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ASX:CYP

6 stories mentioning ASX:CYPUpdated 57d ago

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Asia

Cynata Therapeutics' Failure to Meet Main Endpoints in Two Trials is 'Highly Disappointing Outcome,' Euroz Hartleys Says

Cynata Therapeutics (ASX:CYP) failed to meet the primary endpoints of a phase 3 osteoarthritis trial and a phase 2 graft-versus-host disease study, representing "a highly disappointing outcome," Euroz Hartleys said in a Friday report.The phase 2 results, which showed a lack of efficacy across both the primary and secondary endpoints, are surprising as the earlier phase 1 graft-versus-host disease trial generated encouraging results, the investment firm said.Following Cynata's decision to discontinue the phase 2 study, the equity research firm considers the company's graft-versus-host disease program to be effectively discontinued in its current form.Meanwhile, the phase 3 osteoarthritis trial appears to have been impacted by a stronger-than-anticipated placebo response, as the 48.1% response rate to the patient-acceptable symptom state pain threshold in the control group was much higher than the 35% rate assumed in the study's design, Euroz Hartleys said.It placed its forecasts, recommendation, and price target on Cynata under review.Shares of Cynata Therapeutics plunged 92% in recent Friday trade.

ASX:CYP
Asia

Cynata Therapeutics Terminates Acute Graft Versus Host Disease Trial After Disappointing Phase 2 Results

Cynata Therapeutics (ASX:CYP) decided to terminate a phase 2 clinical trial of CYP-001 in patients with high-risk acute graft versus host disease after primary evaluation results failed to meet expectations, according to a Wednesday filing with the Australian bourse.The results showed no significant differences between the active and control groups in the primary endpoint of overall response rate or in the trial's key secondary endpoints, per the filing.The phase 1 results for CYP-001 were "very positive," but the latest outcome fell "well short of what we were hoping for," said Cynata CEO Kilian Kelly.The company will remain under voluntary suspension from ASX trading pending the results of a phase 3 trial of CYP-004 in patients with knee osteoarthritis, which are expected to be released within the week.

ASX:CYP
Asia

Cynata Therapeutics Gets Positive European Opinion for Acute Graft Versus Host Disease Trial

Cynata Therapeutics (ASX:CYP) received a positive opinion from the European Medicines Agency's Paediatric Committee for a plan to develop its CYP-001 product candidate for the treatment of acute graft versus host disease, according to a Wednesday filing with the Australian bourse.The committee has agreed to the company's proposed pediatric investigation plan, which is a requirement to start a phase 3 clinical trial in the European Union.CYP-001 is designed for intravenous use to modulate the immune system and improve response rates and survival outcomes in acute graft versus host disease, an often life-threatening complication of bone marrow transplantation and similar procedures, per the filing.Cynata Therapeutics plans to launch a phase 3 clinical trial first in adults, and once the primary analysis of the adult trial is complete, it plans to start a pediatric clinical trial.

ASX:CYP
Asia

Cynata Says WHO Selects Generic Name for Cymerus Mesenchymal Stem Cells

Cynata Therapeutics (ASX:CYP) said the World Health Organization (WHO) selected pixenstrocel as the proposed generic name for Cymerus induced pluripotent stem cell (iPSC)-derived mesenchymal stem cells (MSC), according to a Friday Australian bourse filing.The proposed generic name is expected to be published in 2027 in the WHO Drug Information List 136 of Proposed International Nonproprietary Name, the company said. The final confirmation is expected around May 2027.The generic name represents the active agent in iPSC-derived MSC products.

ASX:CYP
Asia

Cynata Therapeutics Says Results for Phase Three Drug Candidate Study for Knee Osteoarthritis Expected in June; Shares Rise 6%

Cynata Therapeutics (ASX:CYP) said the results for the Australian phase three SCUlpTOR trial of its CYP-004 drug candidate in patients with osteoarthritis of the knee are expected in June, according to a Wednesday Australian bourse filing.The trial enrolled a total of 321 patients, who were randomized to receive either CYP-004 or placebo, with co-primary endpoints assessing change in pain and cartilage thickness, the filing said. The study database was locked, and the process of data analysis is ongoing.The results for the company's phase two trial of its CYP-001 drug candidate in adults with acute graft versus host disease are anticipated in late June or early July.A total of 65 participants were enrolled across clinical centers in Australia, the US, and Europe, randomized to receive either steroids plus CYP-001 or steroids plus placebo. The primary endpoint is overall response rate at Day 28.The company's shares rose nearly 6% in recent trading on Wednesday.

ASX:CYP
Asia

Cynata Therapeutics Secures Commitments for AU$1.5 Million Share Placement; Shares Fall 4%

Cynata Therapeutics (ASX:CYP) received firm commitments for a placement of about 6 million ordinary shares priced at AU$0.25 each for gross proceeds of about AU$1.5 million, according to a Monday filing with the Australian bourse.The company plans to use the proceeds for potential commercial partnerships following the release of results for its osteoarthritis and acute graft-versus-host disease clinical trials expected in May and June, respectively.The "strategically sized" placement allows the company to bolster its cash runway beyond the readout of the results while minimizing dilution, it said.Cynata Therapeutics shares fell 4% in recent Monday trade.

ASX:CYP

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