auch mit Übernahme-Bemühungen anderer Player rechnen.
Ich sehe auch die Shorties haben Anfang Oktober schon 1,2 Mio Aktien abgebaut. Ich könnte mir vorstellen, dass es jetzt auch schon weiter mit denen runter geht.
Holden YMB: Folks, There are many exciting things about this. It skips p1a SAD and goes right into p1b MAD seeking recommended dose level regimen. As soon as they have this under AD they will roll right into p2a optimization study (optimal number of doses). Again, they roll right into the p2 upon submission of p1b data. Note I didn't say p1a safety data. This is the first ever AD from the very beginning of the study. This is, IMO a HUGE validation that TRiM is a completely safe deliver platform. NO SAE's of which we are aware. This is the first IND ARWR will have filed directly with the FDA before doing off shore early-stage development studies. This is a massive vote of confidence from the FDA and should be celebrated. And when they are done with p2a they will be able to roll right into p2b with only FDA data review. I am assuming they will be study various patient populations and perhaps a pediatric population, but that may be down the road a bit. (Not sure ccRCC is a pediatric cancer) No new IND from data submission to data submission. So Fast Track Designation, PR and BTD are right around the corner. This is going to be the fastest oncology study in history. This will be the first RNAi extrahepatic study ever and they have a strong multi-year lead in that regard. I am sure we will find out other positive bits as PRs and filings continue. Will it be a global study? Likely...Lastly I assume because the company is so effective at trigger design they will be able to branch out and attack many solid tumors. They still need to discover the differing receptors but time to clinic from discover should be VERY fast. I suspect they already have many receptors lined up, but that is speculation.
Dr. Cheddar, unless some exogenous circumstance exists, new oncology molecules always start in Stage 4 cancer. The thinking there is that these people are very likely going to die, have been treated with the highest standard(s) of care for that circumstance and the therapeutic either wasn't effective or the patient built up a tolerance. As long as a drug can achieve whatever safety/efficacy hurdle is embedded in the application then it's OK to inject the drug. If it is as safe as other compounds in really sick people and provides a measurable improvement than the current standard(s) of care, the thought process continues, you can start studies in earlier stages of the disease and eventually pediatric patients. Or if it proves safer and achieves the same level or better efficacy the same holds true. Some cancers are ~exclusively pediatric. It will be most gratifying to see ARWR cure say, Ewing Sarcoma, for example, is almost always a child cancer. It's a painful death sentence and has no cure. Tragic for all involved.
Holden YMB: for those trying to compare ALN-AAT02 to ARO-AAT please go to the CT site and type in ALN-AAT02. You will find that the study is "Active, Not Recruiting." Why is that? It's because ALNY cannot enroll part B of it study. So it likely completed enrollment of it part A NHVs. But it can't get patients because ARWR has an exclusive on available patients through the Alpha-1 foundation as well as a sister foundation in Germany. Add to that that it would be immoral of a doctor to enroll a patient in the ALNY study that has yet to produce a full safety profile when ARWR has a complete safety profile as well as efficacy data showing 100% KD of all patients in its study to BLLOQ. ALNY and DRNA have both halted their trials for those reasons so looking for a comparison is a complete waste of time.
ALNY no longer has an HBV program. The program it used to have failed twice and was shut down. It sold the carcass of its HBV program to VIR. VIR is a company that recently went public via IPO which is down roughly 50% from its IPO price. HBV is its most advanced program and can be found on the CT site under VIR-2218. The study is a p1/2 with 104 patients. We have no readout. By my estimation it is 2 years behind JNJ (ARWR) if it is found to be successful at all.
DRNA has announced an AAT program but is not yet in the clinic. I suspect they will either not enter the clinic for the same reason AALNY has not moved its AAT program beyond NHVs or will dose NHVs in hopes that ARWR stumbles. DRNA is working through an HBV POC study and has partnered it with Roche. That partnership will not move forward until DRNA completes its POC study and, if results are good, will co-develop its technology with Roche. That data is not expected to be available until mid-2020. If the POC data are good the study may be in the clinic by YE20, appx 1.5 years behind JNJ/ARWR. That lead is probably understated because I suspect JNJ will receive FTD, BTD and PR, leaving both VIR and DRNA in the clinical dust. https://finance.yahoo.com/quote/ARWR/community?p=ARWR
und seine Meinung zwecks Übernahme. Holden YMB: For Bourbonisbest and all the other umday untcays who keep saying ARWR is going to get bought out at price $XYZ. NO THEY AREN'T. If you know anything about how a public company works you would know that that outcome is impossible. Understand that ARWR's Board is the hand picked Board of Chris Anzalone, which is to say that the Board may be independent it is going to whatever Chris wants it to do. If someone steps up today and offers $60Bn to $70Bn the board would certainly consider it. But nobody is going to offer that amount because the presumed "offering Board," would get thrown out by the shareholders of that company. Why? Because it would be impossible to make the acquisition acretive to earnings until 2025,6,7 or whenever. And no shareholder is going to vote for a Board that would do something so stupid as to dilute earnings (and cause the share price to drop like a rock) for that long a period of time. The gap between what ARWR's Board would accept and what any offering company could offer is miles apart and it is NEVER going to narrow.
