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Sarepta's licensing patner Arrowhead expects near-term payments despite setbacks
Sarepta's licensing patner Arrowhead expects near-term payments despite setbacks

Reuters

time3 hours ago

  • Business
  • Reuters

Sarepta's licensing patner Arrowhead expects near-term payments despite setbacks

July 23 (Reuters) - Arrowhead Pharmaceuticals (ARWR.O), opens new tab said on Wednesday it expects to receive near-term milestone payments from Sarepta Therapeutics (SRPT.O), opens new tab as part of their licensing agreement, despite recent setbacks at the Cambridge, Massachusetts-based drugmaker. Sarepta said last week a 51-year-old man who received one of its experimental gene therapies in a study has died. It received investor and analyst criticism for reporting the death a day after the company disclosed cost cutting efforts, including its plans to halt the study and layoffs. Shares of Sarepta have declined 25% in the last week, and have dragged down shares of its partner Arrowhead by 15%. The companies entered into an agreement in late 2024, and Sarepta gained licensing rights to four of Arrowhead's experimental therapies which are in early stages of development. "Sarepta has provided no indication of any intention to fail to fulfill any of its obligations," the Pasadena, California-based drug developer said in a statement on Wednesday. Arrowhead said it expects to receive $300 million by the end of this year, related to patient enrollment for its early-to-mid stage study of ARO-DM1, which is being tested for a genetic condition. It added that Sarepta's restructuring efforts prioritized the funding, development, and commercialization of programs that it has licensed from Arrowhead. The deal has provisions that allow both the parties to terminate the agreement under certain circumstances. Arrowhead said that if Sarepta fails to make certain milestone payments, it would have the right to terminate the partnership. Bernstein analyst William Pickering said earlier in the week that Arrowhead does not have enough financial resources to develop and launch its therapies on its own. He added there was not much reason for Arrowhead to pull out of the deal unless they find another partner.

Do You Believe in the Growth Potential of Amgen (AMGN)?
Do You Believe in the Growth Potential of Amgen (AMGN)?

Yahoo

time4 hours ago

  • Business
  • Yahoo

Do You Believe in the Growth Potential of Amgen (AMGN)?

Aristotle Capital Management, LLC, an investment management company, released its 'Value Equity Strategy' second quarter 2025 investor letter. A copy of the letter can be downloaded here. Although the U.S. equity market started with volatility in the second quarter, it rebounded with strength, with the S&P 500 Index rising 10.94% during the quarter. The composite returned 4.88% gross of fees (4.75% net of fees) in the first quarter, outperforming the 3.78% return of the Russell 1000 Value Index and underperforming the 10.94% return of the S&P 500 Index. In addition, you can check the fund's top 5 holdings to determine its best picks for 2025. In its second quarter 2025 investor letter, Aristotle Capital Value Equity Strategy highlighted stocks such as Amgen Inc. (NASDAQ:AMGN). Amgen Inc. (NASDAQ:AMGN) is a biotech company that discovers, develops, manufactures, and delivers human therapeutics. The one-month return of Amgen Inc. (NASDAQ:AMGN) was 9.04%, and its shares lost 8.92% of their value over the last 52 weeks. On July 22, 2025, Amgen Inc. (NASDAQ:AMGN) stock closed at $305.69 per share, with a market capitalization of $164.371 billion. Aristotle Capital Value Equity Strategy stated the following regarding Amgen Inc. (NASDAQ:AMGN) in its second quarter 2025 investor letter: "Amgen Inc. (NASDAQ:AMGN), the biopharmaceutical company, was one of the largest detractors for the quarter. While the company's branded drugs continued to advance (a previously identified catalyst), with cholesterol medicine Repatha, osteoporosis treatment Evenity and bone-strengthening drug Prolia all growing sales in the double digits, concerns surrounding potential tariff impacts, tax reform and pressure on drug prices weighed on shares. We believe it is too early to assess the full impact of these macro uncertainties and are confident in Amgen's demonstrated ability to adapt through evolving policy and pricing dynamics. The company reaffirmed its long-term commitment to domestic manufacturing and innovation through its upcoming $2 billion expansions in Ohio and North Carolina, building on more than $5 billion in U.S. operational investments since 2017. Furthermore, Amgen continued to advance its robust pipeline, as its 1L bemarituzumab (bema) phase 3 trial for gastric cancer met its primary endpoint, and MariTide, the company's weight-loss drug, demonstrated strong efficacy in phase 1 and 2 trials. MariTide, which could offer more convenient monthly dosing compared to daily or weekly regimens, showed promising early results, though tolerability will be an important focus heading into phase 3. Management noted that modified dose ramp-up strategies may help mitigate these effects. Despite near-term pressures, we remain encouraged by Amgen's continued market share gains across key therapies and the potential to enhance the company's competitiveness and resilience in a dynamic healthcare landscape." A pharmacist filling a prescription for a complex drug developed by the company. Amgen Inc. (NASDAQ:AMGN) is not on our list of 30 Most Popular Stocks Among Hedge Funds. As per our database, 69 hedge fund portfolios held Amgen Inc. (NASDAQ:AMGN) at the end of the first quarter, which was 72 in the previous quarter. In the first quarter, Amgen Inc. (NASDAQ:AMGN) delivered revenues of $8.1 billion, representing a 9% increase from Q1 2024. While we acknowledge the potential of Amgen Inc. (NASDAQ:AMGN) as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. In another article, we covered Amgen Inc. (NASDAQ:AMGN) and shared the list of best low volatility stocks to buy according to analysts. In addition, please check out our hedge fund investor letters Q2 2025 page for more investor letters from hedge funds and other leading investors. READ NEXT: The Best and Worst Dow Stocks for the Next 12 Months and 10 Unstoppable Stocks That Could Double Your Money. Disclosure: None. This article is originally published at Insider Monkey. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data

