BPC February 11 update

​FibroGen FGEN PDUFA date set for December 20; DMAC PHIO ZSAN offerings

Price and Volume Movers

FibroGen, Inc. (NASDAQ:FGEN) announced that the FDA has set a PDUFA date of December 20, 2020 for the New Drug Application (NDA) of roxadustat for the treatment of anemia of chronic kidney disease (CKD), in both non-dialysis-dependent (NDD) and dialysis-dependent (DD) patients. The filing of the roxadustat NDA triggers a $50 million milestone payment from AstraZeneca (NYSE:AZN) to FibroGen.

Genprex, Inc. (NASDAQ: GNPX) shares closed up 30% to $1.61. The company announced that it has licensed diabetes gene therapy technology from the University of Pittsburgh. Development to date has been pre-clinical, with a Phase 1 trial planned.

Zosano Pharma Corporation (NASDAQ:ZSAN) announced after hours an underwritten public offering of units consisting of shares of common stock and warrants to purchase common stock. Shares, which closed up 18%, are trading down 31% to $0.71 after hours following the news.

Phio Pharmaceuticals Corp. (NASDAQ:PHIO) shares slumped, closing down 57% to $2.85, following the pricing of an underwritten public offering of 2m shares and attached warrants at an offering price of $4 per share and warrant to purchase one share.

DiaMedica Therapeutics Inc. (NASDAQ:DMAC) announced the pricing of an underwritten registered public offering of 2,125,000 of its common shares at a price of $4 per share for gross proceeds of $8.5m. Shares closed down 6% to $4.42.

Marker Therapeutics, Inc. (NASDAQ: MRKR) announced that the FDA has lifted the clinical hold on Marker's planned Phase 2 trial investigating MultiTAA T cell therapy in patients with post-transplant acute myeloid leukemia (AML). At the time of the initial clinical hold, the FDA requested additional information and technical specifications for reagents supplied by third parties used in the manufacturing process. This data could not be produced by the original suppliers. As a result, the company has identified an alternative supplier, and a partial clinical hold will be in place until the final data and certificate of analysis of the new supplier are accepted by the FDA. Shares closed up 6% to $2.85.

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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:

Rexahn Pharmaceuticals, Inc. (REXN): $3.66; +79%.

AIM ImmunoTech Inc. (AIM): $1.61; +30%.

Sol-Gel Technologies Ltd. (SLGL): $11.85; +20%.

Otonomy, Inc. (OTIC): $3.97; +20%.

Sierra Oncology, Inc. (SRRA): $15.50; +20%.

DECLINERS:

Xeris Pharmaceuticals, Inc. (XERS): $4.33; -29%.

Brickell Biotech, Inc. (BBI): $1.14; -25%.

Kaleido BioSciences, Inc. (KLDO): $8.10; -15%.

PDS Biotechnology Corporation (PDSB): $1.78; -12%.

Stoke Therapeutics, Inc. (STOK): $30.21; -12%.

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

ARNA – Arena Pharmaceuticals Inc.
Etrasimod
Ulcerative colitis

Phase 3 Phase 3 commencement of dosing announced June 17, 2019.
$2.5 billion

FENC – Fennec Pharmaceuticals Inc.
Pedmark (sodium thiosulfate)
Cisplatin-induced ototoxicity

NDA Filing Completion of rolling NDA filing announced February 11, 2020.
$141.3 million

FGEN – FibroGen Inc
Roxadustat
Anaemia in Chronic Kidney Disease

PDUFA PDUFA date December 20, 2020.
$3.8 billion

INCY – Incyte Corporation
Capmatinib
Non-small cell lung cancer

PDUFA priority review PDUFA date under priority review announced February 11, 2020. PDUFA date not announced but estimated August 11, 2020 based on a 6-month timeline.
$17.1 billion

MRKR – Marker Therapeutics Inc.
MultiTAA-Specific T Cells
Acute Myeloid Leukemia

Phase 2 Phase 2 clinical hold lifted - February 11, 2020. Replaced with partial hold.
$121.6 million

NGM – NGM Biopharmaceuticals Inc.
NGM120
Cachexia syndrome

Phase 1b Phase 1a/1b trial initiation announced February 11, 2020.
$1.3 billion

PTN – Palatin Technologies Inc.
PL-8177
Ulcerative colitis

Phase 2 Phase 2 trial to commence mid-2020 with data due mid-2021.
$131 million

PTN – Palatin Technologies Inc.
PL9643
Dry eye disease (DED)

Phase 2 Phase 2 trial initiation announced February 19, 2020 with data due 4Q 2020.
$131 million

SGEN – Seattle Genetics Inc.
Enfortumab vedotin and Keytruda EV-103
Urothelial cancer

Phase 1/2 Phase 1/2 data noted Overall response rate 73%; Complete response rate 16% (partial response rate 58%).
$20 billion

SLS – SELLAS Life Sciences Group Inc.
Galinpepimut-S and nivolumab
Malignant pleural mesothelioma (MPM)

Phase 1 Phase 1 commencement of enrolment announced February 11, 2020.
$11.4 million