KALA, AXSM, ONTX - A December To Remember?

(RTTNews) - Clinical trials are major catalysts for biotech/pharma companies as positive study data can boost the stock price while unfavorable results can send the stocks plummeting.

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 three companies that are expected to report phase III results or interim analysis of their phase III trials this month.

1. Kala Pharmaceuticals Inc. (KALA)

Shares of Kala Pharma are down 13% this month.

The Company is focused on developing therapies for treating eye diseases. The most advanced clinical programs of Kala Pharma target dry eye disease and post-surgical ocular inflammation and pain.

A phase III trial evaluating KPI-121 0.25% in patients with dry eye disease is underway, and top-line results are expected by the end of 2017.

Dry eye is a condition in which a person doesn't have enough quality tears to lubricate and nourish the eye. People with dry eyes may experience irritated, gritty, scratchy or burning eyes; a feeling of something in their eyes; excess watering; and blurred vision. Advanced dry eyes may damage the front surface of the eye and impair vision. (Source: American Optometric Association).

Recent event:

On October 25, 2017, the Company submitted a New Drug Application for INVELTYS for the treatment of inflammation and pain in patients who have undergone ocular surgery.

After an NDA is received, the FDA has 60 days to decide whether to file it so it can be reviewed.

KALA closed Friday's (Dec.15) trading at $16.65, up 2.08%.

2. Axsome Therapeutics Inc. (AXSM)

Shares of Axsome have lost 14% of their value so far this month.

The Company is developing novel therapies for the management of central nervous system (CNS) disorders.

Axsome has two clinical compounds - AXS-05 and AXS-02.

AXS-05 is currently in a phase III trial for the treatment of treatment-resistant depression, dubbed STRIDE-1, and a phase II/III trial for the treatment of agitation in patients with Alzheimer's disease.

AXS-02 is currently in a phase III trial in complex regional pain syndrome, dubbed CREATE, and a phase III trial in knee osteoarthritis associated with bone marrow lesions, known as COAST-1.

The *interim analysis for CREATE-1 and COAST-1 trials will be conducted by an independent data monitoring committee, and results of the analyses are expected to be available by late December 2017 to early January 2018.

*An interim analysis helps to evaluate the trial's success probability while controlling the overall error rates. (Source: Science Direct).

Top-line data from the phase III STRIDE-1 trial of AXS-05 are expected in the first half of 2018.

AXSM closed Friday's trading at $4.85, up 3.19%.

3. Onconova Therapeutics Inc. (ONTX)

Shares of Onconova are down over 8% this month.

The Company is focused on discovering and developing novel small molecule drug candidates to treat cancer, with a primary focus on Myelodysplastic Syndromes.

Myelodysplastic syndrome (MDS) is a group of diseases that affects normal blood cell production in the bone marrow. About 30% of people with MDS will progress to a form of cancer called acute myeloid leukaemia. (Source: Leukaemia Foundation).

The Company's lead drug candidate is Rigosertib.

A phase III global trial comparing IV Rigosertib against physician's choice of treatment in patients with myelodysplastic syndrome after failure of a hypomethylating agent, dubbed INSPIRE, is underway.

Interim analysis of the INSPIRE trial is expected this month, with top-line data anticipated in 2018.

ONTX closed Friday's trading at $1.38, down 0.72%.