Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL), a commercial stage biotechnology company focused on hematologic disorders and cancer, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug designation to R289 for the treatment of myelodysplastic syndromes (MDS). R2891, Rigel's potent and selective dual inhibitor of IRAK1 and IRAK4, is being studied in an ongoing Phase 1b study evaluating the safety, tolerability, pharmacokinetics and preliminary activity in patients with LR-MDS who are relapsed or refractory to prior therapies.
Thursday, January 9, 2025
J&J Nipocalimab granted U.S. FDA Priority Review for generalized myasthenia gravis
Biologics License Application acceptance supported by results from the Phase 3 Vivacity-MG3 study
Results demonstrate sustained disease control over 24 weeks in a broad population of antibody positive adult patients: anti-AChR, anti-MuSK, anti-LRP4
Exelixis says no FDA AdCom for Cabometyx label expansion
Exelixis, Inc. (Nasdaq: EXEL) today announced it has been notified by the U.S. Food and Drug Administration (FDA) that the supplemental New Drug Application (sNDA) for cabozantinib (CABOMETYX®) for the treatment of adults with previously treated advanced pancreatic neuroendocrine tumors (pNET) and advanced extra-pancreatic (epNET) will no longer be the subject of discussion at an Oncologic Drugs Advisory Committee meeting. The sNDA remains under consideration by FDA with a Prescription Drug User Fee Act action date of April 3, 2025.
Sanofi scores with subcutaneous Sarclisa as it plays catch up with J&J Darzalex
Trailing Johnson & Johnson’s powerhouse Darzalex by roughly five years in its development timeline has made it challenging for Sanofi’s Sarclisa—the only other CD38 antibody on the market for multiple myeloma—to compete in the indication.
But with an on-body delivery system (OBDS) to deliver its subcutaneous (SC) formulation of Sarclisa, Sanofi may be finding the edge it needs.
The company has taken a major step in the development of its OBDS as a phase 3 trial has met its primary co-endpoints, showing non-inferiority to intravenous (IV) Sarclisa. The company reported the trial result in a press release Thursday.
In IRALIA—which Sanofi says is the first ever phase 3 study to evaluate the SC administration of a cancer treatment by way of an OBDS—531 patients with relapsed or refractory multiple myeloma received either Sarclisa SC or Sarclisa IV. Patients in both treatment arms also received pomalidomide and dexamethasone (Pd).
The endpoints on which Sarclisa SC measured up to IV were objective response rate (ORR) and observed concentration before dosing at steady state. The study also hit its key secondary endpoints.
In the SC arm, Sarclisa was administered at a fixed dose weekly for four weeks during the first cycle of treatment and every two weeks for subsequent cycles. In the IV arm, Sarclisa was administered at a weight-based dose via infusions weekly for four weeks during the first cycle and every two weeks for subsequent cycles.
Sanofi said it will reveal detailed results at an upcoming medical conference. The company added that it plans to submit applications for approval in the U.S. and Europe in the first half of this year.
Sanofi’s automated, hands-free OBDS is called enFuse and is produced by Cincinnati-based Enable Injections. The device uses a hidden, retractable needle that is thinner than is commonly used for SC administration, Sanofi said.
The company is currently evaluating Sarclisa SC formulations across different combinations and lines of therapy.
Sarclisa was approved by the FDA in 2020, five years after J&J won its nod for Darzalex. In September of last year, the FDA signed off on Sarclisa—in combination with bortezomib, lenalidomide and dexamethasone (VRd)—to treat first-line patients. The nod came six years after J&J won a comparable approval to treat first-line patients. Additionally, J&J gained an FDA nod for its SC version of Darzalex, which is called Darzalex Faspro, in 2020.
In the first three quarters of 2024, Darzalex generated sales of $8.6 billion, a 19% increase from the same period in 2023. Meanwhile, Sanofi reported (PDF) sales of Sarclisa in the first three quarters of 2024 at $341 million, a 29% increase year-over-year.
AARP Report: Top Medicare Part D Drugs See Average Lifetime Price Hike of 98%
List prices for the 25 top Medicare Part D drugs not currently selected for Medicare drug price negotiation have increased by an average of 98 percent—or nearly doubled—since they first entered the market, according to a new report from AARP’s Public Policy Institute released today. The report also found that, on average, more than 40 percent of the current list prices for the top 25 drugs is due to price increases that have occurred after the products first entered the market. These findings highlight the importance of a 2022 law that addresses high prescription drug prices and drug price increases.
“Brand-name drug prices have been increasing faster than the rate of general inflation for decades, putting life-saving medications out of reach for millions of patients who need them,” said Leigh Purvis, Prescription Drug Policy Principal, AARP Public Policy Institute, and author of the report. “Meanwhile, the median price of a new brand name prescription drug is now approximately $300,000 per year, so even a small price change could increase a drug’s price by thousands of dollars.”
