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FDA To Decide On APRI's ED Drug, KURA Nails It, MBRX Dynamic, GLMD Awaits ARREST

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

1. Moleculin Biotech Inc. (MBRX)

Gained 53.85% to close Thursday's (Feb.15) trading at $2.80.

News: The Company announced the discovery of a new molecule, what it believes, based on preclinical testing, is a major breakthrough in its effort to develop a new cancer treatment that selectively kills highly resistant tumors.

The new compound WP1732 is a STAT3 inhibitor, which is capable of shutting down tumor activity. WP1732's properties make it a promising candidate for treating pancreatic cancer, one of the most resistant and deadly forms of cancer, according to the Company.

There is already 1 STAT3 inhibitor in the Company's pipeline WP1066, for brain tumors, which is expected to enter phase I testing in March 2018.

2. AMAG Pharmaceuticals Inc. (AMAG)

Gained 29.14% to close Thursday's trading at $17.95.

News: The FDA approved the Company's subcutaneous auto-injector form of Makena, designed as a ready-to-administer treatment, to reduce the risk of preterm birth in women who are pregnant with one baby and who spontaneously delivered one preterm baby in the past.

Makena, a long acting form of natural progesterone, in intramuscular injection formulation was approved by the FDA in February 2011.

Makena's market share has increased over the years. Sales of Makena were $251 million in 2015, $334 million in 2016, and it is expected to be $385 million to $395 million in 2017.

Recent event:

-- On February 5, 2018, the FDA approved the Company's supplemental New Drug Application to expand Feraheme's use in all eligible adult patients with iron deficiency anemia who have failed or cannot tolerate oral iron treatment.

Upcoming event:

-- The Company is slated to report fourth quarter and full year 2017 financial results on February 28, 2018.

3. Galmed Pharmaceuticals Ltd. (GLMD)

Gained 27.71% to close Thursday's trading at $6.96.

News: No news

Recent event:

-- Yesterday (Feb.14), the Company announced that its proof-of-concept phase IIa clinical trial of Aramchol in patients with HIV-associated Non-alcoholic fatty liver disease (NAFLD) and lipodystrophy, dubbed ARRIVE, did not meet the primary endpoint of improvement of liver fat at 12 weeks, as measured by MRI-PDFF. The news sent the stock plunging 42.39% to $5.45.

Near-term Catalyst:

-- A phase IIb clinical trial evaluating Aramchol in patients with biopsy proven NASH who are overweight or obese, and who are pre-diabetic or type-II-diabetic, dubbed ARREST, is underway. Top line data from ARREST is expected in Q2 2018.

4. Antares Pharma Inc. (ATRS)

Gained 18.69% to close Thursday's trading at $2.35.

News: Makena auto-injector, which received FDA approval on Thursday, is developed by AMAG with its device partner Antares Pharma.

5. Health Insurance Innovations Inc. (HIIQ)

Gained 14.79% to close Thursday's trading at $31.05.

News: The Florida Office of Insurance Regulation has given consent to the Company to operate as a third-party insurance administrator in the State of Florida.

The Texas Department of Insurance has also closed the investigation that was initiated against the Company in September 2016 for alleged violations of advertising rules and licensing violations. The investigation has found no violation on part of the Company, and the matter is considered resolved without penalty or fine from the Texas Department of Insurance.

6. Apricus Biosciences Inc. (APRI)

Gained 14.75% to close Thursday's trading at $3.19.

News: No news

Near-term Catalyst:

-- The Company's resubmitted New Drug Application for Vitaros awaits the FDA's final word, which is expected on February 17, 2018.

Vitaros is a novel, on-demand topical cream for the treatment of erectile dysfunction, in-licensed from Warner Chilcott Co. Inc., now a subsidiary of Allergan plc. (AGN).

This is Vitaros' second go-around with the FDA. It was turned down by the U.S. regulatory agency in July 2008, with questions being raised about the results of a transgenic mouse carcinogenicity study, which were completed in 2002.

7. ARMO BioSciences Inc. (ARMO)

Gained 14.30% to close Thursday's trading at $48.29.

News: No news

Recent event:

On January 26, 2018, the Company went public, offering its shares at a price of $17 each.

Pipeline:

The Company's lead drug candidate is AM0010, which is under a phase III pivotal clinical trial in pancreatic cancer patients. The compound is also under Phase 1/1b clinical trial as a therapy for non-small cell lung cancer, renal cell carcinoma, colorectal carcinoma and melanoma.

The Company also has a number of other immuno-oncology product candidates under pre-clinical testing, and they include, AM0001; AM0003; AM0015 and AM0012.

8. GenMark Diagnostics Inc. (GNMK)

Gained 12.03% to close Thursday's trading at $4.75.

News: No news

Recent event:

-- On January 9, 2018, the Company provided preliminary financial results for the quarter and year ended December 31, 2017.

Total revenue for the fourth quarter of 2017 is expected to be approximately $16.0 million, representing an increase of 8% over the fourth quarter of 2016. Total revenue for 2017 is expected to be approximately $52.5 million, representing an increase of 7% over 2016.

Upcoming event:

-- The Company is slated to report Q4 and full-year 2017 financial results after market close on Tuesday, February 27, 2018.

9. Kura Oncology Inc. (KURA)

Gained 11.67% to close Thursday's trading at $21.05.

News: The updated preliminary results from the Company's phase II clinical trial of its lead product candidate, Tipifarnib, in patients with head and neck squamous cell carcinomas with HRAS mutations are promising.

Nine patients with HRAS mutant head and neck squamous cell carcinomas had been enrolled in the phase II trial as of the February 8, 2018 data cutoff date.
Five out of the six evaluable patients achieved a confirmed, partial response as defined by standard RECIST criteria for an overall response rate of 83%, including durable responses of more than 18 months in two patients. The sixth evaluable patient experienced tumor shrinkage and prolonged disease stabilization, according to the Company.

A phase III trial of Tipifarnib in HRAS mutant HNSCC is anticipated to be initiated later this year.

10. Denali Therapeutics Inc. (DNLI)

Gained 11.51% to close Thursday's trading at $23.34.

News: No news

Clinical Trials:

-- A phase I study of DNL201 in healthy volunteers in the U.S., and a phase I study of DNL151 in healthy volunteers in the Netherlands are underway. The two compounds are being developed for Parkinson's disease.

The Company plans to select either DNL201 or DNL151 to move into studies in Parkinson's disease patients carrying a LRRK2 mutation after completion of Phase 1 healthy volunteer studies for both molecules.

Recent event:

--The Company made its stock market debut on December 8, 2017, at a price of $18.00 per share.

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