Orexigen To Rise On Very Likely FDA Nod June 11th
Ernest Marmer • 23 Comments
Ernest Marmer • 23 Comments
Orexigen - A Clear Path To The Market
Spencer Osborne • 17 Comments
Spencer Osborne • 17 Comments
Fri, Jul. 8, 5:41 PM
Wed, Jun. 8, 4:23 PM
- Nano cap Orexigen Therapeutics (NASDAQ:OREX) was up 52% today on a 6x surge in volume in response to its announcement of a favorable Markman ruling related to the company and Takeda's (OTCPK:TKPHF)(OTCPK:TKPYY) Contrave patent infringement litigation against Actavis (NYSE:AGN).
- A Markman or claims construction ruling, is a pretrial hearing in which a judge determines the meaning of the disputed patent claims in patent litigation. In this case, Judge Richard Andrews adopted Orexigen's proposed constructions for the majority of the disputed claims, a big win for the company and making it significantly more difficult for Actavis to prevail.
Mon, May 23, 9:37 AM
- Orexigen (OREX +2.7%) EVP, Global Development Preston Klassen, M.D., M.H.S, resigns to accept a drug development position at a private firm. Peter Flynn, Ph.D., has been appointed SVP, Head of Development , Regulatory Affairs and Safety. Toni Foster will continue as SVP, Project Management Office and Clinical Operations.
Wed, May 4, 4:06 PM
Tue, May 3, 5:35 PM
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Fri, Apr. 15, 10:14 AM
- In a regulatory filing, Orexigen Therapeutics (OREX -4.5%) reports that it has terminated the post-marketing study, CONVENE, a cardiovascular outcomes trial (CVOT) recently initiated by former Contrave (naltrexone HCl/bupropion HCl) commercialization partner Takeda Pharmaceutical Company (OTCPK:TKPHF)(OTCPK:TKPYY). The company believes taking over the 8,800-subject trial is too tall a task so a restart under its own IND is the plan. CONVENE was just starting as only 58 patients had been randomized.
- The CVOT study is a requirement stipulated the FDA. Final results are due by January 2022.
- Takeda returned its rights to Contrave to Orexigen last month. Valeant Pharmaceuticals (VRX +0.1%) has the rights in Central and Eastern Europe.
- Now read Orexigen: Contrave Sales Flatten Out At End Of Q1
Fri, Apr. 1, 3:47 AM
- While the rates of obesity have leveled off in some countries where it's already a public health concern, other places are seeing their obesity rates increase, propping up the global average.
- "Over the past four decades, we have transitioned from a world in which underweight prevalence was more than double that of obesity, to one in which more people are obese than underweight," according to a study published in The Lancet.
- By 2025, one-fifth of adults around the world are forecast to be obese, including 40% of adults in the U.S.
- Related tickers: NUTR, PLNT, WTW, NTRI, FIT, HLF, VVUS, ARNA, GNC, MED, NATR, OREX, LTM, FINL
Tue, Mar. 15, 7:35 AM
- Quickly rebounding from Takeda's exit, Orexigen Therapeutics (NASDAQ:OREX) inks a deal with Valeant Pharmaceuticals (NYSE:VRX) for the commercialization rights to Contrave, branded as Mysimba in the EU, in Central and Eastern Europe. The company will host a conference call this morning at 8:30 am ET to discuss the agreement.
Tue, Mar. 15, 7:28 AM
- Takeda Pharmaceutical Company's (OTCPK:TKPHF)(OTCPK:TKPYY) U.S. unit returns the rights to obesity pill CONTRAVE (naltrexone HCl/bupropion HCl) to Orexigen Therapeutics (NASDAQ:OREX). The transition back to Orexigen will take place over the next 180 days, during which Takeda will continue to market the product.
- Takeda's decision was based on its intent to focus on inflammatory bowel disease and major depressive disorder. CONTRAVE never gained traction, though. In Q4, it generated only $13M in sales.
- The FDA approved CONTRAVE in September 2014 for use as an adjunct to a reduced calorie diet and increased physical activity for chronic weight management in obese adults (body mass index > 30 kg/m2) or overweight adults (BMI at least 27 kg/m2) with at least one obesity-related comorbidity (e.g., hypertension, type 2 diabetes, high cholesterol).
- Previously: Orexigen books $2.6M in Contrave royalties in Q4 (Feb. 4)
Fri, Mar. 4, 9:44 AM
- Walgreens Boots Alliance (NASDAQ:WBA) upgraded to Buy from Neutral by Mizuho Securities. Price target raised to $75 (6% downside risk).
- Acceleron Pharma (NASDAQ:XLRN) upgraded to Buy from Neutral by Janney Capital. Price target lowered to $39 (39% upside) from $45.
- Keryx Biopharmaceuticals (NASDAQ:KERX) upgraded to Outperform from Market Perform by FBR Capital. Price target is $10 (145% upside).
- Zimmer Biomet Holdings (NYSE:ZBH) downgraded to Hold from Buy by Argus Research.
- Valeant Pharmaceuticals (NYSE:VRX) downgraded to Hold from Buy by Canaccord Genuity. Price target lowered to $75 (15% upside) from $125. Downgraded to Sector Perform from Outperform by RBC Capital. Price target lowered to $85 (31% upside) from $194.
