The Daily Biotech Pulse: Denali's Parkinson's Candidate Clears Early-Stage Trials, Dexcom's Strong Quarter

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 Aug. 1)

  • Bio-Rad Laboratories, Inc. BIO
  • CAS Medical Systems Inc CASM
  • Chembio Diagnostics Inc CEMI
  • Cardiome Pharma Corp CORV
  • Eli Lilly And Co LLY
  • Inspire Medical Systems Inc INSP
  • G1 Therapeutics Inc GTHX
  • Iradimed Corp IRMD
  • Neurocrine Biosciences, Inc. NBIX )(reported above-consensus Q3 results)
  • Natera Inc NTRA
  • Qiagen NV QGEN(reacted to Q2 results)

Down In The Dumps

(Stocks hitting 52-week lows on Aug. 1)

  • Catabasis Pharmaceuticals Inc CATB
  • ConforMIS Inc CFMS
  • Genocea Biosciences Inc GNCA
  • Midatech Pharma PLC-ADR MTP
  • NewLink Genetics Corp NLNK(reported a narrower loss for Q2)
  • Paratek Pharmaceuticals Inc PRTK
  • Radius Health Inc RDUS
  • Rubius Therapeutics Inc RUBY
  • Verrica Pharmaceuticals Inc VRCA

Stocks In Focus

Denali's Parkinson's Disease Drug Trial Produces Positive Results

Denali Therapeutics Inc DNLI reported positive results for the Phase 1 study of its DNL201, with the Parkinson's disease treatment candidate achieving its safety, pharmacokinetic, and pharmacodynamic objectives. The candidate was well tolerated, with no serious adverse at doses that achieved high levels of cerebrospinal fluid exposure, the company said.

DNL201 is a small molecule inhibitor of leucine-rich repeat kinase 2, or LRRK2 gene. Mutations in the gene are the most frequent cause of Parkinson's disease.

Shares rallied 6.83 percent to $13.60 in after-hours trading.

BioCryst Prices Common Stock Offering

BioCryst Pharmaceuticals, Inc. BCRX priced its public offering of 9.09 million shares at $5.50 per share, with the offering likely to generate gross proceeds of $50 million.

The stock fell 3.99 percent to $5.30 in after-hours trading.

Adamas To Offer Shares

Adamas Pharmaceuticals Inc ADMS said it intends to offer shares in an underwritten public offering.

The stock fell 7.58 percent to $3.05 in after-hours trading.

Stocks Reacting to Earnings

AxoGen, Inc AXGN – Down 20.09 percent to $37 (reported Q2 loss of 9 cents, in line with estimate/Revenues $20.6 million, also in line; reiterated revenue growth guidance of at least 40 percent and gross margins guidance of over 80 percent)

DexCom, Inc. DXCM – rallied 20.49 percent to $11.15 reported a non-GAAP loss of 10 cents per share, narrower than the consensus loss estimate of 18 cents per share; revenues rose 42 percent to $242.5 million; raised its full-year revenue guidance but lowered gross margin guidance) Separately, the company announced the retirement of its Chairman Kevin Sayer)

DURECT Corporation DRRX – rose 3.33 percent to $1.55 (reported a narrower-than-expected Q2 loss)

EXACT Sciences Corporation EXAS – plunged 20.59 percent to $46.95 (reported a Q2 loss of 30 cents per share, narrower than the 32 cents loss estimated by analyst; Revenues jumped 78 percent to $102.9 million and Cologuard test volume rose 59 percent. The company reiterated its 2018 revenue guidance, which is below the consensus estimate.)

Clovis Oncology Inc CLVS – slipped 3.3 percent to $44.48 (reported a wider-than-expected loss for its Q2)

Vanda Pharmaceuticals Inc. VNDA – rose 6.51 percent to $21.995 (reversed to a profit in Q2, belying expectations for a loss)

On The Radar

Earnings

  • Obalon Therapeutics Inc OBLN Q2 EPS $(0.57) Misses $(0.51) Estimate, Sales $2.732M Miss $3.26M Estimate
  • Insmed Incorporated INSM Q2 EPS $(1) Beats $(1.08) Estimate
  • Seres Therapeutics Inc MCRB Q2 EPS $(0.68) Misses $(0.63) Estimate, Sales $4.6M Miss $6.57M Estimate
  • Curis, Inc. CRIS Q2 EPS $(0.26) Beats $(0.39) Estimate, Sales $2.36M Beat $2.34M Estimate
  • Acorda Therapeutics Inc ACOR Q2 EPS $1.40 Beats $0.72 Estimate, Sales $153.302M Beat $138.31M Estimate
  • Agios Pharmaceuticals Inc AGIO Q2 EPS $(1.19) Beats $(1.55) Estimate, Sales $40.414M Beat $11.28M Estimate
  • Becton Dickinson and Co BDX Q3 EPS $2.91 Beats $2.86 Estimate, Sales $4.278B Beat $4.24B Estimate
  • Repligen Corporation RGEN (before the market open)
  • Epizyme Inc EPZM Q2 EPS $(0.42) Beats $(0.51) Estimate
  • Zoetis Inc ZTS Q2 EPS $0.77 Beats $0.70 Estimate, Sales $1.415B Beat $1.38B Estimate
  • Pacira Pharmaceuticals Inc PCRX Q2 EPS $0.24 Beats $0.07 Estimate, Sales $84.1M Beat $78.86M Estimate
  • Regeneron Pharmaceuticals Inc REGN (before the market open)
  • Genomic Health, Inc. GHDX (after the close)
  • Acceleron Pharma Inc XLRN (after the close)
  • AcelRx Pharmaceuticals Inc ACRX (after the close)
  • Arbutus Biopharma Corp ABUS (after the close)
  • Emergent Biosolutions Inc EBS (after the close)
  • T2 Biosystems Inc TTOO (after the close)
  • BioMarin Pharmaceutical Inc. BMRN (after the close)
  • Pacific Biosciences of California PACB (after the close)
  • Nevro Corp NVRO (after the close)
  • Cerus Corporation CERS (after the close)
  • TESARO Inc TSRO (after the close)
  • Revance Therapeutics Inc RVNC (after the close)
  • ResMed Inc. RMD
  • Insulet Corporation PODD (after the close)
  • Glaukos Corp GKOS (after the close)
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