Tactile Systems Sees Revenues In Range Of $132-134M

Tactile Systems Technology Inc:

* FOR 2018, COMPANY NOW EXPECTS REVENUES IN RANGE OF $132 MILLION TO $134 MILLION

* TACTILE SYSTEMS TECHNOLOGY – QTRLY LOSS PER SHARE $0.00

* REVENUES FOR Q1 2018 INCREASED $7.0 MILLION, OR 35%, TO $26.8 MILLION, COMPARED TO $19.9 MILLION FOR QUARTER ENDED MARCH 31, 2017

* Q1 REVENUE VIEW $23.7 MILLION — THOMSON REUTERS I/B/E/S

https://reut.rs/2wkL1KE

Genprex gene therapy IPO fast out of the gate

Recent IPO Genprex (GNPX +86.8%), a gene therapy developer, is up big on a whopping 43x surge in volume. Shares have more than doubled from the $5 debut price.

Lead candidate Oncoprex, in Phase 2 development for lung cancer, is an immunogene therapy consisting of a gene called TUSC2 that is encapsulated in a positively charged lipid nanovesicle. Once injected intravenously, it targets cancer cells which are normally negatively charged. The company says its approach minimizes the uptake of the gene therapy by normal tissue. In studies conducted at MD Anderson, the uptake of TUSC2 in tumor cells was as much as 25x higher than normal cells.

https://bit.ly/2HyITUQ

Genentech to present new data from over 19 medicines at ASCO

Genentech, a member of the Roche Group, announced that new data from early and late-stage clinical studies on more than 19 approved and investigational cancer medicines, will be presented at the 2018 American Society of Clinical Oncology, or ASCO, Annual Meeting, taking place from June 1-5 in Chicago. More than 90 abstracts have been accepted across 13 cancer types, including two “late breakers” and 15 oral presentations. “New data to be presented from our industry-leading oncology portfolio, including lung and hematology programs, will demonstrate how our science-driven approach aims to improve outcomes for people living with cancer,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “At ASCO, we look forward to sharing our progress and commitment to build the future of personalized healthcare in oncology.

https://bit.ly/2wm9qiN

Sangamo sees data readouts beginning in late summer

Sangamo Therapeutics said in its earnings release, “This is an exciting time for Sangamo; we expect potential clinical data readouts from 7 studies in 2018 and 2019, beginning in late summer of this year with anticipated data from our hemophilia A gene therapy and MPS II genome editing programs. In order to realize the potential of our platform technologies, we recently raised additional capital to strengthen our balance sheet. This funding will allow us to retain and invest in valuable programs for development and potential commercialization, particularly in select therapeutic areas including inherited metabolic diseases, rare CNS disorders, and immunology.”

https://bit.ly/2HWl2OO

Akcea hit by FDA safety concerns

Akcea Therapeutics (AKCA) and its controlling holder Ionis Pharmaceuticals (IONS) are moving lower after an FDA panel posted its briefing document ahead of Thursday’s meeting to discuss Akcea’s volanesorsen. The document reads, “Despite the magnitude of the effect observed on TG, the volanesorsen review team remains uncertain whether the benefits of volanesorsen outweighs its risks, considering safety concerns with this product. Although the reviews highlight several safety/tolerability issues, the primary focus for both the applicant and the reviewers has been the risk of thrombocytopenia and resulting potential for serious bleeding.” It adds, “After the NDA review was well-underway, the applicant unexpectedly submitted an amendment that proposed a new dosing and platelet monitoring strategy for labeling that had not been implemented in any of the clinical trials… Regarding platelet monitoring, the review team (including the hematology consultant) questions the feasibility and effectiveness of a monitoring scheme of this intensity for a lifelong therapy. At present, we have no evidence that the risk of severe thrombocytopenia diminishes with time.” Shares of Akcea are down 12% in premarket trading, or $2.67, to $19.00 while Ionis is down 2.5% to $43.22.

https://bit.ly/2jFkjmB

Ionis cut from buy by Evercore

Ionis Pharmaceuticals cut to In Line at Evercore ISI after volanesorsen review. As reporter earlier, Evercore ISI analyst Josh Schimmer downgraded Ionis Pharmaceuticals to In Line from Outperform and lowered his price target to $46 from $55. The analyst cites the safety concerns around volanesorsen discussed in the latest FDA briefing documents, which also “dismantled the company’s claims” that the treatment leads to benefits in pancreatis. Schimmer says that while he did not assign much value around volanesorsen, he is now removing it from the model until there is more certainty around the drug profile while also increasing the discount rate to reflect additional platform uncertainty.

https://bit.ly/2FTH3rV

Bausch Q1 Revenues Beats Views; Ups FY18 Revenue, EBITDA Outlook

Valeant Pharma (NYSE: VRX) reported Q1 EPS of ($7.68), versus $0.60 reported last year. Revenue for the quarter came in at $2 billion versus the consensus estimate of $1.95 billion.

• Outperformed Expectations in the First Quarter of 2018
  • Revenues of $1.995 Billion
  • GAAP Net Loss of $2.693 Billion
  • GAAP Cash Flow from Operations of $438 Million
  • Adjusted EBITDA (non-GAAP)1 of $832 Million
• Delivered Overall Organic Revenue Growth2 for the First Time since 2015, Driven by Branded Rx and Bausch + Lomb/International Segments
• Raised 2018 Full-Year Revenue and Adjusted EBITDA (non-GAAP) Guidance Ranges
• Company\’s Name Will Change to Bausch Health Companies Inc. in July 2018

GUIDANCE:

Valeant Pharma sees FY2018 revenue of $8.15-8.35 billion, versus the consensus of $8.24 billion.

https://bit.ly/2FUhabv