Fate Therapeutics ($FATE) reported receiving the FDA nod for its Investigational New Drug (IND) application for FATE-NK100 in advanced solid tumors. The company now plans to start and open-label, accelerated dose-escalation study called DIMENSION for assessing the candidate as monotherapy and in combination with monoclonal antibody therapy in treatment-resistant patients. The main endpoint of the study is to establish safety and the maximum tolerated dose of a single IV infusion of FATE-NK100. Its secondary endpoints include efficacy endpoints such as progression-free survival and response rate.
The company stock gained over 141 percent in the past 12 months while its YTD gain stands at 65 percent.
OncoSec Medical Inc. ($ONCS) announced that it has agreed to collaborate with Merck on a Phase 2 clinical trial, PISCES. The trial is designed to evaluate the combination of ImmunoPulse IL-12 and KEYTRUDA (pembrolizumab) in metastatic melanoma patients who have progressed after anti-PD-1 therapy. The Phase II study will include the patients whose Stage III/IV metastatic melanoma who are progressing, or have progressed, on previous treatment with an anti-PD-1 therapy. Under the agreement, OncoSec will sponsor and fund the study and Merck will provide KEYTRUDA®.
OncoSec stock has lost 33 percent of its value in the past 12 months and is trading close to its 52 weeks low of $1.03.
Roche ($RHHBY) reported that in a Phase 3 clinical trial, the company’s TECENTRIQ (atezolizumab) failed to demonstrate a statistically valid increase in overall survival (OS) compared to chemo alone. The FDA had granted accelerated approval of TECENTRIQ for this group of mUC patients a year ago. TECENTRIQ (atezolizumab) is designed for the treatment of patients with advanced/metastatic urothelial carcinoma, whose cancer progressed during or after receiving platinum-based chemotherapy.
AstraZeneca ($AZN) reported that its interleukin-13 (IL-13) inhibitor tralokinumab flunked its Phase 3 clinical trial. The drug failed to beat placebo in patients with severe uncontrolled asthma. The efficacy was to be measured by the reduction in annual asthma exacerbation rate (AAER), the primary endpoint.
Proteon Therapeutics ($PRTO) announced receiving the Breakthrough Therapy (BTD) status from the FDA for its lead product candidate vonapanitase for increasing arteriovenous fistula secondary patency. The status provides for more intensive guidance from the FDA on development. It also offers more senior agency personnel and a rolling review of the New Drug Application.
Synthetic Biologics ($SYN) announced receiving a Breakthrough therapy for its co-lead product candidate SYN-004 (ribaxamase) for preventing Clostridium difficile (C. diff) infection. Breakthrough Therapy status provides for more intensive FDA guidance on the best development path, the involvement of more senior agency personnel and a rolling review of the New Drug Application.
Deals and Collaborations
INC Research Holdings ($INCS) announced its merger with inVentiv Health. The all stock deal valued inVentiv at $4.6 billion. The companies claim that the merger will create a biopharmaceutical outsourcing provider with combined net revenue of more than $3.2 billion. INC Research Holdings will own 53% of the combined company.
Mazor Robotics ($MZOR) reported record first quarter revenue of $11.7 million, up 83 percent from $6.4 million in the year-ago first quarter. The Company’s gross margin for the three months ended March 31, 2017 was 64.6% compared to 74.2% in the year-ago first quarter. The company reported its cash generated by operating activities during the first quarter was $0.7 million compared to $2.9 million cash used in operating activities in the year-ago first quarter.
Merrimack Pharmaceuticals Inc. ($MACK) announced its net loss for the first quarter at $29.7 million. On per share basis, it lost $0.23 while its adjusted loss stood at $0.22 per share.
Impact on Share Price
FBR & Co
Mkt Perform -> Mkt Perform
$202.00 -> $200.00
Spark Therapeutics (ONCE)
Goldman Sachs Group
Allergan plc (AGN)
Buy -> Neutral
Cascadian Therapeutics (CASC)
Royal Bank of Canada
$19.00 -> $13.00
Piper Jaffray Companies
Underweight -> Neutral
$11.00 -> $10.00
Henry Schein (HSIC)
Hold -> Hold
$174.00 -> $178.00
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