BPC June 07 update

Biogen BIIB receives FDA accelerated approval for Alzheimer’s disease therapy - shares surge 38%

Price and Volume Movers

Biogen (NASDAQ:BIIB) shares surged to close up 38% to $395.85 following news released with its partner Eisai, Co., Ltd, that the FDA has granted accelerated approval for ADUHELM (aducanumab) for the treatment of Alzheimer's disease The companies noted that the annual cost at the maintenance dose (10 mg/kg) would be $56,000. The approval decision was not without controversy, however, with a panel of experts voting in November last year that there was insignificant efficacy to recommend approval. Continued approval for ADUHELM is contingent upon clinical benefit shown in confirmatory trials.

Several companies with Alzheimer's disease therapies in their respective drug pipelines traded higher in sympathy off the news. Major movers were:

Vaccinex, Inc. (VCNX): $3.00 +30%.

Prothena Corporation plc (PRTA): $37.23; +30%.

AC Immune SA (ACIU): $8.02; +28%.

INmune Bio, Inc. (INMB): $15.97; +19%.

Eli Lilly and Company (LLY): $222.52; +10%.

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Atossa Therapeutics, Inc. (NASDAQ:ATOS) shares closed up 30% to $6.01. The company announced final data from its Phase 2 trial of Endoxifen, administered to breast cancer patients prior to surgery, will be released on June 9.

Johnson & Johnson (NYSE:JNJ) announced that it will not continue the collaboration and license agreement with argenx SE (Nasdaq: ARGX) for cusatuzumab, an investigational therapeutic antibody that targets CD70. The decision is based upon its review of data to date and in consideration of the current standard of care for the treatment of acute myeloid leukemia (AML). Shares of argenx fell 4% to $260.30.

bluebird bio, Inc. (NASDAQ:BLUE) announced the FDA lifted clinical holds on its trials for sickle cell disease and patients with transfusion-dependent β-thalassemia (TDT). Shares closed up 3% to $31.98.

PDS Biotechnology Corporation (NASDAQ:PDSB) shares closed down 26% to $9.40 following the presentation of data from its Phase 2 combination trial of PDS010 in patients with refractory HPV16-associated cancers. Data presented at ASCO today noted an overall response rate of 56% compared with 71% released in its abstract last month. Shares are still up over 60% since prior to their abstract release.

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Other 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:

Liminal BioSciences Inc. (LMNL): $5.17; +29%.

Evofem Biosciences, Inc. (EVFM): $1.03; +19%.

Ocugen, Inc. (OCGN): $10.30; +18%.

Trillium Therapeutics Inc. (TRIL): $9.48; +17%.

DECLINERS:

HOOKIPA Pharma Inc. (HOOK): $13.25; -21%.

Cabaletta Bio, Inc. (CABA): $8.56; -14%.

Gemini Therapeutics, Inc. (GMTX): $10.96; -13%.

Purple Biotech Ltd. (PPBT): $5.17; -13%.

Pipeline updates below:

Pipeline Database Updates

Drug Price Stage Catalyst Market Cap

ALLK – Allakos Inc.
Lirentelimab (ENIGMA 2)
Eosinophilic Gastritis and/or eosinophilic duodenitis (EoD)

$90.74
-2.04  -2%
Phase 3 Phase 3 top-line data due 4Q 2021.
$4.9 billion

ALLK – Allakos Inc.
Lirentelimab (KRYPTOS)
Eosinophilic esophagitis

$90.74
-2.04  -2%
Phase 2/3 Phase 2/3 top-line data due 4Q 2021.
$4.9 billion

ALXN – Alexion Pharmaceuticals Inc.
ULTOMIRIS (ravulizumab-cwvz)
Paroxysmal Nocturnal Hemoglobinuria (PNH) - children

$179.63
-1.03  -1%
Approved FDA approval announced June 7, 2021.
$39.7 billion

ATOS – Atossa Therapeutics Inc.
Endoxifen
Breast cancer

$7.02
+1.13  +19%
Phase 2 Phase 2 final data presented June 9, 2021. Primary endpoint met.
$848.2 million

AZRX – AzurRx BioPharma Inc.
Oral niclosamide (RESERVOIR)
COVID-19

$0.82
+0.01  +2%
Phase 2 Phase 2 initiation of dosing announced June 7, 2021. Data due 1Q 2022.
$64.3 million

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

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

BLUE – bluebird bio Inc.
Betibeglogene autotemcel (beti-cel) (LentiGlobin) - (HGB-210)
Sickle Cell Disease

$32.78
-0.39  -1%
Phase 3 Phase 3 trial temporarily suspended due to a reported Suspected Unexpected Serious Adverse Reaction (SUSAR) of acute myeloid leukemia (AML) - February 16, 2021. Clinical hold lifted June 7, 2021.
$2.2 billion

PDSB – PDS Biotechnology Corporation
PDS0101 and Bintrafusp alfa (M7824)/ NHS-IL12
Human papillomavirus (HPV) associated cancers

$10.69
-0.55  -5%
Phase 2 Phase 2 presentation at ASCO June 7, 2021. Abstract showed overall objective response rate of 71%; 56% during ASCO presentation.
$303.2 million

RDHL – Redhill Biopharma Ltd.
YELIVA (Opaganib)
COVID-19

$6.86
-0.06  -1%
Phase 2/3 Phase 2/3 enrollment has been completed - June 7, 2021.
$320.5 million