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ASX:CUV

6 stories mentioning ASX:CUVUpdated 4m ago

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Asia

Clinuvel Pharmaceuticals Advances US Listing Plan With SEC Filing for Nasdaq ADS Upgrade

Clinuvel Pharmaceuticals (ASX:CUV) filed a Form 20-F registration statement with the US Securities and Exchange Commission (SEC), paving the way to upgrade its American depositary receipt (ADR) program to Level II from Level I and list American depositary shares (ADS) on the Nasdaq Stock Market once the filing is declared effective, according to a Tuesday filing with the Australian bourse.The move is intended to enhance visibility and liquidity in major capital markets, driven by increasing investor interest in its vitiligo treatment development program, per the filing.The company currently trades over the counter in the US under the ADR ticker "CLVLY" and has stated that its ADS is expected to be listed on Nasdaq under the ticker "CUVL," with no intention to raise capital or issue new shares as part of the upgraded ADR program, the filing said.The company said that the listing process remains subject to SEC review and Nasdaq approval, with no assurance of completion or timing, the filing added.The company's shares gained about 1% in recent Tuesday trade.

ASX:CUV
Asia

Clinuvel Pharmaceuticals Advances Nasdaq ADR Uplisting With US SEC Review Underway

Clinuvel Pharmaceuticals (ASX:CUV) said it is working with the US Securities and Exchange Commission (SEC) on its draft registration statement as it advances plans to uplist its American depositary receipt (ADR) program on the Nasdaq stock market, according to a Tuesday filing with the Australian bourse.The company received four rounds of US SEC comments and expects the review process to be completed before the end of the fiscal year, after which it plans to upgrade its ADR program to level two from level one and list on Nasdaq under the revised ticker "CUVL," per the filing.The company stated that the uplisting is still subject to regulatory approval and Nasdaq requirements, and that its success and timing are not guaranteed, the filing added.

ASX:CUV
Asia

Clinuvel Pharmaceuticals Says FDA Removes Post-Authorization Requirement for Implant

Clinuvel Pharmaceuticals (ASX:CUV) said the US Food and Drug Administration (FDA) removed a requirement for a post-authorization phase one study on cardiac repolarization in relation to its Scenesse implant upon reviewing its long-term safety profile, according to a Monday filing with the Australian bourse.Scenesse is used to treat patients with erythropoietic protoporphyria, a disease that causes intolerance to light.The FDA concluded that the study was no longer needed since it would not yield valuable safety information, the filing said.

ASX:CUV
Asia

Clinuvel Unlikely to Seek Scenesse's Vitiligo Approval Before Phase 3 Completion, Says Jefferies

Clinuvel Pharmaceuticals (ASX:CUV) is unlikely to seek regulatory approval for Scenesse in vitiligo until the Phase 3 CUV105 and CUV107 clinical trials are completed, according to a Friday Jefferies note.The company said on Friday that the European Medicines Agency (EMA) has proposed evaluating the company's Scenesse drug for the treatment of systemic vitiligo based on a "totality of evidence" regulatory approach.Jefferies said that the EMA's decision is a positive for the company because of the high unmet medical need for Vitiligo treatment.The investment firm has pushed back its revenue expectations from Scenesse in vitiligo, which is now expected to begin in the second half of fiscal 2029 rather than fiscal 2028.Jefferies kept a buy rating on Clinuvel and cut its price target to AU$39.20 from AU$40.50.

ASX:CUV
Asia

Clinuvel Pharmaceuticals Set for Phase 3 Vitiligo Study After Final Advice From European Medicines Agency

Clinuvel Pharmaceuticals (ASX:CUV) said the European Medicines Agency (EMA) has proposed evaluating the company's Scenesse drug for the treatment of systemic vitiligo based on a "totality of evidence" regulatory approach, according to a Friday filing with the Australian bourse.Vitiligo is a chronic skin condition that results in patches of skin turning white.Following the EMA's final advice on the design of a planned phase 3 study of Scenesse, Clinuvel said the proportion of patients who achieve 50% or more repigmentation of the total body, excluding hands and feet, will be the study's primary endpoint.Photographic evidence of change from baseline will be used to assess primary and secondary endpoints in the study, which is scheduled to start in the second half of this year.The EMA also advised that patients with darker skin would benefit from systemic treatment first, as the visibility of the disease is more pronounced in such patient groups, Clinuvel said.

ASX:CUV
Asia

Clinuvel Pharmaceuticals Says JPMorgan Increases Stake

Clinuvel Pharmaceuticals (ASX:CUV) said JPMorgan Chase & Co. and its affiliates have increased their stake in the company on April 8 to 7.02% or 3.5 million shares from 5.57% or 2.8 million shares, according to a Monday Australian bourse filing.

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