Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM), a leading rare disease company, today announced that the primary endpoint was met in the Phase 3 AZURE-4 study evaluating brelovitug, an investigational fully human monoclonal antibody that binds to hepatitis B surface antigen (HBsAg), for the treatment of chronic hepatitis delta virus (HDV). AZURE-4 is the second of two Phase 3 studies that will form the basis of Mirum's U.S. registration package for brelovitug.
Tuesday, November 10, 2026
US said to delay putting Megaspeed on blacklist
The United States Commerce Department is delaying efforts to add Megaspeed, a Singapore-based company entangled in a China espionage controversy, which also includes Nvidia Corp., to a blacklist, the Financial Times reported on Tuesday.
Sources revealed that despite several US government agencies insisting that Megaspeed should be included on the entity list of groups connected to China, the Commerce Department has been postponing the inclusion of new entities for the past two months, saying that it needs more information about some of the businesses included in the new package.
It is unclear whether the company is indeed a part of the package. Among those pushing for Megaspeed to be included were the Pentagon, as well as the state, energy, and Treasury departments.
https://breakingthenews.net/Article/US-said-to-delay-putting-Megaspeed-on-blacklist/67531288
Capricor BLA amendment for Deramiocel leads FDA to extend review, Nov. 22, 2026 PDUFA date
- Reported Q3 2026 loss of $0.73 per share, missing analyst consensus estimate for a $0.61 loss.
- Q3 2026 net loss totaled $42.7 million for the period.
- Ended Q3 2026 with $198.5 million in cash to support operations.
- Announced a 10% workforce reduction in conjunction with reporting Q3 2026 financial results.
Liquidia resolves United Therapeutics litigation, Q3 YUTREPIA PAH-only sales rise
Liquidia resolves United Therapeutics litigation as Q3 YUTREPIA PAH-only sales rise 31% QoQ
- Litigation overhang removed via $389.7m settlement; YUTREPIA continues with PAH-only label.
- Company retired prior $1B 2027 revenue target following settlement with United Therapeutics.
- Company will provide updated long-term guidance in January after revising outlook post-settlement.
- Q3 YUTREPIA net product sales $222.7m, up 31% QoQ; YoY not disclosed.
- Q3 2026 revenue was $225.3m, up 315% YoY, beating analyst estimates.
- Paid patient demand $212.2m; October shipments highest since launch, stacking refills plus new starts.
- GAAP net loss $236.3m driven by one-time settlement; adjusted EBITDA rose to $140.5m.
- Gross margin ~94% flat QoQ; SG&A fell to 26% of revenue, showing operating leverage.
- PAH now dominates mix: >70% September scripts; conversion rate remains above 87% with ~1,300 prescribers.
- October referrals ran >75% of Q3 daily rate; management views this as a floor, not trend.
- R&D $25.3m, up 47% QoQ, funding Re-Spire, SPRINT, RE-WARM and broader pipeline.
- Settlement ends future royalties to United after April 2027; $380.7m cash payable through then.
- Q&A focused on PAH vs PH-ILD exposure, attestation/reauth dynamics, and L606 PH-ILD/PH-COPD opportunity.
- Main concern: near-term referral volatility and heavy reliance on continued PAH prostacyclin market share gains.
- Strong quarter, driven by robust YUTREPIA PAH growth and margin leverage despite one-time settlement charge.
Legend: Slower-than-expected US earlier-line Carvykti share gain v. competitive myeloma meds, Street views
Legend Biotech posts Q3 2026 EPS $0.13 on revenue $359.5M, beats EPS but misses revenue estimates, highlights slower U.S. earlier-line Carvykti uptake
- Carvykti net trade sales $710m, +36% YoY, with US +19% and ex-US +86%.
- EPS $0.13 rose 218% YoY and total revenue grew 32% YoY, while adjusted net income swung to $55.6m profit.
- Legend Biotech's Q3 2026 net income swung to $51.7M during the quarter.
- Gross margin reached 58%, beating prior low-50s expectation; Q4 guided to high-50s.
- Operating margin excluding one-time credit improved to 6% from -16% a year ago.
- Management said Q4 sales consensus sits at the high end of its internal scenarios for Carvykti.
- Company reiterated double-digit 2027 growth and $5B+ peak sales potential for the Carvykti franchise.
- US Carvykti sales were flat sequentially despite earlier-line adoption, reflecting slower-than-hoped share gains.
- Main concern: Slower-than-expected US earlier-line Carvykti share gains versus competitive myeloma therapies and Street expectations.
