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

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 BIO
  • Immunovant Inc IMVT
  • United Therapeutics Corporation UTHR

Down In The Dumps

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

  • AEterna Zentaris Inc. AEZS
  • Aikido Pharma Inc AIKI
  • Artelo Biosciences Inc ARTL
  • Avita Therapeutics Inc RCEL
  • Benitec Biopharma Inc BNTC
  • BioCardia Inc BCDA
  • Biondvax Pharmaceuticals Ltd – ADR BVXV
  • Catabasis Pharmaceuticals Inc CATB
  • Celsion Corporation CLSN
  • Codiak BioSciences Inc CDAK
  • Cumberland Pharmaceuticals, Inc. CPIX
  • Entasis Therapeutics Holdings Inc ETTX
  • FSD Pharma Inc HUGE
  • Galecto Inc GLTO (went public Thursday)
  • Hoth Therapeutics Inc HOTH
  • Inhibrx Inc INBX
  • Iterum Therapeutics PLC ITRM
  • Jaguar Health Inc JAGX
  • Lexicon Pharmaceuticals, Inc. LXRX
  • Monopar Therapeutics Inc MNPR
  • Nabriva Therapeutics PLC – ADR NBRV
  • Neovasc Inc NVCN
  • Neurobo Pharmaceuticals Inc NRBO
  • Orchard Therapeutics PLC – ADR ORTX (halted dosing in Strimvelis study after it was linked to the development of leukemia in a patient)
  • Orphazyme A S ADR ORPH
  • Pliant Therapeutics Inc PLRX
  • RA Medical Systems Inc RMED
  • Recro Pharma Inc REPH
  • Rockwell Medical Inc RMTI
  • Teligent Inc (NEW JERSEY) TLGT
  • Titan Pharmaceuticals, Inc. common stock TTNP

Stocks In Focus

Aurinia Ends Dry Eye Disease Study

Aurinia Pharmaceuticals Inc 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 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. 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. 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.

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 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 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 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 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 OXFD (before the market open)
  • Catalent Inc CTLT (before the market open)
  • Avanos Medical Inc AVNS (before the market open)
  • Acorda Therapeutics Inc ACOR (after the close)
  • Five Prime Therapeutics Inc FPRX (after the close)
  • GW Pharmaceuticals PLC- ADR GWPH (after the close)
  • Supernus Pharmaceuticals Inc SUPN (after the close)

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

Posted In: BiotechEarningsNewsPenny StocksHealth CareSmall CapFDAGeneral

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