BPC April 21 update

Ocugen OCGN shares rally on partner COVID vaccine data +17%; ​Evolus EOLS offering

Price and Volume Movers

Valneva SE announced it has initiated a pivotal Phase 3 clinical trial for its COVID-19 vaccine candidate, VLA2001. The Phase 3 trial will compare VLA2001, against AstraZeneca’s vaccine, Vaxzevria1, in a comparative immunogenicity trial. The primary endpoint will be to determine the immune response two weeks after completion of the two-dose trial. VLA2001 consists of inactivated whole virus particles of SARS-CoV-2, in combination with two adjuvants, alum and CpG 1018. The CpG 1018 adjuvant, is supplied by Dynavax Technologies Corporation (Nasdaq: DVAX).

Ocugen (NASDAQ:OCGN) announced its partner, Bharat Biotech, released data from a second interim analysis of its Phase 3 trial for its COVID-19 vaccine candidate, Covaxin. The data exhibited a vaccine efficacy in mild, moderate, and severe COVID-19 disease of 78% with efficacy against severe COVID-19 disease of 100%. Ocugen is eligible of 45% of profits in the US market should it receive marketing approval. Shares closed up 18% to $6.50.

INmune Bio, Inc. (NASDAQ:INMB) shares closed up 18% to $13.03. B. Riley FBR initiated coverage with a Buy rating and a price target of $29.

89bio, Inc. (NASDAQ:ETNB) shares closed up 8% to $28.00, also on the back of analyst coverage. Analysts at Cantor Fitzgerald initiated coverage of the stock with an Overweight rating and a price target of $58.

Evolus, Inc. (NASDAQ:EOLS) announced that it has commenced a public offering to sell shares of its common stock. Shares, which closed up 11% during normal trading hours, are currently trading down 13% to $10.14 after hours.

-

Major price movers (stocks priced > $1.00, volume > 50k listed on NASDAQ/NYSE):

Refer to the BioPharmCatalyst Biotech Stocks page for Top 10 Gainers/Losers/Unusual Volume:

ADVANCERS:

Timber Pharmaceuticals, Inc. (TMBR): $1.53; +23%.

Plus Therapeutics, Inc. (PSTV): 2.33; +17%.

Avenue Therapeutics, Inc. (ATXI): $4.55; +16%.

Outlook Therapeutics, Inc. (OTLK): $2.07; +16%.

Oncternal Therapeutics, Inc. (ONCT): $6.64; +15%.

DECLINERS:

Lava Therapeutics B.V. (LVTX): $12.30; -10%.

Brooklyn ImmunoTherapeutics, Inc. (BTX): $8.90; -9%.

Design Therapeutics, Inc. (DSGN): $19.55; -8%.

Instil Bio, Inc. (TIL): $17.61; -6%.

GT Gain Therapeutics SA (GANX): $12.66; -6%.

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

AYLA – Ayala Pharmaceuticals Inc.
AL102 and WVT078
Multiple Myeloma

Phase 1 Phase 1 initiation of dosing announced April 21, 2021.
$132.4 million

CWBR – CohBar Inc.
CB4211
Nonalcoholic Fatty Liver Disease / Obesity / Nonalcoholic steatohepatitis

Phase 1b Phase 1b top-line data due early-July 2021.
$75.4 million

DVAX – Dynavax Technologies Corporation
VLA2001-301 + alum and CpG 1018
COVID-19 vaccine

Phase 1/2 Phase 3 trial initiation announced April 21, 2021.
$889.2 million

OCGN – Ocugen, Inc.
COVAXIN
COVID-19 vaccine

Phase 3 Phase 3 interim data from partner Bharat Biotech noted efficacy rate of 78% - April 21, 2021.
$1.7 billion

PTCT – PTC Therapeutics Inc.
Evrysdi (risdiplam)
SMA type 1/2/3 switching study

Phase 2 Phase 2 data due 2021.
$2.7 billion

RHHBY – Roche Holding AG ADR
Mosunetuzumab
Follicular lymphoma

Phase 1b Phase 1b data due 2021.
$288 billion

RHHBY – Roche Holding AG ADR
Tecentriq (IMvoke010)
Squamous Cell Carcinoma of the Head and Neck (SCCHN)

Phase 3 Phase 3 data due 2021.
$288 billion

RHHBY – Roche Holding AG ADR
Polivy (polatuzumab vedotin) - POLARIX
Diffuse Large B-Cell Lymphoma

Phase 3 Phase 3 data due 2021.
$288 billion

RVMD – Revolution Medicines Inc - Ordinary Shares
RMC-5552
Solid tumors

Phase 1 Phase 1 commencement of dosing announced April 21, 2021 with initial safety, PK and single agent activity data expected in 2022.
$2.3 billion

TGTX – TG Therapeutics Inc.
Ublituximab + UKONIQ (umbralisib) + Venclexta (Venetoclax) (ULTRA-V)
Chronic Lymphocytic Leukemia

Phase 2/3 Phase 3 initiation of enrolment announced April 21, 2021. Phase 2 trial enrollment has been completed with data due in 2022.
$4.8 billion

VBIV – VBI Vaccines Inc.
BRII-835 (VIR-2218) and BRII-179 (VBI-2601)
Hepatitis B

Phase 2 Phase 2 trial initiation announced April 21, 2021.
$767.7 million

VERU – Veru Inc.
Enobosarm
ER+/HER2- breast cancer

Phase 3 Phase 3 trial planned for 2Q 2021.
$619.1 million