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6 Top Gainers In Healthcare Sector (TNDM, MGTX, TCRR...)

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

1. 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 25.20% to close Wednesday's (Feb.27) trading at $61.86.

News: The Company reported better-than-expected financial results for the fourth quarter and full year ended December 31, 2018.

Net income for the fourth quarter of 2018 was $3.68 million or $0.02 per share on revenue of $76.2 million. Analysts polled by Thomson Reuters were expecting a loss of $0.30 per share and revenue of $56.34 million. The Company incurred a net loss of $11.4 million or $1.23 per share on revenue of $40.3 million in the fourth quarter of 2017.

Looking ahead, the Company has forecast annual sales for 2019 to be in the range of $255.0 million to $270.0 million, well above analysts' consensus estimate of $219.48 million. Sales in 2018 are $183.9 million.

Tandem's President and CEO, Kim Blickenstaff will transition to a newly-created position of Executive Chairman of the Board of Directors. John Sheridan will succeed Blickenstaff, assuming the role of President and CEO effective March 1, 2019.

2. Summit Therapeutics plc (SMMT)

Gained 21.93% to close Wednesday's trading at $2.28.

News: No news

Clinical Trials & Near-term Catalysts:

Two phase III trials of Ridinilazole for C. difficile infection, dubbed Ri-CoDIFy 1 and Ri-CoDIFy 2, are underway, with top-line data expected to be reported in the second half of 2021.

3. Regulus Therapeutics Inc. (RGLS)

Regulus Therapeutics is focused on developing microRNA (miRNA) therapeutics.

Gained 17.70% to close Wednesday's trading at $1.33.

News: No news

Clinical Trials:

The Company's lead investigational microRNA therapeutic is RG-012 for the treatment of Alport syndrome, currently in phase II study, dubbed HERA.

Under an amended agreement, signed in November of 2018, Regulus granted Sanofi a worldwide exclusive license to develop and commercialize RG-012 for all indications, including Alport syndrome.

The other microRNA therapeutic in clinical testing is RGLS4326, being developed for the treatment of autosomal dominant polycystic kidney disease.

The Company voluntarily paused the phase I study for RGLS4326 last July due to unexpected observations in its 27-week mouse chronic toxicity study. That toxicity study was terminated, and a new 27-week chronic mouse toxicity study for RGLS4326 was initiated in September.

The preliminary results of a planned interim data analysis from the new mouse chronic toxicity study of RGLS4326 after 13 weeks of dosing was announced on January 4, 2019. The interim data analysis has shown no adverse or other significant findings across the range of doses tested and is intended to support re-initiation of Phase I RGLS4326 study after consultation with FDA, according to the Company.

Last month, the Company nominated RGLS5579 as a clinical candidate for the treatment of glioblastoma multiforme.

4. MeiraGTx Holdings plc (MGTX)

MeiraGTx Holdings is a clinical-stage gene therapy company.

Gained 16.80% to close Wednesday's trading at $15.50.

News: The Company announced that it has agreed to sell approximately 5.8 million ordinary shares at a price of $13.80 per share. The aggregate gross proceeds from the private placement will be approximately $80 million.

5. Diffusion Pharmaceuticals Inc. (DFFN)

Gained 16.61% to close Wednesday's trading at $3.65.

News: No news

Clinical Trials:

The Company's lead drug candidate is Trans Sodium Crocinate.

A phase III study of Trans Sodium Crocinate to target inoperable glioblastoma multiforme brain cancer, dubbed INTACT, is underway. The Company was given FDA clearance last September to conduct a phase II on-ambulance trial of Trans Sodium Crocinate for the treatment of stroke.

6. TCR2 Therapeutics Inc. (TCRR)

TCR2 Therapeutics is a clinical-stage immunotherapy company developing the next generation of novel T cell therapies for patients suffering from cancer.

Gained 15.43% to close Wednesday's trading at $19.15.

News: The Company announced that the underwriters of its recent initial public offering of common stock have exercised in full their over-allotment option and purchased an additional 750,000 shares at $15.00 per share.

The Company went public on the Nasdaq Global Select Market on February 14, 2019, offering its shares at a price of $15.00 each.

Pipeline:

The company's lead solid tumor product candidate is TC-210, which is a phase I/II trial-ready compound to treat patients with mesothelin-positive solid tumors.
Also in the pipeline are a couple of drug candidates in preclinical testing namely TC-220 for ovarian cancer and TC-110, for CD19-positive B-cell hematological malignancies.

Near-term Catalysts:

-- A phase 1/2 clinical trial of TC-210 in patients with mesothelin-positive solid tumors is expected to be initiated in early 2019, with clinical data expected in the second half of 2019.
-- File IND for TC-110 in the second half of 2019 and expects first clinical data for TC-110 in the second half of 2020.
-- File IND for TC-220 in early 2020 and expects to generate first clinical data in the first half of 2021.
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