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Aandeel Arrowhead Pharmaceuticals OTC:ARWR.Q, US04280A1007

Vertraagde koers (usd) Verschil Volume
19,610   +0,190   (+0,98%) Dagrange 19,070 - 20,106 1.041.940   Gem. (3M) 994,4K

Forum Arrowhead Research geopend

8.506 Posts
Pagina: «« 1 ... 421 422 423 424 425 426 »» | Laatste | Omlaag ↓
  1. forum rang 4 nb 3 augustus 2024 01:59
    quote:

    Tom3 schreef op 2 augustus 2024 16:17:

    [...]

    Al een tijd niets meer van 4finance gehoord hier: zeker zijn winst genomen. De heilzame uitwerking van een aanstaande renteverlaging voor de biotech sector lijkt me vandaag weer dichterbij gekomen.
    Lijkt me ook. Ik blijf zitten in biotech. Al doet het een en ander wel pijn. Vooral bleeders bij brunel, flowtraders en nog een paar.
    4finance zit volgeladen in nano, zie canadese aandelen. Die bekostigt ie met de enorme winsten in besi.
  2. forum rang 10 DeZwarteRidder 3 augustus 2024 08:03
    quote:

    nb schreef op 3 augustus 2024 01:59:

    [...]
    Lijkt me ook. Ik blijf zitten in biotech. Al doet het een en ander wel pijn. Vooral bleeders bij brunel, flowtraders en nog een paar.
    4finance zit volgeladen in nano, zie canadese aandelen. Die bekostigt ie met de enorme winsten in besi.
    Die laatste zin wordt z'n ondergang.
  3. forum rang 7 4finance 7 augustus 2024 15:41
    Grappig dat mijn naam hier nog steeds wordt genoemd. Maak u om mij maar geen zorgen.
    Al Jaren in o.a BESI en ASML. Inderdaad enorme winsten op deze aandelen. Overigens 1 van mijn grootste historische winsten komt uit ARROWHEAD. En inderdaad mijn NANO's doen het nog even niet niet. Dat hoort ook bij gespreid beleggen. Ik heb in de weg naar beneden fors veel aandelen NANO bijgekocht. En NEE, ik ga niet meer in biotech. Veel plezier en geluk hier nog met ARROWHEAD.
  4. Acht 8 augustus 2024 22:25
    Arrowhead Pharmaceuticals (NASDAQ: ARWR) has secured a $500 million strategic financing facility with Sixth Street, strengthening its balance sheet with long-term, non-dilutive capital. The deal includes $400 million funded at close and the potential for an additional $100 million. This financing immediately enhances Arrowhead's ability to advance plozasiran towards a 2025 launch and expands possibilities to fund innovation across its RNAi therapeutics pipeline.

    The seven-year credit facility bears an annual interest rate of 15% and matures on August 7, 2031. It provides flexible repayment mechanics, aligning outflows with future inflows from partnerships, collaborations, and commercial revenue. This structure allows Arrowhead to confidently build its commercial capabilities while supporting growth and innovation across its pipeline.
  5. wijzerplaat 9 augustus 2024 10:49
    BioBoyScout ~ Twitter/X :

    Fantastic deal, there is no way any gene editing company ever gets this great of a deal. Sixth Street must have like what they saw under the hood. This is a huge win-win. Losers are the investment banks for keeping the price down, perhaps they'll learn their lesson. $ARWR #RNAi

  6. forum rang 5 Hulskof 13 augustus 2024 14:00
    Ik zie maar één pluspunt aan deze financiering met Sixth Street. Het geeft ARWR wat meer tijd om een gunstige partnerschap af te sluiten na p1/2 data van de diverse longprogramma's (waarvoor het nu nog te vroeg is).

