BioShares Biotechnology Clinical Trials (BBC): $20.61, +$0.16, -29.1% YTD
BioShares Biotechnology Products (BBP): $30.95, +$0.19, +0.4% YTD
U.S. stock index futures pointed to a lower open as uncertainty brewed amongst investors regarding the U.S. Federal Reserve’s likelihood of raising interest rates this year. Market participants look
forward to Fed Chair Janet Yellen’s comments at the Jackson Hole symposium next week where she is likely to cement expectations for a slow pace of rate increases. European shares are poised to post their biggest weekly loss in two months and volumes remained
light, a characteristic of the summer trading period. Asian stocks retreated as traders took profits from shares close to one-year highs. The dollar inched higher but was set for weekly losses, while gold fell. Brent crude oil fell after hitting an eight-week
high as weak fundamentals countered a lift in sentiment over talks next month on a possible output freeze.
Advaxis is pleased to participate in Cervivor School in Louisville, Kentucky. Kim Dorney, MSN/RN, Associate Director of Clinical Operations for the upcoming AIM2CERV Phase 3 clinical study, will
provide the opening keynote remarks during tonight’s welcome dinner. Cervivor is a not-for-profit organization that provides community support, education and resources for women who have or have survived cervical cancer. Launched in 2014, Cervivor School
is a weekend-long retreat led by Tamika Felder, a cervical cancer survivor and founder of Cervivor, that brings cervical cancer patients together from across the country to gain a better understanding of the science behind cervical cancer and empowers them
to tell their stories in an impactful and meaningful way.
Portola Pharmaceuticals announced that the MAA for IndexXa (andexanet alfa; trade name in the United States is AndexXa), a Factor Xa inhibitor antidote, has been submitted to the EMA, completed
the validation period, and has been accepted for review. IndexXa is in development for patients treated with a Factor Xa inhibitor when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding and for patients requiring urgent
or emergency surgery. Portola is seeking conditional approval of IndexXa in the EU through the centralized procedure. With the acceptance of the application, the EMA’s CHMP will now begin the centralized review procedure under a standard 210-day review period.
Casebia Therapeutics, the joint venture founded by
Bayer and CRISPR Therapeutics, started its operations in Cambridge, MA, U.S. In December, 2015 Bayer and CRISPR Therapeutics agreed to create a joint venture to discover, develop and commercialize new breakthrough therapeutics to cure blood disorders,
blindness, and congenital heart disease. The two parties formally closed the transaction in the first quarter of 2016.
Alere announced that its Alere i RSV test has received 510(k) marketing clearance from the FDA for the detection of RSV infection in children and adults. Following Alere i Influenza A & B and
Alere i Strep A, Alere i RSV is the latest testing application on the Alere i platform and is the first molecular test that can be used at the point-of-care to detect RSV in 13 minutes or less.
Innovus Pharmaceuticals announced that its partner
Khandelwal Laboratories received the approval of the product licenses for Zestra, Zestra Glide, EjectDelay and Sensum+ from the Indian FDA, The Drugs Controller General (India), and the Directorate General of Health Services to commercialize the products
Cerulean Pharma announced a restructuring including the elimination of 21 positions across the organization representing approximately 48% of the Company’s workforce.
Reuters reported that
Fortress Biotech filed for a mixed shelf offering of up to $53 million.
BTIG analyst Ling Wang initiated coverage of the following companies:
Rockwell Medical with a “buy” rating and $12 target; Tracon Pharmaceuticals
with a “buy” rating and $15 price target; Ophthotech with a “buy” rating and $92 price target;
Acceleron Pharma with a “buy” rating and $46 price target; Agios Pharmaceuticals
with a “neutral” rating; Geron with a “neutral” rating; Merrimack Pharmaceuticals
with a “neutral” rating.
Citi analyst Yigal Nochomovitz decreased his price target to
Atara Biotherapeutics to $8 from $10, citing the company’s cellular therapies look promising for patients, but the economics look unfavorable for shareholders.
Mizuho analyst Irina Koffler upgraded
Allergan to “buy” from “neutral” and increased her price target to $318 from $246, citing upside from higher gross margins and possible quarter beats.
HC Wainwright analyst Ed Arce downgraded
Juniper Pharmaceuticals to “neutral” from “buy” and decreased his price target to $6.75 from $15, citing COL-1077, failed to achieve its primary and secondary endpoints, and that based on these results, the company is discontinuing development of the
William Blair analyst Katherine Xu initiated coverage of the following companies in the Hepatitis B space:
Arbutus Biopharma with an “outperform” rating and $7 price target; Arrowhead Pharmaceuticals with an “outperform” rating and $9 price target;
Assembly Biosciences with an “outperform” rating and $16 price target;
Spring Bank Pharmaceuticals with an “outperform” rating and $26 price target.
analyst Elemer Piros intiated Arrowhead Pharmaceuticals with a “buy” rating and $15 price target, citing Arrowhead is on the cutting edge to provide potentially curative therapies to hepatitis B patients.
analyst Maxim Jacobs decreased his valuation of Orexigen to $4.80 from $14.70, citing increased expenses and adjustment for reverse stock split.
Following Portola Pharmaceuticals’
reception of a Complete Response Letter for AndexXa, Credit Suisse analyst Vamil Divan decreased his price target of to $25 from $30;
Morgan Stanley analyst Matthew Harrison decreased his price target to $28 from $61.
William Blair analyst Tim Lugo increased his price target of
Aclaris Therapeutics to $34 from $30, citing catalyst-rich second half of 2016, with three Phase III SK trial readouts in the fourth quarter.
analyst Joshua Schimmer decreased his price target of Regenxbio to $25 from $33, citing update to gene therapy coverage universe.