Innate Pharma S.A. (NASDAQ: IPHA) stock is on a sharp increase today after a major regulatory notification. IPHA stock was trading at $2.48 as of the latest pre-market check with a 27.8% rise. The company’s most recent medication research achievement is the cause of this encouraging market shift.
Lacutamab Receives FDA Breakthrough Therapy Designation
Innate Pharma announced that their experimental medication, lacutamab, has been awarded Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration (FDA). Adult patients with relapsed or refractory (r/r) Sézary Syndrome (SS) who have had at least two previous systemic medications, such as mogamulizumab, are being treated with an anti-KIR3DL2 cytotoxicity-inducing antibody.
Based on encouraging results from a Phase 1 research and the Phase 2 TELLOMAK trial, which showed lacutamab’s potent effectiveness and good safety profile in patients who had previously received mogamulizumab, the designation was made. The findings demonstrate lacutamab’s potential as a cutting-edge treatment choice for individuals with advanced Sézary syndrome.
Taking Care of an Emergency Medical Need
The FDA’s Breakthrough Therapy Designation of lacutamab highlights the drug’s potential to provide a significant improvement over current therapies. In order to accelerate the development of lacutamab, Innate Pharma expressed excitement about collaborating closely with the FDA. With the ultimate objective of providing patients with a safer and more effective treatment alternative, the firm sees this certification as a critical step in advancing its strategy for the medicine.
Investing Possibilities
IPHA is currently rated as “Undervalued” on our ST screener suggesting potential investment opportunities within the Biotechnology sector. Interested parties are encouraged to explore peer stocks with similar or greater growth prospects through our ST screener link.
Upcoming Developments
The FDA granted lacutamab Fast Track status in 2019 for the treatment of relapsed or refractory Sézary syndrome. Moreover, it also succeeded to receive PRIME designation from the European Medicines Agency (EMA) next year. As it moves closer to a confirming Phase 3 trial in cutaneous T-cell lymphoma (CTCL), Innate Pharma (IPHA) is still in compliance with regulatory bodies and is actively looking for a development partner to help with its work.