AXSM Has Had An Awesome Run. What Awaits These 13 Biotech Stocks In Q2, 2019?

(RTTNews) - Shares of Axsome Therapeutics Inc. (AXSM) rose more than 6% on Monday, following positive results from its phase II trial of AXS-05 for smoking cessation treatment.

In the trial that involved 58 adult smokers, treatment with AXS-05 resulted in a 25% greater reduction in the average number of cigarettes smoked per day over the 3-week period, the prespecified primary endpoint, compared to Bupropion, an approved medication used as a smoking cessation aid.

Moreover, a greater proportion of smokers receiving AXS-05 experienced a more than 50% reduction in expired carbon monoxide levels, a biochemical marker of smoking intensity, compared to those treated with Bupropion.

The Company has two more pending catalysts for this quarter.

-- A phase III trial of AXS-05 in patients with treatment-resistant depression, dubbed STRIDE-1, is underway. Top-line data from this study are anticipated in the second quarter of 2019. -- A phase II trial of AXS-12 (reboxetine) in narcolepsy, dubbed CONCERT, was initiated in January of this year, with top-line data expected in the second quarter of 2019.

AXSM has traded in a range of $1.94 to $16.80 in the last 1 year. The stock closed Monday's trading at $14.31, up 6.32%. So far this year, the stock has gained 409%.

Let's take a look at some more biotech companies awaiting phase II or phase III clinical trial results this quarter.

1. Akari Therapeutics Plc (AKTX)

Akari Therapeutics is a biopharmaceutical company focused on innovative therapeutics to treat orphan autoimmune and inflammatory diseases.

The Company's lead product candidate is Coversin.

Watch out for...

Interim data from a phase I/II clinical trial of Coversin in atopic keratoconjunctivitis (AKC), a rare and chronic form of eye allergy, is expected to be presented on April 28, 2019.

AKTX has traded in a range of $1.56 to $9.20 in the last 1 year. The stock closed Monday's trading at $3.17, down 2.46%.

2. Ascendis Pharma A/S (ASND)

Ascendis Pharma is a biopharmaceutical company with a pipeline of three independent, rare disease endocrinology product candidates in clinical development, and oncology as its second therapeutic area of focus.

The Company's lead product candidate is TransCon hGH for the treatment of pediatric growth hormone deficiency or GHD, under phase III program.

On March 4, the Company announced positive top-line results from a phase III trial that compared its once-weekly TransCon Growth Hormone to a daily growth hormone (Genotropin) in children with pediatric growth hormone deficiency, dubbed heiGHt, sending the stock up over 74% to $120 that day.

Watch out for...

A phase III trial evaluating TransCon hGH in subjects who switch from daily hGH, dubbed fliGHt, is underway, with top-line data expected in the second quarter of 2019.

ASND has traded in a range of $53.21 to $131.76 in the last 1 year. The stock closed Monday's trading at $113.08, down 3.20%.

3. BioCryst Pharmaceuticals Inc. (BCRX)

BioCryst is a late-stage biotech company developing novel therapeutics for patients with rare and serious diseases.

The Company's core development programs include: -- BCX7353 and additional 2nd generation oral inhibitors of plasma kallikrein for hereditary angioedema (HAE) -- BCX9250 and BCX9499 for Fibrodysplasia Ossificans Progressiva (FOP) -- BCX4430 (galidesivir), a broad-spectrum antiviral for hemorrhagic fevers.

Watch out for...

24-week safety and efficacy results from a phase III trial of BCX7353 administered orally once-daily (QD) as a preventive treatment to reduce the frequency of attacks in patients with hereditary angioedema are expected in the second quarter of 2019.

BCRX has traded in a range of $4.76 to $9.95 in the last 1 year. The stock closed Monday's trading at $8.43, down 1.17%.

4. Cara Therapeutics Inc. (CARA)

Cara Therapeutics is a clinical-stage biopharmaceutical company developing drugs for pruritus and pain by selectively targeting kappa opioid receptors in the United States.

The Company's lead asset is KORSUVA Injection for chronic kidney disease-associated pruritus, or CKD-aP, in hemodialysis patients, under two pivotal phase III trials, dubbed KALM-1 and KALM-2.

Watch out for...

Top-line data from the phase III trial of KORSUVA injection, dubbed KALM-1, are expected in the second quarter of 2019.

CARA has thus far hit a low of $11.50 and a high of $24.30. The stock closed Monday's trading at $19.44, up 3.79%.

5. Constellation Pharmaceuticals Inc. (CNST)

Constellation Pharmaceuticals is a clinical-stage biopharmaceutical company developing novel therapeutics that selectively modulate gene expression to address serious unmet medical needs in patients with cancer.

Watch out for...

An interim update of data from MANIFEST from approximately 18-20 evaluable patients is expected to be presented at a medical meeting in the second quarter of 2019.

MANIFEST is a phase II trial evaluating CPI-0610 in myelofibrosis.

CNST has thus far hit a low of $4.01 and a high of $14.04. The stock closed Monday's trading at $12.32, up 1.82%.

6. Forty Seven Inc. (FTSV)

Forty Seven is a clinical-stage immuno-oncology company.

Watch out for...

Data from a phase Ib/II trial of 5F9 in combination with Rituximab in patients with Relapsed/Refractory Non-Hodgkin's Lymphoma, including safety, efficacy and duration of response across various dosing cohorts, are expected in the second quarter of 2019.

