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Forum Arrowhead Pharmaceuticals US04280A1007

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63,325  
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+0,685   (+1,09%)
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ARR

Forum Arrowhead Research geopend

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    Reactie Reactie van: dd20250708
  1. Missolapola
    Arrowhead Pharmaceuticals Initiates Phase 3 YOSEMITE Study of Investigational Zodasiran for the Treatment of Homozygous Familial Hypercholesterolemia
    July 8, 2025

    - Zodasiran targets ANGPLT3, an emerging therapeutic target to treat HoFH and other dyslipidemias

    - YOSEMITE Phase 3 study further enhances Arrowhead’s late-stage pipeline of RNAi-based cardiometabolic candidates

    PASADENA, Calif.--(BUSINESS WIRE)--Jul. 8, 2025-- Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced that it has dosed the first subject in the YOSEMITE Phase 3 clinical trial of zodasiran, the company’s investigational RNA interference (RNAi) therapeutic being developed as a potential treatment for homozygous familial hypercholesterolemia (HoFH), a rare genetic condition that leads to severely elevated LDL-cholesterol and early onset cardiovascular disease. Zodasiran is the fourth investigational RNAi-based candidate developed by Arrowhead to reach late-stage pivotal studies, after investigational drugs plozasiran, fazirsiran (licensed to Takeda) and olpasiran (licensed to Amgen).

    “Patients living with HoFH are difficult to adequately treat and have a very high risk of developing atherosclerotic cardiovascular disease due to severely elevated LDL-C, often exceeding 500 mg/dL. As an RNAi-based therapeutic targeting ANGPTL3, investigational zodasiran has the potential to treat HoFH in a fundamentally different manner from traditional LDL-C–lowering therapies,” said James Hamilton, M.D., Chief Medical Officer and head of R&D at Arrowhead. “In Phase 2 clinical studies, patients with HoFH receiving zodasiran achieved reductions from baseline in LDL-C, ApoB, non-HDL-C, and triglycerides, supporting its potential therapeutic role for the treatment of HoFH patients.”
    2. Reactie Reactie van: dd20250709
    3. Reactie Reactie van: dd20250718
    4. Reactie
  4. harvester
    quote:

    de tuinman schreef op 18 juli 2025 20:43:

    Uuh, wat gebeurt er????
    Arrowhead partner Sarepta heeft problemen met haar sterproduct ( iets van 30 % van hun omzet kan wegvallen) door 2 doden onder de behandelde patiënten. Sarepta is aan het reorganiseren en gooide meen ik 35% van hun personeel eruit. Zie website Sarepta,
    5. Reactie Reactie van: dd20250720
  5. forum rang 4 de tuinman
    quote:

    harvester schreef op 18 juli 2025 23:57:

    [...]

    Arrowhead partner Sarepta heeft problemen met haar sterproduct ( iets van 30 % van hun omzet kan wegvallen) door 2 doden onder de behandelde patiënten. Sarepta is aan het reorganiseren en gooide meen ik 35% van hun personeel eruit. Zie website Sarepta,
    Dank u.
    6. Reactie Reactie van: dd20250724
  6. Missolapola
    PB van gisteren:

    Arrowhead Pharmaceuticals Issues Statement on the Status of its Ongoing Agreement with Sarepta Therapeutics
    PASADENA, Calif.--(BUSINESS WIRE)--Jul. 23, 2025-- Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today issued a statement to address questions about the status of its ongoing Exclusive License and Collaboration Agreement with Sarepta Therapeutics. Arrowhead continues to conduct clinical and non-clinical studies as stipulated in the agreement, and it expects Sarepta to continue to meet its required financial obligations. Sarepta has provided no indication of any intention to fail to fulfill any of its obligations, however if that occurs there are clear termination provisions that would cause assets and associated intellectual property to be returned to Arrowhead. Arrowhead believes its strong balance sheet and multiple opportunities for additional near- and mid-term business development would be sufficient to support existing and future advancement of these potentially impactful therapies through clinical and preclinical development. Below is an overview of the agreement.

