Latest news with #Mesoblast
Sky News AU
28-05-2025
- Business
- Sky News AU
ASX 200 approaches all-time high as Wall Street booms on positive news on United States-European Union trade discussions
The ASX 200 has surged on Wednesday after investors on Wall Street were buoyed by the positive news of the United States and the European Union coming to a trade deal. The index is about one per cent off its February high point after crashing more than 14 per cent since Donald Trump started executing his trade policies. It is up 0.5 per cent in the first 25 minutes of trading with regenerative medicine company Mesoblast up 4.6 per cent, gaming manufacturer Light & Wonder rising 3.4 per cent and Corporate Travel Management jumping 3.1 per cent. Major indexes on Wall Street surged on Tuesday in the first day of trading since Trump agreed to delay the US-EU tariff deadline until July 9. The US President said there was progress with the discussions and commended the EU getting in contact to 'quickly establish meeting dates'. 'I have just been informed that the EU has called to quickly establish meeting dates. This is a positive event, and I hope that they will,' Trump wrote on Truth Social. The jump also followed a report from non-profit research organisation Conference Board that indicated renewed consumer optimism in the US. The Dow Jones jumped 1.8 per cent, the S&P 500 surged 2.1 per cent and the Nasdaq soared 2.5 per cent on Tuesday. European indexes also surged with London's FTSE 250 Index jumping 1.1 per cent, Germany's DAX rising 0.8 per cent and the STOXX Europe 600 up 0.3 per cent. However, not all markets are in the green as New Zealand's NZX 50 Index has sunk 0.7 per cent since opening on Wednesday. Japan's Nikkei 225 is up 0.8 per cent on Wednesday and South Korea's KOSPI 200 has risen 1.1 per cent.
News.com.au
19-05-2025
- Business
- News.com.au
Dr Boreham's Crucible: Can this biotech emerge from Mesoblast's shadow and ride ‘stem cells 2.0'?
Investors now have three ASX-listed stem cell therapy companies to choose from – and we can thank sector big daddy Mesoblast for inspiring the third. Hitherto a developer of peptide-based drugs for neuroscientific conditions, NeuroScientific Biopharmaceuticals (ASX:NSB) s is in the process of acquiring Stemsmart, the stem-cell portfolio of the public unlisted Western Australia company Isopogen WA Ltd. In December, Mesoblast won US Food and Drug Administration (FDA) approval for Ryoncil, its stem cell treatment for paediatric graft versus host disease (GvHD). Neuroscientific describes this approval as 'momentous', as it was the first FDA assent for a therapy derived from donor bone marrow. Both the Ryoncil and Stemsmart therapies are based on mesenchymal stromal cells (MSCs). (The other company is Cynata, also working with mesenchymal stem cells but induced pluripotent ones called IPSCs.) 'Stem cell therapy is a cornerstone of modern medicine,' the company says. 'Stem cells have the unique ability to develop into different cell types in the body and are often hailed as the body's master cells.' Neuroscientific's initial focus is on the common auto-immune condition Crohn's disease. That makes sense, given Isopogen underwent a phase II trial for that condition that deemed the therapy to be 'potent, efficacious and safe.' About Neuroscientific To date, the Perth-based Neuroscientific has been developing peptide-based drugs for several neuro-degenerative conditions with high unmet medical demand. Neuroscientific was founded by former equities analyst Dr Anton Uvarov, on the back of the Emtinb peptide. This asset was developed by the University of Copenhagen and then acquired by the University of Tasmania. The company listed on July 25, 2018, having raised $6 million at 20 cents apiece. At the time, Emtinb was most advanced for Alzheimer's disease, but recently the board decided to focus on glaucoma. Before founding the company, Uvarov had a two-year stint a biotech analyst at Citigroup. He has also been on the board of several ASX listed biotechnology companies and non-biotechs, including Blinklab, Actinogen, Sun Biomedical (now Dimerix), Acuvax and Imugene. The company's portfolio includes Emtinb (initially targeting glaucoma) and Emtinac, Emtinan, and Emtinbn 'which have demonstrated similar therapeutic potential as Emtinb'. As part of the Stemsmart purchase, current Isopogen directors Robert McKenzie and Paul Fry will join the board. The force behind Stemsmart, Dr Marian Sturm joins as chief scientific adviser. An inaugural member of the local Therapeutical Goods Administration (TGA) advisory committee on biologics – among other things – Sturm is a leading expert in cell therapies in Australia (particularly in stem cell therapies). Peace deal: now for Ukraine and Gaza Uvarov says he had known about Sturm and her work for some time, given they both hail from Perth medical circles. In 2021, Perth's East Metropolitan Health Service (EMHS) launched a legal action over ownership of the stem cell intellectual property on which Isopogen was founded. Sturm was a long-time employee of EMHS's Royal Perth Hospital. The technology was developed in 2007 and registered in Sturm's and Isopogen's names. Neuroscientific swooped after Sturm and EMHS last year reached a 'mutually acceptable' confidential settlement. A joint statement said the peace deal provided the basis for an 'ongoing relationship' – so let's call it friends with benefits. Investors had been excited about Isopogen's prospects as a 'mini Mesoblast' – and an ASX listing seemed on the cards. But the prolonged and increasingly complex legal spat put paid to that. 