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KOD Catches Eyes, MRNS On Watch, Mark Your Calendar For AQST

pharmaup dec06 lt

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

1. Kodiak Sciences Inc. (KOD)

Gained 22.37% to close Thursday's (Dec.6) trading at $9.30.

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.

Kodiak ended the third quarter of 2018 with $11.6 million of cash and cash equivalents.

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.
-- Completion of enrollment in KSI-301 Phase 1b study in 2019.
-- Initiation of KSI-301 Phase 2 head-to-head study against Eylea in patients with wet AMD in 2019.

2. CorMedix Inc. (CRMD)

Gained 22.22% to close Thursday's trading at $1.65.

News: No news

Clinical Trial & Near-term Catalysts:

The lead product candidate Neutrolin, a novel, non-antibiotic antimicrobial solution designed to prevent costly and dangerous bloodstream infections associated with the use of central venous catheters, is under phase III development for patients undergoing chronic hemodialysis.

The phase III trial of Neutrolin, dubbed LOCK-IT-100, demonstrated efficacy in July of this year. The Company is well on its way to completing locking the data set, and simultaneously preparing to file an NDA with the FDA for Neutrolin.

3. PhaseBio Pharmaceuticals Inc. (PHAS)

Gained 18.29% to close Thursday's trading at $3.88.

News: No news

Recent event:

The Company went public on the Nasdaq Global Market on October 18, 2018, offering its shares at a price of $5.00 each.

Clinical Trials & Near-term Catalysts:

The Company dosed the first patient in a phase 2b trial of PB1046 for the treatment of pulmonary arterial hypertension last month.

In September 2018, PhaseBio announced positive preliminary results from its Phase 1 clinical trial of PB2452, a novel reversal agent for the antiplatelet drug Ticagrelor, marketed as Brilinta.

In July, PhaseBio reported the completion of a Phase 1b/2a multiple ascending dose trial of PB1046 in patients with heart failure with reduced ejection fraction, as well as preliminary data from a pilot study of PB1046 in pulmonary arterial hypertension patients.

4. Marinus Pharmaceuticals Inc. (MRNS)

Gained 17.48% to close Thursday's trading at $5.31.

News: The Company announced Ganaxolone data from its Phase 2 clinical trial in pediatric genetic epilepsies, CDKL5 Deficiency Disorder (CDD) and PCDH19-related pediatric epilepsy (PCDH19 epilepsy).

In the CDD cohort of patients, Ganaxolone showed sustained, long-term effectiveness in treating children with CDD, a refractory form of pediatric epilepsy with no currently approved treatments. This is the first time a treatment has demonstrated long-term effectiveness in reducing seizure frequency in CDD, says the Company.

Data from the cohort of patients with PCDH19 epilepsy identified preliminary evidence of a predictive clinical biomarker showing a significant treatment effect of Ganaxolone in biomarker-positive patients.

5. Aquestive Therapeutics Inc. (AQST)

Gained 15.89% to close Thursday's trading at $8.75.

News: No news

Recent events:

On November 16, 2018, the Company's New Drug Application for tadalafil oral film (OF) was turned down by the FDA.

Tadalafil is a PDE5 inhibitor currently marketed in tablet form for the treatment of erectile dysfunction and benign prostatic hyperplasia (BPH) under the brand name Cialis, and for treatment of pulmonary arterial hypertension under the brand name Adcirca.

On November 29, the Company launched SYMPAZAN (clobazam) oral film with availability nationwide through retail pharmacies and mail order.

SYMPAZAN, the first and only oral film indicated for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age or older, was approved by the FDA on November 1, 2018.

On December 3, 2018, the Company presented encouraging findings from phase II studies of Libervant, which is in development for the management of selected patients with refractory epilepsy who require intermittent use of diazepam to control episodes of increased seizure activity.

Near-term Catalysts:

Top-line data from a swallowing study for AQST-117 (riluzole), an oral soluble film formulation for the treatment of Amyotrophic Lateral Sclerosis is expected this month, with an NDA submission anticipated in the first quarter of 2019.

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