Seeking validation

4Q18 offers glimpse of key data and launch trajectories in large markets

The final stretch of the year offers clinical catalysts and early launch data that could validate investments in hot immuno-oncology targets and large untapped markets.

Late-stage readouts from Vertex Pharmaceuticals Inc. in cystic fibrosis and Biogen Inc. in Alzheimer’s disease will take the spotlight in 4Q18.

Buysiders will also be looking to a slew of annual conferences, including the American Society of Hematology (ASH) meeting in December, for additional clinical data on therapies targeting IL-2 and tumor necrosis factor receptor superfamily member 17 (BCMA; TNFRSF17; CD269).

Others have their eyes on launches for large markets such as migraine, or that feature novel modalities, such as RNAi.

ClearBridge Investments’ Marshall Gordon said the quarter is “more tilted towards continuing execution and launches than data.”

Big caps, big risks

Late-stage data from Vertex and Biogen will take the clinical spotlight in 4Q.

Vertex is evaluating two different triple combinations -- VX-445 or VX-659 plus tezacaftor and Kalydeco ivacaftor -- across four Phase III trials. The regimens have the potential to address about 90% of the cystic fibrosis market.

The company expects data from the two Phase III studies of VX-659 in combination with tezacaftor and Kalydeco late this year.

In a Phase II study, once-daily 400 mg VX-659 plus tezacaftor and Kalydeco improved mean percent predicted FEV1 from baseline to day 29 by 13.3 percentage points vs. 0.3 percentage points for placebo.

“The triple combo probably has to hit,” according to Kai Brüning of apo Asset Management, who said Phase III success is baked into Vertex’s current share price.

Ailsa Craig of International Biotechnology Trust and Ivo Staijen of HBM Partners agreed that Vertex’s readout has more downside than upside potential. “The bar for them is high now. They have to hit that same level of efficacy for everybody

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