16.08.2017 04:15:27
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Gainers & Losers Of Aug.15: DOVA, OTIC, GTHX, OMER, ALT...
(RTTNews) - The following are some of the biotech stocks that made their way onto the Day's Gainers & Losers' list of August 15, 2017.
GAINERS
1. Dova Pharmaceuticals Inc. (DOVA)
Gained 22.01% to close Tuesday's (Aug.15) trading at $21.81. This is the second straight day of double digit gain.
News: No news
Recent events:
-- On August 10, 2017, the Company reported Q2, 2017 financial results.
Net loss for the second quarter of 2017 was $5.5 million or $0.32 per share compared to a net loss of $7.3 million or $0.42 per share for the same period in 2016.
-- The Company made its trading debut on the NASDAQ Global Market on June 29, 2017 at an opening price of $19.25, about 13% higher than the IPO price of $17.
Pipeline:
The Company's lead product candidate is Avatrombopag for the treatment for thrombocytopenia in patients with chronic liver disease (CLD). The compound was tested in two pivotal clinical trials, ADAPT 1 and ADAPT 2, in which all primary and secondary endpoints were met with high statistical significance.
Near-term catalyst:
The Company expects to file an NDA for Avatrombopag in the third quarter of 2017.
2. Otonomy Inc. (OTIC)
Gained 13.08% to close Tuesday's trading at $19.45.
News: No news
Near-term catalysts:
-- The top line data from a phase III trial of OTIVIDEX in Ménière's disease, dubbed AVERTS-1, are expected to be announced in September. -- The top line data from its second phase III trial of OTIVIDEX in Ménière's disease, dubbed AVERTS-2, are anticipated by the end of 2017. -- A phase II study of OTO-311 for the treatment of patients with tinnitus is expected to be initiated by the end of 2017. -- The supplemental New Drug Application for the approval of OTIPRIO as a treatment for patients with Acute Otitis Externa is under FDA review - with a decision date set for March 2, 2018. OTIPRIO was approved by the FDA for the treatment of pediatric patients with bilateral otitis media with effusion undergoing tympanostomy tube placement in December 2015.
3. G1 Therapeutics Inc. (GTHX)
Gained 10.77% to close Tuesday's trading at $14.40.
News: No news
The Company made its debut on the NASDAQ on May 17, 2017, offering its shares at a price of $15.00 each.
Pipeline:
The Company has 3 drug candidates in its pipeline namely, Trilaciclib, G1T38 and G1T48.
Trilaciclib is under four Phase 2 clinical trials - three studies in patients with small-cell lung cancer (SCLC), and one study in patients with triple-negative breast cancer. G1T38 is under a phase 1b/2a study for the treatment of ER+, HER2- breast cancer. G1T48 is currently in IND-enabling studies, and is on track for Phase 1 clinical development in the fourth quarter of 2017.
Near-term catalysts:
-- Investigational New Drug application filing for G1T38 in non-small cell lung cancer is expected in the fourth quarter of 2017. -- IND filing for G1T48 in ER+, HER2- breast cancer is expected in the fourth quarter of 2017. -- Top-line data from a phase 2a study of Trilaciclib in first-line small-cell lung cancer are expected in the first quarter of 2018. -- Enrollment for the phase 2a trial of Trilaciclib in second/third-line small-cell lung cancer is expected in the second quarter of 2018. -- Preliminary Phase 1b data for G1T38 plus Faslodex in ER+ breast cancer are anticipated in the second quarter of 2018.
4. ImmunoGen Inc. (IMGN)
Gained 9.79% to close Tuesday's trading at $6.28.
News: No news
Recent event:
On July 28, 2017, the Company reported narrower-than expected Q2 results on higher revenue.
Near-term catalyst:
-- The Company anticipates filing an investigational new drug application for IMGN632, which is being developed to treat a range of hematological malignancies, this quarter (3Q, 2017).
5. Athenex Inc. (ATNX)
Gained 6.87% to close Tuesday's trading at $16.50.
News: No news
Recent event:
The Company announced its financial results and business highlights for the second quarter of 2017 on Aug.14, 2017.
Net loss in the recent second quarter widened to $38.6 million from $12.5 million in the year-ago quarter. Revenue for the second quarter of 2017 was $4.6 million compared to $5.2 million in the same period in 2016.
Looking ahead, the Company expects full-year revenues in the range of $30 million to $34 million.
Near-term catalysts:
-- First interim analysis from phase III study of Oraxol in Metastatic Breast Cancer is expected in the second half of 2017. -- Feedback from FDA post-interim data on path forward for Oraxol NDA is also expected in the second half of 2017. -- Data from phase II study of KX-01 in actinic keratosis are also expected in the second half of 2017. -- Commencement of two phase III studies for KX-01 in the second half of 2017.
