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The Daily Biotech Pulse: Nuvectra Files For Expanded Label For Algovita SCS, Axovant Earnings, FDA Nod For Aratana

The Daily Biotech Pulse: Nuvectra Files For Expanded Label For Algovita SCS, Axovant Earnings, FDA Nod For Aratana

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 June 11)

  • Hemispherx BioPharma, Inc (NYSE: HEB)(started trading on a 1-for-44 reverse split adjusted basis)

Down In The Dumps

(Biotech stocks hitting 52-week lows on June 11)

  • Acer Therapeutics Inc (NASDAQ: ACER)
  • Adamas Pharmaceuticals Inc (NASDAQ: ADMS)
  • Axovant Gene Therapies Ltd(NASDAQ: AXGT)
  • Cyclerion Therapeutics Inc (NASDAQ: CYCN)
  • CymaBay Therapeutics Inc (NASDAQ: CBAY)(reported negative mid-stage trial results for its investigational NASH candidate seladelpar)
  • Endo International PLC (NASDAQ: ENDP)
  • GENFIT S A/ADR (NASDAQ: GNFT)(moved in sympathy with CymaBay)
  • Innovate Biopharmaceuticals Inc (NASDAQ: INNT)
  • Insys Therapeutics Inc (NASDAQ: INSY)
  • Minerva Neurosciences Inc (NASDAQ: NERV)
  • Novavax, Inc. (NASDAQ: NVAX)
  • Puma Biotechnology Inc (NASDAQ: PBYI)
  • RA Medical Systems Inc (NYSE: RMED)
  • Rhythm Pharmaceuticals Inc (NASDAQ: RYTM)
  • Sellas Life Sciences Group Inc (NASDAQ: SLS)
  • TherapeuticsMD Inc (NASDAQ: TXMD)
  • Unum Therapeutics Inc (NASDAQ: UMRX)
  • Vanda Pharmaceuticals Inc. (NASDAQ: VNDA)

Stock In Focus

Nuvectra Files For Approval For Spinal Cord Stimulation System

Medical device company Nuvectra Corp (NASDAQ: NVTR) filed its regulatory submission with the FDA for it full-body MR-conditional approval for its Algovita spinal cord stimulation, or SCS, system.

The company said a MR-conditional approval in the U.S. in addition to the Algovita full-body MR-conditional CE Mark approval will supplement its existing competitive advantages and expand the number of eligible patients,

The approval could come through at or around the year end 2019, following a 180-day review process, it added.

The stock rallied 13.38% to $4.49 in after-hours trading.

See Also: What You Should Know About The Eye Care Product That Sent NovaBay Shares Soaring Nearly 900%

Axovant Q4 Loss Narrows

Axovant Gene Therapies Ltd (NASDAQ: AXGT) reported a fiscal-year 2018 fourth-quarter loss of 45 cents per share compared to a loss of $1.88 per share in the year-ago quarter. The narrower loss was due to a sharp reduction in R&D expenses, primarily due to the discontinuation of the company's development programs for inteperdine and nelotanserin. Analysts had estimated a loss of $1.72 per share for the quarter.

The stock jumped 18.02% to $4.65 in after-hours trading.

Aratana Gets FDA Nod For Additional Vial Size Of Post-Operative Local Analgesia For Pets

Aratana Therapeutics Inc (NASDAQ: PETX) said the FDA has approved an additional vial size, i.e. 10 ml, for Nocita, or bupivacaine liposome injectable suspension. It is a FDA-approved single-dose infiltration into surgical site to provide local post-operative analgesia for cranial cruciate ligament surgery in dogs and as a peripheral nerve block to provide regional post-operative analgesia following owner-elected onychectomy in cats

Currently, Nocita is available in a 20 ml vial size. Aratana expects Nocita 10 ml to be commercially available by fall.

The stock rose 4.14% to $5.03 in after-hours trading.

FDA Grants Priority Review Status For Roche's Genentech Unit's sBLA For Rituxan In Rare Pediatric Autoimmune Disorder Drug

Roche Holdings AG Basel ADR (OTC: RHHBY) said its Genentech unit's sBLA for Rituxan, in combination with glucocorticoids, for treating granulomatosis with polyangiitis, or GPA, and microscopic polyangiitis, MPA, in children two years of age and older has been accepted by the FDA with Priority Review status. GPA and MPA are rare, potentially life-threatening diseases affecting small and medium-sized blood vessels.

Novartis Releases New Positive Late-Stage Data For Psoriatic Arthritis Drug

Novartis AG (NYSE: NVS) released new data from the FUTURE 5 trial of Cosentyx, which showed no progression in almost 90% of psoriatic arthritis patients treated with Cosentyx 300mg over two years.

Separately, the company also released new Phase 3 data from the MAXIMISE trial that is evaluating the efficacy and safety of Cosentyx in the management of axial manifestations of psoriatic arthritis, which showed that the treatment met both the primary and secondary endpoints, with 63.1% of Cosentyx 300mg and 66.3% of Cosentyx 150mg patients achieving ASAS20 at Week 12 versus 31.3% for placebo.

On The Radar

Clinical Trial Readouts

GALAPAGOS NV/S ADR (NASDAQ: GLPG) and Gilead Sciences, Inc. (NASDAQ: GILD) are due to present at the EULAR Annual European Congress of Rheumatology already-released Phase 3 data for Filgotinib from FINCH 1 study in rheumatoid arthritis.

Imv Inc (NASDAQ: IMV) will release Phase 2 top-line data for its DPX-Survivac and Merck & Co., Inc. (NYSE: MRK)'s Keytruda in diffuse Large Cell Lymphoma. The presentation of the data will be done at the International Conference on Malignant Lymphoma to be held between June 18-22, in Lugano, Switzerland.


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