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Artera Secures FDA Clearance for AI-Based Breast Cancer Risk Tool
NewsMay 7, 2026

Artera Secures FDA Clearance for AI-Based Breast Cancer Risk Tool

The U.S. Food and Drug Administration granted clearance to ArteraAI Breast, an AI‑driven digital pathology tool that combines digitized histopathology slides with clinical data to generate a risk score for distant metastasis in early‑stage hormone‑receptor‑positive/HER2‑negative breast cancer. The system stratifies...

By PharmaShots
Oncology Care Ignores Patient Survival vs QoL Preferences
SocialMay 7, 2026

Oncology Care Ignores Patient Survival vs QoL Preferences

"Patient preference for extending survival or maintaining QoL was not associated with up-front treatment modifications or downstream outcomes, suggesting a possible lack of responsiveness of the current oncology care delivery system to patient preference." https://t.co/0RXf4h2dr3 In: Outcomes of Older Adults With Advanced...

By David Barzilai, MD PhD
Immortal Dragons: The Quest to ‘Make Death Optional’
BlogMay 7, 2026

Immortal Dragons: The Quest to ‘Make Death Optional’

Immortal Dragons, a Singapore‑based longevity fund founded by 34‑year‑old CEO Boyang Wang, secured $40 million—$4 million from friends and family and $36 million of Wang’s own money—to back moonshot biotech projects. The fund’s portfolio includes Frontier Bio, which is developing 3D bio‑fabrication techniques...

By Genetic Literacy Project
WA Biotech Duo Takes Aim at Diabetes Beyond Ozempic
NewsMay 7, 2026

WA Biotech Duo Takes Aim at Diabetes Beyond Ozempic

Australian biotech duo ProGenis Pharmaceuticals and Syngenis Labs are developing RNA‑based antisense therapies that target insulin resistance, a root cause of type‑2 diabetes, to complement GLP‑1 drugs. Syngenis is building Australia’s first GMP‑grade synthetic DNA/RNA manufacturing facility, expected to be...

By The Age – Books (Australia)
Japan's TMS-007 Shows Promise for Stroke Treatment
SocialMay 7, 2026

Japan's TMS-007 Shows Promise for Stroke Treatment

@ej23ny @BiotechXGuru @biotech_cash @Ceazar_Black Anyone here look at Japan Biotech? I'm far from an expert, but I think 4891.T (TMS) is worth looking into. Its a nano cap with dilutive equity warrants (and a smallish cash runway) but their main...

By Japan Deep Value
The Latest News in Vaccine Obstruction
BlogMay 7, 2026

The Latest News in Vaccine Obstruction

Large-scale safety studies of COVID‑19 and shingles vaccines, analyzing millions of records, found rare serious side effects, but the FDA blocked their publication citing unsupported conclusions. The agency also refused to file Moderna’s mRNA flu‑COVID combo vaccine, despite European approval...

By In the Pipeline
PYC Therapeutics Advances PKD Program with Phase 1b Multiple Ascending Dose Study Initiation
NewsMay 7, 2026

PYC Therapeutics Advances PKD Program with Phase 1b Multiple Ascending Dose Study Initiation

PYC Therapeutics has dosed the first patient in a Phase 1b multiple‑ascending‑dose (MAD) study of its PKD candidate PYC‑003, targeting safety, tolerability and early efficacy signals such as urinary PC1 protein, total kidney volume and eGFR. Results from the earlier Phase 1a...

By Small Caps Mining
Unfunded $24B Could Have Delivered 100‑Day Prototype Vaccines
SocialMay 7, 2026

Unfunded $24B Could Have Delivered 100‑Day Prototype Vaccines

Every so often I think about how, in 2022, for $24B we could had "prototype vaccines ready for each of the 26 known viral families that cause human disease" so they can be deployed in 100 days if there was...

By Ethan Mollick
The Peptide Problem: Hype Is Outrunning the Evidence
NewsMay 7, 2026

The Peptide Problem: Hype Is Outrunning the Evidence

Health Canada has warned Canadians against buying and injecting unauthorized peptide products such as BPC‑157, CJC‑1295, ipamorelin, TB‑500 and retatrutide, and has already seized several shipments. Influencers on Instagram and TikTok are promoting these compounds for anti‑aging, weight loss and...

