BPC May 02 update

VistaGen VTGN shares slide 47% on mid-stage depression fail

Price and Volume Movers

Agios Pharmaceuticals, Inc. (NASDAQ:AGIO) announced the FDA approved a supplemental New Drug Application (sNDA) expanding the label of Tibsovo, to include adult patients with newly diagnosed acute myeloid leukemia (AML) with a susceptible IDH1 mutation as detected by an FDA-approved test who are ≥ 75 years old or who have comorbidities that preclude use of intensive induction chemotherapy.

GlaxoSmithKline plc (LSE/NYSE: GSK), Innoviva, Inc.(NASDAQ: INVA) and Theravance Biopharma, Inc (NASDAQ:TBPH) announced that their Phase 3 CAPTAIN trial of once-daily single inhaler triple therapy Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol: FF/UMEC/VI) compared to Relvar/Breo Ellipta (FF/VI), in the treatment of patients with asthma, met the primary endpoint, demonstrating a statistically significant improvement in lung function. However, the trial missed the key secondary endpoint of annualised rate of moderate/severe exacerbations for FF/UMEC/VI. Shares of Innoviva closed up 7% to $14.94.

VistaGen Therapeutics (NASDAQ: VTGN) announced that it failed to meet the primary endpoint in a Phase 2 clinical trial of AV-101 in patients with treatment-resistant depression (TRD). Shares slid to close down 47% to $0.56.

Shares of nano-cap Diffusion Pharmaceuticals Inc. (NASDAQ: DFFN) closed up 92% to $5.90 on no news released by the company. It should be noted that the company mentioned in March that it has sufficient cash and cash equivalents to fund operations only through to July 2019, so one would assume a stock offering to raise cash is due soon.

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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:

ARCA biopharma, Inc. (ABIO): $12.65; +24%.

Auris Medical Holding AG (EARS): $5.14; +16%.

Citius Pharmaceuticals, Inc. (CTXR): $1.14; +14%.

vTv Therapeutics Inc. (VTVT): $1.54; +12%.

Marinus Pharmaceuticals, Inc. (MRNS): $4.63; +12%.

DECLINERS:

Ironwood Pharmaceuticals, Inc. (IRWD): $10.27; -13%.

Seres Therapeutics, Inc. (MCRB): $5.35; -12%.

Liquidia Technologies Inc. (LQDA): $8.85; -9%.

Immunic, Inc. (IMUX): $12.32; -7%.

Avadel Pharmaceuticals plc (AVDL): $1.22; -7%.

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

ALDR – Alder BioPharmaceuticals Inc.
Eptinezumab ALD403
Frequent episodic migraine

PDUFA PDUFA date February 21, 2020.
$950.3 million

MCRB – Seres Therapeutics Inc.
SER-109 - ECOSPOR III
Recurrent C. Difficile infection

Phase 3 Phase 3 data due early 2020.
$195.1 million

MNLO – Menlo Therapeutics Inc.
Serlopitant
Pruritus associated with prurigo nodularis

Phase 3 Phase 3 data due 1H 2020.
$119.4 million

MNTA – Momenta Pharmaceuticals Inc.
M281
generalized myasthenia gravis (gMG)

Phase 2 Phase 2 data due 2020.
$1.1 billion

NVCR – NovoCure Limited
Tumor Treating Fields (TTFields) METIS
Brain Metastases Originating from Non-Small Cell Lung Cancer

Phase 3 Phase 3 data due 2021.
$6.6 billion

NVCR – NovoCure Limited
Tumor Treating Fields (TTFields) LUNAR
Non-small cell lung cancer (NSCLC)

Phase 3 Phase 3 interim data 2020. Final data 2021.
$6.6 billion

PTCT – PTC Therapeutics Inc.
PTC596
Diffuse Intrinsic Pontine Glioma (DIPG)

Phase 1 Phase 1 enrolment to be completed by the end of 2019.
$2.5 billion

PTCT – PTC Therapeutics Inc.
Emflaza
Duchenne muscular dystrophy (age 2-5)

Approved FDA Approval announced for label expansion June 7, 2019.
$2.5 billion

RCUS – Arcus Biosciences Inc.
AB928 + AB122
Solid tumors

Phase 1 Phase 1 initial data presented at ASCO June 1, 2019.
$371 million

SAGE – Sage Therapeutics Inc.
SAGE-217 - ARCHWAY
Bipolar depression

Phase 2 Phase 2 Part A data due July 2019.
$9.6 billion

SAGE – Sage Therapeutics Inc.
SAGE-324
Essential tremor

Phase 1 Phase 1 MAD data due July 2019. Top-line data due 2H 2019.
$9.6 billion

TBPH – Theravance Biopharma Inc.
Closed Triple - CAPTAIN
Asthma

Phase 3 Phase 3 data released May 2, 2019 met primary but missed key secondary endpoint.
$983 million

VKTX – Viking Therapeutics Inc.
VK2809
Hypercholesterolemia and Non-Alcoholic Fatty Liver Disease

Phase 2 Phase 2b trial to be initiated 2H 2019.
$593.7 million

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

Phase 2 Phase 2 data due 2019.
$28.1 million

ZYME – Zymeworks Inc.
ZW49
HER2-Expressing Cancers

Phase 1 Phase 1 data due 2H 2019.
$935.3 million