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This story originally appeared on PennyStocks
Biotech Penny Stocks Remain A Focus Heading Into Q3 2021
Penny stocks are well known for their high risk and high reward potential. There aren’t many places where you can buy into an early-stage company, see shares rise 100% or more, and take profit all within a single day or week. Traders seek catalysts for potential moves then speculate on that catalyst ahead of time, in many cases. This can be something like upcoming earnings results, pending retail data, or, in the case of biotech stocks, upcoming FDA decisions, or trial data.
Compared to companies in the materials sector, retail, or even energy, biotech companies tend to pre-announce news. What I mean by this is that you’ll frequently see these companies release news of when they expect to report an event. Again this might be an FDA decision, trial data, “additional trial data,” an industry presentation, or something else. It’s one of the unique things about biotech that attracts momentum hunters.
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Even if the news is bad on the announcement day, speculation can trigger a bullish trend leading up to the official date. This is where the famous saying, “buy the rumor, sell the news,” takes on a bright light. It’s also where we see the “Robinhood traders” becoming a source of speculation. Since it is one of the most widely used platforms among retail traders, the focus, when it comes to penny stocks, is on Nasdaq & NYSE-listed companies. The reason is simple: Robinhood and apps like Webull generally restrict access to other penny stocks like those trading on the OTC.
Biotech Penny Stocks To Watch This Week
Now we’ve got our base case laid out. Something to consider next is timing. Companies will typically do one of two things. They’ll either announce a specific date or conference to present at, or they’ll discuss a broader period. This could be something like “the end of X month” or “in the X quarter or half of the year.”
Right now, we’re approaching a potentially active period of the year. Not only is it the end of the month, but it’s also the end of the quarter and the first half of the year. It’s time to call in all those updates stating “by the end of June, Q2, H1 or before Q3, H2 2021.” With this in mind, here are 12 biotech penny stocks to watch this week with previously announced event dates to keep in mind.
Note: That These Are Tentative Dates & Could Change At The Companies’ Direction
So let’s dive in and see exactly what might be ahead considering we’re in “Late June,” the 29th is Tuesday, and Q2 2021 ends this week.
Robinhoood Penny Stocks To Watch This Week #1: Hepion Pharmaceuticals (NASDAQ: HEPA)
Hepion Pharmaceuticals focuses on developing treatment candidates for non-alcoholic steatohepatitis or NASH. Its CRV431 – AMBITION NASH study completed enrollment earlier this quarter and is the center point of focus right now. Hepion’s June investor deck* shows that this NASH clinical program anticipates Phase 2a data in “Q2” 2021. With the enrollment completion announced in early May, it’s important to keep the study’s timeline in mind. In a May 6th update, Hepion said, “After completion of 28 days dosing with either CRV431 or placebo, study subjects will be monitored for an additional 14 day period.”
2. Daré Bioscience, Inc. (NASDAQ: DARE)
Shares of Daré have climbed over the past week on above-average volume. This may have been due, in part, to a recent company presentation at the 2021 BIO Digital events. President and CEO Sabrina Martucci Johnson gave an overview of the company’s portfolio at this event. One of its products, DARE-BV1, could be the center of focus heading into the end of the quarter. That’s because Daré previously announced plans to submit a New Drug Application (NDA) to the U.S. FDA this quarter.
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DARE-BV1 is a hydrogel used for treating bacterial vaginosis. Previous data has already shown that the treatment delivered “statistically significant efficacy” in the intent-to-treat population. . It also showed improved clinical cure rates compared to current branded products. Furthermore, according to the company’s March 30th, 2021 PR, “Fast track and Qualified Infectious Disease Product (QIDP) designations allow for a priority review request at the time of NDA submission, which, if granted by the FDA, could lead to a 2021 PDUFA goal date.”
