ASX:CYP

5 stories mentioning ASX:CYPUpdated 1d ago

Every FINWIRES story that references ASX:CYP, newest first.

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

Asia15d ago

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

Asia20d ago

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

Asia22d ago

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

Asia45d ago

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.

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