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MYOS Muscling Up, CORT Turns Heads, Former FDA Official Joins PTE Board

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

1. MYOS RENS Technology Inc. (MYOS)

Gained 58.88% to close Tuesday's (Dec.11) trading at $1.70.

News: The Company announced that its muscle-enhancing sports nutrition product line, 'Yolked' formulated with Fortetropin will be distributed by The Vitamin Shoppe.

The Vitamin Shoppe will be the first retailer to carry Yolked at its 775 store locations across the U.S. and online at vitaminshoppe.com later this month.

In the third quarter ended September 30, 2018, the Company's net revenues decreased 59% to $66 thousand from $160 thousand for the three months ended September 30, 2017.

2. Corcept Therapeutics Incorporated (CORT)

Gained 32.28% to close Tuesday's trading at $17.70.

News: The Company has been issued a new patent related to the treatment and differential diagnosis of Cushing's disease and ectopic Cushing's syndrome. Corcept's lead drug is Korlym, which was approved by the FDA in 2012, for patients with endogenous Cushing's syndrome.

Teva has been seeking FDA approval to market and sell a generic version of Korlym prior to the expiration of Corcept's U.S. Patent No. 8,921,348, which expires in 2028, and U.S. Patent No. 9,829,495, which expires in 2036. In March of this year, Corcept filed a lawsuit against Teva Pharmaceuticals for infringement of Korlym patents.

Korlym brought home sales of $184 million for Corcept in the first nine months of 2018, and is expected to generate sales of $250-270 million for full year 2018.

3. AAC Holdings Inc. (AAC)

American Addiction Centers is a provider of inpatient and outpatient substance abuse treatment services.

Gained 21.24% to close Tuesday's trading at $2.74.

News: No news

Recent event:

On December 7, the Company announced that its implemented cost reduction program, which includes an aggregate reduction of approximately 200 positions, is currently expected to reduce the total expenses on an annualized basis by approximately $15 million.

The Company currently expects to incur less than approximately $1 million in one-time cash expenditures to fully execute the cost reduction initiatives, the majority of which is expected to be incurred during 2019.

4. Novan Inc. (NOVN)

Gained 19.05% to close Tuesday's trading at $1.50.

News: The Company announced positive top line results from the fourth cohort, SB206 12% once-daily, of its phase II trial of SB206 for the treatment of molluscum contagiosum.

According to the Company, the results demonstrated a clear treatment effect on the complete clearance of all molluscum lesions at Week 12 for 12% once-daily SB206 gel, with signs of efficacy evident as early as Week 2. The safety and tolerability profiles for all treatment groups were favorable, with no serious adverse events reported.

Preliminary top line results from the first three cohorts, 4%, 8% and 12% of SB206 gel twice-daily, were announced in November.

Now that the full results of the phase II study of SB206 gel are available, the Company intends to request, by the end of December, an end-of-Phase 2 meeting with the FDA. If all goes well as planned, the Company plans to initiate a Phase 3 program of SB206 for molluscum in the first half of 2019 - with top line results possible by the end of 2019 or early in 2020.

5. PolarityTE Inc. (PTE)

PolarityTE is a commercial-stage biotechnology and regenerative biomaterials company.
Gained 17.64% to close Tuesday's trading at $16.67.

News: Minnie Baylor-Henry, a former FDA official and Johnson & Johnson executive, has joined PolarityTE's Board of Directors.

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