CHMP recommends OK for Alnylam's patisiran; Amgen scraps a BCMA ADC
→ Alnylam $ALNY took another big step toward getting a European approval for patisiran. The biotech says that the CHMP recommended an OK for hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis) in adult patients with stage 1 or stage 2 polyneuropathy. A formal OK is likely. The drug is facing an August 11 PDUFA date at the FDA.
→ Portola $PTLA, though, isn’t making any headway with betrixaban. The CHMP batted back the company’s appeal of its earlier rejection. Here’s a summary of all the action at the EMA today.
→ Amgen is scrapping one of its antibody-drug conjugates as it shifts focus to a BiTE program it has in development. In the Q2 call outgoing R&D chief Sean Harper noted that “by the end of this year, we expect initial Phase 1 data from our BCMA BiTE, AMG 420, in multiple myeloma and our CD33 BiTE, AMG 330, in AML. We look forward to additional data from other BiTE programs over the next year or two, including both liquid and solid tumors. We’ve also deprioritized AMG 224, our BCMA antibody-drug conjugate, based on early data reads from our AMG 224 and AMG 420 programs that support our view that our BiTE technology may be superior to current ADC technologies.”
→ Tiny Charlottesville, VA-based Adial Pharmaceuticals joined the IPO crowd today, pricing shares at $5 and raising a little more than $7 million. The money will be used to advance a drug to treat alcohol abuse.