BPC January 11 update

Eli LLY shares rally on Alzheimer's data +12%; Offerings RDHL TNXP

Price and Volume Movers

Eli Lilly and Company (NYSE:LLY) shares closed up 12% to $185.94 following the release of data from its Phase 2 trial of Donanemab for the treatment of Alzheimer's Disease. The trial met the primary endpoint, slowing the decline of patients on the Integrated Alzheimer's Disease Rating Scale (iADRS) by 32% relative to placebo.

BeiGene, Ltd. (NASDAQ:BGNE) announced after hours a deal with Novartis Pharma (NYSE: NVS) to develop, manufacture and commercialize its anti-PD-1 antibody tislelizumab in various countries including the United States, Canada, Mexico, Russian, Japan and European countries. Under the agreement BeiGene will receive an upfront cash payment of $650m and is eligible to receive up to $1.3b upon the achievement of regulatory milestones, $250m upon the achievement of sales milestones, and royalties on future sales of tislelizumab.

Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) announced an intra-day direct offering for the sale of 50m shares at $0.80 per share, for gross proceeds of $40m. Shares, which were trading up over 35% prior to the offering, closed the session down 3% to $0.8150.

Mesoblast Limited (NASDAQ:MESO) shares closed up 32% to $11.40 following the presentation of data from its Phase 3 trial in patients with chronic failure. The company announced in December 2020 that it did not meet the primary endpoint of the trial of a reduction in in recurrent non-fatal decompensated heart failure events.

RedHill Biopharma Ltd. (NASDAQ:RDHL) shares are trading down 9% to $7.90 after hours on news of a registered direct offering of 1,275,510 American Depositary Shares (ADSs) at a price of $ $7.84 per ADS, for gross proceeds of $10m.

Editas Medicine (NASDAQ:EDIT) shares closed down 15% to $76.94. The company made a couple announcements ahead of its presentation today at the J.P.Morgan Healthcare conference, including an update that its Chief Scientific Officer is leaving the company to pursue another opportunity and initial data from its Phase 1/2 trial of its CRISPR-based experimental medicine, EDIT-101, will be released by the end of 2021. Analysts at Baird also reiterated their Underperform rating and price target of $14.

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Major price movers (stocks priced > $1.00, volume > 50k listed on NASDAQ/NYSE):

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

ADVANCERS:

Aileron Therapeutics, Inc. (ALRN): $1.92; +42%.

Diffusion Pharmaceuticals Inc. (DFFN): $1.30; +34%.

EyeGate Pharmaceuticals, Inc. (EYEG): $6.63; +26%.

INmune Bio, Inc. (INMB): $21.77; +19%.

Immunome, Inc. (IMNM): $13.65; +18%.

DECLINERS:

Oncorus, Inc. (ONCR): $30.41; -14%.

Codiak BioSciences, Inc. (CDAK): $26.07; -12%.

Jaguar Health, Inc. (JAGX): $3.60; -10%.

BioMarin Pharmaceutical Inc. (BMRN): $81.24; -10%.

Trevena, Inc. (TRVN): $2.18; -9%.

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

CARA – Cara Therapeutics Inc.
Oral KORSUVA
Pruritus and Notalgia Paresthetica

Phase 2 Phase 2 initiation announced January 11, 2021.
$945.8 million

CYCC – Cyclacel Pharmaceuticals Inc.
Fadraciclib and venetoclax
Chronic lymphocytic leukemia (CLL)

Phase 1 Phase 1 safety and antileukemic activity data due 2021.
$35.8 million

ENTX – Entera Bio Ltd.
EB613
Osteoporosis

Phase 2 Phase 2 interim biomarker data due 1Q 2021 with final data due 2Q 2021.
$32.1 million

HRTX – Heron Therapeutics Inc.
HTX-011
Post operative pain

PDUFA CRL announced June 29, 2020. NDA resubmitted with new PDUFA date May 12, 2021.
$1.6 billion

IFRX – InflaRx N.V.
IFX-1
COVID-19

Phase 3 Phase 3 data due 2021.
$158.6 million

INCY – Incyte Corporation
INCB001158
Biliary tract cancers

Phase 1/2 Phase 1/2 data presented at ASCO GI January 15-17, 2021.
$20.6 billion

LLY – Eli Lilly and Company
Empagliflozin
Heart failure with reduced ejection fraction

PDUFA sNDA acceptance announced January 11, 2021.
$193.6 billion

MGTA – Magenta Therapeutics Inc.
MGTA-117
Conditioning for stem cell transplant

Phase 1 Phase 1 safety data due 2021.
$400.4 million

MRNA – Moderna Inc.
Flu vaccine (mRNA-1010, mRNA-1020, mRNA-1030)
Flu vaccine

Phase 1 Phase 1 trials to commence 2021.
$52.6 billion

OBSV – ObsEva SA
Linzagolix (OBE2109)- EDELWEISS 2
Endometriosis

Phase 3 Phase 3 trial discontinued due to enrollment challenges - January 11, 2021.
$227.8 million

OBSV – ObsEva SA
Linzagolix (OBE2109) - EDELWEISS 3
Endometriosis

Phase 3 Phase 3 data due 4Q 2021.
$227.8 million

RIGL – Rigel Pharmaceuticals Inc.
Fostamatinib
COVID-19

Phase 2 Phase 2 data due April 2021.
$632.8 million

SRRK – Scholar Rock Holding Corporation
SRK-015 - TOPAZ
Spinal muscular atrophy (SMA)

Phase 2 Phase 2 top-line data due 2Q 2021.
$1.8 billion

TAK – Takeda Pharmaceutical Company Limited American Depositary Shares (each representing 1/2 of a share of)
TAK-755
Congenital Thrombotic Thrombocytopenic Purpura

Phase 3 Phase 3 data due 2022.
$54.1 billion