I agree with 19 this year. Holding for long-term target 35-50 inside of 3 years. 8400 will be commercialized by then, and GSO will be awaiting Phase 3 results for multiple indications. Also, 9200 will be mowing down Lupus with a partner.
You are correct, junk. 9200 is for broader condition with partner. Lupus fits perfectly.
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.
With regards to GSO, there is plenty of room outside of oncology where 3rd gen will work miracles. Milano said they will consider licensing opportunities down the road, but that the bottom line is that they intend to build, own, and operate on their own. He also stated IDRA has all the pieces --- brilliant science with pioneers, best of the best investors, management with proven development and commercialization successes. He said some of that was lacking at Viropharm, and he was able to sell it anyway for 60/sh..
During the presentation, Vinny told the story of how IDRA got started on their aggressive gene-targeting. He said a BOD member (no doubt Baker) was at a presentation given by the guy who discovered the gene mutation. During the pres, the guy stated that he thought TLR's were the way to defeat the gene. That BOD member took it to IDRA who "took it and ran with it"...starting WM , DLBCL trials, along with Dermatomysositis and any thing else that carries it. The diagnostic tool collaboration for the gene with Abbott was a brilliant early move.
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.
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.
"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.
"Safety and effectiveness of a drug must be established through adequate and well-controlled studies." Part of it off FDA website.
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
Nice recap TravFam. WM is the biggie. One gene, many orphans. And already proven to work in all trials to date. just a matter of finishing the trials. And remember, these trials only include patients who have tried everything else and have IMO-8400 as their last hope. That spells billions in MC.