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The Daily Biotech Pulse: Affimed's Cancer Drug Placed On Clinical Hold, Celgene's Positive Scalp Psoriasis Trial

The Daily Biotech Pulse: Affimed's Cancer Drug Placed On Clinical Hold, Celgene's Positive Scalp Psoriasis Trial

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 Oct. 8)

  • BioDelivery Sciences International, Inc. (NASDAQ: BDSI)
  • BioNano Genomics Inc (NASDAQ: BNGO)
  • Eli Lilly And Co (NYSE: LLY)
  • Pfizer Inc. (NYSE: PFE)

Down In The Dumps

(Biotech stocks hitting 52-week lows on Oct. 8)

  • AC Immune SA (NASDAQ: ACIU)
  • Alnylam Pharmaceuticals, Inc. (NASDAQ: ALNY)
  • Avenue Therapeutics Inc (NASDAQ: ATXI)
  • Aytu Bioscience Inc (NASDAQ: AYTU)
  • Biocept Inc (NASDAQ: BIOC)
  • Cue Biopharma Inc (NASDAQ: CUE)
  • Endologix, Inc.
  • Genprex Inc (NASDAQ: GNPX)
  • Gritstone Oncology, Inc. (Nasdaq: GRTS)
  • La Jolla Pharmaceutical Company (NASDAQ: LJPC)
  • Magenta Therapeutics Inc (NASDAQ: MGTA)
  • Menlo Therapeutics Inc (NASDAQ: MNLO)(announced Phase 2 top-line data for its serlopitant for treating refractory chronic cough showed that the treatment candidate failed to demonstrate benefit versus placebo on the primary and secondary endpoints.)
  • Moleculin Biotech Inc (NASDAQ: MBRX)
  • Neos Therapeutics Inc (NASDAQ: NEOS)
  • Novelion Therapeutics Inc (NASDAQ: NVLN)
  • Oncolytics Biotech, Inc. (NASDAQ: ONCY)
  • Proteon Therapeutics Inc (NASDAQ: PRTO)
  • Replimune Group Inc (NASDAQ: REPL)
  • Rubius Therapeutics Inc (NASDAQ: RUBY)

See Also: Attention Biotech Investors: Mark Your Calendar For These October PDUFA Dates

Stocks In Focus

Affimed's Cancer Drug Put On Clinical Hold Following A Death and 2 Life-Threatening Events

Affimed NV (NASDAQ: AFMD) said it has put its CD19/CD3-targeting T cell engager AFM11 on clinical hold. AFM11 is being evaluated in two early-stage clinical trials to treat patients with relapsed or refractory CD19 positive B-cell non-Hodgkin lymphoma, or NHL, and acute lymphoblastic leukemia, or ALL.

The company said the clinical hold was initiated after the occurrence of serious adverse in three patients, including a death in the ALL study and two life-threatening events in the NHL study.

Affimed said it would work with global health authorities and the Safety Monitoring Committees, and clinical investigators of the study to review the data and determine next steps for the AFM11 program.

The shares fell 24.89 percent to $3.47 in after-hours trading.

Celgene's Candidate Meets Primary, Secondary Endpoint In Trial For Scalp Psoriasis

Celgene Corporation (NASDAQ: CELG) said its Phase 3 trial that evaluated its Otezla for treating moderate to severe scalp psoriasis met the primary endpoint. Otzela, 30 mg, twice daily achieved a highly statistically significant improvement in the primary endpoint of the Scalp Physician's Global Assessment response, defined as ScPFA score of clear or almost clear, with at least a 2-point reduction from baseline at week 16 compared with placebo, the company said.

The company also said the pipeline asset met statistical significance for the secondary endpoint of the whole body itch numeric rating scale, defined as at least a 4-point reduction from baseline.

Veracyte's Genomic Diagnostic Test to Detect Lung Disease Found Accurate

Veracyte Inc (NASDAQ: VCYT) made an oral presentation of data that demonstrated that the Envisia Genomic Classifier helped physicians more confidently diagnose interstitial lung disease, or ILD, including idiopathic pulmonary fibrosis, without the need for surgery.

The data was presented at the American College of Chest Physicians in San Antonio, Texas.

Arena Says Phase 2 Ulcerative Colitis Data Supports a Direct Readthrough to Phase 3 Program

Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) presented Phase 2 data from a study dubbed OASIS, which evaluated its etrasimod for ulcerative colitis, at the American College of Gastroenterology Annual Meeting.

"Our Phase 2 results demonstrated the potential of etrasimod to allow patients to achieve clinical remission and meaningful improvements in the endpoints measured," the company said. This supports a direct readthrough to its Phase 3 program.


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