Three pivotal trials on three orphans have enormous value because they each lead to incremental pivotals on HUGE incremental large market drugs. But nobody is going to pay up for that all on the come. That's why ARWR has partnered two huge drugs with AMGN and JNJ and probably 3 more with JNJ. Partnering is the safe route for everyone involved. Just because you WANT ARWR to be taken out at $60Bn to $70Bn that isn't on the same planet or even in the same galaxy as reality. Just shut up about it because you are only wasting everyone's time. Stupid bat comes out of retirement and delivers 20 dents to the head!!! https://finance.yahoo.com/quote/ARWR/community?p=ARWR
wurde wohl gesagt, dass sie jetzt offen für Partner im Bereich ihrer Medikamente für Asthma, COPD und Lungenfibrosen sind. Noch ein Millionenschwerer Markt.
Thanks, Ken. These are exciting and important times at Arrowhead. We have always thought to follow science and drive the RNAi field forward with new innovation and technologies. We'll continue this with a series of first for the industry. I think that we'll see the first clinically-relevant oncology RNAi drug candidate in ARO-HIF2. I think we'll have the first meaningful long-targeted RNAi drug candidate in ARO-ENaC. I think we'll be the first to develop a muscle-targeted RNAi drug candidate, and I think we'll be the first to develop an RNAi drug candidate that silences 2 genes simultaneously. Together, these significantly expand the universe of diseases and conditions we expect to treat. The new cell types we are now able to target are key to our pipeline expansion model. We hope -- my hope is that we will have early clinical validation for ARO-ENaC by the end of 2020. That could serve as a springboard for rapidly expanding our loan franchise as we go after various gene targets for diseases such as COPD, asthma and pulmonary fibrosis. We can develop some of these by ourselves and some in collaboration with partners. Similarly, I expect that we could have early clinical valid for ARO-HIF2 by the end of 2020, and that could trigger a rapid push into new solid tumor types and new gene targets. https://finance.yahoo.com/news/...-earnings-conference-083322518.html
Fact
: Kaum zu glauben das das erst der Anfang ist.
MDCO wurde von Novartis für ein RNAI Medikament 9Bio gekauft. ARWR hat eine größere Pipeline und ein sehr effektive und nebenwirkungsfreie Plattform. 200 nächstes Jahr oder höher je nach Ergebnissen locker möglich. Das Apple der Pharmaindustrie. Wenn das Krebs Medikament nächstes JAhr Wirkung zeigt gibts kein halten mehr. Terminal Cancer. Wenn das Medikament bei diesen Patienten anschlägt wird es sehr schnell gehen für Arrowhead. COPD ist riesen Potential.. Zystische Fibrose ... soviel klasse Resultate bis jetzt...
Ihr wißt schon dass der Pfeil-Kopf bereits zu einem guten Teil von J&J (so mein Kenntnisstand) übernommen wurde. Ich glaube zu erinnern, es waren 75%. Unabhängig davon, ein unheimlich inovatives Biotec Unternehmen.
Under the terms of the agreement, Roche transferred to Arrowhead all of its existing RNAi operations and research facilities in Madison, Wisconsin along with its employees, equipment, related technology licenses and intellectual property covering current and planned development programs. Roche obtained a minority stake in Arrowhead as well as rights to negotiate for certain future products, milestone payments and royalties on sales. http://ir.arrowheadpharma.com/news-releases/...s-roche-rna-assets-and
Jetzt mal ganz ehrlich, wo könnten wir bis Weihnachten stehen? Ein bisschen Angst vor einer fetten Korrektur muss man ja schon haben, so steil wie das Ding geht;) Mag mir garnicht ausmalen wo wir nächstes Jahr stehen könnten wenn es bezüglich Hepatitis B weiter gute Infos geben wird
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