Our earnings preview continues as we look forward to the second full week of earnings. We also highlight regulatory events (PDUFA and Advisory Committee meetings) slated for the remainder of February and March.
First, let’s review the week that was with another full week full price-moving healthcare news.
BUYOUTS:
GW Pharmaceuticals plc (NASDAQ:GWPH) announced it will be acquired by Jazz Pharmaceuticals plc (NASDAQ:JAZZ) for $220 per American Depositary Share (ADS), in the form of $200 in cash and $20 in Jazz ordinary shares, for a total consideration of $7.2b, or $6.7b net of GW cash. GW shares closed Wednesday up 45% to $211.37.
Horizon Therapeutics plc (NASDAQ:HZNP) announced it will acquire Viela Bio, Inc. (NASDAQ:VIE) for $53.00 per share in cash, which represents a fully diluted equity value of approximately $3.05b, or approximately $2.67b net of Viela's cash and cash equivalents. Viela shares closed Monday up 52% to $52.80.
COVID-19:
Vaxart, Inc., (NASDAQ: VXRT) released data from its Phase 1 trial of VXA-CoV2-1, its oral COVID-19 tablet vaccine candidate. Neutralizing antibodies were not detected in serum and Immunoglobulin G (IgG) responses, a type of antibody, were also not detected in most subjects. Shares closed the week down 36% to $7.70.
Novavax, Inc. (NASDAQ:NVAX) shares closed the week up 69% to $290.18, continuing with its momentum following last week’s positive COVID-19 vaccine data.
FDA APPROVAL:
Durect Corporation (Nasdaq: DRRX) announced the FDA approved Posimir (bupivacaine solution) to produce post-surgical analgesia following arthroscopic subacromial decompression. Shares closed the week up 19% to $2.06.
TG Therapeutics, Inc. (NASDAQ: TGTX) announced the FDA approved Ukoniq (umbralisib), for the treatment of adult patients with relapsed or refractory marginal zone lymphoma (MZL) and for patients with relapsed or refractory follicular lymphoma (FL). Shares closed Friday up 12% to $54.30.
CLINICAL TRIAL-RELATED (in brief with weekly close and % change)
Arcutis Biotherapeutics, Inc. (NASDAQ:ARQT): $35.04; +28%. Positive data from two Phase 3 trials of of roflumilast cream (ARQ-151) as a potential topical treatment for plaque psoriasis.
Applied Therapeutics, Inc. (Nasdaq: APLT): $26.49; +27%. Partial clinical hold lifted on the AT-007 ACTION-Galactosemia Kids pediatric trial.
Prothena Corporation plc (NASDAQ:PRTA): $14.52; +30%. Intends to initiate a Phase 3 (AFFIRM-AL) trial of birtamimab for the treatment of newly diagnosed, treatment naïve patients with AL amyloidosis.
Concert Pharmaceuticals, Inc. (NASDAQ:CNCE): $6.86; -34%. Phase 2 trial of CTP-692 in patients with schizophrenia did not meet the primary endpoint.
Immunovant (Nasdaq: IMVT): $24.15; -38%. Clinical trials for IMVT-1401 paused following notice of a physiological signal consisting of elevated total cholesterol and LDL levels.
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Biotech Earnings (14 earnings dates to watch) – full calendar for premium members:
Tue: DCPH INCY
Wed: KMDA TEVA EXEL VNDA
Thu: ALKS AZN ALNY KPTI OTIC PRTA RARE
Fri: IMGN
Remaining February/March PDUFA and Advisory Committee dates: