Category Archives: Progress

- Phase 3 pivotal trial evaluating apitegromab in patients with non-ambulatory Type 2 and Type 3 SMA on track to initiate by year-end 2021

- Update from Part A of the DRAGON Phase 1 trial evaluating SRK-181s ability to overcome primary resistance to checkpoint inhibitors being presented at the Society for Immunotherapy of Cancer (SITC) 36th Annual Meeting

- Initiated Part B dose expansion portion of the DRAGON trial

- U.S. patent issued providing additional product protection for SRK-181 to May 2040

CAMBRIDGE, Mass., November 09, 2021--(BUSINESS WIRE)--Scholar Rock (NASDAQ: SRRK), a clinical-stage biopharmaceutical company focused on the treatment of serious diseases in which protein growth factors play a fundamental role, today reported financial results for the third quarter ended September 30, 2021, and highlighted recent progress and upcoming milestones for its pipeline programs.

"The DRAGON trial addresses two key questions; first, can the selectivity of SRK-181 for TGF1 increase the therapeutic window for inhibition of this signaling pathway thereby enabling higher doses safely, and second, does SRK-181 exhibit anti-tumor activity effective in overcoming resistance to checkpoint inhibitors in solid tumors. We are pleased with the results of Part A, as will be provided this week at the Society for Immunotherapy of Cancer (SITC) Annual Meeting, and we look forward to exploring the efficacy dimension of our therapeutic hypothesis in Part B," said Nagesh Mahanthappa, Ph.D., Interim CEO of Scholar Rock. "Building on the momentum from the first half of this year, we are also excited about the progress with apitegromab and are on track to initiate by year-end the Phase 3 pivotal trial evaluating its efficacy in patients with non-ambulatory Type 2 and Type 3 spinal muscular atrophy (SMA)."

Company Updates and Upcoming Milestones

Apitegromab is a selective inhibitor of myostatin activation being developed as the potential first muscle-directed therapy for the treatment of spinal muscular atrophy (SMA).

Story continues

Additional Exploratory Responder Analyses and Pharmacologic Data from the TOPAZ Phase 2 Trial were Presented at Various Medical Congresses. In September 2021, two posters were presented at the World Muscle Society Virtual Congress, including a late-breaker poster featuring an exploratory analysis evaluating time to achieving various thresholds of improvement in Hammersmith Functional Motor Scale Expanded (HFMSE) scores, which are consistent with the observed dose response in clinical efficacy. In October 2021, a poster presented at the 25th World Congress of Neurology (WCN) described the positive correlation between the magnitude of target engagement and motor function improvements following apitegromab treatment. At the 50th Child Neurology Society Annual Meeting, additional exploratory responder analyses on Hammersmith scale scores were presented, including time to achieve different thresholds of improvement in HFMSE scores.

Phase 3 Trial Evaluating Apitegromab in Patients with Non-Ambulatory Type 2 and 3 Patients Remains on Track to Initiate by Year-End 2021. Scholar Rock is preparing to announce the design of the Phase 3 pivotal study later this month. The company is on track to initiate by the end of 2021 the randomized, double-blind, placebo-controlled Phase 3 trial evaluating apitegromab as add-on therapy for patients on either nusinersen or risdiplam with non-ambulatory Type 2 and Type 3 SMA. This patient population comprises an estimated two-thirds of the overall prevalence of SMA, and the greatest improvements in motor function (as measured by HFMSE) observed in the TOPAZ Phase 2 trial were in patients with non-ambulatory Type 2 and Type 3 SMA receiving apitegromab as add-on therapy to background nusinersen.

SRK-181 is a selective inhibitor of latent TGF1 activation being developed with the aim of overcoming primary resistance to and increasing the number of patients who may benefit from checkpoint inhibitor therapy.

