→ Astellas has won a priority review for its FLT3 drug gilteritinib for treating acute myeloid leukemia. The Japanese pharma company, which has been earning some added attention as a possible takeover target, says the fast-paced FDA review was based on data from its ongoing pivotal study. A marketing decision is due November 29. The therapy also has Japan’s Sakigaki designation.
→ A group of Takeda shareholders has been agitating for a vote on the $62 billion Shire takeover. They say that the buyout will damage Takeda, but the board is opposed to the vote and wants to see the deal go through.
→ New York City’s gene therapy company MeiraGTx announced plans Tuesday to raise $92 million in an IPO. The company will sell 5 million shares between $14 and $16 per share, with insiders grabbing up $40 million of the offering. MeiraGTx will list under the ticker symbol $MGTX. Founded in 2015, MeiraGTx is developing treatments for acquired and inherited disorders, including a lead program tackling color blindness. Though first focused on the eye, salivary gland, and central nervous system, MeiraGTx also has plans to take on neurodegenerative diseases including Alzheimer’s, Parkinson’s, and ALS.
→ Pfizer won the FDA’s Breakthrough Therapy designation for Xalkori on two new indications: metastatic non-small cell lung cancer with MET exon 14 alterations with disease progression on or after platinum-based chemotherapy; and systemic anaplastic large cell lymphoma that is ALK-positive.
→ Australia’s Mesoblast is partnering with Cartherics to develop allogeneic ‘off-the-shelf’ CAR-T cells for use in solid cancers. The Australian Government’s Cooperative Research Centres Program is providing $9.6 million to fund their work.
With contribution from Brittany Meiling.
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