Aimmune Therapeutics Inc (AIMT)

Wrong! As of March 13th the short interest was 32% of the float and 22% of the outstanding shares.

https://www.labiotech.eu/medical/dbv-technologies-peanut-allergy-fda/

The short interest is 2.5%, not 25%.

Interesting company here.

https://finance.yahoo.com/news/bingeing-alone-isn-t-enough-114523402.html

25% short interest

RBC Capital Maintains Outperform, Notes 3 Reasons Why The Palforzi Label Is The Best-Case Label Along With Potential Commercial Tailwinds:
9:57 am ET February 3, 2020 (Benzinga) Print
1) an indication for “confirmed diagnosis of peanut allergy” in pediatrics and adolescents that is NOT dependent on undergoing an oral food challenge

2) a monitoring period of “1-hour post-dosing” during dose escalation, which we see as largely in line with monitoring requirements for routine allergy shots

3) label details that do not restrict maintenance and continued updosing to childhood and enable continuation through adulthood

Latest Ratings for AIMT DateFirmActionFromTo

Feb 2020MaintainsMarket Outperform Feb 2020MaintainsOverweight Dec 2019Initiates Coverage OnNeutral

PT > 64.00

Aimmune Therapeutics, Inc. (NASDAQ:AIMT) shares increased by 15.5% to $35.87 during Monday's pre-market session. The most recent rating by Cantor Fitzgerald, on February 03, is at Overweight, with a price target of $64.00.

BOXED WARNING: WARNINGS AND PRECAUTIONS

Anaphylaxis

PALFORZIA can cause anaphylaxis, which may be life threatening. PALFORZIA is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the PALFORZIA REMS because of the risk of anaphylaxis. Only prescribers, healthcare settings, pharmacies, and patients certified and enrolled in the REMS Program can prescribe, receive, dispense or administer PALFORZIA.

Anaphylaxis has been reported during all phases of PALFORZIA dosing, including Maintenance and in subjects who have undergone recommended Up-Dosing and dose modification procedures.

Do not initiate PALFORZIA treatment in a patient who has had severe or life-threatening anaphylaxis within the previous 60 days. PALFORZIA may not be suitable for patients with certain medical conditions that may reduce the ability to survive anaphylaxis, including but not limited to markedly compromised lung function, severe mast cell disorder, or cardiovascular disease. In addition, PALFORZIA may not be suitable for patients taking medications that can inhibit or potentiate the effects of epinephrine.

All Initial Dose Escalation doses and the first dose of each Up-Dosing level must be administered in a certified health care setting.

Patients may be more likely to experience allergic reactions following PALFORZIA administration in the presence of cofactors such as exercise, hot water exposure, intercurrent illness (e.g., viral infection), or fasting. Other potential cofactors may include menstruation, sleep deprivation, nonsteroidal anti-inflammatory drug use, or uncontrolled asthma. Patients should be proactively counseled about the potential for the increased risk of anaphylaxis in the presence of these cofactors. If possible, adjust the time of dosing to avoid these cofactors. If it is not possible to avoid these cofactors, consider withholding PALFORZIA temporarily.

Asthma

Uncontrolled asthma is a risk factor for a serious outcome, including death, in anaphylaxis. Ensure patients with asthma have their asthma under control prior to initiation of PALFORZIA.

PALFORZIA should be temporarily withheld if the patient is experiencing an acute asthma exacerbation. Following resolution of the exacerbation, resumption of PALFORZIA should be undertaken cautiously. Re-evaluate patients who have recurrent asthma exacerbations and consider discontinuation of PALFORZIA.

Eosinophilic Gastrointestinal Disease

Discontinue PALFORZIA and consider a diagnosis of eosinophilic esophagitis in patients who experience severe or persistent gastrointestinal symptoms, including dysphagia, vomiting, nausea, gastroesophageal reflux, chest pain, or abdominal pain.

Gastrointestinal Adverse Reactions

Gastrointestinal adverse reactions were commonly reported in PALFORZIA-treated subjects, and dose modification should be considered for patients who report these reactions. For severe or persistent gastrointestinal symptoms consider a diagnosis of eosinophilic esophagitis.

ADVERSE REACTIONS

The most common adverse events reported in subjects treated with PALFORZIA (incidence ≥ 5% and ≥ 5% than placebo) are abdominal pain, vomiting, nausea, oral pruritus, oral paresthesia, throat irritation, cough, rhinorrhea, sneezing, throat tightness, wheezing, dyspnea, pruritus, urticaria, anaphylactic reaction, and ear pruritus.

Please see full Prescribing Information, including Boxed WARNING, and Medication Guide at www.PALFORZIA.com.

For more information about PALFORZIA, please call 1-844-PALFORZ (1-844-725-3679) or visit www.PALFORZIA.com.

