Biotech Stock Roundup: BIIB To Acquire Nightstar, Other Pipeline News & More

Mergers and acquisitions continue to grab headlines in the biotech sector. Shares of Nightstar Therapeutics (NASDAQ:NITE) soared after Biogen (NASDAQ:BIIB) announced an agreement to acquire the former. Meanwhile, as the reporting cycle draws to a close, regular pipeline updates and data read-outs are also in news. Celgene Corporation (NASDAQ:CELG) obtained a priority review for its drugs from the FDA while CHMP gave a positive opinion on the label expansion of Regeneron’s Dupixent.

Recap of the Week’s Top Stories:

Biogen to Acquire Gene Therapy Company Nightstar: Biogen announced that it has entered into an agreement to acquire London based clinical-stage gene-therapy company, Nightstar Therapeutics. Per the deal, Biogen will pay $25.50 in cash for each share of Nightstar or approximately $800 million. Biogen expects to complete the buyout by mid-2019.

Nightstar is focused on adeno-associated virus (AAV) treatments for inherited retinal disorders. The company has two potentially first-in-class mid- to late-stage candidates and other preclinical programs. The company’s lead asset, NSR-REP1, is being evaluated for the treatment of choroideremia (CHM) in an ongoing phase III STAR study. Data from the same is expected in the second half of 2020. The second candidate is NSR-RPGR, currently evaluated for the treatment of X-linked retinitis pigmentosa (XLRP).

The phase I/II results from the dose escalation portion of the XIRIUS investigation on NSR-RPGR demonstrated an increase in central retinal sensitivity. The phase II/III dose expansion part of the XIRIUS analysis is currently underway. The preclinical pipeline includes NSR-ABCA4 for Stargardt disease and potential programs targeting Best vitelliform macular dystrophy (Best disease) and other genetic forms of retinitis pigmentosa. The transaction is expected to accelerate Biogen’s foray into ophthalmology space.

Celgene Gets Priority Review for Myelofibrosis Drug: Celgene announced that the FDA has accepted its New Drug Application (NDA) for fedratinib and granted a priority review to the same. Fedratinib, a highly selective JAK2 inhibitor, is being evaluated for treating patients with myelofibrosis. The FDA has set an action date of Sep 3, 2019. The NDA was based on encouraging outcomes from a randomized, placebo-controlled, phase III probe (JAKARTA) on patients with primary or secondary myelofibrosis and a single-arm, open-label phase 2 evaluation (JAKARTA2) of patients with primary or secondary myelofibrosis, previously exposed to Jakafi. The candidate also enjoys an Orphan Drug designation for secondary and primary myelofibrosis. The company also plans to evaluate fedratinib in combination with luspatercept.

The FDA also granted a priority review designation to Celgene’s supplemental New Drug Application (sNDA) for its lead drug — Revlimid — combined with rituximab (R²) for the treatment of patients with previously treated follicular and marginal zone lymphoma. The FDA has set its action date as Jun 27, 2019.

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Celgene currently sports a Zacks Rank #1 (Strong Buy). You can see Biotech Stock Roundup: ONCE, CMTA Soar on Merger News, Other Pipeline Updates )

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