US 'Immediately Lifts' Pause On Intel & Military Aid To Ukraine As 30-Day Truce Plan Agreed Upon

 An apparent breakthrough in Jedda talks between the US and Ukraine, as the United States has announced it "will immediately lift the pause on intelligence sharing and resume security assistance to Ukraine."

The Zelensky government has also "expressed readiness to accept the U.S. proposal to enact an immediate, interim 30-day ceasefire, which can be extended by mutual agreement of the parties, and which is subject to acceptance and concurrent implementation by the Russian Federation," the statement said.

Via Reuters

"The United States will communicate to Russia that Russian reciprocity is the key to achieving peace," it added. This comes after a reported over eight hour-long meeting between the US and Ukrainian delegations in the Saudi port city on Tuesday. No doubt, the Ukrainians came hat in hand, ready to please Trump after relations had fallen off a cliff with the Zelensky Oval Office confrontation earlier this month.

Shortly before the announced US-Ukraine agreement for a 30-day ceasefire, a TASS headline said that the Kremlin has no information on any details coming out of the Jeddah meeting.

But will Putin agree? There's as yet little incentive for him to enact a temporary ceasefire, given as Trump recently admitted... he has all the cards (and Zelensky doesn't).

By all accounts the Russians are fast taking back territory in Kursk and advancing along front lines in the Donbas. Likely Russia fears that Kiev could simply use this ceasefire as an opportunity to rearm, rest, resupply and regroup - especially given Washington just said the US arms and intel pipeline is back on.

Moscow is likely to see this is simply a matter between Washington and Kiev, and it appears to be a version of Zelensky's 'partial ceasefire' which demands a halt to all air assaults. Or in essence it sounds like Zelensky just wants his satellite images turned back on.

Ukraine's presidential office presenting this as the joint statement following the talks led by Rubio, Waltz, and Witkoff:

• "The United States will immediately lift the pause on intelligence sharing and resume security assistance to Ukraine."
• "Both countries’ presidents agreed to conclude as soon as possible a comprehensive agreement for developing Ukraine’s critical mineral resources to expand Ukraine’s economy, offset the cost of American assistance, and guarantee Ukraine’s long-term prosperity and security."

The full statement:

From Russia's point of view, there's nothing about turning back on the halt in weapons and intel assistance which will help anything, given also just last night Ukraine launched its biggest drone attacks in Russian territory to date, targeting the capital of Moscow.

developing...

https://www.zerohedge.com/geopolitical/us-immediately-lifts-pause-intel-military-aid-ukraine-30-day-truce-plan-agreed-upon

Egg Prices Plummet After Trump Unveiled Plan To Reverse Biden's Bird Flu Mess

 The rudderless and delusional Democratic Party attempted to blame President Trump for the Biden-Harris regime's egg price hyperinflation crisis. However, the prior administration was hellbent on culling 150 million chickens nationwide, plunging the nation's egg-laying hen population into a disaster without any meaningful countermeasures to offset lost production. 

Monday's print of the Urner Barry Egg Index (EBP) shows that wholesale prices have plunged from a record high of $7.57 on Jan. 24 to $5.72—a 24% drop in just weeks—while remaining essentially unchanged since President Trump took office. 

One week ago, Trump told a joint session of Congress that "Joe Biden especially let the price of eggs get out of control. The egg price is out of control. And we're working hard to get it back down."

Trump is entirely correct in blaming the Biden-Harris administration who culled, according to Dr. Peter McCullough, upwards of 150 million egg-laying hens over avian flu risks. Not once did the admin offer proper countermeasures to offset the loss of production after mass government-led cullings nationwide. It's almost as if the prior administration wanted egg-flation.

With egg prices sliding from their peak, the Trump administration recently outlined plans to import between 70 million and 100 million eggs over the next two months to cap prices. There was a follow-up report last week that US officials were speaking with large egg producers worldwide to procure new supplies. 

• Trump's Bold Plan: Boost Egg Imports To Reverse Biden's Bird Flu Blunder That Tanked Nation's Hen Population

• US Scours World For Egg Supplies After Biden's "Insane Slaughter Of 150 Million Chickens"

Meanwhile... 

