Today's Healthcare Pulse
FDA greenlights durvalumab combo for high‑risk bladder cancer
The FDA approved durvalumab (Imfinzi) combined with Bacillus Calmette‑Guerin for BCG‑naïve, high‑risk non‑muscle invasive bladder cancer. The POTOMAC trial enrolled 1,018 patients and showed a 32% reduction in disease recurrence risk (hazard ratio 0.68, p=0.015). Durvalumab is given at 1,500 mg IV every four weeks for up to 13 cycles.
Also developing:
By the numbers: Apogee Therapeutics raises $1.3B royalty financing
Viz.ai Secures ISO/IEC 42001 Certification, Setting Benchmark for Agentic AI in Healthcare
Viz.ai announced it has achieved ISO/IEC 42001 certification, the first international standard for AI Management Systems, positioning the company as a pioneer in responsible agentic AI. The audit covers the full AI lifecycle and reinforces confidence for the 2,000 hospitals that run its platform.
Parker Institute Hires Former Zillow, Starbucks Exec Aimee Johnson as CMO
The Parker Institute for Cancer Immunotherapy announced Aimee Johnson, a former CMO of Zillow and senior leader at Starbucks, as its new chief marketing officer. Johnson will steer brand, marketing and digital strategy as the nonprofit seeks to expand awareness...
Gilead’s Yeztugo Sees 9,000 Q1 Prescriptions Yet Faces Insurance Hurdles
Gilead Sciences' long‑acting HIV pre‑exposure prophylaxis, Yeztugo, logged more than 9,000 prescriptions in Q1 2024, but clinicians say uptake is uneven. Insurers’ reliance on medical‑benefit billing and a $14,000‑plus price tag create out‑of‑pocket costs that deter many patients.
Premier Inc. Names Physician-Executive Emad Rizk as CEO, President and Chairman
Premier Inc. announced that Dr. Emad Rizk, M.D., will serve as chief executive officer, president and chairman of the board. The move brings a physician‑executive with three decades of transformation experience to the helm of a company that has already...
Spinogenix Secures FDA Fast Track for ALS Drug Tazbentetol
Spinogenix announced that the U.S. FDA granted Fast Track designation to its oral ALS candidate tazbentetol, accelerating development after Phase 2a data showed 82% of patients stabilized or improved and a 76% slower decline versus historical controls.
Akebia Therapeutics Inc (AKBA) Q1 2026 Earnings Call Transcript
Akebia Therapeutics reported 2025 total revenue of $236.2 million, a 47% increase year‑over‑year, driven by the commercial launch of its oral HIF‑PH inhibitor Vafseo and higher sales of the phosphate binder Auryxia. Vafseo now reaches 290,000 dialysis patients across 24 organizations,...
Monte Rosa Therapeutics Inc (GLUE) Q1 2026 Earnings Call Transcript
Monte Rosa Therapeutics reported Q1 2026 worldwide revenue of $141.2 million, a 14.3% year‑over‑year increase, driven primarily by strong U.S. sales of its AtriClip and Cryosphere product lines. Adjusted EBITDA rose to $17 million, nearly doubling the prior‑year quarter, while gross margin...
Ironwood Pharmaceuticals Inc (IRWD) Q1 2026 Earnings Call Transcript
Ironwood Pharmaceuticals reported 2025 LINZESS U.S. net sales of $865 million, matching guidance despite a 6% price erosion tied to Medicare Part D changes. Prescription demand grew 11% for the second year, maintaining a 45% market share in the IBS‑C and chronic...
Tandem Diabetes Care Inc (TNDM) Q1 2026 Earnings Call Transcript
Tandem Diabetes Care reported record first‑quarter results, with worldwide sales of $247 million and over 29,000 pump shipments, driven primarily by U.S. demand. The company posted a 55% gross margin, the highest ever for a Q1, and narrowed its operating loss...
Inogen Inc (INGN) Q1 2026 Earnings Call Transcript
Inogen reported Q1 2026 revenue of $85.1 million, a 3.4% year‑over‑year increase driven primarily by an 18% surge in international sales and a 14% rise in unit volumes. U.S. revenue fell 5% as rental and direct‑to‑consumer channels faced mix‑shift pressure,...
There Is No Vaccine for Deadly Hantavirus: What that Means for Future Outbreaks
An outbreak of Andes hantavirus on the cruise ship MV Hondius left three confirmed cases and three deaths, highlighting the deadly potential of the rodent‑borne virus. The World Health Organization confirmed the strain has no approved treatments or vaccines. Virologist...
