BPC December 05 update

Supernus SUPN Phase 3 data due Thursday; ​Conatus CNAT misses NASH trial primary endpoint

Price and Volume Movers

Yesterday, we noted that the next newsletter would be delivered Thursday due to the closure of markets today. 

However, despite the market close, a number of companies released important announcements that will likely have price moving effects Thursday. In light of this, an abbreviated newsletter is posted today. 

Supernus Pharmaceuticals, Inc. (NASDAQ:SUPN) announced that on Thursday, December 6 at approximately 7am ET, it will announce data from two Phase 3 trials for SPN-812 for the treatment of attention deficit hyperactivity disorder (ADHD). 

Conatus Pharmaceuticals Inc. (Nasdaq:CNAT) announced data from its Phase 2b ENCORE-PH trial for the treatment of NASH cirrhosis did not meet the primary endpoint.

Momenta Pharmaceuticals, Inc. (Nasdaq: MNTA) announced that it is commencing an underwritten registered public offering of $150m shares of its common stock.  

AbbVie (NYSE: ABBV) announced the decision to stop enrollment for the TAHOE trial, a Phase 3 study evaluating Rovalpituzumab Tesirine (Rova-T) as a second-line therapy for advanced small-cell lung cancer (SCLC). An Independent Data Monitoring Committee (IDMC) recommended stopping enrolment due to shorter overall survival in the Rova-T arm compared with the topotecan control arm. 

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

ABBV – AbbVie Inc.
Rova-T (TAHOE)
Second-line Small Cell Lung Cancer

Phase 3 Phase 3 enrolment to be stopped due to shorted overall survival following recommendation from Independent Data Monitoring Committee (IDMC) December 5, 2018.
$128.8 billion

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

Phase 2 Phase 2b data released December 5, 2018 did not meet primary endpoint.
$50.4 million

CYTK – Cytokinetics Incorporated
CK-3773274
Healthy volunteers (hypertrophic cardiomyopathy (HCM))

Phase 1 Phase 1 initiation announced December 5, 2018. Data due 2019.
$421.3 million

EXEL – Exelixis Inc.
CABOMETYX (cabozantinib) + atezolizumab (TECENTRIQ) - (COSMIC-312)
Hepatocellular Carcinoma

Phase 3 Phase 3 initiation announced December 5, 2018.
$6.3 billion

IMGN – ImmunoGen Inc.
Kadcyla (KATHERINE).
HER2-positive breast cancer - residual invasive disease

Phase 3 Phase 3 data released October 15, 2018 met primary endpoint. Data released December 5, 2018 noted HR = 0.50 (reduction of the risk of disease recurrence or death by 50%).
$772.3 million

RHHBY – Roche Holding Ltd ADR (Sponsored)
Tecentriq+cb+etoposide - IMpower133
Squamous non-small cell lung cancer (NSCLC)

Phase 3 PDUFA date under priority review March 18, 2019.
$212.5 billion

SUPN – Supernus Pharmaceuticals Inc.
SPN-812
ADHD

Phase 3 Phase 3 data from two of its trials in children released December 6, 2018 met primary endpoints but with concerns regarding effect size vs competition. Data from first adolescent trial due by the end of December 2018 while data from the second trial are due 1Q 2019.
$1.9 billion