27.07.2017 03:22:13
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Gainers & Losers Of July 26: TTPH, PETQ, AXSM, EGRX, ANAB...
(RTTNews) - The following are some of the biotech stocks that made their way onto the Day's Gainers & Losers' list of July 26, 2017.
GAINERS
1. Tetraphase Pharmaceuticals Inc. (TTPH)
Gained 14.20% to close Wednesday's (July 26) trading at $7.88.
News: The Company reported positive top line results from its phase III trial of intravenous (IV) Eravacycline in complicated intra-abdominal infections (cIAI), dubbed IGNITE4.
The IGNITE4 trial evaluated the efficacy and safety of intravenous (IV) Eravacycline against Meropenem in complicated intra-abdominal infections. According to the study results, Eravacycline achieved high clinical cure rates in patients with complicated intra-abdominal infections, comparable to patients in the Meropenem group.
In a previous phase III study, dubbed IGNITE1, the results of which were reported in December 2014, Eravacycline met the primary endpoint of statistical non-inferiority of clinical response at the test-of-cure (TOC) visit.
Tetraphase plans to submit a New Drug Application for intravenous (IV) Eravacycline, based on data from the IGNITE1 and IGNITE4 clinical trials, to the FDA in the first quarter of 2018. The Company also remains on track to submit a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) during the third quarter of 2017.
Up next...
The Company has commenced an underwritten offering of $60 million of shares of its common stock. Tetraphase intends to grant the underwriters a 30-day option to purchase up to an additional $9 million of shares of its common stock on the same terms and conditions as the offering.
2. InVivo Therapeutics Holdings Corp. (NVIV)
Gained 9.09% to close Wednesday's trading at $2.40.
News: No news
Pipeline:
The Company's lead product candidate is Neuro-Spinal Scaffold, an investigational device, currently being evaluated in a pivotal study for the treatment of patients with spinal cord injury, dubbed INSPIRE.
Near-term catalyst:
The Company expects to complete enrollment in the INSPIRE study during the third quarter of this year.
3. PetIQ Inc. (PETQ)
Gained 8.04% to close Wednesday's trading at $23.64.
Recent events:
-- The Company made its stock market debut on July 24, 2017 at an opening price of $24.30, higher than the offering price of $16.00 per share. -- On May 8, 2017, the Company launched Advecta3, a new to market flea and tick treatment for dogs with the same active ingredients used in K9 Advantix II that sells at a fraction of the price at Walmart.
4. Axsome Therapeutics Inc. (AXSM)
Gained 7.89% to close Wednesday's trading at $6.15.
News: The Company reported positive top line clinical trial results from a Phase 1 pharmacokinetic study of AXS-06, being developed for the treatment of osteoarthritis and rheumatoid arthritis.
AXS-06 is a novel, oral, non-opioid, fixed-dose combination of meloxicam and esomeprazole.
The study, conducted in healthy volunteers, compared the pharmacokinetics of meloxicam and esomeprazole (meloxicam 15 mg, esomeprazole 40 mg) against commercially available Mobic tablets (15 mg meloxicam) and Nexium capsules (40 mg esomeprazole). The median Tmax for meloxicam, the trial's primary endpoint, was 9 times faster for AXS-06 compared to Mobic. (T max is the time taken to reach the maximum concentration).
AXS-06 also demonstrated higher mean maximum plasma concentration (Cmax), faster time to therapeutic plasma concentration, and time to half-maximal plasma concentration compared to Mobic.
LOSERS
1. Eagle Pharmaceuticals Inc. (EGRX)
Lost 23.80% to close Wednesday's trading at $53.37.
News: The FDA has refused to approve RYANODEX for the treatment of exertional heat stroke, in conjunction with external cooling methods.
Ryanodex is already approved for the treatment of malignant hyperthermia, a potentially fatal, inherited disorder causing a rapid rise in body temperature (fever) and severe muscle contractions associated with administration of certain general anesthetics and/or the drug succinylcholine.
The drug brought in sales of $11.7 million for Eagle Pharma last year.
2. Pernix Therapeutics Holdings Inc. (PTX)
Lost 8.70% to close Wednesday's trading at $3.15.
News: No news
Recent events:
-- On July 20, 2017, the Company announced a series of refinancing transactions to provide up to $45 million in aggregate new capital to grow its business. -- The same day, the Company also announced certain preliminary unaudited financial results for the second quarter ended June 30, 2017.
The net revenue for Q2, 2017 is expected to be between $33.0 and $35.0 million compared to net revenue of $36.7 million in the second quarter of 2016. Net loss for the second quarter of 2017 is expected to be between $20.5 million and $24.5 million, an improvement over second quarter net loss of $31.1 million.
The full second quarter 2017 financial and operating results are scheduled to be announced on July 27, 2017.
3. Dicerna Pharmaceuticals Inc. (DRNA)
Lost 7.66% to close Wednesday's trading at $3.98.
News: No news
Near-term catalysts:
-- The Company plans to commence Phase 1 clinical trials of liver-targeted GalXC product candidates in the first quarter of 2018. -- The Company expects to file an IND application for a second GalXC clinical candidate targeting an undisclosed rare disease in the second quarter of 2018. -- The Company expects to file an IND application for DCR-HBV, which targets HBV directly, around the end of 2018.
4. AnaptysBio Inc. (ANAB)
Lost 7.63% to close Wednesday's trading at $25.77. This is the second straight day of loss for the stock.
News: No news
Near-term catalysts:
-- Top-line results from a phase 2a clinical trial for ANB020 in adult patients with severe peanut allergy are anticipated during the second half of 2017. -- Top-line results from a phase 2a clinical trial for ANB020 for the treatment of adults with moderate-to-severe atopic dermatitis are anticipated during the second half of 2017. -- Top-line results from a Phase 1 clinical trial in healthy volunteers in Australia in which ANB019 is being administered in single and multiple doses, through subcutaneous and intravenous routes of administration are expected during the second half of 2017. AnaptysBio plans to initiate Phase 2 studies for the treatment of two orphan inflammatory diseases, generalized pustular psoriasis and palmo-plantar pustular psoriasis, using ANB019 during 2018.
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Aktien in diesem Artikel
AnaptysBio Inc Registered Shs | 21,20 | 4,95% | |
Axsome Therapeutics Inc | 93,82 | -0,40% | |
Eagle Pharmaceuticals Inc | 3,54 | -4,84% | |
PetIQ Inc Registered Shs -A- | 17,60 | 1,73% |