Anika Therapeutics: U.S. Approval To Drive Profit And Valuation
KEMS Research • 12 Comments
KEMS Research • 12 Comments
Anika Therapeutics: Profitable, Cheap And Overlooked
Yesterday, 4:23 PM
Tue, Jul. 26, 5:35 PM
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Mon, Mar. 28, 10:15 AM
- Anika Therapeutics (ANIK +1.4%) receives CE Mark clearance for CINGAL (hyaluronic acid plus triamcinolone hexacetonide) for the treatment of pain associated with osteoarthritis of the knee.
- CINGAL is a combination viscosupplement that combines the lubricant hyaluronic acid with a steroid (triamcinolone hexacetonide) to treat inflammation. It's the company's third-generation product, following ORTHOVISC and MONOVISC. In clinical studies, patients experienced immediate pain relief lasting six months after a single injection into the knee joint.
- The company's premarket approval application (PMA) is currently under FDA review. CINGAL was cleared in Canada in November 2015.
- Previously: Anika's CINGAL cleared in Canada for OA of the knee (Nov. 3, 2015)
Wed, Feb. 24, 4:08 PM
Tue, Feb. 23, 5:35 PM
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Wed, Jan. 6, 4:46 PM
Dec. 29, 2015, 4:24 PM
- The first patient has been enrolled in a Phase 3 clinical trial, FastTRACK, assessing Anika Therapeutics' (NASDAQ:ANIK) HYALOFAST for the treatment of articular knee cartilage defect lesions. The aim of the prospective, randomized, active-treatment-controlled, multicenter study is to establish the superiority of a hyaluronan-based scaffold (HYALOFAST) compared to autologous bone marrow aspirate concentrate (BMAC). About 200 subjects will be recruited across 30 sites in the U.S. and Europe. The projected date for top-line data is not given.
- HYALOFAST is a biodegradable hyaluronic acid-based scaffold that is used to enable cartilage regeneration in patients with cartilage defects. Clinical data from Europe showed that patients treated with HYALOFAST plus autologous BMAC in a one-step arthroscopic procedure were able to regenerate hyaline-like cartilage.
- HYALOFAST is CE Mark'd in Europe and is commercially available in 18 countries.
Nov. 3, 2015, 9:54 AM
- Health Canada approves Anika Therapeutics' (ANIK +0.5%) CINGAL (hyaluronic acid plus triamcinolone hexacetonide) for the treatment of symptoms of osteoarthritis (OA) of the knee. This is the first clearance for the company's next-generation viscosupplement.
- CINGAL combines the lubricant hyaluronic acid with a steroid (triamcinolone hexacetonide) to treat inflammation.
Oct. 29, 2015, 9:52 AM
Oct. 28, 2015, 4:36 PM
- Anika Therapeutics (NASDAQ:ANIK): Q3 EPS of $0.55 beats by $0.21.
- Revenue of $23.7M (+7.4% Y/Y) beats by $1.34M.
- Shares -2.4%.
Oct. 27, 2015, 5:35 PM
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Jul. 29, 2015, 4:09 PM
- Anika Therapeutics (NASDAQ:ANIK): Q2 EPS of $0.51 beats by $0.17.
- Revenue of $22.9M (-12.8% Y/Y) beats by $1.25M.
- Shares +2.93%.
Jul. 28, 2015, 5:35 PM
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Jun. 17, 2015, 11:35 AM
- Anika Therapeutics (ANIK +0.8%) inks a collaborative research agreement with the University of Massachusetts Amherst with the aim of developing a therapy for rheumatoid arthritis (RA), a chronic inflammatory disorder affecting almost one quarter of adult Americans.
- The specific purpose of the research is to develop a novel modality for the treatment of RA. If successful, clinical development of a product candidate could start in 2017.
- Financial terms are not disclosed.
Anika Therapeutics, Inc. develops, manufactures and commercializes therapeutic products for tissue protection, healing and repair. The company's products are based on hyaluronic acid, a natural chemical occurring, biocompatible polymer found throughout the body. It offers therapeutic products... More
Country: United States
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