Putting a list of penny stocks together? You might want to check for important dates. The biotech sector is well-known for giving the market plenty of lead time before releasing key information. Furthermore, the beauty of organizations like the Food & Drug Administration is that it will issue dates months in advance as to when it will give a final answer for things like New Drug Applications, phase trial design, and the like.
Since there are so many steps to each phase of a trial, for instance, there’s sure to be plenty of news and potential catalysts to be aware of. Take, for instance, Pfizer Inc. (NYSE: PFE). Back in December, the company announced that the Prescription Drug User Fee Act (PDUFA) goal date for a decision on its supplemental New Drug Application (sNDA) for LORBRENA by the FDA would be in April 2021.
That was nearly 4 months in advance of this event even happening. Those who have PFE on their list of stocks to watch right now know that April could be an important month for the company and, specifically, its LORBRENA treatment.
While your average public company will release dates related to things like earnings, biotech stocks have much more to factor in. Not only are we talking about earnings but also formal and interim data along with all other regulatory filing dates dealing with bodies like the FDA or European Medicines Agency.Biotech Penny Stocks & Volatility
This also makes biotech penny stocks some of the most volatile. One positive update on phase data or one surprise miss of trial endpoints can trigger huge spikes or drops in certain stocks. While favorable data can send shares higher, even the slightest misstep can send biotech penny stocks into a free fall.
This is something that we covered when discussing Odonate Therapeutics (NASDAQ: ODT) last week. On March 19th, ODT shares were actively trading above $19. But at the start of the following week, on March 22nd, the stock had fallen to lows of $3.83. The massive drop came after the company had expressed that its treatment package was “unlikely to support FDA approval.”
Now, since making that update and sliding further, ODT as a penny stock has actually performed well over the last few weeks. But from a bigger picture, it has become one of the worst-performing biotech stocks in 2021.Hot Penny Stocks To Watch For April 2021
Those who understand this can be a very real risk also tend to trade penny stocks in the niche a bit differently. Thanks to volatility, day traders continue focusing on the industry. Knowing that there are upcoming events can help condense your list of penny stocks even further. In this case, here are 3 companies that have previously announced important events coming this month.
- Rigel Pharmaceuticals Inc. (NASDAQ: RIGL)
- Auris Medical Holding Ltd. (NASDAQ: EARS)
- Aptinyx Inc. (NASDAQ: APTX)
Rigel works with novel small molecule drugs for hematologic disorders, cancer, and rare immune diseases. Its first FDA-approved product, TAVALISSE® (fostamatinib disodium hexahydrate) tablets, is an oral spleen tyrosine kinase inhibitor for treating patients with chronic immune thrombocytopenia. TAVALISSE® is also available in Europe (TAVLESSE) and Canada (TAVALISSE) for treating chronic immune thrombocytopenia in adult patients.
Something else that Rigel has worked on with regard to TAVALISSE® is the potential use for treating hospitalized COVID-19 patients. The company is conducting a Phase 2 clinical trial that randomly assigned TAVALISSE® plus standard of care (SOC) or matched placebo plus SOC to 58 patients. Treatment was administered orally twice daily for 14 days.
The primary endpoint of this study is “cumulative incidence of serious adverse events through day 29, with multiple secondary endpoints designed to assess the early efficacy and clinically relevant endpoints of disease course as well as in vitro biological correlatives evaluating the effects of the drug on pathways involved in the pathophysiology of COVID-19, including NETosis.”
Why is April important for Rigel? The topline data from this clinical trial expected this month. No official date was given. However, it has become a center point for those trading penny stocks, looking at RIGL. While the last few weeks haven’t been great for the penny stock, the past 52 overall have been big. Since this time last year, RIGL stock is up over 80%. What’s more, the company just closed a license agreement with Eli Lilly (NYSE: LLY) that brought an up-front payment of $125 million.2. Auris Medical Holding Ltd. (NASDAQ: EARS)
Shares of Auris Medical were red hot at the end of last week. In fact, from Monday’s opening bell to Friday’s close, EARS stock price moved up 35%. But the bigger excitement came after the closing bell on April 9th. Shares of EARS shot as high as $5.18 at one point.
The strongest catalyst for the company recently has come from the progress with its AM-301 intra-nasal spray. The treatment has been shown to reduce SARS-CoV-2 virus titers in animals. Not only does the company expect a launch of the product this quarter, but Tuesday could also be an important day for Auris. Why? Last week, the company announced that it plans to provide a business update on the AM-301 program, April 13th.
It appears hopes are high that the business update reveals significant information. However, keep in mind that just because sentiment in the market appears bullish, it doesn’t necessarily guarantee that this will be the trend on Tuesday. Nevertheless, it’s going to be important to see what management says about AM-301 on Tuesday. Because of this, EARS is likely one of the biotech penny stocks to watch this week for many traders.3. Aptinyx Inc. (NASDAQ: APTX)
The last 52-weeks have seen significant volatility for Aptinyx. Though it’s gotten hit hard this year, APTX may be one of the penny stocks to watch in April. That’s because of what the company announced in March. Aptinyx is scheduled to hold a Type C meeting with the U.S. FDA on April 29th. The company plans on discussing the future development path for NYX-783 in PTSD. Furthermore, data from its Phase 2a exploratory study will be presented at the 2021 Society of Biological Psychiatry at the end of the month.
This could be a big deal for the company considering the size of the trial so far. Across the completed Phase 1 and Phase 2 studies, more than 200 human subjects combined were involved. What’s more, based on data so far, Aptinyx said that NYX-783 was well tolerated with no drug-related serious adverse events reported.
Despite its performance in 2021, analysts appear bullish on the company. H.C. Wainwright recently reiterated its Buy rating on the stock and currently has an $8 price target set. Considering the upcoming event at the end of this month, it will be interesting to see if H.C.’s bullish stance is justified after seeing the company’s data.