SpringWorks (SWTX) Completes NDA Submission for Mirdametinib

Zacks Equity Research

2 July 2024 at 12:12 pm·3-min read

SpringWorks Therapeutics, Inc. SWTX announced that it has completed the submission of a new drug application (“NDA”) for its investigational MEK inhibitor, mirdametinib, being developed for the treatment of neurofibromatosis type 1- associated plexiform neurofibromas (NF1-PN), in pediatric and adult patients.

The NDA filing was based on data from the pivotal phase IIb ReNeu study, which evaluated mirdametinib in patients aged two years and above with NF1-associated PN causing significant morbidity.

The primary endpoint of the ReNeu study was the confirmed objective response rate, which is noted as ≥ 20% reduction in target tumor volume as assessed by blinded independent central review and per MRI.

Data from the study showed that treatment with mirdametinib resulted in significant objective response rates confirmed by blinded independent central review and led to improvements in pain and quality of life in both pediatric and adult cohorts.

The data was recently presented at the annual meeting of the American Society of Clinical Oncology 2024.

Shares of SpringWorks have risen 3.1% year to date against the industry’s decline of 6.3%.

Image Source: Zacks Investment Research

In March 2024, the company initiated the rolling submission of the NDA to the FDA for mirdametinib in NF1-PN, a rare genetic disorder.

The FDA and the European Commission have already granted Orphan Drug designation to mirdametinib for the treatment of NF1.

The FDA has also granted Fast Track designation to mirdametinib for the treatment of patients aged two years and above with NF1-PN that is progressing or causing significant morbidity.

The company plans to file a marketing application with the European Medicines Agency seeking approval for mirdametinib for the treatment of children and adults with NF1-PN later in the second half of 2024.

The FDA approved SpringWorks’ Ogsiveo (nirogacestat) for treating adult patients with desmoid tumors who require systemic treatment in November 2023. Following the nod, Ogsiveo became the first and only FDA-approved therapy for treating adults living with desmoid tumors, a rare, aggressive tumor of the soft tissues.

Zacks Rank & Stocks to Consider

SpringWorks currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks in the healthcare sector are Acrivon Therapeutics, Inc. ACRV, Aligos Therapeutics, Inc. ALGS and RAPT Therapeutics, Inc. RAPT, each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

In the past 60 days, estimates for Acrivon Therapeutics’ 2024 loss per share have narrowed from $3.05 to $2.47. Loss per share estimates for 2025 have narrowed from $3.04 to $2.55. Year to date, ACRV shares have rallied 17.8%.

ACRV’s earnings beat estimates in three of the trailing four quarters and missed the same on the remaining one occasion, the average surprise being 3.56%.

In the past 60 days, estimates for Aligos Therapeutics’ 2024 loss per share have narrowed from 84 cents to 73 cents, while loss per share estimates for 2025 have narrowed from 82 cents to 71 cents. Year to date, ALGS shares have declined 44.3%.

ALGS’ earnings beat estimates in three of the trailing four quarters and missed the same on the remaining occasion, the average surprise being 7.83%.

In the past 60 days, estimates for RAPT Therapeutics’ 2024 loss per share have narrowed from $3.19 to $2.93. Loss per share estimates for 2025 have narrowed from $2.40 to $2.05. Year to date, RAPT shares have declined 88.4%.

RAPT’s earnings beat estimates in two of the trailing four quarters while missing the same on the remaining two occasions, the average surprise being 3.19%.

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

SpringWorks Therapeutics (SWTX) : Free Stock Analysis Report

Rapt Therapeutics (RAPT) : Free Stock Analysis Report

Aligos Therapeutics, Inc. (ALGS) : Free Stock Analysis Report

Acrivon Therapeutics, Inc. (ACRV) : Free Stock Analysis Report

To read this article on Zacks.com click here.

