BPC August 03 update

​Immunic IMUX +28% and CymaBay CBAY +37% shares rally on positive data

Price and Volume Movers

Immunic, Inc. (NASDAQ:IMUX) shares closed the normal trading session up 28% to $22.00 following news its Phase 2 trial of IMU-838 in patients with relapsing-remitting multiple sclerosis (RRMS) achieved all primary and key secondary endpoints. The trial met its primary endpoint, demonstrating a statistically significant reduction in the cumulative number of combined unique active (CUA) magnetic resonance imaging (MRI) lesions up to week 24 in patients receiving 45mg of IMU-838 once daily, by 62% (p=0.0002), as compared to placebo. The company followed up the news when it announced after hours that it intends to offer 5m shares of its common stock in an underwritten public offering. Shares are trading down 11% after hours to $19.65.

GW Pharmaceuticals plc (Nasdaq: GWPH) announced the FDA approved Epidiolex (cannabidiol) oral solution to treat seizures associated with tuberous sclerosis complex (TSC) in patients one year of age and older. Shares closed up 4% to $132.87.

CymaBay Therapeutics, Inc. (NASDAQ: CBAY) shares closed up 37% to $4.88 on news of positive top-line data from its ENHANCE trial evaluating the safety and efficacy of seladelpar for the treatment of primary biliary cholangitis (PBC). Seladelpar achieved the primary composite outcome with high statistical significance in 78.2% of patients in the 10 mg group (n=55) and 57.1% in the 5 mg group (n=56) compared to 12.5% on placebo (n=56) after 3 months (p<0.0001).

Aeterna Zentaris Inc. (NASDAQ:AEZS) announced the sale of 12,427,876 common shares at a purchase price of $0.56325 per common share in a registered direct offering for gross proceeds of approximately $7m. Shares closed down 9% to $0.429.

Voyager Therapeutics, Inc. (NASDAQ:VYGR) announced the termination of its tau and alpha-synuclein vectorized antibody collaborations with AbbVie. Shares are trading down 15% to $9.62 after hours.

Achieve Life Sciences, Inc. (NASDAQ:ACHV) shares are trading down 6% after hours to $11.04, adding to its 14% fall during the normal trading session. The company announced after hours a public offering of shares of its common stock and pre-funded warrants to purchase shares of common stock.

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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:

Cocrystal Pharma, Inc. (COCP): $2.36; +40%.

Trevena, Inc. (TRVN): $2.94; +27%.

Durect Corporation (DRRX): $2.35; +20%.

Iteos Therapeutics, Inc. (ITOS): $23.36; +19%.

PDS Biotechnology Corporation (PDSB): $4.30; +17%.

DECLINERS:

Tiziana Life Sciences PLC (TLSA): $5.48; -22%.

Sonnet BioTherapeutics Holdings, Inc. (SONN): $3.54; -14%.

IDEAYA Biosciences, Inc. (IDYA): $11.50; -9%.

Alpine Immune Sciences, Inc. (ALPN): $10.50; -9%.

Alterity Therapeutics Limited (ATHE): $1.35; -8%.


Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

ABBV – AbbVie Inc.
Cenicriviroc + Otezla (apremilast) + Firazyr (icatibant)
COVID-19 (severe)

Phase 2 Phase 2 trial initiation announced August 3, 2020.
$159 billion

ALRN – Aileron Therapeutics Inc.
ALRN-6924
Small Cell Lung Cancer (SCLC)

Phase 1/2 Phase 1b/2 top-line data from the schedule optimization and final data from the dose optimization parts of the trial due 4Q 2020.
$53.4 million

ARAV – Aravive Inc.
AVB-500 and paclitaxel
Ovarian cancer

Phase 1b Phase 1b interim analysis due 2021.
$100.2 million

BHVN – Biohaven Pharmaceutical Holding Company Ltd.
Verdiperstat (HEALEY ALS Platform Trial)
Amyotrophic lateral sclerosis (ALS)

Phase 2/3 Phase 2/3 initiation announced August 3, 2020.
$3.8 billion

CBAY – CymaBay Therapeutics Inc.
Seladelpar
Primary biliary cholangitis (PBC)

Phase 2 Phase 2 open-label data presented at EASL August 27, 2020.
$476.7 million

GWPH – GW Pharmaceuticals Plc
Epidiolex
Tuberous Sclerosis Complex

Approved FDA approval announced August 3, 2020.
$3.1 billion

JNJ – Johnson & Johnson
Esketamine
Major depressive disorder (MDD)

Approved FDA approval announced August 3, 2020.
$392.8 billion

KRTX – Karuna Therapeutics Inc.
KarXT
Pain in healthy volunteers

Phase 1b Phase 1b data released August 3, 2020. Insufficient evidence of an analgesic benefit compared to placebo. Development to be discontinued for pain indication.
$2.3 billion

LLY – Eli Lilly and Company
LY-CoV555 (BLAZE-1/2)
COVID-19 Antibody

Phase 2/3 Phase 2 interim data released September 16, 2020 noted one of three doses met primary endpoint. Five of 302 (1.7%) patients were hospitalised compared with nine of 150 (6%) placebo patients.
$147.5 billion

MYOK – MyoKardia Inc.
Mavacamten - VALOR-HCM
Hypertrophic cardiomyopathy (HCM)

Phase 3 Phase 3 initiation of dosing announced August 3, 2020.
$7.2 billion

NBIX – Neurocrine Biosciences Inc.
VY-AADC02 (RESTORE-1)
Parkinson's Disease

Phase 2 Phase 2 trial to re-enroll 2H 2020. Phase 3 trial to commence 1H 2021.
$9.5 billion

RYTM – Rhythm Pharmaceuticals Inc.
Setmelanotide
Alstrom Syndrome and Bardet-Biedl Syndrome

Phase 3 Phase 3 top-line data due 4Q 2020 or early 1Q 2021.
$1.3 billion

VNDA – Vanda Pharmaceuticals Inc.
HETLIOZ (tasimelteon)
Smith-Magenis Syndrome

PDUFA priority review PDUFA date under priority review December 1, 2020.
$538.3 million

VTVT – vTv Therapeutics Inc.
Azeliragon
Mild Alzheimer’s disease with type 2 diabetes

Phase 2/3 Phase 2/3 top-line data due 2Q 2021.
$147.1 million