Eli Lilly gets FDA approval of Tauvid in patients evaluated for Alzheimer's » 19:2305/2805/28/20
TAUVID, a radioactive…
TAUVID, a radioactive diagnostic agent, has been approved by the FDA for positron emission tomography imaging of the brain to estimate the density and distribution of aggregated tau neurofibrillary tangles in adult patients with cognitive impairment who are being evaluated for Alzheimer's disease, or AD. A neuropathological diagnosis of AD requires the demonstration of the presence of both beta-amyloid neuritic plaques and tau NFTs in the brain. TAUVID is the first and only approved diagnostic agent to image tau NFTs in the brain. Avid Radiopharmaceuticals, a wholly owned subsidiary of Eli Lilly and Company, developed TAUVID and AMYVID to provide physicians with meaningful information on the presence of both pathologies to aid the evaluation of patients suspected of having AD. Availability of TAUVID will initially be limited and will expand in response to commercial demand and payor reimbursement.
Merck, Eisai announce new data from KEYTRUDA plus LENVIMA trials » 18:3805/2805/28/20
Merck and Eisai announced…
Merck and Eisai announced new data from analyses of two trials evaluating KEYTRUDA, Merck's anti-PD-1 therapy, plus LENVIMA, an orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai. In the KEYNOTE-524/Study 116 and KEYNOTE-146/Study 111 trials, the KEYTRUDA plus LENVIMA combination demonstrated clinically meaningful objective response rates in patients with unresectable hepatocellular carcinoma with no prior systemic therapy and in patients with metastatic clear cell renal cell carcinoma who progressed following immune checkpoint inhibitor therapy, respectively. "The tumor response rates demonstrated with KEYTRUDA plus LENVIMA in these studies underscore the potential of this combination regimen in certain types of hepatocellular and renal cell carcinoma," said Dr. Jonathan Cheng, Vice President, Oncology Clinical Research, Merck Research Laboratories. "KEYTRUDA plus LENVIMA is an important pillar of our broad oncology research program, and we continue to advance the study of the combination across multiple types of cancers and stages of disease." "As data from our combination trials continue to read out, our enthusiasm for and belief in the potential of KEYTRUDA plus LENVIMA are strengthened by the growing body of evidence observed in multiple advanced cancers," said Dr. Takashi Owa, Chief Medicine Creation and Chief Discovery Officer, Oncology Business Group at Eisai. "Our ongoing clinical study efforts on this combination exemplify our commitment to following the science and exploring possible solutions for patients affected by difficult-to-treat cancers."
Merck study shows KEYTRUDA reduced risk of progression, death by 40% » 17:0205/2805/28/20
Merck announced the first…
Merck announced the first presentation of results from KEYNOTE-177, a Phase 3 trial evaluating KEYTRUDA, Merck's anti-PD-1 therapy, for the first-line treatment of patients with microsatellite instability-high or mismatch repair deficient unresectable or metastatic colorectal cancer. In this pivotal study, KEYTRUDA monotherapy significantly reduced the risk of disease progression or death by 40% and showed a median progression-free survival of 16.5 months compared with 8.2 months for patients treated with chemotherapy, a current standard of care in this patient population. As previously announced, the study will continue without changes to evaluate overall survival, the other dual primary endpoint. These results were selected for presentation on Sunday, May 31, 2020 in the plenary session of the virtual scientific program of the 2020 American Society of Clinical Oncology Annual Meeting. "For many years, the standard of care for the first-line treatment of patients with MSI-H colorectal cancer has been the combination of mFOLFOX6 plus bevacizumab. This is the first time a single-agent, anti-PD-1 therapy demonstrated a superior, statistically significant and clinically meaningful improvement in progression-free survival compared to chemotherapy for these patients," said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. "There is an unmet need for new treatment options in the first-line setting that may provide sustained, long-term improvements in outcomes for patients with MSI-H colorectal cancer. We are grateful to have the opportunity to present these practice-changing findings at the plenary session of this year's ASCO."