• Dr. Peter McCullough Links Bird Flu Outbreak To USDA Gain-Of-Function Experiment In Georgia

Again, the Democratic Party's misinformation and disinformation propaganda is failing to stick as Trump scrambles leftist talking points with clear action to resolve Biden-era crises.

https://www.zerohedge.com/markets/egg-prices-plummet-after-trump-unveiled-plan-reverse-bidens-bird-flu-response-mess

Arvinas gets positive breast cancer data, but finds differentiation a hard sell

 

• Arvinas lost more than half of its market value Tuesday morning after the Connecticut-based biotechnology company and partner Pfizer disclosed anticipated results from a late-stage clinical trial of a new kind of breast cancer drug they’re developing.

• Arvinas and Pfizer described the findings as a “significant achievement,” citing the pronounced benefit they observed in a subgroup of patients with a specific breast cancer mutation. But analysts had hoped the drug, called vepdegestrant, might work more broadly.

• The companies only released summary data from the study, indicating that results “exceeded the pre-specified target” for showing a benefit on progression-free survival versus the trial’s comparator drug, fulvestrant, in that subgroup of patients. The difference between the groups overall was not significant.

Fulvestrant has been on the market for more than two decades, during which it’s become a standard treatment for metastatic breast cancers that rely on high estrogen levels and don’t express a protein called HER2. It works by binding to, and helping degrade, estrogen receptors on tumor cells.

For several years now, researchers have sought to develop new kinds of estrogen-degrading therapies, including ones that can be taken orally rather than injected like fulvestrant. One, from Menarini Group, was approved in 2023, while another, from Eli Lilly, recently posted positive data in Phase 3 testing.

Arvinas is trying to do the same, but with a drug that works in a different way. Known as a “PROTAC,” or proteolysis-targeting chimera, it is designed to prod cells into trashing disease-linked proteins, such as the estrogen receptor.

Arvinas is a leader in this field of targeted protein degradation, so Tuesday’s data were also looked to as a test of whether these types of medicines can be more effective than other approaches.

At least so far, vepdegestrant doesn’t appear to have clearly outperformed other next-generation estrogen-targeting drugs. The benefit Arvinas and Pfizer reported as statistically significant was in trial participants who have mutations in a gene called ESR1. Treatment led to at least a 40% reduction in the risk of tumor progression or death among this subgroup — about on par with data for Menarini’s approved Orserdu and Lilly’s still experimental imlunestrant.

“Investors were hoping for the drug to work more broadly than the oral [selective estrogen-receptor degrader]s and demonstrate activity in patients without an ESR1 [mutation],” wrote Andrew Berens, an analyst at Leerink Partners, in a client note.

Berens also noted how the data did not yet show a survival benefit in either the ESR1 group or the broader study population. While that’s not unexpected, as survival data takes a longer time to mature, Arvinas and Pfizer didn’t characterize whether results were trending in a direction that might eventually favor their drug.

Analysts Li Watsek, of Cantor Fitzgerald, and Bradley Canino, of Stifel, also view Arvinas’ data as roughly on par, but not better, than the results for Menarini’s and Lilly’s drugs.

“Unfortunately, this means PROTAC may not be as differentiated as oral SERDs, which so far have only been shown to be superior to fulvestrant in the ESR1 [mutant] patients,” Watsek wrote in a client note.

Pfizer and Arvinas said treatment with vepdegestrant was “generally well tolerated,” with a safety profile consistent with prior testing. The company plans to present full data from the study at a medical meeting later this year, as well as discuss the data with regulators to determine the path forward to approval applications.

https://finance.yahoo.com/news/arvinas-gets-positive-breast-cancer-114500237.html

Palvella - Pioneering Therapies For Rare Genetic Skin Diseases With Over $1 Bln Market Opp

 It's been a banner year so far for Palvella Therapeutics Inc. (PVLA), which recently debuted on the Nasdaq, with its share price soaring by as much as 117% year-to-date.

