BPC December 04 update

Revance RVNC +19% - positive data from final trial for frown lines; Markets closed Wednesday

Price and Volume Movers

U.S. financial markets will close Wednesday to honor former President George H.W. Bush. In light of this, the next BioPharmCatalyst update will be distributed on Thursday. 

Revance Therapeutics, Inc. (NASDAQ:RVNC) shares closed up 19% to $24.91 following two announcements Tuesday, the first providing Fosun Pharma Industrial with the exclusive rights to develop and commercialize its DaxibotulinumtoxinA for Injection (RT002) in mainland China, Hong Kong and Macau. RT002 is in development for the treatment of glabellar and upper facial lines, cervical dystonia, plantar fasciitis, adult upper limb spasticity and chronic migraine. Revance will receive an upfront payment of $30m and up to $230.5m in milestone payments and low-double-digit to high-teen royalty payments on future net sales. 

The company also announced data from its Phase 3 Sakura trial of DaxibotulinumtoxinA for Injection (RT002) for the treatment of moderate-to-severe glabellar (frown) lines, the third of its Phase 3 trials with the previous two meeting their primary endpoints. Measuring duration of effect, the median time to return to baseline glabellar line severity was 28 weeks (i.e. approx two treatments required each year). RT002 appeared to be generally well-tolerated, with no new tolerability or safety concerns reported. The company will submit a Biologics License Application (BLA) with the FDA in 1H 2019. 

RedHill Biopharma Ltd. (Nasdaq: RDHL) announced a public offering of its American Depositary Shares (ADSs), each representing ten of its ordinary shares. Shares closed the normal trading session down 10% to $7.27 and are currently halted after hours following news of the offering.

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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:

Iterum Therapeutics plc (ITRM): $7.06; +18%.

ContraFect Corporation (CFRX): $2.47; +9%.

Aldeyra Therapeutics, Inc. (ALDX): $10.04; +8%.

Evofem Biosciences, Inc. (EVFM): $3.85; +7%.

PhaseBio Pharmaceuticals, Inc. (PHAS): $3.28; +7%.

DECLINERS:

Ovid Therapeutics Inc. (OVID): $3.49; -14%.

Tenax Therapeutics, Inc. (TENX): $1.95; -12%.

Genprex, Inc. (GNPX): $1.23; -12%.

Acorda Therapeutics, Inc. (ACOR): $18.55; -11%.

Abeona Therapeutics Inc. (ABEO): $7.59; -11%.

Pipeline updates below: 

Pipeline Database Updates

Drug Stage Catalyst Market Cap

ALRN – Aileron Therapeutics Inc.
ALRN-6924
Peripheral T-cell lymphoma (PTCL)

Phase 2a Noted that development to be discontinued - no pivotal trial.
$17.7 million

ALRN – Aileron Therapeutics Inc.
ALRN-6924 and Cytarabine (Ara-C)
Acute myeloid leukemia (AML); Myelodysplastic syndrome (MDS)

Phase 1b Phase 1/1b interim data due 1H 2019 with final data 2H 2019.
$17.7 million

GTHX – G1 Therapeutics Inc.
Trilaciclib
Triple-negative breast cancer

Phase 2 Phase 2 preliminary data noted ORR 37-43% across two arms. No CRs. PFS 8.8mths (HR 0.52, p=0.0669) and 7.3mths (HR 0.49; p=0.0546) across two arms. Combined PFS 7.9mths (HR 0.50, p=0.0189).
$1.1 billion

INO – Inovio Pharmaceuticals Inc.
MEDI0457
Human papilloma virus (HPV)

Phase 2 Phase 2 commencement of dosing announced December 4, 2018.
$463.4 million

INSY – Insys Therapeutics Inc.
Cannabidiol
Refractory childhood absence epilepsy

Phase 2 Phase 2 data due "soon" - company noted December 4, 2018.
$364.7 million

JNJ – Johnson & Johnson
Daratumumab - MAIA
Newly Diagnosed Multiple Myeloma (NDMM)

Phase 3 Phase 3 data at ASH 2018 noted HR 0.56 (44% reduction of progression/death) - OS not mature.
$356.7 billion

OSMT – Osmotica Pharmaceuticals plc
RVL-1201
Blepharoptosis

Phase 3 Phase 3 data due 1H 2019.
$419.6 million

OSMT – Osmotica Pharmaceuticals plc
Ontinua ER
Spasticity resulting from multiple sclerosis

Phase 3 Phase 3 data due 1H 2019.
$419.6 million

PRQR – ProQR Therapeutics N.V.
QR-421a - STELLAR
Usher Syndrome Type 2

Phase 1/2 Phase 1/2 trial to be initiated in the coming months with data due 1H 2019.
$696.9 million

RTTR – Ritter Pharmaceuticals Inc.
RP-G28
Lactose intolerance

Phase 3 Phase 3 data due 2H 2019.
$4.5 million

RVNC – Revance Therapeutics Inc.
RT002 - SAKURA 1, 2 and 3
Moderate to severe glabellar (frown) lines

Phase 3 Phase 3 data released December 5, 2017 - endpoints met. SAKURA 3 data released December 4, 2018, noted 28 week duration of effect with BLA filing due 1H 2019.
$736.4 million

UBX – Unity Biotechnology Inc.
UBX0101
Osteoarthritis

Phase 1 Phase 1 data due 2Q 2019.
$673.4 million