    In de pijplijn zit momenteel niks dat in deze fase waardevol genoeg is om een substanciële deal mogelijk te maken. Behoudens zodasiran, maar geloof maar dat CA geprobeerd heeft dat middel aan de man te brengen. Blijkbaar lijkt het te veel op plozasiran en heeft ARWR er zichzelf mee in de voet geschoten. Niemand wil het hebben - en dat lijkt me een misser van de bovenste plank. Ik heb te weinig kennis om zo hard te mogen oordelen, maar als je ooit van de daken schreeuwde dat je met ploza én zoda twee potentiële blockbusters in huis hebt en niet lang daarna moet een van de twee op de plank verdwijnen, dan heb je zachtgezegd een grove inschattingsfout gemaakt.

    Naast ploza en zoda heeft ARWR niks in p2 of p3 zitten wat al niet is gepartnerd. Kortom, een deal die flink wat geld op de plank zal brengen, komt er voorlopig niet, omdat ze niks hebben dat zo'n deal rechtvaardigt.
    Nou ja, ze zouden ploza natuurlijk ook kunnen partneren, maar dan houden ze zelf dus echt niks meer over...

    Vandaar de deal met Sixth Street. Voorlopig zijn de geldzorgen eventjes weg, maar belangrijk is nu dat ze het geld voor de juiste dingen gebruiken. NIET dus voor weer nieuwe indicaties om CA's bonus van 20 in 25 te kunnen zekerstellen. Ze moeten zich richten op de NDA van ploza in FSC en zorgen dat het product op de markt komt. Mogelijk stijgt dan eindelijk de koers wat en kunnen ze later tegen een hogere koers een nieuwe emissie doen. Andere mogelijkheid is als de rente verder zakt een nieuwe soortgelijke deal sluiten als de huidige met Sixth Street, maar dan tegen veel gunstigere voorwaarden. Al vrees ik dat ze, eer het zo ver is, weer een nieuwe grote zak met geld nodig gaan hebben.
  7. forum rang 10 DeZwarteRidder 13 augustus 2024 14:28
    quote:

    Acht schreef op 8 augustus 2024 22:25:

    Arrowhead Pharmaceuticals (NASDAQ: ARWR) has secured a $500 million strategic financing facility with Sixth Street, strengthening its balance sheet with long-term, non-dilutive capital. The deal includes $400 million funded at close and the potential for an additional $100 million. This financing immediately enhances Arrowhead's ability to advance plozasiran towards a 2025 launch and expands possibilities to fund innovation across its RNAi therapeutics pipeline.

    The seven-year credit facility bears an annual interest rate of 15% and matures on August 7, 2031. It provides flexible repayment mechanics, aligning outflows with future inflows from partnerships, collaborations, and commercial revenue. This structure allows Arrowhead to confidently build its commercial capabilities while supporting growth and innovation across its pipeline.
    15% rente........!!!!!
  8. forum rang 4 harvester 13 augustus 2024 19:13
    quote:

    Hulskof schreef op 13 augustus 2024 15:29:

    [...]

    Is inderdaad krankzinnig veel. Je vraagt je af hoe groot het vertrouwen van Sixth Street in ARWR is...
    15% is inderdaad veel, maar
    Wat voegt plozaristan toe aan de waarde als dat in 2025 op de markt kan komen?

    Hoe snel kan de schuld worden gereduceerd als zij cash gaan genereren of later alsnog aandelen gaat uitgeven (tegen een veel hogere koers dan nu kan).
  9. GoedeDag 13 augustus 2024 20:58
    Lijkt mij ook wel hoog maar prijzen van medicijnen in de US zijn ook niet om mee te lachen. Druk zit er dan (nog) meer op dat het een succesverhaal moet worden.
    High risk, high reward bij biotech.

    De grootste hoop faalt en dat is niet verwonderlijk als 15% annual interest rate op je financiering gezien wordt als "Fantastic deal, there is no way any gene editing company ever gets this great of a deal" dixit BioBoyScout Twitter/X.

