BPC June 13 update

Intra-Cellular ITCI set to meet FDA Advisory Committee in July; ​​Provention PBIO terminates offering

Price and Volume Movers

Intra-Cellular Therapies, Inc. (Nasdaq:ITCI) announced that the FDA has announced a Psychopharmacologic Drugs Advisory Committee meeting will be held on July 31, 2019, to discuss the New Drug Application (NDA) for lumateperone for the treatment of schizophrenia in adults. The PDUFA date for a final decision by the FDA is September 27, 2019.

Provention Bio, Inc. (Nasdaq: PRVB) shares closed down 5% to $11.21 on news that it has terminated its public offering of common stock following assessment that the “current market conditions are not conducive for an offering on terms that would be in the best interests of the company’s shareholders.”

Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) announced that it intends to offer and sell shares of its common stock in an underwritten public offering.

Spero Therapeutics, Inc. (Nasdaq:SPRO) announced it will sell up to $10m of common stock in a registered direct offering with Novo Holdings A/S in two tranches. The first tranche consists of 465,983 shares sold at a price of $10.73 per share, for gross proceeds of $5m. The closing of the second tranche of $5m is triggered upon the earlier of (i) pharmacokinetic data from the lead-in cohort in its Phase 3 clinical trial of SPR994 and (ii) June 30, 2020. Shares closed up 10% to $11.65.

Amgen (NASDAQ:AMGN) and Allergan plc (NYSE:AGN) announced that the FDA has approved Kanjinti (trastuzumab-anns) for all approved indications of Herceptin (trastuzumab): for the treatment of HER2-overexpressing adjuvant and metastatic breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.

Savara Inc. (Nasdaq: SVRA), which announced after hours Wednesday that it did not meet the primary endpoint in its Phase 3 clinical trial evaluating Molgradex, for the treatment of autoimmune pulmonary alveolar proteinosis (aPAP) aPAP, saw its shares close Thursday’s session down 75% to $2.62, similar to its after-hours close on Wednesday.

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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:

ContraVir Pharmaceuticals, Inc. (CTRV): $10.11; +27%.

CEL-SCI Corporation (NYSEAMERICAN: CVM): $5.99; +20%.

Aeterna Zentaris Inc. (AEZS): $2.75; +20%.

Ocular Therapeutix, Inc. (OCUL): $4.52; +18%.

Axovant Gene Therapies Ltd. (AXGT): $4.85; +16%.

DECLINERS:

Hemispherx Biopharma, Inc. (HEB): $5.35; -21%.

Immuron Limited (IMRN): $3.00; -15%.

Seres Therapeutics, Inc. (MCRB): $2.83; -14%.

Avadel Pharmaceuticals plc (AVDL): $2.65; -13%.

Jaguar Health, Inc. (JAGX): $6.90; -11%.

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

AMGN – Amgen Inc.
ABP 980 (Kanjinti; trastuzumab-anns)
Herceptin biosimilar

CRL FDA approval announced June 13, 2019.
$122.4 billion

ETON – Eton Pharmaceuticals Inc.
DS-200
Nutritional deficiencies

NDA Filing Rolling NDA filing announced March 14, 2019. However, third-party has been granted five years of market exclusivity.
$100.5 million

ETTX – Entasis Therapeutics Holdings Inc.
ETX0282CPDP
Complicated urinary tract infections (cUTI)

Phase 1 Phase 1 data released June 13, 2019, supports further development.
$108.4 million

IFRX – InflaRx N.V.
IFX-1
Pyoderma Gangraenosum (PG)

Phase 2a Phase 2a dosing of first patient announced June 13, 2019.
$68.3 million

IMMP – Immutep Limited
Eftilagimod alpha and Keytruda - TACTI-002
Non-small cell lung cancer; Head and neck cancer

Phase 2 Phase 2 initial data due 3Q 2019.
$50.4 million

ITCI – Intra-Cellular Therapies Inc.
Lumateperone
Schizophrenia

PDUFA PDUFA date extended by three months to December 27, 2019.
$502.1 million

NKTR – Nektar Therapeutics
NKTR-358
Systemic lupus erythematosus (SLE)

Phase 1b Phase 1b data presented at EULAR June 13, 2019 - safe and well-tolerated.
$3.2 billion

PGNX – Progenics Pharmaceuticals Inc.
1095
Prostate Cancer

Phase 2 Phase 2 initiation of dosing announced June 13, 2019.
$319.8 million

RHHBY – Roche Holding Ltd ADR (Sponsored)
Mabthera/Rituxan (rituximab) - PEMPHIX
Pemphigus vulgaris

Phase 3 Phase 3 trial met primary and secondary endpoints - June 13, 2019.
$237.6 billion

SPRO – Spero Therapeutics Inc.
SPR720
Healthy Volunteers

Phase 1 Phase 1 data due 2H 2019.
$189.2 million

XOMA – XOMA Corporation
Gevokizumab
Colorectal Cancer, Gastroesophageal Cancer, Renal Cell Carcinoma

Phase 1 Phase 1 initiation of patient dosing announced June 13, 2019.
$149.4 million