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Biotech

All articles tagged with #biotech

business13 hours ago•1 min saved

Sentivera inks up-to-$1.5B deal for inflammatory drug with Haisco

Sentivera, formed by Arch Venture Partners and Population Health Partners after Metsera’s stealth exit, licensed an inflammatory-disease drug candidate to Haisco Pharmaceutical for up to about $1.5 billion, with $40 million cash upfront and stock valued at roughly $36 million for a 17.5% stake; Haisco retains Greater China rights, while Sentivera is positioned to advance the asset globally as a small-molecule therapy targeting Type 2 inflammatory diseases such as asthma and eczema.

via Fierce Biotech|

#biotech #business #inflammation

business14 hours ago•19 min saved

Moderna Bets on Cancer Vaccine as Trials Near Key Results

Moderna executives remain confident in the personalized cancer vaccine intismeran autogene and plan to share more late-stage trial details with Merck at an upcoming conference. The company is refocusing on renal cell carcinoma and pulling back from bladder cancer, aiming to unlock a multibillion-dollar market, but investors still await full trial results before pricing in the program.

via Barron's|

#biotech #business #cancer-vaccine

business1 day ago•4 min saved

Massachusetts Biotech Boom Delivers VC Cash, But Workforce Shrinks

Massachusetts’ biotech scene shows a mixed picture: venture capital funding in H1 2026 totaled $3.45B (up 25% YoY) with Cambridge and Boston leading deals and eight IPOs signaling a strong exit environment, while NIH funding remains a bright spot per capita (Massachusetts at 9.3% of NIH funding and $477 per person) even as total NIH awards fell 6.2%. Early-stage financing looks mixed: seed rounds rose (15→21) but average raises dropped from $7.6M to $4.6M. Biopharma R&D jobs fell about 3,600 in 2025 (3.1%), though there was a late-year rebound and strong pipeline metrics—Massachusetts accounts for a large share of U.S. VC, the drug-development pipeline, and possess abundant lab space (63.2M sq ft with 31% vacancy) that could help fuel a rebound if capital returns to early-stage companies and policy supports competitiveness without unduly limiting China investments.

via Fierce Biotech|

#biotech #business #ipos

biotech1 day ago•2 min saved

FDA hold stalls Regenxbio's RGX-121 refiling amid spine MRI findings

The FDA has placed a clinical hold on Regenxbio’s RGX-121 due to asymptomatic spine MRI findings, derailing plans to refile for approval in MPS II (Hunter syndrome). The hold follows a prior safety signal in RGX-111 and expanded monitoring that identified five patients with likely benign spinal nodules; researchers will continue imaging and use FDA feedback to determine next steps, while Regenxbio forges ahead with RGX-202 and surabgene lomparvovec. Regenxbio’s stock declined in premarket trading.

via Fierce Biotech|

#biotech #clinical-hold #fda

business6 days ago•24 min saved

SpaceX pushback, tariffs paused: a three-front business roundup

A concise roundup notes SpaceX delaying its launch schedule, a pause on new tariffs, and developments in a cancer vaccine, reflecting ongoing activity across aerospace, trade policy, and healthcare.

via Baton Rouge Business Report|

#biotech #business #business-roundup

biotech8 days ago•2 min saved

Oral lac-phe pill aims to mimic exercise, preserving muscle during weight loss in early trials

Enveda reports Phase 1 results for an oral drug candidate that mimics the exercise-induced lactate-phenylalanine pathway (lac-phe) to curb appetite and preserve lean muscle, with the goal of maintaining weight loss without the GI side effects seen with GLP-1 drugs.

via statnews.com|

#biotech #enveda #exercise-mimetic

ai13 days ago•30 min saved

Canine cancer vaccine tale sparks a new AI-backed biotech startup

The Verge reports that Paul Conyngham, who popularized an AI-assisted dog cancer vaccine, has launched Gamgee to commercialize personalized mRNA cancer vaccines for dogs and eventually humans. Backed by Y Combinator and collaborating with Australian universities, Gamgee aims to scale such therapies, but scientists say Rosie’s story is not clearly attributable to AI and the company’s ambitious timelines and costs remain unproven.

