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Asia

Dimerix Signs Exclusive License Agreement for DMX-200 in Greater China, South Korea, Southeast Asia, Shares Surge 18%

Dimerix (ASX:DXB) entered into an exclusive license agreement with Everest Medicines for the commercialization of its phase 3 drug candidate DMX-200 in Greater China, South Korea, and certain Southeast Asian countries, according to a Tuesday Australian bourse filing.The company said it is eligible to receive upfront and potential success-based milestone payments of up to about AU$481 million, comprising an upfront payment of about AU$14.1 million, up to about AU$467 million in potential milestone payments, and tiered royalties on net sales.DMX-200 is being developed for the treatment of focal segmental glomerulosclerosis (FSGS), a rare kidney disease, with the agreement covering the Chinese mainland, Hong Kong, Macao, and Taiwan, South Korea, Singapore, Malaysia, Thailand, Indonesia, Vietnam, and the Philippines, the filing added.Across five transactions in total, Dimerix said it may be eligible to receive up to about AU$1.9 billion in aggregate upfront and potential milestone payments plus additional royalties on net sales, it added.The company's shares surged 18% in recent Tuesday trade

ASX:DXB
Asia

Dimerix's Potential Non-Dilutive Funding May Lead to Ongoing Phase Three Trial Being Fully Funded, Euroz Hartleys Says

Dimerix's (ASX:DXB) potential access to $50 million in non-dilutive funding could lead to it having up to AU$96.6 million in combined cash and non-dilutive funding available, which would be sufficient to fully fund the ongoing phase three trial and dispel any near-term capital raising risk, Euroz Hartleys said in a note on Thursday.It indicated this would not be traditional debt funding, but is rather repayable from future milestone payments and/or royalties.The commercial opportunity remains significant and unchanged, Euroz Hartleys added.The investment firm maintained its speculative buy rating on Dimerix with a price target of AU$1.35 per share.

ASX:DXB
Asia

Dimerix Says Phase 3 Clinical Trial Data Review Shows Over 90% Statistical Power to Detect Proteinuria Treatment Effect; Shares Reach Two-Year Low

Dimerix (ASX:DXB) said an external statistical blinded review of the data from the ACTION3 phase 3 clinical trial, evaluating its DMX-200 drug candidate in patients with focal segmental glomerulosclerosis, confirmed that the study had an over 90% statistical power to detect the treatment effect for the proteinuria primary endpoint, according to a Tuesday Australian bourse filing.The US Food and Drug Administration (FDA) previously confirmed that the proposed primary endpoint of percent reduction in proteinuria compared to placebo could support traditional approval of its DMX-200 drug candidate via the 505(b)(1) pathway, should the findings of the study be positive.Its shares fell 35% in recent trading on Tuesday, reaching a two-year low.

ASX:DXB
Asia

Dimerix Poised to Benefit From US FDA's Approval of Travere Therapeutics' Kidney Disorder Drug, Euroz Hartleys Says

Dimerix (ASX:DXB) is poised to benefit from the US Food and Drug Administration's recent approval of Travere Therapeutics' sparsentan drug to treat focal segmental glomerulosclerosis, a rare kidney disorder Dimerix is also working on, Euroz Hartleys said in a Tuesday note."This outcome has positive implications for [Dimerix] and its lead asset, DMX-200, across both the regulatory pathway and potential future commercialization," the equity research firm said.It noted that sparsentan marks the first full FDA approval for the kidney disease based on a reduction in proteinuria, or the levels of protein in urine, creating a clear precedent for its use as a surrogate endpoint. The development meaningfully de-risks the FDA's acceptance of proteinuria for traditional and accelerated approvals for DMX-200 and highlights the US regulator's flexibility in focal segmental glomerulosclerosis, Euroz Hartleys said."Commercially, Travere is likely to help establish the [focal segmental glomerulosclerosis] market, driving awareness, diagnosis, and reimbursement, which should support a faster uptake of DMX-200," the equity research firm said.It added that sparsentan and DMX-200 are complementary, not competitive, and are expected to be used simultaneously in clinical practice based on the progressive nature of the disease and feedback from clinicians.Euroz Hartleys maintained its speculative buy recommendation and AU$1.65 price target on Dimerix.The company's shares advanced 11% in recent Tuesday trading.

ASX:DXB