BPC May 21 update

Small-cap PDUFA dates and Advisory Committee Meetings through July + the big one Biogen BIIB

Weekly watchlist

This week we preview upcoming regulatory catalysts for small-cap companies through to the end of July, including a selection of PDUFA (FDA approval) and FDA Advisory Committee Meeting dates. We also add one large-cap company to the list, namely Biogen (NASDAQ:BIIB), which is arguably the most eagerly awaited catalyst for 2021.

First, let’s review the week that was with price-moving events.

REGULATORY:

Omeros Corporation (Nasdaq:OMER) shares fell 18% for the week to close down at $14.89, following news the FDA extended the PDUFA date by three months for its Biologics License Application (BLA) of narsoplimab for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA). The new PDUFA date is October 17, 2021.

Reata Pharmaceuticals, Inc. (NASDAQ:RETA) announced that the FDA has advised the company withdraw its meeting request for a Type C meeting and instead request a pre-NDA meeting for its pipeline candidate omaveloxolone in Friedreich's ataxia. Type C meetings are held to discuss the development and review of a product, whereas a pre-NDA meeting focuses on the content of a New Drug Application (NDA). Shares closed the week up 42% to $110.98.

Iovance Biotherapeutics, Inc. (NASDAQ: IOVA) shares fell sharply, closing the week down 30% to $18.05. The company announced its Biologics License Application (BLA) filing for lifileucel has been delayed from 2021 to the first half of 2022. The update follows the receipt of feedback from the FDA regarding the previous submission of assay data.

CLINICAL DATA:

Annovis Bio Inc. (NYSE American: ANVS) shares surged to close Friday up 127% to $60.00 following news that patients with Alzheimer’s Disease in a Phase 2 trial who received ANVS401 for 25 days showed statistically significant cognitive improvement as measured by an 11-part test.

PDS Biotechnology Corporation (NASDAQ:PDSB) was the big winner from Wednesday’s release of abstracts for the upcoming ASCO oncology meeting. Shares surged to close the week up 75% to $8.33. Data from its Phase 2 trial of PDS0101 (in combination with bintrafusp alfa and NHS-IL12) in patients with HPV 16+ cancers saw 5/6 (83%) patients with checkpoint naïve disease and 5/8 (63%) patients with checkpoint refractory disease exhibit objective responses.

OTHER:

Aerpio Pharmaceuticals, Inc. (NASDAQ:ARPO) shares closed the week up 74% to $2.02 on news of a reverse merger with Aadi Bioscience, Inc, a privately-held biopharmaceutical company focusing on precision therapies for genetically-defined cancers.

Agenus Inc. (NASDAQ:AGEN) announced a partnership with Bristol-Myers Squibb Company (NYSE:BMY) where Bristol will be granted a global license to Agenus' pre-clinical TIGIT candidate, AGEN1777. Agenus receives $200 million upfront and up to $1.36 billion in milestones payments. Shares closed the week up 30% to $4.19.


Small-cap PDUFA dates and Advisory Committee Meetings through July + Biogen (BIIB).

Drug Price Stage Catalyst Market Cap

ALBO – Albireo Pharma Inc.
BYLVAY (odevixibat)
Progressive familial intrahepatic cholestasis (PFIC)

$34.74
-0.61  -2%
PDUFA priority review PDUFA date under priority review July 20, 2021.
$666.8 million

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

$7.15
+0.03  +0%
PDUFA PDUFA date extended by three months to July 29, 2021.
$705.8 million

BIIB – Biogen Inc.
ADUHELM (Aducanumab)
Alzheimer’s disease

$374.40
-6.51  -2%
Approved FDA approval announced June 7, 2021.
$56.4 billion

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

$12.89
-0.17  -1%
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.
$899.1 million

CMRX – Chimerix Inc.
TEMBEXA (brincidofovir)
Smallpox

$7.84
-0.36  -4%
Approved FDA approval announced June 4, 2021.
$675.9 million

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

$5.71
-0.25  -4%
CRL CRL announced May 28, 2021.
$139.9 million

FGEN – FibroGen Inc
Roxadustat
Anaemia in Chronic Kidney Disease

$27.65
-0.17  -1%
PDUFA PDUFA date TBC. Advisory Committee meeting July 15, 2021.
$2.5 billion

LMNL – Liminal BioSciences Inc.
RYPLAZIM (plasminogen)
Congenital plasminogen deficiency (C-PLGD)

$4.09
+0.05  +1%
Approved FDA approval announced June 4, 2021.
$122.5 million

LNTH – Lantheus Holdings Inc.
PYLARIFY (piflufolastat F 18)
Prostate cancer

$25.53
+0.37  +1%
Approved FDA Approval announced May 27, 2021.
$1.7 billion

MDWD – MediWound Ltd.
NexoBrid
Severe burns

$4.77
+0.04  +1%
PDUFA PDUFA date June 29, 2021.
$130 million

ORPH – Orphazyme A/S
Arimoclomol
Niemann-Pick disease Type C (NPC)

$5.97
-0.55  -8%
CRL CRL issued June 18, 2021.
$208.7 million

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

$8.37
-0.21  -2%
PDUFA priority review Advisory Committee meeting May 27, 2021 voted 10-7 in favor that benefits outweigh the risks. 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.
$530.4 million

SCYX – SCYNEXIS Inc.
BREXAFEMME (ibrexafungerp)
Vulvovaginal candidiasis (VVC)

$7.22
+0.10  +1%
Approved FDA approval announced June 2, 2021.
$149 million

VRCA – Verrica Pharmaceuticals Inc.
VP-102
Molluscum contagiosum

$11.62
+0.04  +0%
PDUFA CRL announced July 14, 2020. NDA resubmitted. Initial PDUFA date extended by three months to September 23, 2021.
$318.5 million