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BioPharma Dive·2h ago·3 min read
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Capricor shares spike on CEO comments; Cytokinetics sues Bristol Myers

The FDA is “willing to review” an updated submission for Capricor’s Duchenne cell therapy, its CEO said. Elsewhere, a heart drug battle spilled into court and Rigel priced the first “Protac” medicine.

Aug 14, 2026·read at BioPharma Dive ↗

An article from News roundup Capricor shares spike on CEO comments; Cytokinetics sues Bristol Myers The FDA is “willing to review” an updated submission for Capricor’s Duchenne cell therapy, its CEO said. Elsewhere, a heart drug battle spilled into court and Rigel priced the first “Protac” medicine. Published Aug.

14, 2026 By BioPharma Dive staff Share Copy link Email LinkedIn X/Twitter Facebook Print License Add us on Google Today, a brief rundown of news involving Capricor Therapeutics and Cytokinetics, as well as updates from Valneva, InduPro, Zealand Pharma and Rigel Pharmaceuticals that you may have missed. Capricor Therapeutics shares surged more than 60% on Friday after CEO Linda Marbán told analysts that the Food and Drug Administration appears open to reviewing an updated submission for its Duchenne muscular dystrophy cell therapy. An FDA panel last month voted against that therapy, deramiocel, in Duchenne-related cardiomyopathy, but expressed more support for the drug’s impact on upper limb function.

On an earnings call Thursday, Marbán said that, following discussions with regulators, the company intends to amend its application with new follow-up data that can support a “refined” indication. The agency is “willing to review” this amendment and extend the evaluation of deramiocel, Marbán said. It currently has an Aug.

22 decision deadline. — Ben Fidler Cytokinetics is escalating a turf war with Bristol Myers Squibb, announcing Thursday it’s suing the pharmaceutical giant to defend patents covering its newly launched heart drug Myqorzo. In court papers, Cytokinetics alleged Bristol Myers “surprisingly” got a particular patent covering certain methods of treating hypertrophic cardiomyopathy, including by using the active ingredient in Myqorzo, despite having “zero involvement” in its discovery or development.

Cytokinetics claimed the move was an attempt to “burden [it] with litigation” and slow sales of Myqorzo, which competes with Bristol Myers’ Camzyos for market share. The company wants the court to declare Myqorzo doesn’t infringe on that patent and to block Bristol Myers from threatening or launching related litigation. — Ben Fidler Shares of Valneva climbed about 20% on Friday after European drug regulators accepted an application for a Lyme disease vaccine it’s been developing with Pfizer.

With the “validation” of that submission, the European Medicines Agency will begin reviewing Pfizer and Valneva’s shot, PF-07307405. The partners have been planning to pursue global approvals despite mixed results they blamed on fewer-than-expected Lyme disease cases during the evaluation period of their key clinical trial. Stifel analyst Damien Choplain called EMA’s endorsement a “significant de-risking event” for Valneva, with attention now turning to the vaccine’s approval prospects in the U.S.

— Ben Fidler Biotech startup InduPro said Wednesday it banked $77 million in a Series B round that would help the young company advance its portfolio of cancer and autoimmune drugs. InduPro recently took its lead program, a bispecific antibody drug-conjugate codenamed “IDP-001,” into early human testing in patients with advanced squamous non-small cell lung cancer and other solid tumors. The startup, which is headquartered in Seattle and Cambridge, Massachusetts, was backed by The Column Group, as well as Vida Ventures, Merck’s corporate venture arm, Sanofi, Eli Lilly and others.

— Gwendolyn Wu Zealand Pharma is selling the rights it owns to a drug for a rare blood disorder to Royalty Pharma for $100 million. The deal announced Wednesday hands Royalty the economic interests and sales royalties Zealand holds in rusfertide, a polycythemia vera drug the Food and Drug Administration could approve in the third quarter. Zealand first obtained those rights through a 2012, peptide-focused research collaboration with Protagonist Therapeutics, which went on to develop rusfertide and partnered with Takeda Pharmaceutical in 2024.

Zealand will keep a 0.25% royalty on global yearly rusfertide sales topping $1.5 billion, with Royalty getting 0.75% of sales exceeding that total. — Delilah Alvarado Rigel Pharmaceuticals said its protein-degrading breast cancer drug Veppanu is now available for prescription in the U.S. Rigel acquired rights from Arvinas and Pfizer, which had initially aimed to develop the drug for a broad group of breast cancer patients before finding the treatment to be most beneficial in a subset of patients with a mutation to the ESR1 gene.

The partners decided to offload the treatment afterwards, and cut a deal with Rigel following regulatory approval in May. Rigel priced a 30-day supply at $29,400. — Delilah Alvarado Add us on Google Share Copy link Email LinkedIn X/Twitter Facebook Print License Filed Under: Biotech

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Reporting by BioPharma Dive.

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companies & drugs in this story

companies
BRISTOL6CYTOKINETICS6PFIZER3RIGEL PHARMACEUTICALS INC2ZEALAND PHARMA2BRISTOL MYERS SQUIBBBRISTOL MYERS SQUIBB COELI LILLY COEli Lilly and CoLILLYProtagonist Therapeutics, IncSanofiUltragenyx Pharmaceutical Inc.Vera Therapeutics, Inc.
drugs
MYQORZO4aficamten4deramiocel2Lead Programmavacamten
topics
Duchenne Muscular Dystrophy4Oncology4Cardiology3Cell Therapy3Approval2Breast Cancer2NSCLC2PROTAC2Vaccine2Bispecific AntibodyHematologyImmunologyMonoclonal AntibodyPeptide TherapeuticPulmonologyRare Disease

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