BPC December 30 update

AstraZeneca AZN and Oxford University receive approval from U.K. regulators for COVID-19 vaccine

Price and Volume Movers

AstraZeneca Plc (NASDAQ: AZN) and the University of Oxford won approval from U.K. regulators for their COVID-19 vaccine, making it the third vaccine to be approved in the U.S/U.K/Europe. While efficacy levels have shown to be lower in clinical trials compared with the two other approved vaccines (Moderna and Pfizer), it can be stored at refrigerator temperature unlike the other aforementioned vaccines which require super freezing storage.

Silverback Therapeutics, Inc. (Nasdaq: SBTX) shares closed up 14% to $42.04. The company which listed as an IPO earlier this month received a number of analyst initiations Tuesday, including Stifel with a Buy rating and a price target of $58.

KalVista Pharmaceuticals, Inc. (NASDAQ: KALV) shares closed up 21% to $18.89 ahead of key data from its Phase 2 trial in patients with Hereditary Angioedema (HAE) due in the first quarter of 2021.

Osmotica Pharmaceuticals plc (NASDAQ:OSMT) shares closed down 20% to $4.23 following news released late-Tuesday that the FDA issued a Complete Response Letter (CRL) regarding the its New Drug Application (NDA) for arbaclofen extended release tablets to treat spasticity resulting from multiple sclerosis.

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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:

Novan, Inc. (NOVN): $1.05; +50%.

AzurRx BioPharma, Inc. (AZRX): $1.04; +33%.

Matinas BioPharma Holdings, Inc. (MTNB): $1.47; +32%.

Codiak BioSciences, Inc. (CDAK): $28.00; +29%.

VistaGen Therapeutics, Inc. (VTGN): $1.77; +18%.

DECLINERS:

Cyclacel Pharmaceuticals, Inc. (CYCC): $7.15; -13%.

Equillium, Inc. (EQ): $5.44; -12%.

Inozyme Pharma, Inc. (INZY): $21.64; -11%.

Prelude Therapeutics Incorporated (PRLD): $75.43; -10%.

Ocugen, Inc. (OCGN): $1.97; -9%.

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

ALT – Altimmune Inc.
HepTCell
Hepatitis B

Phase 2 Phase 2 commencement of enrollment announced December 30, 2020. Data due 1Q 2022.
$479.5 million

CDAK – Codiak BioSciences Inc.
exoIL-12
Cutaneous T cell lymphoma

Phase 1 Phase 1 initial safety data announced December 30, 2020. No treatment-related adverse events. Biomarker and preliminary efficacy results in CTCL patients due mid-2021.
$485.5 million

PLX – Protalix BioTherapeutics Inc. (DE)
Pegunigalsidase alfa (PRX-102) - BALANCE
Fabry disease

Phase 3 Phase 3 interim data due 1H 2021.
$153.5 million

PLX – Protalix BioTherapeutics Inc. (DE)
Pegunigalsidase alfa (PRX-102) - BRIGHT
Fabry disease

Phase 3 Phase 3 top-line data due 1Q 2021.
$153.5 million