Journey Medical Corporation (Nasdaq: DERM) (“Journey Medical” or “the Company”), a commercial-stage pharmaceutical company that primarily focuses on the selling and marketing of U.S. Food and Drug Administration (“FDA”)-approved prescription pharmaceutical products for the treatment of dermatological conditions, announced today that the FDA has accepted the Company’s New Drug Application (“NDA”) for DFD-29 (Minocycline Hydrochloride Modified Release Capsules, 40 mg) for the treatment of inflammatory lesions and erythema of rosacea in adults. The FDA has set a Prescription Drug User Fee Act (“PDUFA”) goal date of November 4, 2024.
Monday, March 18, 2024
Natera Phase III Trial in France Evaluating Signatera™ in Stage II Colorectal Cancer
Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, today announced a collaboration with the Fédération Francophone de Cancérologie Digestive and CHU Dijon Bourgogne on the CIRCULATE-PRODIGE-70 study, a randomized, multicenter, prospective phase III clinical trial in France investigating molecular residual disease (MRD)-guided adjuvant treatment in stage II colorectal cancer (CRC) patients.
The study’s main objective is to determine the benefit of adjuvant chemotherapy (ACT) in stage II CRC patients with detectable circulating tumor DNA (ctDNA) post-surgery. Patients who are Signatera MRD-positive will be randomized to receive ACT (FOLFOX 6m) or pursue observation (no chemotherapy). Patients who are Signatera MRD-negative will be treated according to the standard of care (observation). Approximately 1,600 patients will be tested with Signatera, and a successful study result is expected to pave the way for the adoption and reimbursement of Signatera in France. The initial readout is expected in 2025.
Putin Warns Of 'Full-Scale WW3' If West Sends Troops To Ukraine
Russian President Vladimir Putin's election victory speech and Q&A with the press was full of familiar themes, but he used the occasion after capturing a record 87% of the vote to warn the US and Europe that a "full-scale World War III" is "possible" should any Western troops enter Ukraine.
The remarks came in response to a journalist's question on President Macron's recent statements saying he thinks sending troops to Ukraine should be a realistic possibility. Putin responded on Sunday: "I think anything is possible in today’s world and it’s clear to everyone that this would be one step from a full-scale World War III."
But the Russian leader also emphasized that NATO military personnel are already present in Ukraine, with Russian intelligence having observed English and French at times being spoken on the battlefield. "There is nothing good in this, first of all for them, because they are dying there and in large numbers," he said.
Putin said, "It seems that France could play a role. All is not lost yet." Over the weekend French President Macron floated the idea of a Ukraine ceasefire during the Paris Olympics, which is set to take place from July 26 to August 11 of this year:
France wants Russia to observe a cease-fire in Ukraine during this summer’s Olympic Games in Paris, French President Emmanuel Macron said in an interview with Ukrainian television on Saturday.
"This is a message of peace," Macron said, before a voiceover interpreter quoted the French president as saying that France is doing so in line with the spirit of the Olympic movement.
Putin appeared to respond to this overture, saying in his Sunday address: "I’ve been saying it over and over again and I’ll say it again. We are for peace talks, but not just because the enemy is running out of bullets," Putin stated.
"If they really, seriously, want to build peaceful, good-neighborly relations between the two states in the long term, and not simply take a break for rearmament for 1.5-2 years."
The Kremlin followed up later with this exchange:
Commenting on the French President’s call for a ceasefire, Russian foreign ministry spokeswoman Maria Zakharova urged Macron to stop weapon supplies to Ukraine, the TASS news agency reported.
Zakharova also said Macron should have proposed the same ceasefire to the sides of the conflict in the Middle East.
Putin elsewhere presented his re-election to another six year term as proof that the Russian populace stands behind him in defending Russia in the 'special military operation' in Ukraine. "Dear friends, it's a great pleasure this evening to be with members of my team, with members of my team, people who think alike, who have the same goals. But let's think about this word, where it came from, comrade in arms, or teammates." He stressed, "The votes of all citizens of Russia express the united will of the Russian Federation."
