|Bid||22.58 x 900|
|Ask||22.59 x 800|
|Day's Range||22.50 - 23.04|
|52 Week Range||16.95 - 36.12|
|Beta (3Y Monthly)||0.49|
|PE Ratio (TTM)||N/A|
|Earnings Date||Aug 8, 2019|
|Forward Dividend & Yield||N/A (N/A)|
|1y Target Est||47.70|
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.
This most-searched list is a feature included in Benzinga Pro's Newsfeed tool. It highlights stocks frequently searched by Benzinga Pro users on the platform. Yuma Energy (AMEX: YUMA) shares were up 53.8% ...
A Food and Drug Administration panel determined Friday the benefits of Aimmune Therapeutics' peanut allergy treatment outweigh the risks. The panel voted 8-1 in favor of the drug's safety.
Aimmune Therapeutics, Inc. (AIMT), a biopharmaceutical company developing treatments for potentially life-threatening food allergies, today announced that the Allergenic Products Advisory Committee (APAC) convened by the U.S. Food and Drug Administration (FDA) voted to support the use of AR101 (proposed trade name PALFORZIA™) in children and teens with peanut allergy. PALFORZIA is a complex, biologic oral immunotherapy (OIT) candidate designed to reduce the incidence and severity of allergic reactions, including anaphylaxis, after accidental exposure to peanut in patients aged 4 through 17 years with a confirmed diagnosis of peanut allergy.
A U.S. Food and Drug Administration advisory panel on Friday recommended approving the first therapy for peanut allergies, which affect over 1.6 million children in the United States, despite raising concerns about the risk of severe allergic reactions it poses to young patients. The body of independent advisers voted 7-2 in favor of effectiveness and 8-1 backing safety of the therapy Palforzia, developed by Aimmune Therapeutics Inc. The verdict of the panel is traditionally an influential factor in the agency's final decision. Peanut allergies are the leading cause of death from food-induced allergic reactions in the United States but a lack of approved preventive treatments has left patients and caregivers desperate for options.
Aimmune Therapeutics Inc.'s stock has been halted for news Friday, as the Food and Drug Administration's Allergenic Products Advisory Committee (APAC) is meeting about the efficacy and safety data of the biopharmaceutical company's treatment for peanut allergies, Palforzia. APAC is discussing whether the data supports licensure of Palforzia as a treatment to reduce the incidence and severity of allergic reactions, including anaphylaxis, after accidental exposure to peanuts in patients 4 through 17 years of age. The meeting had been scheduled from 8:30 a.m. Eastern to 4:30 p.m. Aimmune's stock had gained 25% this week through Thursday, and has advanced 3.1% year to date, while the iShares Nasdaq Biotechnology ETF has climbed 8.6% this year and the S&P 500 has run up 20.3%.
Aimmune Therapeutics, Inc. (AIMT), a biopharmaceutical company developing treatments for life-threatening food allergies, today announced that NASDAQ has halted trading of the company’s common stock. The U.S. Food and Drug Administration (FDA) Allergenic Products Advisory Committee (APAC) is holding a meeting today from 8:30 a.m. to 4:30 p.m. ET to discuss whether efficacy and safety data support licensure of PALFORZIA™ as a treatment to reduce the incidence and severity of allergic reactions, including anaphylaxis, after accidental exposure to peanut in patients 4 through 17 years of age with a confirmed diagnosis of peanut allergy. The briefing materials can be found here on the FDA website.
Aimmune Therapeutics is hlated as the FDA conducts an efficacy meeting on the company's peanut allergy treatment candidate Palforzia.
Aimmune Therapeutics stock rocketed to a six-month high Wednesday ahead of a Food and Drug Administration committee meeting to discuss the biotech company's peanut allergy treatment.
Aimmune Therapeutics Inc (NASDAQ: AIMT) shares have been on an extended downtrend since the start of 2018. This thinly traded, small-cap biotech is on the radar ahead of a key FDA panel meeting scheduled for Friday, Sept. 13. A briefing document posted on the FDA’s website Wednesday reiterated the obvious.
During Monday night's " Mad Money" program, a caller asked Jim Cramer about Aimmune Therapeutics Inc. . "This is speculative, but it's a good story," said Cramer. AIMT is a bio pharmaceutical company developing proprietary product candidates and is advancing a therapeutic approach for the treatment of allergies to peanuts and other foods.
