BPC February 04 update

Celgene CELG shares close lower on reports of hedge fund stake in the company

Price and Volume Movers

Evolus, Inc. (NASDAQ: EOLS) shares closed up a further 12% to $20.50 following Friday’s intra-day announcement that the FDA approved Jeuveau for the temporary improvement in the appearance of glabellar lines.

Argenx (Nasdaq: ARGX) and Halozyme Therapeutics, Inc. (Nasdaq: HALO) announced a license agreement for the use of Halozyme’s Enhanze drug delivery technology by Argnex. Halozyme will receive an upfront payment of $30m and potential future milestone payments of up to $160m per target. Shares of Halozyme closed up 3% to $16.62. 

BioLineRx Ltd. (NASDAQ: BLRX) shares closed normal trading hours up 15% to $0.73 following news the FDA has granted Orphan Drug Designation to its lead oncology candidate, BL-8040, for the treatment of pancreatic cancer.  However, after hours it announced that it has commenced an underwritten public offering of American Depositary Shares ("ADSs"). Shares have retraced earlier gains, currently trading down 14% to $0.63 after hours. 

OPKO Health, Inc.  (NASDAQ: OPK) shares are trading down 13% to $3.05 on news that it intends to offer $200m aggregate principal amount of Convertible Senior Notes in an underwritten public offering. 

Celgene Corporation (NASDAQ: CELG) shares closed down 2.3% to $87.57 following news reported by Bloomberg that activist hedge fund Starboard Value has taken a stake in the company. “Since Bristol announced its plans to acquire Celgene, we have had many investors ask us if the deal might potentially get disrupted,” said Vamil Divan, an analyst with Credit Suisse Group AG. “The possibility of an activist coming in and pushing Bristol to look at other options, including maybe looking for a potential buyer, has also been raised and is interesting.”

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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:

Melinta Therapeutics Inc (NASDAQ: MLNT): $1.46; +71%.

Aileron Therapeutics, Inc. (ALRN): $1.73; +22%.

Eyenovia, Inc. (EYEN): $3.90; +18%.

Therapix Biosciences Ltd. (TRPX): $4.50; +17%.

Constellation Pharmaceuticals, Inc. (CNST): $8.78; +16%.

DECLINERS:

Fortress Biotech, Inc. (FBIO): $2.23; -10%.

Seelos Therapeutics, Inc. (SEEL): $3.90; -8%.

Leap Therapeutics, Inc. (LPTX): $1.39; -7%.

Fate Therapeutics, Inc. (FATE): $14.05; -7%.

resTORbio, Inc. (TORC): $8.01; -7%.

 

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

AIMT – Aimmune Therapeutics Inc.
AR101
Peanut Allergy

PDUFA PDUFA date late-January 2020. Advisory Committee meeting September 13, 2019.
$1.2 billion

ALXN – Alexion Pharmaceuticals Inc.
ALXN1840 (WTX101)
Wilson disease

Phase 3 Phase 3 enrolment to be completed early 2020.
$27.6 billion

ALXN – Alexion Pharmaceuticals Inc.
ALXN1830
Warm autoimmune hemolytic anemia (WAIHA)

Phase 1/2 Phase 1b/2a trial to be completed in 2019.
$27.6 billion

ALXN – Alexion Pharmaceuticals Inc.
ULTOMIRIS (ravulizumab-cwvz)
Generalized myasthenia gravis (gMG)

Phase 3 Phase 3 trial initiated 1Q 2019.
$27.6 billion

ALXN – Alexion Pharmaceuticals Inc.
ULTOMIRIS (ravulizumab-cwvz) subcutaneous
Paroxysmal nocturnal hemoglobinuria (PNH) and atypical Hemolytic Uremic Syndrome (aHUS)

Phase 3 Phase 3 PK data due early 2020.
$27.6 billion

ATNX – Athenex Inc.
KX-01 (KX2-391) Ointment
Actinic keratosis

Phase 3 Phase 3 data released July 26, 2018. Primary endpoint met.
$1.5 billion

BLRX – BioLineRx Ltd.
BL-8040
Consolidation treatment for AML cancer patients

Phase 2b Phase 2b interim data due 2H 2019.
$680.6 million

BLRX – BioLineRx Ltd.
AGI-134
Solid tumors

Phase 1/2 Phase 1/2 initial safety data 2H 2019. Efficacy data due YE 2020.
$680.6 million

CALA – Calithera Biosciences Inc.
CB-839 + Cabozantinib (CANTATA)
Renal cell carcinoma