'As soon as it was resolved we jumped on the opportunity,' Uvarov says. About Stemsmart Neuroscientific describes the Stemsmart cells as having 'potent anti-inflammatory and immune-modulatory properties'. This creates a 'multifaceted and complex interaction' with the body's immune system, dampening inflammation, moderating immune responses and encouraging tissue repair. 'It's quite an advanced program,' Uvarov says. 'Overall, more than 200 patients have gone through this therapy, so we know it's quite safe and active.' Derived from adult human donor marrow, mesenchymal stem cells (MSCs) are grown in a culture and then revved up with the patented cell manufacturing process. To date, patients have received Stemsmart on compassionate grounds for a variety of serious and life-threatening clinical conditions, with 'multiple strong positive clinical responses'. Crohn's disease Isopogen undertook a phase II trial of 18 patients with refractory Crohn's disease. The results were 'promising', with most patients experiencing clinical improvement and even clinical remission. The company's attention has turned to a small, 12-person, phase I trial for fistulating Crohn's disease under a TGA special access program. A severe complication of Crohn's disease, fistulas are abnormal tracts connecting the intestine to another organ or to the external surface of the body. Fistulating Crohn's disease is challenging to treat and sustained healing with standard therapies has been limited. 'Nothing disease modifying exists now, so it's a massive market,' Uvarov says. 'If we do a phase I trial, the next step would be to move to a phase II/III study as a potential step towards a regulatory trial.' The study will aim for a closure of more than 50% of the fistula openings, or a decrease in fistula discharge of more than 50% in at least four patients. Addressable markets Over the next 24 months, the company envisages expanding its stem cells trial from Crohn's disease, to other inflammatory and immune-based disorders including lung disorders and acute kidney transplant rejection. Uvarov says Isopogen has 140 doses frozen and ready for use in further clinical studies. Several patients have received the therapy on compassionate grounds, including both children and adult with graft versus host disease (GvHD). The company cites a US$13.8 billion addressable market for Crohn's disease and a US$640 million opportunity for GvHD by 2026. There's a projected US$7.2 billion market for organ transplant immune-suppressants by 2030 - the majority for renal – and a forecast US$33 billion market for lung disorders by 2023. Legacy program lives on And let's not forget about Neuroscientific's pre-clinical legacy program. Emtinb targets Alzheimer's disease and advanced glaucoma. In 2023, Neuroscientific decided development should focus on the latter as a therapy administered locally, via intravitreal injection. Uvarov says the company moved to stem cells because the legacy program was not moving as fast as investors would have liked. And an Alzheimer's program would have required a much bigger trial. In June last year, the company met with the US Food and Drug Administration for a pre-investigational drug approval powwow, with the agency guiding on the pre-clinical studies required to progress Emtinb to a first-in-human trial. Based on this counsel, the company plans a pharmaco-kinetics rabbit study, by which Emtinb is intravitreally administered. In parallel, the company plans a 13-week study of 'ocular tolerance, systemic toxicity and pharmacokinetic following repeated intravitreal administration in pigmented rabbits'. Given there's shortage of animals for medical research as suppliers withdraw from the market, it's a case of when the company can obtain the specially bred bunnies. 'It's harder to do animal studies because of regulatory pressure,' Uvarov says. 