    Upon closing of the agreement in February 2025, Arrowhead received a $500 million upfront payment and $325 million through the purchase by Sarepta of Arrowhead common stock priced at $27.25 per share. Arrowhead will also receive $250 million to be paid in annual installments of $50 million over 5 years, with the first $50 million payment due in February 2026. Arrowhead is eligible to receive $300 million in near-term payments associated with the continued enrollment of certain cohorts of a Phase 1/2 study of ARO-DM1. Arrowhead believes it is on track to earn the first $100 million soon and the remaining $200 million by the end of the year. Arrowhead is also eligible to receive a further $10 billion in potential milestones and tiered royalties on commercial sales up to low double digits. Included in the agreement were four clinical-stage drug candidates, three pre-clinical programs, and up to six additional targets outside Arrowhead’s pipeline.

    Sarepta has recently experienced setbacks in products and programs unrelated to those licensed from Arrowhead. These setbacks led Sarepta to conduct a strategic restructuring plan that included cost cutting measures and a pipeline review that prioritizes the funding, development, and commercialization of programs licensed from Arrowhead. Sarepta has clearly stated that it believes this represents the future of their company and has taken measures to ensure they meet their financial obligations.

    Should Sarepta fail to make either the $100 million or $200 million near-term payment associated with enrollment of ARO-DM1 cohorts, Arrowhead would have the right to terminate the agreement with respect to ARO-DM1, and the program and all associated intellectual property would revert back to Arrowhead. Similarly, should Sarepta fail to make any development or commercial milestone payment, Arrowhead would have the right to terminate the agreement with respect to the asset for which the payment was owed, and the program and all associated intellectual property would revert back to Arrowhead. If Sarepta fails to make any of the annual $50 million payments, Arrowhead would have the right to terminate the entire agreement and all of Arrowhead’s intellectual property rights that have been licensed to Sarepta under all of the programs would revert to Arrowhead. In such cases, Arrowhead would have no obligation to return any consideration Sarepta had already paid.
    7. Reactie Reactie van: dd20250728
  7. Missolapola
    Arrowhead Pharmaceuticals Earns $100 Million Milestone from Sarepta Therapeutics

    July 28, 2025
    PDF Version
    - Milestone earned upon reaching first enrollment target in a Phase 1/2 study of ARO-DM1 for the treatment of type 1 myotonic dystrophy

    PASADENA, Calif.--(BUSINESS WIRE)--Jul. 28, 2025-- Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced that it has earned a $100 million milestone payment from Sarepta Therapeutics (NASDAQ: SRPT). The milestone was triggered when Arrowhead reached the first of two prespecified enrollment targets and subsequent authorization to dose escalate in a Phase 1/2 clinical study of ARO-DM1, an investigational RNA interference (RNAi) therapeutic for the treatment of type 1 myotonic dystrophy (DM1), the most common adult-onset muscular dystrophy. Arrowhead currently expects to achieve the second enrollment target by the end of 2025, which would trigger an additional $200 million milestone payment from Sarepta.

    In accordance with the license and collaboration agreement, Arrowhead expects to receive this payment within 60 days.

    About the Arrowhead-Sarepta Agreement

    Arrowhead and Sarepta signed a global licensing and collaboration agreement in November 2024, which closed in February 2025, whereby Sarepta received rights to multiple investigational treatments that leverage Arrowhead’s leading Targeted RNAi Molecule (TRiMTM) platform. The agreement covers multiple clinical and preclinical programs in rare, genetic diseases of the muscle, central nervous system, and the lungs, and also allows Sarepta to select up to six new targets for Arrowhead to conduct discovery and preclinical development activities in areas complementary to Sarepta’s leadership in precision genetic medicine for rare diseases.

