(RTTNews) - The following are some of today's top gainers in the healthcare sector.
1. Celsion Corp. (CLSN)
Celsion is an oncology drug development company.
The Company's lead program is ThermoDox, which is currently in phase III development for the treatment of primary liver cancer, dubbed OPTIMA. Also in the pipeline is an immunotherapy candidate, GEN-1, currently in phase I/II development for the localized treatment of ovarian cancer, dubbed OVATION 2.
Gained 27.52% to close Thursday's (Nov.14) trading at $1.39.
News: The Company announced financial results for the third quarter ended September 30, 2019, and provided an update on its development programs for ThermoDox and GEN-1.
As of September 30, 2019, the Company had cash of $18.8 million. On October 1, 2019, the Company announced it received approval from the New Jersey Economic Development Authority's (NJEDA) Technology Business Tax Certificate Transfer (NOL) program to sell its unused New Jersey net operating losses (NOLs) and R&D tax credits.
With the cash in hand of $18.8 million, coupled with planned future sales of the Company's New Jersey NOLs totaling approximately $4 million in 2019 and 2020, the Company believes it has sufficient capital resources to fund its operations into the first half of 2021.
-- The second preplanned interim efficacy analysis for the OPTIMA Study is expected to occur in the second quarter of 2020. -- Last week, the Independent Data Safety Monitoring Board (DSMB) unanimously recommended continuation of the phase I portion of OVATION 2 study.
2. Precision BioSciences Inc. (DTIL)
Precision BioSciences is a genome editing company.
Gained 24.60% to close Thursday's trading at $11.80.
News: No news
Pipeline & Near-term Catalysts:
The most advanced program in the pipeline is PBCAR0191, an allogeneic CAR T cell therapy, being developed for acute lymphoblastic leukemia, or ALL, and non-hodgkin lymphoma, or NHL.
-- A Phase 1/2a clinical trial of PBCAR0191 in adult patients with relapsed or refractory (R/R) non-Hodgkin's lymphoma (NHL) or R/R B-cell precursor acute lymphoblastic leukemia (B-ALL) is underway. Updated results from the trial will be presented at the ASH annual meeting on December 9, 2019. -- A Phase 1/2a clinical trial of PBCAR20A for the treatment of patients with NHL, chronic lymphocytic leukemia (CLL), and small lymphocytic lymphoma (SLL) is expected to be initiated in the fourth quarter of 2019, with initial data expected in 2020.
3. Harrow Health Inc. (HROW)
Harrow Health owns a portfolio of healthcare businesses, including ophthalmology pharmaceutical compounding business, ImprimisRx. The Company's subsidiaries include Eton Pharmaceuticals, Surface Pharmaceuticals, Melt Pharmaceuticals, Mayfield Pharmaceuticals, Radley Pharmaceuticals, and Stowe Pharmaceuticals Inc.
Gained 23.48% to close Thursday's trading at $5.68.
News: The Company announced third-quarter financial results for the period ended September 30, 2019.
Net loss attributable to the Company widened to $11.5 million or $0.45 per share from $2.5 million or $0.12 per share in the year-ago quarter. Total revenue in the recent quarter increased to $12.75 million from $10.74 million in the year-earlier period.
4. XBiotech Inc. (XBIT)
XBiotech is a clinical-stage biopharmaceutical company developing therapeutic antibodies.
Gained 14.59% to close Thursday's trading at $13.12.
News: No news
Clinical Trials & Near-term Catalysts:
-- A phase II clinical trial evaluating anti-IL-1? Therapy Bermekimab in patients with moderate to severe Atopic Dermatitis is underway. -- Another phase II clinical study evaluating Bermekimab in patients with moderate to severe Hidradenitis Suppurativa is underway. An earlier double-blind, placebo controlled, randomized study, which evaluated Bermekimab in the treatment of Hidradenitis Suppurativa, had met its primary endpoint, demonstrating significant improvement of HiSCR in patients treated with bermekimab compared to control after 12 weeks of therapy. -- A phase II study of Bermekimab in patients with systemic sclerosis enrolled the first patients as recently as last month.
5. Axonics Modulation Technologies, Inc. (AXNX)
Axonics Modulation is a medical technology company whose rechargeable sacral neuromodulation (SNM) device, Axonics r-SNM System, has secured marketing approvals in Europe, Canada, and Australia. The device was approved in the U.S. as recently as November 13, 2019.
In the U.S., Medtronic's InterStim and InterStim II are the only other approved SNM devices. Sacral neuromodulation therapy is primarily used to treat patients with overactive bladder ("OAB"), fecal incontinence ("FI") and urinary retention ("UR").
Gained 13.61% to close Thursday's trading at $28.96.
News: The Company announced financial results for the third quarter ended September 30, 2019.
Net loss for the third quarter of 2019 was $25.0 million or $0.89 per share compared to $7.6 million or $2.67 per share in the prior-year quarter. Net revenue in the recent third quarter rose to $1.3 million from $0.2 million for the same period of last year.
The Company is now focused on the launch of Axonics r-SNM System in the U.S. market.