BPC September 09 update

​Intra-Cellular ITCI shares surge on late-stage win +73%; Offerings for Trillium TRIL and Spero SPRO

Price and Volume Movers

Intra-Cellular Therapies, Inc. (Nasdaq:ITCI) shares surged to close up 73% to $31.86 on the back of positive top-line data from its Phase 3 clinical trial (Study 402) evaluating lumateperone as adjunctive therapy to lithium or valproate in the treatment of major depressive episodes associated with Bipolar disorder. The high dose met the primary endpoint for improvement in depression. However, improvements in the lower dose did not reach statistical significance. The company followed up the news when it announced after hours that it has commenced an underwritten public offering of $350m.

Trillium Therapeutics Inc. (NASDAQ:TRIL) shares closed up 44% to $13.59 following news released after hours Tuesday of a $25m investment by Pfizer. Trillium added to this Wednesday when it announced that it has commenced a public offering of up to 8.5m common shares.

Spero Therapeutics, Inc. (NASDAQ:SPRO) also announced after hours a public offering of 8m shares of common stock. Shares are trading down 4% to $12.30 after hours.

GlaxoSmithKline plc (NYSE: GSK) and Innoviva, Inc. (NASDAQ: INVA) announced the FDA has approved a new indication for Trelegy Ellipta for the treatment of asthma in patients aged 18 years and older adding to its current license for use in patients with chronic obstructive pulmonary disease (COPD).

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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:

Immunic, Inc. (IMUX): $16.88; +15%.

BiondVax Pharmaceuticals Ltd. (BVXV): $45.35; +14%.

XTL Biopharmaceuticals Ltd. (XTLB): $2.21; +14%.

RedHill Biopharma Ltd. (RDHL): $9.42; +12%.

Beam Therapeutics Inc. (BEAM): $25.16; +12%.

DECLINERS:

Applied Genetic Technologies Corporation (AGTC): $5.26; -14%.

Inozyme Pharma, Inc. (INZY): $25.46; -11%.

BioSig Technologies, Inc. (BSGM): $6.82; -10%.

Edesa Biotech, Inc. (EDSA): $7.84; -8%.

Innate Pharma S.A. (IPHA): $4.09; -8%.

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

AGTC – Applied Genetic Technologies Corporation
AAV Gene Therapy
Achromatopsia

Phase 1/2 Phase 1/2 interim data due 4Q 2020.
$141.6 million

AGTC – Applied Genetic Technologies Corporation
AGTC-501
X-linked Retinitis Pigmentosa (XLRP)

Phase 1/2 Phase 1/2 12-month data due 4Q 2020.
$141.6 million

ALDX – Aldeyra Therapeutics Inc.
ADX-629
COVID-19

Phase 2 Phase 2 trial to be initiated.
$287 million

ITCI – Intra-Cellular Therapies Inc.
Lumateperone ITI-007-402
Bipolar depression

Phase 3 Phase 3 top-line data released September 9, 2020. High dose met primary endpoint but low dose missed.
$2.5 billion

MEIP – MEI Pharma Inc.
Zandelisib (ME-401)
Relapsed/refractory Follicular Lymphoma (FL) Non Hodgkin Lymphoma

Phase 2 Phase 2 enrollment to be completed soon.
$397.8 million

MYOK – MyoKardia Inc.
Danicamtiv (MYK-491)
Dilated cardiomyopathy (DCM)

Phase 2a Phase 2 trial initiation announced September 9, 2020. Top-line data due 2H 2021.
$7.2 billion

RGNX – REGENXBIO Inc.
RGX-314 (AAVIATE)
Wet AMD using suprachoroidal delivery

Phase 2 Phase 2 initiation of dosing announced September 9, 2020. Interim data from the first cohort due by the end of 2020
$1.1 billion

SRRK – Scholar Rock Holding Corporation
SRK-181
Solid Tumors

Phase 1 Phase 1 update on dose escalation due 4Q 2020; clinical response and safety data anticipated in 2021.
$542.8 million

STRO – Sutro Biopharma Inc.
STRO-002
Ovarian and Endometrial Cancer

Phase 1 Phase 1 updated data September 9, 2020 noted ORR of 24% in 33 evaluable patients.
$425.5 million

TBPH – Theravance Biopharma Inc.
Closed Triple - CAPTAIN
Asthma

Approved FDA approval announced September 9, 2020.
$1.1 billion

VKTX – Viking Therapeutics Inc.
VK0214
X-linked adrenoleukodystrophy

Phase 1 Phase 1 trial initiation announced September 9, 2020.
$497.7 million

XNCR – Xencor Inc.
Tidutamab (XmAb18087)
Neuroendocrine tumors (NET) and gastrointestinal stromal tumors (GIST)

Phase 1 Phase 1 initial data to be presented at Multidisciplinary NET Medical Virtual Symposium October 2, 2020 at 9:00 a.m. ET.
$2.5 billion