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Fly News Breaks for January 21, 2020
Jan 21, 2020 | 09:04 EDT
As previously reported, SVB Leerink analyst Mani Foroohar initiated coverage of Arrowhead (ARWR) with an Underperform rating and $32 price target. The analyst notes that safety profile and regulatory path for lead asset ARO-AAT remains uncertain, and competitor data from Vertex (VRTX) is an existential threat to the program. Non-dilutive financing and potential royalties from the Johnson & Johnson (JNJ) partnership are more than fully valued at current levels, he adds. With a tough catalyst path and current valuation baking in substantial technology value despite very few patient-years of exposure to the TRiM platform, Foroohar sees the next 12 months as far more challenging than the past two years as Arrowhead faces sky-high expectations in the face of increasingly clear competitive headwinds.
News For ARWR;VRTX;JNJ From the Last 2 Days
Dec 2, 2021 | 16:28 EDT
Get caught up quickly on the top news and calls moving stocks with these Top Fives, as compiled by the editors of The Fly. 1... To see the rest of the story go to See Story Here
Dec 1, 2021 | 13:58 EST
Stifel analyst Paul Matteis believes Vertex Pharmaceuticals' APOL1 clinical data on Wednesday looks strong, with a 48% reduction in proteinuria. The company plans to advance the program and this is validating for Vertex Pharmaceuticals' ability to innovate outside of cystic fibrosis, the analyst contends. That said, Matteis notes that the baseline proteinuria level in this study was much lower than he expected and he still thinks there's an "open question here regarding the size of the market opportunity," and whether it is needle moving to the valuation as the cystic fibrosis franchise approaches $9B-$10B. He has a Hold rating on the shares.
Dec 1, 2021 | 13:32 EST
Amgen (AMGN) announced that the U.S. Food and Drug Administration has approved the expansion of the Kyprolis U.S. prescribing information to include its use in combination with Darzalex Faspro and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy. The expansion of the Kyprolis prescribing information to include Darzalex Faspro plus dexamethasone was supported by the ongoing, Phase 2, non-randomized, open-label, multicenter PLEIADES trial evaluating the clinical benefit of Darzalex Faspro administered in combination with four standard-of-care treatment regimens in patients with multiple myeloma. "I am pleased that the addition of subcutaneous daratumumab to Kyprolis plus dexamethasone will offer increased flexibility and convenience for patients with relapsed or refractory multiple myeloma and will greatly reduce the administration burden," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. Separately, the Janssen Pharmaceutical Companies of Johnson & Johnson (JNJ) also announced the FDA approval of Darzalex Faspro in combination with Kyprolis and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy.
Dec 1, 2021 | 11:57 EST
The Food and Drug Administration announced the approval of Johnson & Johnson's (JNJ) daratumumab plus hyaluronidase-fihj and Amgen's (AMGN) carfilzomib plus dexamethasone for adult patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy. Reference Link
Dec 1, 2021 | 10:42 EST
Piper Sandler analyst Do Kim believes the VX-147 Phase 2 data in patients with APOL1-mediated focal segmental glomerulosclerosis is an "incremental positive" for Vertex Pharmaceuticals which could start shifting investor sentiment around the company's pipeline. While the 48% reduction in proteinuria is meaningful, a "number of questions remain" on Phase 3 design, given limited regulatory guidance on proteinuria as a surrogate endpoint, Kim tells investors in a research note. The analyst keeps a Neutral rating on Vertex with a $218 price target ahead of competitor cystic fibrosis data in early 2022 and looks for continued positive pipeline momentum before becoming more constructive on the shares.
Dec 1, 2021 | 10:06 EDT
Check out today's top analyst calls from around Wall Street, compiled by The Fly. 'COMPELLING' RE-ENTRY POINT:... To see the rest of the story go to See Story Here
Dec 1, 2021 | 08:33 EST
Zymeworks (ZYME) announced that Janssen Biotech (JNJ) dosed the first patient with JNJ-78306358, a bispecific antibody developed using Zymeworks' Azymetric and Efect therapeutic platforms. This is the second Janssen bispecific program utilizing Zymeworks' proprietary technology platforms to enter the clinic this year, following the announcement in August of Janssen's dosing of the first patient with JNJ-78278343. Zymeworks will receive a payment in connection with this milestone under Zymeworks' 2017 licensing agreement with Janssen. Under the terms of that agreement, Zymeworks provided Janssen with a worldwide, royalty-bearing license to research, develop and commercialize up to six bispecific antibodies directed to Janssen therapeutic targets using Zymeworks' Azymetric and Efect platforms. Janssen is responsible for all research, development, and commercial activities under the licensing agreement. Zymeworks received an upfront payment of $50M and is eligible to potentially receive up to $282M in development milestone payments and up to $1.12B in commercial milestone payments, as well as tiered royalties on potential sales.