This analysis focuses on the 25 brand-name drugs with the highest total Medicare Part D spending in 2022 that have not yet been selected for Medicare drug price negotiation. Combined, these top 25 drugs accounted for nearly $50 billion in total Medicare Part D spending in 2022 and were used by a total of more than 7 million Part D enrollees. The top five medications include:
- Trulicity (diabetes)
- Ozempic (diabetes)
- Trelegy Ellipta (chronic obstructive pulmonary disease or asthma)
- Biktarvy (human immunodeficiency virus)
- Xtandi (cancer)
Congress passed the Inflation Reduction Act in 2022, which includes two major provisions designed to address high prescription drug prices that are expected to reduce Medicare Part D enrollee and program spending by billions of dollars. The first requires drug companies to pay penalties to Medicare if their drug prices increase faster than the rate of inflation. The law also gave Medicare the ability to negotiate lower drug prices with drug companies for the first time. The negotiated prices for the initial 10 drugs selected by the Centers for Medicare & Medicaid Services will take effect in January 2026, and up to 15 more drugs will be selected for negotiation by February 1, 2025.
To view the full report, visit here.
https://www.thestreet.com/retirement-daily/social-security-medicare/part-d-drugs-price-hike
Walgreens’ potential sale to Sycamore Partners in focus during Q1 earnings
Walgreens Boots Alliance (NASDAQ:WBA) is set to announce the first quarter earnings on Friday, and investors will keep an eye on updates regarding reports of potential sale to Sycamore Partners.
Wall Street expects the drugstore operator to post EPS of $0.36, indicating a 42.4% Y/Y decline, while revenue is expected to increase 1.9% Y/Y to $37.42 billion during the quarter.
Despite beating sales expectations in Q4, the company is facing headwinds due to ongoing execution challenges, footprint optimization and consumer weakness.
“Additional WBA headwinds could be driven by the weaker flu season to date (y/y), with outpatient visits for influenza like illness tracking below last year's levels,” noted Morgan Stanley analyst Erin Wright.
Seeking Alpha's Quant Ratings, Wall Street and Seeking Alpha analysts are cautious about the company and recommended it as a Hold.
Seeking Alpha analyst Daniel Schönberger said despite the low stock price suggesting undervaluation, Walgreens' profitability struggles and potential dividend cuts make it a risky investment. Additionally, the company’s sustainability is questionable due to negative free cash flow and significant debt levels.
Over the last two years, WBA has beaten EPS estimates 63% of the time and has beaten revenue estimates 100% of the time.
Over the last three months, EPS estimates have seen one upward revision versus nine downward moves. Revenue estimates have seen four upward revisions against three downward moves.
Wallgreens was one of the worst performing S&P 500 stocks in 2024 as its shares declined nearly 65%.
Private-Public Crossover ETF Sees Inflows Explode After Addition Of Musk's SpaceX
In a note titled "ETFs Push to Bridge Gap to Private Assets," Bloomberg Senior ETF Analyst Eric Balchunas discussed the ERShares Private-Public Crossover ETF (XOVR), which provides exposure to both public and private equity securities for institutional, retail, and high-net-worth clients.
Balchunas highlighted that XOVR's recent addition of SpaceX as its top holding underscores the ETF industry's efforts to tap into the $14 trillion private-asset market, which has been mostly inaccessible to retail investors. He further noted that since the inclusion of SpaceX, XOVR has attracted $116 million in inflows, quadrupling its assets.
CNBC confirmed last month that SpaceX hit a $350 billion valuation based on a secondary share sale. The round did not include raising new capital. SpaceX's soaring valuation comes as the company dominates the global space race with a near-monopoly on the global satellite launch market. Yet SpaceX is a private company.
Until now: XOVR
Here's more about XOVR via Balchunas' note:
Private-Public Crossover ETF Adds Big Stake in SpaceX
A private company is the largest holding in an ETF for the first-time ever as XOVR has a 9% weighting to Elon Musk's SpaceX via a special purpose vehicle. XOVR isn't a new ETF per se, but it recently changed strategy to focus on entrepreneurial companies, including those that are closely held. SEC rules limit such holdings to no more than 15% of the fund. This isn't totally uncommon in mutual funds, but it's new terrain for ETFs, which have shown a real and determined interest in penetrating the market for private equity and credit.
ETFs are the preferred vehicle of America's financial advisers, which have around $40 trillion in assets but limited access to private assets. The race is on to bridge that gap, similar to how funds' crypto holdings caught up via the hugely successful Bitcoin and Ether ETFs
Flows Show the ETF Is on to Something
Since converting to its public-private strategy and adding SpaceX, XOVR has taken in $116 million, quadrupling its assets. This evidence of investor interest will likely only embolden other ETFs to try the same. XOVR's performance has helped, as the ETF is up 23% since switching to a public-private crossover strategy, which is about double QQQ and triple SPY. It's also besting ARK Venture, an interval fund that also has a big holding in SpaceX. Though an interval fund may arguably be the better format to deliver private-company exposure to retail, it's not the preferred format for these investors. They have shown they want it in ETFs -- even if that means bigger premiums and discounts. The fact that XOVR already has doubled ARKVX shows this.
Balchunas has found a way for investors to own SpaceX through a private-public crossover ETF.
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