It was a busy week for the biotech sector with regulatory updates. The FDA approved Alexion’s ALXN PNH drug, Ultomiris, ahead of scheduled date and Acorda Therapeutics’ ACOR PD therapy. Meanwhile, Agenus soared on a deal with bigwig Gilead Sciences, Inc. GILD.
Recap of the Week’s Top Stories:
Alexion Gets Approval For Blood Disorder Drug: Alexion announced that the FDA has approved long-acting C5 complement inhibitor Ultomiris for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH) to be administered every eight weeks. The FDA approval comes well ahead of its action date set for Feb 18, 2019. The FDA approval was supported by results from two phase III studies, which included 441 patients, who had either never been treated with a complement inhibitor before or who had been stable on Alexion’s lead drug Soliris (eculizumab). The studies showed that the efficacy of Ultomiris, administered every eight weeks, was non-inferior to the efficacy of Soliris (administered every two weeks on all 11 endpoints). The safety profile of Ultomiris was similar to that of Soliris. The approval will complement Alexion’s existing drug Soliris.
Agenus Soars on Deal With Gilead: Shares of Agenus, Inc. AGEN soared after the company stuck a partnership deal with biotech bigwig Gilead. Both companies have entered into an immuno-oncology (I-O) partnership focused on the development and commercialization of up to five novel immuno-oncology therapies. Per the agreement, Agenus will get an upfront $120-million cash payment and a $30-million equity investment. The company is also eligible for about $1.7 billion in potential future fees and milestones.
On the other hand, Gilead will receive worldwide exclusive rights to AGEN1423 and an exclusive option to license two additional programs: AGEN1223 and AGEN2373. The company has filed the IND for AGEN1223 and has a planned IND filing for AGEN2373 in the first half of 2019. Agenus will be responsible for developing the option programs up to the option decision points, at which time the latter can exercise its option and acquire exclusive rights to the programs on option exercise. For one of the option programs, Agenus will have the right to opt-in to shared development and commercialization in the United States. Gilead will also receive the right of first negotiation for two additional, undisclosed preclinical programs.
Gilead Partners with Scholar Rock for Fibrotic Disease Drugs: Gilead announced that it entered into a strategic collaboration with clinical-stage biopharmaceutical company Scholar Rock Holding Corp. SRRK to discover and develop highly specific inhibitors of transforming growth factor beta (TGFβ) activation for the treatment of fibrotic diseases. Scholar Rock will receive $80 million in upfront payments, comprising $50 million cash and $30 million purchase of Scholar Rock Holding Corporation common stock. Gilead will also pay Scholar Rock a one-time milestone payment of $25 million upon the successful completion of specific preclinical studies and be eligible to receive up to an additional $1,425 million in potential payments aggregated across all three programs based on the successful achievement of certain research, development, regulatory and commercialization milestones.
In addition, Scholar Rock would also receive high single-digit to low double-digit tiered royalties on sales of potential future products originating from the collaboration. Per the agreement, Gilead obtained exclusive options to license worldwide rights to product candidates that emerge from three Scholar Rock TGFβ programs — inhibitors targeting activation of latent TGFβ1 with high affinity and specificity, inhibitors selectively targeting activation of latent TGFβ1 localized to extracellular matrix, and a third TGFβ discovery program. On the other hand, Scholar Rock is responsible for antibody discovery and preclinical research through product candidate nomination. If Gilead chooses to exercise the option, the company will be responsible for the program’s preclinical and clinical development and commercialization.
Gilead currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 (Strong Buy) Rank stocks here.
Acorda Gets FDA Nod ForParkinson's Disease Drug: Acorda announced that the FDA has approved its Parkinson's disease (PD) drug Inbrija (levodopa inhalation powder). The product was approved for treating OFF periods (return of Parkinson’s symptoms that result from low levels of dopamine between doses of oral carbidopa/levodopa) in PD patients, who are receiving carbidopa / levodopa regimen. Inbrija is expected to be launched during the first quarter of 2019. The FDA was expected to make its decision on Inbrija in October. However, in September the FDA delayed its verdict by three months and set an action date of Jan 5, 2019. The FDA approval thus comes slightly earlier than expected.
FDA Approves Stemline’s Drug: Stemline Therapeutics, Inc STML received FDA approval for its CD123-targeted therapy, Elzonris (tagraxofusp-erzs; SL-401) for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adult and pediatric patients two years and older, in both treatment-naïve and previously treated populations. The therapy will be available in early 2019. BPDCN is an aggressive hematologic malignancy. The therapy is also under review in the United States.
Medical - Biomedical and Genetics Industry 5YR % Return
Medical - Biomedical and Genetics Industry 5YR % Return
The NASDAQ Biotechnology index lost 8.79% in the last four trading sessions. Among the major biotech stocks, Alexion lost 11.4%. Over the past six months, shares of Regeneron have rallied 4.14%, while Alexion has dropped 24.7%. (See the last biotech stock roundup here: Biotech Stock Roundup: Pipeline Updates From VRTX & AMGN, ADRO Teams Up With LLY)
What's Next in Biotech?
Stay tuned for more regulatory and pipeline updates.
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