CytRx Corp. (NASDAQ: CYTR) just gave an update on its lead oncology candidate, aldoxorubicin. The company is trialing the drug in a global Phase 3, with a target indication of second-line soft tissue sarcomas. The drug is part of an already established family of cancer drugs called anthracyclines chemotherapy drugs. Along with most chemotherapies though, anthracyclines aren’t particularly specific to cancer cells, so that the drug is associated with low tolerability and some serious side effects. With aldoxorubicin, CytRx is attempting to improve the selectivity of this family of drugs, making them more tolerable and safer for patients.
The near-term catalyst has to do with an announcement that the ongoing trial had hit the 191 checkpoints it was required to before the U.S. Food and Drug Administration (FDA) would accept any data analysis. This means CytRx can now use the data to form the basis of a new drug application and pave the way toward an FDA approval and commercialization. The data are set for release before the end of the quarter.
MEIP had a very good data update on the single arm elderly AML Phase II trial at ASH but the stock went down. The trial was a combination of Vidaza and pracinostat. They reported a 14.3+ month OS (still counting) with a high complete response rate of 42%. Anything over 12 months would be a win and 14 months a big win and they still haven’t reached median overall survival on the whole cohort (median OS for patients with high risk genetics was 13.3 months again a big win in my book). The best results for Vidaza as single agent in elderly AML is about 10-12 months OS. The negative is that this was a single arm trial and patients probably had a slightly lower blast count than in the comparative Vidaza trials..The current market cap is only $51.75 million with cash as of September 30th of $58 million and no debt.
What’s the market potential for the drug on approval? Every year, around 75,000 melanoma cases are diagnosed in the US. We’ve used the 25% NRAS mutation figure above, but let’s be conservative (estimates vary) and say 20% have an NRAS mutation. This puts us at around 19,000 cases each year. The average cost of melanoma treatment is around $1,800 per patient, but we have a mitigating factor at play here – NRAS is primarily associated with poor prognosis (i.e. it is much more serious, and often later stage when diagnosed, than BRAF). As melanoma advances, average costs rise to $170,000, with the later stage costs often accounting for more than 90% of total treatment cost. It is not unreasonable to assume, therefore, that Array could put a conservative price tag of $100,000 on this treatment, if approved. This would give it potential revenues of $1.9 billion, based on the NRAS mutation figures. How about $50,000 per treatment that is still a billion dollar drug friends. Novartis funded development, but in a stroke of luck for Array (and in a very unusual deal), Novartis paid Array $85 million to bow out of the agreement last year, returning global rights to the latter.
So end of June sales will be key. Stock will move up... They will raise some cash and we will move forward
So they got 3 quarters of money if sales don't grow ...we know sales are growing .. sales will ramp they should just make it and be ok ....hanging tight and watching
Sales growth should continue just a little slower
poor people have been voting Democratic for 50 years and told to vote democratic by rich people that say they are going to help the poor people ... but guess what the poor people are still poor? Hello ?? Wake up sheep.!!
Total ... DME market ..is ..1,000,000
If ALIM gets 20% of the DME market that is 200,000 x $8,500 per treatment which will equate to $1.7 billion in sales ? Why is this thing at $2 and change ? This should be and will be a $40 dollar a share stock. We are in a nuclear winter for biotech. Be patience my friends and stay thirsty !