via The Verge|

#ai #biotech #dogs

health13 days ago•24 min saved

Pittsburgh Launches Rare Ventures with $25M to Accelerate Rare-Disease Therapies

The Richard King Mellon Foundation is launching Rare Ventures in Pittsburgh with $25 million to create a three-year, venture‑philanthropy hub that unites universities, biotech firms, and EB Research Partnership to accelerate rare-disease drug development. The initiative will use an AI tool called Curator to centralize deidentified patient genetic data for trial matching, with a goal of becoming self‑sustaining by funneling revenues from approved therapies back into future research and expanding collaborations across Pitt, CMU, ElevateBio, UPMC, and Stanford.

via Pittsburgh Post-Gazette|

#ai #biotech #health

biotech15 days ago•2 min saved

Infinimmune lands $75M Series A to push eczema antibodies forward

Biotech startup Infinimmune raises $75 million in a Series A led by Regeneron Ventures (with Playground Global) to advance its human B cell–based antibody platform for eczema, including lead antibodies IFX-201 and IFX-101 moving to Phase 1 next year. Regeneron’s investment aims to complement Dupixent, Merck remains an investor, and the company envisions additional large‑pharma partnerships as it advances its pipeline.

via Fierce Biotech|

#antibodies #biotech #eczema

biotech15 days ago•2 min saved

AbCellera Bets ABCL635 as Best-in-Class Non-Hormonal Hot-Flash Therapy

AbCellera’s Phase 2 readout for ABCL635 in postmenopausal women showed a statistically significant, placebo-adjusted reduction of 5.3 daily hot flashes by Week 4 (8.8/day with ABCL635 vs 3.5/day with placebo) and a 1.4-point severity improvement vs 0.3 for placebo, outperforming the two approved small‑molecule rivals. The company reported a favorable safety profile with no liver signal, positioning ABCL635 as a potential best‑in‑class non‑hormonal therapy. Analysts and investors cheered the data, boosting the stock, and AbCellera plans Week 12 readouts and Phase 3 development discussions.

via Fierce Biotech|

#abcellera #abcl635 #biotech

biotech15 days ago•2 min saved

Silence Therapeutics' divesiran shows strong Phase 2 signals in polycythemia vera

In a 48-patient Phase 2 study for the rare blood cancer polycythemia vera, Silence Therapeutics' RNA drug divesiran achieved a clinical response in 88% of treated patients versus 19% on placebo, suggesting robust efficacy and potential competitiveness with Takeda's near-approval therapy.

via STAT|

#biotech #divesiran #drug-development

biotech16 days ago•2 min saved

FDA Rejects ITM-11 Radiopharmaceutical, Stalling Rival to Novartis Therapy

The FDA rejected ITM-11, ITM Isotope Technologies Munich’s radiopharmaceutical for gastroenteropancreatic neuroendocrine tumors, due to manufacturing issues, halting a potential rival to Novartis’ therapy; early ITM data suggested ITM-11 could extend progression-free survival (23.9 months vs 14.1 months with everolimus).

via STAT|

#biotech #fda #gep-nets

biotech-and-pharma18 days ago•3 min saved

Replimune Wins FDA Nod for Tudriqev After Roller-Coaster Run, Shares Dip

Replimune secures FDA clearance for Tudriqev, used with Opdivo to treat advanced melanoma, on its third submission after two prior denials. The approval, supported by an advisory panel’s positive vote, sets up the company for its first commercial launch, though the stock fell about 6% as investors weighed execution risk and the company’s regulatory history. Initial rollout targets ~200 early-adopter hospital accounts with full launch expected over the next year, and analysts see significant upside if Tudriqev captures a meaningful share of refractory melanoma—potentially $1B+ in annual sales—despite launch challenges and competition from Amgen and Iovance Biotherapeutics.

via Barron's|

#biotech #biotech-and-pharma #fda-approval

technology19 days ago•2 min saved

Biotech Prediction Bets on Trials Prompt Ethical Backlash

Kalshi’s plan to let users bet on the outcomes of clinical trials has drawn sharp ethical objections from researchers and patients who warn such markets could undermine trial integrity and patient welfare, even as Kalshi argues bets would reflect updated evidence and cut through hype. The controversy highlights broader concerns about gamifying lifesaving research and treating trials as speculative bets, rather than purely scientific endeavors.

via Futurism|

#biotech #clinical-trials #drug-development

healthcare19 days ago•2 min saved

FDA clears RP1 melanoma therapy after regulatory rollercoaster

The FDA granted accelerated approval for Replimune's RP1 (brand Tudriqev) for advanced melanoma after an advisory panel backed efficacy signals despite concerns about trial design, ending a regulatory saga that included two prior rejections; the therapy is priced at $450,000 per course.

via STAT|

#accelerated-approval #biotech #fda