BPC February 10 update

Biotech Stock Week in Review - February 10 2017; Ten upcoming key catalysts for 1Q 2017

Weekly watchlist

The latest week was dominated by earnings, more data releases and a plateful of companies raising cash. As we approach the halfway point of the first quarter of 2017, it is apparent that there are a number of key catalysts awaiting data, of which ten are highlighted below.

Immunomedics, Inc. (NASDAQ: IMMU) announced on Friday that it secured a license agreement with Seattle Genetics, Inc. (NASDAQ: SGEN) for the rights to its key pipeline asset, sacituzumab govitecan (IMMU-132). Immunomedicswill receive $250m upfront, with another $1.7b to be secured pending certain milestones. News of the deal saw shares of the company close up 22% to $5.23. The agreement coincidentally comes four business days before the company’s annual meeting where investor venBio Select Advisor LLC is seeking to vote out the current Board. Following news of the deal, Immunomedics have decided to postpone the meeting, originally scheduled for February 16, to March 3.

On the catalyst front, both Acorda Therapeutics, Inc. (Nasdaq:ACOR) and TRACON Pharmaceuticals (NASDAQ: TCON) released clinical data.

Acorda shares rose 21% to $24.65 following its announcement that it met the primary endpoint of its Phase 3 trial of CVT-301 in patients with Parkinson’s disease experiencing OFF periods. The company is due to file a New Drug Application (NDA) by the end of 2Q of 2017. While traders were relatively pleased with the result, hesitancy was noted from some quarters that full data including secondary endpoints had yet to be released.

To the downside TRACON reported it did not meet the primary endpoint in its Phase 2 trial of TRC105 in recurrent glioblastoma (GBM), which saw its shares close down 14% on Friday to $4.15.

Among the larger cap firms Gilead Sciences Inc. (NASDAQ: GILD) shares took a battering following disappointing guidance for future sales of its Hepatitis C drugs Harvoni and Sovaldi. The company expects 2017 net product sales of $22.5b to $24.5b, well below analyst estimates. Shares closed the week at $66.36, down 9% from its Tuesday close of $73.13.

Shares of Tesaro (NASDAQ: TSRO) closed the week 10% higher following media reports that it has been approached regarding an acquisition of the company while Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) also received a welcome boost when the United States Court of Appeals for the Federal Circuit  stayed the permanent injunction for its cholesterol drug, Praluent, allowing it to continue marketing the drug.

On the offering front, companies to raise cash included:

BioTime, Inc. (NYSE MKT and TASE: BTX)

Sierra Oncology, Inc. (NASDAQ: SRRA)

Moleculin Biotech, Inc. (NASDAQ: MBRX)

Galena Biopharma, Inc. (NASDAQ:GALE)

Coherus BioSciences, Inc. (Nasdaq:CHRS) 

Acasti Pharma Inc (NASDAQ:ACST)

Ten Upcoming Biotech Stock Catalysts:

Drug Stage Catalyst

Vapendavir - SPIRITUS trial
Human rhinovirus (HRV)

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

Visual hallucinations in subjects with Lewy body dementia

Phase 2 Phase 2 preliminary data released February 13, 2017. Primary endpoint hit, secondary endpoints missed. Top-line data due January 2018.

mGluR mutation positive ADHD

Phase 2/3 Phase 2/3 data released March 20, 2017 - primary endpoint not met. Subset of data released April 20, 2017 - to be presented April 21, 2017.

Selinexor - SADAL
Cancer - Diffuse Large B-Cell Lymphoma (DLBCL)

Phase 2b Phase 2b additional interim data released June 23, 2017 at EHA. Final top-line data due 2H 2018.

Telotristat etiprate (XERMELO)
Carcinoid Syndrome

Approved Approved February 28, 2017.

ND0612H (Trial 006)
Severe Parkinson's Disease

Phase 2 Phase 2 trial met key primary and secondary endpoints - March 1, 2017.

Lower back pain

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

Cystic fibrosis

Phase 2 Phase 2 28-day data due 4Q 2017.

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

Phase 3 Note this trial is conducted by competitor Roche (RHHBY), NOT by Puma. Primary endpoint was met March 2, 2017. Data released June 5, 2017 - HR 0.81. Disease-free-survival +0.9% over Herceptin.

Oliceridine (TRV130)
Moderate to severe acute pain

NDA Filing Phase 3 APOLLO-1 and APOLLO-2 data released February 21, 2017 - primary endpoints met. NDA filing announced November 2, 2017.