Update from Part A of the DRAGON Phase 1 Trial and Part B Dose to be Presented at the Society for Immunotherapy of Cancer (SITC) 36th Annual Meeting. A poster titled, "First-in-Human Phase 1 Trial of SRK-181: A Latent TGF1 inhibitor, Alone or in Combination with Anti-PD-(L)1 Treatment in Patients with Advanced Solid Tumors (DRAGON trial)" will be presented at the SITC meeting on November 12, 2021. The poster will include initial clinical data from Part A of the DRAGON trial as well as the rationale for the identified Part B dose.

The Company has initiated the Part B dose expansion portion of the trial, which consists of multiple cohorts, each enrolling up to 40 patients with various solid tumors who have demonstrated primary resistance to anti-PD-(L)1 therapy.

U.S. Patent Issued Providing Composition of Matter Product Protection for SRK-181. In September 2021, the United States Patent and Trademark Office (USPTO) issued U.S. Patent No. 11,130,803 with an expiry of May 2040, including 313 days of Patent Term Adjustment (PTA). The European counterpart has also been granted.

Third Quarter 2021 Financial Results

For the quarter ended September 30, 2021, net loss was $37.5 million or $1.02 per share compared to a net loss of $23.6 million or $0.79 per share for the quarter ended September 30, 2020.

Revenue was $5.5 million for the quarter ended September 30, 2021, compared to $3.0 million for the quarter ended September 30, 2020 and was related to the Gilead Collaboration Agreement that was executed in December 2018.

Research and development expense was $31.3 million for the quarter ended September 30, 2021, compared to $18.4 million for the quarter ended September 30, 2020. The increase year-over-year primarily reflects manufacturing costs associated with apitegromab, clinical trial costs for SRK-181, and additional personnel and facility-related costs.

General and administrative expense was $11.3 million for the quarter ended September 30, 2021, compared to $8.3 million for the quarter ended September 30, 2020. The increase year-over-year was primarily attributed to additional personnel, professional fees, and facility-related costs.

"As we approach the end of 2021, I am incredibly proud of the execution by the entire Scholar Rock team this year. Not only have we initiated Part B of the DRAGON trial, but were also very close to initiating our Phase 3 pivotal trial for apitegromab," said Ted Myles, CFO and Head of Business Operations of Scholar Rock. "We ended the third quarter with approximately $246 million in cash and cash equivalents and are well-funded to continue executing on our development programs while continuing to invest in our robust discovery platform."

About Scholar Rock

Scholar Rock is a clinical-stage biopharmaceutical company focused on the discovery and development of innovative medicines for the treatment of serious diseases in which signaling by protein growth factors plays a fundamental role. Scholar Rock is creating a pipeline of novel product candidates with the potential to transform the lives of patients suffering from a wide range of serious diseases, including neuromuscular disorders, cancer, and fibrosis. Scholar Rocks approach to targeting the molecular mechanisms of growth factor activation enabled it to develop a proprietary platform for the discovery and development of monoclonal antibodies that locally and selectively target these signaling proteins at the cellular level. By developing product candidates that act in the disease microenvironment, the Company intends to avoid the historical challenges associated with inhibiting growth factors for therapeutic effect. Scholar Rock believes its focus on biologically validated growth factors may facilitate a more efficient development path. For more information, please visit http://www.ScholarRock.com or follow Scholar Rock on Twitter (@ScholarRock) and LinkedIn (https://www.linkedin.com/company/scholar-rock/).

Scholar Rock is a registered trademark of Scholar Rock, Inc.

