The Daily Biotech Pulse: Prothena Progress In Parkinson's Disease Pipeline, Fast Track For Xeris, Biogen Earnings

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 Oct. 20)

  • Aileron Therapeutics Inc ALRN
  • Anchiano Therapeutics Ltd – ADR ANCN
  • Athira Pharma Inc ATHA
  • Bio-Rad Laboratories, Inc. Class B Common Stock BIO
  • BioSpecifics Technologies Corp. BSTC
  • Blueprint Medicines Corp BPMC
  • Cleveland BioLabs, Inc. CBLI(announced a reverse merger with Cytocom)
  • Halozyme Therapeutics, Inc. HALO
  • Immunomedics, Inc. IMMU
  • Insmed Incorporated INSM
  • Laboratory Corp. of America Holdings LH
  • Pacific Biosciences of California Inc PACB
  • X T L Biopharmaceuticals Ltd XTLB

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows Oct. 19)

  • Aerie Pharmaceuticals Inc AERI
  • Alector Inc ALEC
  • Aligos Therapeutics Inc ALGS
  • Avenue Therapeutics Inc ATXI
  • Baudax Bio Inc BXRX (issued a corporate update)
  • Codiak BioSciences Inc CDAK (listed on Nasdaq on Oct. 14)
  • Corbus Pharmaceuticals Holdings Inc CRBP
  • FSD Pharma Inc HUGE
  • Gilead Sciences, Inc. GILD
  • Intercept Pharmaceuticals Inc ICPT
  • ProQR Therapeutics NV PRQR
  • Titan Pharmaceuticals, Inc TTNP

Stocks In Focus

Prothena to Advance Parkinson's Disease Drug Into Large-scale Confirmatory Study

Prothena Corporation PLC PRTA said, based on positive signals of efficacy consistent with disease modification in the PASADENA study, it along with Roche Holdings AG Basel ADR Common Stock RHHBY plans to advance prasinezumab into a Phase 2b study in patients with early Parkinson's disease. The study is likely to be initiated in 2021, it added.

The study will further assess the efficacy of prasinezumab by expanding upon the patient population enrolled in PASADENA to include patients with early Parkinson's disease on stable levodopa therapy, Prothena said.

Prothena added that it will earn a $60 million clinical milestone payment upon first patient dosed in this study.

"Prasinezumab is the first anti-alpha-synuclein antibody to advance into confirmatory large study in patients with early Parkinson's disease," Prothena said.

The stock gained 11.01% to $12.50 in after-hours trading.

Xeris' Investigational Drug Gets Fast Track Designation For Treating Acute Repetitive Seizures

Xeris Pharmaceuticals Inc XERS said the FDA granted fast track designation for the investigation of XP-0863 (diazepam non-aqueous injection) for the treatment of acute repetitive seizures.

In after-hours trading, the stock was up 9.52% to $5.75.

OncoCyte Rallies On Strong Adoption of its Lung Cancer Diagnostic Test

Molecular diagnostic company OncoCyte Corp OCX said testing volume of DetermaRx, its lung cancer diagnostic test launched in January, more than doubled quarter-over-quarter to 175 billable samples in the third quarter. The company also noted that it maintained a re-order rate of about 60% and onboard hospitals increased to 67.

The stock added 7.38% to $1.60 in after-hours trading.

Crispr Reports Positive Results For Cell Therapy In Early-stage Study In B-cell Malignancies

Crispr Therapeutics AG CRSP announced positive top-line results from its Phase 1 CARBON trial evaluating the safety and efficacy of CTX110, its wholly-owned allogeneic CAR-T cell therapy targeting CD19+ B-cell malignancies.

"While longer follow-up is required, these early data support the potential for CTX110 to become an effective off-the-shelf CAR-T therapy for patients with relapsed or refractory B-cell malignancies," said Joseph McGuirk, an investigator in the study.

The stock was slipping 3% to $103.50 in pre-market trading.

Actinium Announces NIH Grant For Study of its CD45-targeting Antibody Radio-conjugate

Actinium Pharmaceuticals Inc ATNM said the National Institutes of Health has awarded it a Small Business Technology Transfer grant to support a clinical collaboration with Memorial Sloan Kettering Cancer Center to study Iomab-ACT, Actinium's CD45-targeting antibody radio-conjugate, for targeted conditioning to achieve lymphodepletion prior to administration of a CD19-targeted CAR T-cell therapy developed at MSK.

The CD19 CAR-T has been previously studied by MSK in a Phase 2 trial with chemotherapy conditioning in patients with relapsed or refractory B-cell acute lymphoblastic leukemia or diffuse large B-cell lymphoma.

In pre-market trading, the stock was up 6.67% to $11.68.

Offerings

Replimune Group Inc REPL announced a proposed public offering of $125 million of shares of its common stock. All shares of common stock in the offering will be offered by the company.

The stock was down 8.06% to $39 in after-hours trading.

Aptinyx Inc APTX, which announced a positive mid-stage clinical readout late Tuesday, said it intends to offer and sell 12 million shares of its common stock in an underwritten public offering. All of the shares sold in the offering will be sold by the company.

In after-hours trading, the stock shed 4.54% to $4.10.

On The Radar

Clinical Readouts

Pfizer Inc. PFE is scheduled to present at the ID Week 2020 full results of a pediatric Phase 2 proof-of-concept study of 20vPNC and detailed results from a Phase 2 proof-of-concept study of its potential first-in-class pentavalent meningococcal vaccine candidate.

Earnings

Abbott Laboratories ABT (before the market open)
Biogen Inc BIIB (before the market open)
Edwards Lifesciences Corp EW (after the close)

Posted In: BiotechEarningsNewsPenny StocksOfferingsFDATop StoriesPre-Market Outlook