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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

Asia64d ago

XRF Scientific Completes Acquisition of Combustion Gas Analysis Business

XRF Scientific (ASX:XRF) has completed the acquisition of the combustion gas analysis business from Bruker AXS, according to a Monday Australian bourse filing.The company entered a binding agreement to acquire the combustion gas analysis business for $4 million upfront plus a potential $1 million earnout based on 7% of net revenue over three years, an earlier filing showed.

ASX:XRF

Asia64d ago

Sprintex Raising AU$1.1 Million Via Convertible Notes Issue

Sprintex (ASX:SIX) is raising about AU$1.1 million through the issue of nearly 1.1 million convertible notes at a price of AU$1 each, according to a Monday filing with the Australian bourse.The notes will mature on June 30, 2027, and bear interest at 8% per year, per the filing.Holders of the notes can convert them into Sprintex ordinary shares at any time after June 30 and before their maturity.The company said it plans to use the funds for general working capital purposes, to expand its sales team, and to fulfill customer orders.

ASX:SIX

Asia64d ago

Immutep Says Bank of New York Mellon Increases Stake

Immutep (ASX:IMM) received notice that Bank of New York Mellon and its affiliated entities increased their holdings in the company to 21.11% from 20.08%, according to a Monday filing with the Australian bourse.Bank of New York Mellon and its affiliates now owns over 311 million shares in the company, the filing said.

ASX:IMM

Asia64d ago

PYC Therapeutics' Blinding Eye Disease Treatment Candidate Gets Orphan Drug Designation in Europe

PYC Therapeutics (ASX:PYC) said its VP-001 drug candidate for blinding eye disease Retinitis Pigmentosa type 11 received orphan drug designation from the European Medicines Agency, according to a Monday filing with the Australian bourse.The benefits of the designation include scientific advice and other assistance from the European regulator, lower regulatory fees for the drug candidate's review, and 10 years of exclusivity in the European market once approved.VP-001 previously obtained orphan drug designation and fast track status from the US Food and Drug Administration, PYC Therapeutics said.

ASX:PYC

Asia64d ago

Immutep Says JPMorgan Chase Reduces Stake

Immutep (ASX:IMM) received notice that JPMorgan Chase and its affiliates decreased their holdings in the company to 5.88% from 6.89%, according to a Monday Australian bourse filing.JPMorgan Chase and its affiliates now owns 86.7 million shares in the company, the filing said.

ASX:IMM

Asia64d ago

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

Asia64d ago

ASX Preview: Australian Shares Set to Open Flat on Stalled US-Iran Talks; Origin Energy Reports Lower March Quarter Production

Australian shares are set to open flat on Monday, as oil prices climbed almost 2% following stalled US-Iran peace negotiations and restricted flows through the Strait of Hormuz, tightening global supply and pushing Brent crude above $107 a barrel.On April 25, the S&P 500 and the Nasdaq Composite rose 0.8% and 1.6%, respectively, while the Dow Jones Industrial Average fell 0.2%.In the macroeconomy, investors are eyeing the release of Australia's consumer price index report on Wednesday.In corporate news, Origin Energy (ASX:ORG) reported March quarter production of 164.5 petajoules, down from 167.1 petajoules a year earlier, according to a Monday filing with the Australian bourse.IperionX's (ASX:IPX) titanium powder production operations in Virginia, US, transitioned to an around-the-clock production schedule during the March quarter, advancing from commissioning to continuous operations, according to a Monday filing with the Australian bourse.Australia's benchmark index fell 0.1% or 6.9 points to close at 8,786.50 on April 24.

ASX 200ASX:IPXASX:ORG

Asia64d ago

Cobre Appoints Chief Financial Officer

Cobre (ASX:CBE) has appointed Kaveen Bachoo as chief financial officer, effective April 28, according to a Monday filing with the Australian bourse.Bachoo has over 20 years of finance leadership experience in the mining sector, including executive positions at Glencore.

ASX:CBE

Asia64d ago

BSP Financial Group Appoints Group CIO

BSP Financial Group (ASX:BFL) has appointed Ray Naicker as group chief information officer, subject to regulatory approval, with his start date expected in the third quarter, according to a Monday filing with the Australian bourse.Naicker most recently held the position of group CIO at Nedbank Group, per the filing.Naicker will succeed Richard Nicholls, who will move to a new role leading the implementation of the company's new core banking platform for its Pacific markets, the filing added.

ASX:BFL

Asia64d ago

Forrestania Resources Identifies High-Grade Gold Mineralization at Western Australia Projects

Forrestania Resources (ASX:FRS) intersected high-grade gold mineralization during a recent drill program at its British Hill Gold Project, Mt Palmer Gold Project, and Johnson Range Project in Western Australia, according to a Monday Australian bourse filing.The results were up to 9 meters at 2.6 grams per tonne (g/t) gold from 78 meters at British Hill, including 1 meter at about 12 g/t gold from 86 meters.At Mt Palmer, results were up to 6 meters at 7.6 g/t gold from 3 meters, including 1 meter at 19.7 g/t gold from 5 meters and 1 meter at 10.8 g/t gold from 7 meters.At Johnson Range, results were up to 7 meters at 11.6 g/t gold from 17 meters, including 4 meters at 19.7 g/t gold from 19 meters, with assay results still pending at both Mt Palmer and Johnson Range.Forrestania is currently drilling the Lady Lila and Gibraltar gold projects, it added.

