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14 stories mentioning ASX:CUVUpdated 2d ago

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Asia

Clinuvel Pharmaceuticals Strengthens Supply Chain as Part of Commercial Preparations for North American Vitiligo Market

Clinuvel Pharmaceuticals (ASX:CUV) strengthened its supply chain, scaled up its North American infrastructure, and engaged more than 100 potential new specialty centers as part of commercial preparations for the North American vitiligo market, according to a Thursday filing with the Australian bourse.The company is developing Scenesse as the first systemic, or total body, repigmentation therapy for vitiligo, a condition that causes the loss of skin color.Scenesse adopts a different approach to treatment by targeting melanocortin receptors to stimulate the natural body process that creates pigments to color human skin, unlike JAK inhibitor therapies that suppress the immune system, the company said.Extensive vitiligo, where more than 10% of the total body surface is affected by depigmentation, currently lacks an effective therapy, Clinuvel said, adding that prior studies of Scenesse in combination with the current standard of care showed significantly improved repigmentation compared to just standard of care monotherapy.The company plans to release topline results from its first late-stage study of Scenesse in vitiligo in December.Its shares fell 2% in recent Thursday trade.

ASX:CUV
Asia

Clinuvel Pharmaceuticals Plans to Report Late-Stage Vitiligo Study Topline Results in December

Clinuvel Pharmaceuticals (ASX:CUV) is completing its first late-stage study of Scenesse in vitiligo, a condition that causes the loss of skin color, and expects to report topline results in December, according to a Tuesday filing with the Australian bourse.The trial has enrolled 210 patients globally, and its primary endpoint focuses on the proportion of patients who achieve a total body surface area response of equal to or greater than 50%, per the filing.The late-stage trial will be followed by a registration study that is expected to start in November, with a 12-month recruitment period planned, the company said.Clinuvel shares gained 1% in recent Tuesday trade.

ASX:CUV
Asia

Clinuvel Pharmaceuticals to Move Headquarters to US, Plan Workforce Reduction of Up to 20%

Clinuvel Pharmaceuticals (ASX:CUV) said it will relocate its corporate headquarters to the US from Jan. 1, 2027, as the company restructures operations to support US market expansion and enhance access to capital, according to a Thursday Australian bourse filing.The company will reduce its global workforce by around 10% to 20% and redirect resources toward its US-focused pharmaceutical pipeline, with a particular emphasis on late-stage vitiligo programs, the filing said.The company said the move is driven by stronger US investor demand, deeper specialty pharmaceutical capital markets, and the potential for higher valuation multiples than Australian Securities Exchange-listed peers, the filing added.Clinuvel Pharmaceuticals' shares added 2% in recent Thursday trade.

ASX:CUV
Asia

Australian Shares Open Higher as Oil, Gold Rally on Middle East Tensions; Santos Posts Higher Q2 Total Production

Australian shares opened higher on Thursday as oil prices surged to their highest level in more than a month amid escalating US-Iran tensions and growing concerns over potential supply disruptions linked to threats against shipping routes.Gold prices also climbed to a two-week high on a softer US dollar and renewed safe-haven demand, while investors awaited fresh signals on the Federal Reserve's interest rate path.Overnight, the S&P 500, the Nasdaq Composite, and the Dow Jones Industrial Average fell 0.1%, 0.6%, and 0.01%, respectively.In the macroeconomy, Australia's labor force report is due at 11:30 am Sydney time.In corporate news, Santos (ASX:STO) reported total production of 23.1 million barrels of oil equivalent (MMboe) in the second quarter ended June 30, up on last year's 22.2 MMboe.Clinuvel Pharmaceuticals (ASX:CUV) said it will move its headquarters to the US from Jan. 1, 2027, as part of a restructuring that includes a 10% to 20% global workforce reduction and a shift toward US-focused operations, funding access and commercialization of its late-stage pipeline.Australia's benchmark index rose 0.3% or 29.7 points to close at 8,823 on Wednesday.

ASX 200ASX:CUVASX:STO
Asia

Clinuvel Pharmaceuticals Confirms ADS Start Trading on Nasdaq

Clinuvel Pharmaceuticals (ASX:CUV) confirmed that its American Depositary Share (ADS) began trading on the Nasdaq Stock Market on Monday under the ticker symbol "CUVL," according to a Tuesday Australian bourse filing.This completed the uplift of the firm's previous American Depositary Receipt, "CLVLY," from Level I to Level II.

ASX:CUV
Asia

Clinuvel Pharmaceuticals' ADS to Begin Trading on Nasdaq

Clinuvel Pharmaceuticals' (ASX:CUV) American Depositary Share (ADS) are expected to begin trading on the Nasdaq Stock Market on Monday, New York time, under the ticker symbol CUVL, according to a same-day Australian Securities Exchange filing.The firm's existing over-the-counter American Depositary Receipts (ADRs) will be upgraded from Level I to Level II, as an ADS traded on the Nasdaq. Each Clinuvel ADS will represent one ordinary share of the firm listed on ASX.

ASX:CUV
Asia

Clinuvel Pharmaceuticals' Photoprotection Drug Candidate Receives Health Canada Approval

Clinuvel Pharmaceuticals (ASX:CUV) said its Scenesse implant received a notice of compliance from Health Canada, approving its use for preventing phototoxicity in adults with erythropoietic protoporphyria (EPP), according to a Monday filing with the Australian bourse.EPP is a rare metabolic disorder that causes painful skin reactions and burns upon light exposure, per the filing.The approval enables the company to market the drug in Canada, following earlier authorizations in Europe, the US, and Australia, the filing said.

ASX:CUV
Asia

Clinuvel Pharmaceuticals Extends CEO Philippe Wolgen's Term of Employment

Clinuvel Pharmaceuticals (ASX:CUV) extended the term of employment for Chief Executive Philippe Wolgen through June 2029, according to a Thursday filing with the Australian bourse.The executive's annual fixed base remuneration remains unchanged, while all retention payments have been discontinued, per the filing."For us it was obvious we needed to find a way to retain Philippe to execute a plan aiming to generate further value," said Clinuvel Chair Jeffrey Rosenfeld.The company's shares fell nearly 1% in recent Thursday trade.

ASX:CUV
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.

ASX:CUV

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