    Lost wel hun cash probleem op voorlopig en zonder verwatering.
  10. forum rang 5 Hulskof 14 augustus 2024 11:15
    quote:

    harvester schreef op 13 augustus 2024 19:13:

    [...]

    15% is inderdaad veel, maar
    Wat voegt plozaristan toe aan de waarde als dat in 2025 op de markt kan komen?

    Hoe snel kan de schuld worden gereduceerd als zij cash gaan genereren of later alsnog aandelen gaat uitgeven (tegen een veel hogere koers dan nu kan).
    Ploza zal in het begin weinig toevoegen. Genetische FSC is een zeer kleine markt en Arrowhead heeft ook nog eens 1,5 jaar achterstand op Ionis. Ploza kan op z'n vroegst in 2026 op de markt komen. Tegen die tijd zijn de centen van Sixth Street al weer op en zal er dus voor die tijd al een andere oplossing (lees: deal uit het longprogramma) moeten komen, anders zinken we nog dieper in de stront.
    Of Takeda moet eindelijk eens haast maken met AAT, maar dat zie ik niet echt gebeuren.

    Nee, voorlopig is er voor ons aandeelhouders van ARWR niet veel om naar uit te kijken.
  11. Missolapola 14 augustus 2024 20:04
    Arrowhead Pharmaceuticals to Advance Two New RNAi-Based Obesity Candidates, ARO-INHBE and ARO-ALK7, Into Clinical Studies
    August 14, 2024
    PDF Version
    - Company hosting an obesity/metabolic R&D webinar today, August 14, 2024, at 2:00 pm ET as Part IV of the 2024 Summer Series of R&D Webinars

    PASADENA, Calif.--(BUSINESS WIRE)--Aug. 14, 2024-- Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today presented preclinical data and detailed its plans to advance two next generation RNAi-based candidates, ARO-INHBE and ARO-ALK7, into upcoming clinical studies for the treatment of obesity and metabolic diseases. In preclinical studies to date, these candidates demonstrated the potential to reduce body weight and fat mass with a novel mechanism of action that may lead to improved preservation of lean muscle mass compared to currently approved obesity therapies. Arrowhead plans to submit clinical trial applications with regulatory authorities for both programs by the end of 2024 with the goal of initiating clinical studies in volunteers with obesity in early 2025.

    “Arrowhead believes that targeting the hepatic expression of the INHBE gene and the production of the Activin E ligand, and the adipose tissue expression of the ALK7 gene and the receptor it encodes, represent promising novel mechanisms to treat obesity and associated metabolic diseases. When studied as mono therapy and in combination with tirzepatide in diet induced obesity mouse models, ARO-INHBE and ARO-ALK7 both resulted in suppression of body weight and fat mass and, importantly, preservation of lean mass leading to improved body composition,” said James Hamilton, M.D., Chief of Discovery and Translational Medicine at Arrowhead. “Following the approval and positive clinical impact of new agents for obesity over the last few years, new therapeutic strategies with novel mechanisms of action are emerging that may represent the future in successful treatment and management of patients with obesity and associated diseases. We are in the final stages of preclinical development of ARO-INHBE and ARO-ALK7 and we are eager to engage with regulators by the end of this year to begin clinical studies of these exciting new medicines.”

    ARO-INHBE is designed to reduce the hepatic expression of the INHBE gene and its secreted gene product, Activin E. ARO-ALK7 is designed to reduce the adipose expression of Activin receptor-like kinase 7 (ALK7). INHBE and ALK7 are both genetically validated targets with loss of function variants being associated with lower risk of obesity and metabolic diseases, such as type 2 diabetes. Both targets are involved in the same pathway that regulates energy homeostasis in adipose tissue?, with Activin E acting as a circulating ligand and ALK7 as a receptor on adipocytes. Intervening in this pathway with ARO-INHBE and ARO-ALK7 is believed to result in increased lipolysis, and reductions in adipose hypertrophy and dysfunction, visceral adiposity, and insulin resistance.
  12. wijzerplaat 2 september 2024 12:47
    Arrowhead Pharmaceuticals Presents New Pivotal Phase 3 Data at ESC 2024 from PALISADE Study of Plozasiran in Patients with Familial Chylomicronemia Syndrome


    ir.arrowheadpharma.com/node/19286/pdf

    - Plozasiran reduced triglycerides by 80% from baseline and reduced the risk of developing acute pancreatitis by 83%