This clinical-stage biopharmaceutical company is exclusively focused on developing transformational therapies for rare diseases with no FDA-approved treatments. Its lead product candidate is QTORIN rapamycin, currently under development for the treatment of microcystic lymphatic malformations, cutaneous venous malformations, and other serious, functionally debilitating skin diseases driven by the overactivation of the mTOR pathway. The mTOR signaling pathway is a key regulator of cell growth, proliferation, survival, and metabolism.

Ongoing Trials with QTORIN 3.9% Rapamycin Anhydrous Gel:

-- A phase III trial of QTORIN 3.9% Rapamycin Anhydrous Gel for the treatment of microcystic lymphatic malformations (microcystic LMs), dubbed SELVA, is underway. The study is currently enrolling approximately 40 subjects at leading vascular anomaly centers across the U.S. The primary efficacy endpoint is the change from baseline in the overall microcystic LM Investigator Global Assessment (mLM-IGA) at week 24.

Previously, the trial participants were required to be at least 6 years old. Last month, the company announced that it will also include patients ages 3 to 5 years old in the SELVA trial.

Microcystic LMs is a rare, chronically debilitating genetic disease characterized by malformed lymphatic vessels that protrude through the skin, continuously leak lymph fluid (lymphorrhea), and bleed. This often results in recurrent serious infections and cellulitis that can cause hospitalization. Currently, there are no FDA-approved treatments for the more than 30,000 individuals diagnosed with microcystic LMs in the United States.

The company expects to report topline results from the SELVA trial in the first quarter of 2026.

-- QTORIN 3.9% Rapamycin Anhydrous Gel is also being studied in a phase II trial for the treatment of cutaneous venous malformations (cutaneous VMs), dubbed TOIVA. This trial is designed to enroll approximately 15 participants, ages six and older, at leading vascular anomaly centers across the U.S.

The TOIVA study will assess the safety and tolerability based on the incidence and severity of adverse events. It will also evaluate multiple measures of efficacy, including change from baseline to week 12 in clinician and patient global impression assessments as well as assessments of specific individual clinical manifestations that contribute to disease burden.

Cutaneous VMs are a rare genetic disease characterized by dysfunctional veins within the skin. These malformations can cause substantial morbidity and functional impairment, significantly impacting quality of life. They are associated with severe bleeding, ulceration, thrombosis, and other potential complications. In the U.S., there are estimated to be over 75,000 individuals diagnosed with cutaneous VMs with no FDA-approved treatments.

The company expects to report data from the TOIVA study in the fourth quarter of this year.

According to the company, there is a significant commercial opportunity for QTORIN rapamycin in treating Microcystic Lymphatic Malformations and Cutaneous Venous Malformations, with the sales potential for both the diseases estimated to be over $1 billion.

Cash position

Palvella ended the year 2024 with cash and cash equivalents of approximately $80.0 million.

Palvella Therapeutics shares began trading on the Nasdaq Capital Market on December 16, 2024, under the ticker symbol "PVLA", following a reverse merger with Pieris Pharmaceuticals Inc. (PIRS).

https://www.rttnews.com/3519965/palvella-pioneering-therapies-for-rare-genetic-skin-diseases-with-over-1-bln-market-opportunity.aspx

Myomo results, call highlights

 

• Q4 Revenue: $12.1 million, a 154% increase year-over-year.

• Full Year Revenue 2024: $32.6 million, up 69% from 2023.

• Revenue Units Delivered in Q4: 220 units, up 106% year-over-year.

• Average Selling Price (ASP): Approximately $54,900, a 24% increase year-over-year.

• Gross Margin Q4: 71.4%, up from 65.3% in the prior year quarter.

• Operating Expenses Q4: $8.9 million, up 60% year-over-year.

• Net Loss Q4: $300,000 or $0.01 per share, compared to a net loss of $2.5 million or $0.07 per share in Q4 2023.

• Adjusted EBITDA Q4: Positive $200,000, compared to negative $2.1 million in Q4 2023.

• Cash and Equivalents: $24.9 million as of December 31, 2024.

• Q1 2025 Revenue Guidance: $9 million to $9.5 million.

• Full Year 2025 Revenue Guidance: $50 million to $53 million.

• Positive Points

  • Myomo Inc (MYO) achieved record financial and operating results in Q4 2024, with revenues reaching $12.1 million, a 154% increase from the prior year.

