ILA completes Galidesivir anti-viral drug acquisition
Drug has a broad spectrum across viruses
FDA submissions and a meeting request anticipated this quarter
Special Report: Island Pharmaceuticals has finalised its acquisition of the Galidesivir antiviral program from BioCryst Pharmaceuticals after completing due diligence ahead of schedule.
Galidesivir is a clinical-stage antiviral molecule with a broad spectrum of activity in more than 20 RNA viruses, including high-priority threats such as Ebola, Marburg, MERS, Zika and Yellow fever.
Notably, these are all viruses with significant unmet medical needs that may contribute to national security threats.
Island Pharmaceuticals (ASX:ILA) is confident in the drug's potential, thanks to its robust development history and more than US$70m R&D spend from the US government to date.
The company is now focused on fast tracking regulatory initiatives, including potentially leveraging the FDA's Animal Rule, which allows for drug approvals in indications based on animal efficacy data, when human trials are unethical or not feasible, provided safety is shown in humans and the disease is well modelled in animals.
Drug dossier planned to FDA this quarter
Island intends to submit documentation on the Galidesivir program to the FDA in the short term and seek a meeting with the regulator, possibly during the December quarter.
Pending positive feedback, this may allow for the commencement of an animal study before the end of the year.
'We are very pleased to have completed this transaction with BioCryst ahead of schedule,' CEO and managing director Dr David Foster said.
'Following the asset purchase agreement and a final review of the program, we have gained considerable confidence in Galidesivir and the potential to fast track a New Drug Application and the opportunity for a Priority Review Voucher.
'Work will now focus on collating a relevant data package to submit to the FDA, alongside a meeting request to discuss Galidesivir's eligibility under the Animal Rule.
'We expect to submit this dossier this quarter, allowing for a potential meeting next quarter, prior to initiating an animal study in Marburg shortly thereafter.'
This article was developed in collaboration with Island Pharmaceuticals, a Stockhead advertiser at the time of publishing.
This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
The Australian
2 hours ago
- The Australian
India defies Donald Trump on Russian oil despite tariff threats
India is digging in its heels and resisting pressure from the US to curb purchases of Russian oil, despite threats by President Trump to retaliate by imposing higher tariffs on India. Last week, Trump said he would place a 25 per cent tariff on Indian imports to the US in retaliation for India's large-scale purchases of cheap Russian oil. Then, on Monday, the president said he would be 'substantially raising' tariffs on Indian goods — on top of the 25 per cent duty — because of the 'massive amounts' of Russian oil that India buys. India has nonetheless refused to back down and has suggested that it intends to continue to buy Russian oil. Political experts said that Indian Prime Minister Narendra Modi is calculating that Trump will decide that ties between the two countries are ultimately too critical to jeopardise in a trade spat. Many Indian experts believe that Trump is spotlighting the issue to gain short-term leverage in ongoing trade negotiations with New Delhi — and that he will drop it once a deal is signed. In recent years, the US has grudgingly accepted India's close ties with Russia, despite occasional protests, because New Delhi is considered a crucial partner in countering China's growing power. 'The view is that this is not going to affect the overall relationship, and that we don't have to kowtow,' said Sreeram Chaulia, dean at O.P. Jindal Global University's School of International Affairs in Sonipat, India. India has taken advantage of discounted oil prices from Russia following Moscow's invasion of Ukraine. By late 2024, India accounted for over one-third of Russia's oil exports, second only to China at nearly 50 per cent, according to the Observer Research Foundation, an Indian think tank. Before the war, India bought most of its oil from Gulf countries. New Delhi has repeatedly defended its purchases of Russian oil as necessary to support its economy and keep energy prices steady for its huge population. In a Monday statement, India's Foreign Ministry said that its imports of Russian oil ramped up only after its traditional supplies were diverted to European countries during the Ukraine war. The ministry also accused the US and the EU of operating a double standard — continuing to trade with Russia while penalising others for doing the same. 'The targeting of India is unjustified and unreasonable,' it added. When facing pressure from bigger powers, India has also historically defended its autonomy in foreign policy, Chaulia said. That independent streak surprised many when New Delhi remained neutral on Russia's invasion of Ukraine despite a volley of criticism. Over the weekend, Modi vigorously defended India's right to prioritise its own economic wellbeing at a time of global uncertainty. 'Today, the world economy is going through many apprehensions, there is an atmosphere of instability,' Modi said in a speech during a Saturday rally in the northern Indian state of Uttar Pradesh. 'In such a situation, the countries of the world are focusing on their respective interests.' He urged Indians to boost the economy by buying and selling only homegrown products 'made by the sweat of an Indian.' The White House has rapidly ratcheted up pressure on India as Trump looks for ways to push President Vladimir Putin toward ending the Ukraine war. Trump has vowed to impose tariffs on countries that do business with Moscow, and threatened India with a 'penalty' for continuing to buy Russian goods. Stephen Miller, deputy chief of staff at the White House and a top aide to Trump, accused India on Sunday of taking advantage of the US on trade and financing the war by buying Russian oil. He also took aim at India's protectionist policies. 'India portrays itself as being one of our closest friends in the world, but they don't accept our products. They impose massive tariffs on us,' Miller said on Fox News. A sticking point in negotiations is the US's push to open India's agricultural and dairy markets to foreign products, a politically sensitive issue for Modi. But India could pacify Trump in other ways, experts said, such as agreeing to big investments in the US that will allow him to claim a win. Wall Street Journal The Wall Street Journal Congress could limit the mutually assured political destruction as partisans move to redistrict more than once a decade. The Wall Street Journal The White House is preparing to step up pressure against big banks over perceived discrimination against conservatives and crypto companies.
West Australian
6 hours ago
- West Australian
Diggers & Dealers 2026: Greatland Gold boss Shaun Day denies talking disclosures with ASIC
Greatland Resources boss Shaun Day says he 'respects' the market's visceral reaction to a recent production downgrade, but denies speaking with the corporate cop about disclosures. The gold miner's share price had been riding as high as $7.30 on a strong Australian Securities Exchange debut made at the end of June that had shares on offer at $6.60. But a cut to the Telfer gold miner's expected production for the 2026 financial year seemingly spooked investors and wiped nearly 24 per cent off its share price, which fell from $6.89 to $5.24 and is yet to properly recover. The guidance downgrade, made within a short window of Greatland affirming the April numbers in its prospectus for an ASX listing in May, reportedly attracted the attention of the corporate cop. The Australian Financial Review's Street Talk column reported that the Australian Securities and Investments Commission had been asking questions about what the company and its advisers knew at the time of the float. Taking questions from media at Diggers and Dealers on Tuesday about whether ASIC had spoken to the Greatland, Mr Day said:'We weren't contacted to comment on that. If we had been, we would have said no.' An ASIC spokeswoman declined to comment when asked by The West Australian there had been any kind of engagement with Greatland. Asked more about the downgrade and the market's reaction, Mr Day kept things brief. 'I respect the market, but what we what we focused o was just making sure that we gave a clear update, and we're really confident that we can achieve that update.' Production for the 2026 financial year was dropped from a 300,000 ounce to 340,000 ounce band to between 260,000oz and 310,000oz
AU Financial Review
7 hours ago
- AU Financial Review
Pinnacle founder laments ‘tragedy' of funds who can't sell themselves
Pinnacle founder and managing director Ian Macoun says fund managers are growing to appreciate how crucial sales and distribution is for their business after his company delivered another record profit. The $5.2 billion ASX-listed investment firm said on Tuesday that assets under management had topped $179.4 million as the money managers that it takes minority stakes raised $23.1 billon of new funds.