6. Endo International plc (ENDP)
Gained 6.82% to close Tuesday's trading at $8.14.
News: No news
Recent event:
The Company reported second-quarter 2017 financial results on August 8, 2017.
Adjusted income from continuing operations for the recent second quarter rose to $207 million or $0.93 per share from $192 million or $0.86 per share in the year-ago quarter. Revenues for the second quarter of 2017 were $876 million, a 5 percent decrease compared to second-quarter 2016 revenues of $921 million.
Looking ahead to full year 2017, the Company expects total revenues to be between $3.38 billion to $3.53 billion. The Company generated revenues of $4.01 billion in 2016.
The GAAP loss per share from continuing operations for 2017 is expected to be between $4.76 and $4.46 and adjusted EPS from continuing operations are forecast to range between $3.35 and $3.65.
LOSERS
1. Surgery Partners Inc. (SGRY)
Lost 13.68% to close Tuesday's trading at $9.15.
News: No news
Recent event:
On August 8, 2017, the Company reported disappointing Q2, 2017 financial results and trimmed its revenue outlook for the year.
In the second quarter of 2017, the Company's net loss attributable to Surgery Partners was $4.5 million or $0.09 per share compared to net income of $2.1 million or $0.04 per share for the same period last year. Total revenues for the recent second quarter decreased 0.5% to $288.4 million from $289.7 million for the second quarter of 2016.
Looking ahead to full year 2017, the Company now expects revenue in the range of $1.18 billion to $1.20 billion, which reflects 7% to 9% growth over 2016. Previously, the Company was expecting 2017 revenue growth of 9% to 11%. The revised outlook of this year reflects the recent softness in healthcare utilization and payor mix shift experienced during the second quarter.
2. aTyr Pharma Inc. (LIFE)
Lost 10.77% to close Tuesday's trading at $2.90.
News: No news
Recent event:
On August 14, 2017, the Company reported operating results for the second quarter ended June 30, 2017.
Net loss narrowed to $12 million or $0.51 per share from $15.4 million or $0.65 per share in the year-ago quarter.
As of June 30, 2017, the Company had $57.2 million in cash.
Pipeline:
The Company's most advanced drug candidate is Resolaris which is being developed for adult Limb girdle muscular dystrophy 2B; adult Facioscapulohumeral muscular dystrophy (FSHD) and early onset FSHD; iMod.Fc for interstitial lung diseases and ORCA programs.
aTyr recently completed two extension studies of Resolaris in patients with limb-girdle muscular dystrophy 2B (LGMD2B), adult facioscapulohumeral muscular dystrophy (FSHD), and early onset FSHD. Top-line results from Phase 1b/2 trial of Resolaris in patients with early onset FSHD were announced in April of this year.
Another drug candidate iMod.Fc for interstitial lung diseases is expected to move into phase I testing later this year.
3. Altimmune Inc. (ALT)
Lost 9.52% to close Tuesday's trading at $2.09.
News: No news
Near-term catalysts:
-- A Phase 2 trial of NasoVAX influenza vaccine is expected to commence during 3Q-2017 with initial data expected in 1Q-2018. -- Initial clinical data from an ongoing Phase 1 trial of HepTcell for chronic hepatitis B are expected in 4Q-2017. -- A bridging study of SparVax-L anthrax vaccine in the gold standard pre-clinical model is anticipated to begin during the 2H-2017, with topline data anticipated in the 1H-2018. -- A Phase 1 trial NasoShield anthrax vaccine is expected to begin during the 1Q-2018, with topline data anticipated in the 2Q-2018.
4. Tonix Pharmaceuticals Holding Corp. (TNXP)
Lost 8.95% to close Tuesday's trading at $2.85.
News:
The Company reported Q2, 2017 financial results on Aug.14, 2017.
Net loss for the recent second quarter was $4.8 million or $0.65 per share compared to a net loss of $9.8 million or $4.97 per share for the second quarter of 2016.
Near-term catalyst:
Interim results from a phase III trial of Tonmya in military-related PTSD (posttraumatic stress disorder) in the United States, dubbed HONOR, are due 1H18, with top-line results scheduled for 2H18.
5. Omeros Corporation (OMER)
Lost 8.49% to close Tuesday's trading at $22.52.
News: The Company has offered to sell 3 million shares of its common stock to the public at a price of $22.75 per share. The offering is expected to close on or about August 18, 2017.
In addition, Omeros has granted the underwriters a 30-day option to purchase up to 450,000 additional shares of its common stock.
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Aktien in diesem Artikel
Endo International plc | 0,06 | 0,00% | |
Omeros Corp | 7,20 | 19,40% | |
Otonomy Inc | 0,07 | -2,64% | |
Surgery Partners Inc | 22,20 | 0,91% |