By Medical Xpress
Hoth Therapeutics Gains First European Clearance for HT-001 Oncology Trial in Spain
NewsMay 7, 2026

Hoth Therapeutics Gains First European Clearance for HT-001 Oncology Trial in Spain

Hoth Therapeutics announced that Spain’s health authority has granted authorization for its Phase 2a CLEER trial of HT-001, a therapy aimed at reducing EGFR‑inhibitor skin toxicities. Interim results show meaningful efficacy and safety, paving the way for broader European patient enrollment.

By Pulse
Bayer to Acquire Perfuse Therapeutics, Expanding Its Ophthalmology Portfolio
NewsMay 7, 2026

Bayer to Acquire Perfuse Therapeutics, Expanding Its Ophthalmology Portfolio

Bayer disclosed plans to acquire biotech firm Perfuse Therapeutics, aiming to strengthen its ophthalmology pipeline. The deal, announced through Bayer’s newsroom, comes without disclosed financial terms but signals a strategic push into eye‑care. The acquisition could accelerate Bayer’s development of...

By Pulse
Gilead’s Yeztugo Sees 9,000 Q1 Prescriptions Yet Faces Insurance Hurdles
NewsMay 7, 2026

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.

By Pulse
Spinogenix Secures FDA Fast Track for ALS Drug Tazbentetol
NewsMay 7, 2026

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.

By Pulse
Akebia Therapeutics Inc (AKBA) Q1 2026 Earnings Call Transcript
NewsMay 7, 2026

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,...

By Motley Fool – Earnings Transcripts
Monte Rosa Therapeutics Inc (GLUE) Q1 2026 Earnings Call Transcript
NewsMay 7, 2026

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...

By Motley Fool – Earnings Transcripts
Ironwood Pharmaceuticals Inc (IRWD) Q1 2026 Earnings Call Transcript
NewsMay 7, 2026

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...

By Motley Fool – Earnings Transcripts
There Is No Vaccine for Deadly Hantavirus: What that Means for Future Outbreaks
NewsMay 7, 2026

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...

By Nature – Health Policy
NewAmsterdam Pharma Company NV (NAMS) Q1 2026 Earnings Call Transcript
NewsMay 7, 2026

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...

By Motley Fool – Earnings Transcripts
Lantheus Holdings Inc (LNTH) Q1 2026 Earnings Call Transcript
NewsMay 7, 2026

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%...

By Motley Fool – Earnings Transcripts
PTC Therapeutics Inc (PTCT) Q1 2026 Earnings Call Transcript
NewsMay 7, 2026

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...

By Motley Fool – Earnings Transcripts
INmune Bio Inc (INMB) Q1 2026 Earnings Call Transcript
NewsMay 7, 2026

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...

By Motley Fool – Earnings Transcripts
Guardant Health Inc (GH) Q1 2026 Earnings Call Transcript
NewsMay 7, 2026

Guardant Health Inc (GH) Q1 2026 Earnings Call Transcript

Guardant Health reported Q1 2026 revenue of $302 million, a 48% year‑over‑year increase and the fastest annual growth in five years. Oncology revenue rose 36% to $205 million, driven by 86,000 tests—a 47% volume jump—while its Shield screening test generated $42 million from...

By Motley Fool – Earnings Transcripts
Zymeworks Inc (ZYME) Q1 2026 Earnings Call Transcript
NewsMay 7, 2026

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...

By Motley Fool – Earnings Transcripts
Delcath Systems Inc (DCTH) Q1 2026 Earnings Call Transcript
NewsMay 7, 2026

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...

By Motley Fool – Earnings Transcripts
Absci Corp (ABSI) Q1 2026 Earnings Call Transcript
NewsMay 7, 2026

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...

By Motley Fool – Earnings Transcripts
Harmony Biosciences Holdings Inc (HRMY) Q1 2026 Earnings Call Transcript
NewsMay 7, 2026

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...

By Motley Fool – Earnings Transcripts
Lexicon Pharmaceuticals Inc (LXRX) Q1 2026 Earnings Call Transcript
NewsMay 7, 2026

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...

