Big news

Biotech names and milestones investors like heading into 2H15

The performance of big cap biotechs has lagged that of companies one tier down, but the second half includes a host of milestones that could put the bellwethers on a steeper upward trajectory.

Buysiders largely ignored the crop of PDUFA dates in 2Q15, but investors contacted by BioCentury have at least two regulatory milestones at the top of their watch lists this half.

Smaller companies will not be ignored, as dedicated biotech investors are looking to important mid-cap events that range from Phase II results to regulatory actions.

In addition, some investors are adding to their positions in companies that have traded down following important news events.

Finally, a few buysiders told BioCentury they're going to revisit once-hot spaces like epigenetics and RNAi that they believe have been largely passed over during the past one to two years in favor of areas like gene therapy and chimeric antigen receptor (CAR) and T cell receptor (TCR) therapies (see "2H15 Milestones," page 12).

Full slate

With FDA's approval of Vertex Pharmaceuticals Inc.'s Orkambi lumacaftor/ivacaftor kicking off the quarter, the remaining milestones most widely mentioned by buysiders are the PCSK9 approvals and launches, and data from the 6 mg/kg dose group in the Phase Ib PRIME trial of Biogen Inc.'s aducanumab to treat Alzheimer's disease.

Last quarter, hypercholesterolemia candidates Repatha evolocumab from Amgen Inc. and Praluent alirocumab from partners Regeneron Pharmaceuticals Inc. and Sanofi both received positive FDA panel recommendations.

Praluent has a July 24 PDUFA date, Repatha's is Aug. 27.

Biogen's AD results are expected in July. The 6 mg dose of aducanumab represents the middle ground where investors are hoping the company hits the sweet spot of efficacy and acceptable tolerability.

"Biogen is the type of company that can move the sector," said Brad Loncar of Loncar Investments. "It will be important for the 6 mg dose data to be decent. If it's a total disaster and everyone changes their mind on the prospects of AD programs it could change things for the sector."

"Biogen is going to be super active," noted OrbiMed's Sven Borho.

The

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