BIOHAVEN PHARMAC.HLDG CO.

The FDA has imposed a partial clinical hold on new patient enrollment in epilepsy studies with BHV-7000, requiring additional non-clinical studies on a metabolite detected in rodent studies. Patients already randomized (more than 600) will continue to be treated, and the registrational study BHV7000-303 remains on track for topline data in the second half of the year. The enrollment stop and a concurrently filed mandatory notice with the SEC created significant uncertainty and led to a pre-market share drop of around 12%. » Więcej na de.investing.com

Biohaven Pharmaceutical shares fell 1.9% in pre-market trading to $15.40 after RBC cut its rating from "Outperform" to "Sector Perform" and lowered the price target from $23 to $19. RBC cited the higher valuation following strong gains, limited patient data and a poorly validated clinical differentiation of the epilepsy program Opakalim. Positively noted was the Kv7 licensing deal with SK Biopharmaceuticals, which brought in $400 million and strengthened the balance sheet, but increased clinical risk and a short interest of about 13.6% of the float weigh on the stock ahead of upcoming Phase-3 data. Xenon Pharmaceuticals is seen as at least two years ahead in the Kv7 area, dampening expectations for Biohaven. » Więcej na de.investing.com

Biohaven grants SK Biopharmaceuticals exclusive worldwide rights to the Kv7 ion‑channel platform, including epilepsy candidate Opakalim (BHV‑7000). The agreement can total up to $795 million, of which $400 million is cash up front, but it results in the expected phase‑2/3 RISE3 study being removed from Biohaven’s pipeline. Investors reacted with a "sell the news" move, amplified by an earlier downgrade from Bank of America and a revaluation of the remaining immunology and oncology programs. A separate $4 million trade‑secret judgment in Biohaven’s favor provided only limited support. » Więcej na de.investing.com