BPC January 03 update

​Bristol-Myers BMY -13% set to acquire Celgene CELG +21%

Price and Volume Movers

Bristol-Myers Squibb Company (NYSE:BMY) and Celgene Corporation (NASDAQ:CELG) announced a merger agreement under which Bristol-Myers Squibb will acquire Celgene in a cash and stock transaction with an equity value of approximately $74b. Celgene shareholders will receive one Bristol-Myers Squibb share and $50 in cash for each share of Celgene. Celgene shareholders will also receive one tradeable Contingent Value Right (CVR) for each share of Celgene, which will entitle the holder to receive a payment for the achievement of future regulatory milestones. The companies expect to complete the transaction in 3Q 2019. Shares of CELG closed up 21% to $80.43 on the news while BMY shares shed 13% to $45.12.

Novavax, Inc. (NASDAQ: NVAX) shares are trading up 10% to $2.24 after hours in response to data from its Phase 2 influenza trial of NanoFlu. A Phase 3 trial is due to be initiated later this year.

Kitov Pharma (NASDAQ: KTOV) shares closed up 44% to $1.08 on news of a distribution agreement with Coeptis Pharmaceuticals for the U.S. market for its drug, Consensi, for the treatment of osteoarthritis pain and hypertension. The agreement provides for total milestone payments to Kitov of $3.5m.

Verrica Pharmaceuticals Inc.(Nasdaq: VRCA) announced that its two Phase 3 trials, CAMP-1 and CAMP-2, of VP-102 for the treatment of molluscum contagiosum, met the primary endpoint. The company intends to file a New Drug Application (NDA) in 2H 2019. Shares closed up 7% to $8.50.

Ohr Pharmaceutical, Inc. (Nasdaq: OHRP) announced a reverse merger with NeuBase Therapeutics, Inc. under which the stockholders of NeuBase would become the majority holders (80%) of the combined company. Shares of the nano-cap closed up 61% to $0.16.

Sesen Bio, Inc. (Nasdaq: SESN) shares closed down 38% to $0.91 following the release of preliminary efficacy data of its ongoing Phase 3 VISTA trial, of Vicinium for the treatment of patients with high-grade non-muscle invasive bladder cancer (NMIBC). What was seen today was a common example of “buying the rumor, and selling the news”, with the stock price closing more or less at where it was on Christmas Eve.

-

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

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

ADVANCERS:

BioXcel Therapeutics, Inc. (BTAI): $5.02; +44%.

Arsanis, Inc. (ASNS): $3.40; +33%.

AzurRx BioPharma, Inc. (AZRX): $1.63; +25%.

EDAP TMS S.A. (EDAP): $2.19; +17%.

Agenus Inc. (AGEN): $2.80; +12%.

DECLINERS:

Selecta Biosciences, Inc. (SELB): $2.29; -21%.

Atara Biotherapeutics, Inc. (ATRA): $28.40; -19%.

Soleno Therapeutics, Inc. (SLNO): $1.63; -15%.

Idera Pharmaceuticals, Inc. (IDRA): $3.14; -11%.

Epizyme, Inc. (EPZM): $5.98; -10%.

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

BIIB – Biogen Inc.
Natalizumab - NOVA
Multiple sclerosis (MS)

Phase 3 Phase 3b trial initiation announced January 3, 2019.
$45.8 billion

CHMA – Chiasma Inc.
Mycapssa - OPTIMAL
Acromegaly

Phase 3 Phase 3 data due 3Q 2019.
$253.7 million

CNST – Constellation Pharmaceuticals Inc.
CPI-1205 - ProSTAR
Castration-resistant prostate cancer

Phase 1/2 Phase 2 interim data due 2H 2019.
$267 million

CNST – Constellation Pharmaceuticals Inc.
CPI-0610 and ruxolitinib
Myelofibrosis

Phase 2 Phase 2 additional data due 4Q 2019.
$267 million

DCPH – Deciphera Pharmaceuticals Inc.
Rebastinib and carboplatin
Solid tumors

Phase 1/2 Phase 1b/2 trial initiation announced January 3, 2019.
$954 million

DMAC – DiaMedica Therapeutics Inc.
DM199
Chronic Kidney Disease

Phase 2 Phase 1b data June 19, 2019 noted favorable safety profile. Phase 2 initiation expected 2H 2019 with interim analysis 4Q 2019 - 1Q 2020
$66.1 million

ENTA – Enanta Pharmaceuticals Inc.
EDP-938
Respiratory Syncytial Virus

Phase 2 Phase 2 preliminary data June 14, 2019 met primary endpoint.
$1.8 billion

ENTA – Enanta Pharmaceuticals Inc.
EDP-305 ARGON-1
Non-alcoholic steatohepatitis (NASH)

Phase 2 Phase 2 initial data due 3Q 2019.
$1.8 billion

EVFM – Evofem Biosciences Inc.
Amphora - AMPOWER
contraceptive vaginal gel

NDA Filing Phase 3 data released December 17, 2018. Primary endpoint met. NDA to be refiled 2H 2019.
$309.1 million

FOLD – Amicus Therapeutics Inc.
AAV9-CLN3
Batten disease

Phase 1/2 Phase 1/2 enrolment to be completed 2019.
$3.2 billion

JNCE – Jounce Therapeutics Inc.
JTX-4014
Solid tumors

Phase 1 Phase 1 enrolment to be completed in 2019.
$162.2 million

MCRB – Seres Therapeutics Inc.
SER-287
Mild-to-Moderate Ulcerative Colitis

Phase 2b Phase 2b data due 3Q 2020.
$107.9 million

MRKR – Marker Therapeutics Inc.
TPIV200
Platinum-sensitive ovarian cancer

Phase 2 Phase 2 interim data due 4Q 2019.
$305.7 million

NTGN – Neon Therapeutics Inc.
NEO-PV-01 + nivolumab NT-001
Melanoma, Lung Cancer or Bladder Cancer

