BPC May 12 update

​Gamida GMDA shares rally on positive late-stage data +37%; Aerpio ARPO licensing deal restructured +52% AH

Price and Volume Movers

Gamida Cell Ltd. (Nasdaq: GMDA) shares closed up 37% to $6.20 following news its Phase 3 trial evaluating omidubicel, in patients in need of bone marrow transplant, met the primary endpoint. The median time to neutrophil engraftment was 12 days for patients randomized to omidubicel compared to 22 days for the comparator group (p<0.001).

Aerpio Pharmaceuticals, Inc. (NASDAQ:ARPO) shares are trading up 52% after hours to $0.95 following news of a restructuring of their licensing deal with a subsidiary of Gossamer Bio Inc., GB004, Inc. (NASDAQ:GOSS), for its HIF-1 alpha stabilizer, GB004. The terms of the amended agreement include a $15m immediate payment to Aerpio and a total of $90m in milestone payments related to regulatory approvals and commercial sales.

Novavax (NASDAQ:NVAX) shares added to Monday’s gains, surging a further 63% to $39.82. The company announced Monday that the Coalition for Epidemic Preparedness Innovations (CEPI) will provide funding of up to $384m for its COVID-19 vaccine.

Axcella Health (NASDAQ:AXLA) shares closed down 22% to $5.99 following its filing of a preliminary prospectus for an offering of 11m common shares.

Oyster Point Pharma, Inc. (NASDAQ: OYST) announced that it has commenced an underwritten public offering of 2.5m shares of its common stock. Shares are trading down 7% after hours to $30.02, adding to its 9% loss during the normal trading session.

Genfit SA (NASDAQ: GNFT) shares closed down 67% to $7.10 following news released Monday that its Phase 3 NASH trial did not meet the primary endpoint.

-

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): $2.16; +29%.

Plus Therapeutics, Inc. (PSTV): $2.03; +23%.

vTv Therapeutics Inc. (VTVT): $2.56; +22%.

DURECT Corporation (DRRX): $2.73; +21%.

Stealth BioTherapeutics Corp (MITO): $2.11; +21%.

DECLINERS:

Fulcrum Therapeutics, Inc. (FULC): $14.91; -15%.

Cassava Sciences, Inc. (SAVA): $8.28; -14%.

Bellicum Pharmaceuticals, Inc. (BLCM): $6.11; -13%.

Aeglea BioTherapeutics, Inc. (AGLE): $7.12; -13%.

Evelo Biosciences, Inc. (EVLO): $4.79; -13%.


Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

ARQT – Arcutis Biotherapeutics Inc.
ARQ-154
Seborrheic dermatitis

Phase 2 Phase 2 data due 2H 2020.
$1.3 billion

BTAI – BioXcel Therapeutics Inc.
BXCL501 (SERENITY II)
Bipolar disorder - agitation

Phase 3 Phase 3 data due July 2020.
$941 million

CATB – Catabasis Pharmaceuticals Inc.
Edasalonexent (CAT-1004)
Duchenne muscular dystrophy (DMD)

Phase 3 Phase 3 data due 4Q 2020.
$111.1 million

CRTX – Cortexyme Inc.
COR388 - GAIN
Alzheimer’s disease

Phase 2/3 Phase 2/3 interim analysis to occur 4Q 2020. Final data due 4Q 2021.
$1.4 billion

GOSS – Gossamer Bio Inc.
GB001
Nasal polyps / Chronic spontaneous urticaria

Phase 2 Phase 2 data due 2H 2020.
$920.9 million

GRTX – Galera Therapeutics Inc.
GC4419 ROMAN
Oral mucositis

Phase 3 Phase 3 data due 2H 2021.
$259.7 million

IDYA – IDEAYA Biosciences Inc.
IDE196
Solid tumors

Phase 2 Phase 2 interim data expected in 4Q 2020.
$199.7 million

OPNT – Opiant Pharmaceuticals Inc.
OPNT003
Opioid Overdose

NDA Filing Pivotal PK trial to be initiated with NDA to be filed early 2021.
$47.3 million

PFE – Pfizer Inc.
BNT162
Coronavirus COVID-19

Phase 1 Phase 1/2 first clinical data from Europe trial are expected end of June or in July 2020.
$212.1 billion

PTN – Palatin Technologies Inc.
PL9643
Dry eye disease (DED)

Phase 2 Phase 2 data due 4Q 2020.
$116.2 million

SCPH – scPharmaceuticals Inc.
Furoscix
Heart failure

NDA Filing CRL issued June 13, 2018. NDA to be refiled mid-2020.
$223.2 million

SLNO – Soleno Therapeutics Inc.
Diazoxide Choline Controlled-Release (DCCR) - DESTINY PWS
Prader-Willi syndrome (PWS)

Phase 3 Phase 3 data due 2Q 2020.
$150.2 million

STSA – Satsuma Pharmaceuticals Inc.
STS101
Migraine

Phase 3 Phase 3 data due 2H 2020.
$455.6 million

TPTX – Turning Point Therapeutics Inc.
Repotrectinib (TPX-0005) - TRIDENT-1
Non-small-cell lung cancer (NSCLC) and solid tumors

Phase 2 Phase 2 interim data due 3Q 2020.
$2.9 billion