BPC November 20 update

Eiger EIGR FDA Approval; FDA Advisory Committee to discuss Pfizer PFE BioNTech BNTX Covid-19 vaccine December 10

Price and Volume Movers

Pfizer Inc. (NYSE:PFE) and BioNTech SE (NASDAQ:BNTX) announced the submission of an Emergency Use Authorization (EUA) to the FDA for their COVID-19 vaccine candidate, BNT162b2, which will potentially enable use of the vaccine in the U.S. by the middle to end of December 2020. Analysis announced earlier in the week from its Phase 3 trial showed a vaccine efficacy rate of 95%. In separate the news, the FDA announced that the Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet on December 10 to discuss the EUA.

Eiger BioPharmaceuticals, Inc. (NASDAQ:EIGR) received approval from the FDA for Zokinvy (lonafarnib) capsules to reduce the risk of death due to Hutchinson-Gilford progeria syndrome and for the treatment of certain processing-deficient progeroid laminopathies in patients one year of age and older. Shares are currently trading up 13% to $11.35 after hours.

Zymeworks Inc. (NYSE:ZYME) shares closed up 14% to $47.16 following news the European Commission granted Orphan Drug designation for zanidatamab, its HER2-targeted bispecific antibody, in patients with gastric cancer.

ADC Therapeutics SA (NYSE: ADCT) announced that the FDA has accepted its Biologics License Application (BLA) for loncastuximab tesirine (Lonca) for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and granted a PDUFA date under priority review of May 21, 2021. Shares closed up 6% to $35.85.

Stealth BioTherapeutics Corp (Nasdaq: MITO) announced a registered direct offering with several institutional investors to purchase 2,844,446 of its American Depositary Shares for gross proceeds of $3.2m. Shares closed down 13% to $1.30.

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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:

Idera Pharmaceuticals, Inc. (IDRA): $4.26; +19%.

Aprea Therapeutics, Inc. (APRE): $24.84; +18%.

Evolus, Inc. (EOLS): $3.99; +17%.

Mesoblast Limited (MESO): $13.78; +17%.

Delcath Systems, Inc. (DCTH): $14.99; +17%.

DECLINERS:

AVROBIO, Inc. (AVRO): $13.99; -18%.

Kazia Therapeutics Limited (KZIA): $10.34; -14%.

Tiziana Life Sciences PLC (TLSA): $2.48; -13%.

Liminal BioSciences Inc. (LMNL): $4.86; -12%.

XBiotech Inc. (XBIT): $17.41; -12%.

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

ADCT – ADC Therapeutics SA
Loncastuximab Tesirine
Diffuse Large B-Cell Lymphoma

PDUFA priority review PDUFA date under priority review May 21, 2021. Phase 2 data to be presented at ASH December 6, 2020
$2.9 billion

ARDS – Aridis Pharmaceuticals Inc.
AR-301 (Salvecin)
Ventilator associated pneumonia (VAP) / Staphylococcus aureus

Phase 3 Phase 3 interim data due 1H 2021 with top-line data due YE 2021.
$68.8 million

ARDS – Aridis Pharmaceuticals Inc.
AR-501
Chronic bacterial lung infections in patients with cystic fibrosis (CF)

Phase 2a Phase 2a data due 2H 2021.
$68.8 million

ARDS – Aridis Pharmaceuticals Inc.
AR-711
COVID-19

Phase 1/2 Phase 1/2 trial to be initiated 1H 2021.
$68.8 million

EIGR – Eiger BioPharmaceuticals Inc.
Lonafarnib
Hutchinson-Gilford Progeria Syndrome (HGPS)

Approved FDA approval announced November 20, 2020.
$297.3 million

OLMA – Olema Pharmaceuticals Inc.
OP-1250
HR+, HER2- Breast Cancer

Phase 1 Phase 1 initial data due 2H 2021.
$2 billion

PFE – Pfizer Inc.
BNT162b2
COVID-19 vaccine

Phase 3 Phase 3 final efficacy analysis noted vaccine was 95% effective in preventing COVID-19. EUA filing announced November 20, 2020. Advisory Committee meeting December 10, 2020.
$212.9 billion

RDHL – Redhill Biopharma Ltd.
RHB-204
Nontuberculous mycobacteria (NTM) infections

Phase 3 Phase 3 trial initiation announced November 20, 2020.
$333.2 million