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Tom3 schreef op 15 mei 2024 10:20 :
[...]
Slimme move: de helft van de bezittingen bestaat uit een retailer CAVA. Die positie wordt met meer dan 50% winst langzaam ingeruild tegen voornamelijk biotechs. Die zijn de laatste jaren sterk achter gebleven bij de rest.
True maar het is wel speculatief biotechs. Wel gemerkt dat voor arrowhead gedacht dat de rente naar beneden gaat de koers toch wel flink hoger heeft gezet (om dan weer in de afgrond te lopen omdat inflatie toch langer duurt). Echte verlaging van de rente die eens gebeurd zal misschien de koers wat permanent hoger zetten (zonder extra nieuws van al de conferences of onderzoek). Als ik zoveel kapitaal als een holding had zou ik ook wel kleine verhoging durven wagen in arrow. If only :)
Arrowhead Pharmaceuticals Presents New Clinical Data Showing ARO-RAGE Achieves High Level of Gene Knockdown in Patients with Asthma
Een mooi bericht, en vermoedelijk niet het laatste dit jaar.
Arrowhead Pharmaceuticals Presents New Phase 2 Data of Plozasiran in Patients with Mixed Hyperlipidemia May 28, 2024 PDF Version - Plozasiran significantly lowered triglyceride levels with commensurate reductions in APOC3, non-HDL-C, and remnant cholesterol - Data presented at European Atherosclerosis Society 92nd Congress and simultaneously published in the New England Journal of Medicine PASADENA, Calif.--(BUSINESS WIRE)--May 28, 2024-- Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced results from the Phase 2b double blind, randomized MUIR study of investigational plozasiran (formerly ARO-APOC3) in patients with mixed hyperlipidemia. Treatment with plozasiran in the MUIR study achieved reductions in triglyceride rich lipoproteins, a genetically validated target associated with increased risk of atherosclerotic cardiovascular disease (ASCVD)1,2. These data were presented in an oral presentation today at the European Atherosclerosis Society (EAS) 92nd Congress and simultaneously published in the New England Journal of Medicine. “Plozasiran demonstrated potent and durable reductions of atherogenic lipoproteins, such as non-HDL-C, ApoB, and remnant cholesterol in the Phase 2 MUIR study that supports its further development in Phase 3 studies for patients with increased risk for ASCVD,” said Christie M. Ballantyne, M.D., Baylor College of Medicine, and Principal Investigator for the MUIR study. “Despite advances in treatment, patients with mixed hyperlipidemia have elevated and persistent ASCVD risk due in part to high levels of atherogenic triglyceride rich lipoproteins. The promising results from treatment with plozasiran in the MUIR study help to lay the groundwork for a more extensive study to potentially test whether plozasiran reduces ASCVD risk.” Bruce Given, M.D., interim chief medical scientist at Arrowhead added, “Results from the MUIR study of plozasiran in patients with mixed hyperlipidemia are encouraging and we are excited to present data at EAS and publish the results today in the New England Journal of Medicine. We believe plozasiran shows promise in multiple diseases with substantial unmet need, including familial chylomicronemia syndrome, severe hypertriglyceridemia, and mixed hyperlipidemia, and we are eager to further investigate plozasiran in additional clinical studies.” Select MUIR Results By silencing Apolipoprotein C-III (APOC3), plozasiran significantly reduced triglycerides and atherogenic triglyceride rich lipoproteins and increased HDL, across all dose levels at Week 24 in patients with mixed dyslipidemia. At week 24, representing trough effect after 2 quarterly doses, plozasiran treatment was associated with placebo adjusted reductions in triglycerides of -50%, -56%, and -62% (all p<0.001) at the 10, 25, and 50 mg doses, respectively. Fasting triglyceride levels were normalized (achieved levels below 150 mg/dL) in most patients (79-92%) randomized to a treatment arm. Commensurate reductions in APOC3 of -57%, -73%, and -79%, with strong positive correlations with changes in triglyceride levels were observed. Changes in other atherogenic lipoprotein parameters were also observed. At week 24, for the quarterly doses of 10, 25, and 50 