- TeamHealth Holdings (NYSE:TMH) downgraded to Hold from Buy by Jefferies. Price target lowered to $65 (44% upside).
- McKesson (NYSE:MCK) downgraded to Neutral from Buy by Mizuho Securities. Price target lowered to $164 (1% upside).
- Diplomat Pharmacy (NYSE:DPLO) downgraded to Neutral from Overweight by JP Morgan. Price target lowered to $30 (9% upside) from $52.
- Rockwell Medical (NASDAQ:RMTI) downgraded to Hold from Buy by Stifel. $19 price target removed. Also downgraded to Hold from Buy by Craig-Hallum.
- China Biologic Products (NASDAQ:CBPO) downgraded to Neutral from Outperform by Credit Suisse. Price target raised to HK$129.
- Orexigen Therapeutics (NASDAQ:OREX) downgraded to Sector Perform from Outperform by RBC Capital. Price target lowered to $1 (43% upside) from $5.
- Vivus (NASDAQ:VVUS) downgraded to Sector Perform from Outperform by RBC Capital. Price target lowered to $1 (6% downside risk) from $4.
Fri, Feb. 26, 3:58 PM
- Achillion Pharmaceuticals (ACHN +7.4%) upgraded to Outperform from Neutral with a $10 (36% upside) price target by Baird
- Insulet (PODD +8.5%) upgraded to Buy from Hold with a $40 (25% upside) price target by Benchmark.
- DENTSPLY (XRAY -0.1%) upgraded to Neutral from Sell by UBS. Price target raised to $60 (1% downside risk) from $50.
- PTC Therapeutics (PTCT -29.4%) upgraded Hold from Underperform by Jefferies. Price target lowered to $12 (22% upside) from $18.
- AbbVie (ABBV -0.3%) upgraded to Buy from Neutral by Citigroup. Price target raised to $65 (16% upside) from $56.
- Wellcare Health Plans (WCG +0.7%) upgraded to Overweight from Neutral by JP Morgan. Price target raised to $114 (24% upside) from $80.
- Keryx Biopharmaceuticals (KERX +8.7%) downgraded to Neutral from Overweight by JP Morgan.
- Peregrine Pharmaceuticals (PPHM -62.1%) downgraded to Neutral from Buy with a $0.50 (25% upside) price target by Roth Capital.
- EXACT Sciences (EXAS -1.8%) downgraded to Neutral from Buy by Roth Capital and Equal Weight from Overweight by Stephens & Co.
- Radius Health (RDUS -2.8%) downgraded to Hold from Buy with a $37 (23% upside) price target by Jefferies.
- PTC Therapeutics (PTCT -29.4%) downgraded to Neutral from Buy by Citigroup. Price target lowered to $13 (56% upside) from $90.
- Orexigen (OREX -31.9%) downgraded to Market Perform from Outperform by Leerink Swann. Price target lowered to $2 (104% upside) from $4.50.
- Express Scripts (ESRX +2.4%) downgraded to Sell from Hold by Deutsche Bank. Price target lowered to $61(15% downside risk) from $93.
- Perrigo (PRGO) downgraded to Sell from Neutral by Goldman Sachs. Price target lowered to $124 (4% downside risk) from $160.
- Chimerix (CMRX -6.6%) downgraded to Neutral from Buy by Citigroup. Price target lowered to $9 (91% upside) from $13.
Fri, Feb. 26, 12:45 PM
Fri, Feb. 26, 7:01 AM
Thu, Feb. 25, 5:30 PM
Thu, Feb. 4, 11:16 AM
- In a regulatory filing, Orexigen Therapeutics (OREX +6.1%) discloses that commercialization partner Takeda Pharmaceutical (OTCPK:TKPHF)(OTCPK:TKPYY) sold $13M of obesity med Contrave (naltrexone HCl and bupropion HCl extended-release tablets) in Q4. Concurrently, OREX booked $2.6M in Contrave royalties in Q4.
- According to IMS Health, almost 186K Contrave prescriptions were filled in the quarter.
- The companies established their partnership in September 2010 to develop and commercialize Contrave in the U.S., Canada and Mexico. Takeda returned the rights for Canada and Mexico to Orexigen in July 2015.
- Previously: Takeda - Orexigen partnership on the rocks after CV outcomes study halted (May 13, 2015)
Mon, Jan. 11, 2:34 PM
- Orexigen Therapeutics (OREX -4.7%) announces its guidance for 2016. Key points:
- Cash inflows of $40M - 60M comprised of revenues and royalties from net sales of Contrave and Mysimba, a $15M milestone payment from Takeda and upfront payments for new commercial collaborations in new territories.
- $212M in quick assets starting the year.
- GAAP operating expenses of $105M - 115M.
- Total revenues through Q3 '15 were $19.5M.
Orexigen Therapeutics, Inc. is a biopharmaceutical company, which engages in the development of pharmaceutical product candidates for the treatment of obesity. Its product candidate, NB32, is an investigational medicine for weight loss and the maintenance of weight loss; and Empatic used for the... More
Industry: Drug Manufacturers - Other
Country: United States
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