Dec. 23, 2014, 4:05 PM
- The FDA approves Novo Nordisk's (NYSE:NVO) Saxenda (liraglutide [rDNA origin] injection) for the treatment of chronic weight management in addition to a reduced-calorie diet and physical activity in adults with a body mass index (BMI) of 30 or greater (obese) or adults with a BMI of 27 or greater (overweight) who have at least one weight-related co-morbidity such as hypertension, type 2 diabetes or high cholesterol.
- Saxenda is a glucagon-like peptide-1 (GLP-1) receptor agonist in the same class as the company's glucose management medicine Victoza.
- Weight management drug-related tickers: (NASDAQ:OREX) (NASDAQ:VVUS) (NASDAQ:ARNA)
Dec. 15, 2014, 7:43 AM
- Zafgen (NASDAQ:ZFGN) initiates a Phase 2b study in Australia evaluating its lead product candidate, beloranib, for the treatment of patients with both severe obesity and type 2 diabetes. The trial will enroll ~150 subjects. Its primary objective is to demonstrate weight loss over a 6 - 12-month period along with glycemic control.
- The primary endpoint is the change on total body weight from baseline at the end of randomized treatment.
- Beloranib, a MetAP2 inhibitor, is an injectable small molecule therapy that reduces hunger while stimulating the use of stored fat as an energy source.
- The company licensed beloranib from South Korean firm Chong Kun Dang Pharmaceutical Corp.
- Related tickers: (NASDAQ:VVUS) (NASDAQ:OREX) (NASDAQ:ARNA)
Dec. 3, 2014, 3:36 PM
- Actelion Ltd (OTCPK:ALIOF) (OTC:ALIOY) submits a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for Uptravi (selexipag) for the treatment of patients with pulmonary arterial hypertension (PAH).
- Selexipag is selective IP prostacyclin receptor agonist. Prostacyclin activates the IP receptor inducing vasodilation and inhibiting proliferation of vascular smooth muscle cells. If approved, it will be the first such drug cleared for use in PAH.
- In April 2008, the company signed a license agreement with Nippon Shinyaku under which Actelion has global development and commercialization rights to selexipag outside of Japan. The firms will be partners in Japan.
- Actelion plans to submit an NDA to the FDA shortly.
- PAH-related tickers: (GSK -0.8%)(GILD -1.9%)(MSTX -1.5%)(ARNA +1.7%)(OTCPK:BAYRY -1.8%)(UTHR -1.2%)
Nov. 25, 2014, 11:28 AM
- The USPTO awards U.S. Patent No. 8,895,776 entitled "Modulators of the Prostacyclin Receptor Useful for the Treatment of Disorders Related Thereto" covering Arena Pharmaceuticals' (ARNA -1.7%) ralinepag, an orally available prostacyclin receptor agonist.
- The company is developing ralinepag for the treatment of vasospastic diseases such as pulmonary arterial hypertension.
- Patent applications related to ralinepag have been filed in 19 jurisdictions including the U.S., Europe, Japan and China.
Nov. 3, 2014, 7:36 AM| Comment!
Nov. 3, 2014, 6:56 AM
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Sep. 11, 2014, 9:02 AM
- Notes from this morning's call about Orexigen's (NASDAQ:OREX) Contrave:
- Over 13K patients evaluated in clinical trials. FDA specifies six post-marketing requirements (seven + studies).
- Obesity market in U.S.: 100M people. Takeda will promote via 900 sales reps. Launch this fall. Big advantage: Contrave is not a scheduled drug.
- OREX will earn $30M milestone based on FDA approval. Another $70M when launch commences. It has a co-promotion option but will not pursue at this time. Total milestone potential: $880M. Royalties: 20 - 35%.
- Company expects to end the year with ~$177M cash.
- Related tickers: (NASDAQ:ARNA) (NASDAQ:VVUS)
Sep. 11, 2014, 7:05 AM
- The FDA approves Orexigen Therapeutics' (NASDAQ:OREX) Contrave (naltrexone hydrochloride and bupropion hydrochloride extended-release tablets) as a treatment option for chronic weight management in addition to a reduced-calorie diet and physical activity.
- Contrave is indicated for use in adults with a body mass index (BMI) of 30 or greater (obese) or adults with a BMI of 27 or greater who have at least one weight-related co-morbidity (e.g. hypertension, type 2 diabetes, high cholesterol).
- Takeda Pharmaceuticals will be the distributor of the product for Orexigen.
- Orexigen will conduct a conference call this morning at 8:30 am EDT to discuss Contrave's approval and launch. Interested persons can participate via 800-708-4540.
- Related tickers: (NASDAQ:ARNA) (NASDAQ:VVUS)
Sep. 2, 2014, 3:08 PM
Aug. 1, 2014, 7:15 AM
- Arena Pharmaceuticals (ARNA -2.9%) Q2 results: Total Revenues: $12.8M (-81.4%); Belviq: $3.5M (+165.4%); Eisai Collaboration: $8.6M (-87.1%); R&D Expense: $27.0M (+43.5%); SG&A Expense: $9.1M (+6.1%); Operating Expenses: $38.2M (+31.5%); Operating Loss: ($25.4M) (-163.6%); Net Income: $7.5M (-81.3%); EPS: $0.03 (-83.3%); Quick Assets: $219.1M (+22.5%).
- Belviq prescriptions: 110,000.
- No guidance update provided.
- ARNA shares are up 4% premarket on light volume.
Aug. 1, 2014, 5:42 AM
Jul. 31, 2014, 5:30 PM
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Arena Pharmaceuticals Inc is a biopharmaceutical company. The Company is engaged in discovering, developing and commercializing novel drugs that target G protein-coupled receptors, or GPCRs, to address unmet medical needs.
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