15.05.2019 04:32:22
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5 Top Gainers In Pharma Sector (BPTH, MGTX, NVAX...)
(RTTNews) - The following are some of today's top gainers in the pharma/biotech sector.
1. Novavax Inc. (NVAX)
Novavax is a clinical stage biotechnology company developing products to prevent a broad range of infectious diseases like respiratory syncytial virus (RSV) and influenza.
Gained 23.78% to close Tuesday's (May 14) trading at $7.13.
News: No news
Pipeline:
In February 2019, the Company announced that its phase III clinical trial of ResVax, being developed to protect infants via maternal immunization against respiratory syncytial virus (RSV) disease did not meet the primary objective of prevention of medically significant RSV lower respiratory tract infection. However, the trial showed efficacy against secondary objective of RSV LRTI hospitalization, an important indication of the severity of RSV disease in infants.
In January 2019, Novavax announced positive top-line results of its Phase 2 clinical trial of NanoFlu comparing various quadrivalent formulations, with or without Novavax' Matrix-M adjuvant, with two U.S.-licensed influenza vaccines in older adults.
Recent event:
On May 10, 2019, a one-for-twenty reverse stock split became effective.
Near-term Catalysts:
-- Meet with the FDA, European regulatory agencies, and potentially other national regulatory agencies during the second and third quarters, to assess opportunities for submission of marketing applications for ResVax. -- Reach an agreement with the FDA during the third quarter of 2019 on a proposed Phase 3 clinical trial design for NanoFlu utilizing accelerated approval criteria for licensure.
2. Bio-Path Holdings Inc. (BPTH)
Bio-Path Holdings is a clinical and preclinical stage oncology-focused RNAi nanoparticle drug development company.
Gained 22.20% to close Tuesday's trading at $18.00.
News: No news
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.
Upcoming Event:
On May 16, 2019, the Company is slated to report financial results for the first quarter ended March 31, 2019, and to provide a business overview.
3. MeiraGTx Holdings plc (MGTX)
MeiraGTx Holdings is a clinical-stage gene therapy company.
Gained 20.92% to close Tuesday's trading at $21.50.
News: The Company announced positive topline data from its Phase 1/2 trial of AAV-RPE65 for the treatment of patients with RPE65-deficiency.
RPE65-deficiency is associated with severe and progressive loss of vision.
The trial achieved the primary endpoint of safety and tolerability of AAV-RPE65. Additionally, AAV-RPE65 demonstrated statistically significant improvement across several secondary endpoints designed to assess clinical activity, added the Company.
Additionally, MeiraGTx revealed that dosing of patients in its Phase 1/2 trial of AAV-CNGB3, an investigational gene therapy for the treatment of achromatopsia has been completed.
4. Verastem Inc. (VSTM)
Verastem Oncology is a commercial biopharmaceutical company.
Gained 20.92% to close Tuesday's trading at $21.50.
News: No news
Recent event:
-- On May 10, 2019, the Company reported financial results for the first quarter ended March 31, 2019.
Net loss for the first quarter of 2019 widened to $38.1 million or $0.52 per share from $21.1 million or $0.41 per share in the year-ago quarter. Net product revenue for the recent first quarter was $1.7 million, which reflects the second full quarter of recorded sales for COPIKTRA. The Company did not have any product revenue for the 2018 Quarter as the FDA approved COPIKTRA on September 24, 2018.
COPIKTRA is indicated for the treatment of relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and relapsed or refractory follicular lymphoma (FL).
5. Health Insurance Innovations Inc. (HIIQ)
Health Insurance Innovations operates as a cloud-based technology platform and distributor of individual and family health insurance plans, and supplemental products in the United States.
Gained 13.20% to close Tuesday's trading at $21.35.
News: No news
Recent event:
On May 6, 2019, the Company reported financial results for the first quarter ended March 31, 2019.
Net income declined to $2.2 million or $0.11 per share in the first quarter of 2019, from $6.7 million or $0.36 in the same period in 2018. Revenue in the recent first quarter rose to $87.3 million from $75.9 million in the year-ago quarter.
Looking ahead to the full year 2019, the Company expects adjusted net income per share in the range of $3.50 to $3.75 and revenue in the range of $430 million to $440 million. The annual adjusted net income per share was $2.60 and revenue was $351 million in 2018.
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