Ramaswamy big bucks from Roivant

 Vivek Ramaswamy, the 38-year-old Republican presidential candidate who emerged from nowhere to challenge Florida Gov. Ron DeSantis for second place in the GOP primary race, is one of the wealthiest Americans under the age of 40.

Ramaswamy, the son of Indian immigrants who studied biology at Harvard before obtaining a law degree from Yale, was briefly a billionaire before a downturn in the stock market shrunk his wealth to just over $950 million, according to Forbes.

He derives most of his fortune from the 10% ownership stake in Roivant Sciences, the biotechnology firm that he founded in 2014.

Ramaswamy, who was raised in the Hindu faith by his parents but went to a Catholic high school, was a hedge fund analyst at QVT before he started Roivant at the age of 29.

He conceived of Roivant as a company that would create subsidiaries that would develop drugs that were overlooked and abandoned by larger pharmaceutical makers.

One of his first major business moves was to acquire the rights to an Alzheimer’s medication that was developed by GlaxoSmithKline and make the drug the centerpiece of a Roivant subsidiary, Axovant.

GOP presidential hopeful Vivek Ramaswamy has amassed a fortune worth $950 million at the age of 38.

AP

The drug, intepirdine, showed promising results in early clinical trials, enabling Roivant to take Axovant public in a 2015 IPO that raised $360 million.

In 2017, Roivant raised $1.1 billion in equity from several venture capital firms, including SoftBank.

Ramaswamy took Roivant public in 2021 through a merger with a blank-check firm that valued the company at $7.3 billion.

Ramaswamy earned a biology degree from Harvard before going on to Yale Law School.

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Since founding Roivant, Ramaswamy has taken in more than $260 million in salary, bonuses, and capital gains.

Ramaswamy’s 10% stake in the company, which had a market capitalization of $8.87 billion as of Thursday morning, translates into $887 million on paper.

So far this year, Roivant’s stock price is up by more than 82%.

Ramaswamy derives most of his wealth from the 10% ownership stake in biotech firm Roivant.

AP

Ramaswamy has also diversified his investments to include cryptocurrency as well as stakes in YouTube upstart rival Rumble and digital payments firm MoonPay, according to Forbes.

He also founded an “anti-woke” index fund, Strive Asset Manager, which was recently valued at $300 million.

He conceived of Roivant as a company that would create subsidiaries that would develop drugs that were overlooked and abandoned by larger pharmaceutical makers.

roivant.com

Ramaswamy’s stake in Strive is said to be worth $100 million.

In recent years Ramaswamy has become a fierce conservative.

In his 2021 bestseller “Woke, Inc.,” Ramaswamy decries decisions by some big companies to base business strategy around social justice and climate change concerns and lambastes “wokeism” as an insidious influence on hard work, capitalism, religious faith, and patriotism.

The book raised Ramaswamy’s profile among conservatives, and he began his rapid ascension as a right-wing star.

https://nypost.com/2023/08/24/vivek-ramaswamy-is-worth-950-million-heres-how-he-became-rich/

Biden’s food stamp expansion linked to 15% jump in grocery prices

 The Biden administration’s massive expansion of food stamp benefits is linked to at least a 15% rise in grocery prices, a new study said on Thursday. 

President Biden’s Department of Agriculture rolled out revised nutritional standards for federal food benefits in 2021 that expanded the program by roughly 25% from pre-COVID pandemic levels. 

Overall spending on the Supplemental Assistance Nutrition Program (SNAP) more than doubled between 2019 and 2022, according to findings from the Foundation for Government Accountability (FGA) previewed by Fox News Digital.

It went from $4.5 billion in 2019 to $11 billion in 2022, the study said.

The group has argued that the increased spending on food stamps has helped fuel the price hikes that everyday Americans have contended with during a time of high inflation. 

“USDA cooked their books to hike food stamp benefits by 27% — the largest permanent increase in program history. And they bypassed Congress to do it,” said Jonathan Ingram, Vice President of Policy and Research at the Foundation for Government Accountability. 

“Data show the Biden administration’s overreach led to massive spikes in grocery prices. They’re feeding inflation, not stopping hunger.”

