Thu, Jul. 21, 8:31 AM
Thu, Apr. 21, 8:48 AM
Tue, Feb. 9, 8:46 AM
Dec. 22, 2015, 10:12 AM
- The FDA approves Actelion Pharmaceuticals' (OTCPK:ALIOF)(OTCPK:ALIOY) Orphan Drug-tagged selexipag tablets, branded as Uptravi, for the treatment of adults with pulmonary arterial hypertension (PAH), high blood pressure that occurs in arteries that connect the heart to the lungs.
- Uptravi is eligible for a seven-year period of market exclusivity for the indication as afforded under Orphan Drug status.
- The company submitted its Marketing Authorization Application (MAA) in Europe a year ago.
- Selexipag, licensed from Nippon Shinyaku, is a selective prostacyclin receptor (IP receptor) agonist. Prostacyclin activates the IP receptor which induces the dilation of the blood vessels while inhibiting the proliferation of vascular smooth muscle cells.
- Previously: Actelion submits MAA for pulmonary hypertension drug (Dec. 3, 2014)
Sep. 10, 2015, 5:28 PM
- With ZS Pharma (NASDAQ:ZSPH) surging 28% today as investors bought in with takeover on their minds, Actelion Pharmaceuticals (OTCPK:ALIOY +2.5%) has confirmed it's started preliminary talks with ZS.
- ZS Pharma shares were up this morning, surged again after 2:20 p.m. today and were halted for news after the close.
- Earlier, the company canceled its presentation and one-on-ones at a Citi investor conference, stoking memories of Kythera's similar cancellation prior to an acquisition several months ago.
- More than 6.7M shares traded hands today against a daily average of about 439K.
- Updated with ZS Pharma's 5:31 p.m. statement: "ZS Pharma today confirmed that it has participated in preliminary discussions with Actelion Ltd. regarding a potential strategic transaction. ZS Pharma regularly and routinely explores opportunities with various strategic partners and will continue to do so. These discussions may or may not lead to any transaction."
Jun. 7, 2015, 4:55 PM
- Shire (NASDAQ:SHPG) is weighing a £12.4B takeover of Swiss rival Actelion (OTCPK:ALIOF, OTCPK:ALIOY).
- Actelion, which makes treatments for rare diseases, has rebuffed the overture, which has been going on for a few weeks.
- Source: The Sunday Times
- Previously: Shire finalizes takeover of NPS Pharma (Feb. 25)
- Previously: Shire gobbles up privately-held pharma firm (Feb. 24)
Mar. 26, 2015, 8:08 AM
- The Japanese Ministry of Health, Labour and Welfare approves Actelion's (OTCPK:ALIOF) (OTCPK:ALIOY) Opsumit (macitentan) for the treatment of pulmonary arterial hypertension (PAH). The approval was based on the results in the SERAPHIN Phase 3 trial that showed patients treated with macitentan 10 mg per day experienced a 45% risk reduction (p<0.0001) of the composite morbidity-mortality endpoint compared to placebo.
- The company will co-promote Opsumit in Japan with Nippon Shinyaku.
- Opsumit was cleared by the FDA in October 2013 and by the European Commission (EC) in December 2013.
Jan. 7, 2015, 10:41 AM
- Arena Pharmaceuticals (ARNA +33.4%) jumps on higher volume in early trading in response to its report of a dose-dependent effect on lymphocyte count lowering for APD334 in a Phase 1b trial.
- Mean decreases in lymphocyte count in blood from baseline were as high as 69%. Counts recovered from baseline, on average, within one week of cessation of dosing. Lymphocyte lowering has been shown to correlate with clinical efficacy in Phase 2 and 3 trials of other S1P1 modulators in multiple sclerosis, psoriasis and ulcerative colitis.
- APD334 is an oral drug that targets the sphingosine 1-phosphate subtype 1 (S1P1) receptor for the potential treatment of autoimmune diseases. The company plans to proceed to Phase 2 development.
- Related tickers: (OTCPK:ALIOF) (OTC:ALIOY) (NYSE:GSK) (OTCQX:RHHBY)
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. 24, 2014, 8:40 AM
- Tetraphase Pharmaceuticals (NASDAQ:TTPH) is reportedly considering selling itself after being approached by interested suitors. Sources say the acquirer could be Acetelion (OTCPK:ALIOF) (OTC:ALIOY) or Roche (OTCQX:RHHBY).
- The attraction is Tetraphase's antibiotic eravacycline, currently in Phase 3 development. Both oral and IV formulations of the drug have demonstrated higher dose response rates than Johnson & Johnson's (NYSE:JNJ) Levaquin (levofloxacin) for the treatment of complicated urinary tract infections. In the Ignite-2 study, patients receiving 200 mg eravacycline IV-to-oral doses achieved a response rate of 70.8% while patients receiving 250 mg IV-to-oral doses achieved 64.3%, both significantly ahead of Levaquin's 52.2% response rate.
- A trial comparing eravacycline to Merck's (NYSE:MRK) Invanz (ertapenem) for the treatment of complicated intra-abdominal infections is underway.
- TTPH is up 18% premarket on light volume.
- Previously: Tetraphase completes eravacycline Phase 3 enrollment
Aug. 13, 2014, 1:25 PM
- Shares of InterMune (ITMN +14.3%) spike on a 2x surge in volume in response to rumors that Roche (OTCQX:RHHBY +0.4%), Sanofi (SNY +0.7%), Glaxo (GSK -0.1%) and Actelion (OTCPK:ALIOF) (OTC:ACIOY) are preparing offers. Trading in ITMN shares was halted briefly at 1:00 pm EDT due to abnormal volatility.
Apr. 29, 2014, 8:00 AM
- Intermune (ITMN) is the latest pharmaceutical company to be linked with merger news, with the Betaville blog reporting that the firm is the subject of takeover interest from Actelion (ALIOF) and Sanofi (SNY).
- Actelion has apparently lined up $3-4B in financing from several banks, including JPMorgan.
- Intermune shares are +1.8% premarket; its market cap is $3.02B as of yesterday's close.
Dec. 24, 2013, 12:12 PM
- The European Commission has approved Actelion's (ALIOF +1.6%) Opsumit for PAH as a monotherapy or in conjunction with other PAH treatments. (PR)
- The FDA approved the drug in October.
- As FierceBiotech notes, the approvals should give the company a bit of a cushion as Tracleer goes off patent in 2015.
Nov. 21, 2013, 7:48 AM
- AstraZeneca (AZN) may be interested in buying Actelion (ALIOF), Citi says, in a note that sent shares of the Swiss biotech surging in overseas trade.
- Here's the actual quote (via Reuters): "Creative corporate finance
... coupled with 'long runway' acquisitions such as Actelion could provide a useful bridge to organically fueled growth."
- Citi thinks the deal would boost operating profits by double-digits for AZN.
Oct. 18, 2013, 4:21 PM
- The FDA has approved Actelion's (ALIOF.PK) dual endothelin receptor antagonist Opsumit for the treatment of pulmonary arterial hypertension.
Actelion Pharmaceuticals Ltd is a biopharmaceutical company headquartered in Allschwil/Basel, Switzerland, that focuses on the discovery, development and commercialization of innovative treatments to serve high unmet medical needs.
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