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Wednesday, May 7, 2025

Vanda $210M-$250M revenue target for 2025 amid product launches

 

  • CEO Mihael Polymeropoulos highlighted Vanda’s entry into a new growth phase, driven by multiple commercialized products and an expanding pipeline. Fanapt prescriptions reached multi-year highs, surpassing 2,000 weekly prescriptions by the end of April. Total prescriptions and net product sales for Fanapt increased by 14% year-over-year, with new patient starts growing threefold.
  • Vanda has expanded its psychiatry sales force to approximately 300 representatives and its PONVORY sales team to 40 representatives to support market penetration.
  • The company is advancing regulatory filings, including a new drug application for Tradipitant targeting motion sickness with a PDUFA date of December 30, 2025, and a biologic license application for Imsidolimab expected later this year. Fanapt and HETLIOZ applications are also being reviewed by the European Medicines Agency.
  • CFO Kevin Moran reported Q1 2025 revenues of $50 million, a 5% increase year-over-year, attributed to Fanapt’s growth. Fanapt net product sales were $23.5 million, and HETLIOZ sales were $20.9 million. PONVORY sales decreased to $5.6 million due to volume declines.
  • Vanda reiterated its 2025 revenue guidance of $210 million to $250 million, reflecting growth from Fanapt, HETLIOZ, and PONVORY. End-of-year cash is projected between $280 million and $320 million.
  • Management expects Fanapt’s growth trajectory to accelerate throughout the year, supported by its expanding sales force and the commercial launches of its bipolar disorder indication and PONVORY for multiple sclerosis.
  • Medicare benefit redesign under the Inflation Reduction Act is anticipated to impact gross-to-net adjustments, particularly for Fanapt and HETLIOZ.

Mirum Pharmaceuticals beats Q1 estimates, raises 2025 guidance

 Mirum Pharmaceuticals, Inc. (NASDAQ:MIRM) reported better-than-expected first quarter 2025 results and raised its full-year revenue guidance, sending shares up 3.3% in after-hours trading.

The biopharmaceutical company posted adjusted earnings per share of -$0.30, beating analyst estimates by $0.01. Revenue for the quarter surged 61% YoY to $111.6 million, significantly surpassing the consensus estimate of $98.02 million.

Mirum’s strong performance was driven by robust sales growth across its product portfolio. LIVMARLI net product sales jumped 71% YoY to $73.2 million, while Bile Acid Medicines net product sales increased 47% YoY to $38.4 million.

"It’s been a strong start to the year with commercial growth and multiple milestones achieved across our pipeline," said Chris Peetz, CEO of Mirum Pharmaceuticals. "We’re pleased with the FDA’s approval of LIVMARLI’s tablet formulation, which provides more options for the ALGS and PFIC community in the U.S. in the form of a convenient single tablet dose."

Following the strong quarter, Mirum raised its full-year 2025 revenue guidance to a range of $435 million to $450 million, up from its previous forecast and above the analyst consensus of $427.8 million.

The company also reported progress in its clinical pipeline, with the VISTAS study of volixibat in primary sclerosing cholangitis expected to complete enrollment in the third quarter of 2025.

As of March 31, 2025, Mirum had $298.6 million in cash, cash equivalents, and investments, providing a solid financial foundation for its ongoing operations and research initiatives.

https://www.investing.com/news/earnings/mirum-pharmaceuticals-beats-q1-estimates-raises-2025-guidance-shares-rise-93CH-4030177

Vir starts Phase 3 for hep D

 - Initiated Phase 3 registrational ECLIPSE program in chronic hepatitis delta with first patient enrolled in Q1 2025; Program received U.S. FDA Breakthrough and Fast Track designations and EMA PRIME and Orphan Drug designations

- Dose escalation continues for PRO-XTEN™ dual-masked T-cell engagers VIR-5818 (HER2) and VIR-5500 (PSMA)

- On track to initiate a Phase 1 study of VIR-5525, the PRO-XTEN™ dual-masked EGFR-targeting T-cell engager, in the second quarter of 2025

- 24-week post-treatment data from Phase 2 MARCH study in chronic hepatitis B to be presented at EASL on May 9; Further development requires partner

- Strong financial position with approximately $1.0 billion in cash and investments providing runway into mid-2027

- Conference call scheduled for May 7, 2025 at 1:30 p.m. PT / 4:30 p.m. ET

2025 Financial Guidance

Based on current operating plans, the Company expects its cash, cash equivalents and investments to fund its operations into mid-2027.

