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05.03.2017 08:42:11

What Awaits These 10 Biotech Stocks In March?

(RTTNews) - Drug companies spend billions on R&D, which is the lifeline of the pharma industry. According to a report published by the Tufts Center for the Study of Drug Development, it costs about $2.6 billion to develop a new drug and bring it to market.

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 new report from the Biotechnology Innovation Organization on "Clinical Development Success Rates" over the past decade (2006-2015).

Listed below are some of the drug companies, which are expected to report clinical trial results this month. The estimated timing of reporting the Study results are sourced from the companies' latest PRs. The results may be reported in the estimated schedule or may be delayed.

1. Bellerophon Therapeutics Inc. (BLPH)

Bellerophon is focused on developing innovative products combining novel drugs and devices for people suffering from cardiopulmonary and cardiac diseases.

The company's proprietary technology is known INOpulse. Two product candidates are being developed based on this technology - one is for the treatment of Pulmonary Arterial Hypertension, which is under phase III study, and the other for Pulmonary Hypertension (PH) associated with Chronic Obstructive Pulmonary Disease (PH-COPD) and PH associated with Idiopathic Pulmonary Fibrosis (PH-IPF), under phase II testing.

The phase III program includes a one-year INOvation-1 study and a second confirmatory randomized withdrawal study. An interim analysis of the INOvation-1 study is estimated to occur by the end of 2017 and for the withdrawal study in the second half of 2018.

The results from the two phase II trials of INOpulse therapy - pulmonary hypertension (PH) associated with chronic obstructive pulmonary disease (PH-COPD) and idiopathic pulmonary fibrosis (PH-IPF) - are expected to be reported this month. (Q1, 2017).

Bellerophon shares are up an impressive 169% year-to-date, and trade around $1.40.

2. Cara Therapeutics Inc. (CARA)

Cara is focused on developing compounds to treat pain, inflammation and pruritus (itch).

The company's most-advanced clinical program is I.V. CR845, which is under phase III trial for postoperative pain and under phase 2/3 trial in dialysis patients suffering from moderate-to-severe uremic pruritus (UP).

Uremic pruritus is a chronic itching in patients with chronic kidney disease (CKD), for which there are no approved therapies in the United States.

The top line data readout from the phase 2/3 trial of I.V. CR845 is anticipated this month (Q1, 2017) and that of the phase III trial for postoperative pain is expected in the first half of this year.

Shares of Cara have gained 94% so far this year, and trade around $18.00.

3. Corbus Pharmaceuticals Holdings Inc. (CRBP)

Corbus is focused on developing drugs for rare inflammatory and fibrotic diseases.

The company has only 1 drug candidate, Resunab, also known as JBT-101, which is being explored in multiple indications.

A phase II study of Resunab in Cystic Fibrosis has been completed, and data from this trial are expected this month (Q1, 2017).

The company reported positive results from its phase II study of Resunab in Systemic Sclerosis on November 14, 2016, sending its stock up as much as 76% that day.

Investors would love to see an encore performance from Corbus with the Cystic Fibrosis trial. Will it happen? We'll have to wait and see.

Corbus shares are up 10% year-to-date, and trade around $9.30.

4. Aevi Genomic Medicine Inc. (GNMX)

Aevi is focused on genomic medicine, also known as personalized medicine.

The company's most-advanced product in the pipeline is AEVI-001, a first-in-class mGluR neuromodulator, which is under a phase 2/3 efficacy study in adolescent patients with ADHD (attention-deficit/hyperactivity disorder) who have genetic disorders impacting the mGluR network.

The top-line results from this study, dubbed SAGA, are expected this month.

GNMX is down over 8% year-to-date, and trade around $4.75.

5. Ionis Pharmaceuticals Inc. (IONS)

Ionis is a pioneer in antisense drug technology. Antisense drugs work by blocking the production of disease-causing proteins altogether, while traditional drug therapies work by interacting with the disease-causing proteins. Since antisense drugs are target-specific, these drugs have the potential to greatly reduce unwanted side effects.

The company has two drugs under phase III development - Volanesorsen for familial chylomicronemia syndrome, and IONIS-TTRR for familial amyloid polyneuropathy.

Familial chylomicronemia syndrome or FCS is a rare inherited condition where the body is unable to digest fats, such as triglycerides, often causing stomach pain and pancreatitis.

Results from the phase III trial of Volanesorsen, dubbed APPROACH, are expected to be reported this month (March).

Ionis shares are up 14% so far this year, and trade around $54.70.

6. Nektar Therapeutics (NKTR)

Nektar is a research-based biopharmaceutical company developing drugs for the treatment of cancer, auto-immune disease and chronic pain.

One of the phase III drugs in the company's pipeline is NKTR-181 a first-in-class, mu-opioid analgesic, for the treatment of moderate to severe chronic low back pain.

The phase III program of NKTR-181 includes two efficacy and safety studies namely SUMMIT-07 and SUMMIT-12, and a 52-week long-term safety study known as SUMMIT-LTS.

The company expects to report efficacy data from the SUMMIT-07 study evaluating NKTR-181 against placebo in opioid-naïve patients with chronic low back pain later this month.

Shares of Nektar have gained over 19% year-to-date, and trade around $14.00.

7. Merus B.V. (MRUS)

Merus is a clinical-stage immuno-oncology company developing innovative bispecific antibody therapeutics known as Biclonics.

The company's key drug candidate is MCLA-128, whose potential is being explored in phase I/II trials in breast, colorectal and ovarian cancers.

Interim results from Part 2 of the phase I/II clinical trial of MCLA-128 in breast cancer are expected to be reported this month.

Merus shares are up nearly 40% so far this year, and trade around $29.00.

8. Proteostasis Therapeutics Inc. (PTI)

Proteostasis is focused on discovering and developing a new class of drugs that regulate the Proteostasis Network, or PN in short. The PN consists of more than 1,000 proteins, and diseases like cancer and neurodegenerative diseases can occur if this network is challenged or rewired.

The company's lead drug candidate is PTI-428, an investigational oral treatment for cystic fibrosis belonging to the amplifier class, under phase I testing. Results from this phase I trial are expected this month (Q1, 2017).

Shares of Proteostasis are up more than 10% year-to-date, and trade around $13.55.

9. Ritter Pharmaceuticals Inc. (RTTR)

Ritter is focused on developing novel therapeutics that selectively modulate the gut microbiome.

The company's lead product candidate is RP-G28, under a phase 2b/3 clinical trial for the treatment of lactose intolerance.

Lactose intolerance is a large and underserved market with over 40 million Americans suffering from the condition. Current spending on over-the-counter lactose intolerance aids in the United States is estimated at approximately $2.45 billion, but no product on the market today provides reliable or long-term relief. Globally, over a staggering 1 billion individuals suffer from lactose intolerance.

Data readout from the phase 2b/3 trial of RP-G28 is expected this month (Q1, 2017).

Ritter shares have gained nearly 14% year-to-date, and trade around $3.00.

10. Xenon Pharmaceuticals Inc. (XENE)

Xenon Pharma is focused on the development of novel medicines using its proprietary Extreme Genetics platform.

One of the product candidates in the company's pipeline is XEN801, a topical stearoyl Co-A desaturase-1, or SCD1 inhibitor, being developed for the treatment of moderate to severe acne.

XEN801 is under phase II testing for acne, and top line results from the trial are expected this month. (latter part of Q1, 2017).

Xenon shares are up 11% so far this year, and trade around $8.55.

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Aktien in diesem Artikel

Cara Therapeutics Inc 0,27 0,53% Cara Therapeutics Inc
Ionis Pharmaceuticals Inc 34,39 1,84% Ionis Pharmaceuticals Inc
Merus B.V. 42,20 0,00% Merus B.V.
Nektar Therapeutics 1,11 5,22% Nektar Therapeutics
Xenon Pharmaceuticals Inc 39,80 -1,00% Xenon Pharmaceuticals Inc