BPC December 27 update

​Sesen SESN data January 3; Starpharma SPHRY -28% further data required for NDA; BioXcel BTAI +81%

Price and Volume Movers

Starpharma (ASX: SPL, OTCQX: SPHRY) announced that it received notice from the FDA that it will require confirmatory clinical data prior to approving VivaGel BV for treatment of bacterial vaginosis (BV) and the prevention of recurrent BV (rBV). Their original New Drug Application accepted by the FDA under priority review had been due for an approval decision in early 2019. The company noted that it "anticipates being able to address the issues raised through the generation of confirmatory clinical efficacy data."  Shares closed down 28% to $6.90. 

Sesen Bio, Inc.(Nasdaq: SESN) announced it will host a conference call on January 3, 2019 at 8:30 a.m. ET to review updated data from its Phase 3 VISTA Trial of Vicinium for the treatment of patients with high-grade non-muscle invasive bladder cancer who have been previously treated with bacillus Calmette-Guérin. 

BioXcel Therapeutics, Inc. (NASDAQ: BTAI) shares closed up 81% to $4.36. The company announced that the FDA has granted Fast Track Designation for its investigational drug BXCL501, for the treatment of acute agitation. Fast track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need.

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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:

Avadel Pharmaceuticals plc (AVDL): $2.45; +41%.

Novus Therapeutics, Inc. (NVUS): $2.00; +32%.

Chiasma, Inc. (CHMA): $2.63; +24%.

Mustang Bio, Inc. (MBIO): $2.83; +23%.

Onconova Therapeutics, Inc. (ONTX): $2.02; +18%.

DECLINERS:

Replimune Group, Inc. (REPL): $11.08; -20%.

Leap Therapeutics, Inc. (LPTX): $1.92; -17%.

Kodiak Sciences Inc. (KOD): $7.25; -12%.

Aquestive Therapeutics, Inc. (AQST): $6.09; -11%.

Syros Pharmaceuticals, Inc. (SYRS): $5.76; -11%.

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

AXSM – Axsome Therapeutics Inc.
AXS-05
Smoking cessation

Phase 2 Phase 2 top-line data due 2Q 2019.
$431 million

AXSM – Axsome Therapeutics Inc.
AXS-05 STRIDE-1
Treatment resistant depression

Phase 3 Phase 3 data due 2Q 2019.
$431 million

AXSM – Axsome Therapeutics Inc.
AXS-07 - MOMENTUM
Migraine

Phase 3 Phase 3 top-line data due 1Q 2020.
$431 million

AXSM – Axsome Therapeutics Inc.
AXS-05 ASCEND
Major Depressive Disorder

Phase 2 Phase 2 data met primary endpoint - January 7, 2019.
$431 million

BCLI – Brainstorm Cell Therapeutics Inc.
NurOwn
Amytrophic lateral sclerosis (ALS)

Phase 3 Phase 3 top-line data mid-2020. Interim safety analysis due by July 2019.
$83.2 million

MRUS – Merus N.V.
MCLA-128
Gastric cancer, non-small cell lung cancer

Phase 1/2 Noted December 27, 2018 that NSCLC cohort enrolment is ongoing but will discontinue endometrial and ovarian cohorts.
$285.3 million

MRUS – Merus N.V.
MCLA-128
Breast cancer - HER2-positive MBC and ER+/HER2-low MBC

Phase 2 Phase 2 update due 2H 2019.
$285.3 million

MRUS – Merus N.V.
MCLA-117
Acute Myeloid Leukemia

Phase 1 Phase 1 readouts due 2H 2019.
$285.3 million

MRUS – Merus N.V.
MCLA-158
Colorectal cancer

Phase 1 Phase 1 emerging data due YE 2019.
$285.3 million

RTRX – Retrophin Inc.
Sparsentan
IgA nephropathy

Phase 3 Phase 3 data due 1H 2022.
$1 billion

SESN – Sesen Bio Inc.
Vicinium
Non-muscle invasive bladder cancer (NMIBC)

Phase 3 Phase 3 12-month data due mid-2019.
$75.9 million

SPHRY – Starpharma Hldgs S/Adr
VivaGel
Bacterial vaginosis (BV)

PDUFA priority review NDA acceptance under priority review announced July 8, 2018. However, announced December 27, 2018 that confirmatory clinical data required.
$273.2 million

SPPI – Spectrum Pharmaceuticals Inc.
SPI-2012 (ROLONTIS)
Chemotherapy-Induced Neutropenia

BLA Filing BLA withdrawn following request from FDA for further manufacturing information - March 15, 2019.
$1.1 billion

ZIOP – ZIOPHARM Oncology Inc
Sleeping beauty - TCR-T cell therapy
Solid tumors

Phase 1 Phase 1 trial to begin dosing mid-2019.
$658.9 million