BPC January 02 update

​Novan NOVN Incyte INCY Durect DRRX shares fall on disappointing data

Price and Volume Movers

Novan, Inc. (NASDAQ:NOVN) shares have slumped after hours, currently trading down 71% to $0.91, following news its Phase 3 B-SIMPLE program of SB206 for the treatment of molluscum contagiosum did not meet the primary endpoint in either of the two trials.

Incyte Corporation (NASDAQ:INCY) announced that its Phase 3 GRAVITAS-301 trial evaluating itacitinib in combination with corticosteroids in patients with treatment-naïve acute graft-versus-host disease (GVHD), did not meet the primary endpoint of improving overall response rate (ORR) compared to placebo. Shares are trading down 9% to $78.00 after hours.

Durect Corporation (Nasdaq: DRRX) shares closed down 31% to $2.62 following the announcement its Phase 2a clinical trial of DUR-928 in patients with mild to moderate plaque psoriasis did not demonstrate a benefit over vehicle (placebo), missing primary and secondary endpoints.

Trillium Therapeutics Inc. (NASDAQ: TRIL) shares closed up 45% to $1.49. The price action appears to be in reaction to a SEC filing disclosing that Morgan Stanley has taken a 5.9% stake in the company.

Pulmatrix, Inc. (NASDAQ:PULM) announced that it has entered into a licensing and development agreement with the Lung Cancer Initiative at Johnson & Johnson. It will receive a $7.2m upfront payment and an additional $2m milestone payment upon completion of the ongoing Phase 1b study of RV1162/PUR1800 in stable COPD patients, on-track for year-end 2020. Shares closed up 88% to $1.62.

Innate Pharma SA (NASDAQ:IPHA) shares closed up 14% to $7.30 on news the European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) for Lumoxiti (moxetumomab pasudotox-tdfk), indicated for adult patients with relapsed or refractory hairy cell leukemia (HCL) who have received at least two prior therapies.


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

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


Cassava Sciences, Inc. (SAVA): $7.20; +38%.

Advaxis, Inc. (ADXS): $1.09; +27%.

Ideya Biosciences, Inc. (IDYA): $9.14; +22%.

Equillium, Inc. (EQ): $4.09; +21%.

Agile Therapeutics, Inc. (AGRX): $2.97; +19%.


Clearside Biomedical, Inc. (CLSD): $2.11; -27%.

Oncolytics Biotech Inc. (ONCY): $3.95; -17%.

Cidara Therapeutics, Inc. (CDTX): $3.41; -11%.

Kezar Life Sciences, Inc. (KZR): $3.58; -11%.

NewLink Genetics Corporation (NLNK): $2.26; -11%.

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

BNTX – BioNTech SE
Solid tumors

Phase 1/2 Phase 1/2 trial to commence 2H 2020.
$16.3 billion

DRRX – DURECT Corporation

Phase 2a Phase 2 top-line data did not meet endpoints - January 2, 2020.
$455.3 million

GMDA – Gamida Cell Ltd.
NiCord (omidubicel)
Acute myeloid leukemia

BLA Filing BLA filing 4Q 2020.
$197.9 million

INCY – Incyte Corporation
Itacitinib - GRAVITAS-301
Treatment-naïve acute GVHD

Phase 3 Phase 3 trial did not meet primary endpoint - January 2, 2020.
$20.7 billion

MESO – Mesoblast Limited
Remestemcel-L (MSC-100-IV)
acute graft versus host disease (aGVHD) in children

PDUFA priority review PDUFA date under priority review September 30, 2020. FDA Oncologic Drugs Advisory Committee meeting August 13, 2020 voted 8-2 supporting approval.
$2.1 billion

NOVN – Novan Inc.

Phase 3 Phase 3 data did not meet primary endpoint - January 2, 2020. Additional Phase 3 trial to be initiated September 2020 with data due late-2Q 2021.
$67.9 million

SLGL – Sol-Gel Technologies Ltd.
Palmoplantar keratoderma (PPK)

Phase 1 Phase 1 data due 2021.
$183.3 million