BPC April 27 update

​Aldeyra ALDX positive late-stage data +34%; Cyclerion CYCN data delay -18%

Price and Volume Movers

Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) shares rallied to close up 34% to $14.85 following the release of top-line data from a Phase 3 trial of reproxalap in patients with allergic conjunctivitis. The trial achieved statistical significance for the primary endpoint and all secondary endpoints. Aldeyra took advantage of the price surge when it announced after hours it will sell $125 million of shares of its common stock in an underwritten public offering.

Cyclerion Therapeutics, Inc. (Nasdaq: CYCN) shares fell 18% to $2.56 following an update of its pipeline today. Data from its Phase 2 trial for Mitochondrial Encephalomyopathy, Lactic Acidosis and Stroke-like episodes (MELAS) are due now slated for releases by the end of 2021, representing a delay from previous guidance of mid-2021.

Sol-Gel Technologies, Ltd. (NASDAQ: SLGL) announced the FDA will not be taking action on the regulatory application of Epsolay (benzoyl peroxide) 5% topical cream for the treatment of Inflammatory lesions of rosacea in adults until a pre-approval inspection of its production site has been completed. The original PDUFA date was April 26, 2021. Shares fell 13% to $12.00.

Vaxart, Inc. (NASDAQ:VXRT) announced that it will host a webinar regarding its VXA-CoV2-1 on May 3, 2021 at 12:00 p.m. ET. New data comparing the T-cell responses generated from its VXA-CoV2-1 vaccine with those of other vaccines and new antibody data will be presented. Shares closed up 37% to $8.33.

Amgen Inc. (NASDAQ:AMGN) shares are trading down 3% to $246.50 after hours following the release of first quarter earnings. Revenue of $5.9 billion was recorded for the quarter compared with $6.2 billion during the same period last year, which management attributed to the COVID-19 pandemic.

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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): $24.90; +51%.

Nymox Pharmaceutical Corporation (NYMX): $2.46; +17%.

Novavax, Inc. (NVAX): $257.67; +16%.

AzurRx BioPharma, Inc. (AZRX): $1.03; +16%.

Codiak BioSciences, Inc. (CDAK): $19.62; +14%.

DECLINERS:

Reviva Pharmaceuticals Holdings, Inc. (RVPH): $7.30; -16%.

Aligos Therapeutics, Inc. (ALGS): $25.71; -12%.

Larimar Therapeutics, Inc. (LRMR): $13.56; -10%.

Annovis Bio, Inc. (ANVS): $23.80; -9%.

Applied Genetic Technologies Corporation (AGTC): $3.95; -9%.

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

ALDX – Aldeyra Therapeutics Inc.
Reproxalap (ADX-102) - (INVIGORATE)
Allergic conjunctivitis

Phase 3 Phase 3 trial met primary endpoint - April 27, 2021.
$697.3 million

ALKS – Alkermes plc
Nemvaleukin (ARTISTRY-6)
Melanoma

Phase 2 Phase 2 trial initiation announced April 27, 2021.
$3.5 billion

AMGN – Amgen Inc.
Efavaleukin alfa (AMG 592)
Systemic Lupus Erythematosus

Phase 1/2 Phase 1b data to be presented 2H 2021. Phase 2b enrollment to commence 2Q 2021.
$145 billion

AMGN – Amgen Inc.
AMG 510 (Sotorasib)
Colorectal cancer

Phase 2 Phase 2 monotherapy data due 2Q 2021.
$145 billion

AMGN – Amgen Inc.
Tezepelumab (WAYPOINT)
Chronic Rhinosinusitis With Nasal Polyps

Phase 3 Phase 3 trial has been initiated.
$145 billion

BBI – Brickell Biotech, Inc.
Sofpironium Bromide (Cardigan I)
Axillary hyperhidrosis

Phase 3 Phase 3 top-line data due 4Q 2021.
$54.1 million

CRSP – CRISPR Therapeutics AG
CTX120
Relapsed or refractory multiple myeloma

Phase 1 Phase 1 top-line data due 2021.
$8.3 billion

CYCN – Cyclerion Therapeutics Inc.
CY6463
Mitochondrial Encephalomyopathy, Lactic Acidosis and Stroke-like Episodes (MELAS)

Phase 2 Phase 2 top-line data due by end of 2021.
$102.7 million

CYTH – Cyclo Therapeutics Inc.
Trappsol Cyclo
Niemann-Pick Disease Type C

Phase 3 Phase 3 trial to be initiated 2Q 2021. Interim analysis top-line data due 4Q 2022.
$44.8 million

FATE – Fate Therapeutics Inc.
FT516
Acute Myelogenous Leukemia / B-cell Lymphoma

Phase 1 Phase 1 interim data presented May 13, 2021. 5/12 objective responses. Lymphoma data to be presented at ASCO June 4-8, 2021.
$7.2 billion

LOGC – LogicBio Therapeutics Inc.
LB-001 - SUNRISE
Methylmalonic Acidemia (MMA)

Phase 1/2 Phase 1/2 enrollment to commence mid-2021. Interim data due YE 2021.
$151.8 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

TAK – Takeda Pharmaceutical Company Limited American Depositary Shares (each representing 1/2 of a share of)
Mobocertinib (TAK-788)
Non-small cell lung cancer (NSCLC)

PDUFA priority review PDUFA date under priority review October 26, 2021.
$54.2 billion

VXRT – Vaxart Inc.
VXA-CoV2-1
COVID-19 Vaccine

Phase 1 Phase 2 trial to commence mid-2021.
$786.2 million