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Monday, August 3, 2026

TG Therapeutics raises 2026 BRIUMVI guidance to $890–905M, targets ~$1B run-rate

 

TG Therapeutics raises 2026 BRIUMVI guidance to $890–905M, targets ~$1B run-rate with key MS pipeline catalysts ahead

  • Q2 2026 EPS $0.05 on revenue $240.3M, missing EPS expectations while revenue beat forecasts.
  • Q2 U.S. BRIUMVI net revenue $228M, +17% QoQ and 64%+ YoY, above guidance.
  • Total Q2 revenue $240M; gross margin 83% overall, 87% in U.S. business.
  • Underlying operating income about $76M and net income ~$62M excluding $55M manufacturing charges.
  • 2026 U.S. BRIUMVI guidance raised to $890–905M; global revenue expected around $950M.
  • Management targets exiting 2026 with >$250M U.S. quarterly revenue, ~$1B annualized run-rate.
  • ENHANCE Phase III supports single 600mg IV initiation; potential mid-2027 launch to simplify dosing.
  • Subcutaneous BRIUMVI Phase III readout late 2026/early 2027; could more than double addressable market.
  • Commercial metrics strong: record new patient starts, better-than-expected persistence, rising treatment-naive starts on BRIUMVI.
  • 2026 OpEx guided to $350–400M plus ~$100M manufacturing; DTC and pipeline investments increasing.
  • Pipeline broadened into MG, schizophrenia and azer-cel in several autoimmune diseases; current spend described as modest.
  • Main concern: Heavy reliance on BRIUMVI in a competitive anti-CD20 market with critical subcutaneous data and launches still ahead.
  • Strong quarter, driven by accelerating BRIUMVI adoption and higher 2026 guidance with significant MS pipeline catalysts upcoming.

Krystal beats; Europe weighed by German pricing accruals

 

Krystal Biotech beats Q2 2026 EPS estimates on strong VYJUVEK revenue of $119.2M, Europe weighed by German pricing accruals

  • Investor Takeaway: Strong U.S. VYJUVEK growth and profitability; Europe optics skewed by German pricing accruals.
  • Key Results: Q2 revenue $119.2m (+24% YoY); U.S. $91.6m; EPS $1.79 diluted.
  • Guidance & Outlook: 2026 non-GAAP R&D+SG&A $175–195m maintained; registrational readouts expected 2026–2027.
  • Growth Drivers: U.S. VYJUVEK penetration >60% diagnosed DEB; 730+ reimbursements; strong community-setting demand.
  • Problem Areas: Europe/Japan revenue flat QoQ from German price reserves despite underlying vial growth.
  • Margins & Profitability: Gross margin 95% vs 93% prior-year; net income $54.8m.
  • Notable Items: Cash and investments exceed $1.1b; no capital return changes disclosed.
  • Key Metrics: Over 180 international patients treated; 35–50 new U.S. approvals quarterly.
  • Management Tone: Confident on global VYJUVEK ramp, HSV-1 platform, oncology; acknowledges ex-U.S. launch complexities.
  • Q&A Focus: Germany pricing, Europe demand, NK and CF trial design, NK market sizing.
  • Main concern: European revenue volatility and ultimate economics amid ongoing German pricing negotiations.
  • Strong quarter, driven by robust U.S. VYJUVEK growth and high gross margins.

Chinese biotech giant Wuxi AppTec sees first-half earnings surge amid US scrutiny

 Wuxi AppTec, Asia’s largest provider of contract pharmaceutical research, posted net income that smashed market expectations in the first half of the year amid strong demand tied to weight-loss and diabetes drugs, as well as gains in its US business.

Interim net profit attributable to the owners of the Shanghai-based drug contractor advanced 33.7 per cent to 11.08 billion yuan (US$1.64 billion) from a year earlier, surpassing a Bloomberg mean consensus estimate – drawn from a pool of 25 analysts covering the stock – of a 14.5 per cent increase.

Driven by strong commercial momentum across various client drug programmes, “we delivered strong growth across revenue, profit and cash flow” in the first half of 2026, said Li Ge, chairman and CEO of Wuxi AppTec, in a statement on Monday.

The company’s Hong Kong-traded shares edged up 1.37 per cent to HK$162.90 on Monday. The stock has jumped about 62 per cent, year to date. Hong Kong’s stock benchmark, the Hang Seng Index, rose 0.48 per cent on Monday.

Wuxi AppTec generated 28.9 billion yuan in revenue for the first half of the year, marking a 38.9 per cent year-on-year increase.

Sales in the United States climbed to 22.28 billion yuan in the first half of 2026, compared with 14.24 billion yuan during the same period last year. The US revenue accounted for about 77 per cent of its total revenue.

Earlier this year, the company had forecast full-year revenue of between 51.3 billion yuan and 53 billion yuan, with continuing operations expected to expand 18 to 22 per cent, year on year.

