Highlights of weekly biotech stock moves
Regulatory, clinical and other milestones
Alexza Pharmaceuticals Inc. (NASDAQ:ALXA) jumped $1.23 (45%) to $3.97 on Friday after resubmitting an NDA to FDA for Adasuve Staccato loxapine to treat agitation in patients with schizophrenia or bipolar disorder. In May, FDA issued a complete response letter that the company said cited manufacturing deficiencies but did not identify any clinical or safety issues. Alexza was up $1.22 (44%) for the week.
AMAG Pharmaceuticals Inc. (NASDAQ:AMAG) gained $0.61 to $15.05 on Friday after the European Commission approved an MAA from partner Takeda Pharmaceutical Co. Ltd. (Tokyo:4502) for Rienso ferumoxytol to treat iron deficiency anemia in chronic kidney disease (CKD) patients. Takeda plans to launch the drug this year. AMAG was off $0.08 on the week.
KV Pharmaceutical Co. (NYSE:KVA) fell $0.30 (29%) to $0.75 last Monday after FDA found no major safety problems in