Forward-Looking Statements

This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding Scholar Rocks future expectations, plans and prospects, including without limitation, Scholar Rocks expectations regarding its growth, strategy, progress and timing of its clinical trials for apitegromab, SRK-181, and other product candidates and indication selection and development timing, its cash runway, the ability of any product candidate to perform in humans in a manner consistent with earlier nonclinical, preclinical or clinical trial data, and the potential of its product candidates and proprietary platform. The use of words such as "may," "might," "will," "should," "expect," "plan," "anticipate," "believe," "estimate," "project," "intend," "future," "potential," or "continue," and other similar expressions are intended to identify such forward-looking statements. All such forward-looking statements are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include preclinical and clinical data, including the results from the Phase 2 trial of apitegromab or Part A of the Phase 1 trial of SRK-181, are not predictive of, are inconsistent with, or more favorable than, data generated from future clinical trials of the same product candidate, including the planned Phase 3 trial of apitegromab in SMA and Part B of the Phase 1 trial of SRK-181, respectively, Scholar Rocks ability to provide the financial support, resources and expertise necessary to identify and develop product candidates on the expected timeline, the data generated from Scholar Rocks nonclinical and preclinical studies and clinical trials, information provided or decisions made by regulatory authorities, competition from third parties that are developing products for similar uses, Scholar Rocks ability to obtain, maintain and protect its intellectual property, the success of Scholar Rocks current and potential future collaborations, including its collaboration with Gilead, Scholar Rocks dependence on third parties for development and manufacture of product candidates including to supply any clinical trials, Scholar Rocks ability to manage expenses and to obtain additional funding when needed to support its business activities and establish and maintain strategic business alliances and new business initiatives, and the impacts of public health pandemics such as COVID-19 on business operations and expectations, as well as those risks more fully discussed in the section entitled "Risk Factors" in Scholar Rocks Quarterly Report on Form 10-Q for the quarter ended September 30, 2021, as well as discussions of potential risks, uncertainties, and other important factors in Scholar Rocks subsequent filings with the Securities and Exchange Commission. Any forward-looking statements represent Scholar Rocks views only as of today and should not be relied upon as representing its views as of any subsequent date. All information in this press release is as of the date of the release, and Scholar Rock undertakes no duty to update this information unless required by law.

Scholar Rock Holding Corporation

Condensed Consolidated Statements of Operations

(unaudited)

(in thousands, except share and per share data)

Three Months Ended September 30

Nine Months Ended September 30

2021

2020

2021

2020

Revenue

$

5,464

$

3,037

$

14,767

$

11,967

Operating expenses

Research and development

31,265

18,383

79,417

52,282

General and administrative

11,276

8,272

29,907

20,459

Total operating expenses

42,541

26,655

109,324

72,741

Loss from operations

(37,077

)

(23,618

)

(94,557

)

(60,774

)

Other income (expense), net

(430

)

57

(1,328

)

862

Net loss

$

(37,507

)

$

(23,561

)

$

(95,885

)

$

(59,912

)

Net loss per share, basic and diluted

$

(1.02

)

$

(0.79

)

$

(2.62

)

Continued here:

Scholar Rock Reports Third Quarter 2021 Financial Results and Highlights Business Progress - Yahoo Finance

Rail News Home Railroading Supplier Spotlight

11/9/2021

Rail News: Railroading Supplier Spotlight

Wabtec yesterday signed contracts with Egyptian National Railways (ENR) to supply 100 ES30ACi Evolution Series Locomotives, as well as a multiyear service agreement to maintain the fleet. The agreement supports ENRs continued modernization effort by providing the latest fuel-efficient locomotives needed for the growing demands on Egypts rail infrastructure. The locomotive supply contract is funded by the European Bank for Reconstruction and Development, Wabtec officials said in a press release.

Sumitomo Electric Industries Ltd. received an order from Mitsubishi Heavy Industries Ltd. and shipped an assortment of cables for the Red Line Construction Project, a plan involving the building of a new commuter railway route in the Kingdom of Thailand. The government is promoting the Bangkok Mass Transit System Project to alleviate traffic congestion, improve air pollution and respond to increasing transportation demand in the Bangkok metropolitan area.

