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. (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.

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.