Benzinga's Daily Biotech Pulse: Achaogen Slumps On Mixed FDA Panel Vote, Pacific Biosciences Sinks On Q1 Miss

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 2)

• CASI Pharmaceuticals Inc CASI
• Eleven Biotherapeutics Inc EBIO
• Enanta Pharmaceuticals Inc ENTA
• Momenta Pharmaceuticals, Inc. MNTA
• MORPHOSYS AG/S ADR MOR reported Q1 results after the close)
• SIGA Technologies, Inc. SIGA (FDA panel backed its small pox treatment candidate)
• Sophiris Bio Inc SPHS
• Surface Oncology, Inc. SURF

Down In The Dumps

(Stocks hitting 52-week lows on May 2)

• Orgenesis Inc ORGS
• THERAPIX BIOSCI/S ADR TRPX

Stocks In Focus

Exelixis Gains On Q1 Beat, Collaboration Agreement

Exelixis, Inc. EXEL reported Q1 EPS of 37 cents on revenues of $212.3 million, beating expectations.

The company also announced a collaboration with biologics company Invenra to develop multi-specific antibodies for treating cancer, which will provide the former exclusive worldwide rights to one pre-clinical asset.

Exelixis will pay Invenra an upfront payment of $2 million, plus $2 million at the initiation of each of the six additional discovery projects for which it is to collaborate with Invenra, potential developmental milestone payments up to $131.5 million, and global milestone payments up to $325 million on achievement of certain sales targets.

The stock was up 6 percent to $21.90 Thursday morning.

Achaogen's Slumps On Mixed FDA Panel Vote

Achaogen Inc AKAO shares slumped 28 percent after the FDA's Antimicrobial Drugs Advisory Committee voted 11 to 4 that the company didn't provide substantial evidence of safety and effectiveness of its plazomicin to treat bloodstream infections in patients with limited or no treatment options. However, the panel voted 15 to 0 in favor of plazimicin's safety and effectiveness of complicated urinary tract infection.

The PDUFA action date is set for June 25, 2018.

Pacific Biosciences' Q1 Miss

Pacific Biosciences of California PACB reported a Q1 loss of 20 cents per share, wider than the 19 cents loss expected by analysts. Revenues fell about 9 percent to $16.28 million and trailed the $24.54 million consensus estimate.

The stock shed 17.5 percent to $2.21 after hours.

See Also: Attention Biotech Investors: Mark Your Calendar For These May PDUFA Action Dates

Hologic Lowers FY18 Revenue Guidance

Hologic, Inc. HOLX'S Q1 non-GAAP loss per share widened to 53 cents from 50 cents a year ago. Revenues, however, rose 10.3 percent to $789.3 percent. Analysts estimated a loss of 53 cents per share on revenues of $781.84 million.

Citing lower-than-expected sales of Cynosure, the medical aesthetic technology company it acquired last year, Hologic lowered its FY18 revenue guidance but reiterated its non-GAAP EPS guidance.

On The Radar

The following companies report earnings on Thursday:

• ABIOMED, Inc. ABMD Q4 EPS $0.80 Beats $0.64 Estimate, Sales $174.436M Beat $164.31M Estimate
• Adamas Pharmaceuticals Inc ADMS
• Alnylam Pharmaceuticals, Inc. ALNY
• AMAG Pharmaceuticals, Inc. AMAG Q1 EPS $(1.59) Misses $(0.54) Estimate, Sales $146.356M Miss $151.79M Estimate
• Arbutus Biopharma Corp ABUS
• Editas Medicine Inc EDIT
• G1 Therapeutics Inc GTHX
• Lexicon Pharmaceuticals, Inc. LXRX Q1 EPS $(0.40) Beats $(0.43) Estimate, Sales $25.21 Miss $22.96M Estimate
• Pacira Pharmaceuticals Inc PCRX Q1 EPS $0.02 Beats $0.01 Estimate, Sales $74.607M Beat $73.93M Estimate
• Regeneron Pharmaceuticals Inc REGN Q1 EPS $4.67 Beats $4.32 Estimate, Sales $1.511B Beat $1.51B Estimate
• Sarepta Therapeutics Inc SRPT

Adcom Schedule

A joint meeting of the Gastrointestinal Drugs Advisory Committee and the Pediatric Advisory Committee is scheduled for May 3 to discuss Mallinckrodt PLC MNK unit InfaCare Pharma's NDA for stannsoporfin injection, intramuscular formulation. The pipeline candidate is being tested for treating neonates greater than or equal to 35 weeks of gestational age with indicators of hemolysis who are at risk of developing severe hyperbilirubinemia.

IPO

UNITY Biotech announced it has priced its initial public offering, or IPO, of 5 million shares at $17 per share. The company said shares would begin to trade on the Nasdaq on Thursday under the ticker symbol UBX.

Medical technology company Inspire Medical Systems priced its IPO of 6.75 million shared at $16 per share. Shares are due to be listed on the NYSE under the ticker symbol INSP, and will begin to trade on Thursday.