News of Note—Biotech IPOs; CHMP knockbacks

> Vanda Pharmaceuticals has seen the European Medicines Agency once again knock back its schizophrenia antipsychotic Fanaptum (iloperidone). The CHMP, the safety and efficacy arm of the European regulator, said its effectiveness was “modest,” that it took too long to work and also had CV and toxicity safety concerns. It was previously rejected by the CHMP back in 2012. CHMP decision (PDF)

> And Vanda was not the only biopharma to see a rejection during this month’s CHMP decisions: Nektar Therapeutics and partner Daiichi’s advanced breast cancer med Onzeald (etirinotecan pegol) also failed to win recommendation. The CHMP said it didn’t think Nektar has done enough to show the med works in this setting. CHMP decision (PDF)

> While 2016 was pretty dire for IPOs, as we delve deeper into 2017 biotech public offerings are bouncing back, with two announced today. First up is Genprex, a gene therapy company looking to list on the Nasdaq and use the cash to fund work on its Oncoprex immunogene therapy, which is targeting non-small cell lung cancer. SEC filing


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> The second IPO-seeking biotech, which wants a $100 million IPO, is OrbiMed and New Enterprise Associates-backed Clementia Pharmaceuticals. Its lead product candidate, palovarotene, is an oral small molecule that binds and activates retinoic acid receptor gamma. The drug is in clinical testing for the rare disorders fibrodysplasia ossificans progressiva and multiple osteochondroma, with data readouts expected by the end of the decade. SEC filing

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