BPC January 12 update

Regeneron REGN signs deal for COVID-19 antibody; AFMD PRVB offerings

Price and Volume Movers

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) announced after hours that the U.S. government will purchase additional supply of the casirivimab and imdevimab antibody cocktail for use in non-hospitalized COVID-19 patients. Under the new agreement, the government will purchase all finished doses, up to 1.25m, of antibody cocktail delivered by June 30, 2021, in addition to the current supply of doses to treat 300,000 people under a previous agreement. Shares are trading up 3% to $519.50 after hours.

AcelRx Pharmaceuticals, Inc. (NASDAQ:ACRX) shares spiked in late-morning trading to close up 61% to $2.19. Traders seem to have reacted to an article published by Tipranks published at the same time as the spike which suggested upside potential of the stock.

La Jolla Pharmaceutical Company (NASDAQ:LJPC) shares closed up 28% to $5.04 following news of a licensing agreement with Paion AG for Giapreza (angiotensin II) and Xerava (eravacycline) in the European Economic Area, the United Kingdom and Switzerland. La Jolla receives an upfront payment of $22.5m and potential commercial milestone payments of up to $109.5m and double-digit tiered royalty payments based on net sales.

Affimed N.V. (NASDAQ:AFMD) shares are trading down 6% after hours to $6.25 on news it has commenced an underwritten public offering of its common shares.

Provention Bio, Inc. (NASDAQ:PRVB) also announced after hours it has commenced an underwritten public offering of 6m shares of its common stock. Shares, which closed up 8% during normal trading hours, have pulled back 8% after hours to $17.85.

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Major price movers (stocks priced > $1.00, volume > 50k listed on NASDAQ/NYSE):

Refer to the BioPharmCatalyst Biotech Stocks page for Top 10 Gainers/Losers/Unusual Volume:

ADVANCERS:

NovaBay Pharmaceuticals, Inc. (NBY): $1.05; +30%.

Liminal BioSciences Inc. (LMNL): $5.81; +27%.

iBio, Inc. (IBIO): $1.58+; +25%

Tyme Technologies, Inc. (TYME): $2.15; +25%.

Merus N.V. (MRUS): $24.06; +20%.

DECLINERS:

Black Diamond Therapeutics, Inc. (BDTX): $29.61; -15%.

Diffusion Pharmaceuticals Inc. (DFFN): $1.11; -15%.

RedHill Biopharma Ltd. (RDHL): $7.52; -14%.

Regulus Therapeutics Inc. (RGLS): $1.17; -13%.

Ocugen, Inc. (OCGN): $2.23; -10%.

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

ALXN – Alexion Pharmaceuticals Inc.
ALXN1840 (WTX101)
Wilson disease

Phase 3 Phase 3 top-line data due 1H 2021.
$34.5 billion

ALXN – Alexion Pharmaceuticals Inc.
ULTOMIRIS (ravulizumab-cwvz)
Generalized myasthenia gravis (gMG)

Phase 3 Phase 3 top-line data due 2H 2021.
$34.5 billion

ALXN – Alexion Pharmaceuticals Inc.
ULTOMIRIS (ravulizumab-cwvz)
COVID-19 Coronavirus

Phase 3 Independent data monitoring committee recommended pausing enrollment due to lack of efficacy in pre-specified interim analysis - January 13, 2021.
$34.5 billion

ANNX – Annexon Inc.
ANX005 and IVIG
Guillain Barré Syndrome (GBS)

Phase 1/2 Phase 1/2 DDI trial data due early 2021.
$962.7 million

AZRX – AzurRx BioPharma Inc.
Oral niclosamide
COVID-19

Phase 2 Phase 2 trial to commence 1H 2021.
$42.6 million

CLSD – Clearside Biomedical Inc.
CLS-AX
Wet age-related macular degeneration

Phase 1/2 Phase 1/2a commencement of enrollment announced January 12, 2021 with initial safety data from the first cohort expected in mid-2021.
$209.2 million

GSK – GlaxoSmithKline PLC
VIR-7832 (AGILE)
COVID-19 vaccine/therapeutic

Phase 2 Phase 2 trial to commence 1Q 2021.
$95 billion

IMVT – Immunovant Inc.
IMVT-1401 (ASCEND-WAIHA)
Warm autoimmune hemolytic anemia

Phase 2a Phase 2a data from Cohort 1 due 2Q 2021.
$3.4 billion

IMVT – Immunovant Inc.
IMVT-1401 (ASCEND GO-2)
Graves Ophthalmopathy / Thyroid Eye Disease (TED)

Phase 2b Phase 2b top-line data due 3Q 2021.
$3.4 billion

KYMR – Kymera Therapeutics Inc.
KT-474
Hidradenitis suppurativa / atopic dermatitis

Phase 1 Phase 1 trial to be initiated 1Q 2021. Presentation of data due 4Q 2021.
$3.4 billion

LPCN – Lipocine Inc.
LPCN 1144
Non-alcoholic fatty liver disease (NAFLD) / Non-alcoholic steatohepatitis (NASH)

Phase 2 Phase 2 top-line change in liver fat data met primary endpoint January 12, 2021. 36-week biopsy data are expected mid-2021.
$149.8 million

MIRM – Mirum Pharmaceuticals Inc.
Maralixibat
Alagille Syndrome (ALGS)

NDA Filing Rolling NDA to be completed 1Q 2021.
$555.2 million

MRK – Merck & Company Inc. (new)
V114
Pneumococcal disease

PDUFA priority review PDUFA date under priority review July 18, 2021.
$205.4 billion

NGM – NGM Biopharmaceuticals Inc.
Aldafermin (NGM282) - ALPINE 2/3
Non-alcoholic steatohepatitis (NASH)

Phase 2b Phase 2b data due 2Q 2021.
$2.1 billion