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The FDA’s Obstetrics Reproductive and Urologic Drugs Advisory Committee voted nearly unanimously to withdraw the approval of Covis’ preterm birth drug Makena.

While worthy advances have recently been made in sickle cell disease, companies such as Graphite Bio, bluebird bio, Vertex Pharmaceuticals and Editas Medicine have loftier ambitions.

Massachusetts-based PIC Therapeutics has closed a $35 million Series A financing round centered around the advancement of its lead asset, a novel therapeutic for advanced metastatic breast cancer.

A Phase II trial studying PTC Therapeutics’ PTC518 in Huntington’s disease has been paused in the United States following a request from the FDA for additional data.

Jazz and Zymeworks entered into a $50 million licensing agreement over zanidatamab, Zymeworks’ bispecific antibody targeting HER2.

Advaxis and Ayala Pharmaceuticals entered a reverse merger deal to focus on two clinical-stage cancer therapies: AL102 for desmoid tumors and ADXS-504 for prostate cancer.

Backed by Pfizer, Merck KGaA and J&J, Nucleome Therapeutics secured £37.5 million (about $42.16 million) in an oversubscribed Series A financing round.

Ambrx Biopharma Inc. announced it will lay off 15% of its workforce and suspend development of its lead candidate in a strategic realignment initiative.

Editas is reportedly in “advanced discussions” regarding the sale of its preclinical cancer lineup. The company told BioSpace it has undertaken a strategic review to inform opportunities.

PD-L1 expression is not the static, “yes/no” predictor of tumor response for which researchers hoped. Surface Oncology, Immutep and Corbus are each taking a different approach to immuno-oncology.

Genetic engineering company Empyrean Neurosciences stepped into the CNS arena with $22 million and a small molecule platform derived from plants and fungi.

Salarius Pharmaceuticals voluntarily paused enrollment of its Phase I/II trial of seclidemstat for Ewing sarcoma and FET-rearranged sarcomas after a patient’s death.

• Appointment strengthens medical, regulatory, and commercial leadership as Company prepares to complete early market access regulatory filings in the U.S., U.K, Europe and Australia in anticipation of OST-HER2 approval decisions expected by year-end 2026 • Upcoming FDA Pre-BLA meeting will focus on the use of recent seroconversion biomarker data as a key surrogate clinical efficacy endpoint to support a BLA for OST-HER2 under the Accelerated Approval Program • Commercialization and reimbursement preparations well underway for the U.S., U.K., and Europe in parallel with ongoing partnership discussions

• Quarterly revenue up 8% year over year; Annual revenue guidance range remains at $42-$48 million • CDMO fragrance and Saffron projects reach successful milestones; First quarter CDMO revenue grew 135% YoY • VINIA brand customer base grows to 90,000 active users as of the end of April • Two-lens framework enacted in Q1 to optimize performance across CDMO and D2C businesses

Business development appointment is aligned with securing long-term customers for development and manufacturing partnerships

Another major milestone in its continuous global IP strategy, advancing protection of VIVI Cap Smart across international markets Highlights Granted Patent covers the design of VIVI Cap Smart™ across major international, growing market Strengthens the Company’s intellectual property position in one of the world’s largest healthcare and consumer markets Supports commercialization strategy and strategic discussions with appliance manufacturers Design term extends through May 16, 2039 Company enters into financing arrangement to support inventory build for growing portfolio