The Daily Biotech Pulse: FibroGen Kidney Disease Trial Disappoints, Medtronic To Buy Titan Spine, Puma's Weak Breast Cancer Drug Sales

Here's a roundup of top developments in the biotech space over the last 24 hours.

Scaling The Peaks

(Biotech stocks hitting 52-week highs on May 9)

• Alcon AG ALC
• ANI Pharmaceuticals Inc ANIP (reacted to its Q1 results)
• BioSig Technologies Inc BSGM

Down In The Dumps

(Biotech stocks hitting 52-week lows on May 9)

• Adamas Pharmaceuticals Inc ADMS
• Aethlon Medical, Inc. AEMD
• Alkermes Plc ALKS
• Amneal Pharmaceuticals Inc AMRX(reacted to first-quarter results)
• ANCHIANO THERAP/S ADR ANCN
• Atara Biotherapeutics Inc ATRA(reacted to first-quarter results)
• CELLECT BIOTECH/S ADR APOP
• Emergent Biosolutions Inc EBS
• Evoke Pharma Inc EVOK(reacted to first-quarter results)
• Foamix Pharmaceuticals Ltd FOMX
• Harvard Bioscience, Inc. HBIO
• NovaBay Pharmaceuticals, Inc. NBY
• Proteon Therapeutics Inc PRTO
• Sienna Biopharmaceuticals Inc SNNA(reacted to first-quarter results)
• Verastem Inc VSTM

Stock In Focus

Strongbridge Pharma Presents Positive Long-Term Data For Paralysis Drug

Strongbridge Biopharma plc SBBP presented long-term efficacy results for Keveyis, the first and only U.S. FDA-approved treatment for hyperkalemic, hypokalemic and related variants of primary periodic paralysis, or PPP, at the American Academy of Neurology, or AAN, annual meeting. The data showed that long-term treatment with Keveyis in adults is effective in significantly improving both attack frequency and severity in adult patients with PPP.

The stock rose 6.38 percent to $3.50 in after-hours trading.

FirbroGen Drug To Treat Anemia In Chronic Kidney Patients Produces Mixed Results

FibroGen Inc FGEN announced topline results from the pooled safety analyses of the global Phase 3 program for roxadustat in treating anemia in chronic kidney disease patients across the non-dialysis dependent, newly-initiated dialysis and dialysis-dependent populations, which supported safety of the drug.

However, the company said based on the major adverse cardiovascular event, or MACE, safety analyses, there is no clinically meaningful difference in risk of MACE between roxadustat and Johnson & Johnson JNJ's Procrit, chemically epoetin alfa, in dialysis-dependent patients.

Fibrogen is partnering with AstraZeneca plc AZN and ALPMY in the study.

Teva Launches Generic Lung Cancer Drug In U.S.

Medtronic To Buy Titan Spine

Earnings

On The Radar

Clinical Trial Readouts

Earnings

Before the Market Open

The stock declined 15.04 percent to $38.80 in after-hours trading.

Teva Pharmaceutical Industries Ltd TEVA said it is launching generic version of Roche Holdings AG Basel ADR RHHBY's Tarceva tablets, 100 and 150mg strength, in the U.S. Tarceva is indicated to treat metastatic non-small cell lung cancer, whose tumors have epidermal growth factor receptor exon 19 deletions or exon 21 substitution mutations.

Shares were higher modestly in pre-market trading Friday.

Medtronic PLC MDT announced an agreement to acquire privately-held Titan Spine, a titanium spine interbody implant and surface technology company. The deal has been approved by boards of both companies. The company did not disclose the financial terms of the deal.

Verastem reported net product revenues of $1.7 million for the first quarter and a wider-than-expected loss of 52 cents per share.

The stock plunged 26.46 percent to $1.39 in after-hours trading,

G1 Therapeutics Inc GTHX's first quarter loss per share narrowed from 70 cents to 64 cents, while analysts expected a loss of 72 cents.

The stock gained 7.06 percent to $22.15 in after-hours trading.

Guardant Health Inc GH said its first-quarter revenues climbed 120 percent year-over-year to $36.7 million and its loss narrowed from $1.16 per share to 30 cents per share. Analysts estimated a loss of 37 cents per share.

The stock moved up 14.55 percent to $73.39 in after-hours trading.

Puma Biotechnology Inc PBYI's first-quarter total revenues increased from $66.5 million to $99.1 million, with Nerlynx, indicated for previously-treated early-stage HER2-positive breast cancer, accounting for $45.6 million in the recent quarter. The net loss per share narrowed from 65 cents to 26 cents. The stock reacted negatively as Nerlynx sales trailed expectations.

The stock slumped 32.71 percent to $20.20 in after-hours trading.

Nevro Corp NVRO's first-quarter revenues fell 6 percent and net loss per share widened from 59 cents to $1.45. The company issued below-consensus revenue guidance for the second quarter.

The stock slipped 11.97 percent to $55.25 in after-hours trading.

Regulus Therapeutics Inc RGLS reported a strong increase in first-quarter revenues and a narrower net loss per share.

The stock jumped 23.20 percent to $1.54 in after-hours trading.

Uniqure NV QURE is due to release Phase 2b, 26-week follow-up data for hemophilia B treatment candidate AMT-061 at the Hemostasis and Thrombosis Research Society 2019 annual meeting.

• Organogenesis Holdings Inc ORGO
• Pieris Pharmaceuticals Inc PIRS
• Ocular Therapeutix Inc OCUL
• Stemline Therapeutics Inc STML
• Recro Pharma Inc REPH
• PLx Pharma Inc PLXP