06.07.2018 03:35:46
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ECYT Up 269% YTD, MOTS Gains Momentum, PBT434 Breathes Life Into PRAN
(RTTNews) - The following are some of today's top gainers in the pharma/biotech sector.
1. Prana Biotechnology Limited (PRAN)
Gained 25.67% to close Thursday's (Jul 5) trading at $2.35.
News: The Company has enrolled and dosed its first cohort of healthy volunteers in its Phase I clinical trial of PBT434, an experimental drug under investigation for the treatment of Parkinsonian diseases.
The trial is conducted in Melbourne, Australia, and the primary goal is to demonstrate the safety and tolerability of PBT434.
2. Pain Therapeutics Inc. (PTIE)
Gained 20.47% to close Thursday's trading at $2.59.
News: No news
Recent event:
On June 26, 2018, an FDA panel recommended against approval of the Company's investigational pain drug Remoxy ER. The FDA's final decision on Remoxy ER is expected by August 7, 2018.
Remoxy was rejected by the FDA in December 2008, June 2011, and in September 2016.
3. Endocyte Inc. (ECYT)
Gained 14.85% to close Thursday's trading at $15.62. The stock touched a new 52-week high of $15.85 in intraday trading.
News: No news
Clinical trials & Near-term Catalyst:
-- A phase III trial of 177Lu-PSMA-617 in metastatic castrate-resistant prostate cancer, dubbed VISION, was initiated last month. -- A phase II trial comparing 177Lu-PSMA617 Theranostic against *Cabazitaxel in men with progressive metastatic castration resistant prostate cancer is underway.
Cabazitaxel (Jevtana) is an FDA-approved chemotherapy drug used to treat men with metastatic castration-resistant prostate cancer who previously received a docetaxel-containing regimen.
-- The Company expects to have an Investigational New Drug application submitted in the fourth quarter of 2018 for its adaptor-controlled CAR T-cell therapy which will be initially studied in osteosarcoma.
4. Motus GI Holdings Inc. (MOTS)
Gained 14.52% to close Thursday's trading at $8.52.
News: No news
Recent events:
-- On June 22, 2018, the Company was added to the Russell Microcap Index. -- On May 23, 2018, the Company announced the enrollment of the first patient in its REDUCE (Reliable Endoscopic Diagnosis Utilizing Cleansing Enhancement) study.
The REDUCE study is a single-arm multi-center, prospective study that will utilize the Pure-Vu System to facilitate bowel cleansing in approximately 100 hospitalized patients who are indicated for a diagnostic colonoscopy procedure.
The Pure-Vu System is FDA-cleared and CE-Marked in the indication of cleaning of a poorly prepared colon during the colonoscopy procedure.
Near-term Catalyst:
-- Data from the REDUCE study are expected in the fourth quarter of this year.
5. PolarityTE Inc. (COOL)
Gained 11.81% to close Thursday's trading at $28.97.
News: No news
PolarityTE is a commercial-stage biotechnology and regenerative biomaterials company. Shares of PolarityTE have taken a hit, losing 25% of their value, following a report by short-selling firm Citron research on June 25, 2018.
6. Evofem Biosciences Inc. (EVFM)
Gained 11.52% to close Thursday's trading at $2.71.
News: No news
Clinical Trials & Near-term Catalysts:
The Company's lead product candidate is Amphora, a non-hormonal, surfactant-free bioadhesive vaginal gel.
-- A phase III clinical trial of Amphora for the prevention of pregnancy and a phase IIb/III clinical trial of Amphora for the prevention of urogenital chlamydia and gonorrhea in women are underway.
Data from the phase III clinical trial of Amphora for the prevention of pregnancy are expected in Q1, 2019.
-- A phase I trial of multipurpose prevention technology (MPT) vaginal gel for prevention of Bacterial Vaginosis was recently completed. The Company is currently designing a phase 2b/3 trial for this indication.
The first patient in the phase 2b/3 trial of MPT for Bacterial Vaginosis is expected to be enrolled in Q4, 2018.
-- Resubmit Amphora NDA for contraception in Q2, 2019. A Complete Response Letter was issued by the FDA on April 28, 2016.
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