(Bloomberg) -- Aimmune Therapeutics Inc.’s winding road to get its first allergy treatment approved by U.S. regulators faces its next turn when a panel of advisers to the Food and Drug Administration meets later this week.The advisory committee’s discussion and recommendation on Sept. 13 may guide investors seeking details about the potential commercial success of a product designed to protect patients with peanut allergies.Bullish analysts expect the panel to back the drug, AR101, and its ground-breaking potential. They are looking for such an endorsement to lift shares, which have shed more than 30% of their value since a November high. At recent levels, some Wall Street price targets project Aimmune could double or triple in price over the next 12 months.Among skeptics is Stifel’s Derek Archila, who is hesitant to advise clients to buy shares before the “binary catalyst” of the advisory committee. Archila in a research note wrote that he expects the panel to focus on the safety of AR101, which is derived from peanut flour. A negative vote could cut the value of Aimmune’s shares in half, while a positive review from the advisers may prompt a 30% climb.“The FDA is really going to be charged with whether it can get comfortable with the longer-term safety,” he said in a telephone interview. “The crux of the AdComm will be if there is a need for longer-term safety data to really understand if you’re putting these kids at undue risk by giving them the allergen they’re allergic to.”Jayson Dallas, chief executive officer of Aimmune, said in an interview at Bloomberg’s New York headquarters: “There almost surely will be discussion around the macro-level risk/benefit, but then maybe digging into some patient populations.”A successful panel meeting followed by U.S. clearance over the coming months would make Aimmune’s AR101 the first desensitization therapy approved for an allergy that affects more than 1.6 million kids and teens and can produce potentially life-threatening reactions.When thinking about the company’s sales potential, Dallas mentioned GW Pharmaceuticals Plc’s cannabinoid-based drug Epidiolex as a comparison.“They were the only player in town, with a high unmet need and clear pent-up demand,” but sales didn’t really pick up until insurance coverage started to take hold, Dallas said. Epidiolex brought in $68.4 million of U.S. sales for the three months ended June 30, compared with $33.5 million for the prior quarter.While U.S. regulators review Aimmune’s treatment, a nonprofit research group has already weighed in. The Institute for Clinical and Economic Review (ICER) in a July report said there isn’t enough evidence to show that the “long-term benefits of desensitization outweigh short-term risks.”The company, along with analysts like Piper Jaffray’s Christopher Raymond, criticized the report at the time. Raymond called it “yet another example of ICER’s inherent bias against any novel therapy.” Aimmune said “ICER fails to incorporate available data on both long-term outcomes and quality of life.”If AR101 does win approval, analysts project annual sales could exceed $1.2 billion by 2024, data compiled by Bloomberg show. RBC Capital Markets’ Kennen MacKay wrote in an August note that the majority of U.S. allergists are waiting for an FDA-approved therapy to offer patients, which could push sales toward $1.9 billion worldwide.Another aspect that could affect the uptake of AR101 is whether the FDA will require a safety program to help ensure the benefits outweigh its risks. The company’s CEO said such a plan would “not be a big deal” because Aimmune is planning to assess patients over longer periods of time and look for larger groups of patients.An approval would likely come with a “black box” warning, the FDA’s most serious caution, according to both Aimmune’s Dallas and Stifel’s Archila, though this would be in-line with other allergy medicines.If Aimmune can find market success fighting peanut allergy, that might bode well for its experimental approaches to egg and tree-nut allergies. The Brisbane, California-based company enrolled the first patient in a mid-stage egg-allergy study at the end of August.“Validation of the platform and its concept will speed up our egg program and create more excitement for the egg program and our tree nut program,” Dallas said.Options in Aimmune set to expire on Sept. 20 are expecting a 36% move in shares over the next two weeks. Traders appear to be hedging more than making bullish bets, with put options outweighing calls. Investors are also preparing for an outsized move with implied volatility sitting at about 259%, well above a three-month average of 41%.This month’s FDA allergy panel may have implications for DBV Technologies SA, which is developing a patch for peanut-allergic children ages four to 11. DBV last month submitted its application for Viaskin Peanut after the FDA had previously requested additional data.While the FDA typically heeds the advice of its panels, the agency isn’t obligated to follow it. Karyopharm Therapeutics Inc.’s blood cancer drug Xpovio is a recent reminder. Regulators cleared the drug for market four months after a panel voted that a decision should be delayed for more data.\--With assistance from Gregory Calderone.To contact the reporter on this story: Bailey Lipschultz in New York at email@example.comTo contact the editors responsible for this story: Catherine Larkin at firstname.lastname@example.org, Jeremy R. CookeFor more articles like this, please visit us at bloomberg.com©2019 Bloomberg L.P.
