Iridex sees 2019 revenues as high as $43.5M

On a preliminary basis, IRIDEX (NASDAQ:IRIX) expects Q4 and full-year revenues of $11.6M – 11.8M and $43.3M – 43.5M, respectively.

G6 probe shipments were 13.5K – 13.9K and 53.3K – 53.7K, respectively.

Cyclo G6 Glaucoma Laser Systems shipments were 104 – 109 and 385 – 390, respectively.

https://seekingalpha.com/news/3531502-iridex-sees-2019-revenues-high-43_5m

XBiotech +39% on tender offer to purchase $420M shares

XBiotech (XBIT +38.5%) has commenced a “modified Dutch auction” tender offer to purchase up to $420M of its common shares, at a price between $30 and $33 per share.

The Offer will expire at 5:00 p.m., New York time, on February 12, 2020, unless extended.

https://seekingalpha.com/news/3531695-xbiotechplus-39-on-tender-offer-to-purchase-420m-shares

Avrobio on go with study of Gaucher gene therapy

The FDA has signed off on AVROBIO’s (NASDAQ:AVRO) IND for a Phase 1/2 clinical trial evaluating gene therapy AVR-RD-02 for the treatment of Gaucher disease, an inherited disorder caused by the accumulation of a type of lipid in tissues due to the dysfunction in a certain enzyme.

The primary efficacy endpoint of the 16-subject study is change from baseline in GCase enzyme activity at week 52 post-treatment. The estimated primary completion date is May 2021.

https://seekingalpha.com/news/3531610-avrobio-on-go-study-of-gaucher-gene-therapy

Nevro sees FY 2019 revenue as high as $390M

Nevro (NYSE:NVRO) announces preliminary Q4 and FY 2019 revenue and guidance for FY 2020.

Q4 and FY 2019 worldwide revenue is expected to be $114.4M and $390.3M, respectively.

Q4 and FY 2019 U.S. revenue is expected to be $97.9M and $326M, respectively.

Q4 U.S. trial procedure growth was 17% and permanent implant procedure growth was 20%.

Nevro expects FY 2020 worldwide revenue in the range of $435M to $440M.

The company plans to report final Q4 and FY 2019 results in February.

https://seekingalpha.com/news/3531616-nevro-sees-fy-2019-revenue-high-390m

Idera Pharma updates on tilsotolimod

Ahead of its presentation at JPMorgan’s Healthcare Conference, Idera on Thursday, Idera Pharmaceuticals (NASDAQ:IDRA) provides the following pipeline update:

Enrollment in Phase 3 ILLUMINATE 301 study comparing tilsotolimod + Bristol-Myers Squibb’s Yervoy (ipilimumab) to Yervoy alone in PD-1 inhibitor-refractory metastatic melanoma patients should be completed this quarter with topline data expected in Q4/Q1 2021.

Preliminary response rate and safety data from Phase 2 ILLUMINATE 206 study of tilsotolimod + Yervoy and Opdivo (nivolumab) in solid tumors expected next quarter.

Final results from Phase 1/2 ILLUMINATE 204 study of tilsotolimod + Yervoy or Merck’s Keytruda (pembrolizumab) in anti-PD-1-refractory metastatic melanoma patients should be available next quarter.

#JPM20

https://seekingalpha.com/news/3531597-idera-pharma-updates-on-tilsotolimod

Mereo Bio up on new setrusumab data

Thinly traded nano cap Mereo BioPharma Group plc (NASDAQ:MREO) is up 19% premarket on modest volume in reaction to additional data from a Phase 2b clinical trial, ASTEROID, evaluating setrusumab (BPS-804) in adults with Type I, III or IV osteogenesis imperfecta, also known as brittle bone disease. Topline results were first announced in November 2019.

Treated patients showed dose-dependent increases in both failure load and stiffness at the radius (forearm bone) at month 12. The mean percent changes were statistically significant in the high-dose cohort.

The treatment effects in the medium- and high-dose groups were also statistically significant at month 12 as measured by trabecular bone score (TBS) determined by DXA scans of the lumbar spine.

The company plans to meet with the FDA this quarter to review the data and clarify the design of a pivotal study.

https://seekingalpha.com/news/3531625-mereo-bio-up-19-premarket-on-new-setrusumab-data

Perrigo sees 2% sales growth in 2019

Ahead of its presentation at JPMorgan’s Healthcare Conference, Perrigo (NYSE:PRGO) announces preliminary results for Q4 and 2019.

Q4: Consumer Self-Help Americas: +15%; Consumer Self-Help International: -8%; Rx segment: +3%.

Unaudited full-year sales were $4.8B (+2%), global Consumer sales up 2% to $3.9B, Consumer Self-Care Americas up ~3% to $2.5B, Consumer Self-Help International down 1% to ~$1.4B, Rx segment up 5% to ~$970M.

Final results for Q4 and 2019 will be released in late February.

Shares up 4% premarket.

https://seekingalpha.com/news/3531678-perrigo-sees-2-sales-growth-in-2019