BPC January 14 update

Nektar NKTR negative Adcom vote -15% AH; ​Stemline STML falls 30% on lower revenues

Price and Volume Movers

Stemline Therapeutics, Inc. (Nasdaq: STML) shares closed down 30% to $6.57 following the release of disappointing revenues for the fourth quarter. The company noted net revenues for Elzonris of $11.8m for the quarter, down from $13.1m reported the previous quarter.

XBiotech (NASDAQ: XBIT) announced it has commenced a “modified Dutch auction” tender offer to purchase up to $420m of its common shares, at a price between $30 and $33 per share. Shares closed up 31% to $24.33.

Nektar Therapeutics (NASDAQ:NKTR) shares are trading down 15% to $23.68 after hours following news a FDA Advisory Committee voted 27-0 against recommending approval of oxycodegol for the management of chronic low back pain in adults.

Eloxx Pharmaceuticals, Inc. (NASDAQ: ELOX) shares also closed down 30% to $5.28. The company provided an update of its lead pipeline candidate ELX-02 for the treatment of cystic fibrosis. The company released data from the first cohort of the Phase 2 trial of ELX-02 in the treatment of patients with nonsense mutation-mediated nephropathic cystinosis. The company noted that the targeted goal was to reduce white blood cells (WBC) cystine levels to below 1 nmol of ½ cystine/mg protein. Reductions in WBC were not evident in the low-dose cohort and while the two higher dose cohorts saw reductions in WBC the levels did not meet their targeted goal.

Phio Pharmaceuticals Corp. (NASDAQ:PHIO) announced that a reverse stock split at a ratio of 1-for-55 will become effective on January 15, 2020 and will open for trading on a post-split basis on Wednesday.

Denali Therapeutics Inc. (NASDAQ: DNLI) shares closed up 29% to $22.74. The company released data from its Phase 1b trial of DNL201 in patients with Parkinson’s disease and noted that it met the trial’s biomarker goals. The treatment was generally well tolerated at the low dose. However, at the high dose, the majority of subjects experienced either mild or moderate adverse events, with one severe adverse event (headache).


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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:

La Jolla Pharmaceutical Company (LJPC): $8.83; +26%.

Momenta Pharmaceuticals, Inc. (MNTA): $25.36; +24%.

Rigel Pharmaceuticals, Inc. (RIGL): $2.62; +21%.

Anixa Biosciences, Inc. (ANIX): $3.32; +20%.

Gritstone Oncology, Inc. (GRTS): $10.45; +18%.

DECLINERS:

NantKwest, Inc. (NK): $4.90; -28%.

AzurRx BioPharma, Inc. (AZRX): $1.35; -20%.

Oncolytics Biotech Inc. (ONCY): $2.87; -18%.

Daré Bioscience, Inc. (DARE): $1.37; -17%.

Fulcrum Therapeutics, Inc. (FULC): $18.54; -13%.

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

ABBV – AbbVie Inc.
Risankizumab vs secukinumab
Plaque psoriasis

Phase 3 Phase 3 trial met primary endpoint - January 14, 2020.
$126.1 billion

ALXN – Alexion Pharmaceuticals Inc.
ULTOMIRIS (ravulizumab) - CHAMPION-ALS
Amyotrophic lateral sclerosis (ALS)

Phase 3 Phase 3 trial initiation due 1Q 2020.
$24 billion

CARA – Cara Therapeutics Inc.
KORSUVA (CR845/difelikefalin) oral
Atopic dermatitis patients with moderate-to-severe pruritus

Phase 2 Phase 2 interim analysis 2Q 2020. Top-line data 2H 2020.
$762.7 million

CARA – Cara Therapeutics Inc.
KORSUVA (CR845/difelikefalin) oral
Chronic Liver Disease-Associated Pruritus

Phase 2 Phase 2 data due 2H 2020.
$762.7 million

DNLI – Denali Therapeutics Inc.
DNL747
Amyotrophic Lateral Sclerosis

Phase 1b Phase 1b data due mid-2020.
$2.4 billion

DNLI – Denali Therapeutics Inc.
DNL151
Parkinson’s disease

Phase 1b Phase 2/3 trial planned either with DNL201 or DNL151. Decision to be made mid-2020.
$2.4 billion

ELOX – Eloxx Pharmaceuticals Inc.
ELX-02
Cystinosis

Phase 2 Phase 2 data released January 14, 2020.
$180.4 million

IDRA – Idera Pharmaceuticals Inc.
Tilsotolimod + ipilimumab - ILLUMINATE 204
Cancer - melanoma

Phase 2 Phase 2 final data due 2Q 2020.
$54.9 million

IDRA – Idera Pharmaceuticals Inc.
Tilsotolimod (IMO-2125) + ipilimumab - ILLUMINATE 301
Melanoma

Phase 3 Phase 3 data due 4Q 2020/ 1Q 2021.
$54.9 million

IDRA – Idera Pharmaceuticals Inc.
Tilsotolimod + nivolumab and ipilimumab - ILLUMINATE 206
Squamous Cell Carcinoma of the Head and Neck (SCCHN)

Phase 2 Phase 2 interim data due 2Q 2020.
$54.9 million

NK – NantKwest Inc.
PD-L1 t-haNK
Solid tumors

Phase 1 Phase 1 preliminary data noted one complete response - January 14, 2020. Data from the full 11 metastatic pancreatic patients due in 2020.
$665.9 million

NKTR – Nektar Therapeutics
NKTR-181
Lower back pain

PDUFA FDA Advisory Committee voted 27-0 against recommending approval - January 14, 2020.
$3.8 billion

SNGX – Soligenix Inc.
SGX301 (synthetic hypericin)
Cutaneous T-Cell Lymphoma (CTCL) cancer

Phase 3 Phase 3 top-line data due 1Q 2020.
$61.5 million

SNGX – Soligenix Inc.
SGX942 (dusquetide)
Oral Mucositis in Patients with Head & Neck Cancer

Phase 3 Phase 3 top-line data due 2Q 2020.
$61.5 million