Here's a roundup of top developments in the biotech space over the last 24 hours.
Scaling the Peaks
(Stocks hitting 52-week highs on July 26)
- ADMA Biologics Inc ADMA(announced it has addressed the previously identified manufacturing and compliance issues found with its biologics manufacturing facility acquired in June 2017 and that the FDA will review the new data by Oct. 25)
- Abbott Laboratories ABT
- AstraZeneca plc (ADR) AZN(reported strong first-half results)
- Becton Dickinson and Co BDX
- Bio-Rad Laboratories, Inc. BIO
- Edwards Lifesciences Corp EW
- Endo International PLC ENDP
- Haemonetics Corporation HAE
- Medtronic PLC MDT
- Mirati Therapeutics Inc MRTX
- PRA Health Sciences Inc PRAH
Down In The Dumps
(Stocks hitting 52-week lows on July 26)
- Agenus Inc AGEN
- Aileron Therapeutics Inc ALRN
- Auris Medical Holding AG EARS
- Bioblast Pharma Ltd ORPN
- Cellectar Biosciences Inc CLRB
- Cytori Therapeutics Inc CYTX
- Kiniksa Pharmaceuticals Ltd KNSA
- Nabriva Therapeutics PLC – ADR NBRV(announced a common stock offering)
- Neurometrix IncNURO
- Oramed Pharmaceuticals, Inc. ORMP
- Orgenesis Inc ORGS
- Sellas Life Sciences Group Inc SLS
- Surface Oncology Inc SURF
- TrovaGene Inc TROV
Stocks In Focus
Edward Lifesciences Reports Mixed Q2
Edward Lifesciences reported better-than-expected Q2 earnings per share, but its revenues missed expectations. EPS guidance for Q3 was below expectations, however, revenue guidance for Q3 and the full-year guidance were in line.
The stock slid 7.13 percent to $144 in after-hours trading.
Amgen Q2 Results Beats, Raises FY18 Guidance
Amgen, Inc. AMGN reported Q2 non-GAAP EPS of $3.83 compared to the $3.54 per share consensus estimate. Revenues rose 4 percent to $6.059 billion. The company also raised its guidance for FY18.
The stock added 1.03 percent to $196.04 in after-hours trading.
Seattle Genetics Reports Strong Q2 Results
Seattle Genetics, Inc. SGEN reported over 57 percent revenue growth to $170.2 million, with a profit of 47 cents per share, belying expectations for a loss of 39 cents per share.
The company raised its full-year collaboration revenue guidance.
The stock rose 1.05 percent to $72 in after-hours trading.
Achaogen Embarks Restructuring Actions
Achaogen Inc AKAO announced restructuring actions, as it focuses on the commercialization of Zemdri in the U.S. and file for MAA in the European Union, while also continuing to develop C-Scape program.
As part of the restructuring actions, the company said it will eliminate 80 positions or 28 percent of its workforce. On account of the job cuts, the company said it will incur a charge of $6 million in Q3.
Achaogen also said its President, R&D, CFO as well as Chief Scientific Officer will leave the company.
The stock rose 2.19 percent to $7.245 in after-hours trading.
Harvard Bioscience Q2 EPS Beat Estimates
Harvard Bioscience, Inc. HBIO reported a 66 percent increase in Q2 revenues to $31.5 million and its net income per share on a non-GAAP basis rose from 3 cents to 7 cents. The company affirmed its full-year guidance.
The stock rallied 9.43 percent to $5.80 in after-hours trading.
Novocure Q2 Loss Misses Estimate
Novocure Ltd NVCR reported a loss of 17 cents per share, wider than the 16 cents per share loss expected by analysts. Revenues climbed over 60 percent to $61.51 million.
The stock fell 8.49 percent to $33.70 in after-hours trading.
Nabriva Prices Its Common Stock Offering
Nabriva Therapeutics PLC NBRV announced it has priced its underwritten public offering of 18.182 million shares at $2.75 per share. The offering is expected to close on or about July 31, 2018.
The stock ended down 8.11 percent to $2.8301 in after-hours trading.
On The Radar
PDUFA Dates
Insys Therapeutics Inc INSY awaits FDA verdict on Buprenorphine sublingual spray to treat moderate-to-severe acute pain on Saturday.
The FDA is set to rule on schizophrenia treatment RBP-7000 developed by DURECT Corporation DRRX on Saturday. The company has assigned patents for RBP-7000 to U.K.-based biotech INDIVIOR PLC/S ADR INVVY.
Earnings
AbbVie Inc ABBV Q2 EPS $2 Beats $1.97 Estimate, Sales $8.258B Beat $8.21B Estimate
Zimmer Biomet Holdings IncZBH Q2 EPS $1.92 Beats $1.88 Estimate, Sales $2.008B Beat $1.99B Estimate
Merck & Co., Inc. MRK Q2 EPS $1.06 Beats $1.03 Estimate, Sales $10.465B Beat $10.29B Estimate
ImmunoGen, Inc. IMGN Q2 EPS $(0.31) Misses $(0.29) Estimate, Sales $9.3M Miss $13.92M Estimate
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