Corcept beats, ups guidance

 Corcept Therapeutics reported its Q2 2025 earnings on July 31, revealing a significant earnings per share (EPS) beat but a slight revenue miss. The company posted an EPS of $0.29, exceeding the forecasted $0.19 by 52.63%. Revenue came in at $194.4 million, slightly below the anticipated $199.4 million, resulting in a 2.51% surprise. According to InvestingPro data, Corcept maintains a "GREAT" financial health score, with particularly strong profitability metrics. Despite the EPS beat, Corcept’s stock fell 3.92% in after-hours trading, closing at $69.77, as investors reacted to the revenue miss and ongoing supply chain issues.

Key Takeaways

• EPS of $0.29 beat expectations by 52.63%.
• Revenue missed forecasts by 2.51%, impacted by supply chain constraints.
• Stock price decreased by 3.92% in after-hours trading.
• Corcept revised its 2025 revenue guidance to $850-900 million.
• Significant growth in Korlym prescriptions and promising drug pipeline.

Company Performance

Corcept Therapeutics demonstrated resilience in Q2 2025, with revenue reaching $194.4 million, up from $163.8 million in the previous year. The company’s impressive 30.9% revenue growth over the last twelve months reflects strong market momentum. Despite a slight decline in net income to $35.1 million from $35.5 million, the company maintained strong cash and investments totaling $515 million. The launch of an authorized generic product, which now constitutes two-thirds of its business, has been a key driver of performance, despite initial discounts impacting revenue.

Financial Highlights

• Revenue: $194.4 million, up from $163.8 million YoY.
• Earnings per share: $0.29, exceeding the $0.19 forecast.
• Net income: $35.1 million, slightly down from $35.5 million YoY.
• Cash and investments: $515 million.
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• Earnings vs. Forecast

Corcept’s EPS of $0.29 surpassed the forecasted $0.19, marking a 52.63% positive surprise. However, revenue fell short of expectations, coming in at $194.4 million against the projected $199.4 million, a 2.51% miss. This mixed performance reflects both strong cost management and challenges in revenue growth.

Market Reaction

Following the earnings release, Corcept’s stock experienced a 3.92% decline in after-hours trading, closing at $69.77. This drop reflects investor concerns over the revenue miss and supply chain issues, despite the EPS beat. The stock remains within its 52-week range of $32.33 to $117.33, with analysts setting price targets between $131 and $145

Outlook & Guidance

Corcept revised its 2025 revenue guidance to $850-900 million, reflecting confidence in its product pipeline and market expansion efforts. The company is optimistic about its upcoming drug approvals and expects significant contributions from its expanded sales force and new pharmacy partnerships.

https://www.investing.com/news/transcripts/earnings-call-transcript-corcept-therapeutics-q2-2025-earnings-beat-expectations-93CH-4164681

Fulgent Genetics topped estimates, ups guidance

 Fulgent Genetics (NASDAQ: FLGT) reported second quarter EPS of $0.07, $0.25 better than the analyst estimate of $-0.18. Revenue for the quarter came in at $81.8M versus the consensus estimate of $76.21M.

Guidance

Fulgent Genetics sees FY 2025 EPS of $-0.35-$0.00 versus the analyst consensus of $-0.55.

Fulgent Genetics sees FY 2025 revenue of $320.00M versus the analyst consensus of $310.70M.

https://www.investing.com/news/earnings/fulgent-genetics-earnings-beat-by-025-revenue-topped-estimates-4165538

Novavax Stock Dips As Moderna's Woes Weigh On Vaccine Sector

 Shares of Novavax traded lower as vaccine maker Moderna reported disappointing 2 results and cut outlook.

https://www.inkl.com/news/novavax-stock-dips-as-moderna-s-woes-weigh-on-vaccine-sector

FDA Issues Regeneron CRL for Odronextamab in Relapsed/Refractory Follicular Lymphoma

 The FDA has issued a complete response letter (CRL) to the biologics license application (BLA) seeking the approval of odronextamab (Ordspono) for the treatment of adult patients with relapsed or refractory follicular lymphoma who have received at least 2 prior lines of systemic therapy.¹

In an announcement from Regeneron, the developer of the CD20 x CD3 bispecific antibody noted that the CRL was related to observations from an FDA general site inspection at Catalent Indiana, LLC.

