The biotech sector has been in focus over the past week with acquisition news, label expansion of existing drugs and other regulatory updates.
Recap of the Week’s Most Important Stories
:
Vertex Up on Study Results
: Shares of
Vertex Pharmaceuticals Incorporated
VRTX
gained after it announced positive results from a mid-stage study on VX-147. The phase 2 proof-of-concept (POC) study evaluated the efficacy, safety and pharmacokinetics of VX-147 in patients with APOL1-mediated focal segmental glomerulosclerosis (FSGS), a form of chronic kidney disease. Treatment with VX-147 led to a statistically significant, substantial and clinically meaningful mean reduction in proteinuria of 47.6% at 13 weeks compared to baseline and was well tolerated. Based on these positive results, Vertex plans to advance VX-147 into pivotal development in APOL1-mediated kidney disease, including FSGS, in the first quarter of 2022.
Vertex currently carries a Zacks Rank #3 (Hold). You can see
the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here
.
Pipeline Update From Amgen
:
Amgen
AMGN
announced positive top-line results from the phase III, multicenter, randomized, placebo-controlled, double-blind study — DISCREET. The study evaluated the efficacy of Otezla (apremilast) in adults with moderate to severe genital psoriasis and moderate to severe plaque psoriasis. Results showed that oral Otezla 30 mg twice daily achieved a clinically meaningful and statistically significant improvement compared with placebo, in the primary endpoint of the modified static Physician’s Global Assessment of Genitalia (sPGA-G) response at week 16. In addition, all secondary endpoints were met.
Amgen also announced that the FDA has approved the label expansion of the Kyprolis to include its use in combination with Darzalex Faspro and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy.
Blueprint to Acquire Lengo Therapeutics
:
Blueprint Medicines Corporation
BPMC
announced that it will
acquire
Lengo Therapeutics, a privately held precision oncology company, for $250 million in cash. Lengo Therapeutics is also entitled to up to $215 million in milestone payments. The acquisition will add LNG-451, a highly selective brain-penetrant precision therapy targeting EGFR exon 20 insertion mutations, to Blueprint Medicines’ lung cancer pipeline. Lengo Therapeutics expects to submit an investigational new drug (IND) application for LNG-451 to the FDA in December 2021. With the addition of LNG-451, Blueprint Medicines will have three investigational compounds that cover the majority of all activating mutations in EGFR, the second most common oncogenic driver in NSCLC. The acquisition is expected to close in the ongoing quarter.
Deciphera Gains on Restructuring Program
: Shares of
Deciphera Pharmaceuticals, Inc
.
DCPH
gained
following the announcement of a corporate restructuring program whereby the company will prioritize clinical development of select programs, streamline commercial operations, maintain a focus on discovery research and extend its cash runway. The company will reduce its workforce by approximately 35%, or about 140 positions. Deciphera will focus on the clinical development of its vimseltinib and DCC-3116 programs, discontinuing the development of the rebastinib program. Deciphera will continue to commercialize Qinlock for the treatment of fourth-line GIST in the United States with a reduced commercial team. These changes are expected to significantly reduce operating expenses and extend the company’s cash runway into 2024.
CTI BioPharma Plunges on Regulatory Update
: Shares of
CTI BioPharma Corp
.
CTIC
plunged after the FDA extended the review period for the new drug application (NDA) for pacritinib for the treatment of adult patients with intermediate or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis (MF) with a baseline platelet count of <50 × 109/L. The target action date has been extended by three months to Feb 28, 2022. Earlier, the FDA granted priority to the NDA for patients with myelofibrosis with a target action date of Nov 30, 2021. However, the FDA requested additional clinical data, which was submitted to the agency on Nov 24, 2021. The FDA informed the company that it considers the data submission to constitute a “major amendment” to the NDA. Therefore, the target action date has been extended by three months to provide additional time for a full submission review.
Performance
Medical – Biomedical and Genetics Industry 5YR % Return
The Nasdaq Biotechnology Index has lost 2.03% in the past four trading sessions. Among the biotech giants, Moderna has gained 12.39% during the period. Over the past six months, shares of Moderna have soared 89.20%. (See the last biotech stock roundup here:
Biotech Stock Roundup: Drug Approvals for BMRN, Updates From BIIB, BMY, MRNA & More
).
Image Source: Zacks Investment Research
What’s Next in Biotech?
Stay tuned for more pipeline and regulatory updates.
Infrastructure Stock Boom to Sweep America
A massive push to rebuild the crumbling U.S. infrastructure will soon be underway. It’s bipartisan, urgent, and inevitable. Trillions will be spent. Fortunes will be made.
The only question is “Will you get into the right stocks early when their growth potential is greatest?”
Zacks has released a Special Report to help you do just that, and today it’s free. Discover 7 special companies that look to gain the most from construction and repair to roads, bridges, and buildings, plus cargo hauling and energy transformation on an almost unimaginable scale.
Download FREE: How to Profit from Trillions on Spending for Infrastructure >>
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days.
Click to get this free report