BPC April 06 update

FibroGen FGEN shares slide on data disclosure for anemia treatment -30% AH

Price and Volume Movers

FibroGen, Inc. (Nasdaq: FGEN) shares have slid after hours, currently trading down 30% to $24.26, following a disclosure regarding its anemia treatment, roxadustat, in chronic kidney disease patients. The company noted that as it was preparing for its upcoming Advisory Committee meeting for its New Drug Application (NDA), it became aware it submitted altered data (post-hoc changes) in its NDA filing relating to MACE (Major Adverse Cardiovascular Events) safety data. The company now notes that it cannot conclude that roxadustat reduces the risk of (or is superior to) MACE+ in dialysis, and MACE and MACE+ in incident dialysis compared to epoetin-alfa. The company has begun an internal review to ensure such issues do not occur in the future. It expects to hear during the next few weeks when the Advisory Committee will be scheduled.

Homology Medicines, Inc. (NASDAQ:FIXX) announced that it intends to sell $50 million of its common stock in an underwritten public offering. Shares are trading down 10% to $8.37 after hours.

Ionis Pharmaceuticals, Inc. (NASDAQ:IONS) shares are trading down 5% to $44.85 after hours on news of a proposed private placement of $500 million of convertible notes.

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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:

Galectin Therapeutics Inc. (GALT): $2.80; +35%.

Brooklyn ImmunoTherapeutics, Inc. (BTX): $6.07; +30%.

Greenwich LifeSciences, Inc. (GLSI): $50.00; +18%.

Fennec Pharmaceuticals Inc. (FENC): $6.93; +16%.

GT Biopharma, Inc. (GTBP): $9.50; +15%.

DECLINERS:

Scholar Rock Holding Corporation (SRRK): $35.97; -20%.

Praxis Precision Medicines, Inc. (PRAX): $28.12; -15%.

Cullinan Oncology, Inc. (CGEM): $35.14; -14%.

ImmunityBio, Inc. (IBRX): $18.80; -13%.

Harmony Biosciences Holdings, Inc. (HRMY): $28.98; -13%.

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

APTX – Aptinyx Inc.
NYX-458
Parkinson’s Disease Cognitive Impairment (healthy volunteers)

Phase 2 Phase 2 data due 2H 2022.
$190.6 million

AZRX – AzurRx BioPharma Inc.
Oral niclosamide
COVID-19

Phase 2 Phase 2 initiation announced April 6, 2021. Data due 1Q 2022.
$69.2 million

DVAX – Dynavax Technologies Corporation
VLA2001-201 + alum and CpG 1018
COVID-19 vaccine

Phase 1/2 Phase 3 trial to commence by end of April 2021.
$1.1 billion

EVAX – Evaxion Biotech A/S
EVX-01
Melanoma/NSCLC/Bladder cancer

Phase 1/2 Phase 1/2 data due late-2Q 2021.
$116.9 million

EVAX – Evaxion Biotech A/S
EVX-02
Adjuvant melanoma

Phase 1/2 Phase 1/2 data due late-2Q 2021.
$116.9 million

INCY – Incyte Corporation
Baricitinib
Atopic dermatitis

PDUFA PDUFA date extended by three months to early-3Q 2021.
$17.6 billion

MITO – Stealth BioTherapeutics Corp.
Elamipretide (ReCLAIM-2)
Geographic atrophy / Age-related macular degeneration (AMD)

Phase 2b Phase 2b top-line data due 2Q 2022.
$77.9 million

MITO – Stealth BioTherapeutics Corp.
Elamipretide
Friedreich's ataxia

Phase 2a Phase 2a trial to commence 2Q 2021.
$77.9 million

SRRK – Scholar Rock Holding Corporation
SRK-015 - TOPAZ
Spinal muscular atrophy (SMA)

Phase 2 Phase 2 top-line data released April 6, 2021. Phase 3 registrational trial initiation expected by the end of 2021.
$1 billion