Healthcare, Pharma & Life Sciences

Boston – October 19, 2026 -- Servier has dosed the first patients in EMBLEM-1, the pivotal Phase 2 cohort of its Phase 1/2 study of Emiltatug Ledadotin (Emi-Le) in aggressive adenoid cystic carcinoma (ACC), a cancer with no FDA-approved systemic treatment.

Emi-Le is an investigational antibody drug conjugate (ADC) directed against B7-H4. The cohort is enrolling under trial identifier NCT05377996.

EMBLEM-1 uses objective response rate per RECIST 1.1 as its primary endpoint

The trial will measure the percentage of patients who achieve a best overall response of confirmed complete response or partial response. It will also evaluate the safety of Emi-Le in ACC.

New York – October 19, 2026 -- Global MedTech M&A value rose 160% in the first half of 2026 versus the same period of 2025, with total disclosed deal value reaching roughly US$130 billion, the highest level in more than a decade, according to the 20th edition of EY US's Pulse of the MedTech Industry report.

The recovery is narrow. EY found it was driven by a limited number of blockbuster transactions rather than broad-based dealmaking.

Industry revenue reached $325 billion in the first half of 2026, up 7.1%

MedTech generated approximately US$650 billion in revenue in 2025, growth of 11%. First-half 2026 revenue of US$325 billion was 7.1% above the prior-year period. Therapeutic devices led growth, followed by non-imaging diagnostics, imaging, and lab equipment and tools.

Secaucus – October 19, 2026 -- A broader set of lab criteria identified primary aldosteronism (PA) in 26.2% of 60,449 U.S. patients, twice the 13.0% flagged under the Endocrine Society's 2025 guidelines, according to a Quest Diagnostics (NYSE: DGX) study published in the journal Hypertension.

Study compares 2025 guideline cutoffs with a permissive threshold

Researchers from Quest Diagnostics, Mass General Brigham, Harvard Medical School and the University of Texas Southwestern Medical School analyzed deidentified Quest lab results. The 2025 criteria require plasma renin activity (PRA) of 1 ng/mL/h or lower, aldosterone of at least 7.5 ng/dL and an aldosterone-to-renin ratio (ARR) above 15. The permissive criteria keep the PRA limit, set aldosterone above 5 ng/dL and drop the ARR requirement.

The authors describe the 2025 guidelines as "overly restrictive," with cutoffs that capture only the most advanced cases.

Bridgewater – – October 19, 2026 -- Insmed (Nasdaq: INSM) has launched BRINSUPRI Tablets 25 mg (brensocatib hydrate) in Japan, making it the first and only approved, commercially available treatment for non-cystic fibrosis bronchiectasis (NCFB) in the country.

Japan's health ministry cleared the once-daily oral tablet in August 2026

The Ministry of Health, Labour, and Welfare approved BRINSUPRI based on results from the Phase 3 ASPEN study. The label covers adults and pediatric patients aged 12 years and older.

Samuele Butera, Insmed's Senior Vice President and General Manager, Global Respiratory, called the launch "a meaningful step forward for the bronchiectasis community." Makoto Nakamura, Senior Vice President and General Manager, Japan, said the company will focus on providing information to healthcare professionals and promoting proper use of the therapy.

San Diego – October 19, 2026 -- The U.S. Food and Drug Administration has cleared Protego Biopharma's Investigational New Drug application for PROT-001, allowing the company to start SHIELD-AL, a global pivotal Phase 2/3 study in newly diagnosed light chain (AL) amyloidosis patients.

PROT-001 is an oral, investigational, first-in-class lambda light chain stabilizer. Protego will test it as an add-on to standard-of-care plasma cell-directed therapy, which reduces light chain production.

SHIELD-AL combines safety confirmation and pivotal efficacy testing in one randomized trial

The study is randomized, double-blind and placebo-controlled, and enrolls newly diagnosed patients with lambda AL amyloidosis. Part A is an initial safety and dose confirmation study. Part B is the pivotal safety and efficacy study.

Houston – – October 19, 2026 -- Nutex Health, Inc. (NASDAQ: NUTX) will file its Form 10-Q for the third fiscal quarter ended Sept. 30, 2026, on Thursday, Nov. 5, 2026, after the market close.

The company will issue a press release summarizing the quarterly financial results the same day.

Nutex Health schedules Nov. 6 earnings call for 9:30 a.m. CT

Management will discuss financial performance and provide a business update on Friday, Nov. 6, 2026. Participants can join through an operator using the dial-in numbers 1-877-407-9208 or 1-201-493-6784, or through an online Call meTM link that goes live 15 minutes before the start. A transcript and recording will be posted afterward in the "Investor Materials" section of the company website.

Suzhou – October 19, 2026 -- MegaRobo Technologies has launched Poreva Open, a global AI protein design competition that will put more than 10,000 designs through standardized wet-lab experiments and offers US$250,000 in cash prizes.

Megalaxy Lab to run double-blind validation of every submission

Teams from academic institutions, research organizations, university laboratories, and biotech and AI companies can enter. Participants may use any models, algorithms or design methods. All submissions go through double-blind experimental evaluation at MegaRobo's Megalaxy Lab.

Results and experimental data, including data on unsuccessful designs, will be published after the competition. Publication is subject to intellectual property and compliance requirements.

San Diego – October 19, 2026 -- The U.S. Food and Drug Administration's Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC) will meet on July 29, 2026, to review Capricor Therapeutics' Biologics License Application (BLA) for Deramiocel, an investigational cell therapy for Duchenne muscular dystrophy (DMD), less than four weeks before the agency's August 22, 2026 PDUFA target action date.

Panel meeting precedes the August 22 PDUFA decision date

Capricor (NASDAQ: CAPR) said its BLA remains on track against the August 22 deadline. The advisory meeting will be livestreamed. The company pointed to the Federal Register and its own website for meeting details.

San Diego – October 19, 2026 -- Capricor Therapeutics (NASDAQ: CAPR) disputed the post-hoc analyses in the FDA's briefing materials, two days before an advisory committee meets on July 29 to discuss its Biologics License Application (BLA) for Deramiocel, an investigational cell therapy for Duchenne muscular dystrophy (DMD).

Capricor says FDA analyses rely on an obsolete draft analysis plan

The company said the FDA's post-hoc analyses use statistical analysis plan (SAP) version 1.1. Capricor described that version as an unsigned, incomplete internal draft that became obsolete when cohort B was added. It also said the draft lacked content the FDA had specifically requested.

Capricor said its results are governed by SAP version 3.0, which was finalized before unblinding.

San Diego – October 19, 2026 -- Capricor Therapeutics (NASDAQ: CAPR) said The Lancet has published results from its Phase 3 HOPE-3 trial, in which Deramiocel slowed upper limb function decline by 54 percent versus placebo in Duchenne muscular dystrophy (PUL 2.0, p=0.03).

The randomized, double-blind, placebo-controlled trial enrolled 106 participants and met its primary endpoint. Capricor also reports a clinically meaningful cardiac benefit. The results rest on the company's prespecified Statistical Analysis Plan version 3.0 (SAP 3.0).