13.04.2017 03:55:22
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Gainers & Losers Of Apr.12: ADPT, NBIX, NOVN, PLX, ALBO...
(RTTNews) - The following are some of the biotech stocks that made their way onto the Day's Gainers & Losers' list of April 12, 2017.
GAINERS
1. Adeptus Health Inc. (ADPT)
Gained 108.33% to close Wednesday's (Apr.12) trading at $2.25.
News: Schedule 13D filing by hedge fund Wexford Capital LLC reveals that it picked up a stake of 8.54% in the Company on Apr.5, 2017.
By definition, Schedule 13D is a form that must be filed with the SEC when a person or group acquires more than 5% of any class of a company's shares. (Source: Investopedia).
2. Neurocrine Biosciences Inc. (NBIX)
Gained 24.88% to close Wednesday's trading at $51.80.
News: Ingrezza, the Company's drug to treat adults with tardive dyskinesia received FDA approval.
Ingrezza is the first drug approved by the FDA for tardive dyskinesia.
Tardive dyskinesia is a neurological disorder characterized by repetitive involuntary movements, usually of the jaw, lips and tongue, such as grimacing, sticking out the tongue and smacking the lips.
3. Apricus Biosciences Inc. (APRI)
Gained 20.56% to close Wednesday's trading at $2.17.
News: No news
Near-term catalysts:
-- The Company expects to resubmit the NDA for Vitaros, a topical vasodilator cream in development for the treatment of erectile dysfunction, in the third quarter of 2017.
Vitaros was turned down by the FDA in July 2008, with the regulatory agency questioning the results of a transgenic mouse carcinogenicity study, which were completed in 2002.
-- Apricus is also working towards regaining compliance with the minimum $2.5 million shareholder equity requirement as required for continued listing on The NASDAQ Capital Market under NASDAQ Listing Rule 5550(b)(2) on or before May 30, 2017.
4. Novan Inc. (NOVN)
Gained 20.96% to close Wednesday's trading at $6.29.
News: The Company reported positive top-line results with SB208 in a phase II study. SB208 is an investigational broad-spectrum antifungal gel for the treatment of superficial cutaneous fungal infections of the skin and nails, including tinea pedis and onychomycosis.
In the phase II trial, SB208 Gel, at both the 4% and 16% concentrations, demonstrated a statistically significant effect compared to vehicle in a clinical trial in patients with tinea pedis, or athlete's foot.
The Company plans to initiate a phase II trial of SB208 Gel in patients with onychomycosis, as early as the second half of 2017.
5. CorMedix Inc. (CRMD)
Gained 14.42% to close Wednesday's trading at $1.19.
News: The Company has entered into an exclusive commercial agreement with Toulouse-based Hemotech SA for its CE marked flagship product Neutrolin.
Neutrolin is a non-antibiotic anti-infective developed as a preventative solution to decrease the threat of infection and blood clots (thrombosis), thereby keeping central venous catheters (CVCs) operating safely and efficiently. Neutrolin is not yet approved in the U.S.
Under the agreement, Hemotech will launch CorMedix-supplied Neutrolin in France and certain overseas territories and serve as CorMedix's marketing partner for these regions.
Near-term catalysts:
As mentioned earlier, Neutrolin is not yet approved in the U.S., and is under phase III development.
-- A pivotal phase III study of Neutrolin in hemodialysis patients, dubbed LOCK-IT 100, is underway, and enrollment is expected to be completed by year-end 2017 - with top-line data anticipated in the second half of 2018. -- A pivotal phase III study of Neutrolin in oncology patients, dubbed LOCK-IT 200, is anticipated to commence by the end of this year.
6. ZIOPHARM Oncology Inc. (ZIOP)
Gained 9.90% to close Wednesday's trading at $7.44.
News: No news
Near-term catalyst:
-- A pivotal clinical trial of Ad-RTS-hIL-12 plus veledimex in recurrent glioblastoma is planned for initiation by the end of 2017.
LOSERS
1. Protalix BioTherapeutics Inc. (PLX)
Lost 15.27% to close Wednesday's trading at $1.11.
News: The Company reported results from a phase II trial of alidornase alfa (AIR DNase) for the treatment of Cystic Fibrosis.
Although the results were positive in a number of clinically relevant parameters, suggesting improved lung function with alidornase alfa, investors were disappointed that the lung function improvement in today's result as demonstrated by a mean absolute increase in the percent predicted forced expiratory volume in one second (ppFEV1) was only 3.4 points from baseline.
In January of this year, the interim results of the same phase II trial of alidornase alfa (AIR DNase) for the treatment of Cystic Fibrosis had shown an improvement of 4.1 points from baseline.
2. Pulse Biosciences Inc. (PLSE)
Lost 12.18% to close Wednesday's trading at $20.98.
News: No news
Recent event:
The Company submitted a 510(k) to the FDA for its PulseTx System for a general indication for soft tissue ablation on March 14th.
The PulseTx System is based on the Company's proprietary technology called Nano-Pulse Stimulation, or NPS, and it marks Pulse Bio's first FDA 510(k) submission.
Near term catalyst:
-- The Company expects to initiate the first NPS pilot study in immuno-oncology this year.
Pulse Bio featured in our Company Spotlight column on February 17, 2017 when it was trading around $12.30.
3. Albireo Pharma Inc. (ALBO)
Lost 9.37% to close Wednesday's trading at $21.00.
News: No news
Near-term catalysts:
-- A phase III trial of A4250 in patients with progressive familial intrahepatic cholestasis (PFIC) is planned for initiation in the second half of 2017.
4. Aralez Pharmaceuticals Inc. (ARLZ)
Lost 8.77% to close Wednesday's trading at $1.56.
News: No news
Recent event: On Apr.5th, the Company announced that it is reducing its U.S. sales force by 32% and decreasing its marketing spend on Yosprala, a drug approved for the secondary prevention of cardiovascular disease in patients at risk for Aspirin-associated gastric ulcers.
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Aktien in diesem Artikel
Aralez Pharmaceuticals Inc | 0,43 | 10,26% | |
Neurocrine Biosciences Inc. | 128,95 | -0,31% | |
Pulse Biosciences Inc | 16,80 | 0,60% |