By Motley Fool – Earnings Transcripts
Crinetics Pharmaceuticals Inc (CRNX) Q1 2026 Earnings Call Transcript
NewsMay 7, 2026

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...

By Motley Fool – Earnings Transcripts
Arrowhead Pharmaceuticals Inc (ARWR) Q2 2026 Earnings Call Transcript
NewsMay 7, 2026

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...

By Motley Fool – Earnings Transcripts
Scholar Rock Holding Corp (SRRK) Q1 2026 Earnings Call Transcript
NewsMay 7, 2026

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...

By Motley Fool – Earnings Transcripts
Organogenesis Holdings Inc (ORGO) Q1 2026 Earnings Call Transcript
NewsMay 7, 2026

Organogenesis Holdings Inc (ORGO) Q1 2026 Earnings Call Transcript

Organogenesis Holdings reported a 58% drop in Q1 net product revenue to $36.3 million, driven primarily by a 63% plunge in advanced wound‑care sales after CMS reimbursement policy changes created clinician confusion. The company recorded a GAAP operating loss of...

By Motley Fool – Earnings Transcripts
SIGA Technologies Inc (SIGA) Q1 2026 Earnings Call Transcript
NewsMay 7, 2026

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...

By Motley Fool – Earnings Transcripts
Insmed Inc (INSM) Q1 2026 Earnings Call Transcript
NewsMay 7, 2026

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...

By Motley Fool – Earnings Transcripts
Science Spotlight: New Prime Editing Tools for Large DNA Insertions
NewsMay 6, 2026

Science Spotlight: New Prime Editing Tools for Large DNA Insertions

BioCentury’s website employs a tiered cookie framework that classifies cookies into strictly necessary, functional, marketing, advertising, and analytics groups. Strictly necessary cookies power core services such as authentication, registration, and user‑preference management, while functional cookies enhance site personalization. Marketing and...

By BioCentury
AI Speeds Dangerous Bio Design; Economics Drive Safety Race‑to‑bottom
SocialMay 6, 2026

AI Speeds Dangerous Bio Design; Economics Drive Safety Race‑to‑bottom

"What keeps me up at night is the fast pace of acceleration of open weight models in the ecosystem. They do not prioritize the same type of safety refusals." - Yunyun Wang, @OpenAI We just ran a biosecurity panel at...

By John Cumbers
From Discovery to GMP: Building Scalable Cell Therapy Manufacturing
NewsMay 6, 2026

From Discovery to GMP: Building Scalable Cell Therapy Manufacturing

Genetic Engineering & Biotechnology News and ElevateBio released an eBook titled “From Discovery to GMP: Building Scalable Cell Therapy Manufacturing.” It argues that the next growth phase for cell and gene therapies hinges on integrating therapeutic design with manufacturing to...

By GEN (Genetic Engineering & Biotechnology News)
Membrane Complex Aids Rock-Eating Microbes in Converting Carbon Dioxide to Biomass
NewsMay 6, 2026

Membrane Complex Aids Rock-Eating Microbes in Converting Carbon Dioxide to Biomass

Researchers at the Universities of Potsdam and Marburg have detailed the structure of the DAB2 membrane complex in the sulfur bacterium Halothiobacillus neapolitanus. The complex enables lithoautotrophic microbes to convert CO₂ directly into bicarbonate (HCO₃⁻) using the cell’s membrane potential,...

By Phys.org – Biotechnology
An Essential Framework to Navigating Technical Challenges in Contemporary OSD Development
NewsMay 6, 2026

An Essential Framework to Navigating Technical Challenges in Contemporary OSD Development

Oral solid dosage (OSD) development faces mounting technical hurdles as biopharma pipelines become richer in poorly soluble compounds, with 70‑90% of new small‑molecule candidates classified as BCS Class II or IV. Early‑risk identification—through comprehensive physicochemical profiling, excipient compatibility testing, and Quality...

By Pharmaceutical Technology (GlobalData)
First Human Trials Aim to Rejuvenate Immune System by Regenerating the Thymus
NewsMay 6, 2026

First Human Trials Aim to Rejuvenate Immune System by Regenerating the Thymus

The TRIIM‑X trial has begun enrolling participants to test a thymus‑regeneration therapy that could reverse immune aging. Researchers hope the intervention will restore T‑cell production and improve resilience against infection and cancer, marking a shift from measuring immune decline to...

