BPC November 30 update

FDA accepts ​Editas EDIT IND for CRISPR genome editing; Ocular OCUL stock halted

Price and Volume Movers

Ocular Therapeutix, Inc. (NASDAQ: OCUL) shares were halted after-hours Friday after closing the session up 10% to $6.66. As of 7:55pm EST no news or explanation had been released by the company for the halt. The company has an upcoming PDUFA date of December 28, 2018 for the resubmission of its New Drug Application (NDA) for Dextenza for the treatment of ocular pain following ophthalmic surgery. The resubmission was in response to Complete Response Letters issued in 2016 and 2017. 

Editas Medicine, Inc. (NASDAQ: EDIT) announced the FDA has accepted its Investigational New Drug (IND) application for EDIT-101, an experimental CRISPR genome editing medicine being investigated for the treatment of Leber Congenital Amaurosis type 10 (LCA10). With the IND acceptance, Editas earns a $25m milestone payment from Allergan.  EDIT-101 is set to be the first in vivo CRISPR medicine administered to people in the world. Friday’s announcement ends a controversial week regarding the CRISPR technology, following news earlier in the week a Chinese researcher, He Jiankui, claimed he initiated a non-approved CRISPR trial, editing the genomes of two girls as embryos. 

Fate Therapeutics, Inc. (NASDAQ: FATE) shares traded up as much as 15% during early afternoon trading before retracing some of its gains to close the session up 9% to $15.36. The company announced the FDA has allowed its Investigational New Drug (IND) Application for FT500, its off-the-shelf natural killer (NK) cell cancer candidate derived from a clonal master induced pluripotent stem cell (iPSC) line. The trial is expected to be the first in the U.S. of an iPSC-derived cell product.

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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:

Adial Pharmaceuticals, Inc. (ADIL): $3.84; +37%.

Oragenics, Inc. (OGEN): $1.35; +34%.

Intec Pharma Ltd. (NTEC): $6.92; +17%.

Cidara Therapeutics, Inc. (CDTX): $3.64; +13%.

Osmotica Pharmaceuticals plc (OSMT): $7.88; +13%.

DECLINERS:

Tonix Pharmaceuticals Holding Corp. (TNXP): $5.19; -26%.

Tenax Therapeutics, Inc. (TENX): $2.16; -13%.

Novan, Inc. (NOVN): $1.70; -10%.

Pfenex Inc. (PFNX): $4.14; -9%.

OptiNose, Inc. (OPTN): $7.87; -9%.

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

AMGN – Amgen Inc.
EVENITY (Romosozumab)
Osteoporosis

PDUFA CRL issued July 16, 2017. BLA filing resubmission announced July 13, 2018. Advisory committee meeting January 16, 2019.
$122.4 billion

CANF – Can-Fite Biopharma Ltd Sponsored ADR (Israel)
Namodenoson (CF102)
Cancer - advanced liver cancer second line

Phase 2 Phase 2 data due 1Q 2019.
$25.6 million

CANF – Can-Fite Biopharma Ltd Sponsored ADR (Israel)
Namodenoson (CF102)
Non-alcoholic steatohepatitis (NASH)

Phase 2 Phase 2 data due 1H 2019.
$25.6 million

CYAD – Celyad SA
CYAD-101 - alloSHRINK
Colorectal cancer

Phase 1 Phase 1 commencement of enrollment announced November 30, 2018 with top-line data due 2H 2019.
$240.6 million

EDIT – Editas Medicine Inc.
EDIT-101
Leber Congenital Amaurosis type 10 (LCA10).

Phase 1/2 Phase 1/2 IND announced November 30, 2018.
$1.4 billion

FATE – Fate Therapeutics Inc.
FT500
Soild tumors

Phase 1 IND announced November 30, 2018.
$1 billion

RDUS – Radius Health Inc.
Elacestrant - EMERALD
Breast cancer

Phase 2 Phase 3 trial opened for enrolment - noted November 30, 2018.
$718.6 million

RDUS – Radius Health Inc.
RAD140
Breast cancer

Phase 1 Phase 1 trial presentation at SABCS December 2018.
$718.6 million

SLS – SELLAS Life Sciences Group Inc.
NeuVax in combination with Herceptin
Breast cancer - 1+/2+

Phase 2b Will meet with FDA in December 2018 to discuss further development path.
$35.2 million

SPPI – Spectrum Pharmaceuticals Inc.
Leucovorin
Peripheral T-Cell Lymphoma cancer

Phase 2 Phase 2 data at ASH December 2018.
$1.2 billion

XENE – Xenon Pharmaceuticals Inc.
XEN1101
Epilepsy

Phase 1 IND filing due 1Q 2019.
$165.8 million

XENE – Xenon Pharmaceuticals Inc.
XEN901
Healthy Volunteers

Phase 1 Phase 1 data at AES December 2018 noted treatment is overall generally safe and well tolerated.
$165.8 million