EU pharma chief calls for European Nasdaq to boost biotech innovation
EU pharma chief calls for European Nasdaq to boost biotech innovation

Yahoo

time6 hours ago

  • Business
  • Yahoo

EU pharma chief calls for European Nasdaq to boost biotech innovation

Stefan Oelrich, president of Bayer's pharmaceutical division and newly appointed head of the EU's pharmaceutical lobby EFPIA, pointed out the urgent need for capital market reform to support biotech development in Europe. 'We need the equivalent of a Nasdaq in Europe where we can raise capital for biotech. Because biotech is not just about government finance,' Oelrich said during a press conference last week. Launched in 1971, the Nasdaq (originally the National Association of Securities Dealers Automated Quotations) was the world's first electronic stock market. Known for its fully electronic trading model, the exchange has historically been attractive to fast-growing sectors, including life science, listing some of the world's largest tech companies, including Apple, Microsoft, and Google. Oelrich argued that Europe must urgently develop a similar equity-driven financing ecosystem. 'Today, there is very limited venture capital available, which is largely due to the way we manage equities. We invest our equities not in venture, but elsewhere,' he said. According to him, the lack of early-stage capital means European biotech innovations often migrate elsewhere — especially to the US, where funding and commercialisation opportunities are more robust. 'The transition from basic research to patented applications tends to follow where the capital is. We must ensure that innovation generated in European universities and research institutions stays in Europe,' he warned. 'Why don't we do it?' His remarks came just ahead of the unveiling of the EU's long-awaited Life Sciences Strategy, which aims to revive Europe's position as a hub for biotech research and development. The strategy acknowledges that the gap in venture capital investment is widening in Europe. It points to the continent's fragmented capital markets and heavy reliance on bank loans, which are often limited in volume and duration, as major structural issues. The strategy also recommends strengthening innovation hubs and integrating them into value chains to better attract private investment. However, it does not place significant emphasis on completing the EU's Capital Markets Union (CMU), a key demand from Oelrich. 'This may sound ambitious, but it's absolutely doable. Interestingly, everyone I talk to recognises the need: So why aren't we acting on it?' Oelrich asked. He also suggested that part of Europe's pension and life insurance capital could be redirected toward venture investment if appropriate political frameworks were put in place. 'Inventions can find a market here as it's not only about a lack of capital in Europe: It's about how we allocate it. We need to do a better job,' he concluded. The broader context The EU's Capital Markets Union remains incomplete, with progress hindered by regulatory divergence, inconsistent enforcement, and political resistance to deeper integration. While the CMU does not directly aim to create new stock exchanges, it does support efforts to expand access to capital, particularly for small and medium-sized enterprises (SMEs). This improved access could encourage the development of specialised or regional exchanges, though the broader goal remains integration rather than fragmentation. Currently, Europe lacks sector-specific stock exchanges. Major platforms like Euronext, the London Stock Exchange, Deutsche Börse, Nasdaq Nordic, and SIX Swiss Exchange list companies across a wide range of industries. Instead of dedicated exchanges, sector-focused investment is facilitated through indices such as the STOXX Europe 600 family, which tracks sectors like banking, automotive, and leisure. Still, for many in the biotech sector, the absence of a specialised capital-raising platform remains a barrier. Whether the EU will — and can — move to address this remains to be seen. Sign in to access your portfolio

