Market Overview

19 Biotech Stocks With Clinical Trial Outcomes In February

19 Biotech Stocks With Clinical Trial Outcomes In February

The pharma and biotech space, a defensive sector, has outperformed the broader market.

The iShares NASDAQ Biotechnology Index (ETF) (NASDAQ: IBB) and the SPDR S&P Biotech (ETF) (NYSE: XBI) have added 2.09 percent and 6.99 percent, respectively, year-to-date — versus a mere 0.3-percent gain in the S&P 500 Index. 

On Feb. 5 alone, the S&P 500 Index lost 4.1 percent.

Even as market volatility threatens to wipe out valuations, there are a few sector-specific, make-or-break events biotech investors should watch. Apart from FDA decisions, clinical trial results can also create wild swings in biotech stocks, with the directional move dependent on the market's perception of the outcomes. 

The following companies are expected to release clinical trial results in the remainder of February, with some presenting updated or fresh data at conferences while others will roll out initial data or interim analysis.

AVEO Pharmaceuticals, Inc. (NASDAQ: AVEO)

  • Product Candidate: Tivozanib and Opdivo.
  • Indication: advanced renal cell carcinoma.
  • Trial: Additional data on Phase 1 trial and initial results from the Phase 2 portion.
  • Date Expected: Feb. 8–10, at the 2018 Genitourinary Cancers Symposium co-sponsored by the American Society of Clinical Oncology, or ASCO-GU. 

Catalyst Biosciences Inc (NASDAQ: CBIO)

  • Product Candidate: CB2679d/ISU304.
  • Indication: Hemophilia B.
  • Trial: Phase 1/2 top-line interim data to be presented at the American Society of Hematology's 2017 annual meeting. 
  • Date Expected: Feb. 9.

Johnson & Johnson (NYSE: JNJ)'s Janssen Unit.

  • Product Candidate: Erdafitinib.
  • Indication: Bladder cancer.
  • Trial: Phase 2 data.
  • Date Expected: Feb. 9 at ASCO-GU 2018.

Rexahn Pharmaceuticals, Inc. (NYSE: RNN)

  • Product Candidate: RX-3117.
  • Indication: Third-line treatment for advanced urothelial cancer.
  • Trial: Preliminary Phase 2a data; initial Phase 2a data presented at ASCO 2017 on June 4, 2017.
  • Date Expected: Feb. 9 at ASCO-GU 2018.

TRACON Pharmaceuticals Inc (NASDAQ: TCON)

  • Product Candidate: DE-122.
  • Indication: Wet age-related macular degeneration.
  • Trial: Phase 1/2 PAVE trial.
  • Date Expected: Feb. 10 at the Angiogenesis, Exudation and Degeneration Meeting. 

Celgene Corporation (NASDAQ: CELG)

  • Product Candidate: Otezla.
  • Indication: Ulcerative colitis.
  • Trial: Full Phase 2 data set.
  • Date Expected: Feb. 14-17 at the 13th Congress of the European Crohn's and Colitis Organization, or ECCO. Depending on the outcome, the company plans to initiate a Phase 3 study in 2018.

See Also: Attention Biotech Investors: February PDUFA Catalysts Come Calling

Kura Oncology Inc (NASDAQ: KURA)

  • Product Candidate: Tipifarnib.
  • Indication: head and neck squamous cell carcinomas.
  • Trial: Updated Phase 2 data.
  • Date Expected: Feb. 15-17 at the Multidisciplinary Head and Neck Cancers Symposium. 

Immune Pharmaceuticals Inc (NASDAQ: IMNP)

  • Product Candidate: bertilimumab.
  • Indication: moderate to severe bullous pemphigoid.
  • Trial: Positive interim Phase 2 results and Phase 2a results.
  • Date Expected: Feb. 17 — late-breaking presentations at the 2018 American Academy of Dermatology annual meeting.

Aimmune Therapeutics Inc (NASDAQ: AIMT)

  • Product Candidate: AR101.
  • Indication: Peanut allergies.
  • Trial: Top-line data from a Phase 3 trial initiated in January 2017. 
  • Date Expected: No specific date scheduled.

Asterias Biotherapeutics Inc (NYSE: AST)

  • Product Candidate: AST-OPCI.
  • Indication: Cervical spinal cord injuries. 
  • Trial: Six-month data from Cohort 3 and Cohort 4. Twelve-month data from these cohorts is expected in August; six-month top-line Phase 1/2 data is expected in June; and 12-month data in December. 
  • Date Expected: No specific date scheduled.

CorMedix Inc. (NYSE: CRMD)

  • Product Candidate: Neutrolin. 
  • Indication: Hemodialysis Patients with Central Venous Catheters
  • Trial: LOCK-IT-100, an interim analysis of Phase 3 data
  • Date Expected: Early 2018, with a full analysis due in the second half of the year. 

Heat Biologics Inc (NASDAQ: HTBX)

  • Product Candidate: Opdivo.
  • Indication: Non-small cell lung cancer.
  • Trial: Initial Phase 2 data.
  • Date Expected: Feb. 28, at Heat Biologics' analyst and investor event.

Kadmon Holdings Inc (NYSE: KDMN)

  • Product Candidate: KD025.
  • Indication: Idiopathic pulmonary fibrosis.
  • Trial: Phase 2 data.
  • Date Expected: No specific date scheduled.

Madrigal Pharmaceuticals Inc (NASDAQ: MDGL)

  • Product Candidate: MGL-3196.
  • Indication: Heterozygous familial hypercholesterolemia.
  • Trial: Phase 2 data.
  • Date Expected: Madrigal announced Thursday that MGL-3196 achieved the primary endpoint in patients with heterozygous familial hypercholesterolemia. 

Marinus Pharmaceuticals Inc (NASDAQ: MRNS)

  • Product Candidate: Ganaxolone.
  • Indication: Postpartum depression.
  • Trial: Phase 2 data (Amaryllis trial).
  • Date Expected: Early 2018.

Novavax, Inc. (NASDAQ: NVAX)

  • Product Candidate: NanoFlu vaccine.
  • Indication: Influenza.
  • Trial: full Phase 1/2 data (trial initiated Sept. 19, 2017).
  • Date Expected: No specific date scheduled.

RXi Pharmaceuticals Corp (NASDAQ: RXII)

  • Product Candidate: RXI-109-1501.
  • Indication: Retinal scarring in advanced age-related macular degeneration.
  • Trial: Top-line Phase 1/2 data (completion of enrollment announced in June 2017).
  • Date Expected: No specific date scheduled.

Sierra Oncology Inc (NASDAQ: SRRA)

  • Product Candidate: SRA737.
  • Indication: Advanced solid tumors or Non-Hodgkin's lymphoma.
  • Trial: Update on Phase 1 trials.
  • Date Expected: No specific date scheduled.

Ionis Pharmaceuticals Inc (NASDAQ: IONS), Roche Holding Ltd. (ADR) (OTC: RHHBY)

  • Product Candidate: IONIS – HTT Rx.
  • Indication: Huntington's disease.
  • Trial: Phase 1/2 data.
  • Date Expected: The first half of 2018, most likely at the annual HD Therapeutics Conference scheduled for Feb. 26-March 1.

Related Links: 

The Alzheimer's Drug Pipeline: High Failure Rates In Research On An Increasingly Common Disease 

Pharma M&A Picks Up Momentum 


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