Best Of January: Biotech Stocks That Made Triple-digit Gains

(RTTNews) - Historically, biotech stocks have performed reasonably well in the month of January, and this year too, it has been no different. The iShares Nasdaq Biotechnology ETF (IBB) a bellwether of investor sentiment, has so far gained nearly 16%.

Listed below are some of the biotech stocks that made triple-digit gains in January, and their near-term catalysts to watch out for. Please note this list is not exhaustive and includes only the top 6 gainers.

1. Axsome Therapeutics Inc. (AXSM)

Axsome Therapeutics is a clinical-stage biopharmaceutical company developing novel medicines for the management of central nervous system (CNS) disorders like Alzheimer's, treatment-resistant depression, smoking cessation, migraine, narcolepsy, etc.

The Company, which ended 2018 on a somber note, seems to have started this year in a buoyant mood, with the stock price up over 240% since January.

News that mattered:

On January 7, 2019, the Company announced that its phase II trial of AXS-05 in major depressive disorder, dubbed ASCEND, met the prespecified primary endpoint.

The ASCEND study involved 80 adult patients with confirmed moderate to severe major depressive disorder who were treated either with AXS-05 or the active comparator Bupropion, twice daily for 6 weeks. At Week 6, AXS-05 demonstrated a highly statistically significant reduction of 17.2 points in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score compared to a 12.1 point reduction for Bupropion, achieving the primary endpoint.

The news sent the stock up as much as 238% that day to an intraday high of $8.89. The following day, i.e., on January 8, the stock added some more gains to touch an intraday high of $9.16.

Near-term Catalyst:

-- 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 later in the first quarter. -- A phase II study of AXS-05 for smoking cessation treatment is also ongoing- with top-line results expected in the first quarter of 2019. -- Initiation of a planned phase III trial of AXS-07 in patients with migraine is expected in the first quarter of 2019. -- A phase II trial of AXS-12 in narcolepsy, dubbed CONCERT, was recently initiated, and top-line results from this trial are expected in the second quarter of 2019.

AXSM closed Friday's (Feb.1, 2019) trading at $9.22, and that reflects a gain of 228% since January.

2. Microbot Medical Inc. (MBOT)

Microbot Medical is a medical device company specializing in the design and development of transformational micro-robotic medical technologies.

The Company seems to be enjoying the best ever start to a year, with share price having jumped more than 400% since January.

News that mattered:

On January 14, 2019, the Company announced encouraging results from an independent in-vitro study of its Self-Cleaning Shunt, or SCS, for treating Hydrocephalus, also known as "water in the brain".

The news sent the stock up as much as 336% that day to an intraday-high of $10.48. The following day, i.e., on January 15, the stock jumped another 98% to touch an all-time intraday high of $19.40.

Based on the promising results, the Company is confident of exploring additional medical applications for the device in conditions where occlusion occurs, such as in the Traumatic Brain Injury (TBI) space.

Near-term Catalyst:

-- A follow-up study of the Self-Cleaning Shunt, which includes a larger sample size compared to the initial studies, is underway, with data expected in the second half of 2019.

The Company plans to use the findings either for its regulatory submissions in the US, Europe, and other jurisdictions or as part of a pre-submission meeting request, depending on the final results of the ongoing follow-up study.

Although Microbot Medical has retraced most of its recent gains, based on Friday's (Feb.1, 2019) closing price of $9.49, the stock is still up 475% since January.

3. Novus Therapeutics Inc. (NVUS)

Novus is a specialty pharmaceutical company focused on developing products for patients with disorders of the ear, nose, and throat.

The shares have gained steadily since the start of January, and are up 166% so far this year.

News that mattered:

On January 30, 2019, the Company provided updates on several ongoing and planned clinical trials with OP0201, its lead product candidate being developed for otitis media, which are as follows.

Screening has been initiated for phase I Pharmacodynamic Effects Trial with OP0201, and for the second cohort of phase I trial of OP0201 in healthy adults.

Data from the above two clinical trials are expected to be available in the second calendar quarter of 2019.

Enrollment has been completed in a phase I trial of OP0201 in adults with acute Otitis Media, with data expected by the end of the first calendar quarter of 2019.

A new phase IIa trial of OP0201 in infants and children with acute otitis media is expected to commence in the coming weeks, with data available in the second half of 2019.

NVUS touched an intraday high of $4.98 on Friday (Feb.1, 2019) before closing at $4.15, and that represents a gain of 219% since January.

4. OncoCyte Corp. (OCX)

OncoCyte is focused on developing non-invasive, liquid biopsy diagnostics for the early detection of cancer.

The Company's shares, which began the New Year on a flat note and remained so until January 28, looks to get its mojo back, having gained 95% within 4 trading days.

News that mattered:

On January 29, 2019, the Company announced positive results from its key R&D Validation study demonstrating the accuracy of its DetermaVu liquid biopsy test for lung cancer.

The R&D Validation study demonstrated a sensitivity of 90% and specificity of 75% of DetermaVu on a prospectively collected cohort of 250 patient blood samples that were blinded to laboratory operators.

The news sent the stock up as much as 280% to an intraday high of $6.92 that day.

Near-term Catalyst:

DetermaVu Lung is on track for commercial availability in the second half of 2019, according to the Company.

Although OCX has pulled back 28% from its intraday high hit on January 29, based on Friday's (Feb.1, 2019) closing price of $4.98, the stock is still up 266% since January.

5. PLx Pharma Inc. (PLXP)

PLx is a late-stage specialty pharmaceutical company focused on commercializing two patent-protected OTC products, Vazalore 325 mg and Vazalore 81 mg (referred to together as "Vazalore").

Vazalore 325 mg is an FDA-approved aspirin product being developed to provide high-risk cardiovascular and stroke patients. The Company is focused on manufacturing, scale-up and label finalization for Vazalore 325 mg aspirin dosage form and preparing an sNDA for Vazalore 81 mg maintenance dose form.

News that mattered:

The shares have climbed steadily ever since the Company made a presentation at the Biotech Showcase 2019 on January 7, 2019. The stock touched an intraday high of $6.23 on January 17, 2019, and that reflects a gain of 188% since the presentation.

Anticipated milestone:

The launch of Vazalore 325 mg and Vazalore 81 mg is planned for mid-2020.

Although PLXP has pulled back from its intraday high hit on January 17, based on Friday's (Feb.1, 2019) closing price of $5.55, the stock is still up 251% since January.

6. Titan Medical Inc. (TMDI)

Titan Medical is a medical device company focused on the design and development of a robotic surgical system for application in minimally invasive surgery.

Shares of Titan Medical have risen steadily since the beginning of January, gaining as much as 287%.

News that mattered:

On January 3, 2019, the Company announced that it has completed the system engineering confidence build for all components of its single-port robotic surgery system (SPORT).

Although the news sent the stock up only 16% that day to $1.40, it has gained steadily in the successive sessions and it touched an intraday high of $4.65 on January 24, 2019.

Near-term Catalyst:

-- Complete the required human confirmatory studies for its SPORT Surgical System under an Investigational Device Exemption during the second half of 2019.

The SPORT Surgical System is a single-port robotic surgical system, being developed for one or more of gynecologic, urologic, colorectal or general abdominal procedures.

-- File for the CE mark for SPORT Surgical System by year-end 2019.

TMDI closed Friday's trading at $3.78, and that reflects a gain of 215% since January.