Wuxi AppTec’s “tides” business, which includes GLP-1 peptides, has been the company’s growth engine since 2022, according to a Nomura report in July. Revenue from such business rose 44.3 per cent, year on year, to 7.26 billion yuan in the first half, with full-year revenue expected to grow by about 45 per cent.

Wuxi AppTec has increasingly found itself caught in the crossfire of Washington’s efforts to curb China’s growing biotechnology ambitions. In June, the US Department of Defence placed Wuxi AppTec on its 2026 Section 1260H list of alleged “Chinese military companies” – a designation that could jeopardise the firm’s eligibility for future US government contracts under the Biosecure Act.

WuXi AppTec sued the US Department of Defense on June 11.

“This erroneous designation is not supported by facts or law,” CEO Li said in his statement on Monday. “We have taken legal action to protect the interests of our customers, employees and shareholders.

“We believe that the facts will prevail after an objective and fair judicial review of this ongoing litigation.”

The move is part of a broader crackdown by US lawmakers on China’s biotech sector. In late June, the House Select Committee on China opened an investigation into five major American drug makers, Bristol-Myers Squibb, Eli Lilly, Merck, AbbVie and Pfizer, demanding details on clinical trials that the companies conducted at People’s Liberation Army hospitals and in the Xinjiang Uygur autonomous region, citing ethical and national security concerns, according to a statement from the committee.

https://www.scmp.com/business/banking-finance/article/3362817/chinese-biotech-giant-wuxi-apptec-sees-first-half-earnings-surge-amid-us-scrutiny

'Murders In The US Set To Hit 126-Year-Low Following Illegal Immigrant Deportations: DHS'

 by Naveen Athrappully via The Epoch Times,

Crime rates have fallen to “historic lows” across the United States, with homicides this year on track to register the lowest level in at least 126 years, according to the Department of Homeland Security (DHS).

In the first half of 2026, homicides were down 18 percent compared to the first half of last year, DHS said in a July 31 statement. Carjacking crimes tumbled 47 percent during this period, motor vehicle thefts fell 20 percent, robberies dropped 17 percent, and residential burglaries declined 13 percent.

The numbers come from a July 2026 report from the nonpartisan think tank Council on Criminal Justice (CCJ) that assessed crime stats across various U.S. cities.

Compared to the first half of 2022, the second year of the Biden administration, homicides in the first half of 2026, the second year of the current Trump administration, were down by 51 percent, according to the CCJ report.

For violent crimes, 2 percent fewer aggravated assaults and 6 percent fewer gun assaults were reported in the first half of 2026 compared to the same period last year. However, domestic violence incidents were up 8 percent, and sexual assaults by 3 percent for this period.

When compared to the first half of 2019, the year prior to the COVID-19 pandemic onset, homicides, aggravated assault, gun assault, sexual assault, domestic violence, robbery, and carjacking crimes were all lower in the first six months of 2026, the report said.

In its statement, DHS gave examples of some of the illegal immigrants with criminal histories who have been deported from the United States: A Salvadoran national with convictions for homicide and assault, a Costa Rican with convictions for property crimes and burglary, a Honduran Tren de Aragua gang member convicted for robbery, and a Vietnamese national convicted for armed carjacking.

“President [Donald] Trump promised to make America safe again, and he has done just that,” Lauren Bis, assistant secretary at the DHS’s Office of Public Affairs, said in the statement.

“Crime has fallen to record lows under the Trump Administration.”

“It’s no surprise that this drop in crime coincides with deportations of dangerous criminal illegal aliens. It is common sense. When you remove criminals from the country, crime rates fall,” Bis said.

In the first year of the current Trump administration, almost three million illegal immigrants had left the United States, then-DHS Secretary Kristi Noem said in a Jan. 20 DHS statement.

Declining Homicides

The CCJ report said that there is no single explanation for the historic low in homicide crimes in the first half of the year. It cited potential impacts from changes in criminal justice operations and strategies, shifts in society and culture, and technological advances.

In a July 23 statement, CCJ said it planned on convening a two-day summit in September with researchers from fields such as criminology, psychology, economics, and sociology to examine the factors likely driving the decline in homicides.

“Murder and other crime rates are falling across the map, in cities with different political leadership, housing and economic conditions, policing and prosecution strategies, violence reduction models, and levels of federal enforcement activity,” CCJ president Adam Gelb said in the statement.

“Local policies and programs surely matter, but the striking consistency of the decline suggests that macro-level forces are exerting enormous influence as well,” Gelb said.

The White House attributed the crime decline in the first half of the year to the Trump administration’s policies in a July 29 statement.

America’s neighborhoods are now safer, registering fewer victims and a decisive end to the crime surge seen in the last decade, the White House said, highlighting that this was “not accidental.”

