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Here's a roundup of top developments in the biotech space over the last 24 hours.
Scaling the Peaks
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(Stocks hitting 52-week highs on May 14)
- ABIOMED, Inc. (NASDAQ:ABMD)
- Bio-Rad Laboratories, Inc. (NYSE:BIO)
- Haemonetics Corporation (NYSE:HAE)
- Illumina, Inc. (NASDAQ:ILMN)
- Inspire Medical Systems Inc (NYSE:INSP)
- ProPhase Labs Inc (NASDAQ:PRPH)
- Sophiris Bio Inc (NASDAQ:SPHS)
- SurModics, Inc. (NASDAQ:SRDX)
Down In The Dumps
(Stocks hitting 52-week lows on May 14)
- aTyr Pharma Inc (NASDAQ:LIFE)
- OHR Pharmaceutical Inc (NASDAQ:OHRP)
- Unity Biotechnology Inc (NASDAQ:UBX)
Related Link: The Week Ahead In Biotech: PDUFA Dates, Earnings, IPOs And More
Stocks In Focus
Amphastar's Extended Rally On FDA Approval
Amphastar Pharmaceuticals Inc (NASDAQ:AMPH) announced FDA nod for its ANDA for calcium chloride injection 10 percent in the 10ml Luer-Jet Prefilled Syringe System. The company had earlier been selling this unapproved.
The announcement sent shares higher by over 8 percent in Monday's session, with buying continuing into the after-hours session.
FDA Accepts Resubmission of Coherus' BLA for Neulasta Biosimilar
Coherus Biosciences Inc (NASDAQ:CHRS) announced that the FDA accepted the resubmission of the BLA for its pegfilgrastim (Neulasta) biosimilar candidate CHS-1701. The FDA had deemed it as a complete response to its June 9, 2017 action letter. The BSUFA action date is set for Nov. 3.
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Cesca Q1 EPS, Revenues Fall
Cesca Therapeutics Inc (NASDAQ:KOOL) reported a Q1 net loss of 27 cents per share, wider than the 21 cents per share last year. Revenues fell to $1.9 million from $3.3 million last year.
The stock fell 9 percent to $1.01 in after-hours trading.
Aytu Reports Narrower Q1 Loss
Aytu Bioscience Inc (NASDAQ:AYTU) reported a loss of 24 cents per share, narrower than the $9.54 per share loss reported a year ago. Revenues fell from $893,546 to $607,473. Analysts, on average, expected a loss of 1 cent per share on revenues of $1.25 million.
The penny stock soared 39.59 percent to 55 cents per share after hours.
Bovie Completes Enrollment In Clinical Study
Bovie Medical Corporation (NYSE:BVX) said it has completed enrollment for the U.S. Investigational Device Exemption clinical study of its J-Plasma/Renuvion technology for use in dermal skin resurfacing.
The stock rose 4 percent after hours.
On The Radar
The following companies report earnings on Tuesday:
- Affimed NV (NASDAQ:AFMD) Q1 EPS C$(0.19) Misses $(0.18) Estimate, Sales C$399K Miss $470K Estimate
- Aldeyra Therapeutics Inc (NASDAQ:ALDX) Q1 EPS $(0.43) Misses $(0.39) Estimate
- Cancer Genetics Inc (NASDAQ:CGIX) Q1 EPS $(0.16) Misses $(0.13) Estimate, Sales $7.667M Miss $8.2M Estimate
- Onconova Therapeutics Inc (NASDAQ:ONTX) Q1 EPS $(0.34) Beats $(0.39) Estimate, Sales $564K Beat $300K Estimate
- Urogen Pharma Ltd (NASDAQ:URGN) Q1 EPS $(0.88) Down From $(0.70) YoY, Sales $481K
- Palatin Technologies, Inc. (NYSE:PTN)
- Tecogen Inc (NASDAQ:TGEN)
Other Events
Evolus Inc (NASDAQ:EOLS) awaits FDA verdict on its biologic license application, or BLA, for DWP-450 to treat adult patients with Glabellar lines, also known as frown lines between the eyebrows.
Xenon Pharmaceuticals Inc (NASDAQ:XENE) is scheduled to present Phase 1 interim data for its epilepsy treatment XEN1101 at the EILAT conference on Tuesday.
The three-day 2018 Bank of America Merrill Lynch Healthcare Conference gets underway in Las Vegas, Nevada.
Crypto Whales Are Loading Up — Are You?
New research shows the biggest crypto buyers are back. And this time? They could hold for the possibility that Bitcoin will surpass $100,000 in 2024. You don’t want to miss the next massive crypto bull run like we saw in 2020 and 2021. To know exactly what’s going on and what to buy… Get Access To Benzinga’s Best Crypto Research and Investments For Only $1.