U.S. Markets closed
  • S&P 500

    3,841.94
    +73.47 (+1.95%)
     
  • Dow 30

    31,496.30
    +572.16 (+1.85%)
     
  • Nasdaq

    12,920.15
    +196.68 (+1.55%)
     
  • Russell 2000

    2,192.21
    +45.29 (+2.11%)
     
  • Crude Oil

    66.28
    +2.45 (+3.84%)
     
  • Gold

    1,698.20
    -2.50 (-0.15%)
     
  • Silver

    25.30
    -0.17 (-0.65%)
     
  • EUR/USD

    1.1916
    -0.0063 (-0.5243%)
     
  • 10-Yr Bond

    1.5540
    +0.0040 (+0.26%)
     
  • Vix

    24.66
    -3.91 (-13.69%)
     
  • GBP/USD

    1.3834
    -0.0060 (-0.4344%)
     
  • USD/JPY

    108.3600
    +0.3840 (+0.3556%)
     
  • BTC-USD

    50,839.23
    +3,244.45 (+6.82%)
     
  • CMC Crypto 200

    982.93
    +39.75 (+4.21%)
     
  • FTSE 100

    6,630.52
    -20.36 (-0.31%)
     
  • Nikkei 225

    28,864.32
    -65.79 (-0.23%)
     

The Daily Biotech Pulse: Aurinia Pulls The Plug On Dry Eye Disease Study, Karyopharm's Positive Readout, Emergency Use Authorization For OraSure

  • Oops!
    Something went wrong.
    Please try again later.
  • Oops!
    Something went wrong.
    Please try again later.
  • Oops!
    Something went wrong.
    Please try again later.
  • Oops!
    Something went wrong.
    Please try again later.
  • Oops!
    Something went wrong.
    Please try again later.
Shanthi Rexaline
·5 min read
  • Oops!
    Something went wrong.
    Please try again later.
  • Oops!
    Something went wrong.
    Please try again later.
  • Oops!
    Something went wrong.
    Please try again later.
  • Oops!
    Something went wrong.
    Please try again later.
  • Oops!
    Something went wrong.
    Please try again later.

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 Nov. 2)

  • Bio-Rad Laboratories, Inc. Class A Common Stock (NYSE: BIO)

  • Immunovant Inc (NASDAQ: IMVT)

  • United Therapeutics Corporation (NASDAQ: UTHR)

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows Nov. 2)

  • AEterna Zentaris Inc. (NASDAQ: AEZS)

  • Aikido Pharma Inc (NASDAQ: AIKI)

  • Artelo Biosciences Inc (NASDAQ: ARTL)

  • Avita Therapeutics Inc (NASDAQ: RCEL)

  • Benitec Biopharma Inc (NASDAQ: BNTC)

  • BioCardia Inc (NASDAQ: BCDA)

  • Biondvax Pharmaceuticals Ltd – ADR (NASDAQ: BVXV)

  • Catabasis Pharmaceuticals Inc (NASDAQ: CATB)

  • Celsion Corporation (NASDAQ: CLSN)

  • Codiak BioSciences Inc (NASDAQ: CDAK)

  • Cumberland Pharmaceuticals, Inc. (NASDAQ: CPIX)

  • Entasis Therapeutics Holdings Inc (NASDAQ: ETTX)

  • FSD Pharma Inc (NASDAQ: HUGE)

  • Galecto Inc (NASDAQ: GLTO) (went public Thursday)

  • Hoth Therapeutics Inc (NASDAQ: HOTH)

  • Inhibrx Inc (NASDAQ: INBX)

  • Iterum Therapeutics PLC (NASDAQ: ITRM)

  • Jaguar Health Inc (NASDAQ: JAGX)

  • Lexicon Pharmaceuticals, Inc. (NASDAQ: LXRX)

  • Monopar Therapeutics Inc (NASDAQ: MNPR)

  • Nabriva Therapeutics PLC – ADR (NASDAQ: NBRV)

  • Neovasc Inc (NASDAQ: NVCN)

  • Neurobo Pharmaceuticals Inc (NASDAQ: NRBO)

  • Orchard Therapeutics PLC – ADR (NASDAQ: ORTX) (halted dosing in Strimvelis study after it was linked to the development of leukemia in a patient)

  • Orphazyme A S ADR (NASDAQ: ORPH)

  • Pliant Therapeutics Inc (NASDAQ: PLRX)

  • RA Medical Systems Inc (NYSE: RMED)

  • Recro Pharma Inc (NASDAQ: REPH)

  • Rockwell Medical Inc (NASDAQ: RMTI)

  • Teligent Inc (NEW JERSEY) (NASDAQ: TLGT)

  • Titan Pharmaceuticals, Inc. common stock (NASDAQ: TTNP)

Stocks In Focus Aurinia Ends Dry Eye Disease Study

Aurinia Pharmaceuticals Inc (NASDAQ: AUPH) said topline results from its Phase 2/3 AUDREY clinical study evaluating voclosporin ophthalmic solution for the potential treatment of dry eye syndrome revealed the study did not meet its primary endpoint.

