BPC January 03 update

Biotech opens the new year with poor data - shares of Inotek (ITEK) and Agile (AGRX) plummet over 70%

Price and Volume Movers

Inotek Pharmaceuticals Corporation (NASDAQ:ITEK) shares plunged 71% to $1.75 on 40x average volume, following its announcement today that top-line data from its Phase 3 trial of trabodenoson for the treatment of primary open-angle glaucoma (POAG) or ocular hypertension (OHT), did not meet its primary endpoint of superiority in reduction of intraocular pressure (IOP) compared with placebo at all 12 time points.

Shares of CymaBay Therapeutics Inc (NASDAQ:CBAY) are trading up 49% to $2.83 in the after-hours session following its announcement of a license agreement with Kowa Pharmaceuticals America, Inc. The surge in its share price is on top of the 10% gain in normal trading hours. The agreement, for the development and commercialization of arhalofenate in the United States, will see CymaBay receive up to $15m upfront and it will also be eligible for up to $190m based on regulatory and sales milestones.  Kowa will be responsible for all development and commercialization costs which was estimated to cost around $100m.

Agile Therapeutics, Inc. (Nasdaq:AGRX) shares have tumbled over 70% to $1.46 in the after-hours session following the release of disappointing data from its Phase 3 SECURE trial of its contraceptive patch, Twirla. Shares had already fallen over 12% in normal trading hours on 15x average volume. The key efficacy requirement to measure the number of unintended pregnancies was the PEARL index. The company reported data much higher than investors had hoped, sending shares to record lows since its IPO (initial public offering) in 2014.

"The Pearl Index for the overall intent to treat population of subjects 35 years of age and under was 4.80 with an upper-bound of the 95% confidence interval of 6.06." 

Despite the unimpressive data the company plans to resubmit its New Drug Application (NDA) in 1H 2017. The company previously received a Complete Response Letter (CRL) in 2013.

Shares of Tenax Therapeutics Inc (NASDAQ:TENX) rose by 18% to $2.31 on 5x average volume. The company is due to release data this month from its Phase 3 LEVO-CTS trial of Levosimendan in cardiac surgery.

Flamel Technologies (NASDAQ: FLML) announced that it has completed its merger with Avadel Pharmaceuticals (NASDAQ:AVDL). The merged company now traders under the ticker AVDL.

Clovis Oncology, Inc. (NASDAQ:CLVS) announced that it has commenced an underwritten public offering and intends to raise approximately $175 million. Shares of the company fell 3% to $42.95 on 3x average volume.


Other major price movers (+10%):

ADVANCERS:

Kindred Biosciences Inc (NASDAQ:KIN): $5.15; +21%.

XOMA Corporation (NASDAQ:XOMA): $4.97; +18%; 6x average volume.

Affimed NV (NASDAQ:AFMD): $2.10; +17%.

Titan Pharmaceuticals, Inc. (NASDAQ:TTNP): $4.65; +16%; 3x average volume.

AVEO Pharmaceuticals, Inc. (NASDAQ:AVEO): $0.605; +12%.

Calithera Biosciences Inc (NASDAQ:CALA): $3.60; +11%.

Crispr Therapeutics (NASDAQ:CRSP): $22.50; +11%.

Neuralstem, Inc. (NASDAQ:CUR): $0.305; +11%.

KemPharm Inc (NASDAQ:KMPH): $3.25; +10%.


Full pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst

ITEK
Trabodenoson
Primary open-angle glaucoma (POAG)

Phase 3 Phase 3 top-line data released January 3, 2017. Primary endpoint not met.

AGRX
Twirla
Contraceptive patch

PDUFA CRL issued 2013. Phase 3 top-line data released January 3, 2017 - poor data. NDA resubmitted with PDUFA date of December 26, 2017

CORI
Twirla
Contraceptive patch

PDUFA Phase 3 top-line data released January 3, 2017 - poor data. NDA resubmitted by partner Agile Therapeutics with PDUFA date of December 26, 2017

PLX
AIR DNase (PRX-110)
Cystic Fibrosis

Phase 2 Phase 2 interim data released January 3, 2017. Full data released April 12, 2017. Company noted data were positive but results showed efficacy down on January data.

ARDX
RDX227675
Hyperkalemia

Phase 3 Phase 3 trial initiation announced January 3, 2017.

ZYNE
ZYN002
Fragile X syndrome

Phase 2 Phase 2 data released September 28, 2017. Company noted data were positive with primary endpoint met. Note though that trial was uncontrolled/open-label.

DERM
Olumacostat glasaretil (DRM01)
Acne

Phase 3 Phase 3 completion of enrollment announced October 5, 2017. Data are due 1Q 2018.

TCON
TRC105 (TAPPAS)
Angiosarcoma cancer

Phase 3 Phase 3 dosage of first patient announced February 16, 2017. Interim analysis mid-2018.

EGRX
Ready-to-dilute (RTD) Pemetrexed Injection
Nonsquamous Non-Small Cell Lung Cancer (NSCLC) and Mesothelioma

PDUFA PDUFA date October 30, 2017.

AXSM
AXS-05 ADVANCE-1
Agitation in patients with Alzheimer’s disease (AD)

Phase 2/3 Phase 2/3 initiation announced July 17, 2017.