Health Check: Aussie biotechs are navigating a US regulatory minefield
Health Check: Aussie biotechs are navigating a US regulatory minefield

News.com.au

time12 hours ago

  • Business
  • News.com.au

Health Check: Aussie biotechs are navigating a US regulatory minefield

Telix faces unwanted US regulatory attention – but it's not alone Amplia raises $25 million, with another $2.5 million to go A home-grown uni biotech innovation shines again Telix Pharmaceuticals (ASX:TLX) shares this morning slumped up to 16% on news that the radiopharmacy play has attracted unwanted attention from the Securities and Exchange Commission (SEC). But the company is no Robinson Crusoe, in that US regulatory and legal glitches pose a regular minefield for ASX biotechs doing business there. The companies watchdog has subpoenaed 'various documents and information'. These mainly relate to the company's disclosures about its prostate cancer therapeutic program. 'The company is fully cooperating with the SEC and is in the process of responding to the information request,' Telix says. 'At this stage, this matter is a fact-finding request'. Telix adds the SEC's entreaty does not mean that Telix has violated US security laws 'or that the SEC has a negative opinion of any person, entity or security'. Barring more detail, the episode sounds like a case of 'probably nothing or very much something'. Overnight, Nasdaq investors were more chill about the affair, marking Telix shares only marginally lower. At the very least, the SEC's nosing around is likely to distract management from the company's busy agenda. 'In our experience of similar matters, these investigations tend to drag on for years without resolution,' broker Jefferies says. Trouble and strife Other ASX biotechs in the US have run into the odd bit of strife over patent disputes and regulatory interventions. ResMed (ASX:RMD) regularly parries with rivals Fisher & Paykel Healthcare (ASX:FPH) and Philips Respironics over sleep apnoea patents. In 2018 a jury ordered Cochlear (ASX:COH) to pay US$268 million in damages for a patent infringement. The charitable Alfred E. Mann Foundation lodged the action. In 2020 Cochlear lost an appeal. In 2013 CSL (ASX:CSL) paid US$64 million to settle an antitrust class action lodged by hospital groups. 'Business as usual' Telix says it will continue with the prostate cancer program. The SEC action also will not affect its nearer-stage imaging programs for kidney and brain cancers. Telix also reported June quarter revenue of US$204 million, 63% higher year on year, whilst maintaining calendar 2025 revenue guidance of US$770-800 million. This revenue derived mainly from Telix's prostate cancer imaging agent, Illucix. 'Dose volumes for Illuccix rose 7% quarter-on-quarter in the US, reinforcing the strength of our market position and continued customer demand,' Telix co-founder and CEO Dr Chris Behrenbruch says. He adds that 'despite emerging competitive pricing pressure', Telix has 'effective strategies' to maintain average selling prices. Next month, Telix lifts the kimono on June (first) half earnings. Jefferies expects a $50.6 million net profit, with a calendar 2025 tally of $88.3 million. Interestingly, this is a decline on the previous year's US$105.4 million, but the firm plugs in US$183 million for calendar 2026. Perhaps they lost our phone number? Speaking of US regulatory glitches, stroke drug developer Argenica Therapeutics (ASX:AGN) is yet to hear back from the US Food and Drug Administration (FDA) as to why the agency plonked a 'clinical hold' on its US trial plans. On June 10 Argenica said the FDA had deemed the company's supportive material as not being adequate to support its Investigational New Drug application. The trial was aimed at approval under the FDA's fast-track route. Argenica expected to hear back from the FDA within 30 days, but the agency's 'resourcing