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The Daily Biotech Pulse: Novo Nordisk's Ozempic Receives Label Expansion For Cardiovascular Events, Adcom Disappointment Inflicts Pain On Durect Shares

The Daily Biotech Pulse: Novo Nordisk's Ozempic Receives Label Expansion For Cardiovascular Events, Adcom Disappointment Inflicts Pain On Durect Shares

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 on Jan. 16.)

  • Acceleron Pharma Inc (NASDAQ: XLRN)
  • Aimmune Therapeutics Inc (NASDAQ: AIMT)
  • Arvinas Inc (NASDAQ: ARVN)
  • AtriCure Inc. (NASDAQ: ATRC)
  • ChemoCentryx Inc (NASDAQ: CCXI)
  • Collegium Pharmaceutical Inc (NASDAQ: COLL)
  • Eli Lilly And Co (NYSE: LLY)
  • Epizyme Inc (NASDAQ: EPZM)
  • Fate Therapeutics Inc (NASDAQ: FATE)
  • Foamix Pharmaceuticals Ltd (NASDAQ: FOMX)
  • Fortress Biotech (NASDAQ: FBIO) (announced award of pediatric disease designation for its partner company Cyprium's CUTX-101, which is being evaluated for Menkes disease)
  • Frequency Therapeutics Inc (NASDAQ: FREQ)
  • Global Blood Therapeutics Inc (NASDAQ: GBT)
  • Halozyme Therapeutics, Inc. (NASDAQ: HALO)
  • Hologic, Inc. (NASDAQ: HOLX)
  • Inspire Medical Systems Inc (NYSE: INSP)
  • Insulet Corporation (NASDAQ: PODD)
  • Johnson & Johnson (NYSE: JNJ
  • Medtronic PLC (NYSE: MDT)
  • Masimo Corporation (NASDAQ: MASI)
  • Medpace Holdings Inc (NASDAQ: MEDP)
  • Mersana Therapeutics Inc (NASDAQ: MRSN)
  • Mesoblast limited (NASDAQ: MESO)
  • Minerva Neurosciences Inc (NASDAQ: NERV)
  • Nantkwest Inc (NASDAQ: NK) (reacted to JPMorgan Healthcare conference presentation)
  • Nevro Corp (NYSE: NVRO)
  • PTC Therapeutics, Inc. (NASDAQ: PTCT)
  • Rapt Therapeutics Inc (NASDAQ: RAPT)
  • Replimune Group Inc (NASDAQ: REPL)
  • ResMed Inc. (NYSE: RMD)
  • Revance Therapeutics Inc (NASDAQ: RVNC)
  • Rigel Pharmaceuticals, Inc. (NASDAQ: RIGL)
  • Soligenix, Inc. Common Stock (NASDAQ: SNGX)
  • TG Therapeutics Inc (NASDAQ: TGTX) (initiated rolling submission of NDA for umbralisib for the treatment of previously treated marginal zone lymphoma or follicular lymphoma)
  • Vertex Pharmaceuticals Incorporated (NASDAQ: VRTX)
  • Viela Bio Inc (NASDAQ: VIE)
  • Vir Biotechnology Inc (NASDAQ: VIR)
  • Xenon Pharmaceuticals Inc (NASDAQ: XENE)
  • Zoetis Inc (NYSE: ZTS)
  • Zogenix, Inc. (NASDAQ: ZGNX)

Down In The Dumps

(Biotech Stocks that hit 52-week lows on Jan. 16.)

  • Heat Biologics Inc (NASDAQ: HTBX) (priced $7-million common stock offering)

See also: The Week Ahead In Biotech: JPMorgan Healthcare Conference, FDA Panel Reviews Opioid Pain Drugs, I-Mab's IPO

Stocks In Focus

Novo Nordisk's Diabetes Drug Receives Label Expansion For Major Cardiovascular Events

Novo Nordisk A/S (NYSE: NVO) said the FDA has approved a new indication for Ozempic injection 0.5mg or 1mg to reduce the risk of major adverse cardiovascular events such as heart attack, stroke or death in adults with type 2 diabetes and known heart disease. Ozempic has already been approved for Type 2 diabetes in conjunction with diet and exercise.

The company also said the FDA has updated the label for its new diabetes drug Rybelsus to include additional information from the PIONEER 6 CVOT demonstrating cardiovascular safety.

Rybelsus will be covered by Cigna Corp (NYSE: CI)-owned pharmacy benefit manager Express Scripts, Reuters reported, citing the Danish newspaper Borsen.

Novo Nordisk shares were trading 1.03% higher at $61.94 at the time of publication during Friday's premarket session. 

Split Vote In Adcom Review For Durect's Pain Drug 

DURECT Corporation (NASDAQ: DRRX) said the Anesthetic and Analgesic Drug Products Advisory Committee, which reviewed its Class 2 NDA resubmission for Posimir, a bupivacaine extended-release solution, issued a split verdict. Six Adcom members voted to recommend that the efficacy, safety and overall risk-benefit profit of Posimir support approval, while six did not support the approval.

Posimir is being evaluated for the proposed indication of post-surgical analgesia.

Briefing documents released ahead of the Adcom meeting showed that FDA staffers were concerned about neurological safety.

Durect shares, which were halted for trading Thursday pending the FDA panel verdict announcement, were down 11.43% to $2.54 in premarket trading Friday.

Related Link: Attention Biotech Investors: Mark Your Calendar For These January PDUFA Dates


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