Analysts Update: Juno Therapeutics Inc (NASDAQ:JUNO), Lexicon Pharmaceuticals, Inc.(NASDAQ:LXRX)
Juno Therapeutics Inc(NASDAQ:JUNO): FBR & Co. notes the main focus of the earnings call was the tremendous progress the company has made in its pipeline during the year and what to expect throughout a sure-to-be exciting 2016. We could see data this year from Juno’s Phase II ROCKET trial of JCAR015, its most advanced product candidate, for the treatment of adult r/r ALL, which could serve as the basis for a BLA filing late this year with potential approval in 2017. While Juno may not be the first CAR T product to the market, they think Juno’s investment to enhance cell expansion and persistence could set it apart from competitors. The co is also making the investment to create defined cell products, which it thinks could lead to better, more durable responses. Interestingly, Juno mentioned that it is beginning to develop a manufacturing process that could cut down the manufacturing time of its CAR T products to as little as two days. While this goal is far off, they are excited by the possibility.
Maxim notes Juno is rapidly heading toward commercialization of its first of three CD19-targeting CARs, JCAR015, in 2017. In their view, the real value in CD19 CARs has yet to be unlocked: second line and front line therapy. While Juno’s focus now is driving JCAR015 (and the other CD19 CARs) across the finish line in r/r disease and building infrastructure to support commercial launch, the durability of the observed responses in the r/r populations suggest that Juno’s CARs have potential earlier in the course of disease… much larger commercial opportunities.
Lexicon Pharmaceuticals, Inc.(NASDAQ:LXRX) Reports Q4 (Dec) earnings of $0.76 per share, may not be comparable to the Capital IQ Consensus of ($0.40); revenues rose 492.1% year/year to $127.3 mln. As of December 31, 2015, Lexicon had $521.4 mln in cash and investments, as compared to $256.4 mln as of September 30, 2015 and $339.3 million as of December 31, 2014.
In November 2015, Lexicon announced that it entered into a collaboration and license agreement with Sanofi for the worldwide development and commercialization of sotagliflozin. Under the terms of the agreement, Lexicon received an upfront payment of $300 MLN and is eligible to receive development, regulatory and sales milestone payments of up to $1.4 BLN. Lexicon is also entitled to tiered, escalating royalties on net sales of sotagliflozin.
Under the collaboration with Sanofi (SNY), Lexicon will continue to be responsible for clinical development activities relating to type 1 diabetes and Sanofi will be responsible for clinical development activities relating to type 2 diabetes. Lexicon is conducting three Phase 3 clinical trials of sotagliflozin in patients with type 1 diabetes, one of which has already completed enrollment, and expects top-line results from its two pivotal Phase 3 clinical trials to be available in the second half of 2016. Lexicon expects that Phase 3 development of sotagliflozin in patients with type 2 diabetes will be initiated by Sanofi by the end of 2016.
Tags: Inc. (NASDAQ:LXRX), Juno Therapeutics Inc (NASDAQ:JUNO), Lexicon Pharmaceuticals