Conference Call

Vir Biotechnology will host a conference call to discuss the first quarter results at 1:30 p.m. PT / 4:30 p.m. ET today. A live webcast will be available on https://investors.vir.bio and will be archived for 30 days.

https://www.biospace.com/press-releases/vir-biotechnology-provides-corporate-update-and-reports-first-quarter-2025-financial-results

STAAR Surgical misses Q1 estimates, withdraws outlook

 STAAR Surgical Company (NASDAQ:STAA) reported first quarter results that missed analyst expectations and withdrew its previous financial guidance, citing economic uncertainty and tariff policy challenges.

STAA shares were trading 7.4% lower in after-hours Wednesday folllowing the release.

The implantable lens maker posted a net loss of $54.2 million, or $1.10 per share, compared to a loss of $3.3 million, or $0.07 per share, in the year-ago quarter. Adjusted earnings per share came in at a loss of $0.53, missing the analyst consensus estimate of a $0.58 loss.

Revenue fell 45% YoY to $42.6 million, though it exceeded Wall Street forecasts of $40.33 million. The company said the decline was primarily due to a planned reduction of channel inventory in China.

"Our results do not reflect the earnings power of our business or the strength of our brand," said CEO Stephen C. Farrell. "We are making progress working through transitory challenges in our China business, and importantly, we believe that EVO ICL (TASE:ICL) procedure volumes in China are improving compared to the first quarter last year, despite the macroeconomic headwinds."

STAAR withdrew its previous financial outlook for 2025, citing global economic uncertainty and evolving tariff policies that make forecasting more challenging. The company said it is implementing cost controls and restructuring activities to reduce its SG&A run rate.

Despite the near-term headwinds, Farrell expressed optimism about STAAR’s long-term prospects, citing the company’s technology, market share gains, and large addressable market supported by the expanding incidence of myopia.

https://www.investing.com/news/earnings/staar-surgical-misses-q1-estimates-withdraws-outlook-93CH-4029832

India-Pakistan War Could Derail Central Asia's Future

 by James Durso via OilPrice.com,

  • A war between India and Pakistan would significantly destabilize Central Asia, disrupting trade routes, delaying infrastructure projects, and increasing regional militancy.

  • China, Russia, and the U.S. may intensify involvement in Central Asia, leveraging the conflict to protect or expand their influence.

  • Potential nuclear fallout, refugee flows, and the breakdown of regional cooperation could severely impact Central Asia’s economic development, security, and food systems.

If India and Pakistan spiral into war, there will be consequences for Central Asia.

A war between Pakistan and India would likely have significant ripple effects on Central Asia, given the region's proximity to Afghanistan and flourishing economic ties across the region. The conflict could disrupt trade and energy routes, increase militancy, and draw in major powers like China, Russia, and the U.S., potentially straining Central Asian stability.

Intervention by external powers: The Central Asian republics (Kazakhstan, Uzbekistan, Turkmenistan, the Kyrgyz Republic, and Tajikistan) are already arenas for competition among outside powers. A Pakistan-India conflict could draw these powers into the region more aggressively to secure their interests, though Russia is busy in Ukraine, Turkey is busy in Syria, and U.S. forces are fighting in the Middle East, and Washington is ready to confront China.

China is an ally of Pakistan and sponsor of the $65 billion China-Pakistan Economic Corridor (CPEC). China might deepen its presence in Central Asia to secure trade routes and counterbalance India’s regional influence. This could accelerate Chinese investments in infrastructure and energy projects that will increase trade with the region that totaled $89 billion in 2023, up 27% from 2022, $60 billion of which was Chinese exports.

