(RTTNews.com) - The week that went by was a bit disappointing in terms of drug development for Alzheimer's and non-alcoholic fatty liver disease. Merck pulled the plug on potential Alzheimer's drug Verubecestat, which was in late-stage testing, and Galmed's mid-stage study of investigational oral therapy Aramchol in patients with HIV-associated lipodystrophy and non-alcoholic fatty liver disease did not meet the key goals.
However, on the regulatory front, things were a bit positive. Becton, Dickinson and Co.'s Onclarity, a new HPV Assay capable of detecting 14 high-risk HPV types that put women at high risk for cervical cancer, Vertex Pharma's Symdeko, a new cystic fibrosis drug combo, and Janssen Pharma's Erleada for a certain type of prostate cancer are some of the names that deserve a mention for getting the FDA stamp of approval.
Let's take a look at the pharma stocks and upcoming events to keep an ear out for in the coming week.
<B>1. AnaptysBio Inc.</B>
AnaptysBio Inc. (ANAB) is a clinical-stage antibody development company focused on unmet medical needs in inflammation.
The Company announced positive interim data from its phase IIa clinical trial of ANB020 in 12 adult patients with moderate-to-severe atopic dermatitis on October 10, 2017, sending the stock up more than 100% that day to $70.41.
According to the interim analysis reported last October, after a single dose of ANB020, nine of 12 patients (75%) achieved an Eczema Area Severity Index score improvement of 50% (EASI-50) or more at day 15; 10 of 12 patients (83 percent) achieved EASI-50 at day 29, and nine of 12 patients (75%) achieved EASI-50 at day 57.
The updated data, presented at the American Academy of Dermatology (AAD) Annual Meeting on Feb.17, 2018, demonstrated that ANB020 is efficacious in all 12 patients enrolled in the phase IIa clinical trial - with each patient achieving at least EASI-50 on or before day 57 after a single dose of the drug candidate.
The Company plans to initiate a phase IIb clinical trial in 200-300 adult patients with moderate-to-severe atopic dermatitis to evaluate various dose levels and dosing frequencies of subcutaneously-administered ANB020 during the second half of 2018, with data expected in 2019.
ANAB closed Friday's trading at $126.45, up 5.50%. The stock has traded in a range of $18.15 to $132.46 in the last 1 year.
<B>2. Aimmune Therapeutics</B>
Aimmune Therapeutics Inc. (AIMT) is a biopharmaceutical company developing treatments for life-threatening food allergies.
The Company's lead investigational drug is AR101, which is under phase III development, for desensitization of patients with peanut allergy.
The core phase III trial evaluating AR101 in peanut allergy is known as PALISADE, and top-line data from this study are expected this month (February).
AIMT has traded in a range of $15.97 to $40.65 in the last 1 year. The stock closed Friday's (Feb.16) trading at $37.20, down 2.72%.
Novavax Inc. (NVAX) is a clinical stage biotechnology company developing products to prevent a broad range of infectious diseases like respiratory syncytial virus (RSV) and influenza.
A phase I/II trial of the Company's NanoFlu seasonal flu vaccine candidate in healthy older adults is underway, with data expected this month.
NVAX closed Friday's trading at $2.34, up 8.33%. The stock has traded in a range of $0.96 to $2.52 in the last 1 year.
<B>4. Acorda Therapeutics</B>
Acorda Therapeutics Inc. ( ACOR ) is a biotechnology company focused on developing therapies for neurological disorders.
We may get to know in the coming week whether or not the Company's resubmitted NDA for Parkinson's disease drug candidate Inbrija qualifies for a full review.
The FDA had refused to accept the NDA last August on concerns related to the drug candidate's manufacturing process. On December 7, 2017, the Company resubmitted the Inbrija NDA.
The Inbrija NDA is being submitted as a 505(b)(2) application. The FDA is expected to inform Acorda within 74 days if the submission has been deemed complete and permits a full review.
Piper Jaffray analyst Charles Duncan on February 16, boosted his price target on Acorda to $37 from $32.
ACOR has traded in a range of $13.60 to $33.00 in the last 1 year. The stock closed Friday's trading at $25.80, up 2.79%.
On February 23, 2018, the FDA will announce its decision on KemPharm Inc.'s (KMPH) abuse-deterrent product candidate Apadaz for the short-term management of acute pain.
Apadaz is an immediate-release fixed-dose combination product consisting of benzhydrocodone hydrochloride, a prodrug of hydrocodone and benzoic acid, and acetaminophen.
The U.S. regulatory agency had refused to approve Apadaz in June 2016.
KMPH has traded in a range of $2.45 to $6.75 in the last 1 year. The stock closed Friday's trading at $5.79, up 2.62%.
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