BPC March 11 update

Biotech Week in Review - March 10; Eight upcoming March Biotech Stock Catalysts

Weekly watchlist

A look back at last week’s biotech stock watch list saw a couple of the listed events deliver updates.

Radius Health, Inc. (Nasdaq:RDUS) announced on Friday that the FDA has extended the PDUFA action date for its New Drug Application (NDA) for Abaloparatide-SC by three months to June 30, 2017. The extension follows the submission of new information by the company. Shares closed down Friday by 5% to $40.85.

On Thursday Acorda Therapeutics Inc (NASDAQ:ACOR) announced that  the United States Patent and Trademark Office (USPTO) Patent Trials and Appeal Board (PTAB) upheld patents challenged by Kyle Bass via the inter partes review (IPR) process for AMPYRA (dalfampridine) tablets. The positive result saw shares close up 6.5% to $30.15.

In other legal news, Immunomedics, Inc. (NASDAQ:IMMU) shares closed the week up 25% from early afternoon trading on Thursday following news that the company will not be permitted to go ahead with its $2b licensing deal with Seattle Genetics (SGEN), resulting in belief that the newly elected board will be able to secure a much more beneficial financial deal.

Two stocks saw intra-day trading spikes following chatter of potential acquisitions. Shares of Global Blood Therapeutics Inc (NASDAQ:GBT) garnered attention following reports Danish drugmaker Novo Nordisk A/S (ADR) (NYSE:NVO) is interested in a buyout of the company. Shares closed the week up 30% to $37.00 from early trading on Wednesday when the news first hit the screens.

Late on Friday a report by Streetinsider noted that Gilead (Nasdaq: GILD) has expressed an interest in acquiring Incyte Corporation (NASDAQ:INCY). Shares of the company closed up 8% to $149.16.

On the clinical binary event front, there was a lack of significant data releases. The one notable exception was TG Therapeutics (NASDAQ:TGTX) which saw its shares close the week up 113% to $11.40, following its announcement that its Phase 3 GENUINE clinical trial of TG-1101 plus in patients with previously treated high risk Chronic Lymphocytic Leukemia (CLL) met its primary endpoint.

The watch list below highlights eight key events left on the calendar for the final three weeks of March.

Drug Stage Catalyst

Cardiovascular disease

PDUFA Phase 3 cardiovascular outcomes study data released March 17, 2017 - endpoints met but down on expectations. PDUFA date under priority review December 2, 2017.

Lynparza - SOLO 2
Second-line ovarian cancer

Approved Approval announced August 17, 2017.

IV CR845
Uremic pruritus

Phase 2/3 Phase 2/3 top-line data from Part A portion of trial released March 28, 2017 - endpoints met. Phase 3 trial to be initated 4Q 2017.

Anabasum (Resunab)
Cystic Fibrosis

Phase 2 Phase 2 data released March 30, 2017 - primary endpoint met but some concerns regarding efficacy.

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.

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.

Lactose intolerance

Phase 2/3 Phase 2/3 top-line data released March 28, 2017. Primary endpoint met. End of Phase 2 meeting with FDA planned by the end of 2017 with Phase 3 trial to potentially commence 1H 2018.