Progress Rail marked 125 years of manufacturing at its facility in Sandiacre, United Kingdom. Founded by the Taylor Brothers in 1896, the Sandiacre site was developed in the Nottingham area to meet the growing demand for specialized products to support the developing railway transportation network in the U.K. Over the past 125 years, the Sandiacre site has earned a reputation for providing high quality, sustainable, industry-leading switches, castings, crossings and associated products for Network Rail, London Underground and railways around the world.

PSI Repair Services Inc. a subsidiary of Phillips Service Industries, has entered into a service partnership with Dinghan SMART Railway Technology GmbH of Germany. Dinghan develops and manufactures innovative auxiliary power converters for international rolling stock. The product portfolio ranges from single devices, such as battery chargers or air conditioning inverters, to complete auxiliary power converters for passenger cars and multiple-unit trains. The partnership will provide a local expert for time-sensitive part repairs and engineering services for U.S. rail operators that rely on Dinghan SMART Railway Technology products.

Alstom and National Authority for Tunnels announced an agreement for 55 Metropolis trains (nine cars per train) and an eight-year maintenance contract, valued at 876 million euros, for the upgrade of Cairo Metro Line 1. Launched in 1987, Cairo Metro line 1 is the oldest metro line in Egypt.

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Rail News - Rail supplier news from Wabtec, Sumitomo, Progress Rail, PSI and Alstom (Nov. 9). For Railroad Career Professionals - Progressive Rail...

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IrelandUruguay, Eastern Republic ofUzbekistanVanuatuVenezuela, Bolivarian Republic ofViet Nam, Socialist Republic ofWallis and Futuna IslandsWestern SaharaYemenZambia, Republic ofZimbabwe

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United Way making progress toward $500000 goal, but more donations needed - Herald and News

Wendy Williams took to Instagram to give her fans a health update.

The latest season of The Wendy Williams Show was delayed and kicked off October 18, but Williams has not been able to host due to ongoing health issues, including a breakthrough case of COVID-19. Stars like Sherri Shepherd, Leah Remini, Michael Rapaport and Jerry Springer are stepping in to guest host as she recovers.

Waiting for your permission to load the Instagram Media.

Now, Wendy writes to her fans, HOW YOU DOIN? I MISS YOU ALL! As everyone knows, my health has been a hot topic. Im making progress but its just one of those things thats taking longer than we expected.

The 57-year-old said of returning to her show, Im a woman of a certain age, and I know enough to listen to my doctors and will return to my purple chair as soon as we all agree Im ready.

Nick Cannon Gets Candid About Celibacy and Rumors Hes Replacing Wendy Williams View Story

She thanked everyone who helped her along the way, saying, I want to thank all of my staff and our guest hosts for stepping up and stepping in while I cant be there. I also want to thank Debmar-Mercury and our stations for being so understanding and supportive while I work my way back. Most of all, I want to thank my fans.

Williams shared, I have heard your prayers and comments and feel all the love! You are everything to me. I love spending my mornings with you all and Im doing everything I can to get back to work, but right now Wendy has to focus on Wendy. I love you for watching.

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Wendy Williams Gives Health Update: Im Making Progress - Extra

The Public Utility Commission is working to overhaul the Texas power market to make the power grid more reliable. How much progress have they made?

TEXAS, USA A University of Texas/Texas Tribune Poll of 1,200 registered voters reveals only 18 percent of respondents approved of how state leaders are handling the power grid issue. That poll was conducted in October.

The Public Utility Commission (PUC) held another meeting to discuss improvements to the grid last Thursday. 6 News looked into how much progress the state was making the following Monday.

On Nov. 4, the PUC signed an "Order Granting Exception" to allow the Electric Reliability Council of Texas (ERCOT) to procure emergency response service intended to be deployed during an energy emergency alert.

According to the order, the Commission agreed ERCOT must be able to deploy emergency response service before an energy emergency alert is declared to keep the grid reliable. ERCOT had to wait until declaring an energy emergency alert before usingemergency response services according to current rules.

