Things got hot and heavy in the penny stock market last week and this week it could get even hotter. I’m excited to see what’s on tap as a multitude of penny stocks have gone on major, double-digit, triple-digit, and even quadruple-digit intraday runs over the past few weeks. With new traders abound, this could be a serious changing of the times.
Volatility is the name of the game right now as the market appears to be drowning in it. It seems like almost daily we’re witnessing small-cap and micro-cap stocks pop up that we’ve never heard of. Despite the overall market being a little bumpy from time to time, even though it hasn’t happened much recently, a bunch of stocks under $5 have really seen some smoking hot swings.
What do you think will be the hottest headlines this week in the stock market? As this past weekend wrapped up, we saw more and more headlines regarding ongoing protests and a potential “second wave” of the coronavirus begin popping up as the country slowly and steadily tries to re-open. Police reform has also become a significant topic to keep your eyes on. That said, we’ve seen time and time again that a strong news headline can sometimes be enough to power a penny stock on an extraordinary run. Here’s 3 penny stocks with strong news to watch closely this week.
Your No. 1 Top Penny Stock To Watch Closely This Week: Brickell Biotech, Inc.
Brickell Biotech, Inc. (Nasdaq: BBI), a clinical-stage pharmaceutical company, focuses on the development of various prescription therapeutics for the treatment of debilitating skin diseases in the United States. The company’s lead products candidate is sofpironium bromide that is in Phase III clinical trial for patients with axillary hyperhidrosis. It is also developing therapeutics for cutaneous T-cell lymphoma, psoriasis, and other dermatological conditions.
Brickell Biotech, Inc. announced the release of positive Phase 3 pivotal study results from its development partner, Kaken Pharmaceutical Co. Ltd., in Japan. All primary and secondary efficacy endpoints of the study were met. The results were presented as part of the Late-Breaking Research Program during the American Academy of Dermatology (AAD) Virtual Meeting Experience. The presentation is titled “A Phase 3, Randomized, Double-Blinded, Vehicle-Controlled Study to Evaluate the Safety and Efficacy of Topically Applied Sofpironium Bromide Gel, 5% in Japanese Patients with Primary Axillary Hyperhidrosis.” Earlier this year, Kaken announced submission of a new drug application for approval in Japan of manufacturing and marketing of sofpironium bromide gel for primary axillary hyperhidrosis based on these data.
“We are encouraged by these positive results and are pleased by the filing of the Japanese New Drug Application based on this Phase 3 study by Kaken,” said Deepak Chadha, Brickell’s Chief Research & Development Officer. “We believe there is growing interest from the global medical community for novel therapeutic options for the treatment of primary axillary hyperhidrosis and think these data provide additional clinical support for sofpironium bromide to be a potential best-in-class treatment.”
The Phase 3 pivotal study evaluated a total of 281 Japanese subjects randomized 1:1 to apply sofpironium bromide gel, 5% (“SB”) or vehicle gel (placebo) to the axillae for 42 days. All subjects had Hyperhidrosis Disease Severity Scale (HDSS) scores ≥ 3 and ≥ 50 mg/5 min gravimetric sweat production (GSP) in each axilla at baseline.
Your No. 2 Top Penny Stock To Watch Closely This Week: IVERIC bio, Inc.
IVERIC bio, Inc. (Nasdaq: ISEE), is a biopharmaceutical company, developing novel therapies to treat ophthalmic diseases with a focus on age-related and orphan retinal diseases. The company is developing Zimura, an inhibitor of complement factor C5, which is in Phase IIb clinical trials for the treatment of geographic atrophy (GA), a late-stage form of dry age-related macular degeneration (AMD) characterized by retinal cell death and degeneration of tissue in the central portion of the retina known as the macula; and autosomal recessive Stargardt disease (STGD1), which is an orphan inherited retinal disease (IRD). It is also developing High temperature requirement A serine peptidase 1 protein (HtrA1) inhibitors for the treatment of GA secondary to dry AMD and other age-related retinal diseases, such as wet AMD and idiopathic polypoidal choroidal vasculopathy.
