3 Things In Biotech, May 9: New AML Therapy Imminent? AVEO Hedges, Rockwell Boosts Iron

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Includes: AVEO, DSKYF, RMTI
by: Zach Hartman
Summary

Daiichi Sankyo gets an in with an AML subgroup.

AVEO delays a critical stage of a critical trial.

Rockwell Medical shows early signs of rocking in anemia.

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Welcome to another edition of "3 Things In Biotech You Should Learn Today," a daily digest dedicated to helping you keep pace with the fast-moving world of pharmaceutical and biotechnology research.

Daiichi Sankyo gets an in with an AML subgroup

Company: Daiichi Sankyo (OTCPK:DSKYF)

Therapy: Quizartinib

Disease: Flt3-positive acute myeloid leukemia (AML)

News: DSKYF announced results from its QuANTUM-R study, specifically stating that the company's Flt3 inhibitor quizartinib has demonstrated improved overall survival compared with standard chemotherapy following disease relapse on standard first-line treatment. This improvement in overall survival means that the study has met its primary endpoint, and we'll need to wait and see about a full data readout to know more specifics.

Looking forward: Fantastic news on a new-generation Flt3 inhibitor. This field of targeted therapy has had a hard time getting off the ground, due to a lack of effective drugs. But that's changed recently, and the next few years are going to see a new crop of approvals. I expect that quizartinib will be in that list, and I anticipate this will happen around early next year.

Excellent news for patients with this subset of AML, as well as DSKYF.

AVEO delays a critical stage of a critical trial

Company: AVEO Pharmaceuticals (NASDAQ:AVEO)

Therapy: Tivozanib

Disease: Renal cell cancer

News: AVEO announced that the pre-specified number of PFS events have not been reached in its phase 3 TIVO-3 trial to trigger a data analysis, which means the company will be forced to push back the interim data readout from Q2 2018 to Q3 2018. In order to mitigate the delay, AVEO divulged that it will work with its contract research organization to shorten the data analysis period once the PFS events have been reached. TIVO-3 is intended to be used for pursuit of regulatory approval in the United States once data are known.

Looking forward: Delays are no fun for investors and would-be shareholders. And the stock market did not respond well to this news, as AVEO fell 10% after the announcement. Now, of course, the minds of viewers may go in a more optimistic direction as well. If they anticipated reaching the PFS event threshold by now, isn't it a good sign that it hasn't been reached? To that, I have to say "maybe." As always, I caution heavily against trying to extrapolate these kinds of announcements to any kind of data, since we don't have critical pieces of information needed to assess things carefully. However, in the long run, I think we'll see that a delay of one fiscal quarter isn't a back breaker, assuming the company can hew to this schedule.

I don't think this news is as bad as the initial drop made it out to seem.

Rockwell Medical shows early signs of rocking in anemia

Company: Rockwell Medical (NASDAQ:RMTI)

Therapy: Triferic

Disease: Anemia due to chronic renal failure

News: RMTI presented a poster at the 17th Congress of the International Society for Peritoneal Dialysis describing findings from an open-label study with 30 patients with chronic kidney disease who are on dialysis. The use of ferric pyrophosphate as part of its peritoneal dialysis demonstrated a dose-dependent improvement in transport of iron from the dialysis fluid to the circulation, and the therapy was well-tolerated.

Looking forward: The company being able to show proof of concept is an early positive sign for this method of replacing iron in the circulation. Obviously, this particular product is still a ways away from more important data readouts and potential approval, but every bit of proof of concept we can get is important for this. And considering RMTI is relying almost entirely on the development of this agent, kidney failure-related anemia could end up being an important indication the company pursues for commercialization.

Signs of life for RMTI, but these findings alone are too early to warrant a buy from me.

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