In 2021, the Biden administration expanded federal food benefits by roughly 25% from pre-COVID pandemic levels. 

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The study cited research from the World Bank that “found that a one percent increase in per-capita food stamp benefits increased grocery store prices by 0.08 percent.”

“Put another way: Food prices increase by one percent for every 12.5 percent increase in food stamp spending,” the study said.

The Foundation For Government Accountability also estimated that Congress could claw back more than $193 billion in taxpayer funds if lawmakers repealed Biden’s food stamp expansion. 

Overall spending on SNAP more than doubled between 2019 and 2022.

Christopher Sadowski

The Foundation for Government Accountability argued that the increased spending on food stamps has helped fuel food price hikes.

Getty Images

Food prices on average are expected to increase 5.8% over 2023, according to the Department of Agriculture’s website. 

It’s a slower pace compared to 2022 but still higher than “historical-average rates,” the department said.

Food stamp spending is likely to take center stage in Congress’ expected upcoming battle over reauthorizing the Farm Bill, which sets a range of spending from food benefits for urban populations to rural broadband.

Republicans are pushing to rein in SNAP spending, while Democrats are wary – particularly after striking a deal with House Republicans to implement work requirements for some food stamp beneficiaries, a condition of raising the federal debt limit earlier this year. 

https://nypost.com/2023/08/24/bidens-food-stamp-expansion-linked-to-15-jump-in-grocery-prices/

Medtronic: AdComm Barely Nixes Symplicity Spyral Renal Denervation System

 Today, Medtronic announced the outcome of the U.S. Food & Drug Administration (FDA) Circulatory System Devices Panel (CSDP) meeting to review data presented in support of the Medtronic Symplicity Spyral™ Renal Denervation (RDN) System. The panel Committee voted unanimously (13-0) on safety and in favor (7-6) of the effectiveness of the Symplicity blood pressure procedure. The Committee's vote was closely divided on the benefit/risk profile of the device (tied at 6-6 and one abstention), with the panel chair breaking the tie, resulting in a final 6-7 vote.

"We appreciate the robust conversation that occurred prior to the vote," said Jason Weidman, senior vice president and president of the Coronary and Renal Denervation business, which is part of the Cardiovascular Portfolio at Medtronic. "We will continue to collaborate with the FDA on bringing a new option to the millions of people living with high blood pressure."

https://www.biospace.com/article/releases/medtronic-issues-statement-on-the-fda-circulatory-systems-devices-advisory-panel-vote-for-the-symplicity-spyral-renal-denervation-system/

Roche’s Divarasib Scores Phase I Win in KRAS-Mutated Solid Tumors

 Roche’s Genentech on Thursday released early-stage data on its KRAS inhibitor, divarasib, as it hopes to join Amgen and Mirati in the potential blockbuster cancer market. 

Phase I study results published in The New England Journal of Medicine showed divarasib as an oral monotherapy with durable response in patients with non-small cell lung cancer (NSCLC). Of the 60 NSCLC patients treated, over 53% had a confirmed response with a median progression-free survival (PFS) of 13.7 months. Response rate and PFS were slightly higher in the highest dose group, which is the dosing that will be used in future trials. 

In the 55 colorectal cancer patients treated, 29.1% achieved a confirmed response with a median PFS of 5.6 months. Partial response was also observed in 36% patients with other solid tumor types. 

Divarasib is a covalent KRAS G12C inhibitor. This class of drug is designed to bind to the P2 pocket of the cancer protein, trapping it in a state of inactivity.  

Amgen was the first to get a KRAS inhibitor approved by the FDA in late May 2021. Lumakras (sotorasib) was greenlighted under the FDA’s accelerated approval program as a second line treatment for patients with locally advanced or metastatic NSCLC. In a Phase II study, patients on Lumakras saw a confirmed objective response rate (ORR) of 36% with a median PFS of 6.8 months. 

About 18 months later, the FDA approved Mirati Therapeutics’ Krazati (adagrasib) for NSCLC with the G12C mutation in the KRAS gene. Krazati’s Phase II data was a little stronger than Lumakras with a 43% ORR and median PFS of 8.5 months. 

