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Arrowhead Pharmaceuticals, Inc. (ARWR)

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79.66-2.54 (-3.09%)
At close: 4:00PM EST

81.55 +1.89 (2.37%)
Pre-market: 8:00AM EST

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  • P
    Partimefriend
    Wanted to show some info about Aro-enac and compare to Ionis IONIS-ENAC-2.5. It is not a direct comparison but you can get an Idea about the potency and dosing where if things hold true Aro-Enac RNAi (RNA interference) out performs any ASO (antisense oligonucleotide) technologies.

    IONIS Mouse data to compare to Arrowheads Rat and sheep data, Also we will look at LPA data to get a comparison on potency and duration. If you are unaware, Ionis presented Data back in Oct 2020 with their data on IONIS-ENAC-2.5 Rx where it showed the primary endpoint of the study was evaluation of safety and pharmacokinetics of IONIS-ENAC-2.5Rx delivered via a Pari eFlow mesh nebulizer.

    In the single escalating dose study, 32 subjects in four cohorts received a single dose of 3, 10, 37.5, or 100 mg and were followed for 30 days. In the multiple ascending dose study, 24 subjects in three cohorts received four doses of 10, 37.5, or 75 mg once weekly, with an additional dose administered during the first week. An additional cohort of eight subjects received a 37.5 mg dose given thrice weekly for 10 doses. Subjects were followed for 13 weeks after dosing.

    Fiberoptic bronchoscopy including bronchial brushings and bronchoalveolar lavage was performed during screening and after completion of dosing in the MAD cohorts. Quantitative RT-PCR was performed from the bronchial cell brushings to evaluate ENaC mRNA levels.. IONIS-ENAC-2.5Rx demonstrated a significant decrease in the expression of epithelial sodium channel (ENaC) in healthy volunteers. The study showed a mean 55.6 percent decrease (p<0.05) in ENaC mRNA expression at the 75 mg dose in the multidose segment of the trial. The study represents the first time an antisense medicine delivered directly to the lung via a nebulizer has shown a significant reduction in ENaC messenger RNA levels. In preclinical studies, ENaC mRNA reductions of 40 percent or more resulted in significant improvement in mouse models of CF lung disease.

    IONIS-ENAC-2.5 mRNA reductions of 40 percent or more resulted in significant improvement in mouse models of CF lung disease.

    ARO-ENAC mRNA reductions of 66 percent or more resulted in significant improvement in Rat model of cf lung disease.

    So if we look at this, 55.6 percent decrease mRNA expression IONIS-ENAC human data, can we assume ARO-ENAC could do 26% better? Not exactly but you get the idea. ARO-ENAC is safe so far. We will be better in potency duration, and safety IMO.

    Here is some more data Comparing LP(a)Akcea Therapeutics.AKCEA-APO(a) vs Amgen AMG890

    AKCEA-APO(a) 35% drop... dose every 4 weeks or 80% drop... dose weekly 20 mg

    People randomized to one of five dosing regimens of APO(a)-LRx had large drops in Lp(a) by the sixth month, the reduction ranging from 35% from baseline (at a dose of 20 mg every 4 weeks) to 80% (at 20 mg every week) compared with a 6% drop in the saline placebo arm (P=0.003 and P<0.001, respectively).

    Amgen AMG890 90% drop... single dose every 6 months

    AMG 890 was well-tolerated and significantly reduced Lp(a) with observed maximal percent reductions of > 90% and effects persisting for more than 6 months at doses of 9 mg or higher.

    Like CA said we win on potency and dosing.
  • W
    WallStPirate
    @Only Arwr

    I was confused by your statement about IONIS and ENAC. Page 16 of their presentation form last week states ENAC is a target for 2021. It was also mentioned in the cc. Where did you see they are cancelling it.

    Thanks

    https://static.seekingalpha.com/uploads/sa_presentations/345/66345/original.pdf
  • j
    jimmy
    In SD visiting. Stopped by the ARWR site on Sorrento Road and got my wife to snap a pic of me and the sign. Sent it to friends and fam that I have gotten into the stock. Told the daughter’s bf that the investment is going to be part of the family’s legacy. Then off to Poseidon’s in Del Mar for a delicious “Mani can kiss my” Sea Bass dinner. Cheers!!!
  • S
    SpideySense
    I couldnt sleep tonight so up late reading about ARWR and I checked Fridays ATH volume. WOW some big accumulation to note.
  • C
    Chris
    Arrowhead files for phase 2b study for APOC3
  • J
    Jeff
    There are 56 jobs posted on the careers page today. Seven openings are in finance & accounting. The company continues to add staff to support expected growth in research and clinical activities.
  • s
    spot
    I posted this earlier, but the post disappeared.

    I was reviewing SLN's Feb 2021 corp presentation slide 14 :

    Title of slide: Early-stage GalNAc-conjugated RNAi Programs Have a MuchGreater Likelihood of Approval vs. Industry Average

    Likelihood of Approval from Current Phase: GalNAc RNAi vs. Others:

    PI - RNAi 51% vs Others 9%
    PII - RNAi 56% vs Others 17%
    PIII - RNAi 67% vs Others 53%

    as stated by ALNY and others on this board, this seems to be in-line with others.