By Pulse
Inflammatory Genes Link Obesity, Diabetes to Pancreatic Cancer
SocialMay 6, 2026

Inflammatory Genes Link Obesity, Diabetes to Pancreatic Cancer

Shared inflammatory genes are active in both pancreatic cancer and metabolic diseases like obesity and diabetes, providing insight into why metabolic conditions worsen cancer outcomes and highlighting potential targets for improved prediction and treatment. cancerbiology

By Phys.org Threads
MRNA Flu Shot Cuts Illness in 50+, Raises Reactogenicity
SocialMay 6, 2026

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.

By Peter Suzman
Nanobiotix Secures FDA Acceptance of Protocol Amendment to Accelerate Phase 3 NANORAY-312 Trial
NewsMay 6, 2026

Nanobiotix Secures FDA Acceptance of Protocol Amendment to Accelerate Phase 3 NANORAY-312 Trial

Nanobiotix announced that the U.S. FDA has accepted a protocol amendment for its Phase 3 NANORAY‑312 trial, eliminating the interim analysis and moving to a modified final analysis with fewer events. The change is designed to shorten the study timeline for...

By Pulse
SIRT6 Shields Aorta by Cutting Inflammation and Aging
SocialMay 6, 2026

SIRT6 Shields Aorta by Cutting Inflammation and Aging

SIRT6 appears protective in aortic disease, as higher levels reduce vascular inflammation and smooth muscle cell aging, thereby helping prevent both aortic aneurysm and dissection progression. https://t.co/eXuKrR7oNF

By Liz Parrish
Even a Dog Loves Scaling Virtual Biology Panel
SocialMay 6, 2026

Even a Dog Loves Scaling Virtual Biology Panel

Not all our #SynBioBeta2026 attendees walk on 2 legs 🐶 Taco here found the "From Cells to Patients: Solving the Scale Mismatch in Virtual Biology" Main Stage Panel particularly interesting. https://t.co/6xMHnozSqd

By John Cumbers
Merck Completes $5.3 B Purchase of Terns, Adding Oral CML Drug TERN‑701
NewsMay 6, 2026

Merck Completes $5.3 B Purchase of Terns, Adding Oral CML Drug TERN‑701

Merck closed a cash tender offer for Terns Pharmaceuticals at $53 a share, valuing the deal at roughly $5.3 billion. The acquisition brings TERN‑701, an oral BCR‑ABL1 inhibitor with FDA Breakthrough Therapy Designation, into Merck’s oncology pipeline and will be recorded...

By Pulse
First‑in‑class Molecular Glue Shows Breakthrough Pancreatic Cancer Results
SocialMay 6, 2026

First‑in‑class Molecular Glue Shows Breakthrough Pancreatic Cancer Results

We're seeing major advances vs pancreatic cancer. Today @NEJM data for daraxonrasib @RevMedicines https://t.co/IinceclK6w Context for this first-in-class molecular glue https://t.co/IinceclK6w https://t.co/odhmXQqzMF

By Eric Topol
Quick Turnaround: Good Longevity Trial News Arrives
SocialMay 6, 2026

Quick Turnaround: Good Longevity Trial News Arrives

I post about working around longevity clinical trials and an hour later @j_n_justice tells me good news about longevity clinical trials... 😍

By Martin Borch Jensen
Caris Life Sciences Launches AI Test to Predict Early and Late Breast Cancer Recurrence
NewsMay 6, 2026

Caris Life Sciences Launches AI Test to Predict Early and Late Breast Cancer Recurrence

Caris Life Sciences introduced Caris MI Clarity, the first AI-driven test that predicts both early and late distant recurrence in postmenopausal HR‑positive/HER2‑negative, node‑negative breast cancer at diagnosis. Results are returned within three business days, promising faster, more comprehensive risk stratification...

By Pulse
Trump Drug Strategy Clashes With New Funding Policies
SocialMay 6, 2026

Trump Drug Strategy Clashes With New Funding Policies

Trump administration’s drug strategy is at odds with recent actions on funding, policy https://t.co/UDiuVnEMDZ via @statnews

By Matthew Herper