The Daily Biotech Pulse: Novartis Breast Cancer Trial Meets Endpoint, Medpace's Offering, Dexcom Buys TypeZero

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. 22)

• Acer Therapeutics Inc ACER
• Avanos Medical Inc AVNS
• CareDx Inc CDNA
• DexCom, Inc. DXCM
• Emergent Biosolutions Inc EBS
• Kalvista Pharmaceuticals Inc KALV
• Masimo Corporation MASI
• Medtronic PLC MDT
• Minerva Neurosciences Inc NERV(announced results from a recent pre-clinical study that provide evidence of the effect of roluperidone, codenamed MIN-101, on brain-derived neurotrophic factor)
• Myriad Genetics, Inc. MYGN(reported forecast-beating Q4 EPS)
• Natera Inc NTRA
• Neogen Corporation NEOG
• Repligen Corporation RGEN
• Seattle Genetics, Inc. SGEN
• Tandem Diabetes Care Inc TNDM

Down In The Dumps

(Stocks hitting 52-week lows on Aug. 22)

• Genprex Inc GNPX
• See Also: The Week Ahead In Biotech: Conferences, PDUFA Dates, Earnings And IPOs

Stocks In Focus

Medpace Announces Pricing of a Secondary Offering

Medpace Holdings Inc MEDP announced a secondary offering of 5.225 million shares of its common stock, which is being offered by investment funds affiliated with Cinven Capital Management General Partner Limited. Subsequently, the company announced it has priced the secondary offering at $55.50 per share.

DexCom Buys Diabetes Management System Provider TypeZero

DexCom, Inc. DXCM said it has acquired TypeZero Technologies, which is a provider of the inControl diabetes solutions, including technology to automatically adjust and regulate insulin delivery. The company expects to support the first commercial launch of an AID system using the inControl algorithm in 2019.

The stock rallied 2.28 percent to $141.24 in after-hours trading.

Novartis Breast Cancer Drug Meets Primary Endpoint

Novartis AG (ADR) NVS said its global Phase 3 SOLAR-1 trial that evaluated its investigational alpha-specific P1I3K inhibitor BYL719 plus fulvestrant vs. fulvestrant alone in HR+/HER2-advanced breast cancer patients with PIK3CA mutations met primary endpoint, showing an improvement in progression-free survival.

Pfizer Advances Timeline For Prostate Cancer Drug Trial

Pfizer Inc. PFE and Astellas announced changes to the protocols for two registrational Phase 3 trials, namely ARCHES and EMBARK, which evaluate the safety and efficacy of XTANDI, intended to treat hormone-sensitive prostate cancer in men.

The amendments accelerate timelines for the anticipated primary completion dates of both trials.

"With these changes, the estimated primary completion date for the EMBARK clinical trial is mid-2020. Previously, the expected primary completion date for EMBARK was March 2021," the companies said.

On The Radar

Earnings

• Immunomedics, Inc. IMMU(after the market close)
• Global Cord Blood Corp CO (after the market close)

FDA Tidbits

The FDA announced approval of Dompe's Oxervate eye drops, a first-in-class recombinant human nerve growth factor with potential to completely heal rare neurotrophic keratitis, which is a progressive eye disease that can lead to corneal scarring and vision loss.