This marks the second CRL issued by the FDA for odronextamab following an initial letter in March 2024, which was related to the status of confirmatory trial enrollment and not to issues of safety, efficacy, or manufacturing.2 In February 2025, the FDA accepted a resubmission of the biologics license application seeking the approval of odronextamab for the treatment of patients with relapsed/refractory follicular lymphoma.3

The BLA was supported by data from the phase 2 ELM-2 (NCT03888105) and phase 1 ELM-1 (NCT02290951) trials.

Notably, the confirmatory phase 3 OLYMPIA-1 trial (NCT06091254) is currently ongoing.

In August 2024, odronextamab received regulatory approval in the European Union for the treatment of patients with relapsed/refractory FL or relapsed/refractory diffuse large B-cell lymphoma following at least 2 prior lines of systemic therapy.4

Odronextamab is an off-the-shelf, CD20×CD3-directed bispecific antibody designed to redirect T cells to kill malignant B cells.3

ELM-2 Trial Design and Results

The multicenter, open-label ELM-2 study enrolled 128 adult patients with grade 1 to 3a follicular lymphoma who were relapsed or refractory to 2 or more prior therapies, including an anti-CD20 antibody and alkylating agent.5 Patients needed to be ineligible for treatment with rituximab (Rituxan)/lenalidomide (Revlimid), and have an ECOG performance status of 0 or 1. Patients were treated with intravenous odronextamab using a step-up dosing strategy during the first cycle to mitigate cytokine release syndrome (CRS) risk.

In cycles 2 through 4, patients received 80 mg of odronextamab on days 1, 8, and 15 every 21 days. Maintenance dosing at 160 mg every 2 weeks continued until disease progression or other protocol-defined discontinuation.

The median time to first complete response (CR) was 2.6 months (IQR, 2.5-2.9), and the estimated median duration of response was 15.8 months (95% CI, 6.4-not estimable), with the longest ongoing CR reported at 53 months.

ELM-2 Safety Findings

All patients in ELM-2 experienced at least 1 treatment-emergent adverse effect (TEAE), and 92% of patients experienced treatment-related AEs (TRAEs). The most common any-grade TEAEs included CRS (56%), neutropenia (39%), and pyrexia (38%). Grade 3/4 TEAEs most commonly included neutropenia (32%), anemia (12%), and decreased neutrophil counts (12%). Most CRS events occurred during the step-up dosing phase in cycle 1 and were grade 1 or 2 in severity.

Supporting Data From ELM-1

ELM-1 evaluated odronextamab in patients with relapsed/refractory non-Hodgkin lymphoma (n = 145).6 Among efficacy-evaluable patients, the overall response rate (ORR) was 51% (95% CI, 42%-59%), with a CR rate of 37%. In a subset of patients with relapsed/refractory follicular lymphoma treated with odronextamab at doses of at least 5 mg (n = 32), the ORR was 91% (95% CI, 75%-98%), and the CR rate was 72% (95% CI, 53%-86%).

Grade 3 or higher TEAEs occurred in 82% of patients in ELM-1, with anemia (25%), lymphopenia (19%), and hypophosphatemia (19%) among the most frequently reported.

https://www.onclive.com/view/fda-issues-crl-for-odronextamab-in-relapsed-refractory-follicular-lymphoma

Aid Group Marks Delivery of 100 Million Meals to People of Gaza

 The Gaza Humanitarian Foundation reached a milestone Friday: The humanitarian aid organization backed by the U.S. and Israel has delivered 100 million meals to the people of Gaza since its launch at the end of May.

“Reaching 100 million free meals delivered directly to the people of Gaza in just two months of operations is a moment of deep pride and reflection,” the Rev. Johnnie Moore, the group’s executive chairman, told The Daily Signal.  

“This milestone belongs first and foremost to the courageous aid workers, including our Palestinian partners, who make it possible against extraordinary challenges,” Moore said, adding that the foundation’s workers “risk their lives every day to help those in urgent need, and they deserve the world’s respect and thanks.”  

Women pose for a photo at a Gaza Humanitarian Foundation aid site in Gaza. (GHF)

A number of Gaza Humanitarian Foundation workers have been injured while working in Gaza, and Hamas killed a dozen local workers in June, according to the aid group. Hamas has also placed bounties on the heads of American and local foundation workers.  

In addition to suffering severe security threats from Hamas, the foundation has also faced criticism from the U.N. and world leaders following incidents near its distribution sites, some of which have resulted in civilian deaths. In mid-July, about 20 people were trampled to death in a chaotic scene at an aid distribution site as Palestinians sought to collect food. 

