BPC May 19 update

Eiger EIGR Progeria PDUFA date set for November; Aldeyra ALDX development update Wednesday

Price and Volume Movers

Eiger BioPharmaceuticals, Inc. (Nasdaq:EIGR) announced that the FDA accepted its New Drug Application (NDA) for Zokinvy (lonafarnib) for treatment of Progeria and Progeroid Laminopathies. The PDUFA date under Priority Review is November 20, 2020.

Iterum Therapeutics plc (NASDAQ: ITRM) shares closed up 27% to $4.38. Data from their Phase 3 trial in patients with uncomplicated urinary tract infections (uUTI) are due this month.

Tricida, Inc. (NASDAQ:TCDA) announced a proposed offering of $175m Convertible Senior Notes due 2027. Shares closed down 16% to $26.58.

Ocular Therapeutix, Inc. (NASDAQ:OCUL) announced that it has commenced an underwritten public offering of its common stock. Shares closed down 5% to $6.45 and are trading down a further 7% after hours.

Dynavax Technologies Corporation (NASDAQ: DVAX) announced in a SEC filing that it expects that one or more of its collaboration partners will commence a Phase 1 clinical trial of a potential COVID-19 vaccine in July 2020. Shares closed up 34% to $6.51.

Aldeyra Therapeutics, Inc. (NASDAQ:ALDX) will host a conference call and webcast at 8:00 a.m. ET Wednesday, May 20, 2020 to provide a COVID-19 development update. No other details were provided by the company. Shares are trading up 28% to $4.91 after hours.

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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:

Acer Therapeutics Inc. (ACER): $4.53; +29%.

IMab (IMAB): $26.16; +28%.

Salarius Pharmaceuticals, Inc. (SLRX): $1.17; +27%.

Arbutus Biopharma Corporation (ABUS): $2.31; +24%.

Oncternal Therapeutics, Inc. (ONCT): $3.11; +23%.

DECLINERS:

Gamida Cell Ltd. (GMDA): $4.35; -26%.

Bellerophon Therapeutics, Inc. (BLPH): $13.00; -20%.

Sorrento Therapeutics, Inc. (SRNE): $5.42; -17%.

Aprea Therapeutics, Inc. (APRE): $30.92; -17%.

Phathom Pharmaceuticals, Inc. (PHAT): $35.00; -16%.


Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

ADRO – Aduro Biotech Inc.
BION-1301
IgA Nephropathy

Phase 1 Phase 1 data due 1H 2021 in IgA Nephropathy patients. Data from healthy volunteers to be presented June 8, 2020 at 1:00 pm PDT.
$264.3 million

ALDX – Aldeyra Therapeutics Inc.
ADX-629
COVID-19

Phase 1 IND filing due 3Q 2020.
$146.6 million

ASND – Ascendis Pharma A/S
TransCon
Hypoparathyroidism

Phase 2 Phase 2 six-month data from the open-label extension portion due 3Q 2020. Phase 3 trial to commence 4Q 2020.
$7 billion

ASND – Ascendis Pharma A/S
TransCon hGH
Growth hormone deficiency in children

BLA Filing BLA filing due 2Q 2020.
$7 billion

ATRA – Atara Biotherapeutics Inc.
ATA188
Multiple sclerosis

Phase 1 Phase 1 data presented at EAN with abstract released May 22, 2020.
$677.9 million

AZN – Astrazeneca PLC
Lynparza
Castration-Resistant Prostate Cancer

Approved FDA Approval announced May 19, 2020.
$143.3 billion

BFRA – Biofrontera AG
Ameluz
Basal cell carcinoma

Phase 3 Phase 3 data due not before 2021.
$146 million

DVAX – Dynavax Technologies Corporation
COVID-19 vaccine
COVID-19

Phase 1 Phase 1 clinical trial to commence July 2020.
$567.3 million

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

PDUFA priority review PDUFA date under priority review November 20, 2020.
$302.4 million

HEPA – Hepion Pharmaceuticals Inc.
CRV431
Non-alcoholic steatohepatitis

Phase 2a Phase 2a trial to be initiated June 2020 with data due by end of 2020.
$16.7 million

KMPH – KemPharm Inc.
KP415
ADHD

PDUFA PDUFA date March 2, 2021.
$12.3 million

NCNA – NuCana plc
NUC-3373
Solid tumors

Phase 1 Phase 1 initial data due 2020.
$203.6 million

NCNA – NuCana plc
NUC-3373
Colorectal Cancer

Phase 1 Phase 1b data due 2020.
$203.6 million

XLRN – Acceleron Pharma Inc.
Sotatercept - PULSAR (ATS)
Pulmonary arterial hypertension (PAH)

Phase 2 Phase 2 trial met primary endpoint - January 27, 2020. Data to be presented at American Thoracic Society (ATS) June 24, 2020.
$5.3 billion