Maybe but I'm not sure. I've had trouble finding info on the tremor program before (wasn't on the pipeline page) but they mention it in all the presentations. It's in the current presentation on the website. Also, I wondered the same as you about the PI single dose trial (not listed at clinicaltrials, etc.), but then they started talking about starting the PI ascending dose trial and about that finishing in Q4, which points to the first PI having competed. Also the presentation doesn't discuss CAH, but it's on the website. I'm inclined to think they just aren't buttoned up about this stuff. There won't be any efficacy data on tremors for 18 months plus, as the current trial is on healthy volunteers. It's no big deal in the short-term, but could be in the intermediate-term.
Last week of July or first week of August, like clockwork for as long as I've been around the company, which is a long time.
That's interesting analysis, thank you for posting.
One point however..."The AGEN chart has nothing to do with company specific factors and has to do entirely
with the overall market manipulations and ebbs and flows."
That's actually somewhat of an argument poor management. That is, management hasn't done enough to separate from the pack.
I'm long by the way.
I hear you ash. However it seemed like NBIX got a bit ahead of the bio index the previous few days. I haven't looked at the chart, but that's my intuition. Maybe it's just coming back to the norm. Just a thought.
Understood frogs. I was going off "hearsay", specifically what the article seems to say about potential filing date (though I haven't read the article).
Off topic (for others) from here...
You still like AGEN frogs? Anything coming near-term that can move it? Seems like a lot of interesting PI action, but not sure what causes it to move in the near-term. They've been talking about Prophage forever. Thoughts?
I'm just confused because we seemed like we were talking about two different things. Prophage update on pivotal trial is supposed to be Q3 (or as you say, Q4 - LOL). This thread was about the start of PI in solid tumors. Couldn't understand what July had to do with this thread...?
From Seeking Alpha Transcript
2016 is looking to a very and even more exciting year for us as we built on our momentum…advancing our lead vaccine program Prophage into randomized trials including those in combination with checkpoint modulators, and very importantly securing additional strategic alliances and partnerships.
[Question]…And then just in regard to the combination regimens that you’re talking about with both Prophage … And would that be your checkpoint modulators or would that be with someone else’s…
[Garo] … And the answer to your question is both will be our strategy, meaning doing it both with existing marketed products as well as our own checkpoint modulators.
[Question] Okay. And then in conjunction with proved CPMs, would that entail some kind of formal collaboration with the sponsors of those agents or…
[Garo] So if we were to do it with an existing CPM, it would be a formal collaboration.
Strategy -- wait for May data, collaborate, launch in Q3/Q4.
1) Initiation of Phase 1 clinical trials for anti-CTLA-4 antibody candidate (AGEN1884; wholly owned by Agenus), and for anti-GITR antibody candidate (INCAGN01876, partnered with Incyte) in the first half of 2016.
2) Initiation of Phase 1 clinical trials for one or more additional CPM antibody candidates in the second half of 2016.
3) Initiation of a well-controlled randomized Prophage™ clinical vaccine trial in newly diagnosed glioblastoma patients in the second half of 2016.
4) Initiation of Phase 1 clinical trial with our first ASV vaccine product candidate in the second half of 2016. Agenus’ ASV program targets cancer neoantigens with an autologous synthetic vaccine approach.
5) Partner (GSK) filing for regulatory approval of its shingles vaccine candidate containing Agenus’ proprietary QS-21 Stimulon® adjuvant in the second half of 2016.
6) Initiation of combination trials with Agenus vaccines and CPM antibody candidates in the second half of 2016.
Will be interesting to hear what they have to say about #3.
I have been here a long time and am very, very long.
The NDA for TD is supposed to be filed toward year end. Even fast tracked, it has to be 9 months give or take to approval (others may have a better sense). So you are looking at 18+ months. I think that's optimistic but maybe I'm wrong (by a few months more or less).
What’s going to move the PPS significantly this year (beyond any improvement in biotech generally)?
I’m long, but I struggle to see what moves the needle any time soon. Let me be provocative so that others can shoot holes in the argument (please keep the simple-minded nonsense to yourselves). I’d appreciate a reasonable discussion.
- QS-21 has been monetized, such that any news is great, but earnings have been pulled forward. Until there is clarity on speed and scale of royalties, I fear this program doesn’t help much.
- CPA program is all PI, unless I’m missing something, which I might be. No one gives a *&*( about PI programs. PII results and beyond are typically all that matter.
- Heat Shock could potentially move the needle a bit. Results due in May, give or take. If positive, what would that mean? Also, they’ve been talking about a partnership forever, so either potential partners are waiting for results or there is minimal interest.
So, it’s Prophage or nothing. And I say again, I’m long because the price is very compelling versus long-term potential, but the near-term is rough. Thoughts?
Saw that. Nice to see. What's your gut on any kind of partnership for Prophage? Are we going to be waiting until after more trial data? Or what?
NBIX should be due a milestone payment sometime soon I think.
Got it. I felt pretty good about the Elagolix call option. All indications were that the mechanism worked and that safety was there (bone loss would be minimal) based in the science. I just can wrap my head around AGEN's programs in the same way...not sure what to think. I bought some to get me engaged. Love how cheap it is, but can't figure out yet how much conviction to have (e.g., will they get a partner and if so, when; what's the situation with the INDs, etc.)
What do you think of AGEN down here frogs? I can't figure out what's going to get them out of the gutter any time soon with any kind of certainty, unlike NBIX 4-5 years ago, which seemed like it had a winner in Elagolix.