Friday, September 18, 2026
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Policy•STAT News•Sep 17, 2026
Kennedy renews attacks on vaccines at Children’s Health Defense conference
background ▾
- •RFK Jr. is institutionalizing vaccine skepticism across HHS through multiple ongoing initiatives including a vaccination schedule review task force and analysis of 150+ adverse events, representing a significant policy shift in U.S. immunization strategy
- •Kennedy is misrepresenting standard FDA clinical trial acceptance practices and vaccine adverse event reporting requirements—which document reported but not necessarily causally-linked events—as evidence of safety failures
- •The Trump administration has already ended universal newborn hepatitis B vaccination policy; watch for further changes to the CDC childhood immunization schedule and potential legal/scientific challenges to these policy reversals
Hepatitis B vaccine
→ Read original articlePolicy•STAT News•Sep 18, 2026
Opinion: More young men are coming to me for plastic surgery. The way I think about them has changed
background ▾
- •Men represent the fastest-growing demographic in cosmetic procedures (4% growth), with 1.6 million minimally invasive and ~100,000 surgical procedures performed on men in the U.S. in 2024, driven largely by social media influence and the monetization of appearance
Policy•STAT News•Sep 17, 2026
Kennedy announces new effort to speed up autism diagnoses
background ▾
- •ARPA-H launching autism diagnosis acceleration program targeting current bottlenecks of months-to-years assessment wait times and limited specialist availability
- •Significant community concern about scientific bias in project selection given Kennedy's documented promotion of vaccine-autism links and use of dehumanizing language toward autistic individuals
- •Monitor: whether the program's peer review process maintains scientific integrity; autism community reception; funding allocation announcements and which technologies/organizations receive support
ARPA-HAutism Speaks
→ Read original articlePolicy•STAT News•Sep 18, 2026
Opinion: Doctors should educate patients about ‘Asian glow’ and drinking risks
background ▾
- •ALDH2 deficiency affects ~33% of East Asian populations and causes accumulation of toxic acetaldehyde during alcohol metabolism, significantly elevating cancer and cardiovascular disease risk—not merely a benign cosmetic phenomenon
- •Heterozygous carriers often continue drinking despite symptoms because their reactions are less severe than homozygotes, leaving them at high cancer risk while falsely believing antihistamines mitigate the underlying hazard
Pepcid AC
→ Read original articlePolicy•STAT News•Sep 18, 2026
In Sudan, attacks on hospitals force patients to make dangerous journeys
background ▾
- •Sudan's civil war has disabled most healthcare infrastructure including oncology services, forcing cancer patients to travel hundreds of miles to access any treatment
chemotherapy
→ Read original articleMarket Access
Market Access•Fierce Biotech•Sep 17, 2026
After one failed acquisition attempt, Lisata finds lifeline in Marea merger
background ▾
- •Lisata's merger represents a de facto acquisition by Marea with minimal equity retention for Lisata shareholders, signaling distressed M&A dynamics in the biotech sector
- •Both Marea assets have near-term catalysts (Q4 2024 readouts) that will determine the combined company's clinical and commercial trajectory
- •Lisata is pursuing litigation against Kuva for breach of merger agreement with claims for shareholder damages and a $2M termination fee
Lisata TherapeuticsMarea TherapeuticsKuva LabsMAR001MAR002
→ Read original articleMarket Access•Fierce Biotech•Sep 17, 2026
SK pens $315M pact with fellow South Korean company for Parkinson’s prospect
background ▾
- •1ST-104 is a Type 2 LRRK2 inhibitor specifically engineered to mitigate lung safety concerns observed with conventional LRRK2 inhibitors, positioning it as a differentiated approach in a competitive preclinical landscape.
- •SK's total deal value of $314.8 million for a preclinical asset reflects significant confidence but also substantial execution risk, particularly given the company's recent $350M BHV-7000 acquisition that triggered an FDA clinical hold.
- •Monitor 1ST-104's IND filing timeline and preclinical safety package; competitive LRRK2 programs from Neuron23 (Phase 2) and Denali are advancing in parallel, and Biogen's recent Phase 2 failure underscores the clinical bar for this target.
SK Biopharmaceuticals1ST BiotherapeuticsNeuron231ST-104XcopriSunosi
→ Read original articleMarket Access•Fierce Biotech•Sep 17, 2026
North Immunology goes public via reverse merger as eczema drug heads toward clinic
background ▾
- •North Immunology secured $180M in Series B funding from tier-one investors (Bain Capital Life Sciences, Janus Henderson, Deep Track) and is going public via reverse merger at a ~$380M implied valuation to fund a multi-year AD development program.
- •NOR-101's dual IL-13/IL-18 targeting and 42-day half-life in non-human primates offer potential differentiation in a crowded AD market, but clinical proof-of-concept remains 6–12 months away with no human PK/efficacy data disclosed.
- •Monitor NOR-101 initiation timing (Q1 2025 guidance) and interim efficacy/safety data (mid-2025) as the first clinical readouts; compare efficacy, tolerability, and dosing convenience to Dupixent, Ebglyss, and JAK inhibitors to assess competitive positioning.
