8 Top Gainers In Healthcare Sector (BPTH, ORGO, PTE...)

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

1. Bio-Path Holdings Inc. (BPTH)

Gained 54.48% to close Monday's (Mar.11) trading at $32.44.

The stock has been heading higher ever since the Company announced an update to its phase II trial of Prexigebersen for the treatment of acute myeloid leukemia on March 6.

News: No news

Recent events:

On March 6, the Company provided a clinical update to the previously reported interim analysis from Stage 1 of its phase II trial of Prexigebersen for the treatment of acute myeloid leukemia, revealing an improvement in efficacy profile and strong evidence of safety profile.

The Stage 1 of the study evaluated the efficacy and safety of Prexigebersen in conjunction with low dose cytarabine (LDAC), a therapeutic regimen well-established in the treatment of acute myeloid leukemia. The Stage 2 of the study is evaluating the efficacy and safety of Prexigebersen in conjunction with Decitabine in addition to the cohort evaluating Prexigebersen in conjunction with LDAC.

On January 18, a 1-for-20 reverse stock split was implemented.

Clinical Trials & Near-term Catalysts:

-- A phase II study of Prexigebersen, comprising of two Stages, in the treatment of acute myeloid leukemia is underway. -- A phase IIa clinical study of Prexigebersen in combination with the frontline therapy, Dasatinib, for the treatment of chronic myeloid leukemia (CML) in accelerated and blast phase patients is ongoing. -- A phase I clinical trial of Prexigebersen in patients with advanced solid tumors, including ovarian and uterine, pancreatic and hormone refractory breast cancer is expected to be initiated this year. -- A phase I clinical trial of BP1002 in refractory or relapsed lymphoma and chronic lymphocytic leukemia (CLL) patients is anticipated to be initiated in 2019.

2. Organogenesis Holdings Inc. (ORGO)

Organogenesis is a regenerative medicine company focused on the development, manufacture, and commercialization of product solutions for the Advanced Wound Care and Surgical and Sports Medicine market.

Gained 37.70% to close Monday's trading at $10.19.

News: No news

Near-term Catalyst:

The Company is slated to report fourth quarter and fiscal year 2018 financial results after the market closes on Monday, March 18.

3. Agile Therapeutics Inc. (AGRX)

Agile Therapeutics is a women's healthcare company.

Gained 26.32% to close Monday's trading at $1.44.

News: The Company announced that its Senior Vice President and Chief Financial Officer, Scott Coiante will present at Oppenheimer's 29th Annual Healthcare Conference on Tuesday, March 19, 2019.

Near-term Catalysts:

-- The Company's lead product candidate is Twirla, a contraceptive patch. On December 22, 2017, the FDA refused to approve Twirla. Among other requirements, the FDA has recommended a comparative wear study between Twirla and Xulane. The results of this comparative wear study are expected to be reported this quarter. -- The Company expects resubmission of Twirla NDA in the first half of 2019.

4. Seres Therapeutics Inc. (MCRB)

Seres Therapeutics is a microbiome therapeutics platform company developing a novel class of biological drugs. The Company's most advanced program is SER-109, in Phase 3 development for recurrent C. difficile infection. Next up in the pipeline is SER-287, in a Phase 2b study in patients with active mild-to-moderate ulcerative colitis. Seres is also advancing SER-401 into clinical development to augment the efficacy of current immuno-oncology treatments.

Gained 24.85% to close Monday's trading at $6.38.

News: The Company has entered into a three-year research collaboration with AstraZeneca.

Under the collaboration, research will evaluate microbiome-based approaches as a predictor for which patients may respond best to certain cancer immunotherapies.

Additionally, SER-401, an investigational microbiome therapeutic, may be studied in combination with AstraZeneca compounds targeting various cancers.

Seres is entitled to receive $20 million from AstraZeneca in three equal installments over two years, with the first payment due at the start of the agreement. In addition, AstraZeneca will also reimburse Seres for research activity related to the collaboration. Seres will maintain rights to oncology targeted microbiome therapeutic candidates, and AstraZeneca will obtain the option to negotiate for rights to those programs and other inventions arising out of the collaboration.

5. PolarityTE Inc. (PTE)

PolarityTE is a commercial-stage biotechnology and regenerative biomaterials company.

Gained 22.25% to close Monday's trading at $16.43.

News: Cantor Fitzgerald analyst Elemer Piros has set a price target of $65 for the Company's stock in the backdrop of the FDA closing its investigation into the company's manufacturing processes.

6. Tonix Pharmaceuticals Holding Corp. (TNXP)

Gained 20.36% to close Monday's trading at $3.37.

News: The Company has enrolled the first patients in the RECOVERY study, a new phase III study of Tonmya 5.6 mg for the treatment of posttraumatic stress disorder (PTSD). The study is designed to enroll approximately 250 participants across approximately 30 clinical sites in the U.S. The top-line results from this study are expected in the first half of next year.

7. Biocept Inc. (BIOC)

Biocept is a commercial provider of liquid biopsy tests designed to provide physicians with clinically actionable information to improve the outcomes of cancer patients.

Gained 18.63% to close Monday's trading at $1.21.

News: No news

Near-term Catalyst:

The Company is slated to report Q4, 2018, financial results in the last week of March.

The net loss for the third quarter of 2018 was $6.0 million or $2.42 per share on revenue of $762,000.

8. Aridis Pharmaceuticals Inc. (ARDS)

Aridis is a late-stage biopharmaceutical company developing targeted immunotherapy using fully human monoclonal antibodies, or mAbs, to treat life-threatening infections.

Gained 15.99% to close Monday's trading at $10.30.

News: No news

Clinical Trials & Near-term Catalysts:

-- The lead drug candidate is AR-301 (Salvecin, or tosatoxumab), being developed as an adjunctive immunotherapy in combination with standard of care antibiotics to treat acute pneumonia caused by S. aureus infection. AR-301 is a phase III-ready compound. -- A phase I/IIa clinical study of AR-501 for treatment of chronic bacterial lung infections in patients with cystic fibrosis is underway. Phase 1 data are anticipated during the fourth quarter of 2019 and Phase 2a data are anticipated for the fourth quarter of 2020. -- A worldwide phase II clinical study of AR-105 in ventilator-associated pneumonia patients infected with P. aeruginosa is underway, with top-line results anticipated in mid-2019. -- A phase II/III clinical study of AR-101 in hospital-acquired pneumonia (HAP) and ventilator-associated pneumonia patients is planned for 2019.