Oct. 6, 2014, 12:46 PM
Oct. 6, 2014, 9:16 AM| Oct. 6, 2014, 9:16 AM
Oct. 6, 2014, 8:37 AM
- Actavis (NYSE:ACT) acquires Durata Therapeutics (NASDAQ:DRTX) for $675M ($23/share) in cash and contingent value rights entitling the holder to receive up to an additional $5 per share if certain Dalvance (dalbavancin)-related regulatory or commercial milestones are met. Actavis expects the acquisition to be accretive by the end of the first year.
Oct. 3, 2014, 12:45 PM
Oct. 3, 2014, 9:10 AM
- The FDA approves the Phase 3 clinical trial protocol for Durata Therapeutics' (NASDAQ:DRTX) Dalvance (dalbavancin). The study design will compare a single 1500 mg IV dose of dalbavancin to linezolid. Patients randomized to linezolid can switch to oral therapy after an initial period of IV treatment. All patients will also receive a single IV dose of azithromycin.
- Durata CMO Michael Dunne, M.D., says, "The Special Protocol Agreement ensures alignment of the trial objectives with the FDA and helps to delineate the path to registration. If successful, Dalvance would provide a single-dose treatment alternative for patients with community acquired pneumonia effective against the most common bacterial respiratory pathogens, including those resistant to other classes of antibiotics."
- DRTX shares are up 10% premarket on light volume.
Aug. 22, 2014, 8:02 PM
- Durata Therapeutics (NASDAQ:DRTX) exercised its right to defer the $25M milestone payment due Pfizer (NYSE:PFE) that was triggered by the first commercial sale of Dalvance (dalbavancin). The milestone was established in 2009 as part of Durata's acquisition of Vicuron Pharmaceuticals from Pfizer.
- In lieu of the cash payment, Durata delivered a $25M promissory note to Pfizer that bears 10% interest compounded annually and matures on July 7, 2019.
Aug. 7, 2014, 9:21 AM
- Durata Therapeutics (NASDAQ:DRTX) Q2 results: Revenues: $0; Operating Loss: ($18.8M) (-4.4%); Net Loss: ($17.9M) (+4.8%); Loss Per Share: ($0.67) (+10.7%); Quick Assets: $34.7M (-42.0%).
- No guidance given.
Aug. 7, 2014, 7:36 AM
- Durata Therapeutics (NASDAQ:DRTX): Q2 EPS of -$0.57 beats by $0.10.
Aug. 6, 2014, 7:46 PM
- The FDA clears The Medicines Company's (MDCO +0.5%) Orbactiv (oritavancin) for the treatment of acute bacterial skin and skin structure infections ((ABSSSI)) under its Priority Review process.
- Orbactiv is the third antibiotic approved this year for ABSSSI. The agency cleared Dalvance (dalbavancin) in May and Sivextro (tedizolid) in June.
- Related tickers: (DRTX -2%) (CBST -1.1%)
Aug. 4, 2014, 3:39 PM
- Shares of Durata Therapeutics (DRTX +18.8%) pop on a 4x surge in volume as the market comes around to the potential upside of its dalbavancin license deal with Angelini. The Italian firm will commercialize the antibiotic in 36 countries. Durata will receive a $15M upfront payment and another $10M upon EMA approval plus milestones.
Aug. 4, 2014, 12:47 PM
Jul. 30, 2014, 12:17 PM
- Durata Therapeutics (DRTX +1.8%) subsidiary Durata Therapeutics International B.V. enters into a license and supply agreement with Angelini to commercialize dalbavancin in 36 countries, including Russia, Italy, Spain and Poland.
- Under the terms of the agreement, Durata will receive an upfront payment of $15M and another payment of $10M upon EMA approval. It will also be eligible for milestone payments and royalties on sales.
- The MAA for dalbavancin is currently under EMA review. A decision is expected in 1H 2015.
Jul. 18, 2014, 9:52 AM
- Durata Therapeutics' (DRTX +0.8%) Dalvance (dalbavancin) is now available in the U.S. as a treatment for adult patients with acute bacterial skin and skin structure infections ((ABSSSI)). The company began shipping the antibiotic to distributors this week.
- The FDA approved Dalvance on May 23 as a Qualified Infectious Disease Product.
Jun. 13, 2014, 4:45 PM
May 27, 2014, 12:47 PM
May 27, 2014, 9:11 AM