Latest news with #ChronicInflammatoryDemyelinatingPolyneuropathy
Malaysian Reserve
21 hours ago
- Business
- Malaysian Reserve
Halozyme Announces argenx Received European Commission Approval for VYVGART® Subcutaneous Injection with ENHANZE® for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
SC injection of VYVGART® is available as a vial or prefilled syringe and can be administered by a patient, caregiver, or healthcare professional SAN DIEGO, June 20, 2025 /PRNewswire/ — Halozyme Therapeutics, Inc. (NASDAQ: HALO) (Halozyme) today announced that argenx received European Commission (EC) approval of VYVGART® 1000mg (efgartigimod alfa) developed with ENHANZE®, Halozyme's proprietary recombinant human hyaluronidase enzyme (rHuPH20), for subcutaneous (SC) injection as a monotherapy for the treatment of adult patients with progressive or relapsing active chronic inflammatory demyelinating polyneuropathy (CIDP) after prior treatment with corticosteroids or immunoglobulins. VYVGART is the first and only targeted IgG Fc-antibody fragment for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) and the first novel mechanism of action for CIDP treatment in more than 30 years. 'We are pleased to announce the European Commission approval of the subcutaneous injection of VYVGART, which is co-formulated with our ENHANZE drug delivery technology for use in CIDP patients. This marks another milestone in our partnership with argenx and the expansion of access to Europe is another catalyst supporting our growth,' said Dr. Helen Torley, president and chief executive officer of Halozyme. The EC decision is based on positive results from the ADHERE clinical trial, the largest study of CIDP patients to date. For more information on the study and its findings, please view argenx's press release issued on June 20, 2025. The approval by the EC is valid in all 27 European Union (EU) Member States, as well as Iceland, Norway and Liechtenstein. About Halozyme Halozyme is a biopharmaceutical company advancing disruptive solutions to improve patient experiences and outcomes for emerging and established therapies. As the innovators of ENHANZE® drug delivery technology with the proprietary enzyme rHuPH20, Halozyme's commercially-validated solution is used to facilitate the subcutaneous delivery of injected drugs and fluids, with the goal of improving the patient experience with rapid subcutaneous delivery and reduced treatment burden. Having touched one million patient lives in post-marketing use in ten commercialized products in at least one major region and across more than 100 global markets, Halozyme has licensed its ENHANZE® technology to leading pharmaceutical and biotechnology companies including Roche, Takeda, Pfizer, Janssen, AbbVie, Eli Lilly, Bristol-Myers Squibb, argenx, ViiV Healthcare, Chugai Pharmaceutical and Acumen Pharmaceuticals. Halozyme also develops, manufactures and commercializes, for itself or with partners, drug-device combination products using its advanced auto-injector technologies that are designed to provide commercial or functional advantages such as improved convenience, reliability and tolerability, and enhanced patient comfort and adherence. The Company has two commercial proprietary products, Hylenex® and XYOSTED®, partnered commercial products and ongoing product development programs with Teva Pharmaceuticals and McDermott Laboratories Limited, an affiliate of Viatris Inc. Halozyme is headquartered in San Diego, CA and has offices in Ewing, NJ and Minnetonka, MN. Minnetonka is also the site of its operations facility. For more information visit and connect with us on LinkedIn and Twitter. Safe Harbor Statement In addition to historical information, the statements set forth above include forward-looking statements including, without limitation, statements concerning the possible activity, benefits and attributes of ENHANZE®, the possible method of action of ENHANZE®, its potential application to aid in the dispersion and absorption of other injected therapeutic drugs, and statements concerning certain other potential benefits of ENHANZE® including facilitating more rapid delivery of injectable medications through subcutaneous delivery and potentially lowering the treatment burden for patients, including a potential reduction in administration time and broadening the treatment options for the indication referred to in this press release. Forward-looking statements may also include statements regarding potential growth catalysts and opportunities driven by the product development and commercialization efforts of Halozyme's ENHANZE® partners. These forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. The forward-looking statements are typically, but not always, identified through use of the words 'expect,' 'believe,' 'enable,' 