to $31 from $10 at Oppenheimer
Oppenheimer analyst Leland Gershell raised the firm's price target on UroGen Pharma (URGN) to $31 from $10 and keeps an Outperform rating on the shares following yesterday's approval of Zusduri. The firm says key reveal on this morning's conference call was the $21,500 per-dose list price. Oppenheimer awaits clarity on the approval path for UGN-103, which is needed to extend franchise exclusivity beyond early 2031, but notes management does not expect the potential need for a randomized controlled trial in lieu of the recently-initiated single-arm study to materially alter its financial outlook. The analyst sees $1B in sales over time and would would take advantage of any near-term weakness to buy UroGen shares. Confident Investing Starts Here:
Yahoo
2 days ago
- Business
- Yahoo
AstraZeneca forms an AI deal in China; Third Harmonic advances liquidation plans
This story was originally published on BioPharma Dive. To receive daily news and insights, subscribe to our free daily BioPharma Dive newsletter. Today, a brief rundown of news involving AstraZeneca and Third Harmonic Bio, as well as updates from UCB, UroGen Pharma and Insmed that you may have missed. AstraZeneca on Friday formed a new collaboration with Shijiazhuang City, China-based CSPC Pharmaceutical Group, this time to use the firm's AI technology to discover oral drugs for immunological diseases and other unspecified chronic conditions. CSPC will get $110 million in upfront cash and is eligible to receive up to $5.2 billion in additional development and sales milestones. The alliance builds on a 2024 deal that handed AstraZeneca an oral, lipid-lowering therapy, and deepens the British drugmaker's investment in China. In March, the company committed $2.5 billion to a research and development center in Beijing and formed collaborations with three China-based biotechs. — Ben Fidler Belgian drugmaker UCB said on Thursday that it plans to build a new biologics manufacturing plant in the U.S. UCB is currently running a "feasibility study" to determine the ideal U.S. location for the coming facility, but said in a statement that, once operational, it should create about 300 jobs in biologics manufacturing and have an economic impact of around $5 billion. The company currently employs close to 2,000 workers in the U.S. — Ben Fidler Stockholders of Third Harmonic Bio have voted in support of a liquidation plan expected to see them recoup anywhere from $5.30 to $5.44 for each share they own. The company also said Thursday that it's beginning an auction for an experimental drug for chronic hives that's ready for Phase 2 testing. Proceeds from that auction, as well as sales of any other remaining assets, could boost stockholder payouts beyond current estimates. Third Harmonic raised $185 million in a 2022 initial public offering, but its share price plummeted shortly afterwards following a clinical setback. — Ben Fidler Insmed has raised $750 million in a public stock offering, quickly cashing in on positive Phase 2 study results that pushed its market value past $16 billion. The company on Wednesday sold 7,812,500 shares of its common stock at $96 apiece, raising more than it initially projected. Insmed shares climbed by a third this week after mid-stage results indicated its experimental drug could be superior to an inhalable pulmonary arterial hypertension medicine that's sold by United Therapeutics and could reach almost $2 billion in sales this year. The company expects to start a pair of Phase 3 trials later this year and early next. — Ben Fidler The Food and Drug Administration bypassed the advice of one of its expert panels in approving a drug Urogen Pharma has been developing for a form of bladder cancer. The therapy, a formulation of the chemotherapy mitomycin, was cleared on Thursday and will be sold as Zusduri for a recurrent type of non-muscle invasive bladder cancer. FDA advisers last month determined by a slim, 5-4 margin, that the drug's benefits didn't outweigh the risks of treatment. UroGen shares surged more than 60% since the announcement. — Ben Fidler Sign in to access your portfolio
Medscape
2 days ago
- 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
2 days ago
- 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.
