AstraZeneca scores orphan status for PD-L1/CTLA-4 combo; EMA OKs Novartis' MS drug Mayzent
→ AstraZeneca gained an orphan drug designation for its combination of Imfinzi and the CTLA-4 drug tremelimumab for hepatocellular carcinoma (HCC), the most common type of liver cancer. Orphan designations, which are all the rage, provide 7 years of exclusivity to manufacturers.
→ Novartis’ oral treatment for secondary progressive multiple sclerosis, Mayzent (known chemically as siponimod), was given the nod by the EMA on Monday, less than a year after its FDA approval. GlobalData expects global sales for Mazyent to reach approximately $1.8 billion in the seven major markets by the end of 2028. This is approximately half of the peak sales reached by Novartis’ other MS drug, Gilenya, since progressive MS is a smaller patient population compared to relapsing-remitting MS, the analysts said.
→ Chi-Med has once again stopped a Phase III trial for surufatinib early after the drug hit the primary endpoint of progression-free survival. The SANET-p study was testing the drug, a tyrosine kinase inhibitor, in patients with advanced neuroendocrine tumors (pancreatic). Chi-Med, a Hong Kong-based biotech with both AIM and Nasdaq listings, had already laid out positive numbers for a different portion of the late-stage program in extra-pancreatic type tumors, which convinced China’s drug regulators to accept its NDA.
→ Cambridge-based Black Diamond Therapeutics, the first biotech of the new decade to declare its intention to make a public debut, filed its IPO plans in early January. Run by two developers of the cancer drug Tarceva, the oncology-focused company has already raised nearly $200 million in venture funding. On Tuesday, it broke out the terms of its IPO — it plans to raise $151 million by offering 8.9 million shares at a price range of $16 to $18, according to a report by Renaissance Capital.
→ Frazier-backed dermatology startup Arcutis Biotherapeutics has sized up its IPO goals, setting the price range between $15 and $17 for 7.8 million shares. Insiders have signed up for $50 million worth of shares out of what would be a $125 million raise at the midpoint, which would give Arcutis a fully diluted market value of $593 million, as quoted by Renaissance Capital.