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Friday, December 15, 2023
Verrica Partner Torii Pharma: Positive Top-line Results from Confirmatory Phase 3 Trial
Verrica Pharmaceuticals Inc. (“Verrica” or “the Company”) (Nasdaq: VRCA), a dermatology therapeutics company developing medications for skin diseases requiring medical interventions, today announced that its development and commercialization partner, Torii Pharmaceutical Co., Ltd. (“Torii”), reported positive top-line results from its Phase 3 trial of TO-208 (referred to as VP-102 and marketed as YCANTH™ in the U.S.) for the treatment of Molluscum Contagiosum (“molluscum”) in Japan.
The Phase 3 trial was conducted in Japan and is a double blind, randomized and parallel-group comparison study to evaluate the efficacy and safety of TO-208 in comparison to placebo, when applied once every 21 days for up to four applications in patients with molluscum. The top-line results show that the proportion of subjects achieving complete clearance of all treatable molluscum lesions at the completion of the confirmatory study, the primary endpoint of efficacy, was statistically significant versus placebo. TO-208 was well tolerated during the study.
More Firms Set To Add Bitcoin To Balance Sheets After Major Accounting Rule Change
by Jesse Coghlan via CoinTelegraph.com,
The rules now allow crypto-holding companies to report their paper gains, not just losses, which industry observers say could give firms more confidence to buy...
Bitcoin and crypto may soon see another mass wave of adoption by United States-based firms after a new accounting rule change that lets companies more accurately reflect the value of their crypto holdings.
Cory Klippsten, the CEO of Bitcoin-only exchange Swan Bitcoin, told Cointelegraph that Bitcoin-holding companies like MicroStrategy and Tesla, which both had to report impairment on their holdings, “can now more accurately reflect their Bitcoin investments’ true value.”
“This change is crucial for a broad range of companies, not just those primarily focused on Bitcoin, encouraging more mainstream corporate adoption.”
The new Financial Accounting Standards Board (FASB) rules released on Dec. 13 that come into effect in December 2024 see the estimated market value of crypto held by companies represented accurately on companies’ accounting books by allowing them to record when they’re holding assets at a gain.
Previously, crypto held by companies was subject to impairment only when the value of crypto decreased on the books, which could not be increased until sold, even if its value increased while being held.
Klippsten added that companies could now use Bitcoin as a “strategic financial asset,” as they would be able to report on their value gains and losses, a feature that could help drive adoption.
Matrixport research head and Crypto Titans author Markus Thielen told Cointelegraph that the rule change “underscores the palpable corporate demand” for incorporating crypto into a firm’s accounting.
“Digital assets are increasingly becoming a crucial component of financial statements,” said Thielen, adding that companies will now have more confidence when valuing their crypto holdings.
“This signals a resounding confirmation that digital assets have firmly established themselves in the financial landscape.”
Others were also excited by the rule change. David Marcus, co-creator of Facebook’s binned stablecoin project Diem, posted to X (formerly Twitter) on Dec. 13, saying the new rules are “actually a big deal,” which remove “a large obstacle standing in the way of corporations holding Bitcoin on their balance sheet.”
In a Sept. 6 note following the FASB’s approval of the rules, Berenberg Capital’s senior equity research analyst Mark Palmer said crypto-holding companies could “eliminate the poor optics that have been created by impairment losses under the rules that the FASB has had in place.”
"Largest Ever" Options Expiration Imminent With Massive Gamma 'Unclench'
Goldman's John Marshall estimates that today's options expiration will be the largest ever with over $4.9 trillion of notional options exposure expiring, including $490 billion notional of single stock options.
While December expirations are typically the largest of the year, this one breaks all past records.
Options expiring today represent a notional value that is equal to 10% of the Russell 3000 market capitalization. The largest expiration on record.
And with a record $8BN long gamma position about to be unclenched...
As SpotGamma notes, today we see ~30% of S&P500/Nasdaq/Russel gamma expiring, with the bulk of that centered in the:
4,700-4,750 area for S&P (470-475 SPY),
near the 400-405 strikes for QQQ,
and 200 strike for IWM.