And China may make further inroads into the Central Asia arms market given Moscow’s need to dedicate all its resources to the Russia-NATO war in Ukraine. This will allow China to broaden its engagement beyond infrastructure projects into the security realm that, up to now, has been limited to anti-terrorism training and intelligence sharing in Tajikistan.

Russia is an ally of India, a buyer of Russian arms, having purchased $60 billion of Russian arms, 65 percent of its total weapons imports, over the past twenty years With its historical ties to Central Asia and shared membership in the Collective Security Treaty Organization (CSTO), Russia might leverage a conflict to reinforce the region’s border security, and increase intelligence sharing and security forces training.

And just in time, Russia has declared it will help the Taliban government fight the Afghan branch of the Islamic State, the Islamic State – Khorasan Province (IS-K).

The United States could focus on Central Asia to counter China and Russia, potentially increasing military or economic aid to Uzbekistan or Kazakhstan, the major economies in the region. Unlike the leaders of Russia or China, no American president has ever visited Central Asia but President Donald Trump could signal increased U.S. attention by visiting the region.  

Afghanistan as a flashpoint. Afghanistan, bordering both Pakistan and Central Asia, would likely become a hotspot. The Afghan Taliban’s support for the Pakistani Taliban, the Tehreek-e-Taliban-e-Pakistan (TTP) could further destabilize Pakistan, presenting Islamabad with the prospect of a two-front war, though recent visits by Pakistan’s diplomats, and military and security officials seeking a “diplomat reboot” may be just in time to stanch action by the TTP.

Instability would come to Central Asia via Afghanistan in the form of refugees and energized militants, and economic stagnation in the delay of development projects like the Trans-Afghan railway, the Turkmenistan–Afghanistan–Pakistan–India (TAPI) natural gas pipeline, and the CASA-1000 renewable energy infrastructure construction project.

General disorder may spill insecurity into Tajikistan and Uzbekistan, where cross-border militancy (e.g., the Islamic Movement of Uzbekistan (IMU), which has pledged allegiance to al-Qaeda, and IS-K could surge.

And the instability will cause a slowdown in foreign direct investment that has steadily climbed as has foreign trade in goods and accession to bilateral investment treaties. The region’s economy suffered “lost decades” between the start of the Afghan civil war in 1992 and the end of the NATO occupation of Afghanistan in 2021 and has been making steady progress in connecting to the wider world economy; Turkmenistan and Uzbekistan are completing the World Trade Organization (WTO) accession process, and Kazakhstan and Tajikistan are WTO members.

And just in time for a war, the World Bank is predicting economic slowdown for Central Asia:   Kyrgyzstan and Tajikistan will suffer pronounced declines, Kazakhstan’s decline will be less pronounced, and Uzbekistan’s growth rate will remain steady at 5.9%.

The U.S. may try to leverage disorder on Afghanistan’s border with Pakistan to pressure the Kabul government, but that risks empowering Al-Qaeda, IS-K, the hardline Taliban faction in Kandahar, or some combination of the three. Disorder in Pakistan’s Balochistan province, the poorest place in Pakistan, may energize the local separatists and draw in bordering Iran which faces a Baloch insurgence on its side of the border.

India’s Central Asian Ambitions. India’s efforts to access Central Asian and Afghan resources, via Iran’s Chabahar port, could be disrupted, forcing India to seek alternative routes or deepen ties with Russia and Iran, affecting regional alignments, and angering the U.S. which is trying to isolate Moscow and Tehran.

India imports uranium for its nuclear power program from Kazakhstan and Uzbekistan and an uninterrupted supply by the republics will be a sign to India they value their relationship with Delhi.  

