|Bid||35.10 x 1000|
|Ask||35.05 x 800|
|Day's Range||33.68 - 36.80|
|52 Week Range||16.95 - 37.00|
|Beta (5Y Monthly)||-0.01|
|PE Ratio (TTM)||N/A|
|Earnings Date||Nov 05, 2019|
|Forward Dividend & Yield||N/A (N/A)|
|1y Target Est||46.91|
Investors need to pay close attention to Aimmune Therapeutics (AIMT) stock based on the movements in the options market lately.
It's been a long, strange regulatory journey for Aimmune Therapeutics Inc., but by the end of this month, the Brisbane company could secure the first-ever Food and Drug Administration approval of a treatment for a food allergy. At this point last year, however, the future of Aimmune's potential therapy with the FDA was a big unknown. The company (NASDAQ: AIMT) had submitted its paperwork for the treatment — an immunotherapy for peanut allergy, called Palforzia — and paid its FDA review fees by Dec. 21.
In the stock market, sometimes all it takes is a single catalyst to propel shares to sky-high levels. This is especially common with healthcare stocks. While they carry significant risk, these names rely on only a few key milestones such as favorable trial data or attaining FDA approval, so a single dose of good news can have a big impact on share prices.The latter is particularly important as drug or medical device approval from the regulatory agency can lead to sustainable revenues for a company. No wonder, then, that investor focus locks in on healthcare companies ahead of decisions from the FDA.Bearing this in mind, we took a closer look at 3 healthcare stocks awaiting huge decisions from the FDA in January. TipRanks, a company that measures and tracks the performance of analysts, revealed that Wall Street sees each of these names as solid Buys. Here’s what we uncovered.Durect Corporation (DRRX) Recognized for its expertise in both formulation and drug delivery, Durect focuses on developing novel treatments for chronic kidney disease as well as acute organ injury. Its lead candidate, DUR-928, is an orally bioavailable small molecule that’s part of the company’s Epigenetic Regulator program. Representing a new class of therapeutics, it could play a key role in cellular functions like lipid homeostasis, inflammation and cell survival.That being said, the attention directed at DRRX is related to its POSIMIR candidate, designed to provide non-opioid pain relief after surgery. While still commonly used, opioids often have undesirable side effects and can be highly addictive. With 72 million surgical procedures performed each year in the U.S., there is a large unmet need for alternative forms of pain management.On January 16, an AdCom meeting will take place to determine if the FDA will recommend POSIMIR approval for the post-surgical analgesia indication.H.C. Wainwright analyst Ed Arce notes that his bullish thesis remains very much intact. He argues that the company’s submission of new data and re-analysis of the integrated summary of safety bode well for FDA approval.“PERSIST was designed based on extensive consultation and feedback from the FDA, and DURECT has successfully compiled a safety database with over 260 patients in the study to sufficiently address the issues raised in the CRL…We believe POSIMIR's data portfolio that was built upon efficacy data from two completed trials and safety data of all 16 completed trials, assembled under Dr. Simon's guidance, is sufficient to support POSIMIR's approval,” the analyst explained.Based on this conclusion, the five-star analyst told investors that he is staying with the bulls, reiterating the Buy rating. At his $4 price target, shares could surge 23% in the coming twelve months. (To watch Arce’s track record, click here)Cantor's Eliana Merle set a more aggressive price target along with her Buy rating based on not only POSIMIR but also DUR-928’s potential as a treatment for Alcoholic hepatitis (AH), for which there is a huge opportunity. Should the $5 target be met, investors could see 53% upside. (To watch Merle’s track record, click here)Judging from the consensus breakdown, it has been relatively quiet when it comes to other analyst activity. Over the last three months, only 2 analysts have reviewed the biopharma. Both of which, however, were bullish, making the consensus a Moderate Buy. On top of this, the $4.50 average price target puts the upside potential at 38%. (See Durect stock analysis on TipRanks)Aimmune Therapeutics (AIMT)Switching gears now, Aimmune takes aim at food allergies. The biopharma develops new treatments for people with potentially life-threatening food allergies. While shares are up 37% in 2019, investors want to know if AIMT has more fuel in the tank as it approaches the FDA decision for its lead candidate.PALFORZIA (AR101), its oral immunotherapy (OIT) treatment of peanut allergy, could see an approval decision come in late January 2020 for its use in the U.S., with the EU approval outcome expected in the second half of the year. Back in September, the company got a piece of good news as the