5 Healthcare Stocks Facing Key Catalysts In Q4, 2019

(RTTNews) - A drug company's clinical trial data can send its stock skyrocketing or plunging depending on the outcome.

The success rate of phase I clinical programs is the highest, say 63%, while it is the lowest for phase II trials - i.e. 30%. The phase III trials, which are the longest and most expensive trials to conduct, are said to have a success rate of 58%, according to a report from the Biotechnology Innovation Organization on "Clinical Development Success Rates" over the past decade (2006-2015).

Listed below are some of the healthcare stocks facing phase III clinical trial results this quarter (if the companies stick to their timeline).

1. Allena Pharmaceuticals Inc. (ALNA)

Market value: $97.4 million

Allena Pharma is a late-stage, biopharmaceutical company developing first-in-class, oral enzyme therapeutics to treat patients with rare and severe metabolic and kidney disorders.

The Company's lead product candidate is Reloxaliase (formerly ALLN-177), an oral enzyme therapeutic that is initially being developed for the treatment of enteric hyperoxaluria in adults.

Hyperoxaluria is a metabolic disorder characterized by significantly elevated oxalate levels in the urine. This condition can cause kidney stones, damaging the kidney - ultimately leading to kidney failure.

Two pivotal phase III trials of Reloxaliase for the treatment of patients with enteric hyperoxaluria, dubbed URIROX-1 and URIROX-2, are underway.

The primary efficacy endpoint for both trials is the percent change from baseline in 24-hour urinary oxalate (UOx) excretion measured during weeks 1-4, comparing Reloxaliase to placebo.

The Company expects to report topline data from the URIROX-1 trial in the fourth quarter of 2019 and from URIROX-2 in the second half of 2021.

Analysts at Credit Suisse Group have an "Outperform" rating on ALNA, and a price target of $7.00.

ALNA has traded in a range of $3.33 to $11.82 in the last 1 year. The stock closed Friday's trading at $4.00, up 15.27%.

2. Kala Pharmaceuticals Inc. (KALA)

Market value: $128.9 million

Kala is a biopharmaceutical company focused on the development and commercialization of therapeutics, with an initial focus on the treatment of eye diseases.

The Company's lead drug candidate is KPI-121 0.25% for the temporary relief of the signs and symptoms of dry eye disease.

KPI-121 0.25% was denied approval by the FDA in August of this year, with the Company being asked to submit efficacy data from an additional clinical trial.

The NDA for KPI-121 0.25 included data from one phase II trial and two phase III efficacy and safety trials, STRIDE 1 and STRIDE 2.

The third phase III comparing KPI-121 0.25% to placebo in approximately 900 patients with dry eye disease, dubbed STRIDE 3, is underway.

The topline data from the STRIDE 3 trial is expected by the end of 2019, with resubmission of the NDA for KPI-121 0.25% planned during the first half of 2020.

Oppenheimer analyst has a "Buy" rating on KALA, and a price target of $9.00.

KALA has traded in a range of $3.43 to $10.21 in the last 1 year. The stock closed Friday's trading at $4.03, down 0.49%.

3. Acasti Pharma Inc. (ACST)

Market value: $155.72 million

Acasti is focused on the research, development, and commercialization of its prescription drug candidate CaPre for the treatment of severe hypertriglyceridemia (HTG).

CaPre for the treatment of severe hypertriglyceridemia is under two phase III trials, dubbed TRILOGY 1 and TRILOGY 2.

The topline data from TRILOGY 1 trial is expected in December 2019, and that from TRILOGY 2 is anticipated in January 2020. The topline results will include a readout of the primary endpoint, which is intended to show CaPre's overall impact on lowering triglycerides (TGs) after 12 weeks compared to placebo.

Analysts of B. Riley FBR have a "Buy" rating on ACST, with a price target of $ 7.75.

ACST has traded in a range of $0.60 to $2.95 in the last 1 year. The stock closed Friday's trading at $1.87, down 0.53%.

4. Aurinia Pharmaceuticals Inc. (AUPH)

Market value: $469.3 million

Aurinia is a late clinical-stage biopharmaceutical company focused on developing and commercializing therapies in disease areas of high unmet medical need.

The Company's lead drug candidate is Voclosporin, under phase III trial in lupus nephritis, dubbed AURORA; under phase II study in focal segmental glomerularsclerosis, and under a phase II/III study in dry eye syndrome, dubbed AUDREY.

The AURORA trial designed to enroll 324 patients, completed enrollment last September, surpassing the target. The primary endpoint for the study is complete renal response at 52 weeks, after which patients can choose to enroll in a 104-week blinded extension study.

The Company expects to report results from the AURORA trial in late 2019.

Oppenheimer analyst has an "Outperform" rating on AUPH, with a target price of $14.00.

AUPH has traded in a range of $4.92 to $7.85 in the last 1 year. The stock closed Friday's trading at $5.14, down 2.47%.

5. OPKO Health Inc. (OPK)

Market value: $1.34 billion

OPKO Health is a diversified healthcare company with a mature diagnostic business, marketed pharmaceuticals and a robust development pipeline.

The Company's lead drug candidate in the pipeline is Somatrogon (hGH-CTP) for the treatment of growth hormone deficiency in children.

A pivotal phase III study evaluating the safety and efficacy of the once-weekly Somatrogon (hGH-CTP) for the treatment of growth hormone deficiency in children is underway, with top-line results expected to be announced in the fourth quarter of 2019.

OPKO and Pfizer Inc. (PFE) have a worldwide agreement for the development and commercialization of Somatrogon.

Barrington Research currently has a "Buy" rating on OPK, with a target price of $4.00.

OPK has traded in a range of $1.73 to $3.94 in the last 1 year. The stock closed Friday's trading at $2.15, up 2.38%.