Sutro will present updated data from the ongoing Phase 1b study of luvelta in combination with bevacizumab in a poster presentation at ESMO 2024; expansion study is ongoing with data expected in the first half of 2025 -
- REFRαME-O1 Part 2 (randomized portion) of the Phase 3 trial of luvelta for treatment of platinum-resistant ovarian cancer (PROC) is underway-
- REFRαME-P1, a registration-enabling trial of luvelta for pediatric patients with CBFA2T3::GLIS2 (CBF/GLIS; RAM phenotype) AML, is expected to be initiated in the second half of 2024 -
- A Phase 2 trial of luvelta for the treatment of NSCLC is expected to initiate in the second half of 2024, with initial data expected in the first half of 2025 -
- As of June 30, 2024, Sutro had $426.0 million, composed of cash, cash equivalents and marketable securities of $375.6 million and approximately 0.7 million shares of Vaxcyte common stock with a fair value of $50.4 million -
FDA advisory committee voted favorably that the data support arimoclomol as effective treatment for patients with NPC; PDUFA date of September 21, 2024
Pro forma June 30, 2024, cash, cash equivalents, investments and net proceeds from underwritten public offering total $113.8 million following the closing on August 12, 2024
Conference call scheduled for today, August 13, 2024, at 4:30 p.m. ET
Arimoclomol
On August 2, 2024, the U.S. Food and Drug Administration’s (FDA) newly formed Genetic Metabolic Diseases Advisory Committee (the “GeMDAC”) convened for the first time and discussed the benefits and risks of arimoclomol.
The GeMDAC reviewed comments received from independent experts, NPC patients, and patient advocacy group representatives, and voted favorably that arimoclomol is effective in the treatment of NPC.
On Friday, August 9, 2024, the Company received the first round of labeling comments, and is working closely with the FDA.
Conference Call Information
Zevra will host a conference call and audio webcast today at 4:30 p.m. ET, to discuss its corporate and financial results for Q2 2024.
The audio webcast will be accessible via the Investor Relations section of the Company’s website, http://investors.zevra.com/. An archive of the audio webcast will be available for ninety (90) days beginning at approximately 5:30 p.m. ET, on August 13, 2024.
Additionally, interested participants and investors may access the conference call by dialing either:
Following last month's 'deflationary' print (-0.1% MoM), analysts expected headline CPI to rise 0.2% MoM and they were spot on, shifting theYoY CPI print to 2.9% (from 3.0%) - the lowest since March 2021...
Source: Bloomberg
Goods deflation continues to drag overall CPI lower
Source: Bloomberg
For context, Goods prices are down 1.9% YoY - the biggest deflationary impulse since 2004. Services prices continue to rise YoY but at the slowest pace since 2022...
Source: Bloomberg
The 3m and 6m annualized CPI rates continue to trend lower (with Energy a particularly volatile factor)....
Source: Bloomberg
Core CPI also rose 0.2% MoM (as expected), and the YoY rate of inflation slowed to 3.2% (from 3.3%) - the lowest since April 2021...
Source: Bloomberg
While Core CPI is slowing YoY, the Core goods deflation appears to have stalled...
Source: Bloomberg
However, that is the 50th straight month of MoM increases in Core CPI, and a record high...
Source: Bloomberg
Under the hood, used car prices fell 2.3% along with airline fares (-1.2%) while Car insurance costs jumped 1.2% and furniture prices rose 0.3%...
Source: Bloomberg
Perhaps more worrying is the fact that rent inflation has stopped falling...
July Shelter inflation up 0.33% MoM and up 5.05% YoY vs 5.16% in June
July Rent Inflation up 0.42% MoM and up 5.09% YoY vs 5.07% in June
Source: Bloomberg
Finally, the so-called SuperCore CPI rose 0.2% MoM (same as the rest), dragging the YoY down to 4.73% (still notably elevated)...
Source: Bloomberg
Transportation Services jumped notably MoM..
Source: Bloomberg
So, is this 'good' news or bad news?
Finally, money supply growth is reaccelerating...
Source: Bloomberg
Is this the trough for CPI?
As Bloomberg notes, while the pace of inflation has come down, its still growing, and consumers in the New York-Newark-Jersey City, NY-NJ-PA metro, and the Dallas area still are dealing with inflation in excess of 4% -- the highest among large metro areas in the US.
Will The Fed really cut rates as rent inflation inflects higher for the first time since 2023?
After the late Shinzo Abe valiantly tried to break Japan's dismal tradition of having Prime Ministers who last on average about a year - before quitting and eventually getting assassinated - it appears that Japan is back to its own ungovernable self.
On Wednesday morning, Japan’s Prime Minister Fumio Kishida surprised markets when he said he would step down as leader of the ruling Liberal Democratic party in September and effectively end his tenure as the country's prime minister, ending months of speculation over his ability to survive scandal and rising living costs.
At a press conference on Wednesday, Kishida said he would not seek re-election at next month’s internal poll for the LDP presidency, which in effect grants the holder the position of Japanese prime minister.