    IMO, ARWR is significantly undervalued given each drug in PI or beyond is more than 50% likely to be approved.
  • W
    Warren
    Check out this video and read the comments, you get an idea. She most likely will do well as long as we are in a bull market. The rate for the 10-yr T note is aroud 1.5% and rising. If it keeps its momentum and pierce through the pre-pandemic level like a hot knife through butter, she will be in trouble. The 1.9T bill that was just passed will likely add fuel to the fire. This is certain a concern of mine, as we wait for data from Arrowhead.

    https://www.youtube.com/watch?v=_b2qYtl6X4M
    Jim Cramer on Cathie Wood's latest stock purchases
    www.youtube.com
  • T
    TNTNorman
    Seeing down days used to be more worrisome, but in the last 6 months, you come to the realization its just noise. Too many shots on goal going forward. Then thee is the what if scenario - they all score?? Then what do we have? Downside long term risk minimal, upside opportunity - limitless. If you are new to this stock, you really need to investigate each and every drug candidate and then dive into the patents they have filed to get a sneak peak at the next potential drugs. I sleep well at night now, much better than a few years ago.
  • B
    BioBoyScout
    I know that Coldlander and many others already commented on the changes to the ARO-ENaC trial, but I believe it bears repeating. Changing the single dose phase measurements from 15 days down to 5 is a good sign that they could be seeing the drug working much faster than they thought; AND changing the multiple dose measurements to 30 days instead of 21 days suggests that they're seeing more durable knock-down than they initially thought. Lastly, increasing the number of participants by 38 patients from 54 to 92 is yet another great sign. No doubt good news all the way around. I feel like a kid in a candy store!
  • c
    camino
    Well, sold 20 June $100 calls today @ $8--generating proceeds of $16K--Still retaining a very large ARWR share position.--Actually would like, or certainly be quite OK with 2K shares being called away at $100 sometime between now and June 18th. Hopefully a win-win scenario with the call buyer doing well with his or her purchase---This week have raised my long standing $84-$134 year end 2021 price target range to----$100-$134--Historically, have been more conservative than many here--Hopefully the upper end of the range (or higher as some well informed individuals have prognosticated) attained by year end. Thanks, and best wishes to all for a great upcoming weekend.
  • B
    BioBoyScout
    If you haven't noticed, some (if not nearly all) of the news that's now trending, and also beginning to dominate in the markets is "new variants". Just Google it and new variants of the coronavirus have become a huge concern. Nobody was talking about new variants a month or two ago, in fact, that wasn't even a concern back in all of 2020 ...... EXCEPT for Arrowhead. Yes, that's right, Chris was talking about being able to develop drugs that would help stop the coronavirus on multiple fronts, but that it would also apply to other versions or variants of the coronavirus. Pure genius! Hats of to Chris and the Arrowhead team for being way ahead of the game on that call. It would be nice to get a more in-depth update from them on this, as at this point, there really is not much sense in hiding your coronavirus strategy from your competitors.
  • C
    Coldlander
    About to head to work, so I need to make this short. ARO-ENaC updated on Clinicaltrials.gov. Enrollment increased from 54 to 92. Primary completion extended from August to December 2021. Study completion extended from November 2021 to March 2022. Single dose pharmacokinetics were decreased to 5 days and multiple dose PK was increased to up to 30.
    https://clinicaltrials.gov/ct2/show/NCT04375514?term=arrowhead+pharmaceutical&draw=2
  • R
    Rod
    You know what’s a great feeling, finding almost 5000 shares in a Roth IRA I wasn’t counting in my total share count..
  • j
    j
    Just FYI, HBV Patent Application update filed today.
    United States Patent Application 20210052624
    Kind Code A1
    WOODDELL; Christine I. ; et al. February 25, 2021
    RNAI THERAPY FOR HEPATITIS B VIRUS INFECTION
    Abstract
    Described are compositions and methods for inhibition of Hepatitis B virus gene expression. RNA interference (RNAi) triggers and RNAi trigger conjugates for inhibiting the expression of Hepatitis B virus gene are described. Pharmaceutical compositions comprising one or more HBV RNAi triggers optionally with one or more additional therapeutics are also described. Delivery of the described HBV RNAi triggers to infected liver in vivo provides for inhibition of HBV gene expression and treatment.
  • F
    Fro
    Below is a follow up on ARO-ENAC clinical trial increase in patients as reported by Colander....as Lefty alluded to...look for the next trial to be a pivotal one...below is Chris Anzalone excerpt from q4 2020 transcript related to question asked on which pipeline drugs could first get to the finish line....

    "A wildcard here could be ARO-ENaC. I don't -- again, I don't want to get out over my SKIs because we haven't seen any data yet. But should those data be exciting, should the data in this Phase I/II study suggest that we have something here, it could be that WE COULD MOVE DIRECTLY INTO A PHASE II/III STUDY.. The earliest that could be would be the end of next year because we don't have tox coverage until then, but that's a possibility."
  • j
    j
    Favorite CC quote: By the end of the second calendar quarter, we could have proof of concept that we can silence gene expression with RNAi in 3 different cell types across 8 different clinical programs. I don't believe there is another company on the planet that can say that.
  • j
    j
    Sounds like the COPD trial start will possibly be in the next few months as it was delayed due to the switch over to an inhaler vs nebulizer. CA is hoping the "time to market" will not be affected because this development work is taking place now instead of later.
    "We don't think this slows the program's time to market. And in the end, it may actually shave some time off overall development if the inhaler formulation work enables a more direct path. The ultimate goal is to take forward a therapeutic with optimal efficacy, safety and convenience in a form that is useful to physicians and their patients. We will provide an update over the next quarter, pending completion of a few ongoing studies."
  • A
    Alexander
    The whole market was spooked of growth stocks after all the fears about inflation and long term interest rates. Nothing has changed about the science or technology. ARWR is in a good place financially, and the interest rate changes don’t justify the 10% decrease long term. I think we’re in a good place, and if we’re here on Monday, I’m going to buy more.
  • K
    Knownow
    Jim Cramer dropped a bomb on CNBC this morning about Moderna working on a preclinical vaccine for certain forms of cancer. He mentions how these mRNA treatments are the new way to treat diseases.
    OK...we know that and now more of the world keeps knowing. Momentum is building.
    "Stay the course...a thousand points of light".