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KOD For The Long Haul, GMDA Turning Heads, TNDM Jumps On Analyst Upgrade

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The following are some of today's top gainers in the pharma/biotech sector.

1. Kodiak Sciences Inc. (KOD)

Gained 25.74% to close Wednesday's (Nov.21) trading at $9.77.

News: No news

Recent event:

The Company went public on the Nasdaq Global Market on October 4, 2018, offering its shares at a price of $10.00 each.

Expected Upcoming Milestones:

-- Initiation of KSI-301 Phase 1b study in patients with wet age-related macular degeneration(AMD), diabetic macular edema(DME), or retinal vein occlusion(RVO) in 2018.
-- Presentation of Phase 1 dose escalation study of KSI-301 in patients with diabetic macular edema in 2019.
-- Completion of enrollment in KSI-301 Phase 1b study in patients with wet AMD, DME, or RVO in 2019.
-- Initiation of KSI-301 Phase 2 head-to-head study against aflibercept in patients with wet AMD in 2019.
-- Completion of China pre-IND meeting for KSI-301 in 2019.

2. Kiniksa Pharmaceuticals Ltd. (KNSA)

Gained 24.17% to close Wednesday's trading at $20.29.

News: No news

Near-term Catalysts:

-- Report additional open-label phase II proof-of-concept clinical trial data of Rilonacept in recurrent pericarditis and close enrollment in the trial later this year.
-- Initiate phase III study for Rilonacept in recurrent pericarditis this year.
-- Initiate phase II clinical trial for Mavrilimumab in giant cell arteritis in the coming months.
-- Initiate phase IIa/IIb clinical trial of KPL-716 in prurigo nodularis in the first quarter of 2019.

3. OpGen Inc. (OPGN)

Gained 17.92% to close Wednesday's trading at $1.25.

News: No news

Recent event:

On November 14, the Company reported third quarter 2018 financial results and provided business update.

The net loss for the third quarter of 2018 was $3.3 million or $0.53 per share compared to a net loss of $3.3 million or $1.74 per share for the third quarter of 2017. Total revenue for the third quarter of 2018 dropped to $0.6 million from $0.7 million in the comparable year-ago quarter due to a decline in revenue from legacy QuickFISH rapid diagnostic testing products.

Near-term Catalysts:

-- File a 510(k) submission with the FDA in early 2019 for the Acuitas AMR Gene Panel u5.47 (IVD) to support full commercial launch for clinical use for testing of bacterial isolates.
-- Complete clinical evaluations and file 510(k) submissions with the FDA for the Acuitas AMR Gene Panel u5.47 (IVD) and the Acuitas Lighthouse Software for rapid testing of urine specimens and prediction of antibiotic resistance to front-line antibiotics.

4. Gamida Cell Ltd. (GMDA)

Gained 16.57% to close Wednesday's trading at $11.47.

News: No news

Pipeline:

Gamida Cell's lead product candidate is NiCord, a Phase III NAM-expanded cord blood cell therapy in patients with number of hematologic malignancies. NiCord is also being explored for bone marrow failure disorders, and is being evaluated in a Phase I/II trial in patients with severe aplastic anemia.

Also in the pipeline is NAM-NK that is currently in an investigator-sponsored Phase 1 trial in combination with antibodies in adult patients with relapsed or refractory multiple myeloma or non-Hodgkin lymphoma.

Recent event:

The Company went public on the Nasdaq Global Market on October 26, 2018, offering its shares at a price of $8.00 each.

Near-term Catalysts:

-- New translational data for NiCord, under phase III development for allogeneic stem cell, or bone marrow, transplant, will be presented at the American Society of Hematology (ASH) 2018 Annual Meeting on December 1, 2018.

5. Tandem Diabetes Care Inc. (TNDM)

Tandem Diabetes is a medical device company and manufacturer of the only touchscreen insulin pumps with continuous glucose monitoring integration.

Gained 14.69% to close Wednesday's trading at $32.63.

News: The Company's stock has been upgraded to "Outperform" from "Neutral" by Robert W. Baird & Co analyst Jeff Johnson. However, the analyst has lowered his price target to $46 from $49.

Recent event:

On November 1, while reporting its financial results for the quarter ended September 30, 2018, the Company boosted its sales guidance for the year.

The revised sales outlook range for the year ending December 31, 2018, is $160 million to $165 million, which represents an annual sales growth of 49 percent to 53 percent compared to 2017.

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