U.N. Secretary-General António Guterres has called the Gaza Humanitarian Foundation “inherently unsafe,” claiming the group “is killing people.” On Sunday, a group of 21 Senate Democrats sent a letter to Secretary of State Marco Rubio urging the Trump administration to suspend its financial support for the foundation, claiming the group has blurred the lines “between delivery of aid and security operations.” 

The foundation does employ security personnel in an effort to ensure civilians, not Hamas, get access to the aid.  

“We have faced enormous challenges. Our workers have been attacked and killed. Our integrity has been unfairly questioned. We have operated without the resources and recognition given to others. But we have not stopped, and we will not stop. The people of Gaza are starving to death today. They cannot afford to wait for ideal conditions tomorrow,” Moore said, adding:

The crisis in Gaza grows more deadly, more chaotic, and more painful with each passing day. The world is watching closely. While others stand on the sidelines and raise alarms, our team is working.

Every single day, in some of the most dangerous conditions on earth, they are pushing harder, reaching farther, and delivering more food to families in desperate need. 

While the group does not publicize the number of aid workers operating in Gaza for security reasons, the Gaza Humanitarian Foundation team consists of experienced American security personnel, humanitarian workers with experience serving under the U.N. and U.S. Agency for International Development, individuals designated to handle logistics, and local Palestinians with knowledge of the culture.  

Moore also expressed his gratitude to President Donald Trump “and his administration for their continued support of our efforts.” 

The U.S. has backed the work of the Gaza Humanitarian Foundation with $30 million.  

“This milestone is not an end. It is a call to continue,” Moore says of reaching 100 million meals distributed. “We are proud, but we are not satisfied, and we invite anyone who shares our mission to join us.” 

https://www.dailysignal.com/2025/08/01/exclusive-aid-group-delivers-100-million-meals-people-gaza/

Starving for the truth

 by Scott Johnson

Eitan Fischberger is an Israeli journalist who is active on X. Today’s Wall Street Journal carries his corrective column “Gaza Starvation Photos Tell a Thousand Lies.” Subhead: “Hamas propaganda exploits seriously ill children, and Western media go along.” Fischberger writes:

* * * * *

Over the weekend, I embedded with the Israel Defense Forces in Gaza, where I saw the enormous quantities of humanitarian aid the United Nations has been refusing to distribute. What struck me most were the thousands upon thousands of pounds of baby food, baking under the Middle Eastern sun—jar after jar of mashed carrots, pureed potatoes and fruit blends. This food could have gone to children like Mohammed al-Mutawaaq.

Those who don’t know his name will almost certainly recognize his face. Pictures of him, gaunt and fragile, staring vacantly into the camera, were plastered across the homepages of major media outlets last week, from the New York Times and Politico to the BBC. Mohammed, more than anyone else, was made the face of a devastating allegation: that Israel is deliberately starving Palestinian children.

That wasn’t the truth about Mohammed, nor is it the truth about what’s happening in Gaza. Mohammed suffers from cerebral palsy, according to British investigative journalist David Collier, who uncovered a local charity’s May 2025 report mentioning the boy’s condition. CNN, for its part, briefly noted in an offhand comment during a broadcast that Mohammed suffers from a “muscle disorder,” before dropping the point from later reporting. Another notable omission from virtually all media coverage were the photos of Mohammed being held by his mother with his older brother standing nearby. Both mother and brother appear healthy and fed.

“Children in Gaza are malnourished and starving,” noted an unrepentant July 29 editor’s note in the New York Times. The paper admitted it had “since learned new information” and “updated our story to add context about [Mohammed’s] pre-existing health problems.” That context would have been more useful before publishing his image on the front page and fueling global outrage.

Mohammed’s isn’t the only recent case of babies afflicted with terrible illnesses being exploited to promote a false narrative that Israel is intentionally starving Gazan children. Cogat, the Israeli military unit that coordinates humanitarian aid in the Palestinian territories, tweeted Monday about a viral photo of a different child, Osama al-Raqab. Like Mohammed, Osama looked emaciated, and critics claimed that he too was starving due to Israel’s actions. These critics include Dr. Muneer Alboursh, director of the Hamas-run Gaza Ministry of Health, who tweeted that Israel was trying to “mislead public opinion by claiming that he was suffering from other illnesses, not hunger” and that “what is happening is not propaganda, but a real famine.”

