BPC December 10 update

Iterum ITRM misses late-stage primary endpoint - shares down 40% AH; Correvio CORV negative Advisory Committee vote

Price and Volume Movers

Iterum Therapeutics plc (Nasdaq: ITRM) announced that it did not meet the primary endpoint in its Phase 3 clinical trial of Sulopenem in complicated intra-abdominal infections (cIAI). Data from its Phase 3 complicated and uncomplicated urinary tract trials are due in 1Q 2020. Shares, which ironically added 22% during the normal trading session and prior to the data release, are trading after hours down 40% to $2.92.

Correvio Pharma Corp. (NASDAQ:CORV) announced that the FDA Cardiovascular and Renal Drugs Advisory Committee (CRDAC) voted 2-11 that the benefit-risk profile of Brinavess, under review for the rapid conversion of recent onset atrial fibrillation (AF), was not adequate to support approval. The PDUFA date for a final decision by the FDA for the New Drug Application is December 24, 2019. Shares are trading down 62% to $0.53 after hours.

Eloxx Pharmaceuticals, Inc. (NASDAQ: ELOX) shares closed up 27% to $6.92. Data from its Phase 2 cystinosis trial are slated for release by the end of this month.

Forty Seven, Inc. (NASDAQ: FTSV) shares, which closed Monday up 111% following the release of promising early stage data released at the ASH conference, added a further 14% to $34.66.

Rocket Pharmaceuticals, Inc. (NASDAQ:RCKT) shares are trading down 6% to $22.86 after hours following news of a public offering of $75m of shares of its common stock.

Momenta Pharmaceuticals, Inc. (NASDAQ:MNTA) also announced after hours that it is commencing an underwritten registered public offering of $200m of shares of its common stock. Shares are trading down 3% to $17.45 after hours.

Aquestive Therapeutics, Inc. (NASDAQ:AQST) announced after hours that it intends to offer and sell $35m of shares of its common stock in an underwritten public offering. Shares are trading down 15% to $6.37 after hours.

Marinus Pharmaceuticals, Inc. (NASDAQ:MRNS) was yet another company to announce an underwritten public offering. Shares are trading down 3% to $1.25 after hours.

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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:

Neoleukin Therapeutics, Inc. (NLTX): $7.96; +27%.

Gritstone Oncology, Inc. (GRTS): $10.87; +18%.

Equillium, Inc. (EQ): $4.75; +17%.

Avid Bioservices, Inc. (CDMO): $6.82; +17%.

Principia Biopharma Inc. (PRNB): $48.90; +16%.

DECLINERS:

Chimerix, Inc. (CMRX): $2.02; -20%.

Celyad SA (CYAD): $10.45; -13%.

Sangamo Therapeutics, Inc. (SGMO): $9.05; -12%.

Cabaletta Bio, Inc. (CABA): $8.21; -10%.

Molecular Templates, Inc. (MTEM): $11.28; -10%.

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

ARGX – argenx SE
Efgartigimod (ARGX-113)
Immune thrombocytopenia (ITP)

Phase 3 Phase 3 trial initiated December 2019.
$6.7 billion

CORV – Correvio Pharma Corp.
Brinavess
Atrial fibrillation (AF)

CRL CRL announced December 24, 2019.
$23.7 million

GRTX – Galera Therapeutics Inc.
GC4419
Pancreatic cancer

Phase 1/2 Phase 1/2 data due 2H 2020.
$364.4 million

GRTX – Galera Therapeutics Inc.
GC4419
Oral mucositis

Phase 2b Phase 2b data to be presented February 28, 2020, 10:45 a.m. – 12:15 p.m. MST at the Multidisciplinary Head and Neck Cancers Symposium. Phase 3 data due 1H 2021.
$364.4 million

HEPA – Hepion Pharmaceuticals Inc.
CRV431
Non-alcoholic steatohepatitis

Phase 2 Phase 2 trial to be initiated 2H 2020.
$17.4 million

ITRM – Iterum Therapeutics plc
Sulopenem
Complicated urinary tract infections (cUTI)

Phase 3 Phase 3 data due 1Q 2020.
$45.5 million

ITRM – Iterum Therapeutics plc
Sulopenem
Complicated intra-abdominal infections (cIAI)

Phase 3 Phase 3 data missed primary endpoint - December 10, 2019.
$45.5 million

SAGE – Sage Therapeutics Inc.
SAGE-718
Huntington's disease

Phase 2 Phase 2 trial planned.
$3.5 billion

SNDX – Syndax Pharmaceuticals Inc.
SNDX-6352
Chronic graft versus host disease

Phase 1 Phase 1 data to be presented 4Q 2020.
$285 million

TNXP – Tonix Pharmaceuticals Holding Corp.
TNX-102 SL (Tonmya)
Fibromyalgia

Phase 3 Phase 3 interim analysis due 3Q 2020. Top-line data due 1H 2021.
$5.4 million

VCNX – Vaccinex Inc.
Pepinemab (VX15/2503)
Alzheimer’s Disease (AD)

Phase 1 Phase 1 enrolment to commence 2Q 2020 with top-line data late 2021 or early 2022.
$103.9 million

XERS – Xeris Pharmaceuticals Inc.
Self administered glucagon
Post-Bariatric Hypoglycemia

Phase 2 Phase 2b data released December 10, 2019. Further data due 1H 2020.
$111.8 million