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Fly News Breaks for January 31, 2020
Jan 31, 2020 | 10:04 EDT
After Celgene Europe (BMY) announced the decision to withdraw its marketing authorization application, or MAA, for Idhifa for the treatment of relapsed/refractory AML to the EMA, JPMorgan analyst Anupam Rama said there could be some incremental volatility today for Agios (AGIO) on the back of this update. He connected with Agios, which currently receives royalty payments from Idhifa sales from Celgene, and his understanding is that Celgene decided to withdraw the MAA primarily because the single-arm, phase 1 trial did not fully address the major objections raised by the CHMP to support a positive benefit-risk assessment in the proposed R/R indication. The company plans to assess resubmission once the phase 3 IDHENTIFY trial is complete, said Rama. While he does see potential risk to the ongoing Tibsovo review in the EU, given it was also filed based on a single-arm study, his sense from talking to Agios is that there was increased focus on historical control aspect of the Tibsovo filing. The focus for Agios in the near-to-intermediate term is on mitapivat, for which there are important clinical catalysts in 2020, said Rama, who reiterated his Overweight rating on Agios shares.
News For AGIO;BMY From the Last 2 Days
Oct 19, 2020 | 09:52 EDT
Catch up on today's top five analyst upgrades with this list compiled by The Fly: 1. Bristol-Myers (BMY) upgraded to Buy from Neutral at Guggenheim with analyst Seamus Fernandez saying he thinks Opdivo data suggest growth of the immuno-oncology franchise can return in 2021 and accelerate in 2022. 2. Brookfield (BAM) upgraded to Buy from Neutral at Citi with analyst William Katz saying the merits of the American Equity (AEL) equity stake "alters the somewhat stale narrative and opens up an incremental growth path." 3. Archer Daniels (ADM) upgraded to Overweight from Neutral at JPMorgan with analyst Thomas Simonitsch saying he expects the company's multiple to "re-rate" exiting 2020 given "resilient" Nutrition growth through the pandemic and greater confidence in the segment's growth trajectory for 2021 and beyond. 4. Fabrinet (FN) upgraded to Outperform from Market Perform at Northland with analyst Tim Savageaux saying he sees the 15% pullback in the shares being most likely driven by Huawei and Ciena (CIEN) concerns. 5. O'Reilly Automotive (ORLY) upgraded to Outperform from Market Perform at Raymond James with analyst Matthew McClintock saying he has historically been hesitant to recommend owning the stock due to valuation concerns but says the current valuation is actually attractive for a long-term financial algorithm that has many reasons to accelerate relative to recent years. This list is just a portion of The Fly's full analyst coverage. To see The Fly's full Street Research coverage, click here.
Oct 19, 2020 | 06:32 EDT
As previously reported, Guggenheim analyst Seamus Fernandez upgraded Bristol-Myers to Buy from Neutral with a $70 price target following a series of positive Phase 3 data read-outs related to Opdivo. He thinks the data suggest growth of the immuno-oncology franchise can return in 2021 and accelerate in 2022, Fernandez tells investors. However, "surprise negative safety results" for TYK2 could alter his Buy thesis, the analyst noted.
Oct 19, 2020 | 04:55 EDT
Agios Pharmaceuticals announced Friday the withdrawal of its European Marketing Authorization Application for Tibsovo for the treatment of adult patients with relapsed or refractory acute myeloid leukemia with an isocitrate dehydrogenase-1 mutation. The decision is based on feedback from the European Medicine Agency's Committee for Medicinal Products for Human Use that the available clinical data from the company's single arm, uncontrolled Phase 1 study do not sufficiently support a positive benefit-risk balance for the proposed indication. "We are disappointed not to be able to bring TIBSOVO to AML patients in the EU based on our current data in the relapsed/refractory setting, given the tremendous need for new targeted treatment options for this devastating disease," said Chris Bowden, M.D., chief medical officer at Agios. "We continue to believe in the benefit of TIBSOVO(R) for patients with AML and are advancing our two ongoing Phase 3 randomized controlled trials evaluating TIBSOVO(R) combinations in newly diagnosed AML. If these trials are positive, we anticipate pursuing approvals in these indications in both the U.S. and EU."