Trade Route Disruptions: Central Asia relies on connectivity projects like CPEC and the International North-South Transport Corridor (INSTC). A war could disrupt CPEC which links China’s Xinjiang province to Pakistan’s Gwadar port and passes through contested areas like Kashmir. India’s trade routes to Central Asia via Iran and Afghanistan could be jeopardized if conflict escalates or Afghanistan becomes unstable, though if Indian merchantmen are unmolested by Pakistan the impact may be minimized and they will be able to safely dock at Iranian ports.

Tightened border controls will hurt regional trade that was boosted by eased border controls that teased the possibility of a unified regional market, following the resolution of many territorial disputes, a process that began in earnest after the 2016 election of Uzbekistan’s president, Shavkat Mirziyoyev.

The Central Asia republics trade with India and Pakistan and will be reluctant to be drawn into one side’s economic warfare on the other. Kazakhstan, Uzbekistan, and Turkmenistan, the three largest economies in the region, all import packaged medicaments and vaccines from India and mostly food products from Pakistan, and may find it easier to replace the lower-valued agriculture products than disrupting their medical supply chain.

Pakistan and Kazakhstan recently inked a transit trade agreement that would see goods shipped from Central Asia through the Pakistani ports of Karachi, Bin Qasim, and Gwadar, and the start of direct flights between the countries. An India-Pakistan war will bring in the insurance companies who may cancel coverage to aircraft, trucks, and their cargoes, delaying the benefits of the deal.

Spillover of Militancy: A Pakistan-India war, especially if centered on Kashmir, could embolden extremist groups like Jaish-e-Mohammed or Lashkar-e-Taiba, which have historical ties to Afghan and Pakistani militants. 

This could inspire increased terrorist activity in Tajikistan and Uzbekistan, where groups like the IMU and IS-K could exploit regional conflict for recruitment and radicalization.

Nuclear Risks: Both nations possess nuclear arsenals, less than 200 weapons each. Even a limited nuclear exchange could cause dire environmental and climatic effects, disrupting Central Asian agriculture and food security, and pretty much eliminating agriculture exports as customers fret about “contamination,” despite the prevailing westerly winds. In Uzbekistan, agriculture contributes about 25% to the Gross Domestic Product and employs about a quarter of the workforce, so the economic (and political) impact would be profound.

Conflict in Pakistan or Afghanistan could drive refugees into Central Asia, particularly Tajikistan, straining resources and sparking ethnic tensions, and destabilizing resource-strapped governments.

India and Pakistan are members of the Shanghai Cooperation Organization (SCO), as are several Central Asian states, and China and Russia. A war could paralyze SCO initiatives, hindering regional security and economic cooperation. Tensions might also exacerbate India-China rivalries within the SCO, affecting Central Asia’s balancing act.

Specific Impacts on Central Asian States

Tajikistan shares a porous border with Afghanistan, making it vulnerable to militancy and refugee inflows. India’s military training programs with Tajikistan could be disrupted, and its newly-refurbished (by India) Ayni Airbase base may worry Pakistan.) As a regional leader, Uzbekistan might seek to strengthen ties with Russia and China to counter instability, however, its trade with South Asia could suffer. Neutral but energy-dependent, Turkmenistan could benefit from Chinese energy demand. As the major Central Asia economy, Kazakhstan might leverage its SCO and Eurasian Economic Union ties to mitigate disruptions but could face energy market volatility. Kyrgyzstan is economically fragile and be hit hard by trade disruptions increasing reliance on China or Russia.

Long-Term Implications

Regional Polarization: Central Asia could become more divided, with some states aligning with China (e.g., Turkmenistan) and others with Russia or the West (e.g., Kazakhstan, Uzbekistan), hindering regional unity, which may be in the interests of Washington, Beijing, Brussels, or Moscow.

Securitization: Fear of spillover could lead Central Asian states to increase security spending, diverting resources from economic development. More than half of Central Asia’s population is under 30 years of age and they have high expectations that governments are trying to satisfy by increasing educational and economic opportunity, and diversifying the economies away from agriculture and natural resource extraction, and towards technology, services, and tourism. And more security may come at the expense of civil rights.

