BTAI On Fast Track, ERYP Faces Busy Year Ahead, CHMA Turning Heads

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

1. BioXcel Therapeutics Inc. (BTAI)

Gained 80.91% to close Thursday's (Dec.27) trading at $4.36.

News: The Company's investigational drug BXCL501, a proprietary sublingual film of dexmedetomidine, has been granted Fast Track Designation by the FDA for the treatment of acute agitation.

BXCL501 is currently in a phase I single dose, dose-escalation study in healthy adult volunteers. The top-line data from the study is expected in the first half of 2019.

Fast track designation for BXCL501 will help facilitate anticipated registration trials in 2019 upon completion of the phase I study.

2. Avadel Pharmaceuticals plc (AVDL)

Avadel is a branded specialty pharmaceutical company, generating revenue primarily from the sale of pharmaceutical products, previously sold in the U.S. without FDA approval ("Unapproved Marketed Products" or "UMDs").

Gained 40.80% to close Thursday's trading at $2.45.

News: No news

Pipeline:

The lead drug candidate FT218 for the treatment of excessive daytime sleepiness and cataplexy in subjects with narcolepsy is under phase III testing. The study is expected to be completed in September 2019 (Source: ClinicalTrials.gov).

Another company by the name Jazz Pharmaceuticals plc (JAZZ) is developing a drug, Solriamfetol, as a treatment to improve wakefulness and reduce excessive daytime sleepiness in adult patients with narcolepsy or obstructive sleep apnea (OSA). Solriamfetol is under FDA review, with a decision date set for March 20, 2019.

3. Novus Therapeutics Inc. (NVUS)

Novus is a specialty pharmaceutical company focused on developing products for patients with disorders of the ear, nose, and throat.

Gained 31.58% to close Thursday's trading at $2.00.

News: No news

Pipeline:

The lead product candidate is OP-02, a drug-device product being developed as a first-in-class treatment option for otitis media. The first-in-human clinical study with OP-02 in healthy adults was initiated last month.

Near-term Catalysts:

-- A phase I study of OP-02 in children with otitis media with effusion, and a phase I study in adults with acute otitis media are expected to be initiated in the first half of 2019.

-- Top-line data from the phase I studies is expected in the first half of 2019.

4. ERYTECH Pharma S.A. (ERYP)

ERYTECH is a clinical-stage biopharmaceutical company developing innovative red blood cell-based therapeutics for cancer and orphan diseases.

Gained 25.27% to close Thursday's trading at $6.94.

News: No news

Pipeline:

The Company's lead product candidate is Eryaspase, which is in phase III clinical development for the treatment of second-line pancreatic cancer that recently started enrolling patients in Europe.

Near-term Catalysts:

-- A phase III trial of Eryaspase for the treatment of second-line pancreatic cancer in the U.S. is expected to be initiated early in 2019. -- A phase II trial of Eryaspase in first-line triple negative breast cancer (TNBC) is expected to begin enrollment in the United States early in 2019.

5. Chiasma Inc. (CHMA)

Gained 24.06% to close Monday's trading at $2.63.

Chiasma is a clinical-stage biopharmaceutical company developing drugs for rare and serious chronic diseases.

News: No news

Clinical Trials & Near-term Catalysts:

The Company's lead drug candidate is MYCAPSSA (octreotide capsules), being developed as a maintenance treatment for adult patients with acromegaly.

A phase III trial of octreotide capsules in adult acromegaly patients (at least 20% of whom must be recruited from the United States) whose disease is biochemically controlled, dubbed CHIASMA OPTIMAL, is ongoing.

Topline data from the CHIASMA OPTIMAL trial is expected by September 2019 Another trial known as MPOWERED, which is an international phase III clinical trial under a protocol accepted by the European Medicines Agency evaluating octreotide capsules product candidate for the maintenance therapy of adult patients with acromegaly, is also ongoing. The trial is scheduled to be completed in the second quarter of 2019, with top-line data anticipated in the second half of 2020.