BPC March 18 update

COVID-19: ​BioNTech BNTX shares continue surge; Vaxart VXRT adds 21% - trials to commence 2H 2020

Price and Volume Movers

BioNTech SE (Nasdaq: BNTX) shares continued to surge, closing up 38% to $92.00, for a three-day gain of 197%. The move follows announcements of both China and ex-China collaborations to develop its mRNA vaccine candidate BNT162 for the prevention of COVID-19 infections, with trials to commence in late April 2020.

Vaxart, Inc. (NASDAQ:VXRT) shares closed up 21% to $2.34 following news it has entered into an agreement with Emergent BioSolutions Inc. (NYSE:EBS), whereby Emergent will deploy its molecule-to-market contract development and manufacturing (CDMO) services to help develop and manufacture Vaxart's experimental oral vaccine candidate for coronavirus disease (COVID-19). A Phase 1 trial is slated to commence in early 2H 2020.

IMV Inc. (Nasdaq: IMV) shares initially spiked pre-market as it also joined the list of companies announcing that it is advancing a vaccine candidate against COVID-19. The company took advantage of the early price action when it followed with news of an at-the-market-offering, where it may issue up to $30m from time to time. Shares closed well of its highs but still up 13% on the day to $2.30.

IVERIC bio, Inc. (Nasdaq: ISEE) announced that enrolment of its pivotal trial of Zimura for the treatment of geographic atrophy (GA) secondary to dry age-related macular degeneration (AMD), has been delayed due to the coronavirus (COVID-19) pandemic. Expect to see similar announcements from other companies over the next few weeks.

iBio, Inc. (NYSE AMERICAN:IBIO) shares closed up 40% to $1.60, with investors reacting to its progress towards developing vaccine candidates for preventing infection from the SARS-CoV-2 virus that causes the COVID-19 coronavirus disease.

DBV Technologies S.A. (NASDAQ: DBVT) shares closed up 26% to $2.93. Analysts at Morgan Stanley maintained their Equal-Weight rating of the stock, with a price target of $4, compared with its previous target of $11.

Eton Pharmaceuticals, Inc. (NASDAQ: ETON) announced that the FDA issued a Complete Response Letter for the New Drug Application for ET-105. A resubmission of the NDA is due during 2Q / 3Q 2020. Shares closed down 11% to $2.84.

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Major price movers (stocks priced > $1.00, volume > 50k):

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

ADVANCERS:

Entasis Therapeutics Holdings Inc. (ETTX): $5.56; +175%.

Genfit SA (GNFT): $13.50; +21%.

Dynavax Technologies Corporation (DVAX): $3.06; +18%.

Proteostasis Therapeutics, Inc. (PTI): $1.28; +16%.

Portola Pharmaceuticals, Inc. (PTLA): $6.62; +15%.

DECLINERS:

Mallinckrodt Public Limited Company (MNK): $1.08; -36%.

Magenta Therapeutics, Inc. (MGTA): $6.96; -30%.

Aduro BioTech, Inc. (ADRO): $2.01; -27%.

Verona Pharma plc (VRNA): $2.16; -26%.

Strongbridge Biopharma plc (SBBP): $1.57; -26%.

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

ACER – Acer Therapeutics Inc.
ACER-001
Urea cycle disorder (UCD)

NDA Filing NDA filing due early 2021.
$18.7 million

ASLN – ASLAN Pharmaceuticals Limited
ASLAN004
Atopic dermatitis

Phase 1 Phase 1 data due 3Q 2020.
$42.9 million

CAPR – Capricor Therapeutics Inc.
CAP-1002 HOPE-2
Duchenne Muscular Dystrophy (DMD)

Phase 2 Phase 2 12-month data due 2Q 2020.
$6.7 million

DRNA – Dicerna Pharmaceuticals Inc.
DCR-A1AT
Alpha-1 antitrypsin (A1AT) deficiency-associated liver disease

Phase 1/2 Phase 1/2 pause in enrolment at higher doses is likely due to COVID-19.
$1.3 billion

EBS – Emergent Biosolutions Inc.
cGMP vaccine
Coronavirus COVID-19 Vaccine

Phase 1 Phase 1 trial to be initiated early 2H 2020.
$2.6 billion

ETNB – 89bio Inc.
BIO89-100
Nonalcoholic steatohepatitis (NASH)

Phase 1/2 Phase 1b/2 trial top-line data due 2H 2020.
$442.8 million

ETON – Eton Pharmaceuticals Inc.
EM-105
Lennox-Gastaut syndrome, epilepsy

CRL CRL issued March 17, 2020. Additional trial required.
$78 million

IDYA – IDEAYA Biosciences Inc.
IDE196
Solid tumors

Phase 2 Phase 2 interim data expected in 2H 2020.
$86.1 million

IMV – IMV Inc.
DPX-COVID-19
Coronavirus COVID-19

Phase 1 Phase 1 trial planned.
$83.7 million

ISEE – IVERIC bio Inc.
Zimura
Geographic atrophy

Phase 3 Phase 3 trial initiation delayed due to COVID-19.
$144.5 million

JNJ – Johnson & Johnson
Ponesimod
Relapsing multiple sclerosis

NDA Filing NDA filing announced March 18, 2020.
$324.7 billion

PFE – Pfizer Inc.
Abrocitinib - JADE Compare
Atopic Dermatitis

Phase 3 Phase 3 trial met primary endpoints - March 18, 2020.
$171.4 billion

PFE – Pfizer Inc.
PF-06482077
Pneumococcal Disease

Phase 3 Phase 3 trial met primary endpoint - March 18, 2020.
$171.4 billion

RYTM – Rhythm Pharmaceuticals Inc.
Setmelanotide
Alstrom Syndrome and Bardet-Biedl Syndrome

Phase 3 Phase 3 top-line data due 4Q 2020 or early 1Q 2021.
$618.6 million