08.06.2017 06:15:07
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Gainers & Losers Of June 7: NH, CRUS, PTCT, ANAB, ACRX...
(RTTNews) - The following are some of the biotech stocks that made their way onto the Day's Gainers & Losers' list of June 7, 2017.
GAINERS
1. NantHealth Inc. (NH)
Gained 14.38% to close Wednesday's (June 7) trading at $3.58.
News: No news
NantHealth is a personalized healthcare company. It derives revenue from sales of licensed software and maintenance, software-as-a-service, hardware, services, and its universal diagnostics solution GPS Cancer to healthcare providers, payors and self-insured employers. The Company made its debut on the NASDAQ Global Select Market on June 2, 2016, offering its shares at a price of $14.00 each.
Recent event:
On May 10th, the Company reported financial results for its first quarter ended March 31, 2017.
Net loss was $41.1 million or $0.34 per share in Q1, 2017 compared with $33.1 million or $0.36 per share in the year-ago quarter. For the 2017 first quarter, total net revenue increased 16% to $22.5 million from $19.5 million in Q1, 2016.
2. Cerus Corp. (CERS)
Gained 11.49% to close Wednesday's trading at $2.62.
Cerus is a biomedical products company, and its flagship product is INTERCEPT Blood System, designed to reduce the risk of transfusion-transmitted infections. Cerus relies solely on Fresenius Kabi for the production of INTERCEPT Blood System kits.
News: The expected Fresenius Kabi platelet additive solution (PAS) shortage, which the Company announced on May 23, 2017, could be less disruptive to blood center production of INTERCEPT platelets than initially anticipated.
Last month, the Company received a notification of a pending U.S. supply shortage of a platelet additive solution (PAS) manufactured and sold by Fresenius Kabi, which could temporarily impact certain U.S. blood centers that utilize PAS to produce INTERCEPT platelets.
Following last month's notification, the Company had lowered its 2017 product revenue guidance to a range of $38 million to $46 million, down from its prior range of $43 million to $48 million.
3. bluebird bio Inc. (BLUE)
Gained 11.15% to close Wednesday's trading at $109.15. The stock has continued to rally since the ASCO presentation of June 5, 2017.
Recent event:
On June 5, 2017, the Company reported promising updated results from its ongoing Phase 1 clinical study of bb2121 in 18 patients with relapsed/refractory multiple myeloma. bb2121 is co-developed by bluebird and Celgene.
4. Editas Medicine Inc. (EDIT)
Gained 10.22% to close Wednesday's trading at $15.64. The stock has recovered most of its losses after the May 30th research paper.
News: SEC filings dated June 6, 2017 reveals that the Company's Chief Medical Officer Cox Gerald Frank bought 4,000 shares at $14.15 each, and Director Boris Nikolic purchased 35,000 shares at a price of $14.07 each.
Recent event: On May 30, 2017, a research paper titled, "Unexpected mutations after CRISPR-Cas9 editing in vivo" unnerved investors of gene editing companies like Editas, sending the Company's stock down nearly 12% to $13.75.
In a study conducted on mice that had undergone CRISPR gene editing, when their entire genome was sequenced, the researchers found that there were hundreds of unintended mutations in their genome.
Stephen Tsang, co-author of the study, said, " Researchers who aren't using whole genome sequencing to find off-target effects may be missing potentially important mutations. Even a single nucleotide change can have a huge impact."
5. PTC Therapeutics Inc. (PTCT)
Gained 8.11% to close Wednesday's trading at $15.47.
News: The Company's new drug application for Translarna, a treatment for nonsense mutation Duchenne muscular dystrophy, is all set to be reviewed by an FDA panel on September 28, 2017.
The FDA's final decision on Translarna is slated for October 24, 2017.
In the European Union, Translarna has been available for the treatment of nonsense mutation Duchenne muscular dystrophy in ambulatory patients aged five years and older in since December 2014. Translarna was given conditional approval by the European Medicines Agency in August 2014.
Translarna generated net product sales of $81.4 million in 2016 compared to $33.7 million in the prior year.
6. Kite Pharma Inc. (KITE)
Gained 8.11% to close Wednesday's trading at $15.47.
