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Tuesday, October 15, 2019

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

Abbott and Tandem Diabetes to explore integrated solutions for diabetes

Abbott (NYSE:ABT) and Tandem Diabetes Care (NASDAQ:TNDM) intends to develop and commercialize integrated diabetes solutions combining Abbott’s FreeStyle Libre, a sensor-based glucose monitoring system with Tandem’s insulin delivery systems to provide more options for people to manage their diabetes.
TNDM shares were up 5% premarket.
https://seekingalpha.com/news/3505752-abbott-tandem-diabetes-explore-integrated-solutions-diabetes-tndm-shares-5-percent-premarket

Principia Bio up on positive PRN1008 data

Thinly traded Principia Biopharma (PRNB +2.8%) is up out of the gate this morning in response to positive preliminary data from a Phase 1/2 clinical trial evaluating lead candidate PRN1008 for the treatment of immune thrombocytopenia purpura (ITP), a condition characterized by easy bruising and a bleeding tendency due to low blood platelets.
26 participants have been enrolled to date. After a median duration of treatment of almost 13 weeks, 39% (n=10/26) achieved the primary efficacy endpoint of at least two consecutive platelet counts of at least 50K/µL at least five days apart and platelet count increases of at least 20K/µL from baseline without needing rescue medication. Preliminary results across all doses in patients who completed at least 12 weeks of treatment showed a response rate greater than 50% on both both primary endpoints (the other one is safety).
Updated data will be presented at ASH in early December.
PRN1008 is an optimized Bruton’s tyrosine kinase (BTK) inhibitor that the company says enables rapid reversibility of effects on the immune system which makes it suitable for chronic therapy. It is also being developed to treat pemphigus.
https://seekingalpha.com/news/3505761-principia-bio-3-percent-positive-prn1008-data

CRISPR teams up with KSQ Therapeutics on cancer

Gene editor CRISPR Therapeutics (CRSP +3.8%) and CRISPR/Cas9-focused biotech KSQ Therapeutics have inked reciprocal license agreements aimed at advancing cell therapies for cancer.
Under the terms of the respective contracts, CRSP will receive non-exclusive access to KSQ’s intellectual property (IP) for certain novel gene targets in its allogeneic oncology cell therapy programs while KSQ will gain non-exclusive access to CRSP’s IP for editing novel gene targets identified by KSQ as part of its eTIL (engineered tumor infiltrating lymphocyte) cell programs.
Financial terms remain confidential.
https://seekingalpha.com/news/3505780-crispr-teams-ksq-therapeutics-cancer-shares-4-percent