He juxtaposed his 'mandate' with the state of affairs in America. "The whole world is laughing at what is happening there," he said of the United States. "It is just a catastrophe — it is not democracy — what on earth is it?"
Putin was also asked about deceased opposition leader Alexei Navalny, who died Feb.16 in a far northern prison of what was officially listed as 'natural causes'. Putin confirmed reports that a major prisoner swap with the West was about to happen just before his "sad" death. On this swap which had been in the works just days before Navalny's unexpected death, Putin explained: "I said: ‘I am agreed’. I had one condition — we exchange him but he never returns."
Concerning the future of the war in Ukraine at a moment cross-border drone attacks have ramped up on Russian cities and energy infrastructure, Putin spoke of possibly establishing a major buffer zone. "I do not exclude that, bearing in mind the tragic events taking place today, we will be forced at some point, when we deem it appropriate, to create a certain ‘sanitary zone’ in the territories today under the Kyiv regime," Putin said, but without giving further details.
Macron's Long Telegram
By Benjamin Picton, Senior Macro Strategist at Rabobank
The focus of markets last week was, quite rightly, on US inflation figures. US 2-year yields posted gains every day to close the week just over 25bps higher at 4.73%. The move was prodded along by stronger-than-expected US CPI on Tuesday, strong PPI on Thursday, and then rising prices for goods imports on Friday.
So, it was a trio of bad news on the inflation front, with the goods imports inflation providing the cherry on top because disinflation in internationally-traded goods has been doing the heavy lifting for the Fed (and others) up until now. Perhaps unsurprisingly, market pricing on the quantum of cuts expected from the Fed this year fell from 4.2 last Monday to 3.3 as of this morning. The S&P500 picked up on the vibe by closing lower for the second week in a row. That hasn’t happened since October of last year, which happened to be the cyclical low before Jerome Powell’s ‘pivot’ lit the fuse on a whopping Santa rally that has survived well into 2024.
This week will be dominated by central bank actions, even though we fully expect that actual action in the form of shifting policy rates will be pretty thin on the ground. The BOJ will be a major point of interest on Tuesday, with markets now pricing in a 55% probability of an end to the negative interest rates policy (NIRP). A return to ZIRP (zero interest rates policy) is seen as a 70% probability by the April meeting, or 96% by June.
Markets have been gradually bidding up the implied path of the BOJ’s policy rate for weeks as Japanese unions deliver strong wage gains for their members. Rengo, Japan’s largest labour union, last week secured wage increases of ~5.25% for members. That’s the first time in more than 30 years that wage gains have exceeded 5%. BOJ Governor Kazuo Ueda has stressed in the past that he would need to see evidence of persistent wage growth to be convinced that inflation will converge on the 2% target. Given the events of last week, a lift in the policy rate tomorrow is a certainly a possibility but given past dovishness it seems more likely that the BOJ will hold fire until April.
Tomorrow also brings the RBA’s March policy meeting. We expect no change to the policy rate or the bank’s slight hawkish bias, especially since the RBA meeting will predate the February labour market report by two days. We’re forecasting the unemployment rate to dip to 4%, and for the economy to have added 24,500 jobs last month. That will be sufficient to trigger the Sahm Rule, which might explain why Aussie Treasurer Chalmers has recently started the softening-up process for a more growth-oriented budged in May. The RBA’s Financial Stability Review on Friday will also make for interesting reading, especially with regards to Australia’s gravity-defying mortgage market.
Of course, the main event for the week will be the outcome of the March FOMC meeting on Wednesday. Our Senior US Strategist Philip Marey expects no change to the Fed Funds rate this week and maintains our call for the first cut of the cycle to arrive in June. Philip notes that the Fed will give in-depth consideration to the pace of balance sheet runoff at this week’s meeting. Any lowering of $95bn ‘passive QT’ combined monthly cap for Treasuries, MBS and agency debt would be an encouragement for equity managers looking for a fresh round of monetary stim.
