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.

-

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

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

Phase 3 Phase 3 data due mid-2020.
$365.2 million

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

Phase 3 Phase 3 data did not meet primary endpoint - April 6, 2020.
$290.2 million

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

Phase 2 Phase 2 data due 3Q 2020.
$3.5 billion

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

Phase 3 Phase 3 data due 2022.
$6.5 billion

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

Phase 3 Phase 3 interim data 2021. Final data 2023.
$6.5 billion

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

Approved FDA Approval announced for label expansion June 7, 2019.
$3.3 billion

RCUS – Arcus Biosciences Inc.
AB928 + Zimberelimab (AB122)
Solid tumors

Phase 1 Phase 1b expansion data due from mid-2020.
$1.4 billion

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

Phase 2 Phase 2 Part A data July 24, 2019 noted MADRS score of 15.5 points at Day 15 (n=23; p<0.0001) - secondary endpoint.
$1.9 billion

SAGE – Sage Therapeutics Inc.
SAGE-324
Essential tremor

Phase 2 Phase 2 trial to be initiated 1H 2020. Data due 2021.
$1.9 billion

TBPH – Theravance Biopharma Inc.
Closed Triple - CAPTAIN
Asthma

PDUFA sNDA filing announced October 2, 2019. PDUFA date 2Q 2020. Estimate August 2, 2020 using 10-month timeline.
$1.7 billion

VKTX – Viking Therapeutics Inc.
VK2809 VOYAGE
Non-alcoholic steatohepatitis (NASH) and fibrosis

Phase 2b Phase 2b trial ongoing.
$516.2 million

ZYME – Zymeworks Inc.
ZW49
HER2-Expressing Cancers

Phase 1 Phase 1 data due 2020.
$1.7 billion