ASX:FRS

Asia64d ago

IperionX Advances Virginia Titanium Powder Production to Continuous Operations

IperionX's (ASX:IPX) titanium powder production operations in Virginia, US, transitioned to an around-the-clock production schedule during the March quarter, advancing from commissioning to continuous operations, according to a Monday filing with the Australian bourse.The company said all HAMR powder production systems are now in ramp-up and are targeting a run-rate production of around 200 tonnes of titanium powder per year by the close of 2026.Commenting on its titanium product manufacturing operations, the company said additional HSPT sintering furnaces are due to be commissioned in the June quarter, which is expected to ease production bottlenecks and speed up customer qualification timelines.IperionX also anticipates expanding its participation in "high-volume titanium markets where customer engagement is strong and domestic US supply is strategically important, including titanium mill products," the company said.It ended the March quarter with $48.2 million in cash and expects to close fiscal year 2026 with cash in the range of $36 million to $40 million.

ASX:IPX

Asia64d ago

Beetaloo Energy Australia Launches AU$5 Million Share Purchase Plan

Beetaloo Energy Australia (ASX:BTL) has launched a share purchase plan (SPP) to raise up to AU$5 million, following a successful AU$66.3 million institutional placement priced at AU$0.28 per share, according to a Monday Australian bourse filing.The SPP is priced at AU$0.28 per new share and will require shareholder approval at the annual general meeting on May 29, as it is issued within 12 months of the previous SPP and must comply with Australian Securities Exchange listing rules, per the filing.Shareholders in Australia and New Zealand who are eligible as of April 9 may participate, with application amounts ranging from a minimum of AU$500 to a maximum of AU$30,000, subject to reduction for any prior SPP participation in May 2025, the filing added.

ASX:BTL

Asia64d ago

Generation Development Group Unit Reports Unauthorized Access to Part of Network, Says Incident Contained

Generation Development Group (ASX:GDG) unit Generation Life experienced a cyber incident involving unauthorized access to part of its network through a third-party service provider, according to a Monday filing with the Australian bourse.The subsidiary quickly detected and "immediately contained" the incident, with no impact on its core systems, no evidence of unauthorized transactions so far, and "minimal disruption" to operations, per the filing.Generation Life has launched an investigation into the incident.

ASX:GDG

Asia64d ago

Symal Group Appoints CFO

Symal Group (ASX:SYL) has appointed Scott McQueen as chief financial officer, effective May 4, according to a Monday filing with the Australian bourse.McQueen most recently served as executive vice president and chief financial officer of OceanaGold, per the filing.McQueen will succeed David Gill, who has been serving as interim chief financial officer and will ensure a smooth transition before returning to his previous role, the filing added.

ASX:SYL

Asia64d ago

Origin Energy Reports Lower March Quarter Production

Origin Energy (ASX:ORG) reported March quarter production of 164.5 petajoules, down from 167.1 petajoules a year earlier, according to a Monday filing with the Australian bourse.The company reported commodity revenue of AU$1.86 billion for the quarter, down from AU$ 2.31 billion a year ago, per the filing.Origin Energy also said its electricity sales volume increased 4% from a year earlier amid "strong growth" in business volumes driven largely by the data-center sector.

ASX:ORG

Asia64d ago

New Hope Says JPMorgan Chase Ceases to be a Substantial Shareholder

New Hope (ASX:NHC) received notice that JPMorgan Chase and its affiliates are no longer substantial holders of the company from April 22, according to a Monday filing with the Australian bourse.JPMorgan Chase and its affiliates became a substantial holder of the company on April 15, with a total voting power of 5.88%, an earlier filing showed.

ASX:NHC

Asia64d ago

Zip Says JPMorgan Chase Increases Stake

Zip (ASX:ZIP) received notice that JPMorgan Chase and its affiliates increased their holdings in the company to 7.42% from 6.27%, according to a Monday Australian bourse filing.JPMorgan Chase and its affiliates now own 93.2 million shares in the company, the filing said.

ASX:ZIP

Asia64d ago

Resolute Mining Says BlackRock Group Reduces Stake

Resolute Mining (ASX:RSG) received notice that BlackRock Group and its subsidiaries decreased their holdings in the company to 5.08% from 6.2%, according to a Monday filing with the Australian bourse.BlackRock Group now owns 108.7 million shares in the company, the filing said.

ASX:RSG

Asia64d ago

Alkane Resources' March Quarter Production Beat Driven by Higher-Than-Modeled Head Grades, Euroz Hartleys Says

Alkane Resources (ASX:ALK) delivered a material production beat in the March quarter, driven mainly by higher-than-modeled head grades across its operations, a small beat on throughput at its Tomingley gold project in New South Wales, as well as higher recoveries at the Bjorkdal gold mine in Sweden, Euroz Hartleys said in an April 24 note.The company reported consolidated production of abut 45,800 ounces of gold equivalent, an early group record, Euroz Hartleys said.The equity research firm noted that Alkane Resources remains debt-free with the exception of AU$20 million in equipment financing, while the execution of an undrawn AU$110 million revolving facility and a AU$40 million contingent instrument facility provides liquidity to act fast on emerging opportunities.The company is on track to surpass the midpoint of fiscal 2026 guidance of 160,000 to 175,000 ounces of gold equivalent production at all-in sustaining costs of AU$2,600 to AU$2,900 per ounce. However, Euroz Hartleys expects softer quarter-over-quarter production in the three months through June due to lower head grades across the group.Euroz Hartleys kept a buy rating on the company while adjusting its price target to AU$2.53 from AU$2.50.

ASX:ALK

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