“Japan continues to face tough situations at home and abroad. It is extremely important that we tackle these issues with a firm hand,” Kishida said. “The first and clearest step to show that the LDP is changing is for me to step down.”
Kishida said his decision was based on the need to restore trust in politics, and that an ideal successor would be reform-minded.
“Trust in politics and trust from the people is critical,” he told reporters. “It is only by regaining the understanding and trust of the general public that we can move forward, and this is why the LDP must change.”
In short, Kishida wants to get the hell out of Dodge before all hell breaks loose again.
The unexpected shake-up comes at a key moment for Japan, which as the FT reports, has taken on a more muscular defense role in the Pacific and deepened security co-operation with the US in the face of a rising China. The country’s economy also began to emerge from a decades-long campaign against deflation and low growth, while its equity markets have become a favored destination for investors seeking an alternative to China amid rising geopolitical risks.
But Kishida’s three-year premiership was dogged by low approval ratings, caused in large part by a political funding scandal that forced him to sack four cabinet ministers in 2023. In February, a poll by the Mainichi newspaper found that only 14% of voters approved of his administration’s performance, far below the 30% level that has felled previous Japanese prime ministers. The recent transitory surge in inflation - it's transitory because Japan has the highest debt load of any country in the world at over 400% of total debt including government and corporate - did not help Kishida's approval either.
Political analysts have ascribed Kishida’s survival to the weakness of Japan’s opposition parties and a dearth of serious challengers within the LDP.
As the FT notes, Kishida’s decision came as a surprise within the LDP, where very senior figures had firmly believed that the prime minister intended to stand in the leadership election, according to several people close to the cabinet.
By pulling out of the leadership election, which is expected to be held around September 20, Kishida, 67, opens the way for multiple candidates to compete for the position. Speculation among political analysts on his most likely successor has centred on former trade minister Toshimitsu Motegi, 68, former defense minister Shigeru Ishiba, 67, and former foreign minister Taro Kono, 61, all career politicians.
“It is important to show a new face of the LDP in this leadership race,” Kishida said.
Masatoshi Honda, a political analyst and academic, said the depth of the LDP’s woes meant the leadership contest would attract candidates who under normal circumstances would not be seen as potential contenders. But public dissatisfaction with the ruling party went well beyond its top leadership. “Whoever wins, it will be very difficult to revive support for the LDP,” Honda said. One possible younger contender is Takayuki Kobayashi, 49, a graduate of the Harvard Kennedy School, who is credited with showing a steady hand as economic security minister from 2021-22.
Whoever is elected LDP president can expect to lead the party into a general election that must be held by the end of October 2025.
Business executives said one critical question was whether the next LDP leader would be experienced and tough enough to deal with international challenges, including an increasingly assertive China and the possible re-election of Donald Trump as US president.
Kishida, who previously served as foreign minister, came to power in October 2021 with a promise of establishing a “New Capitalism”. His initial failure to fully explain his plans for wealth redistribution resulted in a rapid collapse in the Tokyo stock market that became known as the “Kishida Shock”. Ironically, his tenure ended with another shock, this time the result of the logical rate hike meant to contain Japan's runaway inflation, which sent stocks plummeting, and forced the BOJ to quickly backtrack effectively promising no more rate hikes.
That said, Kishida's three-year term included a number of modest achievements that had eluded his predecessors, including a landmark increase in Japanese defence spending in 2022 that would, in stages, raise the military budget from about 1% of gross domestic product to roughly 2% over five years.
Kishida’s efforts to convince corporate Japan to raise wages also bore fruit. This year’s shunto wage negotiations in March secured the largest pay increase since 1991 for workers at large companies. Alas, that has since led to the highest inflation in Japan in generations, and forced the BOJ to hike rates, jeopardizing the stability of the Japanese bond market, the world's biggest financial Frankenstein monster, where the BOJ owns more than half of all JGBs.
US ambassador to Japan Rahm Emanuel on Wednesday hailed the departing prime minister as “a true friend” of Washington.
“Kishida worked with President Biden to open a new chapter in the US-Japan relationship, which went from alliance protection to alliance projection,” said Emanuel.
A 61-year-old man in the UK was jailed for 18 months for chanting “who the fuck is Allah” and telling police officers “you’re not English anymore” during a protest outside Downing Street.
The sentence handed out to David Spring is the latest shocking example of how low the bar has now been set in terms of free speech in response to rioting that occurred after the murder of three girls in Southport last month.
Spring attended a demonstration of around 700 people in London on July 31 which turned disorderly.
Police bodycam footage that was played in court showed Spring calling police officers “cunts,” making “hostile gestures” and joining in with chants of “who the fuck is Allah” and “you’re not English anymore.”
While Spring’s behavior could be described as offensive and unruly, the fact that he will spent the next year and a half behind bars for saying mean words exemplifies how the UK has slipped into extreme authoritarianism in the space of just two weeks.
When he was arrested, Spring told police, “I didn’t go up to London to riot. I went to complain about people put up in hotels,” referring to illegal immigrants staying in hotels at taxpayer expense.