About Aimmune

Aimmune Therapeutics, Inc. is a biopharmaceutical company that aspires to become the global leader in developing curative therapies and solutions for patients with food allergies. With a mission to improve the lives of people with food allergies, Aimmune is developing and commercializing oral treatments for potentially life-threatening food allergies. The Company’s Characterized Oral Desensitization ImmunoTherapy (CODIT™) approach is intended to provide meaningful levels of protection against allergic reactions resulting from accidental exposure to food allergens by desensitizing patients with defined, precise amounts of key allergens. Aimmune has one FDA-approved medicine for peanut allergy and other investigational therapies in development to treat other food allergies. For more information, please visit www.aimmune.com.

Forward-Looking Statements

Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding: Aimmune’s expectations regarding the potential benefits of PALFORZIA; Aimmune’s expectations regarding the timing and elements of the potential commercial launch of PALFORZIA; and Aimmune’s expectations regarding potential applications of the CODIT approach to treating life-threatening food allergies. Risks and uncertainties that contribute to the uncertain nature of the forward-looking statements include: the expectation that Aimmune will need additional funds to finance its operations; Aimmune’s dependence on the success of PALFORZIA; Aimmune’s ability to build a commercial field organization and distribution network; the degree of acceptance of PALFORZIA among physicians, patients, healthcare payors, patient advocacy groups and the general medical community; Aimmune’s ability to obtain favorable coverage and reimbursement from third-party payors for PALFORZIA; Aimmune’s reliance on third parties for the manufacture of PALFORZIA; Aimmune’s ability to implement and comply with the REMS for PALFORZIA; possible regulatory developments in the United States and foreign countries; and Aimmune’s ability to attract and retain senior management personnel. These and other risks and uncertainties are described more fully in Aimmune's most recent filings with the Securities and Exchange Commission, including its Quarterly Report on Form 10-Q for the quarter ended September 30, 2019. All forward-looking statements contained in this press release speak only as of the date on which they were made. Aimmune undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

This press release concerns PALFORZIA (AR101), which has been approved for marketing by the FDA in the United States and has not been approved for marketing by the EMA or Swissmedic. AR101 in Europe is currently limited to investigational use, and no representation is made as to its safety or effectiveness for the purposes for which it is being investigated.

PALFORZIA™, AIMMUNE™, AIMMUNE THERAPEUTICS™ and CODIT™ are trademarks of Aimmune Therapeutics, Inc.

References

i United States Census Bureau Quick Facts (2015 estimates)
ii Gupta R, Warren C, Blumenstock J, et al. OR078 The Prevalence of Childhood Food Allergy in the United States: An Update. Ann Allergy Asthma Immunol. 2017;119(5 Suppl): S11.
iii American College of Allergy, Asthma & Immunology. Available here: https://acaai.org/allergies/types/food-allergies/types-food-allergy/peanut-allergy. Accessed December 20, 2019.
iv Gupta RS, Warren CM, Smith BM, et al. The public health impact of parent-reported childhood food allergies in the United States. Pediatrics. 2018;142(6):e20181235.
v As reviewed in Burks, Sampson, Plaut et al. Treatment for Food Allergy. Journal Allergy Clin Immunol (2018)



View source version on businesswire.com: https://www.businesswire.com/news/home/20200131005593/en/

Investors:
DeDe Sheel
(917) 834-1494
dsheel@aimmune.com

Media:
Julie Normart
(559) 947-3245
jnormart@w2ogroup.com

Lauren Barbiero
(646) 564-2156
lbarbiero@w2ogroup.com

Aimmune received a $98 million investment from Nestle SA's (NESN.EB) Nestle Health Science in November.

By Ron Leuty
Staff Reporter, San Francisco Business Times
Jan 31, 2020, 3:04pm PST
Updated Jan 31, 2020, 3:15pm PST
Aimmune Therapeutics Inc. ended a nearly nine-year quest Friday by winning Food and Drug Administration for a first-of-its-kind peanut allergy treatment that protects people from potentially lethal accidental exposures.

The oral immunotherapy, a capsule of powderized peanut protein called Palforzia, is approved for kids ages 4-17 — a group whose parents kickstarted the Brisbane company's founding in 2011 after a venting meeting with clinicians, advocacy groups, regulators and drug developers.


"They were frustrated that there had been strides in other areas but not one in food allergy," Aimmune President and CEO Dr. Jayson Dallas told the Business Times earlier this month. "There was no clear and obvious regulatory pathway."

Aimmune (NASDAQ: AIMT) changed all of that, devising a way to create a biologic drug from food proteins, finding a method to consistently manufacture it and working with the FDA along a review process that took more than a year. Dosing of the drug is gradually increased over months to help the immune system acclimate to peanuts.

Palforzia will carry a wholesale acquisition cost of $890 per month, but Aimmune said it plans to offer patient co-pays that could reduce out-of-pocket costs to as low as $20 per month. The company also plans a patient assistance program that would provide the drug at no cost for eligible patients who do not have insurance coverage.

Aimmune's stock, which closed down 93 cents Friday to $31.05 per share, was up nearly 20% in after-hours trading to $37.03.


