With renewed focus on the U.S. Cancer Moonshot, the price of oncology drugs is more than a satellite issue, especially as new drugs launch with ever-increasing prices and other cancer drugs continue to see price hikes.
Just two weeks after winning U.S. FDA approval for the first orally dissolving formulation of dexmedetomidine for agitation in schizophrenia and bipolar disorders, Bioxcel Therapeutics Inc. has secured commitments for up to $260 million to support the product’s commercial launch, slated for this quarter in addition to a planned European marketing application.
Regeneron Pharmaceuticals Inc. proposes to buy Checkmate Pharmaceuticals Inc. though an all-cash price of $10.50 per share for about $250 million. That’s pretty much on target with Checkmate’s April 19 closing share price (NASDAQ:CMPI) of $10.35, as the stock gained a staggering 326% on the day.
Beigene Ltd.’s BTK inhibitor Brukinsa (zanubrutinib) has met the primary endpoints in a phase III trial to treat patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma.
A week before the U.S. FDA’s Oncologic Drugs Advisory Committee was to meet and review TG Therapeutics Inc.’s BLA and sNDA for the combo of ublituximab and Ukoniq (umbralisib) for treating chronic lymphocytic leukemia and small lymphocytic lymphoma, the company voluntarily withdrew the submission and now is rethinking its oncology programs. The move was tied to an FDA-requested analysis of phase III data showing that, while study met its primary endpoint, there was an imbalance in updated overall survival (OS) results favoring the control arm. A June 25 PDUFA date had been set for the combination treatment.
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