BPC October 15 update

Eiger EIGR shares rally on COVID data +18%; Vertex VRTX adds to losses -21%

Price and Volume Movers

Eiger BioPharmaceuticals (NASDAQ:EIGR) shares closed up 18% to $10.13 following its announcement of positive data from an investigator sponsored randomized trial of Peginterferon Lambda (Lambda) in outpatients with mild to moderate COVID-19. The data showed SARS-CoV-2 RNA viral load decline from baseline was significantly greater in the Lambda group than in the placebo group from Day 5 onwards. Patients treated with Lambda were 4.1 times more likely to have cleared their viral loads after seven days than patients in the placebo arm.

Vertex Pharmaceuticals Incorporated (NASDAQ:VRTX) shares closed down 21% to $215.28 following news released after hours Wednesday that it will be discontinuing development of VX-814 in patients with alpha-1 antitrypsin deficiency (AATD) after several patients exhibited elevated liver enzymes. Shares had traded down around 10% during Wednesday's after hours session. Arrowhead Pharmaceuticals, Inc (NASDAQ:ARWR) which is also developing AATD therapies, saw its shares close up 10% to $48.85.

Galapagos NV (NASDAQ: GLPG) and Servier announced after hours that their Phase 2 Roccella trial of GLPG1972 in patients with knee osteoarthritis (OA) failed to meet the primary endpoint.

Anavex Life Sciences Corp. (Nasdaq: AVXL) announced data from its Phase 2 trial of ANAVEX 2-73 in patients with Parkinson’s disease dementia (PDD). The company noted improvements in the Cognitive Drug Research (CDR) computerized assessment system analysis that were clinically meaningful. However, data regarding the degree of improvement compared to placebo were not released with data to be presented at an upcoming medical conference. Shares closed up 9% to $4.75.

-

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:

PolyPid Ltd. (PYPD): $13.45; +27%.

Beam Therapeutics Inc. (BEAM): $32.92; +16%.

AlloVir, Inc. (ALVR): $27.07; +13%.

Replimune Group, Inc. (REPL): $40.97; +13%.

Ayala Pharmaceuticals, Inc. (AYLA): $13.00; +11%.

DECLINERS:

Cellectis S.A. (CLLS): $19.29; -12%.

ADC Therapeutics SA (ADCT): $27.26; -12%.

Cyclerion Therapeutics, Inc. (CYCN): $2.97; -11%.

Liquidia Technologies, Inc. (LQDA): $2.98; -11%.

Fulcrum Therapeutics, Inc. (FULC): $10.08; -11%.


Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

ANVS – Annovis Bio Inc.
ANVS401
Alzheimer’s disease

Phase 2a Phase 2a data due in 2021.
$33.3 million

ANVS – Annovis Bio Inc.
ANVS401
Alzheimer’s disease (AD) and Parkinson’s disease (PD)

Phase 2 Phase 2 initial data due early 2021.
$33.3 million

ARMP – Armata Pharmaceuticals Inc.
AP-PA02
Pseudomonas aeruginosa Infections

Phase 1/2 Phase 1b/2a trial to be initiated by the end of 2020.
$56 million

AVXL – Anavex Life Sciences Corp.
ANAVEX 2-73
Parkinson’s Disease Dementia (PDD)

Phase 2 Phase 2 data released October 15, 2020. Effect on Cognitive Drug Research (CDR) shown to be clinically meaningful. No data on effect relative to placebo.
$336.8 million

BCLI – Brainstorm Cell Therapeutics Inc.
NurOwn
Amytrophic lateral sclerosis (ALS)

Phase 3 Phase 3 top-line data due by the end of November 2020.
$318.2 million

BCLI – Brainstorm Cell Therapeutics Inc.
NurOwn
Progressive Multiple Sclerosis

Phase 2 Phase 2 dosing to be completed 4Q 2020.
$318.2 million

BCLI – Brainstorm Cell Therapeutics Inc.
NurOwn
Prodromal to mild Alzheimer's disease

Phase 2 Phase 2 trial planned.
$318.2 million

EIGR – Eiger BioPharmaceuticals Inc.
Peginterferon lambda (Lambda)
COVID-19

Phase 2 Phase 2 data released October 15, 2020. Four times more likely to have cleared SARS-CoV-2 by Day 7 than those in the placebo arm.
$262.6 million

ETON – Eton Pharmaceuticals Inc.
ET-104 (zonisamide oral suspension)
Neurological indication

PDUFA PDUFA date May 29, 2021.
$179.8 million

GLPG – Galapagos NV
GLPG1972 - ROCCELLA
Osteoarthritis

Phase 2b Phase 2 trial did not meet primary endpoint - October 15, 2020.
$7.9 billion

KALV – KalVista Pharmaceuticals Inc.
KVD900
Hereditary Angioedema (HAE)

Phase 2 Phase 2 data due 4Q 2020.
$286.9 million

KALV – KalVista Pharmaceuticals Inc.
KVD824
Hereditary angioedema

Phase 1 Phase 2 trial to be initiated in 2021.
$286.9 million

MRK – Merck & Company Inc. (new)
Keytruda - KEYNOTE-204
Classical Hodgkin lymphoma

Approved FDA Approval announced October 15, 2020.
$192.7 billion

RGLS – Regulus Therapeutics Inc.
RGLS4326
Autosomal dominant polycystic kidney disease (ADPKD)

Phase 1b Phase 1 initiation of dosing announced October 15, 2020. Data from the first cohort due 1Q 2021.
$17.9 million