While Roche’s Phase I data appear to be potentially stronger than the competition, the trial size was smaller and racial diversity limited. In addition, responses were assessed by investigators as opposed to blinded independent review, so superiority conclusions are as of now premature.  

“[Divarasib] appears to show numerically more responses and longer progression-free survival among patients with either NSCLC or colorectal cancer than those observed with existing single-agent KRAS G12C inhibitors; however, conclusions drawn from cross-trial comparisons must be interpreted cautiously,” the study authors wrote. 

In the Genentech-funded study, 93% of patients experienced treatment-related adverse events. Four patients discontinued treatment and 19 patients had their dosage reduced. Common side effects included nausea, diarrhea and vomiting. The safety profile appears to be similar to that of Krazati and Lumakras.  

“It will be important to evaluate divarasib in larger randomized trials, as well as to evaluate it in combination with other promising agents,” Adrian Sacher, a principal author of the study told Healio News. “These studies are ongoing, and we look forward to their results.” 

https://www.biospace.com/article/roche-s-divarasib-scores-phase-i-win-in-kras-mutated-solid-tumors-/

AbbVie Removes Two Early-Stage Cancer Assets from Pipeline

 AbbVie has removed two early-stage antibody-drug conjugates in an update to its pipeline webpage, suggesting that the company is terminating the development of these candidates, Endpoints News reported Thursday.

The company appears to have dropped ABBV-011 and the Pfizer-partnered ABBV-647, both in Phase I development for cancer targets.

BioSpace was not able to determine exactly when the pipeline changes happened, but according to the Wayback Machine—a digital archive of the internet—these two assets were still on AbbVie’s webpage as late as Aug. 19 but have since been removed. BioSpace has reached out to AbbVie for comment but the company was not immediately available.

ABBV-011 is an antibody-drug conjugate (ADC) targeting SEZ6, a cell surface protein commonly highly expressed in neuroendocrine tumors but typically present in low levels in healthy tissues, according to AbbVie’s website. The investigational ADC carries the toxic calicheamicin payload, which has already been used in two FDA-approved ADCs.

AbbVie was evaluating ABBV-011 either as a monotherapy or in combination with the company’s own budigalimab, a PD-1 inhibitor, for the treatment of relapsed or refractory small cell lung cancer.

During the 2023 Annual Meeting of the American Society of Clinical Oncology (ASCO), held in June, AbbVie presented Phase I data for ABBV-011, demonstrating that the candidate had encouraging efficacy, eliciting an overall response rate of 25% with a median duration of 4.2 months.

AbbVie’s second discontinued candidate, ABBV-647, is also known as cofetuzumab pelidotin and is an investigational ADC designed to target the PTK7 protein. The candidate carries the payload Aur0101, an auristatin microtubule inhibitor, and was being developed for solid tumors.

The company in February 2020 had also launched a Phase Ib trial of cofetuzumab pelidotin in recurrent non-small cell lung cancer. AbbVie presented its methodology for this trial in 2021, during that year’s annual ASCO meeting.

Cofetuzumab pelidotin was first discovered and developed by Stemcentrx, which debuted in September 2015. The company partnered with Pfizer for the development of the candidate, before it was eventually bought by AbbVie in 2016.

AbbVie’s Wednesday pipeline update stands in contrast to an industry trend of growing preference for ADC therapeutics in cancer.

Last month, ImmunoGen signed a multi-target license and option deal with ImmunoBiochem to develop first-in-class ADCs, though the partners declined to reveal specific financial details. The month before that, Eli Lilly bought European biotech Emergence Therapeutics, gaining access to its anti-Nectin-4 ADC assets.

In March 2023, Pfizer made one of the biggest investments in the ADC space so far with its announced $43 billion acquisition of cancer-focused Seagen. If the deal goes through, it will provide Pfizer’s cancer business with four approved treatments and nearly a dozen promising candidates.

https://www.biospace.com/article/abbvie-removes-two-early-stage-cancer-assets-from-pipeline/

Werewolf started at Outperform by Wedbush

Target $9

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