News: The Company made a presentation at Jefferies 2017 Global Healthcare Conference
Near-term catalysts:
-- The Biologics License Application for Axicabtagene Ciloleucel for the treatment of patients with aggressive Non-Hodgkin Lymphoma (NHL) is under priority review, with a decision date set for November 29, 2017. -- The Company expects to make EU submission for Axicabtagene Ciloleucel in Q3, 2017. -- Data from safety expansion of phase II trial of Axicabtagene Ciloleucel for the treatment of patients with relapsed or refractory aggressive non-Hodgkin lymphoma (NHL) who are ineligible for transplant, dubbed ZUMA-1, are anticipated in the second half of 2017. -- Data from a phase 1/2 clinical study of KTE-C19 for the treatment of adult patients with relapsed or refractory Acute Lymphoblastic Leukemia, dubbed ZUMA-3, are anticipated in the second half of 2017. -- Data from a phase 1/2 clinical study of KTE-C19 for the treatment of pediatric and young adult patients with relapsed or refractory Acute Lymphoblastic Leukemia, dubbed ZUMA-4, are anticipated in the second half of 2017. -- Data from a phase 1b/2 clinical study of KTE-C19 in combination with FDA-approved Genentech's Tecentriq in patients with refractory diffuse large B-cell lymphoma (DLBCL) are anticipated in the second half of 2017.
LOSERS
1. AnaptysBio Inc. (ANAB)
Lost 16.17% to close Wednesday's trading at $19.29. This is the third straight day of loss.
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.
2. Fluidigm Corporation (FLDM)
Lost 10.54% to close Wednesday's trading at $3.99.
News: No news
Recent event: On May 4, the Company reported financial results for the first quarter ended March 31, 2017.
Total revenue for Q1, 2017 was $25.5 million, a decrease of 12% from $29.0 million in the first quarter of 2016 and an increase of 2% from $25.1 million in the fourth quarter of 2016.
Non-GAAP net loss for the first quarter of 2017 narrowed to $9.6 million or $0.33 per share from $11.5 million or $0.40 per share for the first quarter of 2016.
For the second quarter of 2017, the total revenue is projected to be in the range of $22 million to $24 million.
3. AcelRx Pharmaceuticals Inc. (ACRX)
Lost 8.16% to close Wednesday's trading at $2.25.
News: The FDA has notified the Company that it no longer plans to hold an advisory committee meeting to review the NDA for DSUVIA, proposed for the treatment of moderate-to severe acute pain.
The decision does not alter the Prescription Drug User Fee Act (PDUFA) goal date for completion of the review of the DSUVIA NDA, which remains October 12, 2017.
In February, when the Company's New Drug Application for DSUVIA was accepted for review by the FDA, the regulatory agency had communicated to AcelRx that it plans to hold an Advisory Committee meeting to review the DSUVIA application, and that the date will be determined later.
4. Jounce Therapeutics Inc. (JNCE)
Lost 6.95% to close Wednesday's trading at $16.87. This is the stock's third straight day of loss.
News: No news
Recent events:
-- The Company made its debut on the NASDAQ Global Select Market on January 27, 2017, offering its shares at a price of $16.00 each. -- The Company commenced enrollment in phase II portion of its Phase 1/2 study of JTX-2011 in patients with solid tumors on April 20, 2017. The Phase 1/2 study of JTX-2011 is known as ICONIC study. -- On June 5, 2017, the Company reported promising phase I data from the ICONIC study of JTX-2011.
The Phase 1 portion of the Phase 1/2 ICONIC study was a dose-escalation study to assess safety and tolerability of JTX-2011 and to determine the recommended Phase 2 dose of JTX-2011 as a monotherapy and in combination with nivolumab.
Near-term catalyst:
-- Preliminary efficacy data from the ICONIC study is expected to be disclosed in the second half of 2017.
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Aktien in diesem Artikel
AnaptysBio Inc Registered Shs | 23,40 | -1,68% | |
bluebird bio Inc | 0,38 | 2,11% | |
Cerus Corp. | 1,70 | 0,29% | |
Editas Medicine Inc | 2,07 | 0,00% | |
Fluidigm Corp | 1,70 | 1,80% | |
PTC Therapeutics Inc | 42,00 | -6,67% |