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The Daily Biotech Pulse: Acceleron Shelves Muscular Dystrophy Drug Trial, Aclaris Aces Late-Stage Study

Shanthi Rexaline

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 Sept. 16)

  • ACADIA Pharmaceuticals Inc. (NASDAQ: ACAD)
  • Alder Biopharmaceuticals Inc (NASDAQ: ALDR)(announced a deal to be bought by Danish pharma company Lundbeck)
  • AxsomeTherapeutics Inc (NASDAQ: AXSM)
  • Kodiak Sciences Inc (NASDAQ: KOD)(announced positive emerging durability data from a Phase 1b study of its pipeline asset KSI-301 in wet age-related macular degeneration)
  • The Medicines Company (NASDAQ: MDCO)
  • Natera Inc (NASDAQ: NTRA)
  • -mAbs Therapeutics, Inc (NASDAQ: YMAB)
  • ZEALAND PHARMA/S ADR (NASDAQ: ZEAL)

Down In The Dumps

(Biotech stocks hitting 52-week lows on Sept. 16)

  • BioNano Genomics Inc (NASDAQ: BNGO)
  • Citius Pharmaceuticals Inc (NASDAQ: CTXR)
  • Helius Medical Technologies Inc (NASDAQ: HSDT)
  • Myovant Sciences Ltd (NYSE: MYOV)
  • Stealth BioTherapeutics Corp (NASDAQ: MITO)
  • Viveve Medical Inc (NASDAQ: VIVE)

Stocks In Focus Acceleron To Discontinue Development Of Mid-Stage Asset To Treat Muscular Dystrophy

Acceleron Pharma Inc (NASDAQ: XLRN) said it's halting the development of ACE-083 as a treatment option for patients with facioscapulohumeral muscular dystrophy. The decision follows the investigational therapy floundering in a Phase 2 trial.

The company said ACE-083 did not meet the functional secondary endpoints, and despite the asset showing a robust statistically significant increase in mean total muscle volume – the primary endpoint – the increase failed to statistically significant improvements in functional tests.

The stock fell 6.83% to $41.60 in after-hours trading.

See Also: Purdue Pharma Files For Bankruptcy: What You Need To Know

Alcon Prices $2B Worth Of Senior Note Offering

Alcon AG (NYSE: ALC) priced a private offering of $500 million aggregate principal amount of its 2.75% senior notes due 2026, $1 billion, aggregate principal amount of its 3% senior notes due 2029 and $500 million aggregate principal amount of its 3.8% senior notes due 2049.

The company expects the offering to close Sept. 23. It intends to use the proceeds to pay off debt and for general corporate purposes.

Aclaris' Wart Treatment Topical Solution Found Effective, Safe In Late-Stage Study

Aclaris Therapeutics Inc (NASDAQ: ACRS) announced positive results from the Phase 3 study of THWART-2 that is evaluating A-101 45% topical solution as an investigational new drug for the treatment of common warts.

The company noted that A-101 met the primary endpoint and all secondary endpoints, achieving clinically and statistically significant clearance of common warts.

A-101 45% topical solution is a proprietary high-concentration hydrogen peroxide topical solution.

"This treatment is self-administered twice a week for 8 weeks (a total of 16 applications) and we believe these results will be of interest to partners seeking to commercialize A-101 45% Topical Solution," said Neal Walker, CEO of Aclaris.

The stock jumped 50% to $1.65 in after-hours trading.

Tonix Pharma In-licenses Drug to Treat Gastric and Pancreatic Cancers

Tonix Pharmaceuticals Holding Corp (NASDAQ: TNXP) announced an in-licensing agreement, under which it will get an exclusive license from the Columbia University for the development of TNX-1700, a preclinical asset, as a treatment option for gastric and pancreatic cancers.

The stock advanced 18.50% to 57 cents in after-hours trading.

Novartis' Spondyloarthritis Drug Aces Late-Stage Study

Novartis AG (NYSE: NVS) announced positive data from the Phase 3 PREVENT trial evaluating the efficacy and safety of its Cosentyx in patients with non-radiographic axial spondyloarthritis, or nr-axSpA. The study met its primary endpoint of ASAS40 at Week 16, showing a significant and clinically meaningful reduction in disease activity for patients treated with Cosentyx versus placebo.

DermTech Appoints New CFO

DermTech Inc (NASDAQ: DMTK) announced the appointment of Kevin Sun as CFO, Treasurer and Secretary, following the planned retirement of founding CEO Steven Kemper, effective October.

On The Radar Clinical Trial Readouts

Lexicon Pharmaceuticals, Inc. (NASDAQ: LXRX) is due to make multiple presentations, both oral an poster, on its Type 1 diabetes product candidate sotagliflozin at the European Association for the Study of Diabetes, or EASD, 55th annual meeting annual meeting in Barcelona, Spain.

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