News of Note—Cytori fail; Gilead HIV data; Pfizer biosim matches Avastin

Positives for Gilead and Pfizer, but not for Cytori.

> Microcap regenerative medicine biotech Cytori took a pummeling this morning after releasing details for a failed test, cutting in half its share price. The preliminary data from its pivotal Star trial of Habeo cell therapy in patients with connective tissue disease scleroderma missed both its primary and secondary endpoints. The biotech dug deep and said it found “clinically meaningful” improvements, but this was not enough to assuage investors. Release

Gilead’s new, once-daily HIV pill Bic/F/TAF was statistically noninferior versus competitor GlaxoSmithKline’s regimen, which was largely in line with analysts’ expectations. Jefferies, in a note to clients, said: “Ultimately, this [sic] data is good for Gilead to get its new pill out there and approved and on market in 2019 and this is already in our and consensus estimates.” Statement

Pfizer says its biosimilar PF-06439535 met its primary endpoint against Roche’s multilicensed oncology blockbuster Avastin (bevacizumab). The trial showed equivalence in the primary endpoint of objective response rate in nonsquamous non-small cell lung cancer. Release


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