Summit Therapeutics Down 20% As FDA Do Not Agree To Endpoint Change To Late-Stage Ri-CoDIFy Studies
Shares of Summit Therapeutics Inc. (SMMT) are slipping over 20% on Wednesday morning after the company announced that the U.S. FDA disagreed with its proposed change to the primary endpoint in Phase 3 Ri-CoDIFy studies.
SMMT is currently trading at $5.07, down $1.41 or 21.76%, on the Nasdaq. The stock has traded between $3.15 and $12.30 in the 52 week period.
In an SEC filing, Summit Therapeutics said it received a feedback from the FDA saying that the regulator “does not agree with the change to the primary endpoint that Summit proposed and has subsequently implemented in its ongoing Phase III Ri-CoDIFy studies when combining the studies.”
In August, Summit said that the two blinded pivotal Phase 3 trials would be combined into a single study. The company plans to provide the results to all stakeholders as the top line results become available, which it expects during the first quarter of 2022.
New Book Details Why Donald Trump Dismissed Africa Golf Course Idea
Donald Trump imagined lions eating a “pretty thick guy” on the golf course after it was suggested he build a resort in Africa, Washington Post journalists Bob Woodward and Robert Costa write in their newly-released book “Peril.”
Trump’s comments came during a round of golf with Sen. Lindsey Graham (R-S.C.) and South African golfer Gary Player, according to multiple reports about the book out Tuesday.
Trump dismissed Player when the nine-time Major champion, who faced backlash in January for accepting the Medal of Freedom from the then-president the day after the U.S. Capitol riot, floated the idea of a resort in Africa.
“What happens, Gary, when two lions look out and say, ’You know, that’s a pretty thick guy. I’d like to eat him. Let’s go eat him,” Trump reportedly joked in response.
Player noted “fences and stuff” could keep the big cats away.
Trump, who as president drew fierce blowback when he referred to Haiti and African nations as “shithole countries,” wasn’t convinced, and asked, “You mean they can’t climb over a fence?”
Player suggested golfers could find safety in a Jeep. Trump was again doubtful, asking, “How do you know they won’t come into the Jeep?”
“I’m not betting my life on it,” Graham, a Trump sycophant, reportedly chimed in.
Marathon Digital Bearish Trend Continues; Bitcoin Remains Volatile
Marathon Digital Holdings, Inc. (MARA) shares are declining on Monday morning trade, continuing a fall for the last six days on Bitcoin volatility.
The Cryptocurrency miner shares are currently at $33.92, down 5.47 percent from the previous close of $35.84 on a volume of 1,830,931.
For the 52-week period, the shares have traded in a range of $1.48-$57.75 on average volume of 9,244,526.
Half of the Fed members now see the central bank hiking rates next year
Half of the Federal Reserve members now see the first interest rate hike in 2022, according to the central bank's so-called dot plot of projections.
Wednesday's forecast showed nine of the eighteen FOMC members expect a rate hike in 2022. That's up from seven in June's Fed projections.
Additionally, all but one member is expecting at least one rate hike by the end of 2023. Thirteen members are forecasting two rate hikes through 2023.
Every quarter, members of the committee forecast where interest rates will go in the short, medium and long term. These projections are represented visually in charts below called a dot plot.
Here are the Fed's latest targets, released in Wednesday's statement:
This is what the Fed's forecast looked like in June 2021:
The Fed also released an updated summary of economic projections.
Bristol Myers Reports FDA Priority Review For Relatlimab And Nivolumab Combination
Bristol Myers Squibb (BMY) said FDA has accepted for priority review the Biologics License Application for relatlimab and nivolumab fixed-dose combination in the treatment of adult and pediatric patients with unresectable or metastatic melanoma. The BLA submission was based on the efficacy and safety results of the phase 2/3 RELATIVITY-047 trial. The FDA assigned a PDUFA goal date of March 19, 2022.
Bristol Myers Squibb is currently evaluating relatlimab, LAG-3-blocking antibody, in clinical trials in combination with other agents in a variety of tumor types.
Lamborghini sales cross 300 unit mark in India
Lamborghini announced that it has crossed the 300-unit sales mark in India. The milestone was achieved in the 15 years since Lamborghini first started operations here.
Lamborghini first entered India in 2006 in partnership with a dealer before making its official entry in 2012. From 2006 until 2012, Lamborghini sold cars in small numbers, but post 2012, there was a noticeable spike in sales. The introduction of the Urus in 2018 boosted the sales figures to such an extent that today more than a third of Lamborghinis sold in India now are Urus SUVs. The company delivered the 100th Urus in India earlier this year.
Commenting on the milestone, Sharad Agarwal, head of Lamborghini India, said, “We are delighted to announce the delivery of 300 Lamborghini cars in India. This year we have seen the exciting launches of the Huracán EVO RWD Spyder, Urus Pearl Capsule and Urus Graphite Capsule, as well as the Huracán STO in India. We also delivered the 100th Urus in India in the first quarter, creating a benchmark of performance for the fastest 100 deliveries in the super luxury sportscar segment. This is a significant achievement in the super luxury segment in India and we are extremely thrilled to celebrate the success with Lamborghini owners.”
FY2021 has proven to be successful for Lamborghini India as it doubled its volumes, bucking the trend that saw every other luxury carmaker in the country lose significant sales in the face of the pandemic.