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9 Top Gainers In Healthcare Sector (BPTH, ARQL, SEEL…)

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

1. Bio-Path Holdings Inc. (BPTH)

Gained 223.29% to close Thursday's (Mar.7) trading at $38.86. In intra-day trading, the stock touched a new high of $73.52.

News: The stock has been on a roll ever since the Company announced an update to its phase II trial of Prexigebersen for the treatment of acute myeloid leukemia on March 6. The stock has gained as much as over 1,400% in 2 trading days.

2. Seelos Therapeutics Inc. (SEEL)

Gained 96.13% to close Thursday's trading at $3.04.

News: The Company announced that it has acquired an exclusive license to intellectual property from the Regents of the University of California to potential disease-modifying Parkinson's disease therapy created at the University of California, Los Angeles.

The new program will be known as SLS-007, and in preclinical studies, the compound has shown evidence of slowing progression of the disease - an early sign of disease-modifying potential in Parkinson's disease.

Under the terms of this exclusive license agreement, Seelos has made an upfront payment to The UC Regents/UCLA of $100,000 and will issue future remuneration in the form of royalties, which are contingent upon commercialization.

3. ArQule Inc. (ARQL)

Gained 67.38% to close Thursday's trading at $5.44.

News: The Company provided a promising update to its phase I trial of ARQ 531 in development for B-cell malignancies refractory to other therapeutic options.

One patient in the trial treated with ARQ 531 experienced an 88% tumor burden reduction after the first scan, according to the Company.

Arqule also reported better-than-expected revenue for the fourth quarter and full-year of 2018.

Revenues for the quarter ended December 31, 2018, were $2.94 million compared with revenues of zero for the year-ago quarter. Revenues for the year ended December 31, 2018, were $25.76 million compared to nil revenue for the prior year.

Analysts polled by Thomson Reuters were expecting revenue of $1.82 million for the fourth quarter, and $24.63 million for the full year of 2018.

However, looking ahead to the full year 2019, ArQule expects revenue to range between $3 million and $5 million, which falls short of analysts' consensus estimate of $5.6 million.

4. Cleveland BioLabs Inc. (CBLI)

Gained 50.77% to close Thursday's trading at $1.96.

News: In its Q4 earnings press release, the Company has revealed that it recently completed an in vivo bio-comparability study in non-human primates (NHP) between the drug formulation used in previously conducted preclinical and clinical studies and the Entolimod drug formulation proposed for commercialization under the pre-Emergency Use Authorization or pre-EUA application with the FDA.

Entolimod is in development as a countermeasure against death following total body irradiation.

Pre-EUA is the regulatory path through which the FDA determines that certain unapproved medical products may be used in an emergency when there are no adequate, approved, and available alternatives.

The Company has also sought a meeting to brief the FDA on the results of the NHP bio-comparability data and is preparing responses to the FDA comments on Entolimod chemistry, manufacturing, and controls.

Last August, the Company withdrew the Entolimod Marketing Authorization Application that it had previously submitted to the European Medicines Agency, following a delay in the analysis of the biocomparability data.

5. Diffusion Pharmaceuticals Inc. (DFFN)

Gained 55.90% to close Thursday's trading at $7.00.

News: No news

Clinical Trials:

The Company's lead drug candidate is Trans Sodium Crocinate.

A phase III study of Trans Sodium Crocinate to target inoperable glioblastoma multiforme brain cancer, dubbed INTACT, is underway. The Company was given FDA clearance last September to conduct a phase II on-ambulance trial of Trans Sodium Crocinate for the treatment of stroke.

6. Altimmune Inc. (ALT)

Gained 50.33% to close Thursday's trading at $4.54.

News: No news

Pipeline:

Altimmune is a clinical-stage immunotherapeutics company having four clinical product candidates in its pipeline namely, NasoVAX, a phase II seasonal influenza vaccine candidate, HepTcell, a phase II-ready immunotherapeutic candidate for the potential cure of chronic hepatitis B, SPARVAX-L, a phase II Anthrax vaccine, and NasoShield, a next-generation Anthrax vaccine, under phase I study.

7. Bioblast Pharma Ltd. (ORPN)

Bioblast is a clinical-stage, orphan disease-focused biotechnology company.

Gained 34.54% to close Thursday's trading at $15.19.

News: No news

Recent events:

On March 6, the Company implemented an eight to one reverse split of its share capital.

Bioblast previously announced the execution of a definitive merger agreement to acquire Enlivex Therapeutics Ltd., a privately-held immunotherapy company. One of the conditions to the closing of the merger is that Bioblast effect a reverse stock split of its ordinary shares at least five trading days before the closing of the merger.

8. Trovagene Inc. (TROV)

Trovagene is a clinical-stage oncology therapeutics company.

Gained 30.70% to close Thursday's trading at $4.13.

News: No news

Clinical Trials & Near-term Catalysts:

-- Enrollment in a Phase 1b/2 trial of Onvansertib in metastatic Colorectal Cancer is expected to begin in mid-2019.
-- Preliminary clinical data from a Phase 1b/2 trial of Onvansertib in Acute Myeloid Leukemia is expected to be presented in early April 2019.
-- Preliminary clinical data from a Phase 2 trial of Onvansertib in metastatic Colorectal Cancer is also expected to be presented in early April 2019.
-- A Phase 2 study evaluating Onvansertib in combination with Zytiga in patients with metastatic Castration-Resistant Prostate Cancer is ongoing.

9. Stealth BioTherapeutics Corp (MITO)

Gained 22.20% to close Thursday's trading at $19.43.

News: No news

Recent event:

On March 5, the Company announced the partial exercise and closing of over-allotment option in connection with its previously announced initial public offering of ADSs.

Stealth's ADSs began trading on The Nasdaq Global Market on February 15, 2019, at a public offering price of $12 per ADS.

Clinical Trials & Near-term Catalysts:

The Company's lead product candidate is Elamipretide for rare mitochondrial diseases, including primary mitochondrial myopathy, Barth and Leber's hereditary optic neuropathy.

-- A phase III clinical trial of Elamipretide for the treatment of primary mitochondrial myopathy is underway, and it is expected to be fully enrolled during the first half of 2019.
-- A phase II/III clinical trial of Elamipretide for the treatment of Barth is ongoing, with an end-of-Phase 2 meeting with the FDA regarding this program is planned during the first half of 2019 to discuss a potential NDA submission.
-- Elamipretide is also expected to enter a phase IIb clinical trial for the treatment of patients with geographic atrophy in the first quarter of 2019.

The second clinical-stage product candidate SBT-20, which has completed two Phase 1 clinical safety trials in early-stage Huntington's disease.

The company is also developing SBT-272, a preclinical-stage product candidate, for rare neurodegenerative diseases, such as amyotrophic lateral sclerosis, or ALS. A phase I trial of SBT-272 is expected to be initiated by the end of 2019.

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