The PUC also requested an assessment of alternative Operating Reserve Demand Curve options from The Brattle Group

This curve dictates how much power producers are paid depending on the current supply of electricity to the market and and close the grid is to failing to meet it's demand.

According to a draft of that assessment, shown below, the current ORDC curve will pay a maximum of $9,000 MWh as the grid is less than 2000 MW away from meeting demand. Other suggested price curves would pay more leading up to an emergency situation and would pay less during that emergency situation. Commissioners hope paying more before the state reaches and energy crisis will help avoid that crisis.

Commissioner Lori Cobos told other commissioners last Thursday she would like to see the PUC take action on the ORDC curve by the beginning of next year.

"I want to stress that I would really like to take action on the ORDC in place by the beginning of January. I think it is prudent to do so to drive reserves online earlier, especially as some reports out there say we might get colder weather in January," Cobos said.

The PUC will also need to incentivize companies to invest in new power plants in the state but they don't have a solution in place as of yet. PUC Chairman Peter Lake said the above change won't go far enough to meet that goal.

"There's zero evidence that it drives new investment. Like I said before I think it helps retain existing units (power plants) and helps justify delaying retirement but it certainty nothing anyone is going to build a new business model on or new infrastructure," Lake said.

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New poll shows Texans aren't happy with power grid progress. What has the PUC done so far? - CBS19.tv KYTX

In light of the coverage surrounding the Jan. 6 committee and its fight to hear from Donald Trump's allies, it may be tempting to think the bipartisan select committee has been stymied in its work.

As NBC News reported, there's fresh evidence to the contrary.

Members of the House panel investigating the Jan. 6 attack on the Capitol have interviewed more than 150 people so far, ranking member Rep. Liz Cheney, R-Wyo., said Thursday. Cheney, the top Republican on the select committee, said that the panel spoke to "a whole range of people connected to the events, connected to understanding what happens."

The select committee's co-chair added, "It is a range of engagements some formal interviews, some depositions.... There really is a huge amount of work underway that is leading to real progress for us."

It led Politico to note, "The public has just seen the tip of the iceberg.... [Cheney's reference to more than 150 interviews] is an indication that the vast majority of the committee's work is happening out of public view."

In related news:

If Clark's name sounds familiar, it's not your imagination. As regular readers may recall, in the aftermath of the 2020 presidential election, as Donald Trump explored ways to weaponize the Justice Department to help him hold power he hadn't earned, Clark became a person of great importance to the then-president.

Clark was the acting head of the Justice Department's civil division at the time, and he used his office to sketch out a map for Republican legislators to follow in which they could try to overturn the will of the state's voters. Trump was impressed enough with Clark's reported anti-election efforts that the then-president considered making Clark the acting attorney general as part of a possible Justice Department overhaul with only two weeks remaining in Trump's term.

We now know, of course, that Clark's proposed scheme was not implemented, but it's hardly a surprise that the Jan. 6 investigatory committee wants to have a chat with him.

Steve Benen is a producer for "The Rachel Maddow Show," the editor of MaddowBlog and an MSNBC political contributor. He's also the bestselling author of "The Impostors: How Republicans Quit Governing and Seized American Politics."

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How (and why) the Jan. 6 committee is making 'real progress' - MSNBC

A formerly stateless family display their newly-obtained identity documents at their home in Dushanbe, Tajikistan. UNHCR/Didor Saidulloyev

More action is needed to resolve the plight of millions around the world who are still without citizenship, UNHCR, the UN Refugee Agency, urged today as it marked seven years since the launch of its #IBelong Campaign to End Statelessness.

Significant progress has been made over the past few years, but governments must do more to close the legal and policy gaps that continue to leave millions of people stateless or allow children to be born into statelessness, said UN High Commissioner for Refugees, Filippo Grandi.

Statelessness, or the situation of not being recognized as a citizen by any country, affects millions of people around the world. Stateless people cannot often access the most basic of rights, including being able to go to school, work legally, access health services, marry, or register the birth of a child.

