BPC November 23 update

Novo Nordisk NVO meets primary endpoint in final Pioneer diabetes trial

Price and Volume Movers

The shortened trading day due to Thanksgiving resulted in very little biotech newsflow Thursday. One company to release data though was Danish Novo Nordisk (NYSE: NVO), which is developing oral semaglutide for the treatment of type 2 diabetes. 

The company which had already reported positive data from nine of its ten PIONEER trials, released data today from its cardiovascular PIONEER 6 trial, its final and arguably most important of the ten trials. The trial met its primary endpoint of demonstrating non-inferiority of major adverse cardiovascular events (MACE) compared with placebo, both in addition to standard of care. The hazard ratio (0.79) showing a 21% reduction in MACE in favor of oral semaglutide did not reach statistical significance.


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

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


Gamida Cell Ltd. (GMDA): $14.90; +30%.

Forty Seven, Inc. (FTSV): $15.33; +14%.

CorMedix, Inc. (CRMD): $1.34; +13%.

XOMA Corporation (XOMA): $16.40; +11%.

Sesen Bio, Inc. (SESN): $1.83; +10%.


Can-Fite BioPharma Ltd. (CANF): $1.45; -10%.

Lexicon Pharmaceuticals, Inc. (LXRX): $7.48; -8%.

Axovant Sciences Ltd. (AXON): $1.82; -7%.

Bellicum Pharmaceuticals, Inc. (BLCM): $4.19; -6%.

Cidara Therapeutics, Inc. (CDTX): $3.37; -5%.

Pipeline update below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

NVO – Novo Nordisk A/S
Semaglutide - oral - PIONEER
Type 2 diabetes

PDUFA priority review NDA filing announced March 20, 2019. Estimated PDUFA date September 20, 2019 assuming 6-month priority review.
$113 billion

TLSA – Tiziana Life Sciences plc
NASH (healthy human volunteers)

Phase 1 Phase 1 trial initiation announced November 28, 2018.
$109.2 million

TLSA – Tiziana Life Sciences plc
Hepatocellular carcinoma (HCC)

Phase 2a Phase 2a top-line data due 3Q 2019.
$109.2 million

TLSA – Tiziana Life Sciences plc
Milciclib and Sorafenib (Nexavar)
Hepatocellular carcinoma (HCC)

Phase 2b Phase 2b trial to be initiated in 2019.
$109.2 million