BPC January 28 update

Trevena TRVN +120% on regulatory path forward for pain relief drug

Price and Volume Movers

Trevena, Inc. (NASDAQ: TRVN) shares closed up 120% to $1.19 following news of the receipt of minutes from its meeting with the FDA regarding the Complete Response Letter (CRL) received for oliceridine for the treatment of pain relief. It noted the FDA will agree on labeling limited to a maximum daily dose of 27 mg. The company will also be required to submit QT interval data from a trial in healthy volunteers, which it anticipates will be initiated in 1H 2019.

Pulmatrix, Inc. (NASDAQ: PULM) announced after hours that it intends to offer shares of its common stock in an underwritten public offering. 

AbbVie (NYSE: ABBV) announced that the FDA approved the use of Imbruvica (ibrutinib) in combination with obinutuzumab (Gazyva) for adult patients with previously untreated chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), marking the 10th FDA approval for Imbruvica in six different disease areas since 2013.

Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) announced that its Phase 3 trial of Ultomiris (ravulizumab-cwvz), met its primary endpoint in complement inhibitor-naïve patients with atypical hemolytic uremic syndrome (aHUS). In the initial 26 week treatment period, 53.6% of patients (95% CI [39.6%, 67.5%]) demonstrated complete thrombotic microangiopathy (TMA) response. A regulatory filing is due 1H 2019.

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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:

Fortress Biotech, Inc. (FBIO): $1.38; +30%.

Achaogen, Inc. (AKAO): $1.62; +17%.

Anixa Biosciences, Inc. (ANIX): $4.96; +11%.

Surface Oncology, Inc. (SURF): $5.88; +11%.

InVivo Therapeutics Holdings Corp. (NVIV): $1.66; +10%.

DECLINERS:

Curis, Inc. (CRIS): $1.13; -11%.

Adial Pharmaceuticals, Inc. (ADIL): $5.20; -11%.

Sorrento Therapeutics, Inc. (SRNE): $2.15; -9%.

OPKO Health, Inc. (OPK): $3.47; -9%.

Minerva Neurosciences, Inc. (NERV): $6.45; -9%.

 

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

ABBV – AbbVie Inc.
Imbruvica and Gazyva - iLLUMINATE
Chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL)

Approved FDA approval announced January 28, 2019.
$120.4 billion

ALXN – Alexion Pharmaceuticals Inc.
ALXN1210
atypical Hemolytic Uremic Syndrome (aHUS)

Phase 3 Phase 3 data released January 28, 2019. Primary endpoint met. Regulatory filing due 1H 2019.
$29 billion

CNAT – Conatus Pharmaceuticals Inc.
Emricasan
NASH fibrosis - ENCORE-NF trial

Phase 2 Phase 2 data are due 1H 2019.
$62.3 million

CNAT – Conatus Pharmaceuticals Inc.
Emricasan
NASH cirrhosis - ENCORE-PH trial

Phase 2 Phase 2b data released December 5, 2018 did not meet primary endpoint. 48-week liver function data due mid-2019.
$62.3 million

CNAT – Conatus Pharmaceuticals Inc.
Emricasan
NASH cirrhosis - ENCORE-LF trial

Phase 2b Phase 2b completion of enrolment announced February 12, 2019 with data due mid-2019.
$62.3 million

DRNA – Dicerna Pharmaceuticals Inc.
DCR-HBVS
Hepatitis B virus (HBV)

Phase 1 Phase 1 commencement of dosing announced January 28, 2019 with data due 2H 2019.
$659.3 million

EVLO – Evelo Biosciences Inc.
EDP1503 and KEYTRUDA (pembrolizumab)
Melanoma

Phase 2a Phase 2a dosing has commenced - noted January 28, 2019 with initial data due 2H 2020.
$306.9 million

IONS – Ionis Pharmaceuticals Inc.
IONIS-HTT Rx
Huntington's Disease

Phase 3 First patient enrolled in Phase 3 trial announced January 28, 2019.
$8.1 billion

PLX – Protalix BioTherapeutics Inc. (DE)
Pegunigalsidase alfa (PRX-102)
Fabry disease

Phase 3 Phase 3 PK data from open label trial to be presented at WORLDSymposium February 7, 2019.
$74.2 million

TRVN – Trevena Inc.
Oliceridine (TRV130)
Moderate to severe acute pain

CRL CRL issued November 2, 2018. Noted January 28, 2019 that additional QT interval data required - trial to commence 1H 2019.
$121 million

XENE – Xenon Pharmaceuticals Inc.
XEN1101
Adult focal seizures

Phase 2 Phase 2b enrolment underway with data due 2H 2020.
$197.9 million