North ImmunologyAethlon MedicalBain Capital Life SciencesNOR-101DupixentEbglyss
→ Read original articleMarket Access•Endpoints News•Sep 17, 2026
A Parkinson's biotech debut, fundraising campaign and licensing deal
background ▾
- •Michael J. Fox Foundation backing signals continued foundation support for Parkinson's disease innovation, though the startup's specific mechanism and clinical stage are not detailed in this excerpt
Michael J. Fox FoundationAltis LabsMatisse Pharmaceuticals
→ Read original articleMarket Access•Fierce Biotech•Sep 18, 2026
Inflammation biotech Electra charges up with $350M from upsized IPO
background ▾
- •Electra raised $350M gross (upsized from $297M guidance), bringing total capital to ~$448M, with $220M earmarked for ipsoprubart phase 2/3 in sHLH and regulatory path
- •Lead program ipsoprubart demonstrated 100% 8-week overall survival in 12-patient malignancy-associated HLH phase 1b cohort, but rare disease focus and small sample size limit near-term commercial risk assessment
- •Enrollment completion and topline data in phase 2/3 sHLH trial expected 2027-2028; key milestone to watch is whether efficacy translates beyond phase 1b setting and whether SIRP-targeting approach gains regulatory traction in inflammatory/hematologic indications
Electra TherapeuticsipsoprubartELA822
→ Read original articleClinical Trials
Clinical Trials•Fierce Biotech•Sep 18, 2026
BMS dumps $100M Orum degrader-antibody conjugate after glimpsing phase 1 data
background ▾
- •BMS terminated ORM-6151 after phase 1 data review, suggesting safety or efficacy concerns with the degrader-antibody conjugate approach in CD33+ hematologic malignancies
- •The DAC field has experienced two major clinical setbacks in rapid succession (AbbVie's ABBV-787 terminated in 2024, now BMS's ORM-6151), raising questions about the therapeutic viability of this modality versus established ADCs
- •Monitor whether other sponsors continue CD33-directed DAC programs or pivot to alternative payloads/targets; track BMS's pipeline prioritization under CEO Boerner, who has systematically terminated inherited programs
Bristol Myers SquibbOrum TherapeuticsAbbVieORM-6151BMS-986497ABBV-787
→ Read original articleClinical Trials•Fierce Biotech•Sep 17, 2026
Rare EGFR mutation increases lung cancer risk 62 times in never smokers
background ▾
- •T790M germline EGFR mutation confers 62-fold lung cancer risk in never-smokers, identifying a previously unrecognized genetic predisposition factor in a population not traditionally targeted by smoking-based screening protocols
- •The mutation's rarity (1 in 15,850) and geographic clustering to southern Appalachia suggests potential for targeted genetic screening strategies in specific populations
- •Clinical validation needed to establish whether carriers benefit from surveillance programs, and future studies required to identify additional genetic modifiers affecting penetrance and lifetime risk
AstraZenecaJohnson & JohnsonBlossomHillTagrissoRybrevantBH-30643
→ Read original articleClinical Trials•Fierce Biotech•Sep 17, 2026
DPHARM: How to address the clinical trial enrollment crisis?
background ▾
- •Clinical trial enrollment delays cost the industry an estimated $50 billion annually, with individual phase 3 oncology trials losing $600,000–$8 million per delayed day, representing a major economic and therapeutic access problem
- •Capacity constraints at trial sites and lack of representative patient populations—particularly U.S. participants with diverse geographic and clinical characteristics—are fundamental structural barriers requiring systemic industry change
- •Community medicine trial sites combined with AI-powered EHR mining and early patient engagement are emerging as key solutions, though organizational hesitancy and reliance on traditional methods remain implementation obstacles
Merck & Co.Gilead SciencesEli Lilly
→ Read original articleClinical Trials•Fierce Biotech•Sep 17, 2026
Goa Therapeutics launches with ‘immeasurably huge’ vision of creating Narcan for alcohol
background ▾
- •Goa Therapeutics is developing GOA26, an engineered alcohol dehydrogenase enzyme claimed to be 1000x more efficacious than natural enzymes, with promising preclinical data showing rapid alcohol metabolism in animal models.
- •The company plans IND filing by end of 2024 and Phase 1 initiation in 2027, with an initial narrow clinical indication in emergency trauma surgery before pursuing broader consumer market access.
- •Monitor IND approval status, Phase 1 trial design and enrollment, and regulatory pathway clarity for both the emergency medicine indication and any future OTC consumer applications, as well as the IPO outcome and funding execution.
Goa TherapeuticsGOA26
→ Read original articleClinical Trials•Endpoints News•Sep 17, 2026
Bristol Myers scraps $100M Orum-partnered cancer drug
background ▾
- •BMS discontinued a Phase 1 ADC candidate in partnership with Orum Therapeutics, indicating strategic portfolio culling
- •The termination suggests the asset did not meet internal efficacy, safety, or differentiation thresholds relative to competing ADC approaches
Bristol Myers SquibbOrum TherapeuticsBMS-986497/ORM-6151
→ Read original article