Alexion rises as documents suggest settlement of Amgen patent challenge » 11:4105/2805/28/20
ALXN, AMGN, SNY, REGN
Shares of Alexion (ALXN)…
Elliott says Alexion settlement may 'leave the door open' for strategic review » 09:1505/2805/28/20
A spokesperson for…
A spokesperson for activist Elliott Management regarding the potential inter partes review settlement between Amgen (AMGN) and Alexion Pharmaceutical (ALXN): "Although Elliott believes the IPR overhang was overblown, a sensible settlement would remove a significant source of uncertainty and leave the door open for the Company to explore strategic alternatives without further delay, the value maximising pathway for the Company in Elliott's view." In December, Alexion announced that even though Elliott recommended it "immediately launch a proactive sale process," its board "unanimously decided that conducting a proactive sale process would not be in the best interest of shareholders and the patients we serve at this time." Shares of Alexion are up 7% to $113.53 in premarket trading.
Fly Intel: Pre-market Movers » 09:1205/2805/28/20
ALXN, AMGN, BA, DLTR, LL, TGI, CSIQ, WDAY, DG, BURL, ANF, HPQ, TWTR, FB, IOVA
Check out this morning's…
Alexion settlement could 'clear the deck' for acquirer, says Piper Sandler » 09:0805/2805/28/20
ALXN, AMGN, SNY, REGN
Piper Sandler analyst…
Piper Sandler analyst Christopher Raymond keeps an Overweight rating on Alexion Pharmaceuticals (ALXN) following news of an impending settlement of Amgen's (AMGN) inter partes review challenge for three U.S. Soliris patents, according to documents posted by the Patent Trial and Appeal Board. A settlement would be a "deck-clearing event" that could also make the Alexion "story cleaner for an acquirer," Raymond tells investors in a research note. Given Elliott Management's involvement and this week's news that Sanofi (SNY) is monetizing its Regeneron (REGN) stake, "this possibility has to be front of mind," says the analyst. Raymond wonders why Alexion would settle now, three months before the PTAB's written decision was due. One possible consideration for Alexion "was to clear the deck to make the story cleaner for an acquirer," contends Raymond. The stock in premarket trading is up 7% to $114.00.
Alexion settlement may yield upside surprise, says Cowen » 08:4805/2805/28/20
Cowen analyst Phil Nadeau…
Cowen analyst Phil Nadeau Noted Alexion (ALXN) and Amgen (AMGN) have reached a settlement in principle in the Soliris IPR challenge. The analyst said most investors assumes Alexion's patents would fall however, he thinks an agreement that preserves some of the term is an upside surprise and his preliminary sensitivity analysis suggests each year the generic entry is pushed past 2022, it is worth $5 per share to Alexion. Nadeau has an Outperform rating and $165 price target on Alexion shares.
Alexion, Amgen appear to have agreed to settlement deal, says Stifel » 07:5905/2805/28/20
Stifel analyst Paul…
Stifel analyst Paul Matteis noted that Alexion (ALXN) and Amgen (AMGN) requested a trial postponement last night and he views filings with the Patent Trial and Appeal Board as suggesting that the parties appear to have agreed in principle on a settlement in Amgen's three PTAB challenges to Soliris patents. While the terms haven't been disclosed, the "bottom line for the stock" is that this is good news and Alexion shares "will likely deservedly trade higher today," Matteis tells investors. However, he keeps a Hold rating on Alexion as he believes that it is debatable as to whether biosimilar or branded competition is the more salient threat and he would argue for the latter. Additionally, Matteis thinks that so far the company's deals for Syntimmune, Affibody and Stealth "have been disappointing."
PDS Biotechnology initiated with a Buy at Alliance Global Partners » 07:0505/2705/27/20
Alliance Global Partners…
Alliance Global Partners analyst James Molloy initiated coverage of PDS Biotechnology (PDSB) with a Buy rating and $4 price target. Molloy, who believes that PDS has "an interesting delivery vehicle in Versamune that could be applicable across multiple disease states," sees the company hitting multiple significant development milestones before the second half of 2021. His sum-of-the-parts analysis values PDS0101, which is being studied in combination with Merck's (MRK) checkpoint inhibitor Keytruda for recurrent/metastatic head and neck cancer, at $2.50 per share, Molloy noted.