Latest news with #therapeutic
Yahoo
3 days ago
- Business
- Yahoo
Eli Lilly (LLY) Gains CHMP Approval for Donanemab in Alzheimer's Treatment
Eli Lilly recently received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) for its Alzheimer's drug donanemab, underscoring the company's advancements in a crucial therapeutic area. During the same period, LLY registered a 5% share price increase, notably outpacing the broader market's 1% rise over the past week. This uptrend in LLY's stock could be attributed to investors' optimism about donanemab's potential impact. Additionally, the company's collaboration with Gate Bioscience to develop novel therapies further strengthens its innovative capabilities, adding weight to its share price momentum amid broader market gains. We've spotted 2 risks for Eli Lilly you should be aware of, and 1 of them doesn't sit too well with us. Find companies with promising cash flow potential yet trading below their fair value. The recent positive opinion from the CHMP about Eli Lilly's Alzheimer's drug, donanemab, could significantly enhance the company's revenue and earnings forecasts. This development positions the company well for future growth, adding credibility to its strategic focus on expanding into high-demand therapeutic areas like oncology and immunology. Coupled with its collaboration with Gate Bioscience, these advances may provide substantial long-term benefits to the company's bottom line. Over the past five years, Eli Lilly's total return, which includes both share price growth and dividends, was a very large 473.44%. This long-term growth far outpaces the recent 1% rise in the broader market over the past year, bolstering investor confidence in the company's strategic trajectory and robust pipeline. In comparison to the US Pharmaceuticals industry, which saw a decline of 5.9% over the past year, Eli Lilly's sharp uptick in share price highlights its strong performance relative to industry peers. The company's earnings growth was a robust 80.9% over the past year, indicative of its potent execution in a challenging market. The current share price of US$812.69, when set against the analyst consensus price target of US$952.27, suggests there is room for potential growth. However, it also indicates investor caution, likely weighed down by concerns over competitive pressure and pricing dynamics. Investors might find reassurance in the company's ongoing manufacturing and R&D investments, which aim to mitigate risks and sustain growth in the coming years. Understand Eli Lilly's track record by examining our performance history report. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Companies discussed in this article include LLY. This article was originally published by Simply Wall St. Have feedback on this article? Concerned about the content? with us directly. Alternatively, email editorial-team@
Globe and Mail
4 days ago
- Health
- Globe and Mail
Amyotrophic Lateral Sclerosis Pipeline Insight 2025: 75+ Companies Accelerating Innovation Across Genetic and Neuroinflammatory Targets
The ALS pipeline is gaining momentum, with over 75 companies advancing R&D across key targets like SOD1 mutations, TDP-43, C9orf72 expansions, and neuroinflammation. Approaches include ASOs, gene therapies, mitochondrial modulators, neuroprotective agents, and immune biologics. A major milestone was the FDA's 2023 accelerated approval of Biogen and Ionis's Tofersen for SOD1-ALS. DelveInsight's ' Amyotrophic Lateral Sclerosis (ALS) – Pipeline Insight, 2025 ' offers a detailed analysis of the evolving therapeutic landscape for ALS, a fatal neurodegenerative disease characterized by progressive loss of motor neurons, leading to muscle weakness, paralysis, and eventually respiratory failure. With most patients succumbing to the disease within 3–5 years of symptom onset, there remains a critical unmet need for effective disease-modifying treatments. Several late-stage candidates are progressing through global Phase II/III studies, including Amylyx's AMX0035, which received full FDA approval in September 2022 as RELYVRIO, and is now being evaluated in confirmatory trials. Additionally, investigational programs from companies like Clene Nanomedicine, QurAlis, Wave Life Sciences, and BrainStorm Cell Therapeutics are advancing promising assets in both sporadic and familial ALS subpopulations, often with orphan drug or fast-track designations. The regulatory landscape continues to support innovation in ALS with flexible pathways and growing biomarker guidance, including neurofilament light chain (NfL) levels, digital endpoints, and functional scores. Patient advocacy, real-world evidence generation, and adaptive trial designs are also helping de-risk development strategies and accelerate access. As 2025 unfolds, the ALS pipeline reflects a shift from symptomatic care to precision medicine and disease modification, driven by robust collaboration among academia, biotech, regulatory bodies, and patient communities. With over 80 therapies in the