'Regulators want to move from pre-clinical animal studies to cell-based research using animal organoids.' Organoids are three-dimensional structures that mimic the architecture and function of human organs and tissues. Finances and performance Neuroscientific must obtain the separate assent from all Isopogen holders, although Sturm is by far the biggest holder. The company has snared 51.4% of Isopogen holders and is confident of the remaining minority holders coming on board. Under the scrip deal, Isopogen holders receive 85,714,286 shares, deemed to be worth 3.5 cents. At today's values the deal is worth a tad over $4 million. Isopogen holders also receive 57,142,857 performance shares convertible to ordinary shares, subject to the aforementioned milestones. These must be achieved within three years of a shareholder meeting to approve the performance shares, scheduled for mid-June. All the issued shares will be escrowed for 12 months. Currently underway, the $3.5 million capital raising is by way of a placement of 100 million shares, at 3.5 cents a share. Post-raising, the company will have cash of $7.5 million. Of the funds raised, just over $2 million is expected to be used for Stemsmart-related stuff. A further $835,000 is earmarked for the Emtinb program. Over the last 12 months Neuroscientific shares have ranged between 3.3 cents (early January this year) and 5.5 cents (early May 2024). The stock peaked at 50 cents in mid-September 2021. The tightly held register is dominated by the Clough family office, of Clough Engineering fame. Clients of Westar Capital account for much of the remainder. Dr Boreham's diagnosis Uvarov says Isopogen's stem cells could be 'even more potent' than Mesoblast's cells, although they work more by way of immune modulation rather than regeneration. 'Our cells … have more growth factors they excrete when you culture them,' he says. He says the FDA's approval of Mesoblast's Ryoncil 'paves the way for renewed enthusiasm and global investment in clinical research of MSC therapies'. It's not just the company that's hyper-enthused: the International Society for Cell and Gene Therapy dubs the Ryoncil approval as 'a pivotal moment in the history of medicine shaping the future of therapeutics'. Uvarov adds that after years of being untrendy, stem cells again were the hot topic at JP Morgan's global biotech gabfest in January. 'We are at the beginning of stem cells 2.0,' he says. Given Mesoblast is worth around $2.3 billion and Neuroscientific is valued at not much more than its cash backing, Neuroscientific will be walking in the shadow of a giant. 'When Mesoblast was at a similar stage they had a market cap of several hundred million dollars,' Uvarov says. How soon the company emerges from this penumbra depends on the pace of its trials and – ultimately – its first port of call of initial TGA approval. 'It's complex and tricky so we are taking it slow,' Uvarov says. At a glance: ASX Code: NSB Share price: 4.8 cents Shares on issue: 144,604,870 * * Increases to 333,176,299 shares post-Isopogen WA acquisition and placement Market cap: $6.9 million Chief executive officer: Dr Anton Uvarov (founder) Board: Chris Ntoumenopoulos (chair), Dr Tony Keating, Clarke Barlow, Uvarov, Dr Linda Friedland Financials (March quarter 2025): revenue nil, cash burn $182,000, cash of $4.3 million (ahead of $3.5 million capital raising).
Yahoo
15-05-2025
- Business
- Yahoo
FDA Provides Seven Years of Orphan-Drug Exclusive Approval for Ryoncil®
NEW YORK, May 14, 2025 (GLOBE NEWSWIRE) -- Mesoblast (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that it has received seven years of orphan-drug exclusive approval from U.S. Food and Drug Administration (FDA) for Ryoncil® (remestemcel-L) for treatment of steroid-refractory acute graft versus host disease (SR-aGvHD) in pediatric patients 2 months of age and older. This period of statutory exclusivity means that the FDA will not approve another mesenchymal stromal or stem cell (MSC) products for this indication during the 7-year period from the approval of Ryoncil®. Separately, Mesoblast has biologic exclusivity preventing another sponsor from referencing the Ryoncil® biologic license application (BLA) until December 2036, twelve years from its first approval which would prevent market entry by a biosimilar. These statutory exclusivities are in addition to Mesoblast's strong U.S. intellectual property position on MSC composition of matter, manufacturing and indications, including SR-aGvHD, that provide a commercial barrier to entry against competitors through 2044. About Mesoblast Mesoblast (the Company) is a world leader in developing allogeneic (off-the-shelf) cellular medicines for the treatment of severe and life-threatening inflammatory conditions. The therapies from the Company's proprietary mesenchymal lineage cell therapy technology platform respond to severe inflammation by releasing anti-inflammatory factors that counter and modulate multiple effector arms of the immune system, resulting in significant reduction of the damaging inflammatory process. Mesoblast's RYONCIL® (remestemcel-L) for the treatment of steroid-refractory acute graft versus host disease (SR-aGvHD) in pediatric patients 2 months and older is the first FDA approved mesenchymal stromal cell (MSC) therapy. Please see the full Prescribing Information at Mesoblast is committed to developing additional cell therapies for distinct indications based on its remestemcel-L and rexlemestrocel-L