    - Similar responses were observed in patients with genetically confirmed and clinically diagnosed FCS

    - Based on these findings, Arrowhead plans to file a New Drug Application by year-end 2024

    - PALISADE results simultaneously published in The New England Journal of Medicine

    - Company hosting a virtual analyst and investor event on September 3, 2024, at 8:00 am EDT to discuss results

    PASADENA, Calif.--(BUSINESS WIRE)--Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced results from the Phase 3 PALISADE study of investigational plozasiran in patients with familial chylomicronemia syndrome (FCS), a severe and rare genetic disease which currently has no approved treatments in the U.S. PALISADE successfully met its primary endpoint and all multiplicity-controlled key secondary endpoints, including statistically significant reductions in triglycerides (TGs), apolipoprotein C-III (APOC3), and the incidence of acute pancreatitis (AP). These data were presented today in a late-breaking oral presentation at the European Society of Cardiology (ESC) Congress 2024 and simultaneously published in The New England Journal of Medicine.

    Based on these positive findings from the PALISADE study, Arrowhead intends to file a New Drug Application with the United States Food and Drug Administration (FDA) by year-end 2024 and plans to seek regulatory approval with additional global regulatory authorities thereafter.

    “People living with extremely high triglyceride levels, like those in the PALISADE study, have a substantially higher risk of developing acute pancreatitis and associated long-term sequelae, including a poor quality of life. There are currently no approved therapies in the U.S. to specifically treat FCS, so as physicians we have very few options to help our patients other than various triglyceride-lowering medications which provide minimal benefit, and very strict diet restrictions that take a significant toll on patients and their families,” said Gerald F. Watts, D.Sc., M.D., Ph.D., Winthrop Professor of Cardio-metabolic Medicine at the University of Western Australia, Perth. “Plozasiran demonstrated very deep reductions in triglycerides in the PALISADE study and is the only investigational medicine to achieve a statistically significant reduction in the risk of developing acute pancreatitis in patients with genetically confirmed and clinically diagnosed FCS in a controlled study. These results are encouraging and offer hope to people living with FCS and their physicians who are in desperate need of new safe and effective treatment options.”

    Bruce Given, M.D., chief medical scientist at Arrowhead, added, “We continue to be impressed by the promising results from the SUMMIT program of clinical studies of plozasiran in various patient populations, including SHASTA in patients with severe hypertriglyceridemia, MUIR in patients with mixed hyperlipidemia, and now PALISADE in patients with FCS. Based on the data generated to date, we view plozasiran as potentially best-in-class and supportive of development across the spectrum of triglyceride disorders. Specifically, today we showed that in PALISADE a high proportion of patients receiving plozasiran achieved triglyceride levels below guideline-directed risk thresholds associated with the risk of acute pancreatitis, which is a critical treatment goal that physicians communicate to us frequently. Further, PALISADE included patients with an established genetic diagnosis of FCS and patients with symptomatic, persistent chylomicronemia suggestive of FCS. The consistency of results in PALISADE suggests that plozasiran response may be independent of the presence of known FCS-associated genetic variants. This is supportive of the potential value of plozasiran in patients with clinically diagnosed disease, regardless of genetic status.”

    Select PALISADE Results

    In PALISADE, 75 patients with persistent chylomicronemia, with or without a genetic diagnosis, were randomly assigned to receive subcutaneous plozasiran at 25 mg (n=26) or 50 mg (n=24) or placebo (n=25) every three months for 12 months. At baseline, the median triglyceride level was 2044 mg/dL. Forty-four patients (59%) had genetically confirmed FCS and 31 patients (41%) had clinically diagnosed persistent chylomicronemia suggestive of FCS.

