Rare disease biotech raises $47M Series C, plans for Phase 2 trial
Cambridge, UK-based Healx has pulled in $47 million in a Series C round and has nabbed IND clearance from the FDA to run its first Phase 2 clinical trial with an oral drug in neurofibromatosis type 1,...
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It took more than two decades for MDMA to reach the FDA. In two months, its...
Lykos Therapeutics had planned to be the first company to bring PTSD patients a much-needed new treatment. Then in May, an influential outside group raised serious concerns about how its trial was run....
View ArticleJim Wilson to step down from gene therapy center at UPenn, will form two new...
Gene therapy pioneer Jim Wilson will leave his academic post at the University of Pennsylvania and launch two new companies, one focused on developing rare diseases and another meant to provide...
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VC firm venBio secures $528M for ‘extremely selective’ fifth fund after...
San Francisco-based investment firm venBio plans to back about a dozen new biotech startups over the coming three years with its latest fund, disclosed Thursday morning. Aaron Royston The firm...
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AbbVie closes $8.7B Cerevel deal in bid to compete with Bristol Myers in...
AbbVie has received regulatory clearance to complete its $8.7 billion acquisition of neuroscience biotech Cerevel Therapeutics, the companies said Thursday. The move gives the Chicago-area pharma giant...
View ArticleWith $144M Series B, Outpace Bio beats funding goal for solid tumor cell...
Seattle startup Outpace Bio, a Lyell Immunopharma spinout using AI to design proteins for solid tumor cell therapies, has raised a $144 million Series B to gather clinical data from its first two...
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Biogen CEO sees Alzheimer's drug on right path despite tiny sales, will keep...
A year after unveiling its “Fit for Growth” restructuring effort, Biogen is on track to reverse multiple years of declining revenues, CEO Chris Viehbacher told reporters Thursday. The Cambridge,...
View ArticleSanofi pours €1.3B into new insulin manufacturing plant in Frankfurt
Sanofi is investing €1.3 billion into a new insulin production facility in Germany to help with long-term supply and add power to its European supply chain. The 36,000 square-meter facility will be...
View ArticleArbutus reduces headcount after axing HBV combo trial that features Imfinzi
Arbutus plans to lay off 40% of its staff after ending one of three ongoing midstage hepatitis B trials. The decision to cut the study — testing lead asset imdusiran plus a nucleos(t)ide analogue in...
View ArticleBlueprint ups Ayvakit guidance; Aurinia to advance autoimmune disease asset
Plus, news about Novo Holdings, Oxford Nanopore, Ionis, Valneva, LimmaTech and Bayer: Blueprint pulls in $114.1 million for Ayvakit: The company raised its net product revenue guidance to between $435...
View ArticlePfizer mulls facility sale; GSK penalized in South Korea for administrative...
Welcome to Endpoints News’ manufacturing briefs, where we bring you essential news on new builds, collaborations, recalls and more. Pfizer is considering selling a facility it bought from Abzena in...
View ArticleNovartis sues FDA over approval of Entresto generic, following rejection of...
Novartis is going after the FDA over the agency’s decision to approve a generic version of the cardiovascular drug Entresto earlier this year. The Swiss drugmaker sued the government after the FDA in...
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RSV market pressure leads to slower launch for Moderna's vaccine
The RSV market is turning out to be tougher than Moderna hoped. Jamey Mock The company’s mResvia is the third RSV vaccine to enter a market dominated by GSK’s Arexvy and Pfizer’s Abrysvo. That pressure...
View ArticleDespite recent trial success, uniQure plans to cut 65% of staff
Less than a month after promising data sent uniQure’s shares soaring, the company is disclosing significant layoffs to 65% of the company. The new wave of cuts disclosed in the biotech’s second-quarter...
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GSK scores expanded label for Jemperli in first-line endometrial cancer
GSK’s Jemperli can now be used as a first-line treatment for all adult endometrial cancer patients following an expanded label approval in the US. The FDA approved the PD-1 antibody in combination with...
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Vir's overhaul brings an end to most virology work — and a beginning with cancer
Last year’s layoffs were just the start for Vir Biotechnology. The company is now shifting the direction of its clinical and corporate operations by prioritizing clinical-stage hepatitis B and D...
View ArticleVertex says about 20 patients have started sickle cell therapy; cuts two rare...
Vertex Pharmaceuticals is picking up momentum in its strategy of branching out beyond cystic fibrosis. About 20 patients have had their cells collected for Casgevy, Vertex’s sickle cell gene therapy...
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Adaptimmune gets FDA accelerated approval for T cell receptor cell therapy in...
The FDA granted accelerated approval to a cell therapy for synovial sarcoma, a rare type of cancer typically found in the tissue of the arms and legs. Developed by Adaptimmune Therapeutics, it’s the...
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Exclusive: Ultragenyx secures first funds for Alzheimer's gene therapy spinout
Rare disease specialist Ultragenyx reeled in a $14 million seed round for its Alzheimer’s gene therapy spinout Amlogenyx, the company exclusively told Endpoints News. The California biotech’s...
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Former RayzeBio CEO quickly returns with new biotech; Amgen’s global research...
Ken Song Ken Song is back in business. He left RayzeBio in February after leading the radiopharmaceuticals startup from Series A to IPO in three years, and then a $4.1 billion exit to Bristol Myers...
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