"This is a defining moment for the peanut allergy community and for Aimmune Therapeutics, and we are excited to bring the first FDA-approved treatment for peanut allergy to patients and their families," Dallas said in a statement.

Palforzia's approval doesn't mean those with peanut allergy can down dozens of peanuts — it should be used in conjunction with a peanut-avoidance diet, the company said — but in clinical trials some patients were able to tolerate exposure to the nuts.

Peanut allergy is one of the most common food allergies in the world, affecting more than 1.6 million children and teens in the United States alone. It has long been treated by allergy doctors by building up exposure to the allergen that perturbs the immune system and forces a reaction.

But there has not been a single drug available to patients on a widespread basis, and accidental exposures — from food cooked with peanut oil at a restaurant, for example — is a constant worry for patients and parents. Those exposures can be treated with an epinephrine pen, but coming in contact with peanuts can send those with the allergy into anaphylactic shock, which can be deadly.

Palforzia does come with caveats, namely side effects in the gut and potential complications for asthma patients. The drug also can cause anaphylaxis, the company said, and is available only through a restricted program

WILL this pull back or retrace in the am?
$AIMT

https://www.msn.com/en-us/health/health-news/fda-approves-first-treatment-for-kids-with-peanut-allergy/ar-BBZwRw8?ocid=spartandhp
$AIMT Congrats

This looks like the news you guys have been looking for. Congratulations. I got a proverbial boatload of this in after hours trading after the PR today. This may have as much potential as my other stock. Well not really ;)
Who would the most likely buy out offers come from?
This is going to be big.

———————————-
FDA Approves Aimmune’s PALFORZIA™ as First Treatment for Peanut Allergy

Source: Business Wire
More than 1.6 Million Children and Teens in the U.S. are Allergic to Peanutsi,ii

Company to Host Conference Call Today at 5:30 p.m. ET

Aimmune Therapeutics, Inc. (Nasdaq: AIMT), a biopharmaceutical company developing and commercializing treatments for potentially life-threatening food allergies, today announced that the U.S. Food and Drug Administration (FDA) approved PALFORZIA™ [Peanut (Arachis hypogaea) Allergen Powder-dnfp]. PALFORZIA is the first approved treatment for patients with peanut allergy. It is an oral immunotherapy indicated for the mitigation of allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanut. PALFORZIA is approved for use in patients with a confirmed diagnosis of peanut allergy. Initial dose escalation may be administered to patients aged 4 through 17 years. Up-dosing and maintenance may be continued in patients 4 years of age and older. PALFORZIA is to be used in conjunction with a peanut-avoidant diet. PALFORZIA is not indicated for the emergency treatment of allergic reactions, including anaphylaxis.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200131005593/en/

Scared of non FDA approval but this will get approved. Back in business. Saddle up

Why did this sell off today?

3 Healthcare Stocks to Watch With Huge FDA Decisions in January.

$DRRX $AIMT $EPZM

https://www.transparenttradersblackbox.com/post/3-healthcare-stocks-to-watch-with-huge-fda-decisions-in-january-drrx-aimt-epzm

Well, that worked out well.

I'm surprised nobody in here is watching this one. The price target just went from $69 to $75 on this $25 stock....

So confused by the low price here. Schwab has this as a sell. Cramer saying its trading too low. WTH....? Anyone seeing something I'm not?

Aimmune Therapeutics Share Up After DBV Withdraws FDA Application
7:27 pm ET December 19, 2018 (Dow Jones) Print
By Josh Beckerman

Aimmune Therapeutics Inc. (AIMT) shares were recently up 10.8% to $24.05 after hours. Another company focused on food allergy treatments, DBV Technologies SA (DBVT, DBV.FR), said it withdrew an application with the U.S. Food and Drug Administration for its Viaskin Peanut patch.

On Wednesday morning, Aimmune said it started a Phase 3 trial of AR101 in peanut-allergic children from one to three years old. During the regular session, Aimmune shares fell 1.2%.

Aimmune received a $98 million investment from Nestle SA's (NESN.EB) Nestle Health Science in November.

Write to Josh Beckerman at josh.beckerman@wsj.com

(END) Dow Jones Newswires

December 19, 2018 19:27 ET (00:27 GMT)

Copyright (c) 2018 Dow Jones & Company, Inc.

Anyone know why this isn't getting much action? I just read that Nestle increased their position in this from 15% to 18% and the stock was coming down quick until the end of yesterday.

Seems to be slowly gaining again but schwab has this as underperform F rating. Any opinions on this one?

Anyone have any info on $AIMT and what will be announced at the conference?

Any news around the name?

No..... All wrong

AIMT buy 38.68



















normal chart




log chart

https://seekingalpha.com/article/4115467-aimmune-soars-rival-drug-flop-peanut-allergy

Any near term catalyst?

Hello all.. Call my the Grandfather!

EPS = -69

AIMT D 4 MONTHS

NEW IPO AMIT