A number of companies released significant data over the last trading week, all of which were slated for March release in the BioPharmCatalyst FDA Calendar.
Nektar Therapeutics (Nasdaq: NKTR) announced Monday that it met the primary efficacy endpoint in its Phase 3 trial of NKTR-181 in patients with chronic back pain relief. Shares surged to close the day up 43% to $22.11 and closed the week higher at $22.42.
Jazz Pharmaceuticals plc (Nasdaq: JAZZ) announced that it met the co-primary endpoints its two trials of JZP-110 in adult patients with excessive sleepiness associated with obstructive sleep apnea (OSA). Shares closed the session up 7% to $144.08, before closing the week at $143.14.
Aevi Genomic Medicine, Inc (NASDAQ: GNMX) announced Monday that it did not meet the primary endpoint in its SAGA trial of AEVI-001 in adolescents with mGluR mutation positive (mGluR+) ADHD. Shares ended the session down 59% to $2.21 and closed the week at $1.60, a fall of over 70%.
Xenon Pharmaceuticals Inc. (Nasdaq:XENE) announced Friday that its Phase 2 trial of XEN801 for the treatment of moderate to severe facial acne did not meet both its primary and key secondary efficacy endpoints. Shares tumbled to close down 53% to $4.65.
Ultragenyx Pharmaceutical Inc. (NASDAQ:RARE) announced Wednesday that it did not meet the primary endpoint in its Phase 2 study of UX007 in glucose transporter type-1 deficiency syndrome (Glut1 DS) patients with seizures. Shares dropped to close down 10% to $70.32 from Wednesday’s close.
Esperion Therapeutics, Inc. (NASDAQ:ESPR) shares surged Monday to close the day up 74% to $41.22 before closing the week at $38.94. The company announced that its current late-stage program of bempedoic acid will be sufficient to support approval for low-density lipoprotein cholesterol (LDL-C). Data from the trials are due in 2018, with a New Drug Application (NDA) to be filed 1H 2019.
Merck & Co., Inc. (NYSE:MRK) and Pfizer Inc. (NYSE:PFE) received approval Thursday from the FDA for Bavencio (avelumab), the first FDA-approved treatment for Merkel cell carcinoma (MCC).
TEN Upcoming biotech stock catalysts below slated for March/April: