MM302 already in a trial structured with FDA for accelerated approval. In other words, it's a phase II trial that can be used to submit an NDA. See clinical trials.gov
Oct options expiration. Could be the run-up tops out just before options expiration. That's been a typical pattern around this stock, but PDUFA introduces a new factor... so it's anyone's guess.
IMHO MACK could have gotten a deal, but not the deal they want (note Mulroy's recent comments about wanting to retain control of the asset).
Now it's on the new guy to put a value on it and try to get something done. It looks akin to replacing the RE agent after failing to sell a house that was priced too high.
At least given the Daiichi Sankyo ErbB3 trials, we have confirmation that there is still value here even in the face of upcoming new modalities of treatment.
Qualify "better" because the FOLFIRINOX regimen has more SAE in first line which is probably why it isn't used as widely as gem + abraxane. Hopefully there are fewer SAE's when MM-398 is used.
Medicare pays for off-label use of cancer treatments (private insurers MAY start paying after full phase II results). As I'm sure you're aware, FOLFIRINOX added 4 months to PC cancer patients lifespan over gemcitabine in a front line trial (results from the trial, conducted at 48 hospitals in France, were published in the May 12, 2011, New England Journal of Medicine - this was the one of the trials ChinamanNYC was touting). Gemcitabine with Abraxane adds 1.8 months... so it looks obvious which regimen is better. I'm thinking there may be a bit of off-label use of MM-398 in the FOLFIRINOX regimen in first line PC before MM-398 is actually approved for that indication where reimbursement is possible (Medicare). Inns has repeatedly made this point.
Also looking to develop their own immune-oncology agents. Inns should be happy.
Director, Cancer Immunology
We are seeking a highly-motivated immunologist to lead our efforts to develop both antibody and nanoparticle drug candidates that function as immune modulators in the treatment of cancer.
MACK looking to explore MM-141 with immunological agents. See MACK Job Listings for Immunology Scientist.
•Develop in vivo models to test the activity of MM-141 in combination with immunotherapeutic agents
•Design and implement experiments to validate mechanistic links between biomarkers of MM-141 and immune-oncology agents and associated therapeutic response
Another thing to note is that the indication for NSCLC would be different for Daiichi and MACK. I wonder if MACK intentionally avoided including Erlotinib (Tarceva) in their trial. I'm also surprised Daiichi didn't include chemo in their trial.
More informed OP's perhaps could speak to the rationale behind choice of second line treatment of chemo vs Tarceva in NSCLC.
That's possible. I just double checked the annual report and Baxalta does not have any rights over 151 or 121.
In addition to 398, Baxalta has right of first negotiation to obtain a license to develop and commercialize MM-111, MM-141 and MM-302 outside of the United States.
I still wonder if MACK may agree to be acquired by Baxalta in an attempt to add value to defend against Shire's hostile takeover attempt. I would be very happy if MACK got bought out for 20+/share.
Time is of the essence given Novartis and Roche are also still moving forward (hard to tell how quickly, but I believe Novartis still estimating filing 2019 or later for first indication). AVEO has dropped out (looking for new partner) and REGN hasn't advanced REGN1400 beyond phase I.
At least it looks like Amgen and Daiichi Sankyo are pushing full steam ahead with their erbB3 inhibitor program, racing as fast a possible in NSCLC. Some OP's seemed to be looking for confirmation of erbB3 as a viable target.
Patritumab in Combination With Erlotinib in Subjects With Locally Advanced or Metastatic Non-Small-Cell Lung Cancer: link - http://1.usa.gov/1ghbtqJ
He compares CSIQ's margins to those of another integrated provider (SPWR likely). However, he fails to acknowledge that CSIQ is not selling all of its high margin projects. Had they been sold, how high would the margins have been?
He has failed to mention this point in the past few articles he's written. There's no question he's well versed in the sector, so he is doing this intentionally... and I also question why?
The Solactive Global Uranium Total Return Index tracks the price movements in shares of companies which are active in the uranium mining industry. A maximum of 40 components are included which are weighted according to freefloat market capitalization. The Index is calculated as a total return index and published in USD. The composition of the index is ordinarily adjusted twice a year.
URA is a passively managed ETF. You seem to be thinking that it's actively managed. Most ETFs just passively follow an index with a predefined allocation.
From the prospectus:
The Adviser uses a “passive” or indexing approach to try to achieve the Fund’s investment objective. Unlike many investment companies, the Fund does not try to outperform the Underlying Index and does not seek temporary defensive positions when markets decline or appear overvalued.
CSIQ broke out module sales to "itself" in their earnings report. Those would be modules sold to those projects it is holding on its balance sheet for a possible yieldco. The value of those projects is shown as the big increase in assets under plant and equipment.
Does a merger between CSIQ and TSL make sense, given TSL wants to move downstream into projects where CSIQ already has a global presence... and given TSL's module business has higher margins than CSIQ's... seems a good match... and perhaps could get around EU's tariffs CSIQ is facing.
Shire's CEO has made public statements that he liked Baxalta's oncology partnerships. If you look at them, I believe MACK is the biggest in monetary terms. Remember BXLT's partnership goes beyond just MM-398. Who knows, if BXLT is acquired, Shire might go after MACK before MM-121 is partnered.