BPC September 27 update

Intercept ICPT files NASH NDA; ​Concert CNCE shares fall 37% on late-stage drug fail

Price and Volume Movers

Concert Pharmaceuticals, Inc. (NASDAQ:CNCE) shares closed down 37% to $6.25 following news from its partner, Avanir Pharmaceuticals, that its Phase 3 trial of AVP-786 for the treatment of moderate-to-severe agitation in patients with Alzheimer’s dementia did not meet its primary and key secondary endpoints.

Intercept Pharmaceuticals, Inc. (Nasdaq:ICPT) announced that it has submitted a New Drug Application (NDA) to the FDA for obeticholic acid (OCA) for the treatment of patients with fibrosis due to nonalcoholic steatohepatitis (NASH). Intercept has requested a Priority Review for the NDA, which, if granted, would result in an a six-month review period.

Seattle Genetics, Inc. (NASDAQ: SGEN) shares closed up 5% to $76.00. The company released updated data from its trial of Tucatinib and Herceptin in HER2-amplified metastatic Colorectal cancer (CRC) patients, which showed an overall response rate (ORR) of 55%, median progression-free survival of 6.2 months and overall survival 17.3 months.

Pfizer Inc. (NYSE: PFE) announced that its second Phase 3 pivotal trial evaluating the efficacy and safety of abrocitinib, in patients aged 12 and older with moderate to severe atopic dermatitis (AD), met both primary and secondary endpoints. Complete results from the trial will be presented as a late-breaking abstract at a scientific meeting in October 2019.

Roche Group (OTCQX:RHHBY) announced the FDA has approved Rituxan (rituximab), in combination with glucocorticoids, for the treatment of granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) in pediatric patients 2 years of age and older.

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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:

Tetraphase Pharmaceuticals, Inc. (TTPH): $5.73; +21%.

Arcus Biosciences, Inc. (RCUS): $10.18; +16%.

Endo International plc (ENDP): $3.19; +10%.

Capricor Therapeutics, Inc. (CAPR): $3.08; +8%.

Gossamer Bio, Inc. (GOSS): $17.19; +7%.

DECLINERS:

Pieris Pharmaceuticals, Inc. (PIRS): $3.61; -22%.

Atreca, Inc. (BCEL): $11.12; -14%.

Krystal Biotech, Inc. (KRYS): $35.40; -14%.

AxoGen, Inc. (AXGN): $12.09; -12%.

Axsome Therapeutics, Inc. (AXSM): $22.09; -11%.

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

ACRS – Aclaris Therapeutics Inc.
ATI-450
Rheumatoid arthritis (RA)

Phase 1/2 Phase 2 trial to be initiated 1H 2020.
$47.3 million

CNCE – Concert Pharmaceuticals Inc.
AVP-786
Agitation in patients with Alzheimer's disease

Phase 3 Phase 3 trial did not meet primary endpoint - September 27, 2019.
$250.2 million

ICPT – Intercept Pharmaceuticals Inc.
Ocaliva (Obeticholic acid (OCA)) - REGENERATE
Adult nonalcoholic steatohepatitis (NASH) patients.

PDUFA priority review Advisory Committee meeting April 22, 2020. PDUFA date originally set for March 26, 2020 extended to June 26, 2020.
$3 billion

INCY – Incyte Corporation
Pemigatinib (FIGHT-202)
Cholangiocarcinoma

PDUFA priority review PDUFA date under priority review May 30, 2020.
$16.3 billion

PFE – Pfizer Inc.
Abrocitinib
Atopic Dermatitis

Phase 3 Phase 3 trial met primary and secondary endpoints - September 27, 2019.
$185 billion

RHHBY – Roche Holding Ltd ADR (Sponsored)
MabThera/ Rituxan (rituximab)
Granulomatosis with polyangiitis (GPA) / microscopic polyangiitis (MPA)

Approved FDA Approval announced September 27, 2019.
$273.1 billion