challenges' have blown out this timeline. In the meantime, Argenica is on track to report topline results from its local, proof-of-concept trial in the current quarter. The 92-patient phase II study tests Argenica's candidate ARG-007, in view of safety and preliminary efficacy in ischaemic (blockage) stroke patients. Courtesy of $4 million of government and private grants, Argenica is also investigating the 'potential utility' of ARG-0007 for other neurological conditions, including traumatic brain injury. Argenica disclosed June quarter cash burn of $2.36 million and a closing cash balance of $10.5 million. Nyrada advances heart protection trial In other trial news, Nyrada (ASX:NYR) is advancing its locally developed drug Xolatryp into phase IIa stage. Xolatryp targets the unmet need of protecting the heart following cardiac injury where patients are at high risk of tissue damage. Nyrada notes there's been no significant new cardiac drug developed for more than two decades. Xolatryp could become the first drug of its kind to protect the heart actively from ischemia-reperfusion injury. Nyrada anticipates a randomised, double-blind, placebo-controlled study, enrolling 150 subjects. These patients have acute myocardial infarction undergoing percutaneous coronary intervention (stenting). The company hopes to kick off the study in the March quarter of 2026. We now have Ample-ia funds, says cancer drug developer Prostate cancer drug hopeful Amplia (ASX:ATX) has raised $25 million in an institutional placement and is eyeing a further $2.5 million in a share purchase plan. The deed was done at 23 cents, a 19% discount to last Friday's 'frozen' price ahead of a trading halt. Amplia shares have been on a tear on the back of remarkable phase II results, covering patients with advanced metastatic forms of the deadly disease. Last month Amplia reported 17 partial responses, which meant the tumour size shrunk by at least 30%. Two of the 55 patients reported a complete response, which pretty much means a – can we say it? – cure. Amplia now plans a US trial combining Amplia's candidate AMP-945 with a different chemotherapy. The raising takes Amplia's cash to $42.7 million, including $8.2 million of expected R&D tax refunds. Don't forget who invented it Sanofi's $2.5 billion purchase of vaccine tech outfit Vicebio again highlights the role of Australian universities as a springboard for money-making life sciences ideas. The Paris-based Big Pharma is paying up to US$1.6 billion for the UK-based Vicebio and its so-called molecular clamp technology. The deal involves an upfront payment of US$1.15 billion, with regulatory milestones of US$450 million. Discovered at the University of Queensland (UQ), the clamp stabilises viral proteins enabling the immune system to respond to them more effectively. The upshot is the quicker development of fully liquid combination vaccines that can be stored at fridge temperatures. Vicebio was formed in 2018 to develop the clamp to make vaccines against life-threatening respiratory viral infections. During the pandemic, Vicebio had a stab at a Covid-19 vaccine. Courtesy of a US$100 million Series B financing last year, Vicebio's investors include Goldman Sachs Alternatives, Avoro Ventures and Venbio Partners. Uniquest, UQ's commercialisation arm has an unquantified direct investment and benefits from a licensing arrangement. Uniquest formed more than 130 start-ups, which went on to raise more than $1 billion and glean $86 million in product sales. This included licensing the UQ-invented cervical cancer vaccine Gardasil. The UQ bright sparks responsible for the molecular clamp are professors Paul Young, Daniel Watterson and Keith Chappell. UQ describes the deal as 'the largest involving a company that is commercialising intellectual property from an Australian university.'

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