    Summary Financial Terms

    Upon closing, Arrowhead received a $500 million upfront payment and $325 million through the purchase by Sarepta of Arrowhead common stock priced at $27.25 per share, representing a 35% premium to the 30-day volume weighted average price (VWAP) when the agreement was signed. Arrowhead will also receive $250 million to be paid in annual installments of $50 million over five years, and has the potential to receive an additional $300 million in near-term milestone payments associated with the continued enrollment of certain cohorts of a Phase 1/2 study of ARO-DM1, $100 million of which has now been earned.

    Arrowhead is also eligible to receive further development milestone payments of between $110 million and $180 million per program, sales milestone payments of between $500 million and $700 million per program, and tiered royalties on commercial sales up to the low double digits.

    Summary of Programs Under the License and Collaboration Agreement

    Clinical Stage

    ARO-DUX4, which is designed to target the gene that encodes the DUX4 protein as a potential treatment for patients with facioscapulohumeral muscular dystrophy type 1, currently dosing patients in a Phase 1/2 clinical study.
    ARO-DM1, which is designed to reduce expression of the dystrophia myotonica protein kinase (DMPK), gene in skeletal muscle as a potential treatment for patients with type 1 myotonic dystrophy, currently dosing patients in a Phase 1/2 clinical study.
    ARO-MMP7, which is designed to reduce expression of matrix metalloproteinase 7 (MMP7) in the lung as a potential treatment for idiopathic pulmonary fibrosis, currently dosing patients in a Phase 1/2 clinical study.
    ARO-ATXN2, which is designed to silence expression of the toxic ATXN2 protein in the CNS as a potential treatment for spinocerebellar ataxia 2 (SCA2), currently in a Phase 1/2 study that is open for enrollment.
    Preclinical Stage

    ARO-HTT for patients with Huntington’s disease, expected to be CTA-ready in 2025
    ARO-ATXN1 for patients with spinocerebellar ataxia 1 (SCA1) expected to be CTA-ready in 2026
    ARO-ATXN3 for patients with spinocerebellar ataxia 3 (SCA3) expected to be CTA-ready in 2026
    Discovery

    During the five-year term, Sarepta can propose up to six new CNS or muscle targets for which Arrowhead will perform discovery and preclinical development. Sarepta would then receive an exclusive license to those programs and would be responsible for subsequent clinical development and commercialization.

    Drug Manufacturing

    Under the terms of the agreement, Arrowhead will manufacture clinical drug supply for all programs arising out of the license and collaboration, and commercial drug product for the four programs currently in clinical trials.
    8. Reactie Reactie van: dd20250801
  8. Missolapola
    Arrowhead Subsidiary Visirna Sells Rights to Hypertriglyceridemia Candidate Plozasiran in Greater China to Sanofi

    August 1, 2025

    - Sanofi to pay $130 million upfront and up to $265 million in potential regulatory milestones to Visirna Therapeutics, a majority-owned subsidiary of Arrowhead, which was previously granted rights to investigational plozasiran in Greater China

    - Sanofi will receive an exclusive license to develop and commercialize investigational plozasiran in Greater China from Visirna Therapeutics, offering potential treatment to people living with elevated triglycerides

    PASADENA, Calif.--(BUSINESS WIRE)--Aug. 1, 2025-- Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced the signing of an asset purchase agreement between Sanofi and Visirna Therapeutics, a majority-owned subsidiary of Arrowhead created to develop and commercialize four of Arrowhead’s investigational cardiometabolic candidates in Greater China. Under the terms, Sanofi will acquire rights to develop and commercialize investigational plozasiran, Arrowhead’s first-in-class RNA interference (RNAi) therapeutic candidate designed to reduce production of apolipoprotein C-III (APOC3) as a potential treatment for familial chylomicronemia syndrome (FCS) and severe hypertriglyceridemia (SHTG), in Greater China.

