BPC October 07 update

Eli Lilly LLY requests FDA to authorize COVID-19 antibody treatment +3%; Ocular OCUL higher revenues +29%

Price and Volume Movers

Eli Lilly and Company (NYSE: LLY) announced that its Phase 2 combination trial of LY-CoV555 and LY-CoV016, in patients with COVID-19, significantly reduced viral load at day 11 (p=0.011), meeting the primary endpoint. Viral levels were also reduced at day 3 (p=0.016) and day 7 (p<0.001) . COVID-related hospitalization visits were 0.9% versus placebo 5.8%, a relative risk reduction of 84.5 percent (p=0.049). It has submitted an initial request for emergency use authorization (EUA) for LY-CoV555 monotherapy, with a request for the combination EUA due in November. Shares closed up 3% to $148.96.

Alkermes plc (NASDAQ:ALKS) announced that the FDA posted briefing documents for the October 9, 2020 joint meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee to review the company's New Drug Application (NDA) for ALKS 3831, for the treatment of adults with schizophrenia and for the treatment of adults with bipolar I disorder. Shares, which closed up 6% to $16.94, will likely be halted during Friday’s meeting.

Ocular Therapeutix, Inc. (NASDAQ:OCUL) reported preliminary net product revenue for the third quarter ended September 30, 2020 of $5.8 to 5.9m, representing a greater than 250% sequential increase over the second quarter. Shares closed up 29% to $10.82 in response to the news.

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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:

Taiwan Liposome Company, Ltd. (TLC): $5.94; +35%.

Chimerix, Inc. (CMRX): $3.02; +20%.

Orchard Therapeutics plc (ORTX): $4.58; +16%.

Chinook Therapeutics, Inc (KDNY): $16.79; +14%.

Tiziana Life Sciences PLC (TLSA): $4.41; +14%.

DECLINERS:

Axovant Gene Therapies Ltd. (AXGT): $3.69; -11%.

C4 Therapeutics, Inc. (CCCC): $24.60; -9%.

ARCA biopharma, Inc. (ABIO): $4.74; -8%.

Akouos, Inc. (AKUS): $17.99; -8%.

PolyPid Ltd. (PYPD): $10.03; -8%.

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

ABIO – ARCA biopharma Inc.
AB201
COVID-19

Phase 2b Phase 2b trial to be initiated 4Q 2020. Top-line data due 2Q 2021.
$35.9 million

ACHV – Achieve Life Sciences Inc.
Cytisine - ORCA-2
Smoking cessation

Phase 3 Phase 3 trial initiation announced October 7, 2020.
$29.3 million

AZRX – AzurRx BioPharma Inc.
MS1819 - OPTION 2
Cystic fibrosis

Phase 2b Phase 2b top line data due in 1Q 2021.
$22.2 million

BMY – Bristol-Myers Squibb Company
Nivolumab Plus Ipilimumab (CM 816)
Non-Small Cell Lung Cancer (NSCLC)

Phase 3 Phase 3 trial met primary endpoint - October 7, 2020.
$130.2 billion

JAGX – Jaguar Health Inc.
Mytesi (crofelemer)
Cancer Therapy-Related Diarrhea

Phase 3 Phase 3 trial initiation announced October 7, 2020.
$11.9 million

KRTX – Karuna Therapeutics Inc.
KarXT
Healthy elderly volunteers / dementia-related psychosis

Phase 1b Phase 1b data due early-2Q 2021.
$2.1 billion

KURA – Kura Oncology Inc.
KO-539
Relapsed or refractory acute myeloid leukemia (AML)

Phase 1 Phase 1/2 trial presentation at ASH December 5, 2020 10:30 AM.
$1.8 billion

LLY – Eli Lilly and Company
LY-CoV555 / LY-CoV016 (BLAZE-1)
COVID-19 Antibody

Phase 2/3 Phase 2 combination trial met viral load primary endpoint - October 7, 2020. Hospitalization visits 0.9 percent versus placebo 5.8 percent, reduction of 84.5 percent (p=0.049). EUA request for monotherapy filed. Combo request due November 2020.
$125.6 billion

RDHL – Redhill Biopharma Ltd.
Opaganib
COVID-19

Phase 2a Phase 2a U.S. trial data due 4Q 2020.
$318.3 million

SGMO – Sangamo Therapeutics Inc.
Giroctocogene fitelparvovec (SB-525) AFFINE
Hemophilia A

Phase 3 Phase 3 initiation of dosing announced October 7, 2020.
$1.5 billion

SRNE – Sorrento Therapeutics Inc.
SP-102
Lumbosacral radicular pain (sciatica)

Phase 3 Phase 3 top-line data due 2Q 2021.
$1.9 billion

STOK – Stoke Therapeutics Inc.
STK-001 - MONARCH
Dravet syndrome

Phase 1/2 Phase 1/2 preliminary safety and pharmacokinetic data due 2021.
$1.3 billion

TLC – Taiwan Liposome Company Ltd.
TLC19 Inhalable Liposomal Hydroxychloroquine
COVID-19

Phase 1 Phase 1 commencement of enrolment announced October 14, 2020.
$194.8 million

TPTX – Turning Point Therapeutics Inc.
TPX-0022
Solid tumors

Phase 1 Phase 1 interim data presented at EORTC-NCI-AACR 24 October 2020. 5/10 partial responses among MET TKI-naïve patients, Phase 2 trial to be initiated 2H 2021.
$4.4 billion