The removal of this gamma with expiration should allow for index volatility to increase - a factor which has already started to come into play.
As you can see below, December expiration is huge with ~1.3trillion of call delta notional set to expire. Puts are essentially nonexistent.
A blow-off-top seems to be consensus now, but options positions seem poised to support a sharp move. Seasonality, rates, and sentiment seem to support higher stocks into year end - and a "stock up, vol up" scenario would accelerate movement. Further, single stock call skews are not all that heavy when we look broadly across names (i.e. calls are not bid to the extremes).
https://www.zerohedge.com/markets/largest-ever-options-expiration-imminent-massive-gamma-unclench
US Futures Waver With a March Rate Cut in Doubt: Markets Wrap
- Quarterly options and futures expiry Friday is year’s largest
- ‘Definitely don’t want to go against’ Fed: BlackRock’s Li
S&P 500 futures were little changed after a Federal Reserve official threw cold water on optimism for an interest rate cut early next year.
New York Fed President John Williams told CNBC it was “premature” to be thinking about a March rate cut. Contracts on the US gauges erased early gains, though Nasdaq 100 futures clung to a 0.2% advance. Meanwhile, a measure of New York state factory activity came in well below estimates, signaling a slowdown in activity.
https://www.bloomberg.com/news/articles/2023-12-14/stock-market-today-dow-s-p-live-updates
FDA Approves First Oral High-Risk Neuroblastoma Maintenance Therapy
The FDA on Wednesday approved US WorldMeds’ oral drug eflornithine for the maintenance therapy of high-risk neuroblastoma. Eflornithine, which will now carry the brand name Iwilfin, is indicated to reduce the risk of relapse in adult and pediatric patients.
Wednesday’s approval, announced by the company and FDA on Thursday, makes Iwilfin the first authorized oral maintenance therapy for this indication, according to the announcements. The drug is indicated to decrease the risk of relapse in adults or children with high-risk neuroblastoma (HRNB) who had shown at least a partial response to multiagent, multimodality treatment—including anti-GD2 immunotherapy.
Iwilfin is also the first approved therapy meant to reduce the risk of relapse in children with HRNB, according to the FDA’s announcement.
US WorldMeds CEO Breck Jones in a statement called Iwilfin a “new and much-needed treatment option” for HRNB, particularly for pediatric patients.
“The goal for treating these young patients is to prevent relapse, and advancing therapeutic options is critical to this mission,” Jones said. “Iwilfin offers new hope and improved outcomes for these vulnerable children.”
Iwilfin is an orally available inhibitor of ornithine decarboxylase, which is a key enzyme involved in neoplastic transformation. According to the drug’s label, using Iwilfin led to a drop in expression levels of two oncogenic drivers—MYCN and LIN28B—which in turn could promote cell aging and prevent cancer development.
The FDA’s approval is backed by data from a single-arm, externally controlled study of children with HRBN, who had initially been treated with standard regimens, including immunotherapy. Results showed an 84% event-free survival at four years compared with 73% in an external control arm.
Overall survival after Iwilfin treatment was 96% at four years versus 84% in external controls. These data indicate that Iwilfin cut the risk of relapse by 52% and the risk of death by 68%, according to US WorldMeds.
In October 2023, the FDA’s Oncologic Drugs Advisory Committee was split on whether to recommend elfornithine for approval but eventually voted 14-6 in favor of US WorldMeds—despite the lack of a randomized clinical trial to support the drug’s efficacy.
At the time, adcomm panelists said that elfornithine was of a lower toxicity than the drugs that they usually discuss, while also noting that its efficacy in the externally controlled study might be overstated given the lack of randomization.
Adcomm members also cautioned that the drug’s approval without a randomized trial might lead to a slippery slope in what the FDA requires of manufacturers for future applications.
Iwilfin’s label does not come with a boxed warning but carries precautions against myelosuppression, hepatotoxicity, hearing loss and embryo-fetal toxicity.
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