Seven biotech IPOs ready to roll; Celltrion's Herceptin biosim gets second review at FDA
→ Renaissance Capital is tracking 7 new biotech IPOs this week. The lineup includes Magenta, Avrobio and Autolus, all high-profile ventures that will be testing the market again.
→ Forty Seven set terms on its IPO, looking to sell 6.7 million shares at $14 to $16 apiece.
→ South Korea’s Celltrion is finally getting back on track with the US regulatory process for Herzuma, its biosimilar for Herceptin. The company had filed for resubmission in May after receiving a complete response letter in April; now that the review is resumed, a decision is expected within six months. The reversal is notable given that the FDA had, just days ago, snubbed a copycat from Amgen/Allergan — another rival vying for Roche’s blockbuster cancer drug, which brought in $7 billion last year. As is the case for Amgen/Allergan’s and Pfizer’s Herceptin biosims, Herzuma is already approved in Europe, where regulators are quicker to give OKs in this category.
→ Shares of ObsEva $OBSV surged 10% Monday morning after the biotech put out word that its Phase IIb study of linzagolix hit the primary and secondary endpoints for endometriosis pain. The company touted results for their top three doses, though the two highest dose groups achieved significant but rather marginal improvements over a placebo, with the sugar pill group achieving close to a 34.5% response rate compared to 56.4% and 56.3% for the drug arms.
→ Vertex $VRTX has had its problems rolling out its cystic fibrosis drugs in Europe, where single payers have proven stubbornly resistant to the price of what they see as an imperfect therapy. Sweden, though, has now worked out a reimbursement deal with the Boston-based biotech, making the drug available to patients suffering from CF.