BPC February 06 update

Assertio ASRT sells off Nucynta franchise +53%; Zogenix ZGNX releases late-stage data -33%

Price and Volume Movers

Assertio Therapeutics, Inc (NASDAQ:ASRT) shares have spiked after hours, currently trading up 53% to $1.59, following news Collegium Pharmaceutical, Inc. (NASDAQ: COLL) will acquire the Nucynta franchise of products for $375m in cash. Collegium shares are trading up 8% to $22.00 after hours.

Cortexyme, Inc. (NASDAQ:CRTX) shares closed up 20% to $54.85 following its announcement of a private placement of $125m, with shares priced at $50 per share, a 9.6% premium to the closing share price the previous day.

Zogenix, Inc. (NASDAQ: ZGNX) shares are trading down 33% to $35.20 after hours following the release of data from its Phase 3 trial of Fintepla (ZX008) for the treatment of Lennox-Gastaut Syndrome (LGS). Zogenix noted that the trial met its primary endpoint in reducing the frequency of drop seizures at a dose of 0.7 mg/kg/day compared with placebo (p=0.0012). However, the decrease with the lower dose (0.2 mg/kg/day), a secondary endpoint, did not reach statistical significance (p=0.0915).

Sanofi (NYSE: SNY) announced fourth quarter earnings, while also releasing news that its Phase 2b trial evaluating SAR442168 in patients with multiple sclerosis (MS), achieved its primary endpoint, significantly reduced disease activity associated with multiple sclerosis (MS) as measured by magnetic resonance imaging (MRI). Actual data will be released at an upcoming meeting. Shares closed up 5% to $51.66. Sanofi obtained global rights to develop and commercialize SAR442168 under a license agreement with Principia Biopharma, Inc. (NASDAQ: PRNB), which saw its shares close up 14% to $69.01.

aTyr Pharma, Inc. (NASDAQ:LIFE) shares closed down 12% to $3.99 following news of an offering of 4,235,294 shares at a price of $4.25 per share for gross proceeds of $18m.

Moleculin Biotech, Inc., (NASDAQ:MBRX) shares closed down 20% to $0.84 after it announced a direct offering of 7.5m shares and warrants to purchase 5.625m shares at a price of $0.80 per share and related warrants for gross proceeds of $6m.

Corbus Pharmaceuticals Holdings, Inc. (NASDAQ:CRBP) announced after hours that it plans to offer and sell shares of its common stock in an underwritten public offering. Shares are currently trading down 5% after hours to $6.50.

miRagen Therapeutics, Inc. (NASDAQ:MGEN) also announced after hours a public offering of shares with attached warrants. Shares are trading down 15% to $1.09 after hours.

ADMA Biologics, Inc. (Nasdaq: ADMA), yet a further company to announce an offering, noted it intends to raise $75m through the sale of its common stock. Shares are trading down 5% to $3.80 after hours.

-

Major price movers (stocks priced > $1.00, volume > 50k):

Refer to the BioPharmCatalyst Biotech Stocks page for Top 10 Gainers/Losers/Unusual Volume:

ADVANCERS:

Kezar Life Sciences, Inc. (KZR): $3.85; +28%.

Lineage Cell Therapeutics, Inc. (LCTX): $1.31; +21%.

PDS Biotechnology Corporation (PDSB): $2.64; +14%.

Cerecor Inc. (CERC): $4.27; +14%.

BioNTech SE (BNTX): $32.93; +13%.

DECLINERS:

Applied Genetic Technologies Corporation (AGTC): $5.71; -19%.

Cleveland BioLabs, Inc. (CBLI): $2.15; -17%.

Nymox Pharmaceutical Corporation (NYMX): $3.21; -15%.

Bellicum Pharmaceuticals, Inc. (BLCM): $10.28; -14%.

Zosano Pharma Corporation (ZSAN): $1.00; -13%.

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

AGEN – Agenus Inc.
Balstilimab (AGEN2034) anti-PD-1
Cervical cancer

BLA Filing Phase 1 data from interim analysis noted ORR of 11.4% - February 20, 2020. BLA filing 2020.
$461.5 million

AQST – Aquestive Therapeutics Inc.
AQST-108
Anaphylaxis

Phase 1 Pivotal pharmacokinetic (PK) trials to be initiated before the end of 2020
$135.4 million

BPMC – Blueprint Medicines Corporation
Avapritinib
Fourth-line GIST

PDUFA priority review PDUFA date extended by three months to May 14, 2020 to allow for data from the Voyager trial.
$3.3 billion

CYTK – Cytokinetics Incorporated
Omecamtiv mecarbil GALACTIC-HF
Acute heart failure

Phase 3 Phase 3 second interim analysis due 1Q 2020. Top-line data due 4Q 2020.
$869.7 million

ENTA – Enanta Pharmaceuticals Inc.
EDP-305 INTREPID
Primary biliary cholangitis (PBC)

Phase 2 Phase 2 top-line data due by early-2Q 2020.
$1 billion

ENTA – Enanta Pharmaceuticals Inc.
EDP-938
Respiratory Syncytial Virus

Phase 2b Phase 2b data due 1H 2021.
$1 billion

JNCE – Jounce Therapeutics Inc.
JTX-4014
Second-line non-small cell lung cancer (NSCLC) patients

Phase 2 Phase 2 trial to be initiated mid-2020 with preliminary efficacy and biomarker relationships to clinical outcomes due in 2021.
$191.4 million

MEIP – MEI Pharma Inc.
ME-401
Relapsed/refractory Follicular Lymphoma (FL) Non Hodgkin Lymphoma

Phase 2 Phase 2 enrolment to be completed summer of 2020.
$241.7 million

RVNC – Revance Therapeutics Inc.
DAXI (RT002)
Moderate to severe glabellar (frown) lines

PDUFA PDUFA date November 25, 2020.
$1.4 billion

SGEN – Seattle Genetics Inc.
Tisotumab Vedotin (innovaTV 204 )
Cervical Cancer

Phase 2 Phase 2 data due 1H 2020.
$20 billion

SNY – Sanofi
SAR442168 (PRN2246)
Multiple sclerosis

Phase 2 Phase 2 data met primary endpoint - February 6, 2020. Data to be presented at upcoming meeting.
$124.6 billion

SRRK – Scholar Rock Holding Corporation
SRK-015 - TOPAZ
Spinal muscular atrophy (SMA)

Phase 2 Phase 2 interim efficacy data due mid-2020 with top-line data 4Q 2020.
$484.6 million

ZGNX – Zogenix Inc.
ZX008 - (Study 1601)
Lennox-Gastaut syndrome

Phase 3 Phase 3 data met primary endpoint with high dose, low dose secondary endpoint not met - February 6, 2020.
$1.3 billion