The Bank of England also meets this week and will publish their decision on the Bank Rate on Thursday. We’re expecting no changes there either. Stefan Koopman, our Senior Macro Strategist covering the UK thinks that the BOE will trail both the Fed and the ECB in delivering any policy easing, despite signs of softening in labour markets.
If equity markets do take encouragement from central bankers this week, it will be in defiance of a geopolitical environment threatening escalation. Crude oil last Thursday joined other asset classes making year-to-date highs. That coincided with Russian state media reporting claims that the Houthis now have a hypersonic missile, and comments from Houthi Supreme leader Abdul Malik al-Houthi where he said that the group will begin targeting ships heading around the Cape of Good Hope at Africa’s Southern tip.
If the Houthis DO possess a hypersonic missile (a big ‘if’), it could only have come from Russia (by way of Iran) and would pose a worrying risk to US and allied navies operating in the area. The targeting of commercial shipping taking the long route to Europe via the Cape of Good Hope would be a further detriment for insurance costs and would deal a blow to prospects of an ECB rate cut in June.
Last week also saw a stunning interview delivered by French President Emmanuel Macron. We touched on this on Friday, but it bears repeating that Macron is now taking a much firmer line on the War in Ukraine. Macron’s interview follows Vladimir Putin’s well-publicized history lecture of Tucker Carlson, and news that Russia has shifted tactical nuclear weapons westward into Belarus. It also came just before the weekend’s Russian elections, where Putin dubiously secured 88% of the vote. In this context, there are echoes of George Kennan’s ‘Long Telegram’ that established the US policy of Soviet containment in the 1940s.
Macron’s speech reads like a greatest hits of Realpolitik. Europe must do ”whatever it takes”. “If Russia wins this war, Europe’s credibility will be reduced to zero.” “If Ukraine were to fall, our security is threatened. And so, the time has come to resist.” “If the situation were to deteriorate, we have to be ready, and we will be ready. We will be ready to make the decisions to ensure that Russia never wins.”
These comments arrive in the context of Macron’s earlier refusal to rule out committing French troops to fighting in Ukraine. That was met with threats from Putin and denials from European counterparts that “boots on the ground” could ever happen. Seemingly addressing this, Macron said: “Two years ago we said we would never send a tank. We did. Two years ago we said we would never send medium-range missiles. We did. We said we would never send planes. Some are now in the process. We set too many limits.”
Christine Lagarde is famously on the record saying that the ECB’s commitment to the Euro has “no limits”. Macron is making the same commitment on security.
Protagonist in Worldwide Rusfertide License and Collaboration Agreement with Takeda
Protagonist Therapeutics, Inc. ("Protagonist" or the "Company") today announces the closing of the worldwide collaboration and license agreement for rusfertide with Takeda, a leading values-based, R&D-driven biopharmaceutical company, disclosed on January 31, 2024. Closing of the transaction was contingent on completion of review under the Hart-Scott-Rodino (HSR) Antitrust Improvements Act of 1976 in the United States. Protagonist will receive the $300 million upfront payment associated with the transaction in the second quarter of 2024.
Pharvaris: Phase 3 Study Design for Recently Initiated RAPIDe-3 Hereditary Angioedema Study
- The company announced the initiation of RAPIDe-3, the Phase 3 clinical trial evaluating the efficacy and safety of deucrictibant immediate-release capsule (PHVS416) for the treatment of HAE attacks
Pharvaris (Nasdaq: PHVS), a late-stage biopharmaceutical company developing novel, oral bradykinin B2 receptor antagonists to treat and prevent hereditary angioedema (HAE) attacks, presented at two recent congresses: the 3rd National Congress of the Italian Network for Hereditary and Acquired Angioedema (ITACA) and the 2024 HAE International (HAEi) Regional Conference Americas.
CytomX Milestone in PROBODY® T-Cell Engaging Bispecific (TCB) Collaboration with Astellas
- Initiation of GLP toxicology study for the first clinical candidate in the collaboration triggers a $5 million milestone payment to CytomX -
- Program is one of several ongoing collaboration projects in broad CytomX-Astellas alliance on T-cell engaging bispecifics -
- CytomX retains option for US co-commercialization and economic rights for certain programs -
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