Benzinga's Biotech Pulse: Pfizer's Xeljanz Gets EU Nod, NewLink Losses Narrow, Neuralstem Commences Stroke Drug Trial

Shanthi Rexaline
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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 31)

  • Allakos Inc (NASDAQ: ALLK) (listed July 19 following its IPO)

  • AstraZeneca plc (ADR) (NYSE: AZN)

  • Cardiovascular Systems Inc (NASDAQ: CSII) (reported above-consensus results for Q4)

  • Cardiome Pharma Corp (NASDAQ: CORV)

  • Eli Lilly And Co (NYSE: LLY)

  • Endo International PLC (NASDAQ: ENDP)

  • Illumina, Inc. (NASDAQ: ILMN)(reported strong Q2 results and raised its full-year guidance)

  • Medtronic PLC (NYSE: MDT)( received FDA approval for implantable system for Remodulin to treat patients with pulmonary arterial hypertension

  • Medpace Holdings Inc (NASDAQ: MEDP)(reported strong Q2 results)

  • Pfizer Inc. (NYSE: PFE)(reported above-consensus Q2 EPS and raised its full-year EPS guidance)

  • Unum Therapeutics Inc (NASDAQ: UMRX)

Down In The Dumps

(Stocks hitting 52-week lows on July 31)

  • Achillion Pharmaceuticals, Inc. (NASDAQ: ACHN)

  • Aileron Therapeutics Inc (NASDAQ: ALRN)

  • Cue Biopharma Inc (NASDAQ: CUE)

  • DelMar Pharmaceuticals Inc (NASDAQ: DMPI)

  • Genocea Biosciences Inc (NASDAQ: GNCA)

  • Idera Pharmaceuticals Inc (NASDAQ: IDRA)

  • Neos Therapeutics Inc (NASDAQ: NEOS)

  • Radius Health Inc (NASDAQ: RDUS)

  • Reshape Lifesciences Inc (NASDAQ: RSLS)

  • Rubius Therapeutics Inc (NASDAQ: RUBY) (began trading on July 18)

  • Sonoma Pharmaceuticals Inc (NASDAQ: SNOA)

  • Translate Bio Inc (NASDAQ: TBIO)(began trading on June 28)

Stocks In Focus

Pfizer's Xeljanz Gets EU Approval For Another Indication

Pfizer announced Xeljanz, its treatment for adult patients with moderately to severely active ulcerative colitis, has been approved by the European Commission. This Janus kinase inhibitor has already been approved for three other indications in the EU.

Neuralstem Starts Mid-stage Trial For Stroke Drug

Neuralstem, Inc (NASDAQ: CUR) said it's initiating a Phase 2 trial evaluating NSI-566, its lead neural stem candidate, for treating ischemic stroke. The company said it had announced positive topline results from a Phase 1 study in June. The company plans to allocate $3 million toward this trial.

The stock rose 9.57 percent to $1.26 in after-hours trading.

Zoetis Completes Abaxis-Buy

Zoetis Inc (NYSE: ZTS) announced the completion of its acquisition of Abaxis, a maker of diagnostic instruments for veterinary point-of-care services, for $2 billion.

Progenics Reports Wider-Than-Expected Q2 Loss

Progenics Pharmaceuticals, Inc. (NASDAQ: PGNX), which announced Monday FDA approval for Azedra for treating obenguane scan positive, unresectable, locally advanced or metastatic pheochromocytoma or paraganglioma, reported Q2 revenues of $3.878 million, higher than $2.765 million in the year-ago period. The net loss per share narrowed from 24 cents to 20 cents. Analysts on average estimated a loss of 19 cents per share.

The stock fell 1.38 percent to $7.88 in after-hours trading.

Geron Reports A Loss For Q2

Geron Corporation (NASDAQ: GERN) reported a Q2 loss of 4 cents per share, flat year-over-year. The loss is in line with expectations Revenues rose from $174,000 to $208,000.

The stock slipped 4.48 percent to $3.41 in after-hours trading.

Hologic Q2 EPS Beats Estimates; Raises Full-year Guidance

Hologic, Inc. (NASDAQ: HOLX) reported Q3 revenues of $824 million, up 2.2 percent year-over-year. EPS climbed 16 percent year-over-year from 50 cents to 58 cents, ahead of the 56 cents per share estimate. The company raised its full-year 2018 revenue growth guidance and also the low-end of its non-GAAP EPS guidance.

Separately, the company announced the departure of Bob McMahon as its CFO, and the promotion of chief accounting officer Karlenn Oberton as its CFO.

View more earnings on IBB

The stock added 1.14 percent to $43.40 in after-hours trading.

Acer to Raise Capital In a Secondary Offering

Acer Therapeutics Inc (NASDAQ: ACER) announced intention to sell shares of its common stock in an underwritten public offering, with all shares to be sold by Acer.

The stock jumped 8.14 percent to $17.80 in after-hours trading.

NewLink Genetics' Q2 Loss Narrows

NewLink Genetics Corp (NASDAQ: NLNK) reported a loss of 47 cents per share, narrower than the year-ago loss of 57 cents per share.

The company also announced the completion of an organizational realignment to support clinical development efforts, with the organizational changes including the elimination of 30 percent of the headcount.

The stock rose 7.14 percent to $4.05 in after-hours trading.

Neurocrine Q3 Beats Estimates

Neurocrine Biosciences, Inc. (NASDAQ: NBIX) reported Q2 revenues of $96.91 million compared to $6.335 million in the year-ago quarter. The net loss per share was 7 cents compared to a loss of 68 cents last year.

The company said its partner AbbVie Inc (NYSE: ABBV) intends to commercialize Orilissa, which the FDA approved for managing endometriosis with associated moderate-to-severe pain, in August. AbbVie will pay Neurocrine a $49 million event-based payment.

The stock rallied 6.46 percent to $107 in after-hours trading.

On The Radar

Earnings

  • Amarin Corporation plc (ADR) (NASDAQ: AMRN) Q2 EPS $(0.10) Missed $(0.09) Estimate, Sales $52.643M Missed $56.58M Estimate

  • IDEXX Laboratories, Inc. (NASDAQ: IDXX) Q2 EPS $1.23 Beats $1.17 Estimate, Sales $581M Beat $574.55M Estimate

  • ArQule, Inc. (NASDAQ: ARQL) Q2 EPS $0.05 Beats $0.03 Estimate, Sales $13.71M Beat $10.15M Estimate

  • Blueprint Medicines Corp (NASDAQ: BPMC) Q2 EPS $(0.62) Beats $(1.32) Estimate

  • AxoGen, Inc (NASDAQ: AXGN)

  • AtriCure Inc. (NASDAQ: ATRC) (after the close)

  • Conatus Pharmaceuticals Inc (NASDAQ: CNAT) (after the close)

  • EXACT Sciences Corporation (NASDAQ: EXAS) (after the close)

  • Vanda Pharmaceuticals Inc. (NASDAQ: VNDA) (after the close)

  • Globus Medical Inc (NYSE: GMED) (after the close)

  • Clovis Oncology Inc (NASDAQ: CLVS) (after the close)

  • DURECT Corporation (NASDAQ: DRRX) (after the close)

  • Exelixis, Inc. (NASDAQ: EXEL) (after the close)

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