pipeline, the future of ALS treatment is poised for transformative change. Key Takeaways from the Amyotrophic Lateral Sclerosis Pipeline Report • DelveInsight's amyotrophic lateral sclerosis pipeline analysis depicts a strong space with 75+ active players working to develop 80+ pipeline drugs for amyotrophic lateral sclerosis treatment. • The leading amyotrophic lateral sclerosis companies include Ionis Pharmaceuticals, 1ST Biotherapeutics, Scholar Rock, Revalesio, QurAlis Corporation, Sanofi, MediciNova, Helixmith, Verge Genomics, UCB, and others are evaluating their lead assets to improve the amyotrophic lateral sclerosis treatment landscape. • Key amyotrophic lateral sclerosis pipeline therapies in various stages of development include ION363, FB418, SRK-015, RNS60, QRL-201, SAR443820, MN-166, VM202, VRG-50635, Zilucoplan, and others. • In July 2025, Neurizon Therapeutics submitted a formal response to the FDA addressing the clinical hold on its IND application for NUZ-001, its lead ALS therapy. • In July 2025, Klotho Neurosciences received FDA Orphan Drug Designation for KLTO-202 ( its novel gene therapy targeting ALS. • In June 2025, Amylyx Pharmaceuticals, Inc. (NASDAQ: AMLX) announced that the FDA granted Fast Track designation to AMX0114, an investigational antisense oligonucleotide targeting calpain-2 for treating ALS. • In May 2025, BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI) announced FDA clearance to begin its Phase IIIb trial of NurOwn® for treating amyotrophic lateral sclerosis (ALS). • In May 2025, Neuralink announced that it received the FDA's " breakthrough" designation for its device aimed at restoring communication for individuals with severe speech impairment. The device, designed to assist patients with conditions like ALS, stroke, spinal cord injury, cerebral palsy, and multiple sclerosis, represents a significant step forward in neurotechnology. • In March 2025, DiagnaMed Holdings Corp. announced a significant milestone in rare disease research, receiving Orphan Drug Designation (ODD) from the FDA for molecular hydrogen in the treatment of ALS. • In January 2025, the FDA granted approval for Zydus Lifesciences to proceed with a randomized Phase IIb trial of its oral NLRP3 inflammasome inhibitor, Usnoflast, for the treatment of ALS. Request a sample and discover the recent breakthroughs happening in the amyotrophic lateral sclerosis pipeline landscape. Amyotrophic Lateral Sclerosis Overview Amyotrophic Lateral Sclerosis (ALS) is a rare, progressive neurodegenerative disorder that affects nerve cells in the brain and spinal cord. It leads to the loss of muscle control, eventually impacting the ability to speak, move, eat, and breathe. ALS is often classified into sporadic (the most common form) and familial types, with the latter being linked to genetic mutations. Although the exact cause of ALS is unknown in most cases, environmental and genetic factors are believed to contribute to its development. Currently, there is no cure for ALS, but several treatment options aim to slow disease progression and manage symptoms. FDA-approved drugs like riluzole and edaravone offer modest benefits in extending survival or preserving function. Ongoing research is focused on gene therapies, neuroprotective agents, and immune-targeting approaches to better address the underlying mechanisms of the disease and improve patient outcomes. Find out more about amyotrophic lateral sclerosis medication at Amyotrophic Lateral Sclerosis Treatment Analysis: Drug Profile MN-166: MediciNova MN-166 is an orally administered small molecule glial attenuator that reduces neuroinflammation by suppressing pro-inflammatory cytokines such as IL-1β, TNF-α, and IL-6, while potentially increasing the anti-inflammatory cytokine IL-10. It also functions as a toll-like receptor 4 (TLR4) antagonist, contributing further to its anti-inflammatory effects. MN-166 is currently in Phase II/III clinical trials for the treatment of ALS. RNS60: Revalesio RNS60 is designed to offer disease-modifying and potentially regenerative effects in neurological disorders. It works by activating signaling pathways that enhance mitochondrial function and reduce inflammation, offering neuroprotection and immune modulation. The FDA has granted RNS60 both Orphan Drug and Fast Track status for ALS. It is currently in Phase II clinical trials. VM202: Helixmith VM202 is a gene therapy aimed at tissue regeneration by promoting the production of hepatocyte growth factor (HGF) at the site of injection along peripheral nerves. HGF supports nerve protection, neuron growth, and muscle atrophy prevention. The FDA has granted VM202 Orphan Drug and Fast Track designations. It is being evaluated in Phase II trials for ALS treatment. Learn more about the novel and emerging amyotrophic lateral sclerosis pipeline therapies. By Product Type • Mono • Combination • Mono/Combination. By Stage • Late-stage products (Phase III) • Mid-stage products (Phase II) • Early-stage product (Phase I) along with the details of • Pre-clinical and Discovery stage candidates • Discontinued & Inactive candidates By Route of Administration • Intravenous • Subcutaneous • Oral • Intramuscular By Molecule Type • Monoclonal antibody • Small molecule • Peptide Scope of the Amyotrophic Lateral Sclerosis Pipeline Report • Coverage: Global • Key Amyotrophic Lateral Sclerosis Companies: Ionis Pharmaceuticals, 1ST Biotherapeutics, Scholar Rock, Revalesio, QurAlis Corporation, Sanofi, MediciNova, Helixmith, Verge Genomics, UCB, and others. • Key Amyotrophic Lateral Sclerosis Pipeline Therapies: ION363, FB418, SRK-015, RNS60, QRL-201, SAR443820, MN-166, VM202, VRG-50635, Zilucoplan, and others. Explore detailed insights on drugs used in the treatment of amyotrophic lateral sclerosis here. Table of Contents 1. Introduction 2. Executive Summary 3. Amyotrophic Lateral Sclerosis Pipeline: Overview 4. Analytical Perspective In-depth Commercial Assessment 5. Amyotrophic Lateral Sclerosis Pipeline Therapeutics 6. Amyotrophic Lateral Sclerosis Pipeline: Late-Stage Products (Phase III) 7. Amyotrophic Lateral Sclerosis Pipeline: Mid-Stage Products (Phase II) 8. Amyotrophic Lateral Sclerosis Pipeline: Early Stage Products (Phase I) 9. Therapeutic Assessment 10. Inactive Products 11. Company-University Collaborations (Licensing/Partnering) Analysis 12. Key Companies 13. Key Products 14. Unmet Needs 15. Market Drivers and Barriers 16. Future Perspectives and Conclusion 17. Analyst Views 18. Appendix About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform, PharmDelve. Media Contact Company Name: DelveInsight Contact Person: Jatin Vimal Email: Send Email Phone: +14699457679 Address: 304 S. Jones Blvd #2432 City: Las Vegas State: Nevada Country: United States Website:
India Today
6 days ago
- India Today
LA doctor pleads guilty to giving Matthew Perry ketamine before actor's death
A Los Angeles doctor at the centre of the federal investigation into Matthew Perry's overdose death has pleaded guilty to distributing ketamine to the late "Friends" star, despite knowing he was battling Salvador Plasencia, 43, admitted in court on Wednesday to four felony counts of ketamine distribution — making him the fourth of five people charged in the high-profile case to enter a guilty before US District Judge Sherilyn Peace Garnett, Plasencia said 'guilty' four times as the charges were read in federal court. His plea agreement spares him a trial originally set for August, but he still faces a potential maximum sentence of 40 years in prison. Plasencia, prosecutors said, was one of Perry's primary suppliers in the weeks leading up to the actor's death on October 28, 2023. The Emmy-nominated star was found dead in the hot tub of his Los Angeles an emailed statement following the plea, Plasencia's attorney Debra White said: 'Dr. Plasencia is profoundly remorseful for the treatment decisions he made while providing ketamine to Matthew Perry. He is fully accepting responsibility by pleading guilty to drug distribution.'Plasencia has agreed to surrender his medical licence voluntarily. 'He acknowledges his failure to protect Mr. Perry, a patient who was especially vulnerable due to addiction,' White documents reveal disturbing details about the doctor's conduct. After one injection caused Perry's blood pressure to spike and his bdy to freeze up, Plasencia allegedly left additional doses of ketamine for the actor's assistant to prosecutors confirmed that Plasencia did not supply the lethal dose that ultimately killed Perry, they emphasized that the doctor knowingly prescribed ketamine to someone he understood was in to only as 'victim MP' in court, Plasencia charged Perry thousands of dollars for ketamine treatments, a drug primarily used as a surgical anaesthetic but increasingly misused as a recreational or therapeutic exchange for the plea, prosecutors dropped three additional distribution counts and two counts of falsifying records. According to the Associated Press, Plasencia has been free on bond since his arrest in August 2024 and will remain free until his sentencing on December defence team assured the court that he is not a flight risk. 'He was born and raised here and is one of the primary caretakers for his 2-year-old son,' said defence attorney Karen has already surrendered his DEA license to prescribe controlled substances and had been practising under restrictions — including notifying patients of the charges — until now. The doctor left the courthouse silently, accompanied by his legal team, and declined to speak with reporters.- EndsWith inputs from Associated Press
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Business Standard
21-07-2025
- Health
- Business Standard
Researchers map hair growth pathways for non-surgical hair restoration
