The Daily Biotech Pulse: Denali's Positive Results, Novartis' Substance Abuse Therapy Launch, Medtronic Earnings

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

Scaling The Peak

(Biotech stocks hitting 52-week highs on Nov. 19)

• Merck & Co., Inc. MRK

• Down In The Dumps

(Biotech stocks hitting 52-week lows on Nov. 19)

• Adamas Pharmaceuticals Inc ADMS
• Aduro BioTech Inc ADRO
• Cancer Genetics Inc CGIX
• Cue Biopharma Inc CUE
• Enzo Biochem, Inc. ENZ
• Diffusion Pharmaceuticals Inc DFFN
• Foamix Pharmaceuticals Ltd FOMX (announced resignation of Darrell Rigel from the board and the appointment of Anthony Bruno to the board)
• Innovate Biopharmaceuticals Inc INNT
• Keryx Biopharmaceuticals KERX
• Neos Therapeutics Inc NEOS
• Neovasc Inc NVCN
• Neuronetics Inc STIM
• Sonoma Pharmaceuticals Inc SNOA
• Spark Therapeutics Inc ONCE
• Stellar Biotechnologies Inc SBOT
• Stemline Therapeutics Inc STML
• SUMMIT THERAPEU/S ADR SMMT
• Teligent IncTLGT
• VIVUS, Inc. VVUS

Related Link: The Week Ahead In Biotech: Earnings, Conferences, PDUFA Dates

Stocks In Focus

J&J's Janssen Unit Initiates Mid-stage Trial For Skin Disease Drug Developing Using Morphosys' Technology

MORPHOSYS AG/S ADR MOR announced Johnson & Johnson JNJ unit Janssen, which has licensed its proprietary HuCAL antibody technology for developing guselkumab that is being evaluated for treating patients with moderate to severe hidradenitis suppurativa, a kind of chronic skin disease, has initiated a Phase 2 trial.

The trial is expected to enroll about 180 adult patients.

Denali Reports Positive Phase 1 Results For Drug Studied For Neurologic and Systemic Inflammatory Diseases

Denali Therapeutics Inc DNLI announced positive Phase 1 healthy volunteer study of its lead molecule DNL747 - a brain penetrant small molecule inhibitor of receptor-interacting serine/threonine-protein kinase 1. In a study of 56 healthy subjects who received either single or multiple ascending doses or placebo, the pipeline asset achieved its safety, pharmacokinetic, and pharmacodynamic objectives.

"DNL747 was generally well tolerated with no serious adverse events at doses that achieved high levels of brain exposure and robust target engagement as measured by a blood-based biomarker of RIPK1 activity," the company said.

Denali also said along with its partner Sanofi SA SNY, it will evaluate DNL747 in clinical studies for Alzheimer's disease, amyotrophic lateral sclerosis, and multiple sclerosis.

Novartis' Sandoz Unit Commercially Launches Therapy For Substance Abuse

Novartis AG NVS unit Sandoz and Pear Therapeutics announced the commercial launch of reSET, a FDA-approved prescription digital therapeutic, for patients with substance use disorder.

On The Radar

Earnings

• Medtronic PLC MDT Q2 Adj. EPS $1.22 Beats $1.15 Estimate, Sales $7.5B Beat $7.35B Estimate; Raises Organic Sales Growth Guidance From 4.5%-5.0% To 5.0%-5.5%