6 Top Gainers In Healthcare Sector (AVDL, KOOL, MLNT…)

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

1. 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 32.64% to close Monday's (Sep.23) trading at $4.47.

News: The FDA has agreed to reduce the sample size for the Company's ongoing phase III trial of lead drug candidate FT218 for the treatment of excessive daytime sleepiness and cataplexy in subjects with narcolepsy, dubbed REST-ON.

The REST-ON study will now target enrolling 205 patients, and the Company now expects to complete enrollment by the end of 2019 and have topline data in the second quarter of 2020. Previously, the REST-ON trial had a target of 264 patients and was expected to complete enrollment in the second half of 2020.

2. Melinta Therapeutics Inc. (MLNT)

Melinta is a commercial-stage company focused on the development and commercialization of novel antibiotics to treat serious bacterial infections. The Company has four marketed products - Baxdela, Vabomere, Orbactiv, and Minocin for Injection.

Gained 22.44% to close Monday's trading at $3.82.

News: No news

Clinical Trials & Near-term Catalysts:

-- A supplemental New Drug Application for Baxdela seeking to expand the current indication to include adult patients with community-acquired bacterial pneumonia is under FDA review, with a decision expected on October 24, 2019. The drug is already indicated in adults for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible bacteria. -- A phase I study of a new formulation of Orbactiv versus the approved formulation in subjects with acute bacterial skin and skin structure infections (ABSSSI) is underway.

3. Cesca Therapeutics Inc. (KOOL)

Cesca Therapeutics develops, commercializes and markets a range of automated technologies for CAR-T and other cell-based therapies.

Gained 20.08% to close Monday's trading at $6.40. The stock is up 99% so far this month.

News: No news

Recent events:

On September 9, 2019, the Company signed an exclusive, global distribution agreement to supply its X-Series cell processing products to a major life sciences distributor who will market them globally. The X-Series products are major components of the Company's CAR-TXpress platform, a semi-automated, closed cellular processing platform used for high-efficiency cell purification and cell washing.

On August 13, 2019, the Company reported operating results for the second quarter ended June 30, 2019.

The comprehensive loss attributable to common stockholders for the second quarter of 2019 shrunk to $1.3 million or $0.47 per share on revenue of $4.3 million. This compared with a comprehensive net loss of $27.0 million or $17.49 per share and revenue of $2.0 million in the year-ago quarter.

A one (1) for ten (10) reverse split was effected on June 4, 2019.

4. Dova Pharmaceuticals Inc. (DOVA)

Dova is a pharmaceutical company developing drugs for diseases with a high unmet need. The Company has one approved commercial product, DOPTELET, for the treatment of thrombocytopenia in adult patients with chronic liver disease scheduled to undergo a procedure and the treatment of thrombocytopenia in adults with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment.

Gained 18.48% to close Monday's trading at $17.89.

News: No news

Recent event:

On August 6, 2019, the Company reported financial results for the second quarter ended June 30, 2019.

Net product sales for DOPTELET were $3.5 million for the second quarter of 2019 compared to $1.96 million in the year-ago quarter.

Near-term Catalyst:

A phase III trial evaluating the safety and efficacy of DOPTELET for the treatment of chemotherapy-induced thrombocytopenia is underway, with top-line results expected in the first half of 2020.

5. Atreca Inc. (BCEL)

Atreca is a biopharmaceutical company developing novel antibody-based immunotherapeutics to treat a range of solid tumor types.

Gained 18.18% to close Monday's trading at $13.78.

Recent event:

The Company went public on the Nasdaq Global Select Market on June 20, 2019, offering its shares at a price of $17.00 per share.

Pipeline and Near-term Catalysts:

-- The Company's lead product candidate is ATRC-101, a monoclonal antibody in preclinical development that has demonstrated reactivity with ovarian, non-small cell lung, colorectal and breast cancer samples from multiple patients. -- The Company expects to file an IND application for ATRC-101 in late 2019 and initiate a phase 1b clinical trial in patients with solid tumors in early 2020, subject to FDA approval of IND application.

6. Morphic Holding Inc. (MORF)

Morphic Holding is a preclinical stage biopharmaceutical company developing oral small-molecule integrin therapeutics for serious chronic diseases, including autoimmune, cardiovascular and metabolic diseases, fibrosis and cancer.

Gained 17.33% to close Monday's trading at $20.85.

News: No news

Recent event:

On June 27, 2019, the Company went public on The Nasdaq Global Market, offering its shares at a price of $15 each.

Pipeline and Near-term Catalysts:

-- The Company's lead drug candidate is MORF-720, which is being developed in collaboration with AbbVie Inc. (ABBV) for the treatment of idiopathic pulmonary fibrosis. -- An Investigational New Drug application for MORF-720 is expected to be filed by the end of 2019.