'may,' 'will,' 'could,' 'intends,' 'estimate,' 'anticipate,' 'plan,' 'predict,' 'probable,' 'potential,' 'possible,' 'should,' 'continue,' and other words of similar meaning. Actual results could differ materially from the expectations contained in forward-looking statements as a result of several factors, including uncertainties concerning unexpected results or delays in the timing of the Halozyme's expected growth catalysts or in the launch or commercialization of our partner's product for the indication referred to in this press release, unexpected adverse events or patient experiences or outcomes from being treated with the ENHANZE® co-formulated treatment referred to in this press release, and competitive conditions. These and other factors that may result in differences are discussed in greater detail in Halozyme's most recent Annual and Quarterly Reports filed with the Securities and Exchange Commission. Except as required by law, Halozyme undertakes no duty to update forward-looking statements to reflect events after the date of this release. Contacts: Tram BuiVP, Investor Relations and Corporate Communications609-333-7668tbui@ Sydney CharltonTeneo 917-972-8407
Sky News AU
20-05-2025
- Sport
- Sky News AU
'I'm mixing it up': Aussie swimming legend Michael Klim rocks striking new look as he bravely opens up about his rare autoimmune disease
Australian swimming great Michael Klim has debuted a bold new look as he launches a foundation dedicated to raising awareness and funding research into Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), the rare autoimmune condition he was diagnosed with in 2020. The 47-year-old, best known for his stellar performance at the Sydney 2000 Olympics, where he took home gold in the 4x100m and 4x200m freestyle relays, as well as silver in the 100m butterfly and 4x100m medley relay, first began noticing symptoms several years ago. Initially attributing them to the toll of elite sport, further testing revealed Klim had CIDP - a disease that causes progressive muscle weakness, particularly in the lower limbs. Appearing on The Project on Tuesday night from his home in Bali, the father-of-three showcased his new facial hair and opened up about the challenges of living with the condition. "I'm just mixing it up, you know?" he said of the goatee. "I've had one look for 47 years, so I had to come up with something different." Despite his diagnosis, Klim said he's now in a good place physically and mentally. "I'm feeling really well. Life has really stabilised physically and mentally since the diagnosis five years ago," he said, adding that the launch of his new charity, The Klim Foundation, felt like the natural next step. "I feel like I'm up for the challenge- it's going to be a big one- but I think my history has given me a lot of insight and knowledge which I can now pass onto others that are going through this pretty tough journey." The Polish-born Australian also spoke about how CIDP has affected his mobility. "My mobility is compromised," he said, explaining he uses AFOs, ankle-foot orthoses, to help him stay mobile. "With that assistance, I can still do most things. Unfortunately, some of my favourite things like surfing and playing tennis are kind of out of the question. "But I had a ski for the first time in 12 years last year, so there are still a lot of things that you can do." The goal of The Klim Foundation, he said, is to empower others living with CIDP and help them reclaim their lives. "That can be achieved through things like blood donations, AFOs, the right physios, and also having the support of counsellors," he said. "For me, mentally coming out of that hole and realising that life still had a lot to give was probably the biggest win." The foundation was founded by Klim alongside his partner of two years, Michelle Owen. It's board includes some of the biggest names in sport- Ian Thorpe, Grant Hackett and even Klim's former rival, American swimmer Gary Hall Jr, who once famously said he would "smash him like a guitar". "The boys just wanted to help me raise the awareness of this condition," Klim said. "We do have a board that's got a lot of experience," he added, referencing key members like Paul Bird from Mission Australia, Mark Saubi from Mark Sowerby, and his best friend, former Olympic table tennis player David Zalcberg. "…It's going to take a group of champions to find not only a cure but to overcome this challenge." Reflecting on Hall Jr's involvement, Klim laughed as he recalled their former rivalry. "Gary - he's a diabetic, he's been in the medical field most of this life. He is probably the only Olympic gold medallist with diabetes," Klim said. "He loves Australia, even though some of the Aussies don't like him. "I'm going to make it my mission he'll be a favoured Aussie very soon."
