28.07.2017 03:40:01
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Gainers & Losers Of July 27: CAPR, ANIK, MMSI, AZN, TTPH, AGEN...
(RTTNews) - The following are some of the biotech stocks that made their way onto the Day's Gainers & Losers' list of July 27, 2017.
GAINERS
1. Capricor Therapeutics Inc. (CAPR)
Gained 28.71% to close Thursday's (July 27) trading at $1.30.
News: The Company announced the results of FDA meeting on Intravenous CAP-1002 for Duchenne muscular dystrophy.
CAP-1002 is under a phase I/II study, dubbed HOPE, in DMD patients. The Company announced positive 6-month results from the HOPE trial in April of this year. The 12-month results from the HOPE Trial are expected to be announced in the fourth quarter of 2017.
The minutes of the meeting indicate:
-- the FDA's willingness to accept Capricor's proposal to use the Performance of the Upper Limb (PUL), an outcomes instrument that was specifically designed to assess upper limb function in ambulant and non-ambulant patients with DMD, as the basis for the primary efficacy endpoint for clinical studies intended to provide substantial evidence of effectiveness of CAP-1002 in support of a Biologics License Application and,
-- the sufficiency of the existing nonclinical safety and efficacy database to support submission of an Investigational New Drug application to clinically evaluate repeat intravenous administration of CAP-1002.
2. Anika Therapeutics Inc. (ANIK)
Gained 7.73% to close Thursday's trading at $51.70.
News: The Company reported strong double-digit revenue and earnings growth for the second quarter of 2017.
Net income for the second quarter of 2017 increased 32% to $11.4 million or $0.76 per share on total revenue of $33.5 million. This compared with a net income of $8.6 million or $0.57 per share and total revenue of $26.6 million for the second quarter of 2016.
Anika also announced the appointment of Joseph Darling, an orthopedic and medical device veteran with broad commercial experience, to the role of President.
3. Merit Medical Systems Inc. (MMSI)
Gained 7.67% to close Thursday's trading at $40.70.
News: The Company reported stellar Q2, 2017 financial results and upped its revenue guidance for the full year.
On a non-GAAP basis, the Company's net income was $18.28 million or $0.36 per share compared to $11.53 million or $0.26 per share in the year-ago quarter. Revenue for the recent second quarter jumped to $186.5 million from $151 million in the comparable year-ago quarter.
Looking ahead, the Company now expects revenue to be in the range of $722-$727 million, up from its prior forecast range of $713-$723 million.
LOSERS
1. AstraZeneca PLC (AZN)
Lost 14.91% to close Thursday's trading at $28.88.
News: The Company failed to achieve the endpoint in its checkpoint inhibitor combo trial, dubbed MYSTIC.
The MYSTIC trial evaluated Imfinzi monotherapy or Imfinzi in combination with investigational Tremelimumab versus platinum-based standard-of-care (SoC) chemotherapy in previously-untreated patients with metastatic (Stage IV) 1st-line non-small cell lung cancer.
Imfinzi and Tremelimumab both belong to a class of drugs known as checkpoint-inhibitors. Imfinzi was approved by the FDA as recently as May of this year. Tremelimumab is an investigational drug, and it was licensed from Pfizer in 2011.
According to the study results, Imfinzi plus Tremelimumab combination did not meet the primary endpoint of progression-free survival compared to chemotherapy. Also, as a secondary endpoint, although not formally tested, Imfinzi monotherapy would not have met a pre-specified threshold of PFS benefit over SoC, noted the Company.
2. Agenus Inc. (AGEN)
Lost 14.83% to close Thursday's (July 27) trading at $4.48.
News: No news
The failure of AstraZeneca's MYSTIC trial is having a domino effect on Agenus, as it is also developing two checkpoint inhibitor antibodies.
3. Tetraphase Pharmaceuticals Inc. (TTPH)
Lost 11.68% to close Thursday's trading at $6.96.
News: The Company announced that it has commenced an underwritten offering of $60 million of shares of its common stock.
Recent events:
On July 26, 2017, the Company reported positive top line results from its phase III trial of intravenous (IV) Eravacycline in complicated intra-abdominal infections (cIAI), dubbed IGNITE4.
Near-term catalysts:
The Company remains on track to submit a Marketing Authorization Application for intravenous (IV) Eravacycline for the treatment of complicated intra-abdominal infections to the European Medicines Agency during the third quarter of 2017. A New Drug Application for intravenous (IV) Eravacycline for the treatment of complicated intra-abdominal infections is expected to be submitted in the first quarter of 2018.
4. Proteostasis Therapeutics Inc. (PTI)
Lost 10.17% to close Thursday's trading at $3.09.
News: No news
Near-term catalysts:
-- Additional data from phase I/II clinical trial of PTI-428 in patients with Cystic Fibrosis are expected to be reported this month. -- Preliminary data from phase I/II clinical trial of PTI-428 in adults diagnosed with CF, who are actively taking Kalydeco are expected during this quarter (3Q, 2017).
5. Minerva Neurosciences Inc. (NERV)
Lost 9.40% to close Thursday's trading at $6.75.
News: No news
Recent events:
-- On July 24, 2017, Michele Ollier and Nico Vandervelpen resigned from the board of directors to focus on their private equity activities. -- On July 5, 2017, the Company announced the closing of its previously announced public offering of 5.75 million shares of its common stock, including 750,000 shares sold pursuant to the underwriters' full exercise of their option to purchase additional shares, at a price to the public of $7.75 per share.
Near-term catalyst:
The Company is scheduled to release financial results and business updates for the second quarter of 2017 on Thursday, August 3, 2017.
6. Strongbridge Biopharma plc (SBBP)
Lost 8.39% to close Thursday's trading at $6.55.
News: No news
Pipeline:
Strongbridge's pipeline includes RECORLEV for treating endogenous Cushing's syndrome under phase III trial, and Veldoreotide for treatment of patients with acromegaly, under phase II testing.
Recent event:
The Company completed its target enrollment of 90 patients in its phase III study of RECORLEV for the treatment of endogenous Cushing's syndrome, dubbed SONICS, as recently as June 27, 2017.
Near-term catalyst:
The top-line results from the SONICS study are expected in the second quarter of 2018.
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Aktien in diesem Artikel
Agenus Inc | 0,44 | 10,94% | |
Anika Therapeutics Inc. | 16,40 | 1,86% | |
AstraZeneca PLC (spons. ADRs) | 60,00 | -0,83% | |
Merit Medical Systems Inc. | 99,00 | 1,02% |