BPC July 22 update

JAZZ receives FDA Approval for narcolepsy; ​BioNTech BNTX shares rally on vaccine deal with the White House +14%

Price and Volume Movers

Jazz Pharmaceuticals plc (Nasdaq: JAZZ) announced that the FDA approved Xywav oral solution for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy. Shares closed up 4% to $110.26.

BioNTech SE (NASDAQ:BNTX) shares closed up 14% to $104.17 on news of an agreement with the White House, together with its partner Pfizer (PFE), to supply the U.S. with 100m doses of BNT162, their COVID-19 vaccine candidate. The U.S. government with pay $1.95b upon the receipt of the first 100m doses, following FDA authorization or approval, with an option to acquire up to 500m additional doses. If the clinical trials are successful, Pfizer and BioNTech expect to be ready to seek Emergency Use Authorization in October 2020. They expect to manufacture up to 100m doses by the end of 2020 and potentially more than 1.3 billion doses by the end of 2021.

Genocea Biosciences, Inc. (NASDAQ:GNCA) announced that it has entered into a private placement for $80m of its common stock and warrants to purchase shares of common stock. The company is due to present initial data from its Phase 1/2a trial of GEN-009 in solid tumors on July 30. Shares closed up 15% to $3.14.

Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH) announced that it has commenced a public offering of its common shares. After closing 15% higher, shares are trading down 7% to $15.50 following news of the offering. The company announced Tuesday that it has been assigned a PDUFA date under priority review of January 22, 2021, for its regulatory application of voclosporin, as a potential treatment for lupus nephritis.

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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:

Genprex, Inc. (GNPX): $4.10; +20%.

Assertio Holdings, Inc. (ASRT): $1.08; +17%.

Millendo Therapeutics, Inc. (MLND): $2.02; +15%.

Atossa Therapeutics, Inc. (ATOS): $4.15; +12%.

TFF Pharmaceuticals, Inc. (TFFP): $7.09; +11%.

DECLINERS:

Tonix Pharmaceuticals Holding Corp. (TNXP): $1.30; -22%.

CASI Pharmaceuticals, Inc. (CASI): $1.90; -15%.

Onconova Therapeutics, Inc. (ONTX): $1.19; -14%.

Immuron Limited (IMRN): $12.69; -14%.

Tiziana Life Sciences PLC (TLSA): $9.95; -14%.

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

AXGN – Axogen Inc.
Avance Nerve Graf
Severed peripheral nerves

Phase 3 Phase 3 preliminary report of trial data due 2Q 2022.
$446.2 million

AZRX – AzurRx BioPharma Inc.
MS1819 - OPTION 2
Cystic fibrosis

Phase 2 Phase 2 top line data due in 1Q 2021.
$27.6 million

BIIB – Biogen Inc.
Opicinumab (AFFINITY)
Multiple sclerosis (MS)

Phase 2b Phase 2b data due 2H 2020.
$46.6 billion

BIIB – Biogen Inc.
BIIB054
Parkinson's disease

Phase 2 Phase 2 data due 1H 2021.
$46.6 billion

BIIB – Biogen Inc.
BIIB111
Choroideremia

Phase 3 Phase 3 data due 1H 2021.
$46.6 billion

BIIB – Biogen Inc.
BIIB112
X-linked Retinitis Pigmentosa

Phase 2/3 Phase 2/3 data due 1H 2021.
$46.6 billion

BIIB – Biogen Inc.
TMS-007
Acute ischemic stroke

Phase 2 Phase 2 data due 1H 2021.
$46.6 billion

IONS – Ionis Pharmaceuticals Inc.
Tofersen
Amyotrophic lateral sclerosis (ALS)

Phase 3 Phase 3 data due 2H 2021.
$7.4 billion

JAZZ – Jazz Pharmaceuticals plc
Xywav
Cataplexy and Excessive Daytime Sleepiness in Narcolepsy

Approved FDA Approval announced July 22, 2020.
$6.8 billion

RDHL – Redhill Biopharma Ltd.
Opaganib
COVID-19

Phase 2/3 Phase 2/3 global trial initiation announced July 30, 2020.
$315.3 million

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

Phase 1 Phase 1 trial completion of dosing announced July 22, 2020. Well-tolerated with no serious adverse events reported. Phase 1b trial planned.
$18.6 million

SWTX – SpringWorks Therapeutics Inc.
Nirogacestat
Desmoid tumors

Phase 3 Phase 3 top-line data due 2Q or 3Q 2021.
$1.9 billion