Today - Thursday, December 12, 2013
5:00 PMCoronado Biosciences +12.4% AH on interim CNDO-201 study
- Coronado Biosciences (CNDO) shares jump 12.4% AH after the company releases interim data for a pilot study of oral CNDO-201 to treat autism.
- In the first 5 patients that completed the double-blind, randomized, placebo-controlled cross-over study, a statistically significant separation from the placebo in favor of CNDO-201 was demonstrated in 3 measures of the disease. Treatment was well tolerated, the study found.
- The study is ongoing and final results are expected in mid-2014.
4:34 PMMerck gets FDA nod for allergy drug| Comment!
4:11 PMXOMA -4.5% AH, to sell shares in follow-on| Comment!
2:14 PMStates ask FDA to reconsider approval of Zogenix painkiller
- More than two dozen state prosecutors send a letter to the FDA asking the agency to reconsider its approval of the new Zogenix (ZGNX +3%) painkiller Zohydro, saying the narcotic pill could add to the national epidemic of prescription drug abuse.
- The FDA approved Zohydro in October, making it the first single-ingredient hydrocodone drug ever cleared for U.S. patients; the pill uses an extended release formulation reportedly 5x-10x more potent than currently available hydrocodone combination pills such as Vicodin.
- ZGNX has said it is working on a version of the drug that is more difficult to abuse.
1:30 PMMiMedx up 7% on expanding EpiFix Medicare coverage
- MiMedx Group (MDXG +7%) charges ahead after its wound care allograft EpiFix receives coverage from Medicare contractor CGS. The move brings coverage from Medicare Administrative Contractors to six of eight, and 86% of Medicare beneficiaries will now be eligible for coverage for EpiFix products.
- Press release
11:49 AMHerbalife and Google Trends
- Reiterating his Buy rating and $92 price target on Herbalife (HLF +0.4%) analyst Tim Ramey has some fun with Google Trends.
- Searches for the term "my Herbalife" are off the charts - notable since myherbalife.com is the portal for distributors. The broader search term "Herbalife" is less "growthy," but also shows strong gains.
- Also notable: Searches for "Herbalife Ackman" - after a spike about a year ago amid the presentation of his short thesis - have disappeared.
10:18 AMKindred prices IPO in middle of expected range
- Kindred Biosciences (KIN) prices its 7.5M share IPO at $7 each, the middle of the expected $6-$8 range.
- From IPOdesktop's IPO preview: KIN is a development stage biopharmaceutical company focused on saving and improving the lives of pets ... KIN's lead product candidates are CereKin for the treatment of osteoarthritis pain and inflammation in dogs; AtoKin for the treatment of atopic dermatitis in dogs; and SentiKin for the treatment of post-operative pain in dogs."
9:59 AMSarepta pops amid Duchenne policy forum| 1 Comment
9:46 AMFDA advisory panel partially backs Bristol-Myers drug for rare fat disorder
- An FDA advisory panel says Bristol-Myers Squibb (BMY -0.1%) had provided adequate evidence of the benefits of the metreleptin experimental drug to treat rare and potentially fatal disorders involving loss of body fat.
- However the panel felt the risks of the medicine were too high to recommend it for metabolic disorders associated with partial lipodystrophy, such as diabetes and high triglycerides inadequately controlled by a current therapy.
- BMY and co-developer AstraZeneca(AZN +0.3%) say they are confident in the safety and efficacy data provided to the agency for both indications discussed by the panel.
8:57 AMSynta Pharma offers positive ganetespib interim results, +15% premarket
- Synta Pharmaceuticals (SNTA) +15% premarket after announcing "positive" Interim results from the ENCHANT-1 trial of ganetespib in metastatic breast cancer at a breast cancer symposium.
- Early results demonstrated the drug is clinically active as a single-agent in both HER2+ and triple-negative metastatic breast cancers, SNTA says.
8:30 AMBoston Scientific’s Watchman wins FDA panel’s backing, shares +3.7%
- Boston Scientific (BSX) +3.7% premarket after its Watchman device won the backing of an FDA advisory panel yesterday for use as a treatment to prevent strokes in people with irregular heartbeats.