mg, the following placebo adjusted changes were observed: non-HDL-C levels -17%, -18%, and -24%; apoB levels -10%, -13%, and -19%; and remnant cholesterol levels -43%, -49%, and -48% with strong correlations with changes in triglyceride levels. Safety and Tolerability Plozasiran demonstrated a favorable safety profile in the MUIR study. The overall rates of occurrence of treatment-emergent adverse events (TEAEs) and discontinuations were similar for plozasiran and placebo throughout the 48 weeks of observation. Observed adverse events generally reflected the comorbidities and underlying conditions of the study population. TEAEs occurring in 5 or more patients were COVID-19, worsening glycemic control, upper respiratory tract infection, urinary tract infection, headache, and bronchitis. Arrowhead is also presenting data from the SHASTA-2 study of plozasiran and the ARCHES-2 study of zodasiran (formerly ARO-ANG3) at EAS. Details about the EAS presentations are listed below. European Atherosclerosis Society (EAS) 92nd Congress – May 26-29, 2024 Title: PLOZASIRAN (ARO-APOC3), DECREASES APOC3 AND TRIGLYCERIDES (TG) IN PATIENTS WITH MIXED DYSLIPIDEMIA: MUIR FINAL RESULTS Date/Time: May 28, 2024, 12:04 p.m. CEST Presenter: Christie M Ballantyne, M.D. Session: New Therapeutics Title: PLOZASIRAN (ARO-APOC3), AN INVESTIGATIONAL RNAI THERAPEUTIC, DEMONSTRATES PROFOUND AND DURABLE REDUCTIONS IN APOC-3 AND TRIGLYCERIDES (TG) IN PATIENTS WITH SEVERE HYPERTRIGLYCERIDEMIA (SHTG), SHASTA-2 FINAL RESULTS Date/Time: May 28, 2024, 2:49 p.m. CEST Presenter: Daniel Gaudet, M.D., Ph.D. Session: SaaG Session: The Enigmas of TG-rich Lipoproteins Title: ZODASIRAN SILENCES HEPATIC ANGPTL3 LEADING TO DEEP AND DURABLE REDUCTIONS IN ATHEROGENIC LIPIDS AND LIPOPROTEINS IN MIXED DYSLIPIDEMIA PATIENTS: FINAL RESULTS FROM ARCHES-2, DOUBLE-BLIND PERIOD Date/Time: May 29, 2024, 11:30 a.m. CEST Presenter: Robert Rosenson, M.D. Session: Late Breaker Session 2: New Therapeutic Agents
Arrowhead Pharmaceuticals Presents New Phase 2 Data of Zodasiran in Patients with Mixed Hyperlipidemia May 29, 2024 PDF Version - Zodasiran significantly reduced triglycerides and atherogenic triglyceride rich lipoproteins across all dose levels at Week 24 - Data presented at European Atherosclerosis Society 92nd Congress and simultaneously published in the New England Journal of Medicine PASADENA, Calif.--(BUSINESS WIRE)--May 29, 2024-- Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced results from the Phase 2b double blind, randomized ARCHES-2 study of investigational zodasiran (formerly ARO-ANG3) in patients with mixed hyperlipidemia. Zodasiran was associated with robust and durable reductions in triglycerides, triglyceride rich lipoprotein remnants, and total atherogenic lipoproteins, including LDL-C. These data were presented in a late-breaking oral presentation today at the European Atherosclerosis Society (EAS) 92nd Congress and simultaneously published in the New England Journal of Medicine. “Results from clinical studies of zodasiran, including those for the ARCHES-2 study in patients with mixed hyperlipidemia presented today at EAS and published in the New England Journal of Medicine, continue to support ANGPTL3 as an exciting target for an RNAi-based gene silencing strategy,” said Bruce Given, M.D., interim chief medical scientist at Arrowhead. “Genetic studies show that ANGPTL3 loss-of-function variants lead to enhanced lipoprotein lipase and endothelial lipase activity, resulting in lower concentrations of most plasma lipoproteins, including triglyceride rich lipoproteins, LDL-C, VLDL/remnant cholesterol, and HDL-C. Individuals with these variants also have demonstrated a markedly reduced risk of ASCVD and have no known adverse clinical phenotypes1-3.” Robert Rosenson, M.D., Icahn School of Medicine at Mount Sinai, and Principal Investigator for the ARCHES-2 study added, “The potent reductions in serum lipids and lipoproteins and favorable safety profile seen in the ARCHES-2 clinical study of zodasiran suggest its potential to treat residual ASCVD risk in patients with elevated triglyceride rich lipoproteins. The genetic data around ANGPTL3 as a target are very compelling and support