Benzinga's Daily Biotech Pulse: Aytu Rallies On Earnings, Evolus Awaits FDA Verdict, BofA Conference Underway

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 May 14)

• ABIOMED, Inc. ABMD
• Bio-Rad Laboratories, Inc. BIO
• Haemonetics Corporation HAE
• Illumina, Inc. ILMN
• Inspire Medical Systems Inc INSP
• ProPhase Labs Inc PRPH
• Sophiris Bio Inc SPHS
• SurModics, Inc. SRDX

Down In The Dumps

(Stocks hitting 52-week lows on May 14)

• aTyr Pharma Inc LIFE
• OHR Pharmaceutical Inc OHRP
• Unity Biotechnology Inc 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 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 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.

Cesca Q1 EPS, Revenues Fall

Cesca Therapeutics Inc 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 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 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 AFMD Q1 EPS C$(0.19) Misses $(0.18) Estimate, Sales C$399K Miss $470K Estimate
• Aldeyra Therapeutics Inc ALDX Q1 EPS $(0.43) Misses $(0.39) Estimate
• Cancer Genetics Inc CGIX Q1 EPS $(0.16) Misses $(0.13) Estimate, Sales $7.667M Miss $8.2M Estimate
• Onconova Therapeutics Inc ONTX Q1 EPS $(0.34) Beats $(0.39) Estimate, Sales $564K Beat $300K Estimate
• Urogen Pharma Ltd URGN Q1 EPS $(0.88) Down From $(0.70) YoY, Sales $481K
• Palatin Technologies, Inc. PTN
• Tecogen Inc TGEN

Other Events

Evolus Inc 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 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.