May 8, 2014, 12:48 PM
May 8, 2014, 9:16 AM
May 8, 2014, 8:36 AM
- By acquiring Chelsea Therapeutics (CHTP), Lundbeck (HLUKF) gains the rights to Chelsea's Northera treatment for neurogenic orthostatic hypotension, a disease that is associated with neurological disorders such as Parkinson's.
- Northera recently won FDA approval and is due to be launched later this year.
- Lundbeck's offer of $7.94 a share comprises $6.44 a share in cash and up to $1.50 of contingent value rights (CVRs) that will be related to Northera's commercial performance.
- The transaction is expected to close in Q3.
- Chelsea Therapeutics' shares are +32% at $6.60. (PR)
Mar. 13, 2014, 1:58 PM
Feb. 19, 2014, 12:45 PM
Feb. 19, 2014, 9:38 AM
- Deutsche Bank raises its price target for Chelsea Therapeutics (CHTP) to $8 following the FDA's approval of the company's Northera treatment. Needham ups its target to $10.
- Shares are surging 33% to $6.61.
- The drug is indicated for preventing sudden drops in blood pressure, which can lead to dizziness and fainting, in patients with neurogenic orthostatic hypotension, a disease that is associated with neurological disorders such as Parkinson's.
- Wedbush analyst Liana Moussatos expects the company to explore partnerships or to even be acquired, although it could launch Northera on its own. Moussatos estimates that the treatment could generate $430M in global peak sales.
- The FDA authorized Northera on an "accelerated basis", which means patients will get access to it while the company carries out a post-market study of 1,400 people to see whether Northera has a durable effect - efficacy beyond two weeks has yet to be demonstrated.
Feb. 19, 2014, 9:13 AM
Feb. 18, 2014, 5:35 PM
Feb. 18, 2014, 9:13 AM
Feb. 14, 2014, 7:07 PM| Feb. 14, 2014, 7:07 PM | 15 Comments
Feb. 14, 2014, 4:10 PM
- With nervous Chelsea Therapeutics (CHTP -4%) still awaiting word from the FDA on Northera, Deutshce Bank's Robyn Karnauskas sees fair value for the stock in the $8-$9 range if the drug is approved and - more or less - $0 for the shares if declined.
- Her team is modeling market share of 50% and peak sales of about $550M worldwide. Possibly higher market share and peak sales of about $780M could bring the stock up to the $12-$13 area.
- Cash on the balance sheet in the case of non-approval is $21M, or $0.27 per share.
Feb. 12, 2014, 10:29 AM
- Chelsea Therapeutics (CHTP +2.6%) is 70% likely to win FDA approval Friday for its Northera treatment of neurogenic orthostatic hypotension, Adam Feuerstein predicts, adding that there's a small chance of a delay given the short time period between Friday's approval decision date and last month's positive advisory panel.
- A Northera approval would be good news as long as the FDA doesn't saddle the drug with significant use restrictions; an FDA-approved label which says Northera should not be used longer than a week or two would be a disappointment.
Jan. 15, 2014, 9:40 AM
- The sell-side continues to weigh in on Chelsea Therapeutics (CHTP +125.2%) following Thursday's Northera panel.
- Deutsche's Robyn Karnauskas lifts her target to $5 from $4, but notes the FDA could still decide against approval. Fair value is $8-9 assuming approval.
- Meanwhile, Wedbush is out reiterating an Outperform rating and an $8 target. "Our impression was that the panel came to appreciate the vagaries of clinical trials for neurological disorders—especially in orphan diseases like NOH," analyst Liana Moussatos says.
Jan. 15, 2014, 9:11 AM
Jan. 15, 2014, 7:50 AM
- Shares of Chelsea Therapeutics (CHTP) look set for a spectacular session on the back of Tuesday's positive Ad Com for Northera.
- The company says it is "appreciative of the FDA bringing [the] Northera NDA before the Cardiovascular and Renal Drugs Advisory Committee, and for the Committee's thoughtful discussion of the application." (PR)
- Needham says the vote "represents a meaningful reduction in risk to the potential commercialization of Northera."
- Analyst Alan Carr lifts his price target on the shares to $8 from $4. Carr does say that "a degree of caution may [still] be prudent until the FDA responds, however, given strength of regulatory opposition to the drug to date."
- CHTP +160% premarket
Jan. 10, 2014, 1:19 PM
- Wedbush is out in defense of Chelsea Therapeutics (CHTP -31.3%) amid a steep sell-off triggered by the release of Northera briefing docs.
- "The reviewers brought up no material new arguments against approval, in our view," analyst Liana Moussatos says, adding that "the previous panel recommended approval (7-4) —so we anticipate the panel on January 14th is likely to also recommend approval."
- Price target is $8.
Chelsea Therapeutics International, Ltd., is a pharmaceutical company focused on acquisition, development and commercialization of pharmaceutical products for the treatment of a variety of human diseases.
Country: United States