Since UNHCR launched its #IBelong campaign in 2014 to raise attention and advocate for an end to global statelessness,more than 400,000 stateless people in 27 countries have acquired nationality, while tens of thousands of people across Asia, Europe, Africa and the Americas now have a pathway to citizenship as a result of newly enacted legislative changes.

Over the past seven years, 29 states have acceded to the Statelessness Conventions, signalling strengthened political will to end statelessness.

We are encouraged by this global momentum to tackle statelessness, which with concerted efforts by States, we can eradicate. But unless progress accelerates, the millions who remain deprived of a nationality will be stuck in a human rights limbo, unable to access the most basic rights, said Grandi.

Statelessness has many causes which are typically the result of gaps or flaws in nationality laws, and how they are implemented. Discrimination - including on the basis of ethnicity, religion and gender - is a major driver of statelessness.

Because they are not recognized as citizens, stateless people are often deprived of legal rights or basic services. This leaves them politically and economically marginalized and vulnerable to discrimination, exploitation, and abuse. They may also not be able to access COVID-19 testing, treatment or vaccination, and may have little access to support or protection in the face of climate risks.

Governments hold power to enact legal and policy reforms that can help stateless people on their territory acquire citizenship or prevent statelessness from occurring in the first place, sometimes with the stroke of a pen, or a relatively simple legal change. It remains an easily avoidable and solvable issue.

UNHCRs decade long #IBelong campaign calls on states to end statelessness by 2024.

Background notes for editors:

Worldwide, UNHCRs statistical reporting counts 4.2 million stateless people in some 94 countries. Given that most countries do not collect any data on statelessness, the actual figure is believed to be substantially higher.

To date, 96 States are party to the 1954 UN Convention on the Status of Stateless Persons, and 77 are party to the 1961 UN Convention on the Reduction of Statelessness.

Since the start of the #IBelong Campaign:

For more information on this topic, please contact:

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UNHCR urges governments to accelerate progress and resolve plight of world's stateless - UNHCR

A close look at the primary mirror of a Worldview Legion satellite during assembly and inspection.

Maxar

Maxar Technologies' stock jumped on Thursday after reporting third-quarter results, with Wall Street analysts welcoming the space company's progress toward the launch of key satellites next year.

The company reported an adjusted EBITDA profit of $113 million for the third quarter, above the $109.9 million expected by analysts surveyed by FactSet, while Maxar's revenue came in below predictions at $437 million, versus $447.7 million expected.

But the focus of Wall Street is Maxar's headway on its WorldView Legion satellites.

A WorldView Legion satellite in the final stages of assembly.

Maxar

Legion is the company's constellation of six imagery satellites and is crucial to the company continuing to win lucrative contracts from U.S. defense and intelligence agencies. Maxar in August announced a delay to the launch of the first two Legion satellites, with the company targeting between March and June of 2022 a timeline the company reiterated in its latest report.

Baird upgraded its rating on Maxar to outperform from neutral, with a $39 price target that represents a 44% climb from the stock's most recent close.

"The outlook has been considerably de-risked given visibility to Legion's first launch, and current prices provide a safer entry point," Baird analyst Peter Arment wrote in a note to clients.

Shares of Maxar climbed nearly 18% in trading from their previous close of $27.05.

Baird said its previous neutral rating "was largely out of caution around potential" further Legion delays, but "line of sight to first launches is now much clearer."

JPMorgan analyst Seth Seifman, who has an overweight rating and $47 price target, similarly emphasized that Legion's launch is "the most important event" for Maxar.

"We see a clear path to operational improvement, with strong cash flow generation in 2023, driven largely by the launch of Maxar's WorldView Legion," Seifman wrote to clients.