Most biotech stocks have been under pressure recently, but as we approach the end of the year, many analysts are quite bullish as to what is next for these stocks.While the biotech industry carries substantial risk based on the fact that any negative event such as disappointing results from a clinical study can trigger a drop in share prices, analysts argue that a few stocks in this space are set to heal the market flu ahead of their upcoming FDA advisory committee (AdCom) meetings.During an AdCom, both the company and agency will give presentations, with patients often getting a chance to speak as well. A vote will then take place to decide if a drug gets an approval recommendation. This recommendation can help determine whether or not a drug receives final FDA approval, with a positive AdCom outcome acting as a catalyst that can cause shares to skyrocket.We wanted to take a closer look at 3 biotech stocks poised to soar ahead of their upcoming FDA AdCom meetings. Each boasts almost 100% upside potential as well as significant support from the Street with a “Strong Buy” analyst consensus, based on TipRanks’ Stock Screener.With that in mind, let’s dive in:Aimmune Stock Is Looking for a TurnaroundAimmune Therapeutics (AIMT) develops treatments to help protect people with food allergies by potentially reducing the risk of allergic reactions, thus making accidental exposures to allergens less dangerous.Going into its September 13 AdCom for its primary drug AR101, the company’s long-term growth narrative appears healthy. As Food Allergy Research & Education states that 32 million Americans have food allergies, including 5.6 million children under age 18, there’s a large market available for AIMT.While shares are down 18% year-to-date, the panel is expected to put AIMT back on an upward trajectory assuming all goes according to plan.AIMT is on track in terms of its timeline. A regulatory decision for AR101 should be announced in January 2020 but could come before. This means that the company would be able to launch the drug at the beginning of Q4 2019.Adding to the good news, AIMT’s management stated that it would be initiating its P2 AR201 trial for egg allergies. Investors could also get an update regarding its AR301 program for walnut allergies by the end of 2019.5-star Piper Jaffray Christopher Raymond commented: “With all eyes ahead to September, we continue to like the setup and remain buyer.” As a result, he reiterated his Buy rating and $60 price target. Raymond’s price target demonstrates his confidence in AIMT’s potential to surge 207% over the next twelve months. (To watch Raymond’s track record, click here)“As investors are well aware, the AR101 AdCom is scheduled for Sept 13th, an event that we think could help reverse the stock’s downward trend if things go well. With this in mind, we’ve looked beyond the compelling data package and instead focused on factors affecting how the meeting may go, digging deeper on APAC panelists’ views on OIT, and becoming more comfortable that FDA understands that allergen immunotherapies cause allergic reactions during patient desensitization (per sublingual immunotherapy commentary). Though the small minority of (vocal) naysayers might continue to debate the risk/reward of OIT, we feel very comfortable that FDA understands this point well,” Raymond wrote.Wall Street is on the same page. AIMT boasts a ‘Strong Buy’ analyst consensus as well as a $51 average price target, suggesting 158% upside potential. (See AIMT’s price targets and analyst ratings on TipRanks)Agile Therapeutics Shares Can Soar ~250%Agile Therapeutics (AGRX) is working to fulfill the unmet healthcare needs of women globally. Its current product candidates were developed to provide a contraceptive method for women that don’t want to commit to a longer-acting method or take a daily pill.With the U.S. contraceptive market expected to grow from $7.6 billion in 2017 to reach $11.6 billion by 2025 according to a Grand View Research report, AGRX stands to reap the benefits.The FDA announced at the end of June that an AdCom would take place for lead candidate Twirla, its once-weekly transdermal low-dose combination hormonal contraceptive (CHC) patch, on October 30. This news had investors excited as the AdCom will fall closely before AGRX’s November 16 Prescription Drug User Fee Act (PDUFA), the date that the FDA will reveal is if it has approved the treatment. Some have interpreted this timing to mean that the FDA may already have draft labeling ready.4-star H.C. Wainwright analyst, Oren Livnat, argues that the FDA wants to “tease out labeling issues regarding lower CHC efficacy in obese subjects, an issue that has long been ripe for discussion”. However, he thinks the Twirla SECURE Phase 3 trial was “the most robust CHC trial ever”, especially regarding AGRX’s inclusion of a significant number of obese patients.