IVERIC bio, Inc. announced positive 18 month results from the Company’s first Phase 3 clinical trial (OPH2003) for Zimura® (avacincaptad pegol), a novel complement C5 inhibitor, for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). The 18 month data supports the previously announced 12 month data from this trial, at which time point Zimura met the pre-specified primary efficacy endpoint with statistical significance. The reduction in the mean rate of GA growth over 18 months was 28.11% for the Zimura 2 mg group as compared to the corresponding sham control group and 29.97% for the Zimura 4 mg group as compared to the corresponding sham control group. The pre-specified efficacy analysis for the primary endpoint was performed at month 12 using all of the power in the trial to detect a statistically significant difference. Therefore, the p-values for the 18 month statistical analyses are descriptive in nature. The descriptive p-values for the treatment effects at month 18 were p=0.0014 for the Zimura 2 mg group and p=0.0021 for the Zimura 4 mg group.
In this trial, the treatment effect was observed as early as 6 months, with an increase in the absolute difference of the mean change in GA growth for treatment with either Zimura 2 mg or Zimura 4 mg, as compared to sham, at each subsequent time point, suggesting the progressive benefit of continuous treatment with Zimura. Zimura maintained its favorable safety profile at 18 months with no reported Zimura related adverse events, no cases of endophthalmitis and a lower rate of choroidal neovascularization (CNV) than reported for C3 inhibition. The overall 18 month data may suggest a dose response relationship.
“We are extremely excited by the new 18 month data from this Phase 3 clinical trial, both with respect to efficacy and safety,” stated Glenn P. Sblendorio, Chief Executive Officer and President of IVERIC bio. “In the OPH2003 clinical trial, the 18 month results indicated continuous Zimura treatment benefit with a favorable safety profile in patients with GA secondary to AMD. This is an impressive achievement since we believe OPH2003 is currently the only Phase 3 clinical trial showing suppression of GA growth with continuous treatment for 18 months.”
“We are one step closer to potentially bringing a clinically meaningful therapy to patients with GA who currently do not have any FDA or EMA approved treatments available to them,” stated Kourous A. Rezaei, MD, Chief Medical Officer of IVERIC bio. “We believe the robust 18 month efficacy data further validates the potential role of complement C5 inhibition in GA secondary to AMD and has the potential to differentiate Zimura from other product candidates in development. We are poised to initiate our second pivotal trial, ISEE2008, comparing Zimura 2 mg with sham later this month. We want to thank our patients, our clinical trial investigators and their staffs for their support and participation in this trial.”
Your No. 3 Top Penny Stock To Watch Closely This Week: Myomo, Inc.
Myomo, Inc. (NYSE American: MYO), a wearable medical robotics company, designs, develops, and produces myoelectric orthotics for people with neuromuscular disorders in the United States. The company offers MyoPro, a myoelectric-controlled upper limb brace or orthosis used for the purpose of supporting a patient’s weak or deformed arm to enable and improve functional activities of daily living, ADLs, in the home and community. Its products are designed to help restore function in individuals with neuromuscular conditions due to brachial plexus injury, stroke, traumatic brain injury, spinal cord injury, and other neurological disorders. The company sells its products to orthotics and prosthetics providers, the Veterans Health Administration, rehabilitation hospitals, and through distributors.
Myomo, Inc. reported the success of its initiative to conduct safe patient screenings remotely using telehealth technologies.
Micah Mitchell, Chief Commercial Officer of Myomo, stated, “When a candidate expresses interest in MyoPro® through our network of physicians, therapists, and O&P providers, or by finding us directly on the web, we need to screen them to determine if MyoPro would be right for them. To keep patients and staff safe in this COVID-19 environment, and to control costs, we tested an online approach using secure telehealth technology to perform these screenings remotely. This has proven very successful, and we have fully implemented remote screenings across the country. In addition to safety and lowering costs per screening, we are able to conduct these screenings in a more timely manner while eliminating the reluctance of some patients to see a clinician during the COVID-19 Pandemic.”
Myomo’s field clinicians are now doing nearly 100 remote screenings per month. In May, 92% of the candidates evaluated via this process were medically qualified for a MyoPro, and these patients then move into our reimbursement pipeline for an insurance authorization. Over 500 such candidates have entered the insurance process since the beginning of the year.
Mr. Mitchell continued, “After we receive the insurance authorization, expert clinicians evaluate the patient in-person to do a thorough hands-on evaluation and take a cast and measurements of the patient’s arm for custom fabrication. The MyoPro is then delivered in-person to the new user, where the software settings are adjusted, and a referral is made to a trained therapist in their area for follow-on support.”