BPC April 07 update

Seelos SEEL rallies ahead of data readout +18%; Otonomy OTIC offering

Price and Volume Movers

FibroGen (NASDAQ:FGEN) shares closed down 43% to $19.74 following news disclosed late-Tuesday by the company that previously reported cardiovascular data for roxadustat in patients anemia of chronic kidney disease were inaccurate, noting it cannot conclude that roxadustat reduces the risk of MACE (Major Adverse Cardiovascular Events) compared to epoetin-alfa. Following the revelation, the company announced the FDA has scheduled an Advisory Committee meeting to review the New Drug Application on July 15, 2021.

Seelos Therapeutics, Inc. (NASDAQ:SEEL) shares closed up 18% to $5.85 ahead of its initial Phase 2 data release early this quarter for its pipeline candidate SLS-002, for the indication of Acute Suicidal Ideation and Behavior in patients with Major Depressive Disorder (ASIB in MDD).

Otonomy, Inc. (NASDAQ:OTIC) announced that it has commenced an underwritten public offering of its common stock. Shares, which fell 5% during normal trading hours, have fallen a further 9% to $2.24 after hours.

Biohaven Pharmaceutical Holding Company Ltd. (NASDAQ:BHVN) shares closed up 8% to $71.35 following the release of preliminary product revenues for Nurtec ODT, its treatment for migraine. Sales of $43.8 million for the first quarter of 2021 were above estimates of $27 million.

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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:

Odonate Therapeutics, Inc. (ODT): $3.88; +12%.

180 Life Sciences Corp. (ATNF): $7.93; +12%.

9 Meters Biopharma, Inc. (NMTR): $1.23; +11%.

Frequency Therapeutics, Inc. (FREQ): $10.99; +9%.

Ocugen, Inc. (OCGN): $6.89; +9%.

DECLINERS:

Homology Medicines, Inc. (FIXX): $7.18; -23%.

Galectin Therapeutics Inc. (GALT): $2.38; -15%.

Ideaya Biosciences, Inc. (IDYA): $20.89; -13%.

Lantern Pharma Inc. (LTRN): $17.14; -12%.

Longboard Pharmaceuticals, Inc. (LBPH): $15.24; -12%.

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

ALKS – Alkermes plc
Nemvaleukin (ALKS 4230)
Ovarian cancer

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

FGEN – FibroGen Inc
Roxadustat
Anaemia in Chronic Kidney Disease

PDUFA PDUFA date TBC. Advisory Committee meeting July 15, 2021.
$1.7 billion

KDNY – Chinook Therapeutics Inc.
CHK-336
Primary Hyperoxaluria

Phase 1 Phase 1 trial to be initiated. IND filing due late 2021 or early 2022.
$624.8 million

KDNY – Chinook Therapeutics Inc.
Atrasentan (AFFINITY)
Chronic kidney disease

Phase 2 Phase 2 trial initiation of dosing announced April 7, 2021. Initial data due 2022.
$624.8 million

PFE – Pfizer Inc.
Abrocitinib
Atopic Dermatitis

PDUFA priority review PDUFA date under priority review extended by three months to July 2021.
$204.2 billion

PFE – Pfizer Inc.
Tofacitinib - Xeljanz
Ankylosing spondylitis

PDUFA PDUFA date extended by three months to early-3Q 2021.
$204.2 billion