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GLMD On Watch, ARDS On The Move, MDCO Gets New CEO

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

1. Teligent Inc. (TLGT)

Teligent is a specialty generic pharmaceutical company.

Gained 30.80% to close Wednesday's (Dec.12) trading at $1.80.

News: No news

Recent events:

-- On November 16, the Company was notified that it is not in compliance with NASDAQ Listing Rule 5250(c)(1), which requires timely filing of periodic financial reports with the SEC.

The Company has time until January 14, 2019, to either file the Form 10-Q or submit a plan to NASDAQ in order to regain compliance with NASDAQ's Listing Rules. Additional time to file the Form 10-Q was required primarily due to transition to its newly engaged audit firm, as well as the need to amend its second quarter results, according to the Company.

-- On November 13, the Company announced its financial results for the third quarter ended September 30, 2018.

Total revenue was $18.3 million in the third quarter of 2018, an increase of 42% over the same period in 2017. So far this year, the Company has received FDA approval for twelve ANDAs and has launched six products in the U.S. The Company has 22 ANDAs on file with the FDA.

2. Galmed Pharmaceuticals Ltd. (GLMD)

Gained 18.56% to close Wednesday's trading at $9.39.

News: No news

Near-term Catalysts:

-- Initiation of ARMOR, a phase III pivotal study of Aramchol in subjects with non-alcoholic steatohepatitis, or NASH, is expected at the end of the second quarter of 2019 or early in the third quarter of 2019.

The Company's cash and cash equivalents, short term deposits and marketable debt securities totaled $92.3 million as of September 30, 2018.

3. Aridis Pharmaceuticals Inc. (ARDS)

Gained 16.88% to close Wednesday's trading at $9.00.

News: The Company has enrolled the first subject in its phase 1/2a clinical study of AR-501 for treatment of chronic bacterial lung infections in patients with cystic fibrosis.

The study will accrue 48 healthy adult volunteers and 48 cystic fibrosis patients from approximately 15 sites in the U.S. Phase 1 data are anticipated during the fourth quarter of 2019 and Phase 2a data are anticipated for the fourth quarter of 2020.

Clinical Trials & Near-term Catalysts:

-- The lead drug candidate is AR-301 (Salvecin, or tosatoxumab), being developed as an adjunctive immunotherapy in combination with standard of care antibiotics to treat acute pneumonia caused by S. aureus infection. A phase III study of AR-301 is expected to be initiated near the end of 2018.
-- AR-105, as an adjunctive immunotherapy with standard of care antibiotics to treat acute pneumonia caused by P. aeruginosa infection, is under a phase II trial. Top-line results from this study are anticipated in mid-2019.
-- AR-101 to treat acute pneumonia caused by P. aeruginosa serotype O11, which is expected to enter a phase II/III trial in 2019.

4. Alliqua BioMedical Inc. (ALQA)

Gained 12.38% to close Wednesday's trading at $2.31.

News: No news

Recent event:

On November 28, the Company announced that it will be spinning off its AquaMed Technologies Inc. subsidiary and merging it with TO Pharmaceuticals LLC to create an independent, publicly traded company focused on cannabinoid-based pharmaceutical therapies. The transaction is expected to close by the first quarter of 2019.

5. The Medicines Company (MDCO)

Gained 11.64% to close Wednesday's trading at $23.11.

News: The Company announced that it proposes to offer $150 million aggregate principal amount of convertible senior notes due 2024.

Recent event:

On December 11, the Company announced the appointment of Mark Timney as its new Chief Executive Officer and a member of the Board of Directors, effective immediately.

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