Zacks Investment Research

The Independent
Nearly 500 people hospitalised in Japan after taking red yeast supplements
Kobayashi Pharmaceutical’s beni koji dietary supplements have been linked to 175 deaths so far
INSIDER
Russia's war-driven economy is so hot that the World Bank upgraded it to a 'high-income country'
Russia's trade rebounded by nearly 7% last year, while activities in the financial sector and construction grew by 6.6% and 3.6% respectively.
Bloomberg
6 family office funds tied to Singapore launder case got tax breaks
Six single family office funds linked to a S$3 billion money laundering case in Singapore have received tax incentives from the Monetary Authority of Singapore.
The Guardian
Coffee, eggs and white rice linked to higher levels of PFAS in human body
US study that researchers say highlights chemicals’ ubiquity also shows PFAS association with seafood and red meat
The Wrap
Paramount, Skydance Merger Is on Again in $2.4 Billion Deal
But NAI's controlling shareholder Shari Redstone might be setting off a bidding war ahead of Sun Valley The post Paramount, Skydance Merger Is on Again in $2.4 Billion Deal appeared first on TheWrap.
NextShark
Chinese researchers discover gene that protects Asians from obesity
Researchers at Fudan University in China have identified a specific gene variant that appears to protect people in southern China and Southeast Asia from obesity. The study, published in the Journal of Genetics and Genomics last month, involved the analyses of 16 basal mitochondrial DNA (mtDNA) haplogroups, genetic families that trace back to a common ancestor.
The Telegraph
Rheumatoid arthritis forced me to change my diet – and now I’m pain free
I can’t remember a time in my life when there hasn’t been pain somewhere in my body. It came to dominate much of my adult life. If somebody hasn’t been in constant pain, it’s hard to describe it to them. You’re masking the whole time, and everything is so much more difficult. The mornings were the worst for me as the throbbing and aching sensations would set in when I was lying still. The day it took me 45 minutes just to get out of bed because of the agony I was in, I knew something had to chan
Malay Mail
A-G’s report: Mara Inc’s inefficient operations lead to RM286m loss
KUALA LUMPUR, July 4 — Government-linked Mara Inc has incurred RM286.30 million in losses due to inefficient business op...
Yahoo Finance
Fed officials touted 'modest further progress' on inflation at last meeting: Minutes
Fed officials offered encouragement about the path of inflation while meeting in June, but they made it clear they didn’t expect to lower rates until they saw more evidence of a downward trend.
Tom's Guide
Forget weights — I tried this Pilates roll-up exercise that strengthens your core and boosts your posture
You don't need equipment to build a stronger core and boost spine mobility. Here are the benefits of the Pilates roll-up exercise, and how it can help your body.
Zacks
BP CEO Halts Offshore Wind Projects, Enacts Hiring Freeze
BP's new CEO Murray Auchincloss has implemented a hiring freeze and paused new offshore wind projects, shifting the company's focus to oil and gas to address investor concerns over its energy transition strategy.
Zacks
Shell (SHEL) Hits Pause on Major Biofuels Plant in Europe
Shell (SHEL) remains committed to achieving its net-zero emissions target by 2050 despite abandoning several renewable projects to focus on its more profitable ventures, primarily in oil and gas.
The Independent
Teen severs his spinal cord after jumping into pool to avoid wasp: ‘This is a long road’
Doctors do not believe that the teen will regain the ability to use his hands or feet
Zacks
Mondelez (MDLZ) Navigates Hurdles Through Portfolio Strength
Mondelez's (MDLZ) focus on core categories and portfolio strength place it well in a challenging and dynamic operating environment.
Evening Standard
LAS introduces 'cuddle pockets' for grieving parents to take miscarried babies to hospital
Knitted pouches will allow bereaved families to hold baby after birth and in ambulance
Zacks
SLB and TotalEnergies Ink 10-Year Digital Solutions Partnership
SLB and TotalEnergies enter into a 10-year collaboration to co-develop scalable digital solutions, focusing on enhancing energy resource access and efficiency through advanced AI technologies.
Yahoo Finance Video
Fed won't hit 2% target until 2026: Economist
With somewhat cooling inflation and stagnant labor market growth, conversations about whether the Federal Reserve's interest rate cut timing persist. Interactive Brokers senior economist José Torres joins Market Domination to give insight into the labor market, the broader stock market, and the Fed's future policy decisions. "I think we're going to hit the Fed's 2% target somewhere in 2026. Fed Chair Powell was asked about it; he didn't think that we would hit it this year or next year. In fact, when we consider the disinflation that occurred last year in the second half, now those base effects become unfavorable into the second half of this year. So we're going to actually see core PCE start to tick higher. And if you look at the dots of summary of economic projections from the Fed, they're expecting core PCE to finish the year around 2.8," Torres tells Yahoo Finance. For more expert insight and the latest market action, click here to watch this full episode of Market Domination. This post was written by Nicholas Jacobino
The Telegraph
What watching England play football does to your body
Watching England play in a major tournament is an emotional rollercoaster with moments of joy, despair and high stress arriving in quick succession. But have you ever wondered what the impact of putting yourself through such highs and lows is? We decided to put it to the test by finding out exactly what my body went through while watching England’s 2-1 win over Slovakia – and probably yours, too.
AFP News
London stocks, pound climb as Britons vote
London's stock market and the pound advanced versus the dollar Thursday as Britons voted in a general election expected to be won by the centre-left and main opposition Labour party."Today's UK election looks unlikely to cause too many shockwaves given just how resounding the Labour party victory is expected to be, with markets feeling optimistic over the potential change at Downing Street," said Scope Markets analyst Joshua Mahony.
The Telegraph
US market exceptionalism is approaching its dramatic denouement
The investment focus naturally shifts to the US on Independence Day but more so than ever this year as the completion of elections here on Thursday and in France at the weekend moves the political spotlight across the Atlantic too.

Zacks Rank & Stocks to Consider

Latest stories