The week before Christmas is typically a slow time of the year for news releases, a staple of biotech valuation changes. But Clovis Oncology (CLVS +0.00%), Akebia Therapeutics (AKBA 0.32%), Merus (MRUS +0.00%), and Ionis Pharmaceuticals (IONS +0.08%) all had news this week that sent their shares higher -- an early present for investors.
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An accelerated accelerated approval
On Monday, the Food and Drug Administration handed Clovis Oncology an accelerated approval for its ovarian cancer drug Rubraca. The FDA had set a goal of making its decision by Feb. 23, so an approval this early was unexpected, but certainly not unwelcome.
Rubraca's accelerated approval was based on two open-label clinical trials that didn't have placebo controls, but the data were clearly good enough -- and the advanced patients sick enough -- that the FDA was willing to approve the drug for patients that had already failed two or more chemotherapies.
To stay on the market, Clovis will have to confirm Rubraca's efficacy in additional clinical trials. The biotech is running a phase 3 clinical trial called ARIEL4 comparing Rubraca to chemotherapy that's already under way. And Clovis is also testing Rubraca in earlier-stage patients as a maintenance treatment after chemotherapy, which could expand Rubraca's market substantially.
A hand up
Both Akebia Therapeutics and Merus saw their shares skyrocket this week after signing licensing deals for drugs they're developing.
Akebia gave up half of the rights to its lead drug vadadustat, an oral hypoxia-inducible factor-prolyl hydroxylase (HIF-PH) inhibitor that treats anemia, to Japanese drugmaker Otsuka Pharmaceutical. As part of the deal, Otsuka will pay $160 million in cash and potentially up to $765 million more if undisclosed development and commercial milestones are met. From here on out, Akebia and Otsuka will share development costs as well as profits and losses on sales if the drug is approved.
In a rather broad development deal, Merus signed up Incyte (INCY 0.60%) to use its Biclonis technology platform to develop up to 11 bispecific antibody research programs. As part of the deal, Incyte is paying $120 million upfront and is also making an $80 million equity investment in Merus.
For eight of the programs, Incyte will pay for all development and commercialization activities, and Merus is eligible for undisclosed milestone payments of up to $350 million per program and royalties of 6% to 10%. For the other three programs, Merus retains some rights to develop the drugs in the U.S. either with Incyte or on its own.
Data now, approval soon?
On Monday, Ionis Pharmaceuticals announced positive data for its lipid-lowering drug volanesorsen. In the first phase 3 trial, volanesorsen reduced triglycerides by an average of 71.2% compared to a 0.9% reduction for the patients that received a placebo. Ionis expects data from a second phase 3 trial in the first quarter of next year.
Before then, Ionis and its partner Biogen (BIIB +0.88%), could see approval of their spinal muscular atrophy drug Spinraza. The FDA's goal is to make a decision by May, but like Clovis' Rubraca, Spinraza treats an unmet need -- in infants, no less -- so Ionis' management has hinted that the FDA is highly motivated to approve the drug quickly, potentially this year or in the first quarter of next year.
