BPC February 05 update

Week Two - Biotech earnings preview; Biotech week in Review

Weekly watchlist

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:

Drug Stage Catalyst Market Cap

BBIO – BridgeBio Pharma Inc.
Fosdenopterin (BBP-870/ORGN001)
Molybdenum cofactor deficiency type A

Approved FDA approved February 26, 2021.
$402 million

BLUE – bluebird bio Inc.
ide-cel bb2121 - KarMMa
Relapsed/refractory multiple myeloma

PDUFA priority review PDUFA date under priority review March 27, 2021.
$2.1 billion

CRMD – CorMedix Inc.
Defencath (Neutrolin)
Hemodialysis patients with central venous catheters

CRL CRL announced March 1, 2021.
$244.8 million

FGEN – FibroGen Inc
Roxadustat
Anaemia in Chronic Kidney Disease

PDUFA PDUFA date March 20, 2021. Company announced March 1, 2021 that an Advisory Committee meeting will be held. Date TBC. PDUFA date likely to be extended.
$3.5 billion

GTHX – G1 Therapeutics Inc.
Trilaciclib
Second/third-line small-cell lung cancer

Approved FDA approval announced February 12, 2021.
$981.4 million

JNJ – Johnson & Johnson
JNJ-78436735 (Ad26.COV2-S) - (ENSEMBLE)
COVID-19 vaccine (single dose)

Approved Phase 3 data released January 29, 2021. Efficacy rate 66% in overall population, 72% effective in U.S. and 57% in South Africa. EUA Approval by FDA announced February 27, 2021.
$418 billion

KMPH – KemPharm Inc
KP415
ADHD

PDUFA PDUFA date March 2, 2021 (submitted by KMPH).
$177.8 million

KNSA – Kiniksa Pharmaceuticals Ltd.
Rilonacept
Pericarditis

PDUFA priority review PDUFA date under priority review March 21, 2021.
$1.4 billion

REGN – Regeneron Pharmaceuticals Inc.
Evinacumab (ANGPTL3 Antibody)
Homozygous familial hypercholesterolemia (HoFH)

Approved FDA approval announced February 11, 2021.
$48.7 billion

REGN – Regeneron Pharmaceuticals Inc.
Libtayo
Basal cell carcinoma (BCC)

Approved FDA approval announced February 9, 2021.
$48.7 billion

SRPT – Sarepta Therapeutics Inc.
Casimersen
Duchenne muscular dystrophy

Approved FDA approval announced February 25, 2021.
$7 billion

ZEAL – Zealand Pharma A/S
Dasiglucagon
Severe hypoglycemia in diabetes

PDUFA PDUFA date scheduled for March 27, 2021.
$1.4 billion