Data from a phase Ib trial of 5F9 as a monotherapy and in combination with azacitidine in patients with Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome, including safety and initial efficacy data, are also anticipated in the second quarter.

FTSV has thus far hit a low of $12.02 and a high of $23.83. The stock closed Monday's trading at $18.84, up 1.29%.

7. Gemphire Therapeutics Inc. (GEMP)

Gemphire is a clinical-stage biopharmaceutical company developing treatments for patients with cardiometabolic disorders, including dyslipidemia and nonalcoholic steatohepatitis, or NASH.

Watch out for...

Topline results from a proof-of-concept phase II trial investigating Gemcabene in familial partial lipodystrophy are expected in the second quarter of 2019.

Familial partial lipodystrophy is a rare condition characterized by an abnormal distribution of fatty (adipose) tissue. (Source: NIH).

GEMP has traded in a range of $0.57 to $11.43 in the last 1 year. The stock closed Monday's trading at $1.23, down 5.38%.

8. Intra-Cellular Therapies Inc. (ITCI)

Intra-Cellular Therapies is developing novel drugs for the treatment of neuropsychiatric and neurodegenerative diseases and diseases of the elderly, including Parkinson's and Alzheimer's disease.

The Company's lead drug candidate is Lumateperone, which is under phase III clinical development for the treatment of schizophrenia, bipolar depression and agitation associated with dementia, including Alzheimer's disease.

Watch out for...

Topline results from two phase III trials of Lumateperone as monotherapy in bipolar depression, dubbed Study 401 and Study 404, are expected in the second quarter of 2019.

ITCI has traded in a range of $10.21 to $23.64 in the last 1 year. The stock closed Monday's trading at $12.64, up 0.24%.

9. Minerva Neurosciences Inc. (NERV)

Minerva Neurosciences is a clinical-stage biopharmaceutical company focused on developing innovative therapies to treat unmet medical needs of central nervous system (CNS) disorders.

The Company's lead product candidate is Roluperidone, being evaluated as a monotherapy in a phase III trial for negative symptoms in patients diagnosed with schizophrenia.

Also in the pipeline are Seltorexant, under three phaseIIb clinical trials, including two in major depressive disorder (MDD) and one in insomnia disorder, and MIN-117, in a phase IIb trial in patients with MDD who also have symptoms of anxiety.

Watch out for...

The top-line results from the phase IIb trial of Seltorexant in major depressive disorder, dubbed Trial 2001, are anticipated in the second quarter of 2019.

NERV has traded in a range of $5.80 to $12.95 in the last 1 year. The stock closed Monday's trading at $7.37, up 3.66%.

10. Myovant Sciences Ltd. (MYOV)

Myovant Sciences is a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapies for the treatment of women's health and endocrine diseases.

The Company's lead product candidate is Relugolix, under phase III development.

Relugolix is under five international Phase 3 clinical trials namely: -- Two phase III trials in women with heavy menstrual bleeding associated with uterine fibroids, dubbed LIBERTY 1 & LIBERTY 2. -- Two phase III trials in women with endometriosis-associated pain, known as SPIRIT 1 & SPIRIT 2. -- A phase III trial in men with advanced prostate cancer, dubbed HERO.

Watch out for...

Top-line data from phase III study of Relugolix in women with heavy menstrual bleeding associated with uterine fibroids, dubbed LIBERTY 1, is expected in Q2, 2019.

MYOV has traded in a range of $14.32 to $27.45 in the last 1 year. The stock closed Monday's trading at $20.93, up 2.40%.

11. Tiziana Life Sciences PLC (TLSA)

Tiziana Life Sciences is a clinical stage biotechnology company focused on targeted drugs to treat diseases in oncology and immunology.

Watch out for...

A phase IIa clinical trial of Milciclib in Sorafenib-refractory or -intolerant patients with unresectable or metastatic Hepatocellular Carcinoma, being conducted in Italy, Greece and Israel, is underway. The topline data is expected to be available in the second quarter of 2019.

The Company's American Depositary Shares were listed on the Nasdaq Global Market on November 20, 2018, at an offering price of $9.90 per ADS.

TLSA has thus far hit a low of $5.00 and a high of $12.17. The stock closed Monday's trading at $6.25, up 8.32%.

12. Vanda Pharmaceuticals Inc. (VNDA)

Vanda Pharma is a global commercial-stage biopharmaceutical company.

Watch out for...

Results from a phase II clinical study of Tradipitant in motion sickness are expected in the second quarter of 2019.

VNDA has traded in a range of $13.88 to $33.44 in the last 1 year. The stock closed Monday's trading at $17.41, down 1.47%.

13. Verrica Pharmaceuticals Inc. (VRCA)

Verrica Pharmaceuticals is a medical dermatology company.

The Company's lead product candidate is VP-102, a proprietary topical drug device combination therapy containing a novel topical solution of 0.7% cantharidin, for the treatment of molluscum and verruca vulgaris (common warts).

In January of this year, the Company announced positive topline results from its phase III pivotal trials with VP-102 for the treatment of molluscum contagiosum, dubbed CAMP-1 and CAMP-2.

Watch out for...

Topline results from a phase II trial of VP-102 in common warts, dubbed COVE-1, are expected in the second quarter of 2019.

VRCA has thus far hit a low of $6.44 and a high of $23.29. The stock closed Monday's trading at $10.31, down 1.62%.