16.05.2018 03:52:41
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MEIP Gets Funded, PFNX Riding High, GNPX Turns Heads
(RTTNews) - The following are some of today's top gainers in the pharma/biotech sector.
1. MEI Pharma Inc. (MEIP)
Gained 34.39% to close Tuesday's (May 15) trading at $3.40.
News: No news
Recent event:
On May 14, 2018, the Company entered into a definitive securities purchase agreement for the sale of its common stock and warrants to purchase common stock in a private placement led by Vivo Capital and CAM Capital. The gross proceeds from the transaction is expected to be about $75 million.
Near-term Catalysts:
-- An abstract with results from a Phase 1b study of ME-401 in relapsed/refractory chronic lymphocytic leukemia and follicular lymphoma will be presented at the 2018 American Society of Clinical Oncology Annual Meeting in June. -- Results from stage 1 of a Phase 2 dose-optimization study of Pracinostat in myelodysplastic syndrome are expected to be reported in the first half of 2018. -- A phase I single-agent study of Voruciclib in relapsed/refractory B cell malignancies is expected to be initiated in the first half of 2018.
2. Medigus Ltd. (MDGS)
Gained 32.74% to close Tuesday's trading at $1.50.
Medigus is a developer of minimally invasive endosurgical tools.
News: The Company has entered into a 5-year agreement with privately held, Turkey-based MELEKIRMAK, which allows for the distribution of Medigus Ultrasonic Surgical Endostapler (MUSE) equipment in Turkey, Azerbaijan and Georgia.
MUSE enables a single physician to perform an incisionless transoral fundoplication - the procedure intended to treat the anatomical cause of GERD, commonly referred to as acid reflux.
3. Pfenex Inc. (PFNX)
Gained 31.15% to close Tuesday's trading at $8.00.
News: The Company announced positive top-line results from its phase III study of PF708 in osteoporosis patients.
PF708 is a teriparatide therapeutic equivalent candidate to Eli Lilly & Co.'s (LLY) Forteo for the treatment of osteoporosis.
The study results showed comparable overall profiles between PF708 and Forteo after 24 weeks of daily injection in osteoporosis patients.
PF708 is being developed pursuant to the 505(b)(2) regulatory pathway in the United States and references Forteo as the Reference Listed Drug.
Near-term Catalyst:
The Company expects to submit the NDA for PF708 to the FDA in the third quarter of 2018.
4. Genprex Inc. (GNPX)
Gained 20.23% to close Tuesday's trading at $10.58.
News: No news
Clinical Trial:
The Company's initial product candidate is Oncoprex for non-small cell lung cancer, under phase II trial.
Recent event:
The Company went public on the Nasdaq Capital Market on March 29, 2018, offering its shares at a price of $5.00 each.
5. Aptevo Therapeutics Inc. (APVO)
Gained 17.10% to close Tuesday's trading at $5.82.
News: No news
Clinical Trials & Near-term Catalysts:
-- A phase II, two-part, clinical study of Otlertuzumab in combination with chemotherapy drug Treanda in patients with relapsed or refractory peripheral T-cell lymphoma is ongoing. -- Enrollment is underway in a dose escalation phase I study of APVO414, being developed for the treatment of metastatic castration-resistant prostate cancer; top-line preliminary data readout from this trial is anticipated at the end of the year. -- Enroll the first patient in the phase I clinical trial of APVO436 in acute myeloid leukemia and myelodysplastic syndrome in the fourth quarter of 2018. -- Submit an IND for APVO210 in Autoimmune/Inflammatory Diseases in Q4 2018.
6. Heat Biologics Inc. (HTBX)
Gained 16.55% to close Tuesday's trading at $1.69.
News: The Company reported financial and clinical updates for the first quarter ended March 31, 2018.
Net loss attributable to the Company was approximately $3.5 million, or $0.75 per share for the quarter ended March 31, 2018 compared to a net loss of approximately $3.2 million, or $1.18 per share for the quarter ended March 31, 2017.
The Company recognized $0.8 million of grant revenue for qualified expenditures under the CPRIT grant in the recent first quarter.
Near-term Catalysts:
-- Receive $6.9 million in CPRIT (Cancer Prevention Research Institute of Texas) grant funds in Q3, 2018. -- Interim phase II Non Small Cell Lung Cancer data readout of HS-110 in Q4, 2018. -- IND filing for first ComPACT trial of HS-130 in NSCLC in Q4, 2018. -- Enroll first patient in ComPACT trial in Q4, 2018. -- PTX-35 IND filing in Q1, 2019. -- Enroll first patient in PTX-35 trial in Q1, 2019. -- Complete enrollment in Phase 2 NSCLC trial in Q2, 2019. -- Phase II NSCLC data readout in Q2, 2019. -- Interim ComPACT data readout in Q2, 2019. -- Interim PTX-35 data readout in Q3, 2019.
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