Chelsea Therapeutics International, Ltd.NASDAQ
Oct. 20, 2014, 8:27 AM
- In two Phase 2a clinical trials, privately-held Genervon Biopharmaceuticals' drug candidate for Amyotrophic Lateral Sclerosis (ALS), GM6 (known as GM604 in the ALS trial and GM608 in a Parkinson's disease study), showed encouraging disease-modifying results albeit in a small number of patients.
- In the ALS study, GM604 significantly reduced the decline in ALSFRS-R versus the historical control (p=0.0047). Seven of eight patients has their ALS disease progression slowed or stopped at week 12 after six doses of GM604. Five of seven treated patients had their forced air capacity (FVC) disease progression slowed or reversed at week 12 compared to historical placebo (-11.5% compared to -4.7% after treatment).
- In the Parkinson's study, the difference in the treated patients' UPDRS scores versus historical placebo at week 12 were statistically significant (p=0.0085). Changes in secondary clinical outcomes measures at week 2 were statistically significant at the one-tailed 10% level for four of eight patients.
- Genervon has submitted these results to the FDA for guidance on how to make GM6 available for ALS and PD patients. GM604 for ALS has been designated Fast Track and an Orphan Drug by the FDA.
- ALS-related tickers:(NYSEMKT:CUR) (NASDAQ:BCLI) (NASDAQ:MNOV) (NASDAQ:BIIB) (NASDAQ:CYTK)
- PD-related tickers: (NASDAQ:ACOR) (Pending:CVTS) (NASDAQ:ACAD) (OTCQX:CYNAF) (NASDAQ:IPXL) (OTCQB:TTNP) (OTCQB:SGTH) (NYSE:TEVA) (NASDAQ:ADMS) (NASDAQ:PRAN) (NASDAQ:CHTP) (NASDAQ:PRTA) (NASDAQ:FOLD) (NASDAQ:AVNR) (NYSE:BSX) (NYSE:MRK)
Jun. 6, 2014, 7:37 AM
- The waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 has expired pertaining to Lundbeck's planned acquisition of Chelsea Therapeutics (CHTP). It will acquire Chelsea for $6.44/share plus on contingent value right for up to $1.50/share for an aggregate of $658M on a fully diluted basis.
- The expiration of the waiting period satisfies one of the conditions necessary for the closing of the offer and merger.
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)
May 8, 2014, 8:00 AM
Mar. 13, 2014, 1:58 PM
Mar. 11, 2014, 4:55 PM
- Chelsea Therapeutics International, Ltd. (CHTP): Q4 EPS of -$0.07 in-line.
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, 5:09 PM
- The FDA confirms it approved Chelsea Therapeutics' (CHTP) Northera capsules for the treatment of neurogenic orthostatic hypotension.
- Northera will contain a boxed warning to alert doctors and patients about applicable risks, and the package insert indicates that effectiveness beyond two weeks of treatment has not yet been demonstrated, but there's no restriction on prescription use.
- CHTP calls the approval "an extraordinary achievement."
- Shares to resume trading at 5:25.
Feb. 18, 2014, 4:49 PM
Feb. 18, 2014, 9:13 AM
Feb. 14, 2014, 7:07 PM| Feb. 14, 2014, 7:07 PM | 15 Comments