BPC March 01 update

PUMA +40% on earnings; Lexicon LXRX wins positive European opinion for sotagliflozin ahead of PDUFA +28%; ImmunoGen IMGN late-stage fail -47%

Price and Volume Movers

Puma Biotechnology, Inc. (NASDAQ: PBYI) shares closed up 40% to $38.93 on the back of improved 4Q earnings. EPS of -$0.32 beat estimates by $0.37, with sales of Nerlynx, its primary revenue source, reaching $61.1m compared with $20.1m in 4Q 2017.

Lexicon Pharmaceuticals, Inc. (NASDAQ: LXRX) and Sanofi SA (NASDAQ: SNY) announced the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion on the Marketing Authorization of Zynquista (sotagliflozin). Sotagliflozin is also currently being reviewed by the FDA with a PDUFA date of March 22, 2019. Shares of Lexicon closed up 28% to $6.81 on the news.

ImmunoGen, Inc., (Nasdaq: IMGN) shares closed down 47% to $2.51 following news its Phase 3 FORWARD I trial evaluating the safety and efficacy of mirvetuximab soravtansine compared to chemotherapy in patients with ovarian cancer did not meet its primary endpoint of progression-free survival (PFS).

Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) released two announcements after hours. It coincidentally released the good news first that the company has approved a share repurchase program of up to $2m of its outstanding common stock, only to issue negative news soon after that the FDA has rescinded the Breakthrough Therapy designation (BTD) granted for Tonmya for posttraumatic stress disorder (PTSD) in December 2016 because interim analysis data from the Phase 3 HONOR study do not support the continuation of the BTD. Shares, which initially spiked almost 40% on the share buyback news, retraced all gains and more following the BTD news, to be currently trading down 5% to $1.91 after hours.


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


Bio-Path Holdings, Inc. (BPTH): $7.72; +197%.

Apellis Pharmaceuticals, Inc. (APLS): $18.31; +21%.

XBiotech Inc. (XBIT): $9.34; +18%.

NantKwest, Inc. (NK): $1.32; +17%.

Amicus Therapeutics, Inc. (FOLD): $13.92; +15%.


Intrexon Corporation (XON): $5.06; -37%.

Heat Biologics, Inc. (HTBX): $1.35; -22%.

IMV Inc. (IMV): $4.12; -20%.

Oasmia Pharmaceutical (OASM): $2.60; -17%.

Mersana Therapeutics, Inc. (MRSN): $4.71; -15%.

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

EVFM – Evofem Biosciences Inc.
Prevention of urogenital Chlamydia trachomatis infection in women

Phase 2/3 Phase 2b data due fall of 2019.
$171.9 million

IMGN – ImmunoGen Inc.
Mirvetuximab soravtansine - FORWARD I
Cancer - ovarian cancer and relapsed endometrial cancer

Phase 3 Phase 3 top-line data released March 1, 2019 did not meet primary endpoint. Further Phase 3 trial required (noted May 15, 2019).
$288.6 million

NKTR – Nektar Therapeutics
NKTR-262 and NKTR-214 - REVEAL
Solid tumors

Phase 1/2 Phase 1/2 initial data March 1, 2019 noted ORR 2/11 ( 18%) - maximum tolerated dose has not been reached.
$5.8 billion

WVE – Wave Life Sciences Ltd.
Huntington’s disease

Phase 1/2 Phase 1b/2a top line data due by YE 2019.
$854.1 million

WVE – Wave Life Sciences Ltd.
Huntington’s disease

Phase 1/2 Phase 1b/2a top line data due by YE 2019.
$854.1 million

WVE – Wave Life Sciences Ltd.
Suvodirsen (WVE-210201)
Duchenne muscular dystrophy - Exon 51

Phase 1 Phase 1 interim efficacy data from open-label trial due 2H 2019. Phase 2/3 trial to be initiated July 2019.
$854.1 million