FDA’s Allergenic Products Advisory Committee (APAC) voted in favor of approval for the therapy’s use in pediatric patients with peanut allergies.In addition to the vote of confidence from the panel, Wedbush’s Liana Moussatos sees a clear path to approval based on “robust efficacy and safety data to date.” Despite different regions of study, entry criteria, dosing periods and primary endpoints, both of the Phase 3 studies indicated consistent results. If that wasn’t promising enough, the analyst forecasts more than $1.5 billion in annual sales worldwide starting in 2023 if PALFORZIA is in fact approved. To this end, Moussatos left the Outperform rating and $79 price target unchanged. This conveys her confidence in AIMT’s ability to skyrocket 142% in the year ahead. (To watch Moussatos’ track record, click here)Meanwhile, Christopher Raymond of Piper Jaffray cites a recent meeting with management as reason for his bullish approach. He came away with a much more optimistic take on PALFORZIA’s launch. “We are much more confident that Palforzia’s launch can meaningfully outperform expectations, both near- and long-term. Coupling this with the stock’s 30% short interest, we like the opportunity for meaningful upside into this drug’s late January expected approval and launch,” the five-star analyst noted. As a result, Raymond maintained both the bullish call and $60 price target. (To watch Raymond’s track record, click here)Is the rest of the Street in agreement? As it turns out, the analyst consensus is more of a mixed bag. Split almost right down in the middle, 3 Buy ratings and 4 Holds were assigned in the last three months, giving AIMT Moderate Buy status. With a $44.14 average price target, the potential twelve-month gain comes in at 35%. (See Aimmune stock analysis on TipRanks)Epizyme (EPZM) Through the use of targeted epigenetic medicines, Epizyme is developing treatments for cancer and other serious diseases. Ahead of the January 23 PDUFA date for its primary product candidate, tazemetostat, all eyes are on the company.Looking at the results of the AdCom that took place earlier this month, it’s clear why investors have been getting excited. The panel voted unanimously to support the approval of tazemetostat for use in epithelioid sarcoma. Even though there was some concern about an open-label single-arm study, the panelists were impressed by the duration of response for a small indication with high unmet need, its safety and tolerability profile, its efficacy in a second-line (2L) setting and the limited amount of available treatment options.While the outcome doesn’t mean that final FDA approval is a sure thing, the Street is certainly buzzing. Since the AdCom vote, shares have climbed 24% higher, pushing EPZM’s 2019 rise to a whopping 267%.Jeffries analyst Michael Yee believes the AdCom should ease concerns about a possible FDA rejection. “Bottom line: we think the outcome today partially de-risks EPZM's follicular lymphoma program (NDA filing by YE:19) and should enable the company to transition to a commercial stage company by 2020,” he commented. With this in mind, Yee left the Buy rating and $21 price target as is. (To watch Yee’s track record, click here)Like Yee, Morgan Stanley’s David Lebovitz has high hopes for EPZM, pointing out that the FDA usually adheres to the recommendations of its AdCom panels. This prompted the analyst to keep the Overweight rating and $24 price target, suggesting 11% upside potential. (To watch Lebovitz’s track record, click here)Turning now to the rest of the Street, other analysts are on the same page. Based on the 6 Buy ratings vs no Holds or Sells, the Strong Buy consensus comes in just like the AdCom vote, unanimously. Given the recent uptick to the share price, the $20.33 average price target implies 10% downside. (See Epizyme stock analysis on TipRanks)
Editor's note: This article is part of InvestorPlace.com's Best Stocks for 2020 contest. Matt McCall's pick for the contest is Aimmune Therapeutics (NASDAQ:AIMT).On Aug. 1, 2018, Southwest Airlines (NYSE:LUV) stopped serving a long-time favorite on board its flights -- peanuts.Southwest isn't the only airline to make this change. United Airlines (NASDAQ:UAL) and JetBlue Airways (NASDAQ:JBLU) don't serve peanuts. Neither does Delta Air Lines (NYSE:DAL), as long as passengers with allergies notify the carrier at least 48 hours prior to their flight.InvestorPlace - Stock Market News, Stock Advice & Trading TipsAmerican Airlines (NASDAQ:AAL) doesn't pass out peanuts either, and as of December 2018, passengers with allergies can actually board their flights early to wipe down their seats.Airlines began making these concessions because peanut allergies can be severe. Some sufferers can't even be in the vicinity of a peanut. And as we all know, airplanes don't typically have the best airflow.According to the U.S. Food and Drug Administration, severe allergic reactions to food cause 150 deaths each year in the United States -- and as many as 