BPC October 01 update

Minerva NERV shares fall 26% on data delay

Price and Volume Movers

AstraZeneca (NYSE: AZN) announced that the FDA issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for PT010 for patients with chronic obstructive pulmonary disease (COPD).

Minerva Neurosciences, Inc. (NASDAQ: NERV) shares slid to close down 26% to $5.71. The company announced a delay in its readout of its Phase 3 trial of Roluperidone to treat negative symptoms in schizophrenia. Due to a cyber-attack on one of its external contractors, patient recruitment was disrupted. Top-line data are now expected during 1H 2020, compared with previous guidance of 4Q 2019.

Constellation Pharmaceuticals, Inc. (CNST) shares closed up 17% to $7.59. The company announced a private placement of 7,647,057 shares of common stock at a price of $8.50 per share for proceeds of $65m.

NewLink Genetics Corporation (NASDAQ: NLNK) shares closed down 22% to $1.24 following Monday’s announcement of a merger with Lumos Pharma, Inc where Lumos stockholders will own 50% of NewLink and the merged company will be renamed "Lumos Pharma, Inc." and will trade on Nasdaq under the symbol "LUMO."

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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:

Geron Corporation (GERN): $1.50; +13%.

Cellectis S.A. (CLLS): $11.13; +7%.

Tyme Technologies, Inc. (TYME): $1.26; +6%.

Akero Therapeutics, Inc. (AKRO): $23.96; +5%.

Akari Therapeutics, Plc (AKTX): $1.79; +5%.

DECLINERS:

Ocugen, Inc (OCGN): $2.19; -23%.

Surface Oncology, Inc. (SURF): $1.17; -18%.

Axsome Therapeutics, Inc. (AXSM): $16.71; -17%.

Cyclerion Therapeutics, Inc. (CYCN): $10.12; -17%.

Calithera Biosciences, Inc. (CALA): $2.64; -15%.

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

AZN – Astrazeneca PLC
PT010
Chronic obstructive pulmonary disease (COPD)

CRL CRL announced October 1, 2019.
$116 billion

CTIC – CTI BioPharma Corp.
Pacritinib - PACIFICA
Myelofibrosis

Phase 3 Phase 3 trial initiation announced October 1, 2019 with data due mid-2021.
$44.2 million

EQ – Equillium Inc.
EQ001 - itolizumab
Acute graft-versus-host disease

Phase 1/2 Phase 1b top-line data due 2H 2020.
$63.1 million

EQ – Equillium Inc.
EQ001 - itolizumab
Systemic lupus erythematosus (SLE) and lupus nephritis (LN)

Phase 1b Phase 1b trial initiation announced October 1, 2019. SLE data due 2H 2020, LN data due 1H 2021.
$63.1 million

HRTX – Heron Therapeutics Inc.
HTX-011
Post operative pain

NDA Filing CRL announced May 1, 2019. NDA resubmission announced October 1, 2019.
$1.6 billion

JNCE – Jounce Therapeutics Inc.
JTX-4014
Solid tumors

Phase 1 Phase 1 data to be presented at SITC November 8, 2019; 7am ET.
$110.5 million

KZR – Kezar Life Sciences Inc.
KZR-616
Lupus

Phase 1/2 Phase 1b updated data to be presented at ACR/ARP November 12, 2019. Phase 2 interim analysis 1H 2021 with final data 2H 2021.
$60.3 million

NERV – Minerva Neurosciences Inc
Roluperidone (MIN-101)
Schizophrenia

Phase 3 Phase 3 data due 1H 2020 - delayed due to cyber attack.
$166.6 million

NXTC – NextCure Inc.
NC318
Solid tumors

Phase 1/2 Phase 1 initial data due at SITC November 9, 2019; 4:15 pm ET. Phase 2 part to be completed 4Q 2020.
$616.5 million

ONCY – Oncolytics Biotech Inc.
Pelareorep and Tecentriq - AWARE-1
Breast cancer

Phase 1b Phase 1b interim data due at SITC November 8, 2019 7:00 a.m ET.
$11.9 million

PDSB – PDS Biotechnology Corporation
PDS0101
Cervical intraepithelial neoplasia (CIN)

Phase 1 Phase 2 trial will not be initiated - noted October 1, 2019.
$17.8 million

PTGX – Protagonist Therapeutics Inc.
PN-943
Ulcerative colitis

Phase 1 Phase 1 data to be presented October 28, 2019, from 10:30 a.m at ACG meeting.
$307.9 million

TBIO – Translate Bio Inc.
MRT5005
Cystic fibrosis

Phase 1/2 Phase 1/2 MAD data due 2020. Interim SAD data to be presented at NACFC November 1, 2019, 3:35pm CT.
$425.9 million

VCNX – Vaccinex Inc.
Pepinemab (VX15) and avelumab
Non-small cell lung cancer (NSCLC)

Phase 1/2 Phase 1/2 interim data note 2/17 PRs and 5/18 in second cohort - October 1, 2019. Top-line data due 1H 2020.
$82.9 million