Herald Sun
19-05-2025
- Health
- Herald Sun
Swimmer Micheal Klim launches charity and gives CIDP auto-immune condition health update
Don't miss out on the headlines from Health. Followed categories will be added to My News. Champion swimmer Michael Klim has revealed his 'favourite things' are 'out of the question' as he continues to battle a rare auto-immune condition. Klim has launched a charity which funds research into Chronic Inflammatory Demyelinating Polyneuropathy – the same condition which is attacking the former Olympian's nerves. The gold medallist appeared on Channel 10's The Project to launch the Klim Foundation and give an update on his health. Fans were stunned to see the handsome athlete, who normally sports a completely bald look, pulling off an impressive goatee. 'I'm mixing it up. I had one look for 47 years. I had to come up with something different,' Klim joked when asked about his new crop of facial hair. He also added he was 'feeling really well' despite ongoing health challenges. 'My life has stabilised physically and mentally. It's become a – the right time now for myself, Michelle (his partner), the family, and, the board we put together, to launch the Klim Foundation and get out and help other sufferers. I feel up to the challenge,' Klim said. Speaking from his home in Bali, Klim added CIDP continues to wreak havoc on his body. 'My mobility is compromised. But I've got some great AFOs, are kind of prosthetics,' he said. 'Some of my favourite things like surfing and playing tennis are out of the question, but I had a ski for the first time in 12 years last year. 'Still a lot of things you can do. So, with the foundation, it's what we're trying to do, enable a lot of sufferers, give them their life back.' Klim said he not only signed up swimming pals Ian Thorpe and Grant Hackett to join the foundation board, but also recruited former rival, American Gary Hall Jr who once threatened to 'smash him like a guitar.' 'Gary – he's a diabetic, he's been in the medical field most of this life. He is probably the only Olympic gold medallist with diabetes,' Klim said. 'He loves Australia, even though some of the Aussies don't like him. 'I'm going to make it my mission he'll be a favoured Aussie very soon.' People can donate to the Klim Foundation here. Originally published as Michael Klim sports handsome goatee as he launches charity
Cision Canada
11-05-2025
- Sport
- Cision Canada
Wildlife is a winner at WWF's second annual BC Place Climb for Nature
Climbers of all ages tackled BC Place's 3,000 steps and helped raise a record amount for conservation VANCOUVER, BC, May 11, 2025 /CNW/ - In a win for wildlife, families, athletes and nature-lovers from age two to 68 climbed up and down the stadium stands of BC Place on Saturday as part of the WWF BC Place Climb for Nature, presented by Aviso. The climbers in Vancouver — together with the thousands of climbers who conquered the WWF CN Tower Climb for Nature last month and hundreds more who are climbing across the country as part of the WWF Anywhere Climb for Nature — helped raise a record $1.7 million (and counting) for conservation efforts in B.C. and across Canada this year. "I am so inspired and energized by the turnout at our second annual WWF Climb for Nature at BC Place. We've got all these climbers here today, including me, and every step we take is a step for supporting wildlife across Canada. We're so proud that so many people would step up like that, literally, for nature and wildlife. We raised $93,000 today alone. Our hearts are very full," Megan Leslie, WWF-Canada president and CEO, said. "The money we raise goes to supporting wildlife all across Canada. Here in B.C., we're working to support southern resident killer whales, we're in interior B.C. helping restore forests after wildfire, and we're working on restoring salmon habitat in Katzie First Nation territory. From freshwater to saltwater to forests, we've got all the bases covered in B.C. and we're really proud of the work." Shaun Stephens-Whale, a professional tower runner and ninja gym owner from Squamish had the fastest time of the day at 10 minutes and 45 seconds. " Living on the west coast, we're seeing a lot more natural disasters — whether it's flooding like in Chilliwack or wildfires, even if it's not in our town it's directly affecting us with the smoke. Being better stewards of the environment, more sustainable, and protecting more land, goes a long way to making sure that those impacts we feel at home are lessened in the future. Overall, I couldn't think of anything more important than that," Stephens-Whale said. Also among those climbing were Bradley Twaddle, a man regaining his strength and mobility after being diagnosed with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), a rare neurological autoimmune disorder that affects the peripheral nerves and leads to progressive weakness and impaired motor function; and Meagan Morris, a BC-based interior designer and contestant from the second season of Bachelor in Paradise Canada. Cheering them on was event emcee, Don Andrews, the voice of the Vancouver Whitecaps, BC Lions and Rugby 7s. WWF's famous giant panda was also racing up and down the stadium steps, taking photos with climbers and keeping the crowd energized and motivated. The 2025 WWF Climb for Nature continues until June 8 as climbers across Canada complete the Anywhere Climb for Nature. Registration is open at Learn more about WWF-Canada's Climb for Nature, or to donate to WWF-Canada's conservation efforts, here. What the WWF Climb for Nature funds: Funds raised for the WWF Climb for Nature support efforts in B.C. and across Canada to bring back nature, reverse wildlife loss and fight climate change. Learn more about WWF-Canada's 10-year plan to Regenerate Canada here. Photos, footage and interviews can be found here. ABOUT WWF-CANADA WWF-Canada is committed to equitable and effective conservation actions that restore nature, reverse wildlife loss, and fight climate change. We draw on scientific analysis and Indigenous guidance to ensure all our efforts connect to a single goal: a future where wildlife, nature, and people thrive. For more information visit
