tiprankstipranks
Point Biopharma completes randomization in PNT2002’s Phase 3 Splash trial
The Fly

Point Biopharma completes randomization in PNT2002’s Phase 3 Splash trial

Point Biopharma (PNT) announced the completion of enrollment for the randomization phase in the pivotal phase 3 SPLASH trial, on schedule and meeting previous guidance. SPLASH is a multi-center, randomized, open label assessment of 177Lu-PNT2002 in participants with PSMA-expressing metastatic castration resistant prostate cancer who have progressed on androgen receptor pathway inhibitor therapy and refuse, or are not eligible for, chemotherapy. Enrollment for randomization was completed on schedule with more than 390 participants randomized across 55 SPLASH trial sites in North America, Europe, and the United Kingdom. "We are proud to have reached this important milestone for the PNT2002 program," said Jessica Jensen, Executive Vice President, Clinical Development of POINT Biopharma…On November 14 , POINT announced a set of strategic collaboration agreements with Lantheus Holdings (LNTH) related to POINT’s PNT2002 and PNT2003 product candidates, which closed on December 20.Under the agreements, POINT will fund and complete its phase 3 SPLASH trial for PNT2002, following which Lantheus will file the New Drug Application in collaboration with POINT.For PNT2003, POINT recently received the OZM-067 clinical trial data sets from the trial sponsor. POINT will facilitate the analysis of the data sets. Lantheus will prepare and submit the regulatory filings in the U.S. The companies have formed joint steering committees to oversee the clinical studies, regulatory filings, manufacturing, and commercial readiness for both PNT2002 and PNT2003. POINT will develop commercial production capacity and manufacture clinical and commercial supply for both PNT2002 and PNT2003. Lantheus has the rights to commercialize both assets post regulatory approval, excluding certain Asian territories .

Published first on TheFly

See the top stocks recommended by analysts >>

Read More on PNT:

Trending

Name
Price
Price Change
S&P 500
Dow Jones
Nasdaq 100
Bitcoin

Popular Articles