Highlights from Zacks Analyst Blog: Vertex Pharma, Amgen, Blueprint Medicines, Deciphera Pharma and CTI BioPharma

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Chicago, IL – December 3, 2021 – Zacks.com announces the list of stocks featured on the Analysts Blog. Every day, Zacks Equity Research analysts discuss the latest news and events impacting stocks and financial markets. Stocks recently featured in the blog include: Vertex Pharmaceuticals Inc. VRTX, Amgen Inc. AMGN, Blueprint Medicines Corporation BPMC, Deciphera Pharmaceuticals, Inc. DCPH, and CTI BioPharma Corp. ICTC.

Here are highlights from Thursday’s analyst blog:

Biotech Stocks Review: Pipeline Updates, Acquisitions and More

The biotech sector has been the center of attention over the past week with news on acquisitions, expansion of existing drug labels and other regulatory updates.

Recap of the most important stories of the week:

Summit on study results: Actions of Vertex pharmaceutical acquired after announcing the positive results of a mid-term study on the VX-147. The phase 2 proof of concept (POC) study evaluated the efficacy, safety and pharmacokinetics of VX-147 in patients with focal segmental glomerulosclerosis (FSGS) mediated by APOL1, a form of chronic kidney disease. .

Treatment with VX-147 resulted in a statistically significant, substantial and clinically significant mean reduction in proteinuria of 47.6% at 13 weeks from baseline and was well tolerated. Based on these positive results, Vertex plans to advance VX-147 in the pivotal development of APOL1-mediated kidney disease, including FSGS, in the first quarter of 2022.

Vertex currently wears a Zacks Rank # 3 (Hold). You can see The full list of Zacks # 1 Rank (Strong Buy) stocks today here.

Amgen pipeline update: Amgen announced the first positive results of the phase III, multicenter, randomized, placebo-controlled, double-blind study – DISCREET. The study evaluated the effectiveness of Otezla (apremilast) in adults with moderate to severe genital psoriasis and moderate to severe plaque psoriasis.

Results showed that Otezla 30 mg orally twice daily provided clinically significant and statistically significant improvement over placebo in the primary endpoint of modified static response in the overall assessment. genitals (sPGA-G) at week 16. In addition, all secondary endpoints were met.

Amgen also announced that the FDA has approved the extension of the Kyprolis label 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 processing lines.

Lengo Therapeutics acquisition plan: Model drugs announced the acquisition of 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, precision brain penetration therapy targeting EGFR exon 20 insertion mutations, to Blueprint Medicines’ lung cancer pipeline. Lengo Therapeutics plans to submit an Investigational New Drug Application (IND) for LNG-451 to the FDA in December 2021.

With the addition of LNG-451, Blueprint Medicines will have three experimental compounds that will cover the majority of all activating mutations of EGFR, the second most common oncogenic factor in NSCLC. The acquisition is expected to be finalized during the current quarter.

Deciphera Gains on restructuring program: Actions of Deciphering Pharmaceuticals acquired following the announcement of a corporate restructuring program whereby the company will prioritize the clinical development of selected programs, streamline business operations, maintain a focus on discovery research and expand its lead Treasury. The company will reduce its workforce by around 35%, or around 140 jobs.

Deciphera will focus on the clinical development of its vimseltinib and DCC-3116 programs, interrupting the development of the rebastinib program. Deciphera will continue to market Qinlock for the treatment of fourth-line GIST in the United States with a reduced sales team. These changes are expected to significantly reduce operating expenses and extend the company’s cash flow trail to 2024.

CTI BioPharma dives into regulatory update: Actions of CTI BioPharma plunged after the FDA extended the New Drug Review (NDA) period for pacritinib for the treatment of adult patients with intermediate or high-risk primary or secondary myelofibrosis (MF) (post-polycythemia vera) or post-essential thrombocythemia) with a baseline platelet count

Previously, the FDA had prioritized the NDA for patients with myelofibrosis with a target action date of November 30, 2021. However, the FDA requested additional clinical data, which was submitted to the agency on November 24. November 2021. The FDA has informed the company that it considers the data submission to be a “major amendment” to the NDA. Therefore, the target action date has been extended by three months to allow more time for a full review of the submission.

Performance

Medical – Biomedical and genetic industry 5 years of yield in%

The Nasdaq Biotechnology Index has lost 2.03% over the past four trading days. Among the biotechnology giants, Moderna gained 12.39% over the period. In the past six months, Moderna shares have climbed 89.20%. (See the latest rundown of biotech stocks here: Biotech Stock Roundup: drug approvals for BMRN, updates to BIIB, BMY, MRNA and more).

What’s the next step in biotechnology?

Stay tuned for more pipeline and regulatory updates.

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Past performance is no guarantee of future results. The potential for loss is inherent in any investment. This material is provided for informational purposes only and nothing herein constitutes investment, legal, accounting or tax advice, or a recommendation to buy, sell or hold any security. No recommendation or advice is given as to whether an investment is suitable for a particular investor. It should not be assumed that any investment in any identified and described securities, companies, sectors or markets was or will be profitable. All information is current as of the date hereof and is subject to change without notice. The views or opinions expressed may not reflect those of the company as a whole. Zacks Investment Research does not engage in investment banking, market making or securities asset management activities. These returns come from hypothetical portfolios made up of stocks with a Zacks rank = 1 that have been rebalanced monthly without any transaction costs. These are not the returns of actual equity portfolios. The S&P 500 is an unmanaged index. Visit https://www.zacks.com/performance for more information on the performance numbers displayed in this press release.

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CTI BioPharma Corp. (CTIC): Free Stock Analysis Report

Amgen Inc. (AMGN): Free Stock Analysis Report

Vertex Pharmaceuticals Incorporated (VRTX): Free Stock Analysis Report

Blueprint Medicines Corporation (BPMC): Free Inventory Analysis Report

Deciphera Pharmaceuticals, Inc. (DCPH): Free Inventory Analysis Report

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