PETAH TIKVA (dpa-AFX) - A lot happened in the pharma sector in the week, with some bringing joy to investors while some caused heartbreaks.
On Tuesday (Sept.4), EyeGate Pharmaceuticals Inc. (EYEG) announced disappointing results from its phase III study of EGP-437 in patients with non-infectious anterior segment uveitis, sending the shares down 14% to $0.48 that day. The stock has since lost another 20%, and closed Friday's trading at $0.38.
Shares of ProQR Therapeutics N.V. (PRQR) touched a 52-week high of $17.55 on Wednesday (Sep.5), thanks to positive results from its phase I/II trial of QR-110 in patients with Leber's congenital amaurosis 10, a rare genetic eye disorder. However, some of the gains were erased, following a secondary offering, and the stock closed Friday's trading at $15.80.
Histogenics Corp. (HSGX) plunged 73% on Wednesday to $0.76 as its phase III clinical trial of NeoCart in patients with knee cartilage damage failed to meet the primary endpoint of a statistically significant improvement in pain and function. The shares, which have since lost another 7%, closed Friday's trading at $0.72.
Now, here are some of the pharma/biotech stocks to watch out for in the week starting September 10.
1. Kiniksa Pharmaceuticals Ltd. (KNSA)
Kiniksa Pharma is a clinical-stage biopharmaceutical company developing therapeutics to treat a spectrum of autoinflammatory & autoimmune diseases.
The Company's advanced drug candidate is Rilonacept, which is moving into a pivotal phase III clinical trial in approximately 60 subjects with recurrent pericarditis in the second half of 2018.
Also in the pipeline are Mavrilimumab for the treatment of giant cell arteritis, which will advance to a phase II clinical trial of in the second half of 2018; KPL-716, under phase 1a/1b clinical trial in healthy volunteers and subjects with moderate-to-severe atopic dermatitis experiencing moderate-to-severe pruritus; KPL-045 and KPL-404, under pre-clinical testing for autoimmune diseases.
Watch out for...
Data from the single-dose, phase 1a/1b clinical trial of KPL-716 in healthy volunteers and subjects with moderate-to-severe atopic dermatitis experiencing moderate-to-severe pruritus will be presented at the 27th European Academy of Dermatology and Venereology (EADV) Congress in Paris on September 15, 2018.
KNSA closed Friday's trading at $26.98, up 2.74%.
2. Incyte Corp. (INCY)
Incyte is a commercial-stage biopharmaceutical company. Its first commercial product is Jakafi (ruxolitinib), approved in the United States for patients with intermediate or high-risk myelofibrosis and for patients with polycythemia The Company also has a diverse and growing portfolio of product candidates.
Watch out for...
Data from a recently completed phase II randomized trial of topical Ruxolitinib in patients with mild-to-moderate atopic dermatitis are scheduled to be presented at the 27th European Academy of Dermatology and Venerology Congress, September 12-16, 2018 in Paris, France. The data showed a showed a significant benefit over vehicle control.
Preparations are already underway for a global, pivotal phase III program with topical Ruxolitinib in patients with mild-to-moderate atopic dermatitis.
INCY closed Friday's trading at $69.17, down 4.21%.
3. Teva Pharmaceutical Industries Ltd.(TEVA)
The FDA is slated to decide whether or not to approve Teva's Fremanezumab on September 16.
Fremanezumab is an investigational therapy proposed as a quarterly or monthly injection for the preventive treatment of migraine in adults.
The first approved therapy designed specifically for migraine prevention is Novartis' Aimovig. It was approved in the U.S. in May of this year, and in the EU in July. Aimovig works by blocking calcitonin gene-related peptide receptor (CGRP-R), which plays an important role in migraine. Fremanezumab also belongs to the same class as that of Aimovig.
If approved, Fremanezumab is expected to generate peak sales of about $960 million by 2022, according to Clarivate Analytics.
TEVA closed Friday's trading at $21.50, down 1.15%.
4. AnaptysBio Inc. (ANAB)
AnaptysBio is a clinical-stage antibody development company focused on unmet medical needs in inflammation. The Company's lead drug candidate is Etokimab (ANB020), an inhibitor of interleukin-33 cytokine, or IL-33, which has a role to play in various infectious and inflammatory diseases.
A phase IIb trial of Etokimab (ANB020) in moderate-to-severe atopic dermatitis, dubbed ATLAS, and phase IIa trial of Etokimab in severe eosinophilic asthma are ongoing. A phase II trial of Etokimab in adult chronic rhinosinusitis with nasal polyps, called ECLIPSE, is expected to commence soon.
Watch out for...
The top-line efficacy and safety data, including improvement in Forced Expiratory Volume in One Second (FEV1), from the ongoing phase IIa trial of Etokimab in severe eosinophilic asthma are expected to be reported this month.
ANAB closed Friday's trading at $87.77, up 1.89%.
5. Foamix Pharmaceuticals Ltd. (FOMX)
Foamix is a clinical stage specialty pharmaceutical company focused on developing and commercializing proprietary topical foams to address unmet needs in dermatology.
Three phase III trials are underway namely, one phase III trial of FMX101, the Company's minocycline foam 4%, in patients with moderate-to-severe acne , and two phase III trials of FMX103, topical minocycline foam 1.5%, for the treatment of papulopustular rosacea.
Watch out for...
Top-line results from the phase III trial of FMX101 in patients with moderate-to-severe acne are expected this month.
FOMX closed Friday's trading at $5.83, up 1.75%.
Copyright RTT News/dpa-AFX