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The Daily Biotech Pulse: Osmotica Soars On Insider Buys, Ultragenyx's Partnered Rare Disease Drug Moves Into Clinics

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 Jan. 15)

  • 10X Genomics Inc (NASDAQ: TXG)
  • Aimmune Therapeutics Inc (NASDAQ: AIMT)
  • Allergan plc (NYSE: AGN)
  • Apellis Pharmaceuticals Inc (NASDAQ: APLS)
  • Applied Therapeutics Inc (NASDAQ: APLT)
  • Arvinas Inc (NASDAQ: ARVN)
  • Ascendis Pharma A/S (NASDAQ: ASND)
  • AtriCure Inc. (NASDAQ: ATRC)
  • AVITA MED LTD/S ADR (NASDAQ: RCEL)
  • Bristol-Myers Squibb Co (NYSE: BMY)(accepted for priority review the company's sBLA for Opdivo-Yervoy for first-line treatment of non-small cell lung cancer)
  • Collegium Pharmaceutical Inc (NASDAQ: COLL)
  • Editas Medicine Inc (NASDAQ: EDIT)
  • Eli Lilly And Co (NYSE: LLY)
  • Epizyme Inc (NASDAQ: EPZM)
  • Fate Therapeutics Inc (NASDAQ: FATE)
  • Foamix Pharmaceuticals Ltd (NASDAQ: FOMX)
  • Frequency Therapeutics Inc (NASDAQ: FREQ)
  • GALAPAGOS NV/S ADR (NASDAQ: GLPG) ( expanded an existing collaboration agreement with Fibrocor)
  • GlaxoSmithKline plc (NYSE: GSK)
  • Halozyme Therapeutics, Inc. (NASDAQ: HALO)
  • Hologic, Inc. (NASDAQ: HOLX)
  • Horizon Therapeutics PLC (NASDAQ: HZNP)
  • Inspire Medical Systems Inc (NYSE: INSP)
  • Insulet Corporation (NASDAQ: PODD)
  • Masimo Corporation (NASDAQ: MASI)
  • Medpace Holdings Inc (NASDAQ: MEDP)
  • Mesoblast limited (NASDAQ: MESO)
  • Momenta Pharmaceuticals, Inc. (NASDAQ: MNTA)
  • Myokardia Inc (NASDAQ: MYOK)
  • NeoGenomics, Inc. (NASDAQ: NEO)
  • Novo Nordisk A/S (NYSE: NVO)
  • NuVasive, Inc. (NASDAQ: NUVA)
  • Profound Medical Corp (NASDAQ: PROF)
  • Repligen Corporation (NASDAQ: RGEN)
  • Replimune Group Inc (NASDAQ: REPL)
  • ResMed Inc. (NYSE: RMD)
  • Revance Therapeutics Inc (NASDAQ: RVNC)
  • Rigel Pharmaceuticals, Inc. (NASDAQ: RIGL)
  • Selecta Biosciences Inc (NASDAQ: SELB)
  • Syneos Health, Inc. (NASDAQ: SYNH)
  • TG Therapeutics Inc common stock (NASDAQ: TGTX)
  • Vertex Pharmaceuticals Incorporated (NASDAQ: VRTX
  • Viela Bio Inc (NASDAQ: VIE)
  • West Pharmaceutical Services Inc. (NYSE: WST)
  • Zai Lab Ltd (NASDAQ: ZLAB)
  • Zoetis Inc (NYSE: ZTS)

Down In The Dumps

(Biotech Stocks Hitting 52-week lows on Jan. 15)

  • Entasis Therapeutics Holdings Inc (NASDAQ: ETTX)
  • Merrimack Pharmaceuticals Inc (NASDAQ: MACK)

Stocks In Focus Osmotica Reports Insider Purchase of Shares

Osmotica Pharmaceuticals PLC (NASDAQ: OSMT) shares found some strength after it reported share purchases by insiders. Altchem bought 1.25 million shares at $5 Monday, with the number of shares owned beneficially by the firm now at 22.485 million. The company also filed share purchases by Avista Capital Partners III, the Harsaul Foundation and directors David Burgstahler and SriramVenkatraman.

The stock jumped 16.47% to $5.80 in after-hours trading.

Ultragenyx Says IND For Partnered Rare Disease Drug Approved By FDA

Ultragenyx Pharmaceutical Inc (NASDAQ: RARE) said an IND application filed with the FDA by GeneTx for GTX-102 is now effective, GTX-102 is an experimental antisense oligonucleotide being evaluated for Angelman syndrome.

Ultragenyx and GeneTx are partnering in the development of GTX-102 under a Aug. 2019 agreement, with the former receiving an exclusive option to acquire the latter.

The company said enrollment into a Phase 1/2 study is set to begin in the first half of 2020.

On The Radar Adcom Meeting

The Anesthetic and Analgesic Drug Products Advisory Committee will review DURECT Corporation's (NASDAQ: DRRX) NDA for bupivacaine extended-release solution for instillation, for the proposed indication of post-surgical analgesia.

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