    Visirna has completed a Phase 3 clinical trial (CTR20231418/NCT05902598) of investigational plozasiran in Chinese patients with familial chylomicronemia syndrome (FCS), which successfully met its primary efficacy endpoint and all key secondary endpoints. Visirna subsequently submitted a New Drug Application (NDA) for plozasiran to the National Medical Products Administration (NMPA) in China for the treatment of FCS and received official acceptance in January 2025. Plozasiran has also been granted Breakthrough Therapy Designation in the treatment of patients with FCS and Priority Review Designation by the China NMPA.

    “When we founded Visirna in 2022, we believed that Greater China represented an important potential future market for multiple programs in Arrowhead’s pipeline of investigational RNAi-based candidates for cardiometabolic diseases,” said Christopher Anzalone, Ph.D., Arrowhead’s President and CEO. “The team at Visirna understand the intricacies of China’s clinical, regulatory, and commercial environment and have done impressive work moving plozasiran through clinical studies and into the regulatory submission and review process. We now look forward to working with Sanofi and believe they are extremely well positioned as a global company with a strong presence in China.”

    Wayne Shi, President, Sanofi Greater China, added, “We are pleased to have concluded this agreement to enable us to advance plozasiran in Greater China where Sanofi has deep roots and a proud heritage of serving people living with a wide range of diseases. Plozasiran has shown considerable potential in studies across diverse patient populations where serious illness is caused by elevated triglycerides. With our strong presence in China’s cardiometabolic field, we now look forward to bringing it forward to address unmet need.”

    Upon closing of the Asset Purchase Agreement, Visirna will receive an upfront payment of $130 million from Sanofi. In addition, Visirna will be eligible to receive further milestone payments of up to $265 million upon approval of plozasiran across various indications in mainland China. Arrowhead is further eligible to receive royalties on net commercial product sales in Greater China as part of the Arrowhead-Visirna license which was assigned in part to Sanofi.

    Gibson, Dunn & Crutcher LLP and Sidley Austin LLP are serving as legal advisors to Arrowhead.
    9. Reactie Reactie van: dd20250808
    10. Reactie
  10. forum rang 5 Tom3
    Wellicht zou de onverwachte koersstijging vandaag verband kunnen houden met het mogelijk bod dat Novartis een paar dagen geleden heeft uitgebracht op Avidity. Avidity is een rechtstreekse concurrent van Sarepta. Gezien de concurrentie op het gebied van zeldzame spierziekten is de deal die Arrowhead op dit gebied gesloten heeft met Sarepta bijzonder goed doordacht. Sarepta (als die als alles goed op de rit krijgt) zal denk ik een hele kluif krijgen aan Avidity/ Novartis.
    finance.yahoo.com/news/novartis-weigh...
    11. Reactie Reactie van: dd20250809
    12. Reactie Reactie van: dd20250811
    13. Reactie
  13. Acht
    quote:

    Hulskof schreef op 11 augustus 2025 14:34:

    Rage is waarschijnlijk dood en begraven. Of, maar dat acht ik minder waarschijnlijk, toegezegd aan een partner en moeten er enkel nog wat kreukels gladgestreken worden.
    Maar ik vermoed dat ze gewoon geen efficacy hebben gezien.
    Maar het is toch te gek dat niemand daar een vraag over stelt.
    Dat is toch niet zo moeilijk -- of is het enkel de vragen stellen die arwr kiest ...
    Ik vind dat echt raar
    14. Reactie Reactie van: dd20250812
  14. forum rang 5 Tom3
    quote:

    Acht schreef op 11 augustus 2025 15:51:

    [...]

