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 XLRN
- Aimmune Therapeutics Inc AIMT
- Arvinas Inc ARVN
- AtriCure Inc. ATRC
- AVITA MED LTD/S ADR RCEL
- ChemoCentryx Inc CCXI
- Collegium Pharmaceutical Inc COLL
- DENTSPLY SIRONA Inc XRAY
- Eli Lilly And Co LLY
- Epizyme Inc EPZM
- Fate Therapeutics Inc FATE
- Foamix Pharmaceuticals Ltd FOMX
- Fortress Biotech 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 FREQ
- GALAPAGOS NV/S ADR GLPG
- Global Blood Therapeutics Inc GBT
- Halozyme Therapeutics, Inc. HALO
- Hologic, Inc. HOLX
- HEALTH SCIENCES/SH IMVT
- Inspire Medical Systems Inc INSP
- Insulet Corporation PODD
- Johnson & Johnson (NYSE: JNJ
- Medtronic PLC MDT
- Masimo Corporation MASI
- Medpace Holdings Inc MEDP
- Mersana Therapeutics Inc MRSN
- Mesoblast limited MESO
- Minerva Neurosciences Inc NERV
- Nantkwest Inc NK (reacted to JPMorgan Healthcare conference presentation)
- Nevro Corp NVRO
- PTC Therapeutics, Inc. PTCT
- Rapt Therapeutics Inc RAPT
- Replimune Group Inc REPL
- ResMed Inc. RMD
- Revance Therapeutics Inc RVNC
- Rigel Pharmaceuticals, Inc. RIGL
- Soligenix, Inc. Common Stock SNGX
- TELA Bio Inc TELA
- TG Therapeutics Inc TGTX (initiated rolling submission of NDA for umbralisib for the treatment of previously treated marginal zone lymphoma or follicular lymphoma)
- Vertex Pharmaceuticals Incorporated VRTX
- Viela Bio Inc VIE
- Vir Biotechnology Inc VIR
- Xenon Pharmaceuticals Inc XENE
- Zoetis Inc ZTS
- Zogenix, Inc. ZGNX
Down In The Dumps
(Biotech Stocks that hit 52-week lows on Jan. 16.)
- Heat Biologics Inc HTBX (priced $7-million common stock offering)
Stocks In Focus
Novo Nordisk's Diabetes Drug Receives Label Expansion For Major Cardiovascular Events
Novo Nordisk A/S 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 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 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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