NewAmsterdam Pharma Company NV (NAMS) Q1 2026 Earnings Call Transcript
NewAmsterdam Pharma reported Q1 2026 net revenue of $45.1 million, up from $42 million a year earlier, while cash rose to $308 million and the company remains debt‑free. U.S. VASCEPA captured 48% of the IPE market, a 6‑point gain, and branded prescriptions grew...
Skinhealth Systems Inc (SKIN) Q1 2026 Earnings Call Transcript
SkinHealth Systems reported Q1 2026 net sales of $64.9 million, a 6.7% decline year‑over‑year, while adjusted EBITDA rose 17% to $8.5 million, delivering a 13.1% margin. Consumables fell 6.1% largely due to China’s distributor transition, and device placements dropped 8.3%...
Lantheus Holdings Inc (LNTH) Q1 2026 Earnings Call Transcript
Lantheus Holdings reported Q1 2026 revenue of $377.3 million, a 1.2% year‑over‑year increase and 8.6% when excluding divested SPEC revenue. Oncology sales from PYLARIFY fell 6.5% despite a 5.8% volume rise, while cardiology product DEFINITY grew 6.8% and retained over 80%...
Maravai LifeSciences Holdings Inc (MRVI) Q1 2026 Earnings Call Transcript
Maravai LifeSciences reported Q1 2026 revenue of $65.8 million, a 41% year‑over‑year increase and 10% growth in its core business excluding COVID‑related CleanCap sales. Adjusted EBITDA surged to $20.3 million, improving by more than $30 million from a year ago, while free cash...
PTC Therapeutics Inc (PTCT) Q1 2026 Earnings Call Transcript
PTC Therapeutics reported record Q1 2026 product revenue of $226 million, driven by a $125 million Sephience launch that grew 36% quarter‑over‑quarter. The company lifted full‑year product revenue guidance to $750‑$850 million and total revenue to $1.08‑$1.18 billion, citing strong U.S. uptake, the first...
Corvus Pharmaceuticals Inc (CRVS) Q1 2026 Earnings Call Transcript
Corvus Pharmaceuticals reported Q1 2026 results highlighting accelerated R&D spending and a strengthened balance sheet after a $200 million public offering, giving the company cash runway into the second quarter of 2028. Clinical data from the Phase I/Ib atopic dermatitis trial...
INmune Bio Inc (INMB) Q1 2026 Earnings Call Transcript
INmune Bio reported Q1 2026 results showing a cash balance of $21.4 million, sufficient to sustain operations through Q1 2027, and a narrowed net loss of $5.4 million. The company highlighted significant progress on its CORDStrom platform, including approval of the U.K. Pediatric Investigation...
Stevanato Group SpA (STVN) Q1 2026 Earnings Call Transcript
Stevanato Group reported first‑quarter 2026 revenue of €273.6 million, a 10% rise on a constant‑currency basis, driven primarily by the Biopharmaceutical and Diagnostic Solutions (BDS) segment. High‑value solutions, especially syringes and GLP‑1 biologics, grew 17% and now represent 47% of total...
Stable Depression Subtypes Identified Using Functional Connectome Normative Deviation Models and Their Response to rTMS
Researchers applied functional connectome normative deviation models to a large cohort of patients with major depressive disorder, uncovering three stable neurobiological subtypes. Each subtype displayed distinct patterns of network hyper‑ or hypoconnectivity, particularly within the default mode and frontoparietal circuits....
ICU Medical Inc (ICUI) Q1 2026 Earnings Call Transcript
ICU Medical reported Q1 2026 revenue of $526 million, reflecting 1% organic growth but a 12% decline on a reported basis due to the deconsolidation of its IV Solutions joint venture with Otsuka. Adjusted earnings per share rose 15% to...
Zymeworks Inc (ZYME) Q1 2026 Earnings Call Transcript
Zymeworks reported a PDUFA deadline of August 25, 2026 for its zanidatumab HER2‑positive gastroesophageal adenocarcinoma (GEA) indication, with a supplemental BLA filed in China. The company stands to receive up to $265 million in milestone payments contingent on U.S. and Chinese...
Puma Biotechnology Inc (PBYI) Q1 2026 Earnings Call Transcript
Puma Biotechnology reported 2025 total revenue of $75.5 million, driven by a $59.9 million net product revenue for NERLYNX and a sharp rise in royalty income to $15.6 million after a shipment to a Chinese partner. Ex‑factory bottle sales grew 12% quarter‑over‑quarter to...
