Immunome Reports the US FDA’s NDA Submission for Varegacestat to Treat Desmoid Tumors in Adults

Shots: The US FDA has received NDA for Immunome’svaregacestat for the treatment of adults with desmoid tumors NDA is supported by the global P-III (RINGSIDE) trial assessing varegacestat (1.2mg, QD) vs PBO until disease progression or death in 156 pts with progressing desmoid tumors; eligible pts could then enter OLE phase, which is ongoing Trial…

ByRidhi RastogiApril 30, 2026

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Henlius and Organon Receive the EC Approval for Poherdy (Biosimilar, Perjeta)

Shots: The EC has approved Poherdy (420mg/14mL, IV), an interchangeable biosimilar version of Perjeta (pertuzumab) for all indications of the reference product Approval was based on extensive data, incl. structural & functional analytical data, PK & clinical studies, which showed similarity & interchangeability in terms of analytical, PK, efficacy, safety, & immunogenicity between Poherdy &…

ByRidhi RastogiApril 30, 2026

NEWS

Chiesi Group to Acquire KalVista Pharmaceuticals for ~$1.9B

Shots: Chiesi Group has entered into a definitive agreement to acquire KalVista Pharmaceuticals, expanding Chiesi's rare immunology portfolio As per the deal, Chiesi will acquire KalVista for $27/share, representing the total deal value of ~$1.9B, with the transaction expected to close in Q3’26 & remaining shares acquired later via a second-step merger Upon completion, Chiesi…

ByRidhi RastogiApril 30, 2026

NEWS

Teva to Acquire Emalex Biosciences for ~$900M

Shots: Teva has entered into a definitive agreement to acquire Emalex Biosciences, incl. its lead asset, ecopipam, expanding its neuroscience pipeline & accelerating Teva’s pivot to growth strategy As per the deal, Teva will acquire Emalex for $700M upfront, & ~$200M in commercial milestones, plus royalties on global net sales of ecopipam, subject to regulatory approval; closing is expected in Q3’26…

ByRidhi RastogiApril 29, 2026

NEWS

HUTCHMED Reports NMPA’s NDA Acceptance under Priority Review for Sovleplenib to Treat wAIHA

Shots: The Chinese NMPA has accepted NDA & granted priority review to HUTCHMED's sovleplenib for the treatment of adults with warm antibody autoimmune hemolytic anemia (wAIHA) who had an inadequate response to ≥1 previous glucocorticoid treatment NDA was supported by the Chinese P-II/III (ESLIM-02) assessing sovleplenib vs PBO in adults with primary or secondary wAIHA who had…

ByRidhi RastogiApril 29, 2026

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InnoCare Doses First Patient with Orelabrutinib in P-III Trial for Systemic Lupus Erythematosus

Shots: InnoCare has dosed the first patient with orelabrutinib in the P-III trial for the treatment of systemic lupus erythematosus (SLE), assessing its efficacy & safety against PBO, with the SRI-4 response rate at Wk. 52 as the 1EP Orelabrutinib was assessed in the P-IIb trial, which met its 1EP, where orelabrutinib (75mg, QD) showed…

ByRidhi RastogiApril 29, 2026

NEWS

Kestrel Therapeutics Inks AbbVie Deal Worth up to $1.45B with Option to Acquire

Shots: Kestrel has entered into a strategic agreement with AbbVie, structured as a warrant deal, granting AbbVie an exclusive option to acquire Kestrel upon achievement of key development milestones As per the deal, AbbVie will fund development of KST-6051, with an exclusive option to acquire Kestrel based on development & regulatory milestone completion, representing the…

ByRidhi RastogiApril 29, 2026

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Profluent Signs ~$2.25B Pact with Eli Lilly to Advance AI-Designed Recombinases for Genetic Medicines

Shots: Profluent has entered into a multi-program strategic research collaboration with Eli Lilly to develop & commercialize custom site-specific recombinases to address diseases with unmet needs As per the deal, Profluent will use its AI models to design & optimize site-specific recombinases for multiple genomic targets, while Lilly will gain exclusive rights to selected assets…

ByRidhi RastogiApril 29, 2026

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CareDx to Acquire Naveris for ~$260M

Shots: CareDx has entered into a definitive agreement to acquire Naveris, extending CareDx’s Precision Medicine Testing Services strategy into specialty oncology As per the deal, CareDx will acquire Naveris for $160M upfront & up to $100M in revenue milestones; closing is expected in Q3’26 Naveris’ liquid biopsy platform uses TTMV DNA to detect viral DNA…

ByRidhi RastogiApril 29, 2026

NEWS

The US FDA Grants Priority Review and Breakthrough Therapy Designation to GSK’s Bepirovirsen for Chronic Hepatitis B

Shots: The US FDA has accepted NDA & granted priority review as well as BTD to GSK's bepirovirsen for the treatment of adults with chronic hepatitis B (CHB) NDA & designation were supported by the P-III (B-Well 1 & B-Well 2) trial results assessing bepirovirsen vs PBO in nucleos(t)ide analogue-treated pts with CHB & baseline…

ByRidhi RastogiApril 28, 2026

Ridhi Rastogi

Immunome Reports the US FDA’s NDA Submission for Varegacestat to Treat Desmoid Tumors in Adults

Henlius and Organon Receive the EC Approval for Poherdy (Biosimilar, Perjeta)

Chiesi Group to Acquire KalVista Pharmaceuticals for ~$1.9B

Teva to Acquire Emalex Biosciences for ~$900M

HUTCHMED Reports NMPA’s NDA Acceptance under Priority Review for Sovleplenib to Treat wAIHA

InnoCare Doses First Patient with Orelabrutinib in P-III Trial for Systemic Lupus Erythematosus

Kestrel Therapeutics Inks AbbVie Deal Worth up to $1.45B with Option to Acquire

Profluent Signs ~$2.25B Pact with Eli Lilly to Advance AI-Designed Recombinases for Genetic Medicines

CareDx to Acquire Naveris for ~$260M

The US FDA Grants Priority Review and Breakthrough Therapy Designation to GSK’s Bepirovirsen for Chronic Hepatitis B

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