Phase 2 Phase 2 poster at ASCO GU February 16, 2019 noted 5/13 ORR.
$173.8 million

CALA – Calithera Biosciences Inc.
CB-839 + AFINITOR (everolimus)‎ - ENTRATA
Clear cell renal cell carcinoma

Phase 2 Phase 2 top-line data June 17, 2019 noted PFS 3.8 months compared to 1.9 months for everolimus alone.
$173.8 million

EIGR – Eiger BioPharmaceuticals Inc.
Avexitide (Exendin 9-39)
Post-Bariatric Hypoglycemia (PBH)

Phase 2 Phase 2 data released October 16, 2018 - endpoints met. Data presented at ENDO March 25, 2019.
$266.8 million

GILD – Gilead Sciences Inc.
Axicabtagene ciloleucel - (ZUMA-3)
Adult patients with r/r ALL - cancer

Phase 1/2 Phase 2 pivotal trial enrolment to be completed 3Q 2019.
$86.6 billion

GILD – Gilead Sciences Inc.
Axicabtagene ciloleucel - (ZUMA-4)
Pediatric and young adult patients with r/r ALL - cancer

Phase 1/2 Phase 1/2 data due 2Q 2019.
$86.6 billion

GILD – Gilead Sciences Inc.
Axicabtagene ciloleucel - (ZUMA-5)
Indolent B-Cell Non-Hodgkin Lymphoma

Phase 2 Phase 2 data due 1H 2020.
$86.6 billion

GILD – Gilead Sciences Inc.
Selonsertib (GS-4997) - STELLAR 3
Nonalcoholic steatohepatitis (NASH)

Phase 3 Phase 3 data April 25, 2019 did not meet primary endpoint.
$86.6 billion

GILD – Gilead Sciences Inc.
F/TAF (Descovy)
Pre-exposure prophylaxis

PDUFA priority review sNDA filed April 5, 2019. Likely PDUFA date under priority review of October 4, 2019.
$86.6 billion

GILD – Gilead Sciences Inc.
GS-5734
Ebola

Phase 2 Phase 2 trial to complete enrolment 3Q 2019.
$86.6 billion

GILD – Gilead Sciences Inc.
Axicabtagene ciloleucel (ZUMA-7)
Refractory diffuse large B-cell lymphoma (DLBCL)

Phase 3 Phase 3 enrollment to be completed 4Q 2019.
$86.6 billion

GILD – Gilead Sciences Inc.
Selonsertib (GS-4997) - STELLAR 4
Nonalcoholic steatohepatitis (NASH)

Phase 3 Phase 3 trial did not meet primary endpoint - February 11, 2019.
$86.6 billion

GILD – Gilead Sciences Inc.
GS-9131
HIV

Phase 2 Phase 2 data due 3Q 2019.
$86.6 billion

GILD – Gilead Sciences Inc.
Axicabtagene ciloleucel - (ZUMA-2)
Relapsed or Refractory Mantle Cell Lymphoma (r/r MCL) - cancer

Phase 2 Phase 2 data due 3Q 2019.
$86.6 billion

GILD – Gilead Sciences Inc.
Filgotinib and GS-9876
Sjogren’s syndrome

Phase 2 Phase 2 data due 3Q 2019.
$86.6 billion

GLPG – Galapagos NV
Filgotinib
Rheumatoid arthritis (RA)

NDA Filing NDA filing due 2019.
$9.4 billion

GLPG – Galapagos NV
Filgotinib - SELECTION
Ulcerative colitis

Phase 3 Phase 3 data due 2Q 2020.
$9.4 billion

GLPG – Galapagos NV
Filgotinib and GS-9876
Cutaneous lupus erythematosus (CLE)

Phase 2 Phase 2 data due 3Q 2019.
$9.4 billion

GLPG – Galapagos NV
Filgotinib - FINCH 3
Rheumatoid arthritis (RA)

Phase 3 Phase 3 data released March 28, 2019 - primary endpoint met.
$9.4 billion

INCY – Incyte Corporation
Baricitinib
Atopic dermatitis

Phase 3 Phase 3 data met primary endpoint - February 4, 2019. Data to be presented 2019.
$17.5 billion

QURE – uniQure N.V.
AMT-061 (HOPE-B)
Hemophilia B

Phase 3 Phase 3 enrolment to be completed YE 2019.
$2.6 billion

SPRO – Spero Therapeutics Inc.
SPR994 (ADAPT-PO)
Complicated urinary tract infections (cUTI)

Phase 3 Phase 3 PK and DSMB data read 2H 2019.
$188 million