BPC November 29 update

​Alkermes ALKS meets endpoints in late-stage schizophrenia trial but concerns remain

Price and Volume Movers

Alkermes plc (Nasdaq: ALKS) announced that its Phase 3 ENLIGHTEN-2 trial of ALKS 3831 for the treatment of schizophrenia met pre-specified endpoints The trial was designed to compare its weigh profile against placebo olanzapine, which has been noted for high weight gain. The proportion of patients who gained 10% or more of their baseline body weight was 29.8% for olanzapine vs. 17.8% for ALKS 3831, (p=0.003). The data also showed the proportion of patients who gained 7% or more of their baseline body weight was 42.7% for olanzapine vs. 27.5% for ALKS 3831, (p=0.001). Despite the data, shares fell 3% to $35.75 with some investors noting that patients still gained a fair amount of weight which could hamper its marketability. Alkermes plans to submit a New Drug Application (NDA) in mid-2019. 

Dynavax Technologies Corporation (NASDAQ: DVAX) announced that its Phase 2a trial partnered with AstraZeneca of AZD1419 for the treatment of asthma, did not meet the primary endpoint. Shares closed the normal trading session down 6% and have dropped a further 2% to $11.24 after hours.

Histogenics Corporation (Nasdaq: HSGX) noted that it expects to provide an update regarding its NeoCart regulatory pathway regarding a potential BLA filing, by the end of 2018 or early 2019. Shares closed down 12% to $0.47. 

Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) shares closed up 83% to $6.97 on news of its design of its upcoming Phase 3 trial of Tonmya for the treatment of post-traumatic stress disorder (PTSD) slated for initiation in 1Q 2019, with top-line data due 1H 2020. The price surge can be largely attributed to a reduction of its share float following a 1-for-10 reverse stock split Wednesday. 

Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) announced the FDA Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) plans to review the New Drug Application (NDA) for sotagliflozin, for the treatment in adults of type 1 diabetes, on January 17, 2019. The PDUFA date is March 22, 2019.

 

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

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

ADVANCERS:

Adial Pharmaceuticals, Inc. (ADIL): $2.80; +112%.

Genprex, Inc. (GNPX): $1.65; +25%.

Arsanis, Inc. (ASNS): $3.71; +21%.

Oragenics, Inc. (OGEN): $1.01; +20%.

Checkpoint Therapeutics, Inc. (CKPT): $2.61; +16%.

DECLINERS:

Catalyst Pharmaceuticals, Inc. (CPRX): $2.77; -12%.

ZIOPHARM Oncology, Inc. (ZIOP): $3.29; -9%.

BioTime, Inc. (BTX): $1.45; -9%.

Karyopharm Therapeutics Inc. (KPTI): $9.56; -9%.

Vaxart, Inc. (VXRT): $2.95; -8%.

Pipeline updates:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

ALKS – Alkermes plc
ALKS 3831 - ENLIGHTEN-2
Schizophrenia

Phase 3 Phase 3 data released November 29, 2018 met co-primary endpoints. NDA filing due mid-2019.
$5.1 billion

DVAX – Dynavax Technologies Corporation
AZD1419
Asthma

Phase 2a Phase 2a trial did not meet primary endpoint - November 29, 2018.
$665.8 million

HSGX – Histogenics Corporation
NeoCart
Cartilage defects in the knee

Phase 3 Phase 3 data released September 5, 2018. Primary endpoint not met. Update regarding possibility of filing BLA expected by end 2018 or early 2019.
$34 million

JAZZ – Jazz Pharmaceuticals plc
JZP-258
Idiopathic Hypersomnia

Phase 3 Phase 3 commencement of enrolment announced November 29, 2018.
$8.5 billion

LXRX – Lexicon Pharmaceuticals Inc.
Sotagliflozin
Type 1 Diabetes

PDUFA PDUFA date March 22, 2019. Advisory Committee Meeting January 17, 2019.
$769 million

MRTX – Mirati Therapeutics Inc.
MRTX849
Solid tumors

Phase 1/2 Phase 1/2 patient dosing to commence January 2019.
$1.3 billion

PRNB – Principia Biopharma Inc.
PRN1008 - PEGASUS
Pemphigus

Phase 3 Phase 2 trial met primary endpoint. Phase 3 trial initiation announced November 29, 2018.
$683.6 million

TNXP – Tonix Pharmaceuticals Holding Corp.
Tonmya
Post-traumatic stress disorder (PTSD)

Phase 3 New Phase 3 trial to be initiated 1Q 2019 with data due 1H 2020.
$6.7 million

TOCA – Tocagen Inc.
Toca 511 & Toca FC - (NRG-BN006)
Glioblastoma (GBM)

Phase 2/3 Phase 2/3 enrolment to commence 2019.
$182.2 million