Cancer
In what is shaping up to be a back-loaded month, the FDA is set to release a slew of regulatory decisions in February, including two that would expand the labels of blockbuster drugs.
New draft guidance from the FDA on multiple myeloma endpoints reflects the new technology available to assess disease and how patient journeys have changed with better treatments.
The FDA is currently reviewing Summit’s PD-1/VEGF bispecific as part of a chemotherapy combo for the treatment of locally advanced or metastatic non-squamous non-small cell lung cancer.
Cancer-focused Eikon Therapeutics is seeking $273.5 million in its bid to trade on the Nasdaq, while hair growth specialist Veradermics is looking for $181.1 million in its foray onto the New York Stock Exchange.
Darzalex Faspro, in combination with an anti-cancer triplet, is the first anti-CD38-based regimen for newly diagnosed patients with multiple myeloma, regardless of eligibility for stem cell transplantation.
Onvansertib cut the risk of death or disease progression by 62% versus standard of care, but analysts await more detailed data.
Investors are apparently taking bets on when Revolution will be acquired. A handful of pharmas could be interested as Merck backs off.
Corcept’s overall survival data “look competitive” with AbbVie’s Elahere and Merck’s blockbuster Keytruda, Truist Securities said Thursday.
Merck had previously offered anywhere from $28 billion to $32 billion to swallow Revolution Medicines.
The partnership will allow BMS to advance a T cell–based therapy that is only activated once in the vicinity of a tumor.
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