- Watchman failed to prevent stokes as well as the standard treatment using the blood-thinner warfarin, but the panel said the similar results between the two didn’t carry as much weight as total long-term data; the panel also heard from patients who praised its convenience compared with the bleeding risks of blood thinners.
- The market for devices to close the left atrial appendage may total $400M, and Watchman may generate $162M in worldwide sales in 2017, Wells Fargo says.
8:13 AMCentene to buy 68% stake in home health care provider for $200M
- Centene (CNC) agrees to acquire a ~68% interest in U.S. Medical Management, a provider of in-home health services, for $200M in cash and stock as it continues to expand its stable of services.
- In conjunction with the deal, CNC also is forming a new healthcare enterprise holding company that will connect it and other health solution providers.
- CNC expects the deal to add $0.02-$0.05 to EPS next year and $0.20-$0.25 in 2015, and add annual revenue of $220M-$240M.
7:42 AMTetraLogic prices IPO
- TetraLogic Pharmaceuticals (TLOG) prices its 7.15M share IPO at $7 per share. The underwriter greenshoe option is for 1.0725M shares.
- From IPOdesktop's IPO preview: A clinical-stage biopharmaceutical company, TetraLogic is focused on discovering and developing novel small molecule therapeutics that mimic Second Mitochondrial Activator of Caspases, or SMAC-mimetics, and are designed to cause or enable abnormal cells that are resistant to the body's immune system to self-destruct.
- The company currently has no revenue and no collaboration partners.
7:21 AMAetna provides EPS that's above consensus
- Aetna forecasts 2014 EPS of $6.25, above Street expectations of $6.22.
- Revenues are seen at $53B, below consensus of $55.6B.
- The company reiterated that it expects 2013 EPS of $5.80-5.90 vs consensus of $5.87.
- Aetna provided the guidance ahead of an investor day today.
- Leerink Swann analyst Ana Gupte said he expects commercial margins to be resilient in 2014.
- Regarding Medicare plans, Gupte says: "Aetna, which priced for share gains in 2013 by significantly lowering both premiums and out-of pocket maximums, is seen pricing conservatively in 2014." (8-K)
Wednesday, December 11, 2013
5:47 PMProthena +5.3% AH, inks collaboration deal with Roche for Parkinson's antibodies
- Prothena (PRTA) shares jump 5.3% AH after the company enters a worldwide collaboration deal with Roche to develop and commercialize antibodies targeting alpha-synuclein, including PRX002, Prothena's Parkinson's treatment (expected to enter Phase I trials in 2014).
- In the U.S., the companies will share all development and commercialization costs, as well as profits, on a 70%-30% basis in favor of Roche. Outside America, Roche will have sole development responsibility and pay Prothena "up to double-digit royalties."
- Under the agreement, Prothena will receive an upfront payment of $45M, with the company eligible for additional payments of up to $380M contingent on development/sales milestones and up to $175M in ex-U.S. commercial milestone payments.
5:38 PMGenVec +23.6% AH after RAC approves initiation of CGF166 phase I study
- GenVec (GNVC) shares spike 23.6% AH after the company discloses the National Institutes of Health's Recombinant DNA Advisory Committee unanimously approved the initiation of a Phase I study of CGF166, an adenoviral vector engineered to express the atonal gene in patients with severe hearing loss. (8-K)
- CGF166 uses GenVec's adenovectors tech and is being developed by the Novartis Institute for Biomedical Institute under a research collaboration and license agreement with GenVec.
- An investigational new drug application is expected to be filed in Jan.
4:58 PMathenahealth stumbles on weak 2014 outlook
- athenahealth (ATHN) reaffirms its FY13 outlook and provides guidance for FY14.
- FY13: Adjusted EPS of $1.05-1.15 on revenue of $580-615M.
- FY14: Adjusted EPS of $0.98-1.10 on revenue of $725-755M.
- Consensus for 2014 is $1.38/share on sales of $765.28M.
- CFO Tim Adams is "very excited about growth opportunities and [is] pleased to present an ambitious financial plan for fiscal year 2014." (PR)
- Investors don't seem so excited: ATHN -12% AH.