allogeneic stromal cell technology platforms. RYONCIL is being developed for additional inflammatory diseases including SR-aGvHD in adults and biologic-resistant inflammatory bowel disease. Rexlemestrocel-L is being developed for heart failure and chronic low back pain. The Company has established commercial partnerships in Japan, Europe and China. About Mesoblast intellectual property: Mesoblast has a strong and extensive global intellectual property portfolio, with over 1,000 granted patents or patent applications covering mesenchymal stromal cell compositions of matter, methods of manufacturing and indications. These granted patents and patent applications are expected to provide commercial protection extending through to at least 2044 in major markets. About Mesoblast manufacturing: The Company's proprietary manufacturing processes yield industrial-scale, cryopreserved, off-the-shelf, cellular medicines. These cell therapies, with defined pharmaceutical release criteria, are planned to be readily available to patients worldwide. Mesoblast has locations in Australia, the United States and Singapore and is listed on the Australian Securities Exchange (MSB) and on the Nasdaq (MESO). For more information, please see LinkedIn: Mesoblast Limited and Twitter: @Mesoblast. Forward-Looking StatementsThis press release includes forward-looking statements that relate to future events or our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. We make such forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Forward-looking statements should not be read as a guarantee of future performance or results, and actual results may differ from the results anticipated in these forward-looking statements, and the differences may be material and adverse. Forward-looking statements include, but are not limited to, statements about: the initiation, timing, progress and results of Mesoblast's preclinical and clinical studies, and Mesoblast's research and development programs; Mesoblast's ability to advance product candidates into, enroll and successfully complete, clinical studies, including multi-national clinical trials; Mesoblast's ability to advance its manufacturing capabilities; the timing or likelihood of regulatory filings and approvals, manufacturing activities and product marketing activities, if any; the commercialization of Mesoblast's RYONCIL for pediatric SR-aGVHD and any other product candidates, if approved; regulatory or public perceptions and market acceptance surrounding the use of stem-cell based therapies; the potential for Mesoblast's product candidates, if any are approved, to be withdrawn from the market due to patient adverse events or deaths; the potential benefits of strategic collaboration agreements and Mesoblast's ability to enter into and maintain established strategic collaborations; Mesoblast's ability to establish and maintain intellectual property on its product candidates and Mesoblast's ability to successfully defend these in cases of alleged infringement; the scope of protection Mesoblast is able to establish and maintain for intellectual property rights covering its product candidates and technology; estimates of Mesoblast's expenses, future revenues, capital requirements and its needs for additional financing; Mesoblast's financial performance; developments relating to Mesoblast's competitors and industry; and the pricing and reimbursement of Mesoblast's product candidates, if approved. You should read this press release together with our risk factors, in our most recently filed reports with the SEC or on our website. Uncertainties and risks that may cause Mesoblast's actual results, performance or achievements to be materially different from those which may be expressed or implied by such statements, and accordingly, you should not place undue reliance on these forward-looking statements. We do not undertake any obligations to publicly update or revise any forward-looking statements, whether as a result of new information, future developments or otherwise. Release authorized by the Chief Executive. For more information, please contact: Paul Hughes T: +61 3 9639 6036 Allison Worldwide Emma Neal T: +1 603 545 4843 E: BlueDot Media Steve Dabkowski T: +61 419 880 486 E: steve@
Yahoo
07-05-2025
- Business
- Yahoo
Mesoblast Limited's (ASX:MSB) market cap dropped AU$96m last week; Individual investors bore the brunt
