The “quality and robustness” of the data Seattle Genetics reported from the successful Phase III Ecehlon-2 study, which assesses the safety and efficacy of Adcetris plus a three-drug chemotherapy regimen versus the standard of care four-drug chemotherapy regimen in frontline mature T-cell lymphomas, represent the “best case scenario,” William Blair analyst Andy Hsieh tells investors in a research note. The analyst highlights that the indication was approved 11 days after Seattle Genetics submitted the regulatory application to the FDA, which took advantage of the Real-Time Oncology Review Program. He believes Adcetris will be “quickly adopted” in the frontline mature T-cell lymphoma setting, a $400M market in the United States alone. The analyst keeps an Outperform rating on the shares.
Tuesday, December 4, 2018
Clovis upgraded to Outperform after favorable EU patent ruling at Leerink
Leerink analyst Andrew Berens upgraded Clovis Oncology (CLVS) to Outperform from Market Perform after the European Patent Office upheld claims of a European patent on Rubraca. He said the finding of inventiveness in Europe strengthens his confidence in the U.S. patent estate and removes a near-term intellectual property overhang on Clovis shares. Berens now sees a 50% chance of branded exclusivity through 2023 in the U.S. in the “worst case” and through 2031 in the “best case.” He also said Glaxo’s (GSK) acquisition of competitor Tesaro (TSRO) brings a “return of optionality” to Clovis shares. Berens raised his price target on Clovis to $40 from $22.
Veeva slides after short-seller Citron puts $65 target on shares
Shares of Veeva Systems (VEEV) are under pressure after short-seller Citron Research said that market correction should hit the stock “harder than any other SaaS” peer and put a $65 price target on the shares. This morning, Leerink analyst David Larsen started coverage of Veeva with an Outperform rating and $120 price target. MARKET CORRECTION TO HIT VEEVA HARD: In a tweet, Andrew Left’s Citron Research said that, “[Veeva] price target $65. Competition has arrived as multiple is at peak and short interest at low. Same setup as [Nvidia] $NVDA at $280. A market correction will hit $VEEV harder than any other SaaS name. Buyout off the table until $40.” LEERINK SAYS BUY: In a research note this morning, Leerink’s Larsen initiated coverage of Veeva Systems with an Outperform rating and $120 price target, citing a significant number of tailwinds, earnings growth and potential. The analyst told investors that he likes how the company has leading market share in the “very attractive” Life Sciences space, and noted that the breadth of solutions in Veeva’s portfolio seems vast, high quality, and is growing. While Veeva is best known for its customer relationship management platform, Larsen likes how the company is expanding into the Electronic Data Capture market, as well as consumer packaged goods and other areas outside of Life Sciences. Further, Veeva has consistently posted “excellent” top-line growth and operating margins are “impressive” and continue to expand, he contended, adding that he likes how the management team is experienced and proven. PRICE ACTION: In afternoon trading, shares of Veeva Systems have dropped about 5% to $94.37.
AbbVie Phase 3 study shows significantly prolonged progression-free survival
AbbVie shared results from the ECOG-ACRIN Cancer Research Group, National Cancer Institute-sponsored, Phase 3 study evaluating Imbruvica plus rituximab versus the current National Comprehensive Cancer Network guidelines Category 1 treatment of fludarabine, cyclophosphamide and rituximab in previously untreated younger patients with chronic lymphocytic leukemia, CLL, and small lymphocytic lymphoma, SLL. This interim analysis showed that Imbruvica plus rituximab significantly prolonged progression-free survival, the primary endpoint of the study, compared to FCR, with a 65% reduction in risk of progression or death. Furthermore, Imbruvica plus rituximab significantly improved overall survival compared to FCR. The findings were presented today during the Late-Breaker abstract oral session at the 2018 American Society of Hematology, or ASH, Annual Meeting.
