BPC July 01 update

Puma PBYI files sNDA for Neratinib

Price and Volume Movers

Monday’s trading session was bereft of significant price moving clinical catalysts, no doubt due to the shortened trading week. Expect similar on Tuesday. Markets close early at 1pm on Wednesday and are closed Thursday for Independence Day. While trading resumes on Friday expect minimal news flow.

Puma Biotechnology, Inc. (NASDAQ: PBYI) announced it has submitted a supplemental New Drug Application (sNDA) to the FDA for neratinib in combination with capecitabine for the treatment of patients with HER2-positive metastatic breast cancer who have failed two or more prior lines of HER2-directed treatments (third-line disease). The sNDA is based on data from its Phase 3 NALA trial.

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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:

Ovid Therapeutics Inc. (OVID): $2.31; +25%.

Morphic Holding, Inc. (MORF): $23.23; +17%.

Anavex Life Sciences Corp. (AVXL): $3.84; +14%.

Savara Inc. (SVRA): $2.70; +14%.

Principia Biopharma Inc. (PRNB): $37.61; +13%.

DECLINERS:

Adaptive Biotechnologies Corporation (ADPT): $40.10; -17%.

Evofem Biosciences, Inc. (EVFM): $5.65; -15%.

Prevail Therapeutics Inc. (PRVL): $11.24; -15%.

Oncternal Therapeutics, Inc. (ONCT): $5.75; -14%.

Constellation Pharmaceuticals, Inc. (CNST): $10.71; -13%.


Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

BCYC – Bicycle Therapeutics plc
THR-149
Diabetic Macular Edema

Phase 1 Phase 1 safety and tolerability data released July 1, 2019.
$173.8 million

BHVN – Biohaven Pharmaceutical Holding Company Ltd.
Rimegepant
Refractory trigeminal neuralgia

Phase 2 Phase 2 commencement of enrolment announced July 1, 2019.
$2.3 billion

CBIO – Catalyst Biosciences Inc.
Marzeptacog alfa
Hemophilia

Phase 2 Phase 3 trial to commence in 2020.
$64.6 million

CYAD – Celyad SA
CYAD-01 and chemotherapy (DEPLETHINK)
AML or myelodysplastic syndrome (MDS)

Phase 1 Phase 1 Cohort 3 data due year-end 2019.
$131.9 million

CYAD – Celyad SA
CYAD-02
Relapsed/refractory Acute myeloid leukemia (AML) and Myelodysplastic Syndrome (MDS)

Phase 1 Phase 1 trial to commence early 2020 with data due mid-2020.
$131.9 million

GLPG – Galapagos NV
Filgotinib
Rheumatoid arthritis (RA)

NDA Filing NDA filing due 4Q 2019.
$9.7 billion

PBYI – Puma Biotechnology Inc
Neratinib - NALA
Third-line HER2-positive metastatic breast cancer

PDUFA PDUFA date late-April 2020.
$252.8 million

PSTV – Plus Therapeutics, Inc
DocePLUS (ATI-1123)
Platinum-sensitive small cell lung cancer

Phase 1 Phase 2 planned. Protocol to be submitted 2H 2019.
$1.2 million

PTN – Palatin Technologies Inc.
PL-8177
Non-infectious uveitis

Phase 2 Phase 2 trial to commence 4Q 2019.
$189 million

PTN – Palatin Technologies Inc.
PL-8177
Ulcerative colitis

Phase 2 Phase 2 trial to commence 1H 2020.
$189 million

SBPH – Spring Bank Pharmaceuticals Inc.
SB 11285
Solid tumors

Phase 1 Phase 1 data due mid-2020.
$46.4 million

XON – Intrexon Corporation
AG019
Type 1 diabetes

Phase 1/2 Phase 1b/2a data due in 2020.
$818.5 million

YMAB – Y-mAbs Therapeutics Inc.
Omburtamab
CNS/Leptomeningeal Metastases from Neuroblastoma

BLA Filing Rolling BLA filing to commence 4Q 2019.
$916.4 million