- Competition from bispecifics and upcoming BCMA CAR-Ts expected to pressure late-line myeloma market share.
- Ex-US growth benefited from new launches across 20 markets and more active treatment centers.
- Management still targets full-year 2026 adjusted profitability, sees substantial global Carvykti growth, citing strong Carvykti revenue, margin upside, disciplined spending.
- FDA cleared IND for in vivo CD19/CD20 CAR-T LB2501, which showed 100% ORR and 100% CR at dose-level two.
- Company holds $853m cash with no long-term debt, supporting pipeline investments and commercial expansion.
- Legend Biotech confirmed Ingrid Zhang as its new company CEO.
Washington sues 2 biggest dialysis companies over illegal noncompete requirements
The two largest for-profit companies that provide dialysis treatment in Washington have unlawfully imposed noncompete agreements on medical directors in their centers, blocking competition and reducing treatment options for people with kidney failure, Attorney General Nick Brown alleged in a new lawsuit.
Dialysis is a treatment to filter waste and fluid from the blood of people with kidney failure. About 9,000 people across Washington receive dialysis treatment, which usually occurs at a dialysis center three times a week for several hours at a time.
DaVita Inc. and its subsidiaries operate 51 dialysis centers across Washington. Their largest competitor, Fresenius Medical Care Holdings Inc., and its subsidiaries run 29 dialysis centers in the state.
The companies hire kidney specialists known as nephrologists to work as part-time medical directors to run their centers, as required under Medicare regulations. For years, the companies have illegally required medical directors to agree to noncompete provisions that prevent them from taking on part-time work at a competing center in the same geographic region, according to the complaint filed in Thurston County Superior Court. These noncompete provisions have made it difficult for competing dialysis centers to open, limiting treatment options for the thousands of people in Washington suffering from end-stage renal disease.
Some parts of the state have only one dialysis provider, and the use of noncompete provisions helps these companies to maintain monopolies in those regions. The lack of competition also prevents other dialysis providers from entering the market and offering in-home dialysis, which can be much more convenient for patients, according to the complaint.
“These giant, for-profit companies require doctors to sign noncompete agreements that violate Washington state law. They’re doing that to corner the market and dictate to doctors where they can and can’t work, but that leaves people with fewer options for care,” Brown said. “Our office is dedicated to protecting free and open competition so that Washingtonians can work where they want and people can get the treatment that they need.”
The companies have also applied noncompete provisions to entire medical practices, preventing a medical director’s colleagues in a nephrology practice from working for competing dialysis centers.
State law against noncompete agreements
Washington law has long protected open competition in the state Constitution and in the Consumer Protection Act.
In 2019, the Legislature passed the Noncompetition Covenants Act to more explicitly limit noncompete agreements, including for independent contractors who earn less than a certain income threshold.
The AGO alleges that DaVita and Fresenius knew about the law and in some cases, deliberately ignored it to further cement their market dominance.
The AGO alleges that the companies have entered into noncompete agreements that are void and unenforceable under the Noncompetition Covenants Act. The complaint also alleges the companies engaged in unfair methods of competition and unfair or deceptive acts or practices under the Consumer Protection Act. The AGO asks the court to throw out the noncompete agreements and award penalties for each violation.
The team handling the case for Washington includes Assistant Attorneys General Travis Kennedy, Helen Lubetkin, Christina Black, Brooke Howlett Lovrovich, and Will O’Connor, and Paralegals Michelle Oliver, Melanie Francis, and Stephanie Pawlik.
Hims & Hers Plans November Launch of Peptides as Higher Costs Weigh on Profit Outlook
Hims & Hers Health (NYSE:HIMS) announced plans to introduce additional peptide-based treatments in November following changes to US regulatory restrictions, while also reducing its full-year core profit forecast as higher operating costs and a shift towards branded weight-loss medications affected margins.
The telehealth company said its initial offering would include NAD+, sermorelin and glutathione, with plans to expand into compounded versions of BPC-157 and TB-500, substances that have attracted interest in the wellness and fitness markets but have not received approval from the US Food and Drug Administration (FDA).
Hims & Hers shares declined more than 3% in volatile after-hours trading following Monday’s announcements.
Expands into Peptide-Based Treatments
Chief Executive Officer Andrew Dudum said the company intends to manufacture BPC-157 and TB-500 in the United States as part of its expansion into peptide-based products.
The two substances are frequently used together by consumers seeking fitness and recovery benefits, in a combination commonly referred to as the “Wolverine stack.”
Peptides are short chains of amino acids that have attracted increased consumer attention, particularly through social media discussions about potential applications involving ageing, physical recovery and sexual health.
However, the treatments covered by the company’s expansion plans have not received FDA approval for the proposed uses.
Recent changes in US regulatory policy have relaxed certain restrictions on compounding unapproved peptides. The changes involve regulatory enforcement discretion and do not constitute FDA approval or establish the safety and effectiveness of the substances.
Reg Changes Raise Questions About Product Safety
US Health Secretary Robert F. Kennedy Jr. has supported broader access to peptide treatments, describing himself as a “big fan” of the products.
Kennedy has argued that restrictions on domestic access could encourage consumers to purchase potentially unsafe products from overseas suppliers.
Critics of the revised regulatory approach have raised concerns about contamination, impurities and side effects that may not be fully understood.
They have also argued that peptide products should undergo the FDA’s established drug approval process before being manufactured and prescribed.
The distinction between regulatory enforcement discretion and formal drug approval remains relevant to the company’s plans, particularly as it prepares to introduce products that lack FDA authorisation.
Chief Financial Officer Yemi Okupe said revenue generated by the peptide treatments was expected to be immaterial for the remainder of the year.
Branded Weight-Loss Meds Affect Profit Margins
Alongside the peptide announcement, Hims & Hers lowered its full-year core profit forecast, citing higher expenses associated with its transition towards branded weight-loss medications and international expansion.
The company has recently entered into an agreement to offer obesity treatments developed by Eli Lilly, adding to an existing partnership with Novo Nordisk.
The shift towards branded pharmaceutical products has increased the cost of revenue compared with the company’s previous product mix.
Gross margin declined to 57% in the third quarter from 74% in the corresponding period a year earlier.
Paul Cerro, chief investment officer at Cedar Grove Capital Management, which holds shares in Hims & Hers, said the margin decline was consistent with the company’s expansion strategy.
“Margin compression was to be expected,” Cerro said.
“This is all part of growing their condition categories and attracting more subscribers.”
Morningstar analyst Keonhee Kim similarly indicated that a greater proportion of branded weight-loss products was contributing to higher revenue per subscriber while placing pressure on gross margins in the near term.
Subscriber Base Reaches Nearly 2.8 Million
Hims & Hers reported a 13% year-on-year increase in subscribers, bringing its customer base to nearly 2.8 million.
Monthly revenue per average subscriber rose 30% to $105.
In an interview with Reuters, CFO Okupe said menopause therapies and testosterone testing contributed to the increase in revenue generated per subscriber.
The company’s expansion into additional treatment categories has supported higher customer spending, although changes in the product mix have also affected profitability.
Okupe said the agreement with Eli Lilly was expected to support customer retention.
International Revenue More Than Quadruples
Revenue from markets outside the United States increased more than fourfold to $233.3 million, reflecting the contribution from the company’s international expansion.
US revenue rose 21% to $657.1 million.
Despite the increase in both domestic and international revenue, Hims & Hers narrowed its full-year revenue guidance to between $3.13 billion and $3.15 billion, compared with its previous forecast of $3.1 billion to $3.3 billion.
Morningstar’s Kim attributed the revenue shortfall primarily to slower growth in the company’s US operations, which offset the contribution from international markets.
The revised guidance reflects a narrower range of expected annual revenue as the company continues to expand its treatment offerings and geographic operations.
Q3 Revenue Rises 49% as Company Reports Net Loss
Hims & Hers reported third-quarter revenue of $890.4 million, representing a 49% increase from the corresponding period a year earlier.
The result was slightly below the average analyst estimate of $892.9 million, according to data compiled by LSEG.
The company recorded a quarterly net loss of $33 million, compared with net income of $15.8 million in the same period of the previous year.
The change in profitability coincided with increased operating costs, international expansion and a greater proportion of branded medications in the company’s revenue mix.
Outlook
Hims & Hers continues to expand its healthcare offerings through new treatment categories, branded pharmaceutical partnerships and international operations.
The planned introduction of peptide-based treatments represents an additional product initiative, although management expects the contribution to revenue during the remainder of the year to be immaterial.
The company’s near-term financial performance will depend on subscriber growth, revenue per customer, the cost of branded medications and expenses associated with geographic expansion.
Investors will also be monitoring developments in the regulatory treatment of compounded peptides and the company’s ability to manage profitability as its product portfolio changes.
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