The Daily Biotech Pulse: Biogen Alzheimer's Program Back On Track, Novartis Reports Strong Quarter, Takeda In-Licenses Autoimmune Disorder Drug

The following is a roundup of top developments in the biotech space over the last 24 hours:

Scaling The Peaks

(Biotech stocks that hit 52-week highs Oct. 21.)

• Aprea Therapeutics Inc APRE
• AVITA MED LTD/S ADR RCEL
• Celgene Corporation CELG
• Constellation Pharmaceuticals Inc CNST
• The Medicines Company MDCO
• Natera Inc NTRA
• Seattle Genetics, Inc. SGEN (announced positive Phase 2 results for breast cancer drug)

Down In The Dumps

(Biotech stocks that hit 52-week lows Oct. 21.)

• Adaptive Biotechnologies Corp ADPT
• Arbutus Biopharma Corp ABUS
• Assertio Therapeutics Inc ASRT (announced receipt of CRL by its development partner West Therapeutic for its injectable formulation of long-acting cosyntropin.)
• Auris Medical Holding Ltd EARS
• BioSpecifics Technologies Corp. BSTC
• Cocrystal Pharma Inc COCP
• Diffusion Pharmaceuticals Inc DFFN
• Fulcrum Therapeutics Inc FULC
• PDS Biotechnology Corp PDSB
• Precision BioSciences Inc DTIL
• Pulmatrix Inc PULM
• Sophiris Bio Inc SPHS
• Strongbridge Biopharma plc SBBP
• Trinity Biotech plc TRIB
• X T L Biopharmaceuticals Ltd XTLB

See also: Biotech Stock On The Radar: Assessing Mirati's Oncology Franchise With An Eye On Multiple Readouts

Novartis Posts Higher Q3 Sales, Lifts Guidance 

Novartis AG NVS reported net sales growth from continuing operations of 13% in constant currency, thanks to strong uptake of psoriasis medication Cosentyx, gene therapy Zolgensma, heart failure drug Entresto and tumor medication Lutathera.

Core earnings per share increased year-over-year from $1.22 to $1.44, the company said Tuesday. 

The company upwardly revised its fiscal year 2019 net sales growth guidance to high-single digits in constant currency and core operating income growth guidance to the mid-to-high teens. 

Novartis shares were down 0.67% at $85.98 in Tuesday's premarket session. 

Takeda In-Licenses Autoimmune Disorder Drug For Up To $420M

Takeda Pharmaceutical Co Ltd TAK said it has entered into an exclusive global license to develop and commercialize COUR Pharma's investigational medicine CNP-101/TAK-101. CNP-101 is an immune modifying nanoparticle containing gliadin proteins and is a potential treatment targeting the aberrant immune response in celiac disease, a serious autoimmune disease in which the ingestion of gluten leads to inflammation and damage in the small intestine.

The agreement was struck following the presentation of positive results from a study assessing the markers of potential efficacy and safety of the investigational medicine in 34 adults with proven celiac disease at the United European Gastroenterology, or UEG, Week.

Takeda said it plans to initiate a dose-ranging study to further assess the potential of the therapy. For the licensing, the company will pay COUR up to $420 million in future payments and royalties on sales of any commercialized products resulting from the license.

NewLink Genetics Says Licensing Partner Merck's Ebola Vaccine Nets Positive Recommendation

NewLink Genetics Corp NLNK said the European Medicines Agency's Committee For Medicinal Products for Human Use, or CHMP, has adopted a positive opinion, recommending a conditional marketing authorization for investigational V920 Ebola Zaire vaccine.

The vaccine is being developed by Merck & Co., Inc. MRK following the acquisition of license to the vaccine from NewLink Genetics in 2014.

The stock was trading 8.05% higher at $1.61 in Tuesday's premarket session.

Biogen's Alzheimer's Program Still On; Q3 Results Exceed Expectations

Biogen Inc BIIB said it plans to file for regulatory approval for aducanumab for the treatment of early Alzheimer's disease following consultation with the FDA. The decision was based on a new analysis conducted by Biogen in consultation with the FDA of a larger dataset from the Phase 3 clinical studies that were discontinued in March following a futility analysis.

The positive results of the new analysis were due to a greater exposure to high-dose aducanumab in the larger dataset as compared to data available at the time of futility analysis.

The company said it plans to file a BLA in early 2020.

Biogen also reported third-quarter results that exceeded estimates.

Biogen shares were jumping 40.6% to $314.25 in Tuesday's premarket session. 

On The Radar

Clinical Trial Readouts

Protagonist Therapeutics Inc PTGX will present Phase 1 data for PTG-200 in Crohn's disease at the UEG week being held in Barcelona, Spain.

Earnings

Veracyte Inc VCYT (after the market close)

Related Link: The Week Ahead In Biotech: Earnings Trickle In, While Glaxo, Melinta, Foamix And Eton Await FDA Verdict