BPC September 04 update

Mallinckrodt MNK shares slide after hours on restructuring reports; Marinus MRNS and OVID rise on analyst coverage

Price and Volume Movers

Mallinckrodt Plc (NYSE: MNK) shares are trading down 42% to $1.49 after hours on reports by Bloomberg that it is exploring options to absorb potential costs from lawsuits related to the opioid epidemic. The company has hired law firm Latham & Watkins LLP and consulting firm AlixPartners LLP. If the legal liabilities are not manageable, Mallinckrodt may choose to seek bankruptcy protection, according to Bloomberg sources.

Marinus Pharmaceuticals, Inc. (NASDAQ: MRNS) shares closed up 23% to $1.56 following the initiation of coverage by H.C. Wainwright with a Buy rating and a $5 price target.

uniQure N.V. (Nasdaq: QURE) announced that it has commenced an underwritten public offering of $200m of its ordinary shares. Shares are trading down 10% to $50.50 after hours.

Ovid Therapeutics Inc. (NASDAQ: OVID) shares closed up 13% to $1.99 following the initiation of coverage by RBC Capital with an Outperform rating and a price target of $12.

Clearside Biomedical, Inc. (Nasdaq: CLSD) shares closed up 16% to $0.68 on news of a license agreement with Regenxbio Inc. (Nasdaq: RGNX) where Regenxbio will be provided with rights to its in-office SCS Microinjector for the delivery of RGX-314 to treat wet age-related macular degeneration (wet AMD), diabetic retinopathy (DR). Clearside will receive up to $34m in total development milestones and up to $102m in sales milestones and mid-single digit royalties on net sales of products using the SCS Microinjector.

Idera Pharmaceuticals, Inc. (NASDAQ:IDRA) shares closed up 13% to $2.60 on news of a collaboration with AbbVie, where a Phase 1b trial will be initiated of combinations of ABBV-368 plus tilsotolimod in patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). Idera will provide clinical trial supply of tilsotolimod to AbbVie and AbbVie will be responsible for conduct of the trial.

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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:

EyeGate Pharmaceuticals, Inc. (EYEG): $2.78; +13%.

Concert Pharmaceuticals, Inc. (CNCE): $1.99; +13%.

Emergent BioSolutions Inc. (EBS): $56.00; +12%.

TCR2 Therapeutics Inc. (TCRR): $18.88; +11%.

Acasti Pharma Inc. (ACST): $1.99; +11%.

DECLINERS:

Immunic, Inc. (IMUX): $13.20; -17%.

Ardelyx, Inc. (ARDX): $4.96; -15%.

Ultragenyx Pharmaceutical Inc. (RARE): $45.06; -12%.

Brickell Biotech (NASDAQ: BBI): $4.14; -12%.

Tocagen Inc. (TOCA): $3.04; -11%.

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

ADRO – Aduro Biotech Inc.
ADU-S100 and pembrolizumab
Squamous Cell Carcinoma of the Head and Neck (SCCHN)

Phase 1/2 Phase 1b/2 initiation of dosing announced September 4, 2019 with initial data due 2020.
$99.4 million

APLT – Applied Therapeutics Inc.
AT-001
Diabetic cardiomyopathy (DbCM)

Phase 3 Phase 3 trial initiation announced September 4, 2019.
$166.4 million

AVXL – Anavex Life Sciences Corp.
ANAVEX 2-73-RS-003 EXCELLENCE
Rett syndrome

Phase 2 Phase 2 trial initiation announced September 4, 2019.
$176.9 million

CLRB – Cellectar Biosciences Inc.
CLR 131
Multiple myeloma

Phase 1 Phase 1 data September 14, 2019 noted 50% ORR.
$22.9 million

DNLI – Denali Therapeutics Inc.
DNL151
Parkinson’s disease

Phase 1b Phase 1 commencement of dosing announced September 4, 2019.
$1.8 billion

IMMU – Immunomedics Inc.
SACITUZUMAB GOVITECAN - TROPHY U-01
Urothelial cancer

Phase 2 Phase 1/2 interim data to be presented at ESMO September 28, 2019.
$3.3 billion

INFI – Infinity Pharmaceuticals Inc.
AB298 + IPI-549 + Doxil
Triple negative breast cancer (TNBC) and ovarian cancer

Phase 1 Phase 1 initiation announced September 4, 2019.
$67.3 million

INFI – Infinity Pharmaceuticals Inc.
IPI-549 + Tecentriq and Abraxane and IPI-549 + Tecentriq and Avastin (MARIO-3)
Front-line triple negative breast cancer (TNBC); Renal cell cancer (RCC)

Phase 2 Phase 2 initiation announced September 4, 2019.
$67.3 million

KRYS – Krystal Biotech Inc.
KB105
Transglutaminase-1 Deficient Autosomal Recessive Congenital Ichthyosis

Phase 1/2 Phase 1/2 interim data due 2H 2019.
$825.2 million

RARE – Ultragenyx Pharmaceutical Inc.
DTX401
GSD1

Phase 1/2 Phase 1/2 data from second cohort released September 4, 2019.
$2.5 billion

RARX – Ra Pharmaceuticals Inc.
RA101495 zilucoplan
Myasthenia Gravis (MG)

Phase 3 Phase 3 trial to commence 2H 2019.
$1.2 billion

TCDA – Tricida Inc.
TRC 101
Chronic kidney disease

NDA Filing NDA filing announced September 4, 2019.
$1.7 billion

TNXP – Tonix Pharmaceuticals Holding Corp.
TNX-601
PK trial

Phase 1 Phase 1 initiation of dosing announced September 4, 2019 with data due by the end of 2019.
$7 million