Yet according to Cogat—and previously confirmed by the boy’s mother to the Associated Press—Osama actually suffers from cystic fibrosis. On June 12, Israel coordinated his evacuation to Italy, along with his mother and brother, so he could receive medical treatment. “Tragic images rightfully stir strong emotions,” the Cogat post said. “But when they’re misused to fuel hatred and lies, they do more harm than good.”

That harm was clear to me in Gaza, where I stood surrounded by nearly 600 trucks worth of food, water and diapers, all ready to be delivered….

Whole thing here.

https://www.powerlineblog.com/archives/2025/07/starving-for-the-truth.php

Canada’s dangerous embrace of appeasement

 Canada’s new prime minister, Mark Carney, has made his diplomatic debut by announcing that his country plans to recognize a Palestinian state at the U.N. General Assembly this September. While he presents the move as a noble attempt to preserve the two-state solution, in practice, it does the opposite: It rewards terrorism, undermines Israel’s security and legitimizes a Palestinian leadership that has rejected peace time and again.

The timing of this announcement is not just poor but downright appalling. Carney invokes the horrors of Oct. 7, 2023, when Hamas-led terrorists burned, murdered, raped and kidnapped Israeli civilians in the worst atrocity against Jews since the Holocaust. And yet he frames his country’s decision as a reaction to Israel’s actions—not those of Hamas.

Canada, he says, must act because of Israel’s growing presence in Judea and Samaria (aka, the West Bank), and the humanitarian crisis in the Gaza Strip. Somehow, Hamas’s war crimes become Israel’s moral burden.

This is the same perverse logic that animated recent decisions by French President Emmanuel Macron and British Prime Minister Keir Starmer, who have also made gestures toward recognizing a Palestinian state. In each case, the recognition is “conditional,” based on vague promises of Palestinian reform, elections or demilitarization. But those conditions are fantasy.

The Palestinian Authority has not held elections in nearly 20 years. Its president, 89-year-old Mahmoud Abbas, is in the 19th year of a four year term of office. It pays monthly salaries to terrorists. It glorifies murderers in textbooks and on television. It rejected generous offers for peace in 2000, 2001, 2008 and 2014—each time walking away without offering a counterproposal.

If Carney wants reforms, why offer recognition now? What incentive remains for Abbas, or his successor, to change course once Canada has handed over diplomatic legitimacy for free?

Israel’s furious reaction to Carney’s announcement is fully justified. The recognition of a Palestinian state, particularly while Hamas still holds hostages and Gaza remains a launchpad for terrorism, sends a clear message: Violence works. Kill enough civilians, and the West will pressure Israel to make concessions. It’s an inversion of justice.

Instead of standing with the victims, Canada is penalizing the one democracy in the Middle East trying to defend itself while respecting the rule of law. We are now in Bizarro World.

What’s more, the Canadian decision endangers future peace. Recognition should be the result of negotiations, not a substitute for them. By acting unilaterally, Carney’s government undermines the very process it claims to support. You don’t negotiate with someone after they’ve already been handed what they want. And by elevating the P.A., Canada further diminishes the prospect that it will ever come to the table in good faith.

Let’s also dispense with the idea that this is merely a symbolic move. In the Middle East, symbols matter. Recognizing a Palestinian state under current conditions gives international credibility to a governing structure that lacks legitimacy among its own people, that uses foreign aid to finance terrorism and that denies Israel’s right to exist—not just in word, but in deed.

For decades, Canada has been a principled supporter of Israel, recognizing the shared values of democracy, civil rights and human dignity. That legacy is now at risk. Carney is aligning Canada not with the forces of moderation and accountability, but with the bloc of appeasement—those who believe that peace can be bought with gestures, rather than earned through security, mutual recognition and hard diplomacy.

Jews around the world have learned the painful lesson of history: when the world says “yes” to terrorists, it’s the innocent who pay the price. Once a beacon, Canada’s moral clarity is dimming at precisely the moment when it is needed most.

Carney still has time to reconsider. He can reverse course and insist that Palestinian recognition be earned—not handed over as a consolation prize for Hamas’s campaign of destruction. He can stand with Israel and with those who seek real peace, not political points.

If he doesn’t, history will remember that Canada chose symbolism over substance—and made the road to peace longer, bloodier and more uncertain than ever.

Stephen M. Flatow is president of the Religious Zionists of America. He is the father of Alisa Flatow, who was murdered in an Iranian-sponsored Palestinian terrorist attack in 1995, and author of A Father’s Story: My Fight for Justice Against Iranian Terror.

https://www.jns.org/canadas-dangerous-embrace-of-appeasement/