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2 Biotech Stocks Under $10 Could Win Important FDA Approval


The biotech industry can offer investors some really lucrative returns — but these stocks aren’t for the faint of heart. Companies offer a combination of notoriously high operating costs and long product lead times, so investors will need to be patient with companies that regularly lose quarterly over the long term. But the rewards in biotechnology could completely change the game.

Several catalysts — positive results from a clinical trial, government regulatory approval, or a new product launch — can easily drive biotech stock prices higher. So while these companies often face long periods of time before revenue, the stock price will skyrocket when one of these catalysts emerges. And for investors, the best part may be that biotech’s catalysts often operate independently of economic conditions. These are stocks that can skyrocket even when the overall market is plunging.

With this in mind, we used TipRanks database for a closer look at two biotech stocks that are currently trading for less than $10 each ahead of upcoming FDA approval decisions. Both stocks have great upside potential and have received strong support from analysts, enough to earn a consensus rating of “Strong Buy”. Let’s take a closer look.

TG . therapy (TGTX)

The first is TG Therapeutics, a biopharmaceutical research company that is working on new treatments for B-cell diseases. These are serious autoimmune conditions that incapacitate cells. B along with the production of different antibodies is inconsistent. Diseases in this category include multiple sclerosis (MS) and rheumatoid arthritis (RA). TG has a diverse system, including several drug candidates in early clinical or experimental stages – and a drug that is about to be approved by the FDA.

That leading candidate, ublituximab, is a glycoengineered monoclonal antibody designed to target ‘a single epitope on CD20-expressing B cells.’ This drug action is used in the treatment of relapsing forms of MS.

Ublituximab recently completed two Phase 3 trials, Ultimate I and Ultimate II, and based on those results, the company has submitted a Biologics License Application (BLA) to the FDA. The regulator accepted the BLA and granted TG a PDUFA target date of December 28 this year.

The FDA’s ublituximab process is major news for TG, and the company is gearing up for the drug’s market launch early next year. While this will lead to an increase in G&A costs in Q4 FY22, the company is confident that its current cash source, $197.7 million at the end of Q3, can carry out operations – including the commercial launch of ublituximab – in 2024.

Among the bulls is the analyst Ladenburg Matt Kaplanwho believe that ublituximab shows its potential to lead the niche after being approved.

“We expect FDA approval of ubli to treat MS in December 2022… During the Q3 2022 conference call, TG noted that it has completed its end-of-cycle meeting with the FDA. and labeling discussions have recently begun.We are encouraged by the initiation of labeling discussions and are now expecting a market launch in Q1 2023. We continue impressed with the safety and efficacy profile that ublituximab has demonstrated in the R-MS setting and believe it represents a best-in-class profile,” said Kaplan.

Kaplan places a Buy rating on TGTX stock and comparing that rating to a $22 price target shows confidence in a one-year gain of 168%. (To see Kaplan’s achievements, click here)

Overall, with the last 4 analyst reviews recorded here all positive, TGTX stock receives a Strong Buy consensus rating. Shares are selling for $8.2, and an average price target of $19.75 suggests a ~141% gain by the end of next year. (View TGTX stock forecast on TipRanks)

acer treatment (ACER)

The next biopharmaceutical with an advanced drug candidate entering the regulatory process is Acer Therapeutics. The company’s research focuses on serious metabolic diseases that are also extremely rare and lack effective medical treatments. The company’s system currently has three research directions, with the leading drug candidate, ACER-001, being the furthest.

ACER-001 is underdeveloped for the treatment of serious ‘congenital metabolic errors’, including urea cycle disorders, UCD and leprosy urine disease (MSUD). Acer submitted a new drug application (NDA) on -001 to the FDA in July of this year and is seeing the PDUFA date from the regulator as January 15, 2023.

In June 2022, the FDA denied Acer’s application for approval of ACER-001 to treat UCD. A full response letter (CRL) states that the FDA’s field investigator “was unable to complete an audit” of the ACER third-party contract packaging production site because “the establishment was not ready to audit the site.” check.” The FDA also has a comment in the CRL that is “not an issue of approval” regarding the request for additional nonclinical information.

above internal front, we see a clear case ahead of the upcoming PDUFA date. First, CEO Steven Lisi placed $1 million for a block of 819,672 shares in his company. The second major purchase was from Chairman Steve Aselage, who bought 409,836 shares for more than $500,000.

5 star analyst Vernon Bernardino, Acer’s insurance for HC Wainwright, also made no secret of its optimism on the stock. Bernardino clearly understands why Acer has solid prospects ahead and presents it in clear prose.

“Without approval concerns, we are positive about the prospect of ACER-001 getting FDA approval on or before January 15, 2023. As a result, we expect ACER-001 to achieve success in terms of regulatory approval. Commercially and estimated ACER-001 could generate approximately US$750 million in annual sales as a treatment for UCD by 2028. We believe Acer’s achievements in meeting these challenges knowledge in advancing its NDA, and the potential for ACER-001 to achieve commercial success in the short term, has been underestimated,” wrote Bernardino.

Continuing from these comments, Bernardino’s Buy ACER rating and $12 price target imply a strong 664% upside next year. (To see Bernardino’s achievements, click here)

Now turning to the rest of the Street, other analysts are on the same page. With 3 Buys and no Hold or Sell, ACER is rumored to be a strong Buy. The stock has an average price target of $9.67 and a share price of $1.57, with a one-year upside potential of ~516%. (View ACER stock forecast on TipRanks)

To find great ideas for trading biotech stocks at attractive valuations, visit TipRanks’ Best stocks to buyone tool that unifies all of TipRanks’ equity insights.

deny the responsibility: The opinions expressed in this article are those of prominent analysts only. Content is used for informational purposes only. It is very important that you do your own analysis before making any investment.

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