“It is the direct result of the Trump Administration’s relentless efforts to enforce the rule of law, back the police, and surge resources into communities,” according to the White House.

On Jan. 20, 2025, the first day in his second term, President Donald Trump signed an executive order restoring the death penalty, highlighting that capital punishment was an “essential tool” to deter and punish those who would commit heinous crimes.

The same day, Trump signed another executive order targeting illegal immigrants. In the order, Trump clarified that it is the policy of the United States to faithfully execute immigration laws against all removable illegal immigrants, especially those who “threaten the safety or security of the American people.”

And in April last year, Trump signed an executive order that focused on providing new best practices to local and state law enforcement to “aggressively police communities against all crimes.”

https://www.zerohedge.com/political/murders-us-set-hit-126-year-low-following-illegal-immigrant-deportations-dhs

Hate crimes soar under Mamdani — over half committed against Jews: NYPD

 Hate crimes have surged in the Big Apple this year under Mayor Zohran Mamdani – with more than half of the incidents targeting Jewish New Yorkers, unsettling new crime statistics show.

The startling 9.4% uptick in hate crimes citywide comes even as all seven major crime categories saw sharp declines across all five boroughs – including historic lows for murders and shootings – according to NYPD data released Monday.

Year to date, the number of confirmed hate crimes in the city jumped from 329 last year to 360, with 33 coming in July alone. More than half (56.9%) were anti-Jewish hate crimes, despite making up just 10% of New York City’s population.

Stabbing victim Moshe Grunhaus was attacked near a synagogue in Manhattan last month in a suspected hate crime.Facebook/Lidia Lander

Hate crimes against Jewish New Yorkers so far this year have increased by 8.5% – 205 year-to-date compared to 189 for the same period last year.

Meanwhile, other major crimes are experiencing major dips across the board.

In July, shootings decreased 21.3% and were down in every borough. In July 2020, 243 shooting incidents were recorded compared to just 59 this year, representing a 75% drop for the month.

Year-to-date shootings were down 7.5% citywide, with 771 shooting incidents in the first seven months of 2020 compared to just 381 this year.

Murder was down 32.3% in July, and 22.8% year to date.

Burglary, auto theft, robbery, grand larceny and felony assault were also down between 0.4% and 25.3% year to date.

“This summer, the NYPD was called upon to manage an unprecedented series of major and overlapping events, including the NBA Finals, the World Cup, Sail250, and the largest Fourth of July celebration in the country,” NYPD Commissioner Jessica S. Tisch said in a statement.

Skiboky Stora was convicted with two counts of assault in the third degree as a hate crime, among other charges, in New York on Feb. 25, 2026.Steven Hirsch for NY Post
“Through it all, even as the demands on this department reached historic levels, the men and women of the NYPD delivered double-digit declines in major crime and record lows in violent crime across the city,” she said.

She chalked the record lows of violent crime to “our data-driven precision policing policy and the tireless work of the members of the NYPD whose long hours and dedication continue to make New York City safer.”

Mamdani has faced a steady stream of criticism from the city’s Jewish leaders since before he took office, which has only magnified since.

Demonstrators at a “End Jew Hatred” rally in Manhattan on July 26, 2026.Michael Nigro for NY Post

Last month, Jewish community leaders urged Hizzoner to “stop fanning the flames of hatred and division” after a lunatic viciously stabbed a Jewish man in a suspected hate crime and the mayor offered little more than a canned response.

“You know, first and foremost, I want to make clear that this is a city where we have no tolerance for hatred of any kind, the hatred of someone on the basis of their faith, their background, natural identity,’’ he said when asked if he had a reaction to the outrage from the Jewish leaders.

He’s also taken heat from the Jewish community over his longstanding reluctance to condemn the phrase “globalize the intifada,” and his associations with individuals like his chief counsel, Ramzi Kassem, who previously represented an al Qaeda tanker-bombing pilot

Counter-protesters rallied to “End Jew Hatred” on July 26 in New York City.

Mamdani has been a conspicuous no-show at bridge-building events like the annual Israel Day Parade in May, which the mayor skipped to tout his 2029 reelection bid and ride his bicycle.

Moshe Spern, president of United Jewish Teachers, said the surge in antisemitic hate crimes should alarm every New Yorker.

“When one community is being attacked at this disproportionate rate while the rest of the city gets safer, that is not random. It is a failure of leadership,” he said, slamming the mayor over the mushrooming violence unfolding on his watch.

“Jewish New Yorkers have every right to expect that their safety will be treated as a priority, not an afterthought. The mayor must stop the rhetoric that fuels hostility and start treating antisemitic violence with the urgency it demands.”

Mamdani’s office did not immediately respond to The Post’s request for comment.

https://nypost.com/2026/08/03/us-news/hate-crimes-soar-in-nyc-under-mamdani-even-as-major-crime-tumbles-overall/