The primary endpoint was a 10mm or greater improvement in Schirmer Tear Test at four weeks between active dose groups of VOS compared to vehicle.

Aurinia said it is suspending the development program for VOS based upon these results.

The stock was down 8.26% premarket at $14.22. 

Karyopharm's Xpovio Aces Late-Stage Study In Rare Cancer

Karyopharm Therapeutics (Inc NASDAQ: KPTI) announced positive topline results from the Phase 3 portion of the SEAL study evaluating single agent oral Xpovio versus matching placebo in patients with advanced unresectable dedifferentiated liposarcoma.

The SEAL study met its primary endpoint of a statistically significant increase in progression-free survival, with Xpovio reducing the risk of disease progression or death by approximately 30%.

Separately, the company reported higher third-quarter revenues that fell short of some analyst estimates. The loss per share was a penny wider than estimates.

The stock was up 6.76% at $15.48 premarket. 

BioMarin Announces FDA Acceptance Of Regulatory Filing

BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) said the FDA has accepted the NDA for vosoritide, an investigational, once daily injection analog of C-type natriuretic peptide for children with achondroplasia, the most common form of disproportionate short stature in humans.

This acceptance by the FDA marks the first marketing application accepted for a treatment for achondroplasia in the U.S., BioMarin said.

The PDUFA date has been set for Aug. 20, 2021.

Related Link: The Week Ahead In Biotech (Nov. 1-7): Adcom Test For Biogen's Aducanumab, Alzheimer's Conference, SMID-cap Earnings

OraSure Unit Receives Emergency Use Authorization For Device

OraSure Technologies, Inc. (NASDAQ: OSUR) said its DNA Genotek subsidiary has received emergency use authorization from the FDA for the use of the ORAcollect RNA saliva collection device for the collection, stabilization and transport of saliva specimens suspected of containing SARS-CoV-2 RNA.

This is the second FDA EUA that DNA Genotek has received for its saliva collection devices.

View more earnings on IBB

The stock was trading 9.17% higher at $16.25 premarket Tuesday.

Bristol-Myers Squibb Reports Positive Phase 3 Readout In Psoriasis 

Bristol-Myers Squibb Co (NYSE: BMY) announced positive results from POETYK PSO-1, the first pivotal Phase 3 trial evaluating deucravacitinib, a selective tyrosine kinase 2 inhibitor, for the treatment of patients with moderate to severe plaque psoriasis.

The POETYK PSO-1 study evaluated 6 mg of deucravacitinib once daily met both co-primary endpoints versus placebo, with more patients achieving Psoriasis Area and Severity Index 75, defined as at least a 75% improvement in PASI, and a static Physician's Global Assessment score of clear or almost clear after 16 weeks of treatment with deucravacitinib, the company said.

Bristol-Myers Squibb also noted that the trial met multiple key secondary endpoints, including showing deucravacitinib was superior to Otezla in the proportion of patients reaching a PASI 75 response and sPGA 0/1 at Week 16.

In premarket trading Tuesday, the stock was up 3.46% to $61.55. 

Earnings

Halozyme Therapeutics, Inc.'s (NASDAQ: HALO) third-quarter revenues rose from $46.2 million to $65.3 million. The company reversed from a loss of 17 cents per share to a profit of 25 cents per share. The company raised its full year 2020 guidance.

In after-hours trading, the stock gained 7.71% to $30.59.

Pacific Biosciences of California Inc (NASDAQ: PACB) said its third-quarter revenues slipped from $21.9 million to $19.1 million. The loss per share narrowed from 19 cents to 14 cents.

The stock was down 10.94% at $11.80 premarket. 

Inspire Medical Systems Inc (NYSE: INSP) said its third-quarter revenues jumped 72% year-over-year to $35.8 million. The loss per share widened from 34 cents to 39 cents. The company raised its full-year revenue and gross margin guidance.

The stock was trading 12.24% higher at $136.65 premarket Tuesday.

On The Radar Earnings

  • Oxford Immunotec Global PLC (NASDAQ: OXFD) (before the market open)

  • Catalent Inc (NYSE: CTLT) (before the market open)

  • Avanos Medical Inc (NYSE: AVNS) (before the market open)

  • Acorda Therapeutics Inc (NASDAQ: ACOR) (after the close)

  • Five Prime Therapeutics Inc (NASDAQ: FPRX) (after the close)

  • GW Pharmaceuticals PLC- ADR (NASDAQ: GWPH) (after the close)

  • Supernus Pharmaceuticals Inc (NASDAQ: SUPN) (after the close)

Related Link: A Pfizer Analyst's 3 Possible Coronavirus Vaccine Readout Scenarios

See more from Benzinga

© 2020 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.