2,000 hospitalizations. So airlines acknowledging the risk to passengers with allergies is a huge step in the right direction.While allergies change as we grow, there is a huge lack of attention to severe food allergies in the pharmaceutical world. There are currently no FDA-approved preventative treatments for peanut allergies. Only reactionary ones. And that's a major concern for those who have to worry about potentially dire consequences on a daily basis.That brings me to my pick in the Best Stocks for 2020 contest. It's called Aimmune Therapeutics (NASDAQ:AIMT), and it's a leading biopharmaceutical company that focuses specifically on the unmet needs of people who suffer from food allergies. The Year of BiotechAmong the other "hypertrends" predicted by myself and Louis Navellier, 2020 could easily go down as The Year of Biotech.There are so many factors that go into that. For example, next year marks the 20th anniversary of the sequencing of the first human genome, and we're seeing tremendous advancements in gene therapies. We're also seeing growing earnings and stronger stock performance of the best plays in this dynamic sector.I expect this broad strength to play a role in Aimmune's potential next year.Aimmune is a cool story. It was founded in 2012 by a group of parents, advocates, researchers and FDA members who were frustrated with the lack of focus on severe food allergies. Their goal was to turn oral immunotherapy -- which delivers treatment via the gastrointestinal tract -- into a clinically validated, FDA-approved treatment.According to research, orally administered allergy treatments allow people to build a tolerance against accidental exposure -- like being on a plane where peanuts are being served. In other words … the industry's first preventative treatment for food allergies.And so, Aimmune and its Characterized Oral Desensitization Immunotherapy (CODIT) platform were born.The company's lead drug candidate is AR101 -- or Palforzia. It's a treatment for peanut allergies, and it's currently undergoing Phase 3 trials. In September, the FDA's Allergenic Products Advisory Committee voted 7-2 in favor of Palforzia's use in children and teens.Typically the FDA will go along with such an endorsement, so this a great sign for its future. The drug could be approved as early as next month.Aimmune also submitted a marketing application for Palforzia to the European Medical Agency (Europe's version of the FDA). A decision is expected in the second half of 2020. A BIG Upcoming YearApproximately 15 million across the United States and Europe are affected by food allergies, making it a massive $24 billion industry. Peanut allergies account for $3 billion of that market.That puts Aimmune in an enviable position. With approval for Palforzia expected in the relative near term, it could be set up for a huge windfall.Today, Aimmune is a tiny $2 billion company. It generated $0 in revenue in 2019, but 2020 is shaping up to be significantly stronger.Wall Street currently expects the company to generate $55 million in revenue next year and then grow that figure 270% in 2021 to $205 million. That's extremely strong growth in just a couple of years -- especially for a company in the very beginning stages of life.It's also worth keeping in mind that the above estimate only accounts for the potential in treating peanut allergies. But Aimmune has other drugs in its pipeline related to the treatment of egg and walnut allergies, two other potentially big markets.The stage is set for Aimmune. Its potential in tackling the unmet needs of allergy sufferers is nearly endless, and 2020 will only be the beginning.But that's not all.Louis Navellier and myself have teamed up to create the "Power Portfolio" -- a list of our "guaranteed" stock picks for 2020!Between Louis and myself, we've managed to create a list of power players. These stocks all have the same dynamic characteristics:* They're small stocks that haven't been discovered by the mainstream media.* They're growing at impossible speeds.* They're all in unique industries with exorbitant growth potentialBeyond that, you can hear myself and Louis talk with Lauren Sivan about these stocks' enormous wealth-building potential here.Matthew McCall left Wall Street to actually help investors -- by getting them into the world's biggest, most revolutionary trends BEFORE anyone else. The power of being "first" gave Matt's readers the chance to bank +2,438% in Stamps.com (STMP), +1,523% in Ulta Beauty (ULTA) and+1,044% in Tesla (TSLA), just to name a few. Click here to see what Matt has up his sleeve now. Matt does not directly own the aforementioned securities. More From InvestorPlace * 2 Toxic Pot Stocks You Should Avoid * 10 2019 Losers That Will Be 2020 Winners * 5 Retail Stocks That Are Winning Big This Holiday Season * Make the Shift Toward Value Stocks With These 5 Picks The post Best Stocks for 2020: Aimmune's Allergy Solutions Position It for Huge Success appeared first on InvestorPlace.