“We can’t predict the final labeling, if approved, but we maintain our current projection of $300M peak sales with just 2.6% market share, or approximately 50% of transdermal share,” he explained.Based on all of the above factors, the four-star analyst reiterated his Buy rating and $4 price target, implying 251% upside. (To watch Livnat’s track record, click here)Livnat is not the only fan of this healthcare company on Wall Street, as TipRanks analytics exhibit AGRX as a Strong Buy. Based on 4 analysts polled in the last 3 months, all 4 rate Agile stock a Buy. The 12-month average price target stands at $3.50, marking a 207% upside from where the stock is currently trading. (See AGRX’s price targets and analyst ratings on TipRanks)Amarin Has What It Takes to Score Crucial FDA approvalAmarin’s (AMRN) primary drug, Vascepa, is a purified fish oil derivative and has already been approved by the FDA as an EPA treatment to lower triglycerides without increasing bad cholesterol levels.Investors were not as happy to hear that the FDA would be holding an AdCom for Vascepa on November 14. The AdCom is related to its pending supplemental new drug application (sNDA) for expansion of Vascepa labeling based on its ability to reduce the risk of major adverse cardiovascular events from the REDUCE-IT study. Management stated that the AdCom meeting will most likely extend the original PDUFA date from September 28 to the end of December.That being said, the American Heart Association (AHA) published an update on August 20 to its 2002 scientific statement for omega-3 fatty acids for reducing triglycerides in patients with hypertriglyceridemia, with the update working in Vascepa’s favor. While this wasn’t a formal change to guidelines, it is a step in the right direction.The points from the AHA update noted that a wealth of evidence including epidemiological and genetic studies suggest the treatment of triglycerides is valid method to reduce cardiovascular disease. The AHA also highlighted the fact that over-the-counter fish oil agents should not be used for pharmacological treatment for patients, which bodes well for AMRN.Despite some negative investor sentiment, Jeffries’ Michael Yee remains confident in AMRN’s long-term growth narrative. “Scripts continue to grow every week despite no label change and we think 2020 numbers are too low. In our view, we think the totality of AMRN’s data support approval,” he explained.As a result, the four-star analyst reiterated his Buy rating and $30 price target. He believes share prices could gain 86% over the next twelve months. (To watch Yee’s track record, click here)The Street appears to mirror Yee’s sentiment. With 7 Buy ratings and no Holds or Sells assigned in the last three months, AMRN has a ‘Strong Buy’ analyst consensus. Its $32 average price target suggests 96% upside potential. (See AMRN’s price targets and analyst ratings on TipRanks) More recent articles from Smarter Analyst: * Is 33% Upside Good Enough to Risk Buying Fitbit (FIT) Stock? Deutsche Bank Doesn't Think So * Deutsche Bank Remains Sidelined on AMD Stock; Here's Why * Antitrust Investigation Is Not a Major Threat to Alphabet (GOOGL) Stock, Says Top Analyst * Tesla's (TSLA) Gigafactory Is Impressive, But Its Stock Isn't, Says RBC Capital
Aimmune Therapeutics, Inc. , a biopharmaceutical company developing treatments for life-threatening food allergies, today announced that members of the Aimmune execut
Here's a roundup of top developments in the biotech space over the last 24 hours. Scaling The Peaks (Biotech stocks hitting 52-week highs on Aug. 20) Atreca Inc (NASDAQ: BCEL ) Bioanalytical Systems, Inc. ...
Aimmune Therapeutics, Inc. (AIMT), a biopharmaceutical company developing treatments for life-threatening food allergies, today announced that it has randomized its first patient in a phase 2 clinical trial of AR201 for the treatment of egg allergy. AR201, an investigational biological drug for use in oral immunotherapy for egg allergy, is the second development program that Aimmune is advancing to phase 2 using its Characterized Oral Desensitization ImmunoTherapy (CODIT™) platform. Egg allergy is a common and serious condition that disproportionately affects children and can be associated with severe hypersensitivity reactions, including life-threatening anaphylaxis.
In the high-risk world of biotech investing, there are no guarantees of success. Still, sometimes investors can find places where the odds look reasonable enough to consider buying shares.