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8 Biotech Stocks With Clinical Trial Outcomes In April

8 Biotech Stocks With Clinical Trial Outcomes In April

The market-moving nature of clinical trial results is due to the fact that only a small proportion of drugs that move from pre-clinical trials or animal testing stage advance successfully through the three phases of clinical trials. FDA estimates put the percentage of drugs that move out of the Phase 3 trials into the next stage at 25-30 percent of the total number of candidates entering Phase 1 trials.

Here are a few companies scheduled to release trial results in the first half of April.

1. Can Selecta's Select Cohort Data on Its Gout Candidate Get it Moving

  • Company: Selecta Biosciences Inc (NASDAQ: SELB)
  • Product Candidate: SEL-212
  • Indication: Tophaceous gout
  • Trial: Phase 2 data from cohorts receiving three monthly doses of SEL-212- pegsiticase combo followed by two monthly doses of pegsiticase alone
  • Date Expected: April 9 or 10 at the Panamerican League of Associations for Rheumatology Congress

Selecta's lead product candidate SEL-212, a therapeutic enzyme, is touted to be the first biologic treatment for gout, a condition in which defective metabolism of uric acid causes arthritis, especially in the smaller bones of the feet.

Related Link: Attention Biotech Investors: Mark Your Calendar For These April PDUFA Dates

2. Novartis to Present Abstract of Phase 3 Study On Psoriatic Arthritis Candidate

  • Company: Novartis AG (ADR) (NYSE: NVS)
  • Product Candidate: AIN457 (Cosentyx)
  • Indication: Psoriatic arthritis
  • Trial: Abstract of 52-week results from the Phase 3 study (NCT02294227 FUTURE 4) to be submitted to the PANLAR Congress scheduled between April 7-10
  • Date Expected: April 7-10

Novartis' Cosentyx is a fully human interlukin-17A inhibitor, which showed long-term efficacy in treating moderate-to-severe psoriasis, psoriatic arthritis and ankylosing arthritis. It was first approved in 2015 to treat moderate-to-severe plaque psoriasis.

3. Can Galectin Churn Out Better Tidings On its NASH Candidate

  • Company: Galectin Therapeutics Inc. Common Stock (NASDAQ: GALT)
  • Product Candidate: GR-MD-02
  • Indication: Non-alcoholic steatohepatitis (NASH) with cirrhosis
  • Trial: Phase 2b
  • Date Expected: April 14

Galectin's treatment candidate for NASH, which is an acute form of non-alcoholic fatty liver disease, suffered a setback in December, when top-line data from a Phase 2b study did not meet primary endpoint across all patients. However, the company noted improvement in subgroups.

The results of the Phase 2b study is to be presented as a late breaker at the EASL congress.

Data from a Phase 2a study released in September 2017 showed the study did not meet the primary and secondary endpoints.

4. OncoSec to Release Early-stage Results of Breast Cancer Treatment

  • Company: OncoSec Medical Inc (NASDAQ: ONCS)
  • Product Candidate: ImmunoPulse IL-12
  • Indication: Triple Negative Breast Cancer, or TNBC
  • Trial: Phase I data to be presented at the American Association For Cancer Research, or AACR
  • Date Expected: April 15

ImmunoPulse focuses on delivery of DNA-based interlukin-12, a naturally occurring protein with immune-stimulating functions. It is currently being tested for TNBC and metastatic melanoma.

5. ArQule To Present On Oncology Treatment Candidate

  • Company: ArQule, Inc. (NASDAQ: ARQL)
  • Product Candidate: Miransertib (ARQ 092)
  • Indication: Solid Tumors (to treat patients with lymphoma, endometrial cancer and AKT1 E17K mutations)
  • Trial: Phase 1b at the AACR
  • Date Expected: April 15

Miransertib is an orally available, selective, pan-AKT inhibitor that likely inhibits AKT1,2 and 3 isoforms.

6. Blueprint Looking to Print Solid Early Results

  • Company: Blueprint Medicines Corp (NASDAQ: BPMC)
  • Product Candidate: BLU-667
  • Indication: RET-altered solid tumors (to treat patients with advanced non-small cell lung cancer, advanced thyroid cancer and other advanced solid tumors)
  • Trial: Initial Phase 1 data
  • Date Expected: April 15

The Phase 1 study was started in March 2017.

Related Link: Mesoblast's Delayed Launches, Teva Split Turn Credit Suisse Bearish

7. Toca Would Let The Results Talk

  • Company: Tocagen Inc (NASDAQ: TOCA)
  • Product Candidate: Toca 511 - Toca 6
  • Indication: Metastatic solid tumors (colorectal cancer, renal cell carcinoma, melanoma, pancreatic cancer and lung & breast cancer)
  • Trial: Phase 1b
  • Date Expected: April 16

8. Tesaro Also to Release Results For Advanced Solid Tumor Candidate

  • Company: TESARO Inc (NASDAQ: TSRO)
  • Product Candidate: TSR-042
  • Indication: Advanced solid Tumors, including metastatic endometrial cancer
  • Trial: Phase 1 (study dubbed GARNET)
  • Date Expected: April 16

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