We are still in an overall bull market and many stocks that smart money investors were piling into surged through the end of November. Among them, Facebook and Microsoft ranked among the top 3 picks and these stocks gained 54% and 51% respectively. Hedge funds' top 3 stock picks returned 41.7% this year and beat […]
Aimmune Therapeutics, Inc. , a biopharmaceutical company developing treatments for potentially life-threatening food allergies, today announced that the Aimmune execu
Aimmune Therapeutics, Inc. (AIMT), a biopharmaceutical company developing treatments for potentially life-threatening food allergies, today presented new data showing that a strong clinical history, in combination with evidence of peanut sensitization, is the optimal approach to identify peanut-allergic patients who are highly sensitive to peanut protein.
Aimmune Therapeutics, Inc. (AIMT), a biopharmaceutical company developing treatments for potentially life-threatening food allergies, today presented results from two new surveys that examined the effects of peanut allergy on health-related quality of life (HRQoL) among adults and caregivers in the United States. The findings reinforce the need for new treatments in peanut allergy that may reduce concerns related to peanuts, decrease the potential risk of allergic reactions and improve the HRQoL of those impacted by peanut allergy: adult patients, children and their caregivers.
Aimmune Therapeutics, Inc. (AIMT), a biopharmaceutical company developing treatments for potentially life-threatening food allergies, today announced the results from a new analysis showing consistent efficacy and safety with AR101 across the phase 3 PALISADE and ARTEMIS trials, despite differing regions of study, entry criteria, therapeutic dosing periods and primary efficacy endpoints. The data were presented at the American College of Asthma, Allergy and Immunology (ACAAI) Annual Scientific Meeting in Houston.
Aimmune Therapeutics, Inc. (AIMT), a biopharmaceutical company developing treatments for potentially life-threatening food allergies, today revealed that the logistical needs for implementing oral immunotherapy (OIT) for food allergies, such as peanut allergy, into clinical practice is comparable to those for subcutaneous immunotherapy (SCIT) for environmental allergies.
Here's a roundup of top developments in the biotech space over the last 24 hours: Scaling The Peaks (Biotech stocks that hit 52-week highs on Nov. 5.) Agile Therapeutics Inc (NASDAQ: AGRX ) (follow-on ...
Aimmune Therapeutics, Inc. , a biopharmaceutical company developing treatments for potentially life-threatening food allergies, today announced that members of the Aimmune executive management team will participate in a fireside chat at the Credit Suisse 28th Annual Healthcare Conference on Tuesday, November 12, 2019 at 1:15 p.m.
Aimmune Therapeutics, Inc. , a biopharmaceutical company developing treatments for potentially life-threatening food allergies, today announced it will present new data on the safety and efficacy of the company’s lead investigational candidate, AR101 , at the American College of Asthma, Allergy and Immunology Annual Scientific Meeting, taking place November 7-11, 2019, in Houston.
Aimmune Therapeutics, Inc. , a biopharmaceutical company developing treatments for potentially life-threatening food allergies, today announced that it will host a conference call on Wednesday, November 6, 2019, at 4:30 p.m.
We at Insider Monkey have gone over 730 13F filings that hedge funds and prominent investors are required to file by the SEC The 13F filings show the funds' and investors' portfolio positions as of June 28th. In this article, we look at what those funds think of Aimmune Therapeutics Inc (NASDAQ:AIMT) based on that […]
On CNBC's "Fast Money Halftime Report," Pete Najarian spoke about unusual options activity in Activision Blizzard, Inc. (NASDAQ: ATVI ). He noticed that options traders were buying the October ...
AIMT has developed a 'desensitivity' treatment for peanut allergies. Despite the criticism, the FDA's Allergenic Products Advisory Committee clearly supported the safety and efficacy of the product in mid-September, which paves the way for FDA approval, likely in January or earlier. The stock pulled back following the good news but then popped higher last week when an analyst from Piper surveyed 45 allergists and speculated that there was 'massive upside' to AIMT sales.
Aimmune Therapeutics Inc (NASDAQ: AIMT )'s peanut allergy product candidate Palforzia to treat peanut allergy in children and adolescents has received the backing of an FDA panel that reviewed the NDA. ...
Aimmune stock toppled Monday on profit-taking after the biotech company's peanut allergy treatment gained a key recommendation from the FDA's Allergenic Products Advisory Committee.