BPC August 12 update

ETON PDUFA date delayed - new date September 15; Kitov KTOV reverse split -26% AH

Price and Volume Movers

Eton Pharmaceuticals, Inc (Nasdaq: ETON) announced that its partner was notified by the FDA that due to a proprietary name change submission, the FDA has extended the PDUFA date for EM-100 to September 15, 2020 from August 10, 2020.

Nymox Pharmaceutical Corporation (NASDAQ: NYMX) announced a registered direct offering for the sale of shares of its common stock at a price of $2.50 per share for gross proceeds of approximately $9m. Shares closed down 9% to $2.75.

Kitov Pharma Ltd. (NASDAQ: KTOV) shares are trading down 26% to $0.56 after hours following its announcement of a 1 for 10 reverse split, to be effective at the beginning of trading on August 21, 2020.

EyeGate Pharmaceuticals, Inc. (NASDAQ: EYEG) shares closed up 31% to $5.38 following news that following feedback from the FDA, it intends to file an IND (Investigational New Drug) in the first half of 2021 for MoxiGel, a combination product for the treatment of bacterial conjunctivitis.

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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:

Biofrontera AG (BFRA): $30.50; +50%.

Annexon, Inc. (ANNX): $28.63; +20%.

Seres Therapeutics, Inc. (MCRB): $23.56; +18%.

Cassava Sciences, Inc. (SAVA): $3.36; +15%.

Nurix Therapeutics, Inc. (NRIX): $18.23; +14%.

DECLINERS:

Novavax, Inc. (NVAX): $124.42; -17%.

Edesa Biotech, Inc. (EDSA): $6.81; -17%.

Trevena, Inc. (TRVN): $2.29; -16%.

Heat Biologics, Inc. (HTBX): $1.56; -16%.

Vaxart, Inc. (VXRT): $9.20; -14%.

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

DARE – Dare Bioscience Inc.
Sildenafil Cream, 3.6%
Female Sexual Arousal Disorder (FSAD)

Phase 2b Phase 2b data due 2021.
$32.8 million

DARE – Dare Bioscience Inc.
DARE-BV1
Bacterial Vaginosis

Phase 3 Phase 3 top-line data due by the end of 2020.
$32.8 million

ELOX – Eloxx Pharmaceuticals Inc.
ELX-02
Cystic fibrosis

Phase 2 Phase 2 enrollment has resumed following pause due to the COVID-19 pandemic.
$134.1 million

FREQ – Frequency Therapeutics Inc.
FX-322
Hearing loss

Phase 2a Phase 2a data due 2Q 2021.
$839.8 million

MIST – Milestone Pharmaceuticals Inc.
NODE-301B - RAPID
Paroxysmal supraventricular tachycardia (PSVT)

Phase 3 Data due late 2021/early 2022.
$219.4 million

NKTR – Nektar Therapeutics
Bempegaldesleukin (NKTR-214)
Squamous Cell Carcinoma of the Head and Neck

Phase 1/2 Phase 1/2 initiation of dosing announced August 12, 2020.
$3.6 billion

ONTX – Onconova Therapeutics Inc.
IV Rigosertib - INSPIRE
2nd-line HR-MDS (high risk myelodysplastic syndromes)

Phase 3 Phase 3 trial did not meet primary endpoint - August 24, 2020.
$59.1 million

PCVX – Vaxcyte Inc.
VAX-24
Pneumococcal conjugate vaccine

Phase 1/2 Phase 1/2 trial to be initiated 2H 2021 with data due 2022.
$2.6 billion

REGN – Regeneron Pharmaceuticals Inc.
Evinacumab (ANGPTL3 Antibody)
Homozygous familial hypercholesterolemia (HoFH)

PDUFA priority review PDUFA date under priority review February 11, 2021.
$59.1 billion

SWTX – SpringWorks Therapeutics Inc.
Nirogacestat
Desmoid tumors

Phase 3 Phase 3 top-line data due 2Q or 3Q 2021.
$2.1 billion

TCRR – TCR2 Therapeutics Inc.
TC-210
Mesothelin-positive solid tumors

Phase 1/2 Phase 1 interim update 2H 2020.
$676.2 million

VBLT – Vascular Biogenics Ltd.
VB-111
Recurrent platinum resistant ovarian cancer

Phase 3 Phase 3 interim analysis noted trial to continue as planned - August 12, 2020. Next review 1Q 2021.
$62.7 million

VIE – Viela Bio Inc.
VIB7734
COVID-19-Related Acute Lung Injury

Phase 1b Phase 1b trial to be initiated 3Q 2020 with data due 1Q 2021.
$1.6 billion