BPC April 22 update

Biogen BIIB falls on earnings as investors eagerly await FDA approval decision - PDUFA date June 7

Price and Volume Movers

Biogen Inc. (NASDAQ:BIIB) shares closed down 4% to $259 following its report of first quarter earnings, with revenues falling 24% compared with the previous year. However, investors will be more focused on the upcoming FDA decision for the potential marketing approval of Aducanumab for the treatment of Alzheimer’s disease . The PDUFA date for a decision by the FDA is June 7, 2021.

Ocugen (NASDAQ:OCGN) shares closed up 43% to $9.29, adding to Wednesday’s gain of 18%. The company announced yesterday its partner, Bharat Biotech, released data from its Phase 3 trial for its COVID-19 vaccine candidate, Covaxin, which showed an efficacy rate of 78% in mild, moderate, and severe COVID-19 disease, with efficacy against severe COVID-19 disease of 100%. Ocugen is eligible for 45% of profits in the US market should it receive marketing approval.

Novan, Inc. (NASDAQ:NOVN) shares closed up 16% to $1.36. Analysts from Roth Capital initiated coverage of the stock with a Buy rating and a price target of $3.

GlaxoSmithKline plc (NYSE:GSK) announced that the FDA approved Jemperli (dostarlimab), for the treatment of adult patients with mismatch repair-deficient (dMMR) recurrent or advanced endometrial cancer. AnaptysBio, Inc. (NASDAQ:ANAB) earns a $20 million milestone payment as a result of the approval and is eligible for royalties in the range from 8% to 25% of global net sales.

Codiak BioSciences, Inc. (NASDAQ:CDAK) shares closed up 35% to $15.78, with investors reacting to news of the publication of pre-clinical data in the Communications Biology journal from its exoSTING program. Initial data from its Phase 1/2 trial in patients with solid tumors are slated for release mid-year.

Evolus, Inc. (NASDAQ:EOLS) announced the pricing of its offering of 9m shares of its common stock at a price of $9.50 per share, for gross proceeds of $85.5 million. Shares closed down 19% to $9.51.

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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): $12.48; +40%.

CEL-SCI Corporation (CVM): $24.40; +22%.

Kaleido Biosciences, Inc. (KLDO): $7.17; +18%.

Galectin Therapeutics Inc. (GALT): $3.46; +17%.

Renalytix AI plc (RNLX): $29.04; +15%.

DECLINERS:

Aldeyra Therapeutics, Inc. (ALDX): $10.44; -12%.

89bio, Inc. (ETNB): $25.38; -9%.

Adagene Inc. (ADAG): $14.07; -9%.

Zynerba Pharmaceuticals, Inc. (ZYNE): $4.08; -7%.

Oncternal Therapeutics, Inc. (ONCT): $6.24; -6%.

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

ASLN – ASLAN Pharmaceuticals Limited
ASLAN004
Atopic dermatitis

Phase 1 Phase 1 top-line data due 3Q 2021. Phase 2b trial to be initiated 2H 2021.
$191.2 million

BHC – Bausch Health Companies Inc.
IDP-126
Acne

NDA Filing Phase 3 second trial met primary endpoints - April 22, 2021. NDA filing due 2H 2022.
$10.5 billion

GSK – GlaxoSmithKline PLC
Dostarlimab
dMMR endometrial cancer

Approved FDA approval announced April 22, 2021.
$99.6 billion

HOTH – Hoth Therapeutics Inc.
BioLexa
Atopic Dermatitis

Phase 1b Phase 1b trial initiation announced April 22, 2021.
$33.2 million

MDWD – MediWound Ltd.
EscharEx
Lower leg ulcers

Phase 2 Phase 2 pharmacology study initiation announced April 21, 2021. Data due 2H 2021.
$100.5 million

ONTX – Onconova Therapeutics Inc.
Rigosertib
Recessive Dystrophic Epidermolysis Bullosa-Associated Squamous Cell Carcinoma

Phase 2 Phase 2 trial initiation announced April 22, 2021.
$146 million

RARE – Ultragenyx Pharmaceutical Inc.
DTX301
Ornithine Transcarbamylase (OTC) Deficiency

Phase 3 Phase 3 trial to commence 2H 2021.
$7.4 billion

RDUS – Radius Health Inc.
TYMLOS (Abaloparatide) -SC ATOM
Male Osteoporosis

Phase 3 Phase 3 data due 2H 2021.
$986.9 million

RDUS – Radius Health Inc.
Elacestrant - EMERALD
Breast cancer

Phase 3 Phase 3 top-line data due 2H 2021.
$986.9 million

RDUS – Radius Health Inc.
TYMLOS (Abaloparatide) -Transdermal Patch (wearABLe)
Osteoporosis

Phase 3 Phase 3 data due 2H 2021.
$986.9 million

RDUS – Radius Health Inc.
RAD011
Prader-Willi syndrome

Phase 2 Phase 3 trial planned. Phase 2 data to be presented on June 23, 2021 at PWSA/USA meeting.
$986.9 million

YMTX – Yumanity Therapeutics Inc.
YTX-7739
Parkinson’s Disease

Phase 1b Phase 1b preliminary results expected by mid-year 2021.
$145.2 million

YMTX – Yumanity Therapeutics Inc.
YTX-7739
Healthy volunteers

Phase 1 Phase 1 data released April 21, 2021 - generally well tolerated.
$145.2 million