Norges Bank reports 16.86% increase in ownership of AIMT / Aimmune Therapeutics, Inc. 2020-03-03 - Norges Bank has filed a 13F-HR/A form disclosing ownership of 493,939 shares of Aimmune Therapeutics, Inc. (US:AIMT) with total holdings valued at $16,532,000 USD as of 2019-12-31. Below is a listing of new molecular entities and new therapeutic biological products approved by CDER in 2020. The FDA accepted the BLA for AR101 in March 2019, and previously informed Aimmune that completion of its review would be targeted by late January 2020. FDA Approves Ebanga (ansuvimab-zykl) for the Treatment of Zaire Ebolavirus Infection - December 21, 2020; Ebanga FDA Approval History --If Approved, AR101 Will Be the First Medicine for This Life-Threatening Condition --BRISBANE, Calif.--(BUSINESS WIRE)--Mar. Aimmune Therapeutics stock rallies after FDA approves peanut-allergy drug Published: Jan. 31, 2020 at 5:20 p.m. Aimmune Therapeutics received FDA approval for its Palforzia, so AIMT stock will still be one of the best stocks in 2020. 2. January 31, 2020, 2:35 PM PST. Q1 2020 . FDA approves Aimmune’s therapy for use in children, teens. H2 2020 . WHO welcomes the recent decision by the U.S. Food and Drug Administration (FDA) to approve a dispersible 5 mg formulation of dolutegravir (DTG) for use in infants and children living with human immunodeficiency virus type 1 (HIV-1). Ebanga (ansuvimab-zykl) is a monoclonal antibody for the treatment of Zaire ebolavirus (Ebolavirus) infection in adults and children. 4,990 The BLA for AR101 was originally accepted in March 2019, with an original review target date of late January 2020. January 2020 . AR101 is an investigational biologic drug for use in oral immunotherapy, as a treatment to reduce the frequency and severity of adverse events, including anaphylaxis, following exposure to … ET The biologic was previously granted Fast Track and Breakthrough Therapy designations for peanut-allergic children and … Complete enrollment of AR201 phase 2 trial. This listing does not ... Approval Date FDA-approved use on approval date* 53. Shares of Epizyme Inc. (EPZM) have gained nearly 10 percent over the last 1 week as the Company awaits the FDA decision on its New Drug Application for Tazemetostat, slated to be announced on January 23, 2020. Q1 2020 . Aimmune's Palforzia is the first drug for the treatment of peanut allergy for children in the U.S. H2 2020 . As one of the organizations that originally highlighted the need for an FDA-approved oral treatment approach to food allergy back in 2011, we are thrilled with today’s FDA approval … AIMT's stock fell precipitously amid the COVID-19 pandemic, despite receiving FDA approval for its Palforzia treatment (the first FDA approved treatment for peanut allergies). Analysts expect drug to top $1 billion in sales by 2024. Aimmune Therapeutics Inc AIMT 0.03% announced late Friday that it … U.S. Commercial Launch Underway . January 2020 . Nestle invests $200 million more in Aimmune after peanut allergy drug approval finance.yahoo.com Jul 31, 2020 12:07 pm This company doesn't provide a dividend. H2 2020 . Usually, the stocks experience a run-up going into the scheduled FDA Approval decision/FDA … Potential EU approval of AR101 for peanut allergy in children and adolescents ages 4 to 17. The PDUFA date refers to the date the Food and Drug Administration (FDA) are expected to deliver their decision whether or not a approve a companies New Drug Application (NDA) or Biologics License Application (BLA). The PDUFA date under priority review is February 28, 2021. By Matt McCall, Editor, MoneyWire Oct 5, 2020, 9:00 am EST October 2, 2020 Editor’s note: This article is part of InvestorPlace.com’s Best Stocks for 2020 contest . First and Only EZH2 Inhibitor Approved by the U.S. Food and Drug Administration. Expected FDA review action date for PALFORZIA BLA . Potential EU commercial launch of AR101 H2 2020 . Kala Pharmaceuticals, Inc. (NASDAQ:KALA) shares closed the week down 13% to $5.02 following news that it received a Complete Response Letter (CRL) from the FDA regarding its New Drug Application (NDA) for KPI-121 0.25% for the temporary relief of the signs and symptoms of dry eye disease. February 03, 2020 11:47am 2 min read Comments → Click here to get Benzinga's options trading newsletter. Shares of Aimmune Therapeutics Inc. (AIMT) are down over 4 percent from their 52-week high of $37, recorded on January 16, 2020. CABAL: FASTRACKED BY FDA. What Awaits Epizyme (EPZM), Aimmune Therapeutics (AIMT) This Week? Mid-2020 . Some approvals may be added to the Drugs@FDA database after this timespan. Aimmune Therapeutics Inc (NASDAQ: AIMT) Q2 2020 earnings call dated July 30, 2020 2020 Device Approvals The products listed in this section include some of the newest medical technology from the year 2020. Approval late last year of Sarepta's second drug — Vyondys 53 for a different segment of DMD patients — was nearly as dramatic, with the FDA reversing an initial rejection after the company appealed to more senior agency officials.. The goal date set by the FDA for announcing its decision on a company’s New Drug Application/ Biologics License Application/sBLA/sNDA after reviewing the applications is known as the PDUFA date. 4 Healthcare Stocks With FDA Approvals on the Horizon With FDA approval deadlines approaching in 2020, these four drug developers could see substantial gains if they're successful. Date of Approval: December 21, 2020 Treatment for: Zaire Ebolavirus Infection. Recent New and Generic Drug Approvals ... approvals and tentative approvals of original and supplemental applications for the two weeks beginning on the earliest date listed below. Status: BLA accepted with priority review status in October and the PDUFA date has been fixed for second quarter of 2020 Palforzia Sponsor: Aimmune Therapeutics Inc (NASDAQ: AIMT ) Potential U.S. commercial launch of AR101 . Expected completion of enrollment of AR201 phase 2 trial. Potential U.S. commercial launch of PALFORZIA, if approved. The FDA has not asked for any additional data and has not provided a timeline on a new action date. Company to Host Conference Call Tonight at 5:30 p.m. Potential FDA approval of AR101 for peanut allergy in children and adolescents ages 4 to 17 . This represents 19.6 percent ownership of the company. ET On the PDUFA date the FDA will either: - issue approval for marketing. Expected EMA action date for MAA of PALFORZIA for peanut allergy in children and adolescents ages 4 to 17 years. H2 2020 Advisory Committee Meeting calendar dates also included. CorMedix Inc. (NYSE:CRMD) announced that the FDA has accepted for filing the New Drug Application (NDA) for Defencath, its product candidate to be used as a catheter lock solution in hemodialysis patients for the prevention of catheter related blood stream infections (CRBSI). April 24, 2020 - Nestle Health Science US Holdings, Inc. has filed an SC 13D/A form with the Securities and Exchange Commission (SEC) disclosing ownership of 12,727,113 shares of Aimmune Therapeutics, Inc. (US:AIMT). PRNewsWire … The FDA's review of a DMD treatment developed by NS Pharma, a little-known subsidiary of Japan's Nippon Shinyaku, promises to be less eventful. Aimmune Therapeutics NASDAQ Updated Oct 13, 2020 4:00 AM. AIMT 34.49 0.10 (0.29%).