Mumbai-based The Esthetic Clinics (TEC), in collaboration with QR678 Research, have co-authored a research paper that maps the complete molecular network governing human hair growth—potentially offering the clearest path yet to hair restoration without the need for surgery, medication, or transplantation. Shome added that the global hair transplant market is currently valued at $15.22 billion and is projected to reach $23.32 billion by 2030. Published in Stem Cell Research & Therapy, the paper was developed by a multidisciplinary team of researchers from India and the United States. It redefines androgenetic alopecia (AGA)—the most common form of hair loss. Significantly, the study is among the first to integrate stem cell biology, gene therapy, and molecular signalling into a unified therapeutic approach for treating AGA. 'For decades, we have treated hair loss as a cosmetic issue. This paper consolidates what we now understand about the biological breakdown behind it—and reframes baldness as a malfunction of the body's regenerative system,' said Debraj Shome, senior author and Director at TEC. The paper focuses on five main molecular pathways—Wnt/β-catenin, Sonic Hedgehog (Shh), Bone Morphogenetic Protein (BMP), Notch, and AKT/MAPK—that work together to control the hair follicle's growth cycle. In cases of AGA, this communication system breaks down—especially due to reduced Wnt activity and increased BMP signals—causing hair follicles to become inactive or dormant. The research proposes several therapeutic strategies to biologically 'reset' hair follicles, such as using stem cell therapies to restore a healthy follicle environment, among other approaches. The Esthetic Clinics noted that some of these approaches have shown results in lab-grown tissues and animal models, with early-stage clinical trials expected to begin within the next two years.
National Post
18-07-2025
- Sport
- National Post
Colin Montgomerie weighs in on Scheffler's rant, Rory's motivation and LIV Golf
PORTRUSH, Northern Ireland — Sitting comfortably in the Loch Lomond Whiskies tent at Royal Portrush, Colin Montgomerie explained how in this recent period away from playing the game of golf, he enjoys working around the house. Article content 'I do my yard, my backyard, as you would call it. Garden,' he said. 'I like cutting the grass, it's quite therapeutic.' Article content Article content His wife Sarah Taylor, who used to manage the golfer, sat on a nearby couch with an expression that clearly questioned her husband's stated passion for yardwork. Article content Article content More on Monty's time away from golf shortly. With so much going on in the sport, there was plenty to ask the eight-time European Order of Merit winner. Article content During his illustrious playing career around the world, Montgomerie didn't always come across as the most satisfied golfer. Considering that, the 62-year-old Scotsman seemed perfect to discuss Scottie Scheffler's comments ahead of this week's Open Championship, where the world's best golfer said he finds professional sports to be an unfulfilling life, and that he sometimes questions the point of it all. Article content Montgomerie wasn't completely surprised. Article content 'Once you've reached a certain height in anything there is only one place to go, and unfortunately it's down,' Montgomerie told the Toronto Sun in a wide-ranging interview. 'You can't stay there forever. I can understand to an extent what he was trying to say.' Article content 'Like, 'Where do I go from here, I've almost done it all already,' I mean 16 wins in four years including three majors? That's incredible. So, where do you go apart from down? It was very honest. Normally nowadays, they get into these press conferences and say nothing. At least he was honest and said how he feels. He's putting his family first which is great, and good luck to him.' Article content Article content After considering the spot Scheffler finds himself in this week at Royal Portrush, right back in the hunt, Montgomerie floated an alternative theory. Article content 'Is this a way of taking the pressure off possibly?' he asked of Scheffler's speech. 'Is this a way of saying, 'I don't really care.' You never know, but it's working.' Article content Noticing Brian Harman's name atop the leaderboard on the television on the wall, and imagining the groans from these fans at the thought of the American with a passion for hunting winning their cherished Jug yet again, we talked about the diminutive left-hander. And whether it's fair to have a crowd against you in a sport such as golf, something Monty has had some experience with. Article content 'He's obviously become a bit of a links expert suddenly from really nowhere,' he said of Harman. 'I'll tell you what he does do, he putts helluva well. But I think if you're not Rory McIlroy here, you feel everyone is against you as a player. It's an odd sort of thing.' Article content 'Because we are in Northern Ireland, it's harder for the English, Scottish or Welsh to get here so you get a really local audience. And Rory's a god here. This Loch Lomond Whiskeys tent is fairly empty right now, but at three o'clock when he's finished, it sure won't be. They will all be coming in after Rory's done.' Article content As with every discussion in Portrush this week, the conversation had made it's way to McIlroy. It's hard not to wonder what the Northern Irish superstar thought of Scheffler's remarks. After all, Rory been going through a motivational problem of his own since accomplishing his childhood dream of winning the career grand slam in April at the Masters. Article content 'It was Rory's ultimate dream to get the four, and he spent 40 majors trying to finish it,' Montgomerie said. 