further Phase 3 studies to determine whether the large reductions in triglyceride rich lipoproteins observed after zodasiran treatment can replicate the genetic data and reduce ASCVD risk.” Select ARCHES-2 Results Zodasiran treatment was associated with dose-dependent placebo adjusted reductions in triglycerides, remnant cholesterol, LDL-C, ApoB, and Non-HDL-C across all dose levels in patients with mixed hyperlipidemia. At week 24, representing trough effect, zodasiran treatment at 50, 100, and 200 mg on day 1 and week 12 was associated with placebo adjusted reductions in triglycerides of -51%, -57%, and -63% (all p<0.001) respectively. ANPTL3, the genetic target of zodasiran, was reduced compared with placebo by -54%, -70%, and -74%, and remnant cholesterol levels were reduced by -73%, -76%, and -82%, which strongly correlated with changes in triglyceride levels. Changes in other atherogenic lipoprotein parameters were also observed across all three dose levels. At week 24, the following placebo adjusted changes were observed for the 200 mg dose: LDL-C -20%, ApoB -22%; Non-HDL-C -36%. In a subset of patients with baseline liver fat fraction greater than 8%, dose-dependent liver fat reductions, measured by MRI-PDFF, were observed reaching -28% with the 200 mg dose compared with -2% with placebo. Safety and Tolerability Zodasiran demonstrated a favorable safety profile in patients with mixed hyperlipidemia in the ARCHES-2 study. Treatment-emergent adverse events (TEAEs) were generally balanced between treatment and placebo groups and generally reflected the comorbidities and underlying conditions of the study population. There were no clinically meaningful changes in laboratory safety evaluations, no changes in mean platelet counts, and modest changes in HbA1c. Details about the EAS presentation is listed below. European Atherosclerosis Society (EAS) 92nd Congress – May 26-29, 2024 Title: ZODASIRAN SILENCES HEPATIC ANGPTL3 LEADING TO DEEP AND DURABLE REDUCTIONS IN ATHEROGENIC LIPIDS AND LIPOPROTEINS IN MIXED DYSLIPIDEMIA PATIENTS: FINAL RESULTS FROM ARCHES-2, DOUBLE-BLIND PERIOD Date/Time: May 29, 2024, 11:30 a.m. CEST Presenter: Robert Rosenson, M.D. Session: Late Breaker Session 2: New Therapeutic Agents
Lijkt me goed nieuws, concurrent minder zou toch positief moeten zijn. Ben wel niet technisch genoeg om te weten of arrowhead zijn ARO-ANG3 kans heeft om tegen dezelfde issues op te lopen als het gecancelde vupanorsen.
GoedeDag schreef op 31 mei 2024 22:42 :
Lijkt me goed nieuws, concurrent minder zou toch positief moeten zijn.
Ben wel niet technisch genoeg om te weten of arrowhead zijn ARO-ANG3 kans heeft om tegen dezelfde issues op te lopen als het gecancelde vupanorsen.
Voor mij ook een vraagteken. Het is erg stil bij de kenners. Toch zoekt Arrowhead de media. Van X krijg ik een vaag vermoeden dat beleggers bezorgd zijn om de kas positie van Arrowhead.
@Tuinman en GoedeDag: Pfizer trok haar handen af van Vupanorsen in 2022. Het werd op X aangehaald om weer te geven hoe groot de ANGPTL3- markt is en hoe laag Arrowhead momenteel dus gewaardeerd wordt, aangezien Zodasiran (ARO-ANG3) veelbelovend is in die markt en geen last van de issues van Vupanorsen lijkt te hebben. Ik zeg bewust 'lijkt', want geen enkele outsider kan hier naar mijn idee een gedegen oordeel over vellen. Arrowhead lijkt in elk geval zeker van haar zaak, maar was dat voorheen met ARO-ENAC ook en toen kwamen daar ineens die ratten met hun overgevoelige longen. ;-) Ik bedoel maar, je weet nooit hoe eea loopt totdat het zover is. Maar dat Arrowhead nu kiest voor één combinatie CVOT van APOC3 en ANG3 lijkt me alleszins erg positief. Dat MS en GS hun koersdoelen verlagen maar ondertussen aandelen Arrowhead blijven bijkopen is nog positiever. Het enige dat mij steekt (en de markt kennelijk ook) is het uitblijven van een nieuwe deal die flink wat geld op de plank brengt, want die gedane emissie is misschien leuk voor de korte termijn, maar lost de grote geldbehoefte voor genoemde CVOT niet op. Zodra die horde genomen is, schiet de koers omhoog (is mijn voorspelling). Tot die tijd blijven we denk ik tussen de 20 en 25 hangen.
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