Defending lawyer Piers Kiss-Wilson said, “The defendant asked me to put forward his apologies to the court and he says he is embarrassed by his behaviour and he is ashamed by it.”
“He also wants to apologise to his family and friends and his wife who don’t deserve this.”
The man’s wife, who suffers from ill health, will now be deprived of her primary carer thanks to Spring’s imprisonment.
The question once again arises as to why these individuals are continuing to plead guilty despite the fact that it is not preventing them from being handed jail time.
Despite the fact that the legislation surrounding hate speech and incitement is more draconian in the UK than in numerous other major western countries, one would think a good free speech lawyer would be able to defend these people more adeptly.
As we highlighted yesterday, Spring’s sentence is only outdone in its absurdity by cases where online speech of people who never even attended riots is leading to prison sentences.
Another man was imprisoned for 2 months merely for posting the words “coming to a town near you” alongside images of Muslim men on Facebook.
Vaccinex recently announced positive results of the phase 1b/2 study of its lead product, pepinemab, in early stages of Alzheimer’s disease (AD). The purpose of this report is to share additional data related to cognitive effects that may help clarify the goals of this study, how well it succeeded, and how this success supports continued development of pepinemab in AD and other neurodegenerative diseases including Huntington’s Disease (HD), which was the focus of a larger previously completedphase 2 study.
Following completion of its phase 2 study in HD, the Company recognized that a major market and strategic focus of its potential pharmaceutical partners was AD. The Company, therefore, undertook to determine whether pepinemab had similar effects in AD as it had reported for HD. The SIGNAL-AD clinical trial was a smaller, cost-effective study in AD that focused on common features of disease progression in AD and HD, including an important efficacy endpoint, the well-characterized decline in brain metabolic activity reflected by FDG-PET signal in a key brain region that is affected early in disease. For AD, one such region, identified in multiple prior studies, is the medial temporal cortex from which disease manifestations spread to other temporal regions and, over time, to the rest of the brain. In the randomized SIGNAL-AD study, that goal was clearly reached by data showing a statistically significant difference (p=0.0297) in FDG-PET signal in the medial temporal cortex following 12-months of treatment with pepinemab compared to placebo. Pepinemab was well-tolerated in AD, consistent with prior clinical experience in HD.
The Company believes that it has compiled compelling early phase evidence of favorable tolerability and efficacy of pepinemab in neurodegenerative disease and that it is well-positioned to enter into a major partnership for continued development without a need for it to perform additional proof of concept studies. This partnership strategy would greatly reduce the Company’s operating expenses going forward.
In a bid to win back investor confidence, Illumina on Tuesday unveiled a three-year growth plan focused on easier DNA sequencing and improved data analysis for customers.
After the recent divestment of cancer diagnostics company Grail, Illumina on Tuesday hosted a call with investors laying out its plans for boosting revenue growth over the next three years.
Illumina “built the foundation of the genomics industry” and will lean into its expertise and “continue leading innovation across total sequencing workflows” providing new offerings for its customers, according to CEO Jacob Thaysen.
“Over the next three years, we will bring to market impressive new innovations that will redefine the genome and drive significant, deeper biological insights through multiomics,” Thaysen said.
In line with this strategy, Illumina on Tuesday unveiled a research partnership with the Broad Institute of MIT and Harvard. The collaboration—which will focus on single-cell sequencing and help accelerate the widespread use of high-capacity single-cell experiments—will rely on Illumina’s Fluent technology, which the sequencing giant acquired last month.
Developed by Fluent BioSciences, the Fluent single-cell analysis platform uses a proprietary partitioning system to segregate complex cell aggregates into smaller units, which can be further broken apart for single-cell applications, according to the biotech’s website.
Illumina’s announcement of the acquisition noted that Fluent “removes many of the barriers and limitations of current methods,” allowing more precise and higher-resolution analyses “accessible to a broader set of consumers and catalyzing new experiments.”
Niall Lennon, senior director of the Broad Institute’s genomic platform, said that single-cell sequencing “has transformed biomedical research in ways that were unimaginable as recently as 15 years ago.” By gaining access to Illumina’s Fluent technology, the collaboration “will support the road’s efforts toward enabling billion cell experiments.”
Illumina’s growth roadmap also involves “a series of innovations” that will let the company keep up with the “diverse and evolving needs of its customers,” according to the announcement, including helping its clients perform broader whole-genome sequencing, gain deeper insight from their sequences and more easily sequence samples.
Through its new strategy, Illumina is eyeing high-single-digit revenue growth by 2027. The company also expects to hit non-GAAP diluted earnings-per-share growth in the double-digit to teens range from 2025 to 2027.
Illumina’s business update on Tuesday comes after it wrapped up its divestiture of cancer diagnostics-focused Grail. The sequencing giant first moved to buy Grail in September 2020, an $8 billion deal that triggered a host of antitrust and shareholder problems for Illumina. After months of warnings and fines from the U.S. Federal Trade Commission and European Commission, Illumina’s board of directors in June 2024 voted to finally let Grail go.