Delcath Systems Inc (DCTH) Q1 2026 Earnings Call Transcript
Delcath Systems reported Q1 2026 revenue of $25 million, a 26% increase year‑over‑year, driven primarily by $23.3 million from its HEPZATO kit. The company recorded a net loss of $1.1 million but posted adjusted EBITDA of $3.4 million and reaffirmed a 2026 revenue target...
Collegium Pharmaceutical Inc (COLL) Q1 2026 Earnings Call Transcript
Collegium Pharmaceutical reported record full‑year net revenue of $780.6 million, a 24% increase year‑over‑year, and an all‑time high adjusted EBITDA of $460.5 million. Growth was driven by the pain portfolio’s steady performance and a surge in Jornay PM sales, which posted $148.9 million in...
Cytek Biosciences Inc (CTKB) Q1 2026 Earnings Call Transcript
Cytek Biosciences reported Q1 2026 revenue of $44.1 million, a 6% year‑over‑year increase driven primarily by a 32% surge in U.S. sales and strong growth in recurring services and reagents. Recurring revenue now represents 35% of total revenue, up 19%, while...
Absci Corp (ABSI) Q1 2026 Earnings Call Transcript
Absci Corp (ABSI) reported Q1 2026 revenue of $200 K while R&D expenses rose to $19.3 M as the company advances its lead prolactin‑receptor antibody ABS‑201. The Phase 1/2a androgenic alopecia trial is on track, with safety data due next month and interim...
Harmony Biosciences Holdings Inc (HRMY) Q1 2026 Earnings Call Transcript
Harmony Biosciences reported record Q1 product revenue of $243.8 million, a 21% increase year‑over‑year, driven by sustained demand for its Wakix sleep‑wake therapy. The company added roughly 400 patients per quarter, reaching about 8,500 on Wakix, and reaffirmed 2026 revenue guidance...
Lexicon Pharmaceuticals Inc (LXRX) Q1 2026 Earnings Call Transcript
Lexicon Pharmaceuticals reported Q1 2026 revenue of $5.5 million, largely from a $4.3 million Novo Nordisk licensing deal and INPEFA sales. The company cut its quarterly net loss to $15.5 million and reduced annual operating expenses by $129.5 million, boosting cash to $125 million after...
Crinetics Pharmaceuticals Inc (CRNX) Q1 2026 Earnings Call Transcript
Crinetics reported $10.3 million net product revenue from Palsonify in Q1 2026, driven by 232 new patient enrollments and a prescriber base that grew to 263 unique physicians. Treatment‑naive patients rose to 15 % of enrollments, indicating expanding first‑line use. Reimbursement coverage...
Arrowhead Pharmaceuticals Inc (ARWR) Q2 2026 Earnings Call Transcript
Arrowhead Pharmaceuticals reported accelerating uptake of its newly launched triglyceride‑lowering therapy REDEMPLO, surpassing 400 prescriptions with a 40% surge in the last month. The company announced a price reduction to $45,000 per patient per year and secured payer policies that...
Viatris Inc (VTRS) Q1 2026 Earnings Call Transcript
Viatris posted Q1 2026 revenue of $3.76 billion, a 1 percent decline, but achieved 1 percent operational growth when the indoor‑facility disruption is excluded. Europe saw modest gains, emerging markets grew 7 percent, and Greater China sales rose 9 percent, beating expectations. Adjusted gross margin...
Scholar Rock Holding Corp (SRRK) Q1 2026 Earnings Call Transcript
Scholar Rock Holding Corp reported $368 million in cash and secured a $550 million debt facility, providing ample liquidity for 2026 initiatives. The FDA completed a reinspection of the Catalent Indiana site with no further requests, clearing the path for an imminent...
Caris Life Sciences Inc (CAI) Q1 2026 Earnings Call Transcript
Caris Life Sciences reported Q1 2026 revenue of $216 million, up 79% year‑over‑year, propelled by an 85% surge in molecular profiling revenue. Gross margin improved to 65% on a GAAP basis, reflecting a 61% rise in clinical average selling price and...
Kenvue Inc (KVUE) Q1 2026 Earnings Call Transcript
Kenvue reported a solid start to 2024, posting 1.9% organic revenue growth and a 290‑basis‑point rise in adjusted gross margin. Self‑Care sales climbed 4.2% and Essential Health grew 4.9%, while Skin Health and Beauty declined 4.5% on a 6.9% volume...
Vericel Corp (VCEL) Q1 2026 Earnings Call Transcript
Vericel Corp reported record Q1 2026 results, posting $68.4 million total revenue—a 30% year‑over‑year increase that topped guidance—driven by strong MAC I ($56.4 million, +22%) and Burn Care ($12 million, >90% growth). Gross margin rose to 72% and adjusted EBITDA surged 195% to $9.6 million,...
Vaxart Inc (VXRT) Q1 2026 Earnings Call Transcript
Novavax reported Q1 2026 revenue of $140 million, a 79% YoY decline driven by a prior‑year non‑cash sales event. Supply sales rose 139% to $33 million, while licensing royalties and other revenue jumped 116% to $97 million. The company ended...
SIGA Technologies Inc (SIGA) Q1 2026 Earnings Call Transcript
SIGA Technologies reported Q1 2026 revenue of roughly $6 million, a pretax loss of $5 million and a cash balance of $146 million with no debt. The company announced a $13 million oral TPOXX order for an Asia‑Pacific customer in Q2 and sealed an...
Insmed Inc (INSM) Q1 2026 Earnings Call Transcript
Insmed reported that its newly launched Brinsupri generated $144.6 million in its first full quarter and now projects at least $1 billion in U.S. revenue for 2026. The company highlighted strong early adoption, with over 11,500 new patients in 2025, 90%+ payer...
Oncology Institute Inc (TOI) Q1 2026 Earnings Call Transcript
Oncology Institute Inc (TOI) reported 2025 revenue of $502.7 million, a 27.8% year‑over‑year increase, and delivered its first adjusted‑EBITDA‑positive quarter with $147,000 in Q4 profit. The company’s capitation business expanded 17.2% to $80.5 million, adding 260,000 patient lives through new...
Administration Slashes $8‑10 B From Global Health Funding
I can't tell if this is a good or a bad time to remind everyone that this dingdong administration has been busy crippling public health funding and making it more difficult for folks to do their jobs. An $8-10 billion drop...
Live with Dr. Jen Gunter
In this episode, host Dr. Cammy Dahl chats with Dr. Jen Gunter about Gunter's new book, *A Terrible Strength*, which explores how systemic racism and the cultural expectation of endurance among Black women lead to delayed diagnosis and higher mortality...
New Research Could Reshape How Future NHS Treatments Are Evaluated
Researchers at the University of Sheffield have produced a new EQ‑5D‑5L value set using interviews with 1,200 UK citizens, updating the decades‑old metrics that NICE currently relies on. The study reveals a shift in public preferences, notably giving mental health...
Add 1,000 Steps Daily to Boost Surgical Recovery
1,000 more steps: A simple, powerful prescription for surgical recovery https://t.co/6puSPDgMNW via @medical_xpress #surgery #MedTwitter #health #surgeons #operations #lifestylemedicine
How PE Is Adjusting Its Healthcare Playbook Now that It’s Under the Microscope
Federal and state lawmakers are intensifying scrutiny of private‑equity ownership in healthcare, especially physician practice roll‑ups. Matthew Bennett of Invidia Capital says the regulatory focus will be permanent, pushing PE firms to prioritize outcomes and cost reductions over pure consolidation....
MRNA Flu Shot Cuts Illness in 50+, Raises Reactogenicity
Prasad wanted high-dose flu vaccine comparator - hence the original Refusal-to-File. FDA then agreed to a split application for over-65's and under, and accepted the revised application.
Cut Ultraprocessed Foods to Lower Heart Disease Risk
A consensus statement from @escardio today to limit intake of ultraprocessed foods for reduced risk of heart disease https://t.co/5spHDVmkb3 https://t.co/GvTvcVzzjD
The Cost of Systemic Failure and Childbirth Injuries
The NHS has paid roughly $4.45 bn in childbirth‑related medical claims over the past six years, with $3.68 bn in damages and the remainder covering legal costs. The average payout per claim exceeds $1.2 million, highlighting both a financial burden and systemic shortcomings...
![Patients Don’t Need Certainty, They Need Your Reasoning Out Loud [PODCAST]](/cdn-cgi/image/width=1200,quality=75,format=auto,fit=cover/https://kevinmd.com/wp-content/uploads/faron_thumbnail.png)
Patients Don’t Need Certainty, They Need Your Reasoning Out Loud [PODCAST]
In a May 2026 KevinMD podcast, retired surgeon Alan P. Feren argues that vague clinical language fuels unnecessary ER visits, patient anxiety, and 30‑40% of malpractice suits. He introduces a five‑discipline framework—naming the most likely diagnosis, ruling out alternatives, outlining possibilities, defining triggers...
Hospital Workplace Violence Escalates Financial and Workforce Pressures
Violence against hospital staff, especially in emergency departments, is reaching crisis levels, with 85% of surveyed healthcare workers reporting a safety incident and more than a quarter facing weekly threats. The resulting turnover is costly—replacing a registered nurse averages $61,000,...