What else is there to say? GSO Pioneer at the helm of 3rd-gen breakthrough. Enormously successful management team across the board. 90% tumor shrinkage. WM, Dermatomyositis. Duchenne's, Burket's, DLBCL. That's just 8400. 9200 will be partnered for larger indications (Lupus). And 2155 combo wildly successful. Look for mid-year WM trial surprise with Breakthrough designation. ONE SINGLE GENE TARGETED. And that's the trigger for the moonshot.
Sentiment: Strong Buy
"A marketing application for a prescription drug product that has received orphan designation is not subject to a prescription drug user fee unless the application includes an indication for other than the rare disease or condition for which the drug was designated."
Imbruvica is not dedicated to WM. It's been approved or in clinic for about 5 other diseases. 8400 targets 1 gene, and it's a grandslam for all diseases carrying the gene. Very specific and 90% of WM patients have the gene. It's been proven through all testing to date. Just a matter of going through rest of trials. This phase 2 will be interrupted and declared breakthrough mid-year, maybe by ASCO. GS, JPM, BB, and new management all know what they have. And remember, the patients in these trials are all refractory or relapsed to all prior meds, so this is their last chance. This could be 20-40 EOY.
Volume precedes price, and they have got a 90% improvement presentation coming up in days. This is the real deal. All the rats are out to take your shares for the run.. Don't let 'em.
That's what Vin said. So they have already picked it. My money's on lupus. Can you imagine a good drug for that disease? There will be BP partners pounding on the door.
starting now with AACR...expect a PR after hours. Surprise after surprise after surprise. GEVA ran to a 93rsi with less, and IDRA has been percolating much longer with a better platform
IDRA will be the next IDRA, a class of their own with the new GSO. That's why you have Bakers doing everything in their power to own it in any way they can. How about pre-paying for warrants instead of stock? Done. How about 2 board seats for our financial backing? Done. Forget paying us. Give us stock for our BOD seats. Done. Fidelity? Maxed out.
That's a good point, dude. Position of strength with a pile of cash provided by Goldman and JPM. 2055 partnership gotta believe comes sooner than later with the results posted. WM Accelerated Approval mid-year will mean success for all b-cell carrying the gene plus Burket's. 9200 results this qtr or next. The potential AND the results make this worth 2B MC this year....with GSO clinical revving up, 40 next year...JAZZ was 3.70 June 2009, and 35-45 June 2011. IDRA has much more going for it.
Dose-dependent Lupus results already presented. Phase 1 should be wrapping up now based on October start. Lead indication announcement soon. My money is on Lupus. Great for the patients and enormous market to partner out for big money.
"Expansion of the TLR Antagonist Pipeline. We have developed a second novel synthetic oligonucleotide antagonist of TLR7, TLR8, and TLR9, IMO-9200, as a drug candidate for clinical development in broader autoimmune diseases in which TLRs are implicated. Consistent with our business strategy, we plan to develop IMO-9200 through clinical proof-of-concept, and explore potential collaborative alliances to support late-stage development and commercialization. In October 2014, we presented preclinical data at the 10th Annual Meeting of the Oligonucleotide Therapeutics Society showing that IMO-9200 inhibited TLR-mediated immune responses in multiple preclinical models. These data showed that IMO-9200 dose-dependently inhibited the induction of multiple inflammatory cytokines, including IL-12, IP-10, IFN-a, IL-6, IL-1ß and MCP-1, in cell-based assays, mice and non-human primates. In addition, we have demonstrated preclinical proof-of-concept for IMO-9200 in a well-characterized autoimmune disease model. Data from this study showed that IMO-9200 improved disease-associated parameters in the MRL/lpr mouse model of lupus, with decreases in blood urea nitrogen levels, proteinuria, autoantibodies and kidney interstitial inflammation. In October 2014, we initiated patient dosing in a Phase 1 clinical trial of IMO-9200 in healthy volunteers. Following completion of the Phase 1 clinical trial, we plan to select a lead indication for further clinical development of IMO-9200 in the first half of 2015."
CEO called them VERY interested off ASH data. He described them as key members in critical development of not only oncology, but immuno-oncology. Don't over-analyze the collaborators label. It could mean a future partnership, but he said they were in discussions and expected to launch a Ph 1/2 trial in 6-9 mos with collaborator. So expect announcement a little earlier than that, perhaps ASCO.
Read the abstract. Can't wait to see that one Monday morning. AACR after hours PR today. PJ tomorrow to oil the wheels for ASH. Now is not the time to flip.
Can't argue with the overbought statement. Mid 3s very possible, even low 3s, then major run back to 6-9. Long-term, however, this is a $50 stock as early as 2017. $10-20 2015.
I agree. That was my biggest takeaway from the presentation. The results were at 90%. Incredible. That partnership may be the reason MMs have been ripping the trail stops every morning for the last week.
"Safety and effectiveness of a drug must be established through adequate and well-controlled studies." Part of it off FDA website.