Environmental Fallout: A nuclear conflict, even limited, could cause global climate disruptions, devastating Central Asia’s agriculture-dependent economies.

Conclusion

India has been active in Central Asia with its Connect Central Asia Policy, which aims to enhance trade, connectivity, and diplomatic engagement, and hinges on India’s development of Chabahar port in Iran, though the Trump administration rescinded the sanctions waiver on Chabahar. Washington’s fixation on Iran, specifically ruining its economy to press it for a favorable nuclear deal, may see India and Central Asia as collateral damage.

The republics import higher value goods from India (Packaged Medicaments) than they do from Pakistan (food products), and sell uranium – a strategic good – to India. India has a larger market than Pakistan and is a provider of technology products that Pakistan cannot match, and the republics’ future is with India, though they have no reason to antagonize Islamabad.

A Pakistan-India war would destabilize Central Asia by disrupting trade, fueling militancy, and intensifying great power rivalries. The region’s proximity to Afghanistan and reliance on connectivity projects make it particularly vulnerable. Central Asian states would face economic strain, security threats, and pressure to align with external powers, potentially fracturing regional cooperation. The nuclear risk underscores the catastrophic potential, with global climatic effects threatening Central Asia’s food security and economic stability. To mitigate these risks, Central Asian states might pursue neutrality, strengthen SCO ties, or seek mediation roles, but their limited clout may constrain effective responses.

https://www.zerohedge.com/geopolitical/how-india-pakistan-war-could-derail-central-asias-future

Officials knew about Nashville shooter’s ‘suicidal’, ‘homicidal’ ideations years before killings

 


Leaked documents reveal that health “professionals” at the Vanderbilt University Medical Center knew that Audrey Hale, the disturbed “trans” individual who slaughtered six innocent people during a school shooting rampage in 2023, had “suicidal” and “homicidal” ideations years before the killing spree.

Who knows how long Hale had been receiving mental health care by 2019, but that was four years before the shooting. Mental health “professionals” noticed Hale’s evident “anger” grow with “greater frequency,” and she admitted she had thoughts of killing herself and killing others—which is why I use air quotes to describe these people. What kind of “professionals” and “doctors” don’t alert law enforcement when they have an obviously sick and homicidal patient saying her only “escape” is death?

But what does the Tennessee Bureau of Investigation do though?

Do they go after the failed therapists who neglected to warn the authorities?

Do they go after the drug companies making money off of Hale’s anguish to her detriment? You can’t take synthetic cross-sex hormones without suffering serious mental issues, and here’s a censored truth: almost all (or all of them entirely, depending on who you’re asking) school shooters are eventually found to have been “hypermedicated,” specifically on SSRIs or barbiturates:

And here:

Do they go after Vanderbilt and any responsibility in the tragedy it may bear?

No, no, and no. They go after the man who leaked the documents, getting the truth that the government wants to hide out to the public:

Rare Earths Need a Big, Beautiful University Home Here in America


The New York Times published a piece on April 14th entitled “China’s Halt of Critical Minerals Poses Risk for U.S. Military Programs,” in which they breathlessly reported that “the Pentagon and defense contractors are heavily reliant on … rare earth minerals” which are “present in almost every form of American defense technology.” Additionally, “China’s decision to retaliate against President Trump’s sharp increase in tariffs… is a warning shot across the bow of American national security….

Gosh, sounds serious, huh?

Rare earths are a group of 17 elements, including neodymium, yttrium, scandium and dysprosium, that are difficult to separate into usable forms. They are not actually rare at all but can be difficult to extract from the earth, and the process of mining and refining them into usable form carries substantial environmental costs.

Aaaaand there it is.  Didja catch it?  “Mining and refining them into usable form carries substantial environmental costs [emphasis added].”  That’s why we are so reliant on China for them.  America’s greenies have all but crippled America’s rare earth mining, despite E.O.s from Trump’s first term and even Biden’s single term. Now, why would Biden sign such an E.O.?  Because all that green technology needs them too.   Solar panels, etc.