Yahoo
27-02-2025
- Business
- Yahoo
KORU Medical Systems, Inc. (KRMD): A Bull Case Theory
We came across a bullish thesis on KORU Medical Systems, Inc. (KRMD) on Substack by Shareholdersunite. In this article, we will summarize the bulls' thesis on KRMD. KORU Medical Systems, Inc. (KRMD)'s share was trading at $3.58 as of Feb 26th. KRMD's trailing P/E was 398.47 according to Yahoo Finance. Ideya/ KORU Medical (KRMD) is a leader in subcutaneous drug delivery solutions, providing patient-friendly infusion systems that are transforming the market. After a period of overvaluation, a recent correction has created an attractive entry point, as KORU benefits from strong industry tailwinds, including the shift from intravenous to subcutaneous immunoglobulin (SCIg), greater adoption of prefilled syringes, international expansion, and its growing role in novel therapy development. The company's FREEDOM System, consisting of portable, maintenance-free infusion devices and consumables, has established itself as a preferred solution for treating conditions like primary immunodeficiency diseases (PIDD), Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), and Paroxysmal Nocturnal Hemoglobinuria (PNH), providing superior patient comfort while reducing healthcare costs. KORU's recurring revenue model, driven by its high-margin consumables business, ensures consistent growth. Its multi-channel sales and distribution approach, which includes direct supply agreements with pharmaceutical companies, specialty pharmacies, and home infusion providers, reinforces its market penetration. Additionally, strict quality controls in U.S. and Nicaraguan manufacturing facilities guarantee compliance with regulatory standards. The company is also investing in R&D to develop a next-generation infusion system, further strengthening its market position. The domestic core business remains the backbone of KORU's growth, with revenue increasing 14% in Q2 2024 and 12% in Q3, outpacing the broader SCIg market. This momentum is driven by growing patient adoption, expanded SCIg drug labels such as XEMBIFY, and a rising CIDP market. Prefilled syringe adoption is another significant tailwind, enhancing convenience and compatibility with KORU's devices. Internationally, the company has seen strong growth, with adjusted revenue increases of 20% in Q2 and 24% in Q3, bringing year-to-date international growth to 38%. With operations now spanning 25 countries and 26 global distributors, KORU is well-positioned to capitalize on expanding SCIg adoption in new markets like Japan and Austria. Novel Therapies is an emerging high-growth segment, with revenues surging 276% in Q3 2024 following a 50% increase in Q2. This segment, which includes feasibility studies, clinical trials, and engineering services for pharmaceutical companies developing subcutaneous biologics, represents a significant long-term growth opportunity. As more therapies transition to subcutaneous delivery, KORU's FREEDOM System stands to benefit, reinforcing its leadership in this expanding market. Financially, KORU has delivered strong performance, with total revenue increasing 17% to $8.2M in Q3 2024, led by 12% growth in domestic core sales and 5% in international sales, which normalized to 25% after accounting for Q2 BSI stocking orders. The Novel Therapies segment contributed $600K, driven by robust product sales supporting clinical trials and non-recurring engineering (NRE) services for six pharmaceutical collaborations. Preliminary Q4 results indicate revenue growth of 23% to $8.9M, bringing FY24 growth to 18% at $33.7M. Profitability is improving, with gross profit up 19% and margins expanding 140 basis points to 63.4%, aided by higher NRE margins and price increases. Cash flow is turning positive, with preliminary Q4 figures showing a $9.6M cash balance, reflecting $0.8M positive cash flow for the quarter and a 67% reduction in FY24 cash burn. With zero debt and access to a $10M credit facility, KORU is financially stable. FY24 guidance has been raised to $32.75M-$33.25M, though preliminary results suggest an even stronger $33.9M. Gross margins are projected at 62%-63%, while operating expenses are expected to land at $24.5M-$25M, excluding stock compensation. KORU anticipates achieving cash flow breakeven in Q4 and sustained positive cash flow in 2025. At $3.6 per share, KORU's market cap stands at $170M, with an enterprise value of $160.5M. It is projected that FY25 revenue of $38.4M, equating to a 4.17x EV/S multiple. While a $0.07 EPS loss is expected, the company's improving fundamentals, margin expansion, and accelerating growth in novel therapies suggest further upside. Despite difficult comps in FY25, momentum is expected to strengthen in FY26, reinforcing the long-term investment case. Investors may find the current $3.5-$3.7 range an attractive entry point, as KORU's disciplined financial management and multiple growth drivers position it for sustained success. KORU Medical Systems, Inc. (KRMD) is not on our list of the 30 Most Popular Stocks Among Hedge Funds. As per our database, 15 hedge fund portfolios held KRMD at the end of the third quarter which was 6 in the previous quarter. While we acknowledge the risk and potential of KRMD as an investment, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns, and doing so within a shorter timeframe. If you are looking for an AI stock that is more promising than KRMD but that trades at less than 5 times its earnings, check out our report about the cheapest AI stock. READ NEXT: 8 Best Wide Moat Stocks to Buy Now and 30 Most Important AI Stocks According to BlackRock. Disclosure: None. This article was originally published at Insider Monkey.