Aridis Pharmaceuticals granted Fast-Track, QIDP tags for cystic fibrosis med
Aridis Pharmaceuticals announced that the Cystic Fibrosis Foundation has more than doubled its research agreement for the clinical development of AR-501 from $2.9M to up to $7.5M. Aridis also announced that the U.S. Food and Drug Administration has granted both Fast-Track Designation and Qualified Infectious Disease Product Designation for AR-501. Additionally, the FDA cleared AR-501’s Investigational New Drug Application and the company intends to initiate the Phase 1/2a clinical trial next month.
Revance Therapeutics’ Botox rival succeeds in late-stage trial
A potential rival for Allergan Plc’s blockbuster Botox has passed a late-stage study, putting drug developer Revance Therapeutics Inc on course to file for U.S. marketing approval next year.
Revance shares climbed as much as 13 pct to $23.60 on Tuesday.
More than 95 percent of patients administered with Revance’s long-acting neuromodulator injection RT002 were found to have none or mild frown lines after four weeks, according to data from the third late-stage study.
The treatment, which requires two or less doses a year, was effective in maintaining reduced wrinkle severity in patients for a median duration of 24 weeks.
Revance Chief Executive Dan Browne said on a conference call the treatment, if approved, could receive a 24-week label.
Analysts have noted that patients are keen on long-lasting alternatives as opposed to treatments like Botox, which is labeled to be administered in 12-16 week or longer intervals.
Revance said the market for nerve activity regulating neuromodulators, which recorded total global sales of $4 billion in 2017, remains underpenetrated as currently available products do not address patient need for long-term results.
Revance’s treatment, which has a six-month median duration of effect, provides a meaningful advantage over competitive products such as Botox, analysts said.
The trial lessened some concerns investors had with respect to repeat dosing, SunTrust Robinson Humphrey analyst John Boris said in a note.
“Data was in-line with our expectations and supports premium pricing for RT002 when it’s launched in 2020,” said Boris, who expects the drug to bring in sales of $400 million in 2023.
Separately, Revance signed a license deal with China’s Fosun Pharma, covering exclusive rights to develop and commercialize RT002 in mainland China, Hong Kong and Macau.
According to the deal, Revance will receive an upfront payment of $30 million and is eligible to receive additional milestone payments of up to $230.5 million, besides tiered low-double-digit to high-teen royalty payments on future net sales.
Monday, December 3, 2018
Amgen 1st-In-Human Data Evaluating Immunotherapies At ASH 2018
of Amgen’s BiTE® Platform in Heavily Pre-Treated Patients With Multiple Myeloma and Acute Myeloid Leukemia
FDA Grants Fast Track Designation for AMG 420
Amgen (NASDAQ:AMGN) today announced the first clinical results from studies evaluating investigational novel bispecific T cell engager (BiTE®) immunotherapies AMG 420 and AMG 330. In two separate Phase 1 dose escalation studies, AMG 420, which targets B-cell maturation antigen (BCMA), and AMG 330, which targets CD33, provided early evidence of tolerability and anti-tumor activity in patients with relapsed and/or refractory multiple myeloma and relapsed or refractory acute myeloid leukemia (AML), respectively. These data were highlighted during oral presentations at the 60thAmerican Society of Hematology (ASH) Annual Meeting & Exposition in San Diego.
BiTE® antibody construct technology, pioneered by Amgen, is an innovative treatment approach that helps the body’s immune system attack cancer cells without the removal of immune cells from the patient. Amgen is studying a number of “off-the-shelf” investigational BiTE®immunotherapies, with distinct targets, across a range of hematologic and solid tumors.
“Building on our success with the only approved BiTE® immunotherapy available for patients, Amgen is emphasizing our commitment to the potential of this platform by advancing the development of approximately a dozen novel molecules across hematologic and solid tumor targets in hopes of continuing to offer meaningful advances to patients in need,” said David M. Reese, M.D., executive vice president of Research and Development at Amgen. “We’re encouraged by the early results of investigational BiTE® immunotherapies AMG 420 and AMG 330, especially when considered in the context of these heavily pre-treated patients, many of whom have run out of available options. We look forward to sharing more results from our BiTE® pipeline at future medical meetings.”
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