BPC February 14 update

Merck (MRK) stops Phase 3 Alzheimer’s due to lack of efficacy; Ohr (OHRP) halts enrollment in Phase 3 Squalamine trial; Auris (EARS) offering; INCY FBIO full pipeline updates

Price and Volume Movers

Merck (NYSE: MRK) announced that it will be stopping its Phase 2/3 EPOCH (trial 017) trial of verubecestat for the treatment of mild-to-moderate Alzheimer’s disease (AD). The decision follows a recommendation from the Data Monitoring Committee that there was virtually no chance of finding a positive clinical effect. Shares of the company are trading down 1.77% to $64.50 in the after-hours session.

Incyte Corporation (Nasdaq:INCY) and Agenus Inc.(Nasdaq:AGEN) announced today that the companies have amended their license agreement for the ongoing GITR and OX40 antibody programs. Originally decided as co-funded development and profit-sharing arrangements, the agreement has now changed to royalty-bearing programs, with Incyte now responsible for funding and conducting global development and commercialization. Agenus will now be eligible to receive 15% royalties on global sales. Agenus will also receive up to $80m from Incyte, $60m in stock purchases and $20m in development milestones. Shares of Agenus closed up 7% to $4.40.

Ohr Pharmaceutical, Inc. (NASDAQ:OHRP) shares dropped 19% to $1.10 following news that the company has halted enrollment in its Phase 3 trial of Squalamine for the treatment of neovascular age-related macular degeneration (wet AMD). The company noted that the halt was not due to efficacy reasons. In its release it said;

 “This approach is intended to provide prospective efficacy data before year end 2017 to enable us to potentially confirm the visual acuity benefits observed in the patient population we identified as the most likely to benefit from Squalamine combination therapy. Given the recent study readouts from other combination therapy agents and the reaction to these results, we feel that a change in our clinical development program is warranted.  We remain confident about the potential of Squalamine, a differentiated, topical, multi-target angiogenesis inhibitor, to provide improved visual function to patients suffering from wet-AMD.”

As noted in yesterday’s update, Aviragen Therapeutics (NASDAQ:AVIR) announced that top-line data from its Phase 2b SPIRITUS trial did not meet the primary endpoint. Shares dropped 37% to $0.678 in Tuesday’s session.

Auris Medical Holding AG (NASDAQ: EARS) shares are trading down 17% to $0.95 in the after-hours session following its announcement that it is offering to sell common shares and warrants in an underwritten public offering.


Other major price movers:

 ADVANCERS:

Galectin Therapeutics Inc (NASDAQ:GALT): $1.80; +41%.

Bellerophon Therapeutics Inc (NASDAQ:BLPH): $1.02; +38%.

XOMA Corporation (NASDAQ:XOMA): $5.82; +21%.

Zosano Pharma Corp (NASDAQ:ZSAN): $2.02; +19%.

Cara Therapeutics Inc (NASDAQ:CARA): $15.53; +15%.

DECLINERS:

Catalyst Biosciences Inc (NASDAQ:CBIO): $7.83; -18%.

Celsion Corporation (NASDAQ:CLSN): $0.33; -15%.

Galmed Pharmaceuticals Ltd (NASDAQ:GLMD): $4.15; -10%.

Cerulean Pharma Inc (NASDAQ:CERU): $1.44; -6%.

Regulus Therapeutics Inc (NASDAQ:RGLS): $1.15; -6%.


Full pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst

CBIO
CB 2679d/ ISU304
Hemophilia B

Phase 1/2 Phase 1/2 completion of dosing announced June 14, 2017 with interim data to be presented at ASH December 9, 2017. Top-line data due 1Q 2018.

CBIO
Marzeptacog alfa
Hemophilia

Phase 2 Phase 2 planned for 4Q 2017.

INCY
Itacitinib - GRAVITAS-301
Treatment-naïve acute GVHD

Phase 3 Phase 3 initiation of dosing announced July 20, 2017.

INCY
Baricitinib
Psoriatic arthritis

Phase 3 Phase 3 trial to be initiated in 2018.

INCY
INCB50465 (CITADEL-202)
Diffuse large B cell lymphoma

Phase 2 Phase 2 commenced February 2017.

INCY
Ruxolitinib (RESET-272)
Essential thrombocythemia

Phase 3 Pivotal Phase 2 trial initiation announced November 15, 2017.

INCY
Ruxolitinib - REACH 3
Steroid-refractory chronic GVHD (Graft versus host disease)

Phase 3 Phase 3 trial commenced June 2017.

INCY
Ruxolitinib - REACH 2
Steroid-refractory acute GVHD (Graft versus host disease)

Phase 3 Phase 3 enrollment commenced March 2017. Trial to be completed in 2020.

FBIO
N-acetyl-D-mannosamine (ManNAc)
GNE Myopathy

Phase 2/3 Phase 2 trial ongoing with Phase 3 to be initiated in 2017.

FBIO
Pepvax vaccine
Cytomegalovirus (CMV)

Phase 2 Phase 2 data due 1H 2018.

FBIO
IV Tramadol
Post-operative Pain

Phase 3 Phase 3 initiation announced September 27, 2017 with data due 2Q 2018.

FBIO
CEVA101
Severe Traumatic Brain Injury

Phase 2 Phase 2 data in children due 1H 2018.

MRK
MK-8931 (017) - Verubecestat
Mild-to-moderate Alzheimer's

Phase 3 Phase 3 trial stopped due to lack of efficacy - February 14, 2017.

OHRP
OHR-102 (MAKO)
Neovascular (Wet) Age-related Macular Degeneration (AMD)

Phase 3 Phase 3 data due early 2018.