3. Palisade Bio, Inc. (NASDAQ: PALI)
You might know Palisade Bio by its former name, Seneca Biopharma (f/k/a SNCA), or a private company, Leading BioSciences. The two joined forces earlier this year in a merger that resulted in the formation of this new company. Palisade focuses on therapies for gastrointestinal complications stemming from post-op digestive enzyme damage. Earlier this month, the company announced that a Phase 2 study of its LB1148 treatment candidate expects preliminary top-line data “by the end” of the second quarter. This treatment is the company’s candidate for post-surgical GI complications. Heading into the week, the countdown begins to see if Palisade delivers on the previously announced milestone. Overall, PALI stock doesn’t seem to have experienced any unusual market activity so far.
4. Ocuphire Pharma, Inc. (NASDAQ: OCUP)
In May, Ocuphire announced a potential milestone period for investors to note. The company focuses on ophthalmic pharmaceutical development. In particular, Ocuphire has been building upon efforts to advance its Nyxol candidate in treating multiple indications for eye care.
The company has built an estate of patent and patent applications around the treatment. This month, in particular, could be an important one for the company. Ocuphire previously announced that top-line data from its VEGA-1 Phase 2 presbyopia trial is expected by the end of June.
5. Kintara Therapeutics, Inc. (NASDAQ: KTRA)
Another one of the biotech penny stocks with pending data to report is Kintara. Earlier this quarter, the company announced that it completed enrollment of the recurrent arm of a Phase 2 clinical study of its VAL-083 at MD Anderson Cancer Center. This is the company’s candidate for treating glioblastoma multiforme. This current study is anticipated to report top-line results this quarter. VAL-083 has previously shown clinical activity against several cancers. These include central nervous system, ovarian, and other solid tumors (e.g., NSCLC, bladder cancer, head, and neck) in U.S. clinical trials sponsored by the National Cancer Institute.
Robinhoood Penny Stocks To Watch This Week #6:Diffusion Pharmaceuticals Inc. (NASDAQ: DFFN)
Diffusion Pharma focuses on ways to deliver oxygen to the body in areas that need it most. Its trans sodium crocetinate (TSC) is being developed for peripheral tissue oxygenation to prevent hyperoxia. Heading into this week, details from a May 10th release bring TSC into focus. The company announced that data from a Phase 1 study would be completed and announced by the end of the second quarter. Diffusion trial is evaluating the effects of TSC on peripheral tissue oxygenation using a transcutaneous oxygen monitoring device. Last week, CEO Robert Cobuzzi, Jr., Ph.D., presented at the Life Sciences Investor Forum on June 24th.
7. MediWound Ltd. (NASDAQ: MDWD) & Vericel Corporation (NASDAQ: VCEL)
Late last year, the FDA accepted Vericel’s Biologics License Application submission for NexoBrid. This is the company’s candidate for eschar removal in adults with deep partial-thickness/ full-thickness thermal burns. “The FDA’s acceptance of the NexoBrid BLA for review represents another important milestone toward our goal of providing a new standard of care for eschar removal in patients with severe burns,” said Nick Colangelo, President, and CEO of Vericel Corporation (NASDAQ: VCEL).
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The FDA assigned a Prescription Drug User Fee Act (PDUFA) target date of June 29th. Considering that this is coming up on Tuesday, VCEL stock could have a potentially volatile week ahead, depending on the outcome. How is MediWound tied into this? Vericel holds an exclusive license from MediWound Ltd. for North American rights to NexoBrid®.
8. AzurRx BioPharma, Inc. (NASDAQ: AZRX)
Another company focusing on gastrointestinal diseases is AzurRx Biopharma. The company’s MS1819, in particular, is being developed and evaluated in a Phase 1 trial for treating severe exocrine pancreatic insufficiency in cystic fibrosis patients. Interim data from the first 18 patients in the 20 patient trial showed meaningful interim data already. According to the company, the treatment in combination with the current standard of care showed potential to help 25-30% of refractory cystic fibrosis patients unable to gain adequate nutrition. Full top-line results from all 20 patients are expected to be reported this quarter. So heading into the week, the countdown has begun.
