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WVE

Wave Life Sciences

$34.05

-0.02 (-0.06%)

07:08
04/16/19
04/16
07:08
04/16/19
07:08

Wave Life Sciences presents final results from Phase 1 suvodirsen study at MDA

Wave Life Sciences announced the final results from its Phase 1 clinical trial of investigational suvodirsen in boys with Duchenne muscular dystrophy, or DMD, who are amenable to exon 51 skipping. The company also announced the design of its planned Phase 2/3 clinical trial of suvodirsen in DMD, DYSTANCE 51. The Phase 1 data and DYSTANCE 51 details will be presented at the Muscular Dystrophy Association, or MDA. Wave's Phase 1 clinical trial was a global, multicenter, double-blind, placebo-controlled study designed to evaluate the safety, tolerability and plasma concentrations of single ascending doses of suvodirsen administered intravenously. Thirty-six patients received a dose of suvodirsen or placebo in five ascending dose cohorts and were followed for 85 days. No serious adverse events, deaths or discontinuations due to adverse events were reported in any study patients treated with suvodirsen. Suvodirsen was generally safe and well tolerated with 67% of patients who received suvodirsen and 80% of patients who received placebo experienced one or more adverse events. The most common adverse events occurring in two or more patients who received suvodirsen were pyrexia, headache, vomiting and tachycardia, consistent with infusion-associated reactions. Adverse events in patients receiving suvodirsen were mild to moderate in intensity and resolved spontaneously or with symptomatic treatment. No clinically relevant changes were observed in renal or hepatic parameters or platelet levels. In patients receiving 5 mg/kg of suvodirsen, the adverse events that occurred within 24 hours of infusion were associated with transient increases in high-sensitivity C-reactive protein and complement factor Bb levels, both of which were resolved within a week and no changes were observed in complement C3 levels. Based on results of the first four ascending dose cohorts, the independent safety monitoring committee of the Phase 1 clinical trial endorsed continued dose exploration by proceeding to the last planned cohort. Doses of 7 mg/kg or 10 mg/kg of suvodirsen were administered to two patients in the fifth cohort and were associated with similar adverse events as those observed at lower doses but were more severe in intensity. The full data from the Phase 1 clinical trial will be presented in an oral presentation and poster at the MDA conference.

WVE Wave Life Sciences
$34.05

-0.02 (-0.06%)

08/07/18
STFL
08/07/18
INITIATION
Target $56
STFL
Buy
Wave Life Sciences initiated with a Buy at Stifel
Stifel analyst Paul Matteis initiated Wave Life Sciences (WVE) with a Buy rating and $56 price target, stating that he sees Takeda's (TKPYY) $170M upfront payment as validating to its platform and set of CNS candidates. Wave is one of his favorite names ahead of a catalyst-rich 12-18 months that includes proof-of-concept data in Huntington's in the first half of 2019, and safety and efficacy data for Wave's candidate in Duchenne, Matteis tells investors.
11/27/18
LEER
11/27/18
INITIATION
Target $61
LEER
Outperform
Wave Life Sciences initiated with an Outperform at Leerink
Leerink analyst Mani Foroohar initiated Wave Life Sciences with an Outperform rating and a price target of $61.
11/27/18
LEER
11/27/18
INITIATION
LEER
Leerink initiates select Genetic Medicine names on increasing regulatory clarity
Leerink analyst Mani Foroohar initiated select Genetic Medicine stocks, stating that the field is "is rich with companies developing drugs" to treat rare diseases and that he is increasingly more bullish on "innovation velocity and increasing regulatory clarity in the sector. Based on his "balanced view of pricing dynamics", the analyst issues an Outperform rating on Wave Life Sciences (WVE), Rocket Pharmaceuticals (RCKT), Intellia Therapeutics (NTLA), Eidos Therapeutics (EIDX), Dicerna (DRNA) and Bluebird Bio (BLUE). The analyst likes Wave Life Sciences as a pure play on Oligotherapeutics and its stereopure chemistry platform as a differentiated approach to oligo drug design. Foroohar is positive on Rocket Pharma's lead assets in gene therapies for Fanconi Anemia and Leukocyte Adhesion Deficiency-I "which will likely be the company's first potential approved product." The analyst is positive on Intellia Therapeutics' "robust balance sheet to support development, trading at a material discount to closest comps peers". For Eidos, the analyst cites the prospects of its drug candidate for TTR amyloidosis currently in a placebo-controlled Phase 2 study that may offer a competitive profile relative to Pfizer's (PFE) tafamidis. For Dicerna, Foroohar notes that its DCR-PHXC "is an RNAi therapeutic that targets lactate dehydrogenase A for the treatment of all subtypes of Primary Hyperoxaluria vs. competitor Alnylam's (ALNY) lumasiran, which only treats PH Type 1. For Bluebird Bio, the analyst is positive on its position as a "leader in ex vivo gene therapy, with four programs with visibility towards near-term regulatory approval". Foroohar initiates Avrobio (AVRO), Alnylam (ALNY), and Ionis Pharmaceuticals (IONS) with Market Perform rating based on competitive launches for their products along with "mixed" early signs of their results. The analyst also rates Regenxbio (RGNX) at underperform, saying that its "current valuation more than accounts for robust royalty streams from sales in spinal muscular atrophy" and other partnered assets.
12/06/18
12/06/18
NO CHANGE

Mizuho defending Wave Life Sciences after stock decline
Mizuho analyst Salim Syed maintained a Buy rating and $65 price target on Wave Life Sciences, and defended the stock after its double digit decline. Syed said some of the decline was related to the broader market decline, as the tape is generally red, but some is Wave Life specific, as a lack of details in the company's recent press release has disappointed some investors. The analyst said he spoke to management and believes the decline is unwarranted, as management alleviated concerns regarding the drug trial.

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