BPC October 08 update

​Amgen AMGN and Cytokinetics CYTK shares fall on heart drug data; ETON PDUFA May 2021

Price and Volume Movers

Amgen (NASDAQ:AMGN) and Cytokinetics, Incorporated (NASDAQ:CYTK) announced their GALACTIC-HF Phase 3 pivotal clinical trial of omecamtiv mecarbil in patients with heart failure with reduced ejection fraction (HFrEF), met the primary composite efficacy endpoint reducing cardiovascular (CV) death or heart failure events compared to placebo (HR: 0.92; p=0.0252). However, shares of the respective companies fell on news it did not meet the secondary endpoint of reduction in cardiovascular (CV) death. Cytokinetics shares closed down 42% to $16.00, while Amgen shares closed 7% lower to $240.09.

Intercept Pharmaceuticals, Inc. (NASDAQ:ICPT) shares closed down 8% to $37.69 following a report by STAT News that the FDA is investigating whether its drug Ocaliva (obeticholic acid), is tied to potential liver injury risk. The inquiry began in May and could take one year to complete. FDA approval was granted in 2016.

Eton Pharmaceuticals, Inc (NASDAQ:ETON) announced the FDA has accepted its New Drug Application (NDA) for dehydrated alcohol injection and set a PDUFA date of May 27, 2021.

Jazz Pharmaceuticals plc (NASDAQ:JAZZ) shares closed up 8% to $154.82 on news it met the primary endpoint in its Phase 3 trial of Xywav in adult patients with idiopathic hypersomnia.

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Major price movers (stocks priced > $1.00, volume > 50k listed on NASDAQ/NYSE):

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

ADVANCERS:

SCYNEXIS, Inc. (SCYX): $6.15; +34%.

Cardiff Oncology, Inc. (CRDF): $17.30; +28%.

Aileron Therapeutics, Inc. (ALRN): $1.62; +22%.

Keros Therapeutics, Inc. (KROS): $46.32; +16%.

Selecta Biosciences, Inc. (SELB): $1.93; +14%.

DECLINERS:

Taiwan Liposome Company, Ltd. (TLC): $4.83; -19%.

Enlivex Therapeutics Ltd. (ENLV): $11.44; -15%.

Cogent Biosciences Inc (COGT): $2.53; -10%.

Otonomy, Inc. (OTIC): $4.22; -8%.

AlloVir, Inc. (ALVR): $28.32; -8%.

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

CLBS – Caladrius Biosciences Inc.
CLBS119
COVID-19 Induced Pulmonary Damage

Phase 1 Phase 1 trial initiation announced October 8, 2020.
$29.4 million

CRBP – Corbus Pharmaceuticals Holdings Inc.
Lenabasum (resunab) - DETERMINE
Dermatomyositis

Phase 3 Phase 3 data due 4Q 2021.
$77.3 million

CYTK – Cytokinetics Incorporated
Omecamtiv mecarbil GALACTIC-HF
Acute heart failure

Phase 3 Phase 3 top-line data met primary composite endpoint of reduction in cardiovascular death or heart failure but did not meet secondary endpoint of reduction in cardiovascular death - October 8, 2020. Late breaker at AHA, November 13, 2020
$1.1 billion

EBS – Emergent Biosolutions Inc.
COVID-HIG
COVID-19

Phase 3 Phase 3 initiation announced October 8, 2020.
$4.8 billion

ETON – Eton Pharmaceuticals Inc.
Dehydrated alcohol injection (DS-100)
Methanol poisoning

PDUFA PDUFA date May 27, 2021
$179.8 million

FBIO – Fortress Biotech Inc.
MB-105
Prostate cancer

Phase 1 Phase 1 further data due 2H 2021.
$203.7 million

IMV – IMV Inc.
DPX-COVID-19
COVID-19 vaccine

Phase 1/2 Phase 1/2 trial to commence before the end of 2020.
$212.1 million

JAZZ – Jazz Pharmaceuticals plc
JZP-258
Idiopathic Hypersomnia

Phase 3 Phase 3 trial met primary endpoint - October 8, 2020. sNDA filing 1Q 2021.
$8.1 billion

MRNA – Moderna Inc.
mRNA-1345
Respiratory syncytial virus (RSV) vaccine

Phase 1 Phase 1 initiation announced October 8, 2020.
$25.9 billion

NBIX – Neurocrine Biosciences Inc.
NBI-921352
SCN8A developmental and epileptic encephalopathy (SCN8A-DEE)

Phase 2 Phase 2 trial to commence 2021.
$9.2 billion

OPK – Opko Health Inc.
Somatrogon (hGH-CTP)
Children - growth hormone deficiency

Phase 3 Phase 3 trial met primary endpoint - October 8, 2020.
$2.7 billion

XENE – Xenon Pharmaceuticals Inc.
XEN496
Epilepsy

Phase 3 Phase 3 trial to be initiated before the end of 2020.
$332.1 million

XFOR – X4 Pharmaceuticals Inc.
Mavorixafor (X4P-001)
WHIM syndrome

Phase 3 Phase 3 data due 2022.
$88.1 million