J&J gains on Q3 beat; guidance raised

Johnson & Johnson (JNJ) Q3 results: Revenues: $20,729M (+1.9%); Consumer: $3,469M (+1.6%); Pharmaceuticals: $10,877M (+5.1%); Medical Devices: $6,383M (-3.1%).

Net Income: $4,833M (+22.9%); EPS: $1.81 (+25.7%); Non-GAAP Net Income: $5,672M (+1.5%); Non-GAAP EPS: $2.12 (+3.4%).

Key Product Sales: Remicade: $1,136M (-17.6%); Simponi/Simponi Aria: $586M (+9.6%); Stelara: $1,698M (+29.6%); Tremfya: $290M (+69.0%); Darzalex: $765M (+53.5%); Xarelto: $613M (+0.1%); Zytiga: $741M (-22.7%); Imbruvica: $921M (+30.6%); Velcade: $149M (-44.8%); Invega Sustennn/Xeplion/Trinza/Trevicta: $851M (+13.7%); Edurant/rilpivirine: $218M (+7.9%); Prezista/Prezcobix/Rezolsta/Symtuza: $508M (+3.7%); Precrit/Eprex: $198M (-22.4%); Opsumit: $347M (+11.7%); Uptravi: $210M (+23.4%).

2019 Guidance: Revenues: $81.8B – 82.3B from $80.8B – $81.6B; Non-GAAP EPS: $8.62 – 8.67 from $8.53 – 8.63.

Shares were up 2% premarket.

https://seekingalpha.com/news/3505685-j-and-j-gains-q3-beat-guidance-raised

Neovasc nabs new patent in U.S

The USPTO has issued Neovasc (NASDAQ:NVCN), Patent No. 10,433,952, titled: “PROSTHETIC VALVE FOR AVOIDING OBSTRUCTION OF OUTFLOW”.

The granted claims are directed to a prosthetic valve that helps reduce LVOT obstruction and improve unobstructed blood flow through the Tiara and the native ventricle.

Shares are up 14% premarket.

https://seekingalpha.com/news/3505712-neovasc-nabs-new-patent-u-s-shares-14-percent-premarket

Kyowa Kirin’s Nourianz now available in U.S. for Parkinson’s

Kyowa Kirin (OTCPK:KYKOF) launches NOURIANZ (istradefylline), an adenosine receptor antagonist in U.S. as an adjunctive treatment to levodopa/carbidopa in adult patients with Parkinson’s disease (PD) experiencing “off” episodes.
https://seekingalpha.com/news/3505724-kyowa-kirins-nourianz-now-available-u-s

Arcadia Bio +4% premarket on JV update with Archipelago Ventures

Arcadia Biosciences (NASDAQ:RKDA) is up 4% premarket after an update on its Joint Venture (JV) with Legacy Ventures Hawaii, Archipelago Ventures. The JV has:

Expanded its cultivation footprint on Hawaii by 3x, from 10 to 30 acres, through partnerships with two new license holders.

Introduced a new autoflowering hemp varietal to Hawaii’s pilot program.

Begun the build of large-scale mobile extraction and processing equipment to produce tetrahydrocannabinol (THC)-free, sun-grown hemp isolate or distillate.

https://seekingalpha.com/news/3505726-arcadia-bio-plus-4-percent-premarket-jv-update-archipelago-ventures

Relmada up on positive REL-1017 data in treatment-resistant depression

Relmada Therapeutics (NASDAQ:RLMD) announces positive results from a Phase 2 clinical trial evaluating REL-1017 (dextromethadone) in adult patients with major depressive disorder (MDD) who have failed to respond adequately to as many as three prior courses of treatment with antidepressant medication. The study assessed two daily doses (25 mg and 50 mg) as adjunctive treatment.

Participants in both dose arms experienced statistically significant improvements in their depression compared to placebo across all efficacy measures (four scales) with a favorable safety profile.

The company plans to meet with the FDA to clarify a registration path.

Fast Track-tagged dextromethadone is an orally administered NMDA receptor antagonist. The company says it does not have the unwanted psychomimetic side effects of ketamine.

Shares up 84% premarket on increased volume, albeit on turnover of only 14K shares.

https://seekingalpha.com/news/3505730-relmada-84-percent-premarket-positive-relminus-1017-data-treatment-resistant-depression

ViewRay gains on preliminary Q3 results

ViewRay (NASDAQ:VRAY) is up 13% premarket on announcing preliminary Q3 2019 results:

Q3 total revenue of $20.9M, compared to $17.7M in Q3 2018.

Received 8 new orders for MRIdian systems, totaling ~$35M.

Total backlog grew to ~$231M as of September 30, 2019.

Cash and equivalents were ~$92M as of September 30.

The Company reaffirmed its FY 2019 guidance of revenue in the range of $80M – 95M, and cash use in the range of $80M – 90M.

The company will hold a conference call on November 12, 2019 at 4:30 p.m. ET / 1:30 p.m. PT to discuss results.

https://seekingalpha.com/news/3505743-viewray-plus-13-percent-premarket-preliminary-q3-results

Cel-Sci up on continuation of Phase 3 Multikine study

CEL-SCI (NYSEMKT:CVM) is up 4% premarket on modestly higher volume in reaction to its announcement that its Phase 3 clinical trial evaluating MultiKine (leukocyte interleukin, injection), combined with chemo agent cyclophosphamide, NSAID indomethacin and zinc in a multivitamin combo prior to radiotherapy, in head and neck cancer patients will continue unchanged until the requisite number of events (deaths) have occurred for the primary endpoint of overall survival.

Secondary endpoints include progression-free survival and quality of life measures.

The estimated completion date is December per ClinicalTrials.gov.

MultiKine is mass-produced biologic containing 14 natural human cytokines designed to boost the immune response to cancer. The company is developing the immunotherapy as a neoadjuvant to be administered right after diagnosis and before surgery.

https://seekingalpha.com/news/3505750-cel-sci-4-percent-premarket-continuation-phase-3-multikine-study