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August 11, 2014
07:07 EDTRXDX, SNYIgnyta names Adrian Senderowicz as Chief Medical Officer
Ignyta (RXDX) announced that Adrian Senderowicz, M.D., has been appointed as Chief Medical Officer and SVP, Clinical Development and Regulatory Affairs. Senderowicz was most recently Vice President, Global Regulatory Oncology at Sanofi (SNY).
News For RXDX;SNY From The Last 14 Days
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September 30, 2014
16:39 EDTSNYCMS discloses drug makers' payments to doctors, WSJ says
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10:53 EDTSNYRegeneron dupilumab opportunity improved with new data, says Piper Jaffray
Piper Jaffray said it is increasingly optimistic about dupilumab's broad potential in allergic diseases following the Phase II data on chronic sinusitis with nasal polyps as well as prior data in atopic dermatitis and asthma. The firm views dupilumab as a potential blockbuster and reiterates its Overweight rating and $382 price target on Regeneron (REGN), which announced the data in partnership with Sanofi (SNY).
07:30 EDTSNYSachs Associates to hold a conference
14th Annual Biotech in Europe Forum for Global Partnering and Investment to be held in Basel, Switzerland on September 30-October 1.
05:16 EDTSNYRegeneron, Sanofi announce positive Phase 2 top-line dupilumab results
Regeneron Pharmaceuticals (REGN) and Sanofi (SNY) announced that a Phase 2a proof-of-concept study of dupilumab, an investigational therapy that blocks IL-4 and IL-13 signaling, met all primary and secondary endpoints in patients with moderate-to-severe chronic sinusitis with nasal polyps, or CSwNP, who did not respond to intranasal corticosteroids. In the study, dupilumab resulted in a statistically-significant improvement in the size of nasal polyps, as measured by endoscopic Nasal Polyp Score, the primary endpoint of the study. Statistically significant improvements in all secondary efficacy endpoints were also observed, including objective measures of sinusitis by CT scan, nasal air flow, and patient-reported symptoms. In a pre-specified exploratory analysis, dupilumab-treated patients who also had asthma demonstrated significant improvements in asthma control. The safety profile was consistent with previous studies. The most common AEs with dupilumab were injection site reactions, nasopharyngitis, oropharyngeal pain, epistaxis, headache and dizziness.
September 28, 2014
12:56 EDTRXDXIgnyta announces interim data from RXDX-101 Phase I clinical trial
Ignyta announced that interim results from the first-in-human ALKA-372-001 Phase I clinical trial of RXDX-101, the company’s proprietary oral tyrosine kinase inhibitor targeting solid tumor indications, were presented in a poster discussion session at the 2014 Congress of the European Society for Medical Oncology in Madrid, Spain. “We continue to be encouraged by the data we have seen to date from this Phase I clinical trial of RXDX-101, which has shown promising signs of antitumor activity and no dose-limiting toxicities,” said Jonathan Lim, M.D., Chairman and CEO of Ignyta. “We recently observed our first complete response in the study, in a patient with ROS1-positive non-small cell lung cancer after two cycles of treatment. We have now also seen a total of five partial responses in patients with each of TrkA, ROS1 and ALK alterations and across three different tumor histologies, and another two patients with prolonged stable disease.” “We are also in the early stages of dose escalation in evaluating two alternate dosing schedules in this clinical trial,” Dr. Lim continued. “Between those evaluations and the continuous daily dosing schedule we are assessing in our recently-initiated STARTRK-1 Phase I clinical trial of RXDX-101 under our U.S. IND, we are making solid progress toward the determination of a recommended Phase II dose of RXDX-101.”
September 24, 2014
17:01 EDTSNYMannKind announces closing of global licensing agreement with Sanofi
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08:10 EDTSNYSanofi unit announces research collaboration
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September 23, 2014
09:00 EDTSNYBofa/Merill special situations team to hold an analyst/industry conference call
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September 22, 2014
07:21 EDTSNYEBD Group to hold a conference
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September 19, 2014
10:13 EDTRXDXIgnyta management to meet with Leerink
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