BPC November 14 update

​Amarin AMRN receives positive Advisory Committee vote; Agile AGRX PDUFA date delayed by three months

Price and Volume Movers

Amarin Corporation plc (NASDAQ: AMRN) announced that the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the FDA has voted unanimously (16-0) to recommend approval of an indication and label expansion for Vascepa capsules to reduce the risk of cardiovascular events in high-risk patients. The PDUFA date for a final decision by the FDA is December 28, 2019. Shares of the company were halted for the entire trading session. In reaction to the news, Matinas BioPharma Holdings Inc (NYSE AMERICAN) shares closed the after-hours session up 30% to $1.17, while Acasti Pharma Inc (NASDAQ: ACST) shares closed up 15% to $2.25, with both companies holding pipeline candidates in trials for hypertriglyceridemia.

VistaGen Therapeutics (NASDAQ: VTGN) shares slumped to close down 72% to $0.30 following news its Phase 2 trial of AV-101, as an adjunctive treatment of major depressive disorder (MDD), did not meet the primary endpoint.

Agile Therapeutics, Inc. (Nasdaq: AGRX) shares closed the after-hours session down 32% to $1.62 on news that the FDA has extended the PDUFA date for its review of the New Drug Application (NDA) of its Twirla contraceptive patch, from November 16, 2019 to February 16, 2020. The delay follows submission by the company of requested information by the FDA, which were determined to be a major amendment and will take additional time to review.

Rubius Therapeutics, Inc. (NASDAQ: RUBY) shares closed down 20% to $7.88 following a pipeline update in its third-quarter earnings release. The company noted that data from its Phase 1b trial of RTX-134 for the treatment of patients with phenylketonuria, will now be released in 1Q 2020. The company had previously guided that data would be released this year.

Tricida, Inc. (Nasdaq: TCDA) announced that its New Drug Application (NDA) for veverimer, in patients with chronic kidney disease, has been accepted by the FDA, with an assigned PDUFA date of August 22, 2020. The company noted the FDA indicated it is currently planning to hold a Cardiovascular and Renal Drugs Advisory Committee meeting to discuss the application.

BeiGene, Ltd. (NASDAQ: BGNE) announced the FDA issued approval for Brukinsa (zanubrutinib) for the treatment of mantle cell lymphoma (MCL) in adult patients who have received at least one prior therapy.

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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:

Celsion Corporation (CLSN): $1.39; +29%.

Precision BioSciences, Inc. (DTIL): $11.80; +25%.

XBiotech Inc. (XBIT): $13.12; +15%.

Spring Bank Pharmaceuticals, Inc. (SBPH): $3.18; +14%.

Equillium, Inc. (EQ): $3.65; +13%.

DECLINERS:

Tonix Pharmaceuticals Holding Corp. (TNXP): $2.21; -16%.

PhaseBio Pharmaceuticals, Inc. (PHAS): $3.36; -14%.

Assembly Biosciences, Inc. (ASMB): $12.07; -14%.

EyeGate Pharmaceuticals, Inc. (EYEG): $4.30; -13%.

scPharmaceuticals Inc. (SCPH): $4.64; -11%.

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

AMRN – Amarin Corporation plc
Vascepa
High Triglycerides With Mixed Dyslipidemia

Approved FDA Approval announced December 13, 2019.
$2.7 billion

ASND – Ascendis Pharma A/S
TransCon
Hypoparathyroidism

Phase 2 Phase 2 six-month data from the open-label extension portion due 3Q 2020. Phase 3 trial to commence 4Q 2020.
$7.5 billion

BGNE – BeiGene Ltd.
Zanubrutinib (BGB-3111)
Relapsed or refractory mantle cell lymphoma (MCL)

Approved FDA Approval announced November 14, 2019.
$18.9 billion

JAGX – Jaguar Health Inc.
Mytesi (crofelemer) HALT-D
Cancer related diarrhea (CRD)

Phase 2 Phase 2 trial to enrol through to completion - November 14, 2019.
$25.6 million

LPTX – Leap Therapeutics Inc.
TRX518
Solid tumors

Phase 1/2 De-prioritizing further development - November 14, 2019
$116.8 million

MDWD – MediWound Ltd.
NexoBrid
Severe burns

BLA Filing BLA filing announced June 30, 2020.
$101.2 million

RUBY – Rubius Therapeutics Inc.
RTX-134
Phenylketonuria (PKU)

Phase 1/2 Phase 1b trial to be discontinued - noted March 12, 2020
$452.7 million

TRVI – Trevi Therapeutics Inc.
Nalbuphine ER - PRISM
Prurigo Nodularis

Phase 2/3 Phase 2b/3 enrolment to be completed in 3Q 2021 with top-line data due 4Q 2021.
$77.4 million

VBIV – VBI Vaccines Inc.
BRII-179 (VBI-2601)
Hepatitis B vaccine

Phase 2 Phase 2 data due 2H 2020.
$949.1 million

VBLT – Vascular Biogenics Ltd.
VB-111
Recurrent platinum resistant ovarian cancer

Phase 3 Phase 3 next interim analysis due 3Q 2020.
$61.8 million

VTGN – VistaGen Therapeutics Inc.
AV-101 - ELEVATE
Adjunctive Treatment Major Depressive Disorder

Phase 2 Phase 2 data did not meet primary endpoint - November 14, 2019.
$54.9 million

ZEAL – Zealand Pharma A/S
Dasiglucagon
Severe hypoglycemia in diabetes

PDUFA PDUFA date scheduled for March 27, 2021.
$1.4 billion

ZSAN – Zosano Pharma Corporation
Qtrypta (M207)
Migraine

PDUFA PDUFA date October 20, 2020.
$107.4 million