BPC February 04 update

Upcoming Biotech Stock Catalysts of 1Q 2017 - as of February 6 2017

Weekly watchlist

The last week saw a number of clinical catalysts hit the screens and as has been the case for much of 2017, the data were overwhelmingly disappointing.

Ocera Therapeutics, Inc. (NASDAQ:OCRX) started the rot on Monday when it announced that its Phase 2b trial of OCR-002 in patients with Hepatic Encephalopathy (HE) did not meet its primary endpoint. Shares were sent falling 71% to $0.60.

Tuesday saw the release of three key pieces of data from firstly Tenax Therapeutics, Inc. (NASDAQ: TENX) which announced the primary endpoints were not met in its Phase 3 LEVO-CTS trial. Shares of the company closed the week down 64% post-data. Catabasis Pharmaceuticals, Inc. (NASDAQ:CATB) collapsed to close the week down 69% post-data following news that its Phase 1/2 trial of edasalonexent (CAT-1004) for the treatment of Duchenne muscular dystrophy (DMD), did not meet the primary efficacy endpoint. Investors were also not impressed with Phase 1/2 trial data released by Dimension Therapeutics, Inc. (NASDAQ:DMTX) from its candidate, DTX101 for the treatment of adult patients with moderate/severe to severe hemophilia B. Shares closed the week down 55% post-data to $1.90.

It was not, however, all doom and gloom in the biotech space. Calithera Biosciences, Inc. (NASDAQ:CALA) announced Monday a partnership with Incyte for CB-1158 in hematology with Calithera to receive up-front $45m from Incyte. Shares of the company surged to close the week 100% higher to $9.20.

Esperion Therapeutics Inc (NASDAQ:ESPR) +29% and The Medicines Company (NASDAQ:MDCO) +21%, both surged to the upside following positive data released by Amgen (NASDAQ: AMGN) on Thursday where its PCSK9 inhibitor, Repatha met both primary and secondary endpoints in reducing the risk of cardiovascular events in its FOURIER trial. Both Esperion and The Medicines Company have late stage candidates for the treatment of Hypercholesterolemia.

Weekly Watch list as follows (some likely to be March events)

Drug Stage Catalyst

ACOR
CVT-301
OFF episodes of Parkinson’s disease (PD)

Phase 3 Phase 3 data released February 9, 2017 - primary endpoint met. NDA filing due by the end of 2Q 2017.

ACOR
Ampyra
Improve walking in patients with multiple sclerosis

Decision on Inter Partes Review (IPR) released March 10, 2017 - patents upheld.

AVIR
Vapendavir - SPIRITUS trial
Human rhinovirus (HRV)

Phase 2b Phase 2b top-line data released February 13, 2017 - primary endpoint not met.

KITE
Axicabtagene ciloleucel (KTE-C19) - ZUMA-1
Refractory Non-Hodgkin's Lymphoma (NHL) - cancer

BLA Filing Phase 2 pivotal top-line data released September 26, 2016. Primary analysis released February 28, 2017 showed trial met primary endpoint. Rolling BLA filing initiated December 2016 with completion expected 1Q 2017.

LXRX
Telotristat etiprate (XERMELO)
Carcinoid Syndrome

Approved Approved February 28, 2017.

NKTR
NKTR-181
Lower back pain

Phase 3 Phase 3 data released March 20, 2017 - endpoints met.

PBYI
Roche (RHHBY) - Perjeta + Herceptin (APHINITY)
Adjuvant HER2+ breast cancer

Phase 3 Note this trial is conducted by competitor Roche (RHHBY), NOT by Puma. The event was likely to have a significant impact on the share price of Puma (e.g. positive data would likely have a negative impact on Puma and vice versa). Data were released March 2, 2017 - primary endpoint was met. Late breaker at ASCO - June 5, 2017. Abstract LBA500.

TRVN
Oliceridine (TRV130)
Moderate to severe acute pain

Phase 3 Phase 3 APOLLO-1 and APOLLO-2 data released February 21, 2017 - primary endpoints met but commercial doubts raised. NDA filing due 4Q 2017.