So let’s just pause for a moment and really take this all in, because we extrapolate, unlike the left.  We actually think things through, which is why we can see none of this makes any sense.

The American left wants to be the king of all things green, but lefty-greenies have deemed the rare earths we need to manufacture all things green too dirty to mine domestically.  Now, as a result, China mines darned near 100% of the entire world supply of rare earths.  They don’t have an E.P.A. and frankly, don’t care. (Neither, evidently, do the greenies.  Out of sight, out of mind.) So — go with me here — in order to not be reliant on dirty foreign oil we have to be reliant on dirty foreign rare earths.  A sensible person might observe that we are simply “recycling” the problem; trading one “dirty” energy (oil) for another (rare earths), but now with a green imprimatur.  In short:  it’s basically a net-net in terms of “dirt” for the planet, but they, the left, get to feel better about themselves.

Told you it was stupid.

Take some solace. We weren’t always this stupid.

From the 1960s to the 1980s, the United States was the leader in global production of rare earths. Since that time, production of the world’s supply of rare earths has shifted almost entirely to China, in part due to lower labor costs and lower environmental standards. China produces about 97% of rare earth oxides….

 

And the New York Times wasn’t always so breathless.  When China stiffed us on rare earths during Obama’s first term, The New York Times breathed calmly in and out, hoping to score invites to the State Dinner held in then-President Hu’s honor.  Obama was, as usual, embarrassing us with his weakness.  In a joint presser with then-President Hu hours before the dinner, Obama said he was mindful of “the multiple areas in which we have to cooperate (with China) not only for the sakes of our countries but also for the sake of the world….”  And that’s precisely what he did.  He feted them with his standard issue Obama “foreign policy,” which was to believe he could smooth-talk his way into whatever it was he wanted, which, as was typical for him, ended up not only failing but spectacularly backfiring.  The State Dinner was in January 2011.  By December of that year Beijing was “grouchy” with Obama then, only weeks later, was telling its Navy to prepare for war.  Obama styled himself America’s first “Pacific president” and, well, you can see how well that worked out.

Understand the environment Obama was operating in when he held this dinner:

In July 2010, the China Ministry of Commerce announced that China would cut its exports of rare earth minerals by 72%. In September 2010, China temporarily cut rare earth exports to Japan apparently over a maritime dispute. This dispute highlighted the potential for disruption of the world’s supply of rare earth minerals. For 2011, it appears that China has cut exports further and raised export tariffs for rare earths.

If Obama thought cocktails and dancing was going to get him his rare earths, he was seriously mistaken. Just as any kind of charm offensive now with President Xi.  It won’t work.  And we’re well behind the eight ball. Hell’s bells, even the commie rag The New Republic sees it.  Thirty years ago,

China saw these materials as foundational to its high-tech ambitions—from EVs and wind turbines, to missile guidance systems and MRIs. So, it invested tremendous time and capital… At the same time, the West saw metal making as a dirty industry, ripe for outsourcing. …We ended up gutting the industry.

The U.S. once spoke the language of mining and metallurgy. Now we can barely understand it. … China, meanwhile, speaks this language fluently—helped by nearly 40 universities specializing in extractive metallurgy and another 40 in mineral processing. In the U.S., that number is zero.

Before Linda McMahon shutters the Department of Education entirely, maybe she could incentivize metallurgy as a major.

Fewer than 700 students in the U.S. are enrolled in mining-related fields today.  That’s not a pipeline—it’s a warning. We need new programs, new professors, and global experts teaching the next generation how to extract, refine, and process the materials that power modern economies.

Of course, The New Republic wants our federal tax dollars to “invest” in a new metallurgical renaissance, but we know better.  Show these kids there’s beaucoup bucks to be made being the smartest metal-head in the room, and the market will take care of it. We need to get serious about this.  China ain’t playing.  We simply have to mine our own — again.  Happily, we have a president willing to do just that.

https://www.americanthinker.com/articles/2025/05/rare_earths_need_a_big_beautiful_university_home_here_in_america.html