    At month ten, the median reduction from baseline in the fasting triglyceride level (the primary endpoint) was -80% in the 25 mg plozasiran group, -78% in the 50 mg plozasiran group, and -17% in the placebo group (p<0.001).

    Marked reductions in the median triglyceride level below guideline-directed risk thresholds associated with acute pancreatitis occurred as early as one month after trial initiation and showed modest variation throughout the 12-month blinded treatment period. The mean percentage change in triglyceride level was similar to median values.

    At month ten, APOC3 was significantly reduced with median reductions of -93% in the 25 mg plozasiran group, -96% in the 50 mg plozasiran group, and -1% in the placebo group (p<0.001).

    The final alpha-controlled secondary efficacy end point compared the incidence of positively adjudicated acute pancreatitis in a pre-specified pooled analysis of the 25 mg and the 50 mg plozasiran groups versus the pooled placebo group. Among the 38 suspected cases of acute pancreatitis that were referred for adjudication, nine episodes in seven patients were positively adjudicated.

    Plozasiran demonstrated statistical significance for this endpoint, with patients receiving plozasiran achieving an 83% reduction in the risk of developing acute pancreatitis versus placebo. A total of two cases occurred in two of 50 patients (4%) receiving plozasiran, and seven cases occurred in five of 25 patients (20%) receiving placebo (odds ratio, 0.17, p=0.03).

    Safety and Tolerability

    Plozasiran demonstrated a favorable safety profile in the PALISADE study. The most common adverse events were abdominal pain, COVID-19, nasopharyngitis, headache, nausea, back pain, upper respiratory tract infection, and diarrhea. Adverse events among the patients in the two plozasiran dose groups were generally similar to those in the placebo group. Severe and serious adverse events were more common in the placebo group. Hyperglycemia was observed in a limited number of patients in the treatment groups but was confined to patients with pre-diabetes and diabetes.

    ESC 2024 Presentation Details

    Title: A Randomised, Placebo-Controlled Phase 3 Study of Plozasiran in Patients with Familial Chylomicronemia Syndrome
    Date/Time: September 2, 2024, 11:36 am BST
    Presenter: Professor Gerald Watts, University of Western Australia
    Session: Small trials, trial updates, and other studies on lipid therapy
    Session Type: Late Breaking Science
  13. forum rang 6 Tom3 2 september 2024 15:15
    @wijzerplaat, topnieuws van Arrowhead, ook volgens Dirk Haussecker:

    x.com/RNAiAnalyst/status/183056448361...

    "And to shut up all the analysts suggesting $ARWR's superior results were driven by inclusion of MCS (multifactorial FCS)...no real difference there.

    $ARWR just doubled the market opportunity for their ApoCIII drug. sHTG (in development) will 100x it. $IONS"
  14. forum rang 6 de tuinman 2 september 2024 15:41
    quote:

    Tom3 schreef op 2 september 2024 15:15:

    @wijzerplaat, topnieuws van Arrowhead, ook volgens Dirk Haussecker:

    x.com/RNAiAnalyst/status/183056448361...

    "And to shut up all the analysts suggesting $ARWR's superior results were driven by inclusion of MCS (multifactorial FCS)...no real difference there.

    $ARWR just doubled the market opportunity for their ApoCIII drug. sHTG (in development) will 100x it. $IONS"
    Top
  15. forum rang 6 Tom3 2 september 2024 20:39
    BikeRieder, een andere blogger met focus op Arrowhead, maakte Dirk attent op een rekenfout: niet erfelijke FCS komt veel vaker voor dan door Dirk aangenomen. Met klinische FCS wordt een potentieel van tegen de 100.000 patiënten (in de VS!!) aangeboord:

    x.com/BikeRieder/status/1830643536208...
8.506 Posts
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