BPC May 22 update

​Iovance IOVA granted Breakthrough Therapy designation +11% AH; Avadel AVDL and Agile AGRX issued PDUFA dates

Price and Volume Movers

Iovance Biotherapeutics, Inc. (NASDAQ:IOVA) shares are trading up 11% to $18.39 after hours on news that its pipeline candidate, LN-145, currently in trials for cervical cancer, has been granted Breakthrough Therapy designation by the FDA. Data from its trial will be presented on June 1, 2019, at the annual ASCO meeting. Breakthrough Therapy designation is designed to expedite the development and review of candidates intended to treat serious or life-threatening diseases in the case where preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint.

Avadel Pharmaceuticals plc (Nasdaq: AVDL) announced that the FDA has accepted the New Drug Application (NDA) for its hospital product, AV001. A six-month priority review has been granted, generating a PDUFA date of September 15, 2019.

Agile Therapeutics, Inc. (Nasdaq:AGRX) also announced that its New Drug Application (NDA) resubmission for Twirla contraceptive patch has been accepted for review, following Complete Response Letters issued in 2013 and 2017. The PDUFA date is November 16, 2019.

Affimed N.V. (Nasdaq: AFMD) announced that it will terminate its Phase 1 clinical program of AFM11, a CD19/CD3-targeting bispecific T cell engager. The trial had been earlier placed on clinical hold in October 2018. Shares closed down 7% to $3.09.

Tocagen Inc. (Nasdaq: TOCA) shares closed down 39% to $5.41. As noted yesterday, an Independent Data Monitoring Committee (IDMC) recommended that its Phase 3 Toca 5 trial evaluating Toca 511 and Toca FC in patients with recurrent high-grade glioma (HGG), to continue following an interim analysis.

OncoSec Medical Incorporated (NASDAQ: ONCS) shares closed down 33% to $2.70 following its public offering of shares of its common stock and warrants.

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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:

Novan, Inc. (NOVN): $2.31; +24%.

Tonix Pharmaceuticals Holding Corp. (TNXP): $2.03; +19%.

vTv Therapeutics Inc. (VTVT): $1.83; +14%.

Kodiak Sciences Inc. (KOD): $10.24; +13%.

DelMar Pharmaceuticals, Inc. (DMPI): $2.79; +11%.

DECLINERS:

Outlook Therapeutics, Inc. (OTLK): $2.53; -18%.

Diffusion Pharmaceuticals Inc. (DFFN): $4.84; -10%.

Arbutus Biopharma Corporation (ABUS): $2.09; -10%.

PDS Biotechnology Corporation (PDSB): $6.36; -10%.

Neon Therapeutics, Inc. (NTGN): $4.59; -10%.

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

AFMD – Affimed N.V.
AFM11
Non-Hodgkin lymphoma (NHL) and acute lymphoblastic leukemia (ALL)

Phase 1 Phase 1 program terminated - noted May 22, 2019.
$189.2 million

AGRX – Agile Therapeutics Inc.
Twirla
Contraceptive patch

PDUFA CRLs issued 2013 and 2017. New PDUFA date November 16, 2019. Advisory Committee Meeting October 30, 2019.
$73.5 million

AMAG – AMAG Pharmaceuticals Inc.
AMAG-423 / Digoxin immune fab (DIF)
Severe preeclampsia in pregnant women

Phase 2/3 Phase 2/3 top-line data due 1H 2020.
$381.5 million

ARGX – argenx SE
Cusatuzumab (ARGX-110)
Acute myeloid leukemia (AML)

Phase 2 Phase 2 trial to commence 2H 2019.
$4.4 billion

AVDL – Avadel Pharmaceuticals plc
AV001
Hospital product

PDUFA PDUFA date extended by three months to December 15, 2019.
$129.2 million

BPMX – BioPharmX Corporation
BPX-04
Rosacea

Phase 2b Phase 2b data June 25, 2019 met endpoints.
$4.7 million

EGRX – Eagle Pharmaceuticals Inc.
Ryanodex
Exertional heat stroke (EHS)

Phase 3 Intends to meet with FDA June 2019 to discuss path forward.
$846 million

JNJ – Johnson & Johnson
INVOKANA - CREDENCE
Diabetic Kidney Disease

Approved FDA Approval announced September 30, 2019.
$356.7 billion

ONCS – OncoSec Medical Incorporated
TAVO + KEYTRUDA KEYNOTE-890
Triple negative breast cancer (TNBC)

Phase 2 Interim data May 22, 2019 noted 2/10 partial responses.
$21.3 million

PIRS – Pieris Pharmaceuticals Inc.
PRS-060
Asthma

Phase 1 Phase 1 presentation at European Respiratory Society International Congress, October 1, 2019.
$154.6 million

QURE – uniQure N.V.
AMT-130
Huntington's disease

Phase 1/2 Phase 1/2 trial to commence 2H 2019.
$1.6 billion

SLGL – Sol-Gel Technologies Ltd.
TWIN
Acne

Phase 3 Phase 3 data due 4Q 2019.
$166.3 million

SLGL – Sol-Gel Technologies Ltd.
VERED (Epsolay)
Papulopustular rosacea

Phase 3 Phase 3 top-line data met primary endpoints - July 8, 2019.
$166.3 million

SYBX – Synlogic Inc.
SYNB1891 and atezolizumab
Solid tumors

Phase 1 IND to be filed 2H 2019.
$71 million