1. There will be additional data next week at EHA on ARRY-520 relative to the combinability of 520 with carfilzomib (safety). The Phase 2 efficacy data of the combo will be presented in December at ASH.
2. ARRY previously talked about needing to combine 520 with Kyprolis or Velcade for full approval but mentioned here, for the first time I believe, the possibility of obtaining accelerated approval with this combo. I am curious if Squarer was hinting at the possibility of 520 obtaining AA based solely on the Phase 2 combo data of 520/carfilzomib that will report at ASH or the 520/Velcade data (not 100% sure if that data will be at ASH or later). Squarer did mention that in discussions with FDA that FDA believes 520 is an active drug and discussions have been positive.
3. The Phase 3 selumetinib KRAS NSCLC trial will begin dosing in October.
4. The Phase 3 selumetinib thyroid cancer trial has already begun dosing and AZN has moved selumetinib up into first-line in this pivotal study testing in combo with radioactive iodine as opposed to a refractory setting.
5. Memorial-Sloan Kettering has announced plans to initiate a 100-patient confirmatory, randomized uveal melanoma trial with selumetinib. ARRY hopes this will lead to approval of selumetinib in this indication.
6. Slide 9 compared the NVS/ARRY BRAF/MEK combo to that of the competition (GSK and Roche). ORR in BRAFi-naive was 88%, 76%, 92%, respectively. ORR in BRAFi-prior was 18%, N/A, 19%, respectively (showing similarity of NVS/ARRY combo to competition on efficacy front). On safety front, in attempting to show superiority of NVS/ARRY combo to GSK and Roche combos, fever was 0%, 71%, not reported, respectively. Rash was 3%, 27%, 53%, respectively. Diarrhea was 33%, 36%, and 51%, respectively. Chills was
Nice - conversion price prior to 2020 wont take place till SP is at $16.21. Thats good.
Prior to March 1, 2020, holders may convert the Notes only under the following circumstances: (1) during any fiscal quarter commencing after June 30, 2013, if the last reported sale price of Array's common stock for at least 20 trading days (whether or not consecutive) during the period of 30 consecutive trading days ending on the last trading day of the immediately preceding fiscal quarter is greater than or equal to 130% of the applicable conversion price on each applicable trading day; (2) during the five consecutive business day period after any five consecutive trading day period (the "measurement period") in which the trading price per $1,000 principal amount of Notes for each trading day of the measurement period was less than 98% of the product of the last reported sale price of the common stock and the applicable conversion rate on each such trading day; (3) if Array calls the Notes for redemption, at any time prior to the close of business on the business day prior to the redemption date; or (4) upon the occurrence of specified corporate events. On or after March 1, 2020 until the close of business on the scheduled trading day immediately prior to the maturity date, holders may convert their Notes at any time, regardless of the foregoing circumstances. Upon conversion, the holders will receive, at Array's option, shares of Array's common stock, cash or a combination of shares and cash. The Notes will be convertible at an initial conversion rate of 141.8641 shares per $1,000 in principal amount of Notes, equivalent to a conversion price of approximately $7.05 per share, subject to certain adjustments set forth in the Indenture.
Nice summary and very much appreciated as I don't hear very well and I don't see a transcript anywhere. I think the testing of selumetinib with radioactive iodine as a first-line treatment is huge. Also, I kind of was predicting to myself that the FDA might prefer an ARRY-520 and Kyprolis combo after they showed a complete response in the first cohort.
Seems like your posting was cut off. Was there more? Thanks in advance.
A little was cut off, but nothing of great importance.
A little anecdotal evidence: my hematologist just got back from a hematology conference. He said there was a lot of buzz about 520. I always thought 614 would be the real value driver, but I may have underestimated 520
I figure Squarer needs to do another capital raise before year-end to shore up the balance sheet. I think ARRY needs another $100 million to execute on its game plan. The asthma drug and pain drug partnerships are very problematical, especially the latter. ROW partnerships on 520 and 614 will only happen after ASH in December. Milestones from AZN and NVS on starting enrollment in Phase III's probably won't amount to that much, especially if ARRY has to start burning more cash to develop 520 and 614 on its own. I expect 520 to be partnered, if data is impressive enough. ONXX seems like a logical partner on 520.
The ASLAN and Oncothyreon partnerships are like free option calls.
Once the balance sheet is put in order, we're off to the races.