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STAT810 Endpoints607 BioPharma Dive231 onclive165 BioSpace77 Fierce Biotech75 raps32 fda press20

therapy area

all Oncology81 Cardiology27 Psychiatry & CNS21 Vaccines17 Immunology17 Rare Disease12 Hepatology

STAT+: Bracing for another Fauci hearing
Plus: Democrats take on Trump over IVF, and Trump's White House releases a new science funding blueprint.
STAT · 22h agoRegulatoryNeutral↗ source
STAT+: GSK lays out plans to cut costs, pursue more late-stage drug trials
New GSK CEO Luke Miels outlined his strategy to help the company navigate a patent cliff and get on a path toward long-term growth.
STAT · 1d agoRegulatoryNeutral↗ source

page 2 of 43

globenewswire health20

6

Infectious Disease4

STAT+: FDA staff reiterate concerns about Replimune skin cancer treatment

Regulators at the FDA have reiterated concerns that Replimmune does not have adequate data to support an approval of its investigational skin cancer treatment.

STAT · 1d agoRegulatoryNeutral↗ source

STAT+: Pharmalittle: We’re reading about FDA views on a Duchenne drug, GSK cost savings, and more

The FDA said a Capricor stem cell treatment for Duchenne muscular dystrophy did not meet a Phase 3 trial's objectives — contrary to company claims

STAT · 1d agoRegulatoryNeutral↗ source

STAT+: Three questions with Whoop’s new CMO

In this edition of STAT Health Tech: A chat with Whoop's new chief medical officer, an update on CMS health tech initiative, and more.

STAT · 1d agoRegulatoryNeutral↗ source

Altimmune rises as GLP-1/glucagon drug curbs heavy drinking in mid-stage study

Pemvidutide showed a “highly statistically significant” treatment effect in patients with alcohol use disorder. Altimmune is going up against Eli Lilly and newcomer Baseline Therapeutics, among oth…

BioSpace · 1d agoRegulatoryNeutral↗ source

Anthony Fauci’s pandemic-era diary entries

New data on American substance use, concerns of a global HIV resurgence, and more health news from Morning Rounds

STAT · 1d agoRegulatoryNeutral↗ source

Apnimed eyes up to $160M IPO to prep for sleep apnea drug launch

If the offering closes, Apnimed will join the 2026 IPO class that has already far surpassed last year’s total.

BioSpace · 1d agoRegulatoryNeutral↗ source

Oak Hill takes SPAC track to Nasdaq with Roche asset in tow

Oak Hill Bio is developing the antisense therapy rugonersen, which it licensed from Roche in 2025, for Angelman syndrome.

BioSpace · 1d agoRegulatoryNeutral↗ source

After PCOS became PMOS, there’s hope for new awareness among Black and Latina women

Growing awareness of a painful endocrine disorder now named PMOS is good news for women of color, who have high prevalence and low diagnosis.

STAT · 1d agoRegulatoryNeutral↗ source

Opinion: STAT+: Dementia finally has a business model

The big takeaway from the recent Alzheimer’s Association International Conference in London is an economic message: Dementia finally has a business model, writes Jason Karlawish.

STAT · 1d agoRegulatoryNeutral↗ source

STAT+: From ‘lost cause’ to gold rush: Biotechs swarm to cure AATD

Biotech companies are racing to cure alpha-1 antitrypsin deficiency, AATD, fueling patent disputes, startup defections, arbitration, and a U.S.-China rivalry.

STAT · 1d agoRegulatoryNeutral↗ source

STAT+: CMS evaluates one year of health tech progress, announces eight new pledge categories

One year after launching the CMS Health Tech Ecosystem, officials convened in D.C. to celebrate the Trump administration modernizing health technology.

STAT · 1d agoRegulatoryNeutral↗ source

ADA faces member backlash and calls for CEO and CSO resignations after expert expulsions

The American Diabetes Association’s 2026 Scientific Sessions in New Orleans ended with the expulsion of five diabetes experts, sparking a wave of criticism. More than 200 members signed an open le…

STAT · 15h agoNegative↗ source

Otsuka’s ADHD approval opens up new drug class with $615M opportunity

Otsuka Pharmaceutical plans to launch Simtriyo—the first norepinephrine, dopamine, serotonin reuptake inhibitor—later this year following scheduling by the U.S. Drug Enforcement Agency.

BioSpace · 2d agoApprovalPositive↗ source

UPDATE: FDA disputes Capricor's claims of Phase 3 success for DMD cell therapy

In briefing documents published Monday ahead of an advisory committee meeting for deramiocel, the FDA disagreed with Capricor's assertion that a Phase 3 trial met its primary outcome measures.

BioSpace · 1d agoPositive readoutPositive↗ source

Lilly, AbbVie and others pursue in-vivo CAR-T, but safety concerns loom

Analysts at H.C. Wainwright say safety will be the decisive factor for in‑vivo CAR‑T therapies, noting that convenience and efficacy alone will not win over investors. In‑vivo CAR‑T aims to genera…

BioSpace · 2d agoNeutral↗ source

Summit Therapeutics reports positive Phase 3 data for lung cancer drug ivonescimab, highlighting regulatory hurdles for US approval

Summit Therapeutics and its Chinese partner Akeso announced that their PD-1/VEGF antibody ivonescimab showed positive results in a Phase 3 trial for non-small cell lung cancer in Western patients.…

BioSpace · 2d agoPositive readoutPositive↗ source

AstraZeneca has no plans to ramp up dealmaking in wake of Wainua failure

AstraZeneca remains "very much on track" to hit its 2030 goal of reaching $80 billion in revenue despite the recent late-stage failure of Wainua in ATTR-cardiomyopathy, CEO Pascal Soriot said durin…

BioSpace · 2d agoDealNeutral↗ source

Argenx deepens immuno expertise with $2.2B Forte Biosciences buy

The star of the takeover is Forte Biosciences' investigational antibody therapy, FB102, which has shown early potential in vitiligo and celiac disease.

BioSpace · 2d agoDealNeutral↗ source

STAT+: RA Capital backs upstart rival to Ultragenyx and Ionis in rare brain disease

Oak Hill Bio, a new company backed by RA Capital and other investors, will take on Ultragenyx and Ionis in developing an Angelman syndrome medicine.

STAT · 2d agoDealNeutral↗ source

STAT+: Argenx to buy Forte Biosciences for $2.2B

Argenx plans to buy Forte Biosciences for $2.2 billion, expanding its pipeline of drugs that could treat multiple autoimmune diseases.

STAT · 2d agoDealNeutral↗ source

STAT+: HIV resurgence is feared as global funding to combat the disease falls 18%

The world risks a resurgence of the HIV epidemic after international financing to combat the disease suffered a “profound shock” last year, according to a new report from UNAIDS.

STAT · 1d agoRegulatoryNeutral↗ source

STAT+: Pharma’s drug spending deflection

Job lock, surging prescription drug costs, No Surprises Act update, and more from STAT's Health Care Inc.

STAT · 1d agoRegulatoryNeutral↗ source

MapLight’s schizophrenia pill remains in Cobenfy’s shadow after mixed Phase 2 readout

While MapLight Therapeutics’ oral schizophrenia candidate reached the main endpoint of a Phase 2 trial, analysts say Bristol Myers Squibb's Cobenfy is likely to hold its market share.

BioSpace · 1d agoRegulatoryNeutral↗ source