'And everyone was saying now the flood gates will open once he's done this, and he'll win everything. Hang on.' Article content 'One, it's not that easy. Two, I think what happened to him over the PGA Championship and the U.S. Open was he thought, 'God, hang on a minute. Do I have to keep doing this? Do I have to keep all this up?' I think this was a good one for him at Portrush, a great place to try to get back on the rails again.' Article content As for how Rory must have felt standing on the first tee at Portrush on Thursday, six years after hitting his tee shot out of bounds in front of a country of worshippers? Article content 'Very strange feeling,' he said. 'He made a complete hash of it six years ago. Doesn't matter who you are, he was thinking about it. There's no question it was in his head. That iron he hit wasn't flying in the air very much.' Article content It's been nearly a year since reports came out that Montgomerie was having health issues and would be stepping away from the Champions Tour for a time. Article content 'I haven't been very well, I've had a bad year health-wise. So what do I do when I'm not golfing? Well, three children and two grandchildren now, that's good. The grandchildren are becoming people now, they're not babies anymore they are children. I just love being at home. After 40 years of travel, where do you want to be? Sleeping in my own bed, to be honest.' Article content Monty and Sarah live in Sunningdale, England, where the golfer keeps a close eye on the game he loves. His favourite current player is Ludvig Aberg from Sweden. Article content Article content 'I like him. He gets on with,' Montgomerie said. 'He's European, but fine. I like the attitude I like the way he swings the club, he's a modern player. He makes a few too many mistakes at the moment, but his good is as good as anyone's.' Article content His attention to the game is yet to extend to LIV Goif, where a number of his former rivals are presently plying their trade. Article content 'Not that I'm not interested, I just can't find it, it's not readily available,' he said if LIV, 'These people have disappeared off the screen. I mean: Henrik Stenson, Graeme McDowell, Ian Poulter, the guys I used to play with. Lee Westwood? I have no idea how they've finished or what they're doing or whatever. It's crazy and a shame. Article content 'It's very important the game comes back together. If this Saudi Arabian fund is what they say it is and they want to support golf, well let's bring it back together and use that money in a more positive way. What I'm trying to say is give opportunity to others and not just the wealthy get wealthier, let's use it for grassroots golf in places like India and China and Indonesia, wherever. The world's great populations. The sooner we come back together the better for everybody.' Article content Article content Apart from having trouble finding LIV broadcasts, like many fans, Montgomerie seems to struggle with the questionable competitive spirit on LIV. Article content 'When I think of LIV, I think what's the point? I mean, why? This is something here to be champion golfer of the year, it's something. It's tradition,' he said. Article content One thing many of the topics we had covered had in common was money, and how it's changed golf and possibly changed an athlete's motivation in all professional sports. Fulfillment and job satisfaction were much less of a topic in the past when generational wealth wasn't a reality for every player. Article content 'We earned a lot of money but it wasn't retirement money in a year. What's happened now is that Scottie Scheffler is earning $50-60 million in a year and that's retirement money. After one good year you are set,' he said. Article content 'The 90s was my era. What was I doing it for? I had three children born in that time and the lifestyle was improving and I wanted to continue to improve it for the family. So I guess, yes, it was for the money. But now all these guys are making a lot more money than we ever made. Everything has changed in sports.' Article content Montgomerie said he doesn't blame players for leaving for LIV, although he thinks it's a bit more of a peculiar choice for young players trying to make their way in the game. Article content 'But the Westwoods, Poulters and McDowells were plateauing at best and I can't blame them at all,' he said. 'If someone had come to myself it would have been a very difficult decision. Loyalty is one thing but the mighty dollar is another. It's life-changing money.' Article content
