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Home » Topics » Inflammatory, BioWorld

Inflammatory, BioWorld
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Ekterly pill and packaging

Missed PDUFA history as Kalvista wins FDA approval for HAE

July 7, 2025
By Lee Landenberger
No Comments
After delaying a June PDUFA date, the U.S. FDA has approved Kalvista Pharmaceuticals Inc.’s Ekterly (sebetralstat) for hereditary angioedema (HAE) in those aged 12 and older. The plasma kallikrein inhibitor now joins a market with previously approved drugs for the rare, genetic, life-threatening condition, as well as other companies with HAE drugs in development. Ekterly is the first orally-delivered on-demand treatment, as all others in the U.S. are intravenously or subcutaneously administered.
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Wuhan Healthgen gets chance at China IPO with SSE market reforms

July 7, 2025
By Marian (YoonJee) Chu
No Comments
Wuhan Healthgen Biotechnology Co. Ltd. gained clearance from the Shanghai Stock Exchange July 1 to list under a recently reinstated IPO growth tier geared towards supporting “unprofitable” biotechnology firms.
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Deal handshake with coin, chart background

After axing 95% workforce, Vor bets $4B+ on Remegen’s telitacicept

June 26, 2025
By Marian (YoonJee) Chu
No Comments
Just a month after laying off 147 employees and announcing plans to mull “strategic alternatives,” Vor Biopharma Inc. reported raising $175 million in private placement in public equity financing and inking a new $4.23 billion license deal for Yantai Rongchang Biotechnologies (Remegen) Co. Ltd.’s telitacicept, a dual-target fusion protein drug approved in China for three autoimmune indications. The news was disclosed after U.S. market hours June 25. Vor’s shares (NASDAQ:VOR) gained 34 cents, or 60.5%, to close June 26 at 89 cents. The company’s shares had risen for eight consecutive trading days since June 17.
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Multiple sclerosis
Neurology/psychiatric

At EAN 2025, DEI Hub launches to improve care for all

June 26, 2025
By Anette Breindl
No Comments
In recognition of the fact that diversity, equity and inclusion are necessary prerequisites for precision medicine, the European Academy of Neurology announced the launch of a DEI Hub at its 11th Congress, which is being held in Helsinki through June 24.
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Multiple sclerosis
Neurology/psychiatric

At EAN 2025, DEI Hub launches to improve care for all

June 23, 2025
By Anette Breindl
No Comments
In recognition of the fact that diversity, equity and inclusion (DEI) are necessary prerequisites for precision medicine, the European Academy of Neurology (EAN) announced the launch of a DEI Hub at its 11th Congress, which is being held in Helsinki through June 24. “We know now that when we talk about personalized medicine, we have to understand that talking about stroke, for example, in a woman is different than talking about stroke in a man,” EAN president Elena Moro told the audience at the opening session of the conference.
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Swollen face

HAE research continues to swell post-CSL Andembry win

June 20, 2025
By Randy Osborne
No Comments
The U.S. FDA clearance June 16 of CSL Behring LLC’s humanized anti-factor XIIa monoclonal antibody garadacimab (CSL-312) to prevent hereditary angioedema (HAE) attacks juiced up the space in which – although other therapies are available as well – developers continue working on new prospects.
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South Korea flag with stock chart, gold coins

Korea biotech roundup: four financings, six R&D deals mid-June

June 13, 2025
By Marian (YoonJee) Chu
No Comments
Four biotech companies from South Korea announced new or planned financings mid-June, including GC Genome Corp. Rznomics Inc., G2Gbio Inc. and Mezzion Pharma Co. Ltd. Six major mid-June deals included R&D pacts between Y-Biologics Inc. and Crosspoint Therapeutics, Daewoong Pharmaceutical Co. Ltd. and Salipro Biotech AB, Next & Bio Inc. and GC Cell Corp., Galux Inc. and Hanall Biopharma Co. Ltd., Celltrion Inc. and Onconic Therapeutics Inc., and SK Plasma Co. Ltd. and Aimedbio Inc.
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LYR-210 device unfurling

Redemption for Lyra as second phase III rhinosinusitis trial hits goal

June 2, 2025
By Jennifer Boggs
No Comments
Shares of Lyra Therapeutics Inc. soared more than 310% on data from its second phase III trial testing drug-device candidate LYR-210 in patients with chronic rhinosinusitis, with results from the Enlighten 2 study showing statistical significance on primary and key secondary endpoints and offering hopes of a regulatory pathway ahead.
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Lungs wireframe illustration

Split ends itepekimab in COPD? Regeneron phase III setup hairy

May 30, 2025
By Randy Osborne
No Comments
Facing erosion of its mighty Eylea (aflibercept) franchise and near-term loss of exclusivity with Dupixent (dupilumab), Regeneron Pharmaceuticals Inc. took a blow as one of two phase III trials with IL-33-blocking monoclonal antibody itepekimab failed in chronic obstructive pulmonary disease (COPD). The Tarrytown, N.Y.-based firm’s shares (NASDAQ:REGN) closed May 30 at $490.28, down $115.11, or 19%. Partner Sanofi SA, of Paris, saw its stock (NASDAQ:SNY) dip somewhat, too, and ended at $49.37, down $2.98. Cantor analyst Carter Gould opined that the latest news “all but [ruled] out a path forward short of a new study” with the compound.
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Nibec stock soars 30% on $435M peptide deal with US biotech

May 29, 2025
By Marian (YoonJee) Chu
No Comments
Nibec Co. Ltd. announced May 28 the signing of a potential $435 million license deal for NP-201, its phase II-ready peptide-based pulmonary fibrosis therapy candidate, with an undisclosed U.S.-based biotech company.
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