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Hello, everyone. Damian here with a look at a biotech rarity, a milestone on Wall Street, and pharma’s latest run-in with Washington.
The need-to-know this morning
- Advisers to the European regulatory agency reaffirmed a previous recommendation to withdraw from the market Translarna, a treatment for a certain type of Duchenne muscular dystrophy made by PTC Therapeutics, because its efficacy could not be confirmed. Translarna was granted European conditional approval in 2014, but subsequent studies designed to confirm the drug’s benefit were negative.
- European regulatory advisers also recommended an expanded approval for Abecma, the CAR-T therapy made by Bristol Myers Squibb, to cover treatment of patients with less advanced stages of multiple myeloma.
IPOs can pop in 2024
The year’s first biotech IPO, from CG Oncology, got off to a good start when the company up-sized its offering and priced its shares above its expected range. And then, as if it were 2021 again, CG Oncology actually traded up.
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