BPC April 23 update

CDC advisory committee vote to resume JNJ COVID-19 vaccine; Inovio INO funding for Phase 3 COVID-19 vaccine trial withdrawn -25%

Price and Volume Movers

An advisory panel convened by the US Center for Disease Control and Prevention (CDC) met Friday following reports of rare blood clots among six women after been dosed with the Johnson & Johnson (NYSE:JNJ) COVID-19 vaccine. The panel voted 10-4 with one abstention that dosing recommence in adults. There will be no restrictions on who will have access to the vaccine.

INOVIO (NASDAQ:INO) announced that the Department of Defense Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) in coordination with the Office of the Assistant Secretary of Defense for Health Affairs (OASD(HA)) and the Defense Health Agency (DHA), will discontinue funding for its Phase 3 COVID-19 vaccine trial. The company cited increased availability of vaccines authorized for emergency use for the withdrawal of funding. The company still plans to initiate a Phase 3 trial but predominantly outside of the US. Shares closed down 25% to $6.85.

ADC Therapeutics SA (NYSE:ADCT) announced the FDA approved Zynlonta (loncastuximab tesirine) for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more previous treatments. Continued approval may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Coherus BioSciences, Inc. (Nasdaq: CHRS) announced that its partner Junshi Biosciences’ Phase 3 trial of toripalimab, in combination with paclitaxel/cisplatin as first-line treatment for patients with advanced esophageal squamous cell carcinoma (ESCC), met the primary endpoints of progression free survival (PFS) and overall survival (OS) at the interim analysis. Shares closed up 2% to $14.89.

Ocugen, Inc. (NASDAQ:OCGN) announced an intra-trading day registered direct offering for the sale of 10 million shares at a price of $10 per share for gross proceeds of $100m. Shares, which had added as much as 47% earlier in the session prior to the offering, retraced most of its gains to close the session up just 4% to $9.63. Ocugen announced Wednesday that its partner, Bharat Biotech, Covaxin exhibited efficacy of 78% against COVID-19 and efficacy of 100% for severe disease.

Protara Therapeutics (NASDAQ:TARA) shares closed down 18% to $12.19 following news that the company will need to conduct an additional clinical trial of TARA-002 to support its submission of a Biologics License Application for the treatment of Lymphatic Malformations (LMs). It intends to complete confirmatory, large-scale, GMP manufacturing comparability in the second half of 2021 and then initiate a clinical trial in pediatric patients.

Calliditas Therapeutics AB (NASDAQ:CALT) announced that its lead product candidate Nefecon for the treatment of primary IgA Nephropathy (IgAN), has been granted accelerated assessment procedure by the European Medicine Agency's (EMA) Committee for Human Medicinal Products (CHMP). Accelerated assessment reduces the maximum timeframe for review of the application for marketing authorization from up to 210 days to 150 days (excluding clock-stops). Calliditas expects to submit a marketing authorization application (MAA) to the EMA in 2Q 2021. Shares closed up 5% to $28.36.

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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:

Brooklyn ImmunoTherapeutics, Inc. (BTX): $16.16; +29%.

Larimar Therapeutics, Inc. (LRMR): $14.35; +22%.

GT Biopharma, Inc. (GTBP): $11.54; +17%.

Genocea Biosciences, Inc. (GNCA): $2.82; +16%.

Codiak BioSciences, Inc. (CDAK): $18.17; +15%.

DECLINERS:

EDAP TMS S.A. (EDAP): $7.36; -13%.

Rubius Therapeutics, Inc. (RUBY): $24.66; -12%.

Lyra Therapeutics, Inc. (LYRA): $10.51; -10%.

Cabaletta Bio, Inc. (CABA): $10.23; -10%.

Olema Pharmaceuticals, Inc. (OLMA): $31.04; -9%.

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

ADCT – ADC Therapeutics SA
ZYNLONTA (Loncastuximab Tesirine)
Diffuse Large B-Cell Lymphoma

Approved FDA approval announced April 23, 2021.
$1.6 billion

BBI – Brickell Biotech, Inc.
Sofpironium bromide gel (ARGYLE)
Primary Axillary Hyperhidrosis

Phase 3 Phase 3 open-label data announced April 23, 2021 - generally well-tolerated. Clinically meaningful improvement in axillary hyperhidrosis severity.
$54.1 million

CHRS – Coherus BioSciences Inc.
Toripalimab (JUPITER-06)
Esophageal Squamous Cell Carcinoma

Phase 3 Phase 3 trial met primary endpoints of Progression Free Survival and Overall Survival - April 23, 2021. Data expected later in 2021.
$1.1 billion

PPBT – Purple Biotech Ltd.
CM-24 and Opdivo
Non-small cell lung and pancreatic cancer

Phase 1/2 Phase 1/2 top-line data due 2H 2021.
$69 million

PRQR – ProQR Therapeutics N.V.
Sepofarsen (InSight extension trial)
Leber Congenital Amaurosis type 10 (LCA10)

Phase 1/2 Phase 1/2 new data to be presented 2H 2021.
$429.8 million

VRNA – Verona Pharma plc
Ensifentrine
COVID-19

Phase 2 No further development planned.
$331.6 million