BPC September 04 update

​CureVac CVAC receives funding for COVID vaccine program +11%; Ascendis ASND PDUFA June 2021

Price and Volume Movers

CureVac N.V. (NASDAQ:CVAC) shares closed up 11% to $63.45 on news that it is expected receive up to 252m euros to support the development of its COVID-19 vaccine candidate. Payments are contingent on reaching predefined milestones. CureVac expects funding of up to 103m euros in 2020 and up to 149m euros in 2021. The company has guided that it expects data from its Phase 1 trial next quarter.

Ascendis Pharma A/S (Nasdaq: ASND) announced that the FDA has accepted its regulatory application for TransCon hGH for the treatment for pediatric Growth hormone deficiency (GHD). The PDUFA date is set for June 25, 2021. The FDA also has indicated that it is currently not planning to hold an Advisory Committee Meeting.

Seelos Therapeutics, Inc. (NASDAQ:SEEL) announced a registered direct offering for the sale of 8.865m shares of common stock at a price of $0.79 per share for gross proceeds of approximately $7m. Shares closed down 29% to $0.60.

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Major price movers (stocks priced > $1.00, volume > 50k):

Refer to the BioPharmCatalyst Biotech Stocks page for Top 10 Gainers/Losers/Unusual Volume:

ADVANCERS:

Cleveland BioLabs, Inc. (CBLI): $1.84; +12%.

Edesa Biotech, Inc. (EDSA): $9.00; +11%.

PDS Biotechnology Corporation (PDSB): $2.30; +10%.

Tracon Pharmaceuticals, Inc. (TCON): $3.10; +10%.

Leap Therapeutics, Inc. (LPTX): $1.85; +9%.

DECLINERS:

Syros Pharmaceuticals, Inc. (SYRS): $9.91; -17%.

Checkmate Pharmaceuticals, Inc. (CMPI): $12.31; -17%.

Cardiff Oncology, Inc. (CRDF): $6.09; -13%.

AlloVir, Inc. (ALVR): $24.77; -12%.

Ayala Pharmaceuticals, Inc. (AYLA): $8.80; -12%.

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

ASND – Ascendis Pharma A/S
TransCon hGH
Growth hormone deficiency in children

PDUFA PDUFA date June 25, 2021.
$7.8 billion

GILD – Gilead Sciences Inc.
Axicabtagene ciloleucel - (ZUMA-5)
Indolent B-Cell Non-Hodgkin Lymphoma

sNDA Filing sBLA filing announced September 4, 2020.
$81.6 billion

LXRX – Lexicon Pharmaceuticals Inc.
LX9211 (RELIEF-DPN 1)
Diabetic Peripheral Neuropathy

Phase 2 Phase 2 trial initiation of dosing announced September 4, 2020.
$173.5 million

MESO – Mesoblast Limited
Remestemcel-L
COVID-19

Phase 3 Phase 3 interim analysis recommended trial to continue - September 4, 2020. Enrollment to be completed 4Q 2020.
$2.1 billion