BPC June 10 update

INSYS files for bankruptcy; Provention PRVB shares +217% on diabetes data

Price and Volume Movers

INSYS Therapeutics, Inc. (NASDAQ: INSY) shares slumped to close down 51% to $0.64 on news that it has filed for Chapter 11 bankruptcy.

Seattle Genetics, Inc. (Nasdaq:SGEN) and Roche (OTCQX: RHHBY) announced the FDA approval of Polivy in combination with bendamustine plus Rituxan (rituximab) for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). The approval was announced more than two months ahead of the PDUFA date of August 19, 2019.

NovaBay Pharmaceuticals Inc. (NYSE: NBY) shares closed up 875% to $3.10 following news from the nano-cap company that its Avenova eye-care product in now available to purchase on Amazon.com.

Provention Bio, Inc. (Nasdaq:PRVB) shares surged to close up 217% to $13.79 on the back of data from a Phase 2 trial in patients at risk of developing Type 1 diabetes. Data showed that patients taking PRV-031 (teplizumab) significantly delayed the onset and diagnosis of Type 1 diabetes compared to placebo, by a median of 2 years in children and adults considered to be at high risk. A Phase 3 trial in patients with Type 1 diabetes was recently initiated with enrolment to be completed in 2020. The trial has a primary completion date of May 2022. The company also announced after hours an underwritten public offering of 5.5m shares.

Oncternal Therapeutics, Inc., (Nasdaq: ONCT) announced that following the reverse merger with GTx, Inc., shares of the merged company began trading today under a new ticker of ONCT.

Aptinyx Inc. (Nasdaq: APTX) shares closed up 15% to $3.47. The company announced that its Phase 2 trial of NYX-2925, in patients with fibromyalgia, resulted in statistically significant effects on the primary endpoint, brain activity biomarkers associated with central pain processing, measured using advanced imaging techniques.

Sesen Bio (Nasdaq: SESN) shares closed down 18% to $1.90 following an update of its Pre-Biologics License Application (BLA) meeting with the FDA regarding Vicinium for the treatment of non-muscle invasive bladder cancer (NMIBC). An accelerated pathway was agreed on with a rolling BLA set to commence in 4Q 2019.

Novavax, Inc. (NASDAQ: NVAX) announced that the FDA has recommended an additional Phase 3 clinical trial to confirm efficacy against medically significant RSV disease in infants born to mothers vaccinated with ResVax. Phase 3 data released from its Prepare trial in March failed to meet the primary endpoint. Shares closed the session down 12% to $5.37.

Spark Therapeutics, Inc. (NASDAQ: ONCE) shares closed down 8% to $100.21 on news of a further delay regarding its pending acquisition by Roche (OTCQX: RHHBY). Additional information has been requested from the U.S. Federal Trade Commission. The company has extended the deadline to finalise the deal to July 31.

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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:

CEL-SCI Corporation (CVM): $5.72; +22%.

Bellicum Pharmaceuticals, Inc. (BLCM): $2.08; +18%.

Avadel Pharmaceuticals plc (AVDL): $2.69; +17%.

CorMedix, Inc. (CRMD): $7.40; +17%.

Regulus Therapeutics Inc. (RGLS): $1.04; +16%.

DECLINERS:

Sienna Biopharmaceuticals, Inc. (SNNA): $1.00; -18%.

La Jolla Pharmaceutical Company (LJPC): $10.62; -17%.

Trevi Therapeutics, Inc. (TRVI): $7.80; -16%.

Novan, Inc. (NOVN): $2.53; -14%.

ContraVir Pharmaceuticals, Inc. (CTRV): $7.00; -12%.

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

ADXS – Advaxis Inc.
ADXS-HOT 503
Non-small cell lung cancer (NSCLC)

Phase 1/2 Phase 1 data noted 50% (3 of 6) of evaluable patients from monotherapy arm and 1/1 patients on combo arm (Keytruda) showed stable disease - February 20, 2020.
$34.4 million

ALXN – Alexion Pharmaceuticals Inc.
Danicopan (ACH-4471)
Paroxysmal nocturnal hemoglobinuria (PNH)

Phase 3 Phase 3 trial to be initiated by the end of 2020.
$24 billion

APTX – Aptinyx Inc.
NYX-2925
Fibromyalgia

Phase 2 Phase 2 enrolment has been suspended due to COVID-19.
$213.2 million

ARPO – Aerpio Pharmaceuticals Inc.
Razuprotafib (AKB-9778)
Open-angle glaucoma (OAG)

Phase 2 Phase 2 initiation announced June 24, 2020 with top-line data due 4Q 2020.
$53.6 million

BTAI – BioXcel Therapeutics Inc.
BXCL501 (SERENITY I)
Schizophrenia - Agitation

Phase 3 Phase 3 data due July 2020.
$1 billion

INNT –
INN-202
Celiac disease

Phase 3 Phase 3 top-line data due 2021.
$

KZR – Kezar Life Sciences Inc.
KZR-616 (MISSION)
Lupus

Phase 1/2 Phase 1b data noted 2/2 patients saw greater than 50% reduction in proteinuria.
$233.9 million

MRK – Merck & Company Inc. (new)
ARQ 092
Overgrowth Diseases

Phase 1/2 Phase 1/2 MOSAIC initiation of dosing announced October 2, 2019.
$193.6 billion

NVAX – Novavax Inc.
RSV vaccine - prepare trial
Respiratory Syncytial Virus (RSV) in healthy pregnant women - protect infants via maternal immunization

Phase 3 Phase 3 top-line data released March 28, 2019 - primary endpoint not met. Noted June 10, 2019 that a further Phase 3 trial is required.
$5.7 billion

NVUS – Novus Therapeutics Inc.
OP0201- C-002
Healthy volunteers

Phase 1 Phase 1 data presented June 11, 2019, 1pm.
$8 million

SGEN – Seattle Genetics Inc.
Polatuzumab vedotin and bendamustine plus Rituxan (rituximab)
Diffuse large B-cell lymphoma (DLBCL)

Approved FDA approval announced June 10, 2019.
$31.4 billion

XOMA – XOMA Corporation
Vicinium
Non-muscle invasive bladder cancer (NMIBC)

BLA Filing Rolling BLA filing to be completed 2H 2020.
$213.1 million