BPC September 10 update

​Satsuma STSA shares tumble on failed migraine trial -76%; Sol-Gel SLGL PDUFA April 2021

Price and Volume Movers

Satsuma Pharmaceuticals, Inc. (Nasdaq: STSA) shares plunged to close down 76% to $5.62 on news data from its Phase 3 EMERGE efficacy trial of STS101 powder as an acute treatment for migraine did not meet the co-primary endpoints of freedom from pain and freedom from most bothersome symptom (from among photophobia, phonophobia and nausea) at two hours post-administration.

Agenus Inc. (NASDAQ: AGEN) shares closed up 24% to $5.19. The company is due to present data from two Phase 2 trials of balstilimab alone and in combination with zalifrelimab at next week’s European Society of Medical Oncology (ESMO) Conference.

Sol-Gel Technologies, Ltd. (NASDAQ: SLGL) announced that its New Drug Application (NDA) for Epsolay, a topical cream for the treatment of inflammatory lesions of rosacea, has been accepted for filing by the FDA with an assigned PDUFA date of April 26, 2021.

Athenex, Inc. (NASDAQ:ATNX) announced the pricing of a public offering of 10m shares of its common stock at a price of $11 per share for gross proceeds of $110m. Shares closed down 16% to $11.09.

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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:

Paratek Pharmaceuticals, Inc. (PRTK): $5.63; +21%.

Tracon Pharmaceuticals, Inc. (TCON): $4.23; +18%.

IGM Biosciences, Inc. (IGMS): $60.47; +14%.

Checkpoint Therapeutics, Inc. (CKPT): $2.80; +13%.

Corvus Pharmaceuticals, Inc. (CRVS): $3.95; +13%.

DECLINERS:

Sutro Biopharma, Inc. (STRO): $11.00; -16%.

Spero Therapeutics, Inc. (SPRO): $11.12; -13%.

SpringWorks Therapeutics, Inc. (SWTX): $38.49; -13%.

X4 Pharmaceuticals, Inc. (XFOR): $7.96; -11%.

Progenity, Inc. (PROG): $8.64; -10%.

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

ADXS – Advaxis Inc.
ADXS-HOT 503
Non-small cell lung cancer (NSCLC)

Phase 1/2 Phase 1/2 additional data due before the end of 2020.
$29.5 million

AVXL – Anavex Life Sciences Corp.
ANAVEX 2-73 - U.S. RS-001
Rett syndrome

Phase 2 Phase 2 top-line data due 4Q 2020.
$255.8 million

BCYC – Bicycle Therapeutics plc
BT8009
Solid tumors

Phase 1/2 Phase 1/2 initiation of dosing announced September 10, 2020.
$382.2 million

DFFN – Diffusion Pharmaceuticals Inc.
Trans sodium crocetinate (TSC)
COVID-19

Phase 1b Phase 1a/b commencement of dosing announced September 10, 2020 with first data due 4Q 2020.
$54.5 million

HALO – Halozyme Therapeutics Inc.
DARZALEX (Daratumumab) using ENHANZE
Amyloidosis

sNDA Filing sBLA filing announced September 10, 2020.
$3.8 billion

HSTO – Histogen Inc.
HST 001
Androgenic Alopecia

Phase 1/2 Phase 1b/2 completion of dosing announced September 10, 2020. Top-line data due 4Q 2020.
$20.1 million

OCUL – Ocular Therapeutix Inc.
DEXTENZA
Post-surgical ocular inflammation and pain - children

Phase 3 Phase 3 initiation of dosing announced September 10, 2020.
$581.7 million

SLGL – Sol-Gel Technologies Ltd.
VERED (Epsolay)
Papulopustular rosacea

PDUFA PDUFA date April 26, 2021.
$173.2 million

STSA – Satsuma Pharmaceuticals Inc.
STS101 (EMERGE)
Migraine

Phase 3 Phase 3 trial did not meet primary endpoint - September 10, 2020.
$80.6 million

VBLT – Vascular Biogenics Ltd.
VB-111 and Nivolumab
Colorectal Cancer

Phase 2 Phase 2 initiation of enrollment announced September 10, 2020.
$62.7 million

VRTX – Vertex Pharmaceuticals Incorporated
TRIKAFTA (elexacaftor/tezacaftor/ivacaftor and ivacaftor)
Children (6-11 years old) with cystic fibrosis (CF) with two copies of F508del mutation or one copy of F508del mutation and one minimal function mutation

sNDA Filing sNDA filing due 4Q 2020. Phase 3 data released September 10, 2020 noted treatment was well tolerated and safety data were consistent with those observed in previous Phase 3 studies.
$69.1 billion