  • The company successfully expanded its market access by securing Medicare Part B coverage for the MyoPro powered arm brace, allowing them to serve a larger patient base.

  • Myomo Inc (MYO) trained 160 certified prosthetist orthotists, surpassing their goal of 100, which is expected to drive future growth through the O&P channel.

  • The international business, particularly in Germany, performed well, generating over $1 million in profitable revenue in Q4 and over $4 million for the full year.

  • The company achieved positive adjusted EBITDA for the first time in its history, marking a significant financial milestone.

  Negative Points

  • Myomo Inc (MYO) continues to face challenges with Medicare Advantage and other commercial payers, with many patients being denied coverage for the MyoPro.

  • The appeals process for denied claims remains slow, often requiring escalation to administrative law judge hearings, which can delay revenue recognition.

  • Operating expenses increased by 60% in Q4 2024 compared to the prior year, driven by higher headcount and R&D expenses.

  • Despite the growth, the company anticipates negative cash flows in the first three quarters of 2025 due to increased advertising expenses and incentive compensation payments.

  • The cost per pipeline add increased, and there is uncertainty about maintaining the efficiency of marketing spend in the future.

  Q & A Highlights

  Q: Can you walk through your assumptions on unit or revenue contribution in 2025 from the O&P channel? What goals do you have for that channel in '25? A: We plan to have more revenue from our direct provider business, which we are expanding by hiring more CPOs and increasing advertising spend. The O&P channel showed promising growth, with revenues doubling from Q3 to Q4 of last year. We trained 160 clinicians by the end of the year and expect this channel to contribute more significantly, but the majority of revenue will still come from our direct provider channel this year. (Paul Gudonis, CEO)

  Q: How quickly can you ramp advertising spend, and what do you expect from a spend perspective in Q1? A: It's too early to tell if the cost per pipeline add will remain low. We're working through changes made by Meta with Facebook, which affected lead generation. We expect a slight increase in cost per pipeline add in Q1, but we've had a decent start to the year. (David Henry, CFO)

  Q: What are the main reasons for authorization denials, and is there anything the company can do to reduce their frequency? A: Denials often cite the device as experimental or investigational, which we counter by highlighting CMS approval and past payments. Medical necessity is another reason, and we rely on physician documentation to demonstrate necessity. Our Chief Medical Officer engages with medical directors to advocate for coverage. (Paul Gudonis, CEO)

  Q: How should we think about the international market in 2025? A: Germany has performed well, with many statutory health insurance plans covering MyoPro. We have over 100 O&P clinical partners in Germany, and we expect continued growth in this market. We are focusing on expanding marketing and clinical staff in Germany, as opening new international markets requires significant investment. (Paul Gudonis, CEO)

  Q: Are there any risks to your 70%-71% gross margin with possible tariffs, and will tariffs impact your sales into Germany? A: We don't see any impact from tariffs on our current supply chain, as most components are sourced from the US. There are no tariffs affecting our exports to Germany currently, but potential tariffs could raise prices for O&P providers there. (Paul Gudonis, CEO)

  For the complete transcript of the earnings call, please refer to the full earnings call transcript.

• https://finance.yahoo.com/news/myomo-inc-myo-q4-2024-070320531.html

Tenon OKd for Notice of Allowance from the European Patent Office

 Tenon Medical, Inc. (NASDAQ:TNON) ("Tenon" or the "Company"), a company transforming care for patients suffering from certain Sacroiliac Joint (SIJ) disorders, announced today the Company has been notified by the European patent office that two additional patents directed to the novel Catamaran SI Joint Fixation Device have been approved for grant of a European patent within the European Community.

"The Tenon Medical team is pleased to receive recognition from the European Community for our novel Catamaran® SI joint prostheses," commented Richard Ginn, Co-Founder and Chief Technology Officer of Tenon Medical. "Receiving notification of approval for two additional patents by the European patent office reinforces Tenon's increasingly robust patent position worldwide as well as our commitment to continued innovation."

https://www.accessnewswire.com/newsroom/en/healthcare-and-pharmaceutical/tenon-medicalr-receives-approval-for-notice-of-allowance-from-the-euro-998197