BPC April 16 update

Small and mid-cap PDUFA and Advisory Committee meeting dates slated for April and May; Biotech week in Review

Weekly watchlist

Following on from our list of likely price-moving Phase 2 and Phase 3 catalysts to watch for this quarter, we look this week at PDUFA (FDA approval) dates and FDA Advisory Committee meetings slated for April and May for small and mid-cap companies. First quarter earnings season also gets underway this coming week.

First, let’s review what was another quiet week of price moving news.

COVID:

The FDA announced Tuesday that it is recommending the pause of use of Johnson & Johnson's COVID-19 vaccine. The move follows news that six recipients in the US developed blood clots following vaccination. Just over 6.8 million people in the US have received the Johnson & Johnson vaccine. The company will also delay the rollout of its vaccine in Europe.

Shares of vaccine competitors rose on the news, with weekly moves noted below:

Moderna (NASDAQ:MRNA): $170.81; +21%.

Novavax (NASDAQ: NVAX): $227.35; +26%.

BioNTech SE (NASDAQ:BNTX): $151.54; +24%.

Curevac (NASDAQ: CVAC): $109.29; +21%.

REGULATORY:

Avenue Therapeutics, Inc. (NASDAQ: ATXI) announced that the FDA is still reviewing its New Drug Application (NDA) for IV tramadol and has not provided a decision regarding the NDA. The scheduled PDUFA date for a decision by the FDA was April 12, 2021. Shares closed the week down 34% to $4.54, while its parent company, Fortress Biotech, Inc. (NASDAQ:FBIO), fell 24% for the week to $4.12.

CLINICAL DATA:

NovoCure Limited (NASDAQ:NVCR) shares closed up 50% to $197.22 following an update from its Phase 3 pivotal LUNAR trial of Tumor Treating Fields (TTFields) in patients with non-small cell lung cancer (NSCLC). Following an interim analysis, an independent data monitoring committee (DMC) recommended the number of participants in the trial be reduced which could accelerate trial completion by around one year. Data were previously expected in 2023. Shares closed the week up 60% to $192.50, while Zai Lab Limited (NASDAQ:ZLAB), which has rights in China, added 24% to $164.29.

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1Q 2021 Biotech earnings calendar:

Tue: JNJ

Thu: BIIB

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PDUFA dates and Advisory committee meetings for April and May

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

APLS – Apellis Pharmaceuticals Inc.
Empaveli (pegcetacoplan)
Paroxysmal Nocturnal Hemoglobinuria (PNH)

Approved FDA approval announced May 14, 2021.
$4.3 billion

ARDX – Ardelyx Inc.
Tenapanor
Serum phosphorus - chronic kidney disease (CKD) on dialysis

PDUFA PDUFA date extended by three months to July 29, 2021.
$674.2 million

CCXI – ChemoCentryx Inc.
Avacopan - CCX168 (ADVOCATE)
Associated vasculitis (AAV)

PDUFA Advisory Committee May 6, 2021 voted 10-8 that the benefit-risk and safety profiles are adequate to support approval and 9-9 that the efficacy data supports approval. PDUFA date July 7, 2021.
$689.8 million

ETON – Eton Pharmaceuticals Inc.
ET-104 (zonisamide oral suspension)
Neurological indication

PDUFA PDUFA date May 29, 2021.
$203.9 million

ETON – Eton Pharmaceuticals Inc.
Dehydrated alcohol injection (DS-100)
Methanol poisoning

PDUFA PDUFA date May 27, 2021
$203.9 million

FBIO – Fortress Biotech Inc.
Intravenous (IV) tramadol
Postoperative pain following bunionectomy surgery

PDUFA CRL announced October 12, 2020. New PDUFA date April 12, 2021. Announced April 13, 2021 that the FDA is still reviewing the NDA.
$344.3 million

HRTX – Heron Therapeutics Inc.
ZYNRELEF (HTX-011)
Post operative pain

Approved FDA approval announced May 13, 2021.
$1.4 billion

LNTH – Lantheus Holdings Inc.
PyL
Prostate cancer

PDUFA priority review PDUFA date under priority review May 28, 2021.
$1.4 billion

PLX – Protalix BioTherapeutics Inc. (DE)
Pegunigalsidase alfa (PRX-102)
Fabry disease

CRL CRL announced April 28, 2021.
$131.2 million

PRVB – Provention Bio Inc.
PRV-031 (teplizumab)
Type 1 diabetes

PDUFA priority review Advisory Committee scheduled for May 27, 2021. PDUFA date under priority review July 2, 2021. Noted April 8, 2021 that FDA has identified deficiencies that preclude discussion of labeling and post-marketing requirements/commitments.
$434.8 million

SLGL – Sol-Gel Technologies Ltd.
VERED (Epsolay)
Papulopustular rosacea

PDUFA PDUFA date April 26, 2021. Decision has been deferred as the FDA has not been able to conduct a pre-approval inspection of the production site due to COVID-19.
$231.2 million