BPC November 06 update

Constellation CNST shares surge 90% on release of ASH abstract; Offerings AGIO AGRX ARVN EOLS CYTK SRRA

Price and Volume Movers

Constellation Pharmaceuticals Inc (NASDAQ: CNST) shares surged to close up 90% to $28.10 following the release of its abstract for next months ASH conference. Preliminary data from its Phase 2 trial of CPI-0610 in patients with treatment naïve myelofibrosis noted that all 4 evaluable patients achieved both ≥35% SVR (spleen volume reduction) and ≥50% improvement in TSS (total symptom score) as early as 3 months after treatment.

Inflarx NV (NASDAQ: IFRX) announced after hours data from the open label extension (OLE) part of the international SHINE Phase 2b trial of IFX-1 in patients with moderate to severe Hidradenitis Suppurativa (HS). The company noted that 70.6% of the responder group maintained their HiSCR (Hidradenitis Suppurativa Clinical Response) response during extension part of the trial. It should be noted that the company announced in June that it failed to meet the primary endpoint in the double-blind, placebo-controlled part of the trial. Shares are trading up 31% to $3.39 after hours.

Vanda Pharmaceuticals Inc. (NASDAQ: VNDA) shares are trading up 21% to $15.85 after hours following a positive third-quarter earnings report. Net income was $100.4m for the quarter, compared to net income of $7.2m for the same period last year.

Amneal Pharmaceuticals, Inc. (NYSE:AMRX) shares closed down 20% to $2.76 following a worse than expected third-quarter earnings release. Net revenue was $378m in the quarter, a decrease of 21% compared to the third quarter of 2018. Guidance for 2019 earnings per share of $0.31 was issued compared with previous forecasts of $0.52 - $0.62.

Puma Biotechnology Inc (NASDAQ: PBYI) shares are trading down 18% after hours to $5.85 following the release of a disappointing third-quarter earnings. Third quarter revenues were $56.4m compared with $62.6m for the same quarter in 2018.

Aerie Pharmaceuticals, Inc. (NASDAQ:AERI) announced in its earnings release that it expects full-year 2019 net revenues in the range of $61 to $66m for the combined net revenues for Rhopressa and Rocklatan compared to the previous guidance range of $70 to $80m. Shares are trading down 19% to $19.30 after hours on the news.

SELLAS Life Sciences Group, Inc. (NASDAQ:SLS) shares closed down 33% to $0.14 following news it will effect a 1-for-50 reverse stock split of its common stock at 5pm EST on November 7, 2019.

A number of companies listed below announced stock offerings after hours:

Cytokinetics, Incorporated (Nasdaq: CYTK) $100m convertible senior notes.

Sierra Oncology, Inc. (NASDAQ:SRRA) preferred stock and warrants.

Arvinas, Inc. (Nasdaq: ARVN) $90m of shares of common stock.

Agios Pharmaceuticals, Inc. (Nasdaq: AGIO) 7.5m shares of common stock.

Evolus, Inc. (Nasdaq: EOLS) offering of its common stock.

argenx (Nasdaq: ARGX) $450m offering of common stock.

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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:

ASLAN Pharmaceuticals Limited (ASLN): $2.28; +30%.

Aquestive Therapeutics, Inc. (AQST): $5.23; +24%.

Provention Bio, Inc. (PRVB): $8.29; +21%.

Precision BioSciences, Inc. (DTIL): $8.11; +18%.

Forty Seven, Inc. (FTSV): $8.01; +18%.

DECLINERS:

Supernus Pharmaceuticals, Inc. (SUPN): $19.93; -32%.

NextCure, Inc. (NXTC): $67.01; -27%.

Eloxx Pharmaceuticals, Inc. (ELOX): $5.14; -22%.

ArQule, Inc. (ARQL): $8.00; -18%.

GW Pharmaceuticals plc (GWPH): $111.76; -17%.

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

ABUS – Arbutus Biopharma Corporation
AB-729
Hepatitis B (HBV)

Phase 1 Phase 1a/b data released September 15, 2020 noted favorable safety and tolerability profile.
$264 million

ADAP – Adaptimmune Therapeutics plc
MAGE-A4 (ADP-A2M4)
Solid tumors

Phase 1 Phase 1 durability and translational data from patients with synovial sarcoma due at a medical conference 2H 2020.
$1.6 billion

ALBO – Albireo Pharma Inc.
Odevixibat (A4250) - PEDFIC- 1
Progressive familial intrahepatic cholestasis (PFIC)

Phase 3 Phase 3 top-line data met primary endpoints - September 8, 2020.
$738.7 million

AMRX – Amneal Pharmaceuticals Inc. Class A
K127
Myasthenia Gravis

NDA Filing NDA filing planned.
$1.3 billion

BCRX – BioCryst Pharmaceuticals Inc.
Berotralstat BCX7353
Reduce or eliminate attacks in HAE patients

PDUFA PDUFA date December 3, 2020
$708 million

BLPH – Bellerophon Therapeutics Inc.
INOpulse delivery device
Pulmonary Hypertension associated with Pulmonary Fibrosis (PH-PF)

Phase 3 Phase 3 initiation due 2H 2020.
$100.4 million

GLMD – Galmed Pharmaceuticals Ltd.
Aramchol - ARMOR
Non-Alcoholic Steatohepatitis (NASH)

Phase 3 Phase 3 initial data due 2H 2023.
$84.5 million

MRNS – Marinus Pharmaceuticals Inc.
Ganaxolone - Marigold
CDKL5 Deficiency Disorder (CDD)

Phase 3 Phase 3 trial met primary endpoint - September 14, 2020.
$422.8 million

ODT – Odonate Therapeutics Inc.
Tesetaxel - CONTESSA
Metastatic breast cancer (MBC)

Phase 3 Phase 3 trial met primary endpoint - August 24, 2020. Median PFS was 9.8 months for tesetaxel plus capecitabine vs 6.9 months capecitabine alone. High levels of neutropenia noted (71.2%). Overall survival data due in 2022.
$483.2 million

PRQR – ProQR Therapeutics N.V.
Sepofarsen (QR-110 )
Leber's Congenital Amaurosis (LCA) - Genetic blindness

Phase 2/3 Phase 2/3 trial delayed due to COVID-19.
$274.3 million

PTI – Proteostasis Therapeutics Inc.
PTI-428 + PTI-801 + PTI-808
Cystic fibrosis

Phase 2 Phase 2 negative data released December 17, 2019. Mean changes in ppFEV1 were not statistically significant in the heterozygous population. Phase 3 trial to be initiated in 2020.
$66.3 million

VBIV – VBI Vaccines Inc.
Sci-B-Vac - CONSTANT
Hepatitis B vaccine

Phase 3 Phase 3 data met primary endpoint - January 9, 2020. Data to be presented at EASL August 29, 2020.
$827.7 million

VBLT – Vascular Biogenics Ltd.
VB-111
Recurrent glioblastoma multiforme (rGBM)

Phase 2 Phase 2 trial to be initiated following COVID-19.
$62.7 million