    Maar het is toch te gek dat niemand daar een vraag over stelt.
    Dat is toch niet zo moeilijk -- of is het enkel de vragen stellen die arwr kiest ...
    Ik vind dat echt raar
    Dit is ook mijn insteek. Als hier geen vragen over gesteld mogen worden is zo'n kwartaalbijeenkomst een veredeld soort poppenkast. In het verleden werd hoog van de toren beglazen over RAGE. Nu wordt er enkel nog hoeraverhalen verteld over de obesitas trials...... je hoeft in de VS natuurlijk ook maar 1 kaskraker te hebben om de show te stelen (lees Vertex) natuurlijk, maar toch. En Arrowhead heeft wel vaker verrassingen .... RAGE antilichamen kun je trouwens gewoon bestellen bij Termo Fisher Scientific. Er geen grote farmaceut die iets in die richting op de markt heeft. Maw het helpt niet bij astma.
    15. Reactie
    16. Reactie Reactie van: dd20250813
  16. forum rang 4 Hulskof
    Van Discord een interessante visie. Geen idee hoe waar dit kan worden...

    Imo.. i still view Pulmonary platform intact. It is just not ready for primetime yet. I think will be saved until Q1 or Q2 2026. The focus right now is Plozasiran in November and their Muscle targets. Both ARWR and SRPT are aligned to support each other and carry both through the the recent harsh turbulence and will come out successful. With recent updates on DM1. looks like high probability of success on the Muscle drugs. Clearly the silence even on MMP7 was the agreed instructions to DI from CA. Their actions to date, imo, cement their relationship even further. CA picked DI over NVS to run their Muscle targets knowing they hold the better gems on treating these devastating diseases and would get a more fair treatment than from a traditional big BP. I think the outlook for both is very bright at the moment and am expecting big moves ahead on both companies. They will continue to trade in tandem but eventually SRPT will break away higher but also carries on more risk than ARWR.. we will slowly chug along and end outcome will be a merge b/t the 2 companies after they have successfully commercialized their muscle, lung and CNS projects.
    17. Reactie
  17. forum rang 4 Hulskof
    Een gedachte van o.a. Holden wijst mogelijk in de richting van een steeds verder gaande samenwerking tussen ARWR en SRPT.

    I would expect a DUX4 update any day now. Similar to DM1. Study showing "recruiting" but p1/2a sb complete, just like DM1. So one might assume (I am) that DUX4, if it shows a hair of positive efficacy, patients wb added and a new PCD and SCD wb added. My guess is patients increased to 100ish (Already increased from the initial 52 to present 60). If this happens it would be in line with Ingram's statement that siRNA is the future of SRPT AND would spit on the pathetically slow development efforts put forth by CA and the, "Fly Through the Clinic" team. All in my opinion, of course. clinicaltrials.gov/study/NCT06131983
    18. Reactie
  18. forum rang 4 Hulskof
    Would seem to me, based on what Anzalone said here about being in discussions with Sarepta about a deal since 2023, that the original deal they had for DUX4 that “fell through” may have also been with Sarepta. He seems to indicate that the deal only took so long because it kept growing in scope.

    Holden: I agree. It seemed at the time CA wanted to only do a deal for one or perhaps 2 indications but Ingram knew he was pipeline-deficient so he backed away and generated a bunch of cash until CA rolled. I think CA was willing to give up DUX4 and MAYBE DM1 although likely did not want to give up CNS and other undisclosed assets but he eventually caved. The structure of DM1 makes sense in that regard, which is, ~"If we are going to sell off (partner) something as far along as DM1, with only a handful of patient enrollments outstanding before a full potentially registrational data set is generated, then we want some serious cash shortly after we close the deal subject to successful enrollment." If that speculation is correct, then we now know the number = $300Mn + royalties. Maybe some modest DUX4 MSPs also on the table. We shall see. All in my opinion, of course.
    19. Reactie Reactie van: dd20250821
  19. forum rang 5 Tom3
    De wind lijkt te draaien voor Arrowhead na de 50% betaling door Sarepta dmv aandelen die vervolgens op de plank zijn gelegd. Sarepta bewandelt inmiddels het traject in omgekeerde volgorde. Duidelijk is wel dat Sarepta inmiddels geheel afhankelijk is van ARWR technologie. Wellicht zijn er nog meer die de gentechnolgie in spieren vaarwel zeggen.
    20. Reactie Reactie van: dd20250831 Laatste reactie
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