9. Cerecor Inc. (NASDAQ: CERC)
Cerecor is a company focusing on developing treatment candidates for immunology, oncology, and rare diseases. This week, its CERC-002 treatment could be a focus for the market. This is Cerecor’s Crohn’s disease treatment. It has already demonstrated improvement in a primary endpoint of a Phase 2 COVID-19 acute respiratory distress syndrome trial. As far as the week is concerned, the company’s June investor deck** showed that initial data from severe pediatric-onset Crohn’s is expected in Q2.
10. Optinose (NASDAQ: OPTN)
This has been a relatively flat year for OPTN stock. However, the coming week could be an important one for those with Optinose on their watch list. The company specializes in ear, nose, throat, and allergy treatments. It has a pipeline of different assets, all targeting different treatment types. Right now, its OPN-019 could be the more immediate focus.
This is Optinose’s candidate for treating those who’ve tested positive for SARS-CoV-2, are recently infected, and who have mild or no symptoms. In March, the company announced the plan to conduct this proof of concept study. It was designed to evaluate the magnitude and duration of viral load reduction after a single dose for OPN-019. While regulatory approval was pending at the time of a May update, the company said it expected topline data this quarter.
11. NeuroBo Pharmaceuticals, Inc. (NASDAQ: NRBO)
NeuroBo’s ANA001 treatment could be a point of focus this week. The company is designing it as a potential treatment for moderate to severe COVID-19. Right now, NeuroBo is advancing a 60-patient Phase 2/3 clinical trial.
In a late-May update, Richard J. Kang, Ph.D., President and Chief Executive Officer of NeuroBo, explained, “We remain on track to report the data monitoring committee safety results of this study and pharmacokinetic (PK) data from the Phase 1 in the second quarter. In order to enhance enrollment in the Phase 2/3 study, we are in the process of expanding to sites in the U.S. where the number of COVID-19 cases are increasing and including clinical sites in countries overseas where COVID-19 is growing, and vaccinations are well behind the U.S. In addition, we expect to report preclinical in vitro data demonstrating Gemcabene’s ability to treat COVID-19 variants alone and in combination with ANA001.”
12. Lineage Cell Therapeutics, Inc. (NYSE: LCTX)
Lineage has been a top performer for the better part of the last year. Since last summer, LCTX shares have climbed from under $0.80 to over $3 earlier this year. Now, heading into the new week, the penny stock is back above $3 with the company expected to release updates sometime “in Q2.” In light of the current timing, there aren’t many days left for this to be done. Here’s the “skinny” on why I say this.
Last month, Lineage gave its Q1 2021 update. Its lead drug candidate, OpRegen. Lineage has this under development for treating Dry Age-related Macular degeneration – AMD – with Geographic Atrophy – GA. Previous clinical data has already shown that OpRegen is “suggestive of clinically meaningful benefits,” most notably in early-stage disease patients. In particular, last month, the company announced that it would be presenting more interim data from its Phase 1/2a study “anticipated” in Q2.
Penny Stocks To Buy Or Avoid Right Now?
Clearly, it’s important to do your research when it comes to biotech stocks. Not only is this to prepare for any upcoming events but to also not get blindsided either. For instance, if you look at just the last few weeks of information from a company and see promise, you might miss some of the information reported as far back as months or years ago about what’s to come.
I talked about Vericel earlier. It gave its June 2021 PDUFA target date in September of 2020. Things like this aren’t uncommon either. If you don’t know that there’s an important event planned, it could be harmful if things come out less than favorable. So you can see how not knowing an update from so far back could pose a potential risk. At the same time, it can also be a happy surprise if the news is good. At the end of the day, however, it’s essential to know the corporate landscape. After reading this article, however, you’ll have additional information to keep in mind heading into the final days of the month, quarter, and half.
*https://hepionpharma. com/wp-content/uploads/2021/06/Corporate-deck-June-2021-FINAL. pdf**https://d1io3yog0oux5.cloudfront. net/_c9dce8b9ea83152afd4224eb4cb0a98f/cerecor/db/282/1110/pdf/Cerecor+Jefferies+Virtual+Healthcare+Conference+2JUNE2021. pdf