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 (NYSE: ALC)
• ANI Pharmaceuticals Inc (NASDAQ: ANIP) (reacted to its Q1 results)
• BioSig Technologies Inc (NASDAQ: BSGM)

Down In The Dumps

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

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

Stock In Focus

Strongbridge Pharma Presents Positive Long-Term Data For Paralysis Drug

Strongbridge Biopharma plc (NASDAQ: 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 (NASDAQ: 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 (NYSE: JNJ)’s Procrit, chemically epoetin alfa, in dialysis-dependent patients.

Fibrogen is partnering with AstraZeneca plc (NYSE: AZN) and (ASTELLAS PHARMA/ADR (OTC: ALPMY) in the study.

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

Teva Launches Generic Lung Cancer Drug In U.S.

Teva Pharmaceutical Industries Ltd (NYSE: TEVA) said it is launching generic version of Roche Holdings AG Basel ADR (OTC: 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 To Buy Titan Spine

Medtronic PLC (NYSE: 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.

Earnings

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 (NASDAQ: 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 (NASDAQ: 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 (NASDAQ: 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 (NYSE: 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 (NASDAQ: 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.

On The Radar

Clinical Trial Readouts

Uniqure NV (NASDAQ: 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.

Earnings

Before the Market Open

• Organogenesis Holdings Inc (NASDAQ: ORGO)


• Pieris Pharmaceuticals Inc (NASDAQ: PIRS)


• Ocular Therapeutix Inc (NASDAQ: OCUL)


• Stemline Therapeutics Inc (NASDAQ: STML)


• Recro Pharma Inc (NASDAQ: REPH)


• PLx Pharma Inc (NASDAQ: PLXP)