Biotech Digest – BSX Gets FDA Nod, AMRS Inks Equity Deal, XRAY Reports Q1 Results

Top Pick of the Day: ARRY

Array Biopharma Inc. (ARRY) announced its new collaboration with Merck for a clinical trial for investigating the safety and efficacy of its binimetinib MEK inhibitor with MRK's Keytruda anti-PD-1 therapy in metastatic colorectal cancer patients with microsatellite stable tumors. The trial will be sponsored by Merck and will attempt to establish a recommended dose regimen of binimetinib and Keytruda. The trial will also focus on exploring the preliminary anti-tumor activity of several novel regimens. The study is expected to begin in the second half of 2017. Results from this first study will be used to determine optimal approaches to further clinical development of these combinations.
Array Biopharma stock has gained 136 percent in the past 12 months.

Focus Ticker: BSX

Boston Scientific Corporation (BSX) announced that the FDA has approved its Resonate family of implantable cardioverter defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) systems. The Resonate products are powered by the company's EnduraLife Battery Technology which delivers almost twice the usable battery capacity of certain other pacers. The approval includes new features in the Resonate devices including SmartCRT™ technology with Multisite Pacing capability for multi-electrode pacing. Boston Scientific has also initiated a series of clinical trials, the SMART Registry, SMART CRT Study and SMART MSP, to demonstrate improved response to CRT therapy with SmartCRT technology.
The company has gained 22 percent this year so far.

Sector News

Johnson & Johnson (JNJ) announced that it is being investigated by the Justice Department with regard to its services to a pair of arthritis drugs. Its co-payment support programs are also being looked into by the U.S. Attorney's office in Massachusetts. The support programs being probed are related to hepatitis C drug Olysiotm and Simponi and Crohn's disease drug Stelara.

PTC Therapeutics (PTCT) announced that it will receive a net price of $35k per year per patient for Emflaza, the Duchenne muscular dystrophy drug. The company had acquired the drug from Marathon Pharmaceuticals, which had announced a wholesale list price of $89K annually for the drug after it was approved by the FDA in February.

Approvals

Kite Pharma (KITE) suffered a setback as it reported the death of a patient in safety study testing of its lead product candidate, its KTE-C19 cancer drug. In its latest 10Q, the company said that one of 30 patients in a safety expansion cohort developed multiple organ failure and then fatal cerebral edema.

Deals and Collaborations

Amyris (AMRS) announced that it has inked a deal for equity financing. The deal is expected to be worth as much as $95 million and consists of a direct offering of convertible preferred stock and private placements of convertible preferred stock and warrants. The company said that it is looking to reduce its debt by nearly $75 million.

Alexion Pharmaceuticals (ALXN) reported that its Brazilian office was visited by the authorities as part of an investigation into the company's sales practices in the region. The company spokeswoman said that the firm is “fully cooperating with the authorities.”

Earnings

Endo International Plc (ENDP) reported its revenue at $1.03 billion, an 8 percent increase compared to first-quarter 2016 revenues of $964 million. The company’s reported net  loss from continuing operations stood at $165 million compared to first-quarter 2016 reported net loss from continuing operations at $89 million. Its adjusted net income from continuing operations of $275 million, a 14 percent increase compared to first-quarter 2016 adjusted net income from continuing operations of $241 million.
Dentsply Sirona Inc. (XRAY) reported its net sales for the first quarter of 2017 at $900.5 million, up 16.6% compared to $772.6 million in the first quarter of 2016. Its GAAP EPS stood at $0.26, down 64%, and non-GAAP adjusted EPS was reported at $0.49, a 29% decrease The company reiterated its EPS guidance for 2017 in the range of $2.80 to $2.90 per diluted share.

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