Key Insights Significant control over Mesoblast by individual investors implies that the general public has more power to influence management and governance-related decisions 50% of the business is held by the top 8 shareholders Recent purchases by insiders This technology could replace computers: discover the 20 stocks are working to make quantum computing a reality. To get a sense of who is truly in control of Mesoblast Limited (ASX:MSB), it is important to understand the ownership structure of the business. The group holding the most number of shares in the company, around 39% to be precise, is individual investors. That is, the group stands to benefit the most if the stock rises (or lose the most if there is a downturn). While insiders who own 37% came under pressure after market cap dropped to AU$2.2b last week,individual investors took the most losses. Let's delve deeper into each type of owner of Mesoblast, beginning with the chart below. View our latest analysis for Mesoblast ASX:MSB Ownership Breakdown May 7th 2025 What Does The Institutional Ownership Tell Us About Mesoblast? Many institutions measure their performance against an index that approximates the local market. So they usually pay more attention to companies that are included in major indices. Mesoblast already has institutions on the share registry. Indeed, they own a respectable stake in the company. This can indicate that the company has a certain degree of credibility in the investment community. However, it is best to be wary of relying on the supposed validation that comes with institutional investors. They too, get it wrong sometimes. It is not uncommon to see a big share price drop if two large institutional investors try to sell out of a stock at the same time. So it is worth checking the past earnings trajectory of Mesoblast, (below). Of course, keep in mind that there are other factors to consider, too. ASX:MSB Earnings and Revenue Growth May 7th 2025 Hedge funds don't have many shares in Mesoblast. Looking at our data, we can see that the largest shareholder is Gregory George with 20% of shares outstanding. Silviu Itescu is the second largest shareholder owning 6.2% of common stock, and Grant George holds about 5.2% of the company stock. Silviu Itescu, who is the second-largest shareholder, also happens to hold the title of Chief Executive Officer. We also observed that the top 8 shareholders account for more than half of the share register, with a few smaller shareholders to balance the interests of the larger ones to a certain extent. Researching institutional ownership is a good way to gauge and filter a stock's expected performance. The same can be achieved by studying analyst sentiments. There are a reasonable number of analysts covering the stock, so it might be useful to find out their aggregate view on the future.
Sky News AU
22-04-2025
- Business
- Sky News AU
ASX 200 tumbles after Donald Trump's attack on Federal Reserve chairman Jerome Powell sends Wall Street plummeting
The ASX 200 initially dropped about one per cent on Tuesday after markets tumbled in the US when Donald Trump lashed out at Federal Reserve chairman Jerome Powell for failing to lower interest rates. Medical tech company Mesoblast sank 4.2 per cent, while uranium miners Deep Yellow (down 5.5 per cent) and Paladin Energy (down about 5.5 per cent) have dropped since the market opened on Tuesday. The tech and energy sectors are down about two per cent while real estate has dropped more than 1.5 per cent. The ASX 200 has recovered some losses since opening and hovers about half a per cent lower than its closing price on Thursday afternoon. Wall Street tumbled on Monday after Trump lashed the Federal Reserve chairman, who was appointed by Trump during his first term, in a scathing social media post where the US President demanded an interest rate cut. Trump labelled Mr Powell a 'major loser' and claimed there was 'virtually no inflation' and that energy and food prices were 'trending down'. 'With these costs trending so nicely downward, just what I predicted they would do, there can almost be no inflation, but there can be a SLOWING of the economy unless Mr. Too Late, a major loser, lowers interest rates, NOW,' Trump wrote on Truth Social. 'Europe has already 'lowered' seven times. 'Powell has always been 'Too Late,' except when it came to the Election period when he lowered in order to help Sleepy Joe Biden, later Kamala, get elected. How did that work out?' The US President's attack is just one of many against the Federal Reserve chairman and follows a White House executive saying Trump was looking into whether he could fire Mr Powell. Markets fell after the post went live with the tech-heavy Nasdaq dropping about 2.5 per cent, the S&P 500 fall 2.4 per cent and the NYSE sinking 1.8 per cent by the end of the day. Gold has surged to a new record high as investors turn to the valuable commodity amid fears the trade war between China and the US will continue to escalate. Sky News Business Reporter Ed Boyd said this was a boon for gold stocks with West African Resources up almost four per cent, Regis Resources rising more than two per cent and Westgold Resources jumping 2.5 per cent on Tuesday. 'We've never seen the price of gold as high as it is right now,' Boyd said. 'Investors are flocking to gold over the past year.' Gold is up more than 40 per cent over the past 12 months and has now surpassed US$3400. New Zealand's NZX 50 Index is down about 0.9 per cent as Japan's Nikkei 225 is down about 0.3 per cent and South Korea's KOSPI 200 opened relatively flat on Tuesday.