Phase 1 Phase 1b top-line data due July 2019.
$137.1 million

NTGN – Neon Therapeutics Inc.
NEO-PV-01 + Keytruda - NT-002
Non-small Cell Lung Cancer (NSCLC)

Phase 1b Phase 1b data due 3Q 2020.
$137.1 million

NTGN – Neon Therapeutics Inc.
NEO-PV-01 and nivolumab - NT-003
Melanoma

Phase 1b Phase 1b data due 2H 2020.
$137.1 million

NVAX – Novavax Inc.
NanoFlu vaccine
Influenza

Phase 2 Phase 2 immunogenicity and safety data data released January 3, 2019. Phase 3 trial to be initiated in 2019.
$122.4 million

OTIC – Otonomy Inc.
OTO-313
Tinnitus

Phase 1/2 Phase 1/2 trial initiation announced April 11, 2019 with data due 1H 2020.
$79.5 million

OTIC – Otonomy Inc.
OTO-413
Hidden hearing loss

Phase 1/2 Phase 1/2 trial to be initiated 3Q 2019 with data due 2H 2020.
$79.5 million

PFE – Pfizer Inc.
PF-06651600 - JAK3
Alopecia areata

Phase 3 Phase 3 data due 2H 2021.
$244.2 billion

REPL – Replimune Group Inc.
RP1 and nivolumab
Solid tumors

Phase 1/2 Phase 2 part of trial initiation announced June 1, 2019. Phase 1 data to be presented 4Q 2019.
$411.1 million

RETA – Reata Pharmaceuticals Inc.
Bardoxolone - FALCON
Chronic Kidney Disease

Phase 3 Phase 3 enrolment has commenced - May 30, 2019.
$2.6 billion

RGNX – REGENXBIO Inc.
RGX-111
Mucopolysaccharidosis Type I (MPS I)

Phase 1 Phase 1 update due 2H 2019.
$2 billion

RGNX – REGENXBIO Inc.
RGX-121
MPS II

Phase 1/2 Phase 1/2 update due 2H 2019.
$2 billion

RGNX – REGENXBIO Inc.
RGX-314
Wet age-related macular degeneration (wet AMD)

Phase 1/2 Phase 1/2a data due by end of 2019. Phase 2b trial to be initiated late 2019.
$2 billion

SCYX – SCYNEXIS Inc.
SCY-078 - oral (FURI)
Invasive candidiasis

Phase 3 Phase 3 open label interim data released January 30, 2019 - 11/17 partial or complete responses. Data to be presented at ECCMID April 16, 2019.
$70.3 million

SCYX – SCYNEXIS Inc.
SCY-078 - oral ibrexafungerp - VANISH
Vulvovaginal candidiasis (VVC)

Phase 3 Phase 3 data due 1H 2020.
$70.3 million

SELB – Selecta Biosciences Inc.
SEL-212 (COMPARE) - Head to head trial vs Krystexxa
Tophaceous gout

Phase 2 Phase 2 interim data due 4Q 2019 and full data 1Q 2020. Phase 3 trial to be initiated 4Q 2019.
$92.3 million

SESN – Sesen Bio Inc.
Vicinium
Non-muscle invasive bladder cancer (NMIBC)

BLA Filing Rolling BLA filing to commence 4Q 2019.
$117.1 million

SYBX – Synlogic Inc.
SYNB1020
Cirrhotic patients with elevated ammonia

Phase 1/2 Phase 1/2 top-line data due 3Q 2019.
$300.5 million

SYBX – Synlogic Inc.
SYNB1618
Phenylketonuria (PKU)

Phase 1 Phase 1/2 top-line data due 3Q 2019.
$300.5 million

SYN – Synthetic Biologics Inc.
SYN-010
Constipation-Predominant Irritable Bowel Syndrome (C-IBS)

Phase 2b Phase 2b data due 2H 2019.
$8.6 million

TBIO – Translate Bio Inc.
MRT5005
Cystic fibrosis

Phase 1/2 Phase 1/2 interim data 3Q 2019.
$580.3 million

TBIO – Translate Bio Inc.
MRT5201
OTC deficiency

Phase 1/2 Phase 1/2 IND placed on clinical hold - January 22, 2019. Additional preclinical toxicology data to be submitted 4Q 2019.
$580.3 million

UMRX – Unum Therapeutics Inc.
ACTR707 + rituximab (ATTCK-20-03)
CD20+ Non-Hodgkin Lymphoma (NHL)

Phase 1 Phase 1 dose escalation and preliminary cohort expansion data due late-2019 with Phase 2 portion to be initiated 2H 2019.
$77.7 million

UMRX – Unum Therapeutics Inc.
ACTR087 + rituximab (ATTCK-20-2)
Non-Hodgkin Lymphoma (NHL)

Phase 1 Phase 1 data to be presented end of 2019.
$77.7 million

UMRX – Unum Therapeutics Inc.
ACTR087 + SEA-BCMA (ATTCK-17-01)
Multiple Myeloma

Phase 1 Phase 1 dose escalation data due 2H 2019.
$77.7 million

UROV – Urovant Sciences Ltd.
Vibegron
Irritable bowel syndrome (IBS)

Phase 2a Phase 2 top-line data due 2020.
$254.8 million

VRCA – Verrica Pharmaceuticals Inc.
VP-102
Molluscum contagiosum

NDA Filing NDA filing due 2H 2019.
$238.8 million