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Space stock Maxar jumps after Q3 results, as Wall Street welcomes progress on key satellites - CNBC

When Mark Wahlberg helped ring in the grand opening of Walmarts second health clinic in Calhoun, Ga., alongside a raucous crowd of customers in January 2020, the world was a very different place. It was a celebrated moment at an exciting time in Walmarts push to open a string of new clinics scattered across America. The plan to build out its health care footprint seemed to have a shot at success: What busy parent wouldnt jump at the chance to tackle the grocery list and their childs earache in a single trip?

The pandemic that soon followed has blurred the prospect of that success. Today, with Covid-19 curbing foot traffic and giving virtual care a clear, if temporary, edge, Walmart appears to be facing a reality check on its lofty visions of high-touch, in-person care. The retailer has opened just 20 of the 125 clinics it planned to have operational by the end of the year, Insider reported. The efforts of Best Buy, another retail giant with health aims, are meanwhile gaining steam after an acquisition of remote monitoring company Current Health. Analysts and industry observers say that for all the progress and setbacks, its clear that major retail players are still committed to using their multibillion-dollar budgets to position themselves for a long game in hybrid health care.

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A progress report on Walmart and Best Buy's ambitions in health care - STAT

SOUTH BEND It felt more like that middle school algebra class you thought you would never use again in life than a stepping stone for a Notre Dame football team still trying to find a backdoor into the College Football Playoff conversation.

Parsed out on its own and detached from the bigger picture, first-year defensive coordinator Marcus Freemans best week at Notre Dame to date when not counting the recruiting trail was a paragon of blending scheme and execution.

Rover/linebacker Jack Kiser, though, saw Notre Dames squelching of the triple-option in its 34-6 discharge of Navy Saturday at Notre Dame Stadium as at least partially transferable to the rest of the Irish regular-season schedule, beginning with next Saturdays night game at pass-happy Virginia (7:30 p.m. EST; ABC-TV).

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The discipline is the big thing, said Kiser, recast Saturday in his old high school defensive position, as a free safety in NDs modified defensive structure. You have to be disciplined in everything you do. That was a big concern of ours heading into the week.

Then having the grit and toughness to come out here and compete every single snap. We did that this week in practice. This week was a very gritty week in practice, very tough uncomfortable at times. We have to do that heading into next week, and it will only get better.

How that translated Saturday for the AP No. 8/CFP No.10 Irish (8-1) was 184 yards in total offense yielded the fourth-lowest total allowed in the 12-year Brian Kelly Era. For comparisons sake, fullback Alexander Teich gashed the Irish for more than that on his own (210) yards in 2010 the first time Kelly butted up against Navy in a humbling 35-17 loss.

Also Saturday, Notre Dame recorded its first safety in four seasons and allowed the fewest points scored by Navy in the (almost) annual series since a 30-0 Irish shutout in 1998.

And the defense did it for the second week in a row without All-America safety Kyle Hamilton, whose return from an Oct. 23 knee injury hasnt been given a timetable for public consumption.

Gets us another step closer to where we want to be, ND head coach Brian Kelly said of the defensive about face.

Where the Irish are, even with the smattering of Top 10 upsets, is still on a treadmill pointed toward a Peach Bowl date in the New Years Six with the eventual ACC champion.

Should the Irish win out and not make the playoff, the only plausible scenarios to nudge them into the Fiesta Bowl rather than the Peach is if either Cincinnati makes the playoff or Virginia wins the ACC.

Chaos, at least when its happening to other Top 10 teams, is Notre Dames best friend, moving forward.

Scoring summary: No. 8 Notre Dame 34, Navy 6

Stats: What the numbers say: Team and individual statistics from Notre Dame-Navy

Speaking of chaos, grad senior nose guard Kurt Hinish was so good at it Saturday against the Midshipmen (2-7), he was awarded the game ball by Kelly but not a postgame voice to speak about it with the media.

So others spoke for and about the 6-2, 300-pound Pittsburgh product, who doubled his previous high in career tackles, with 10, despite playing in a heavy and deep rotation of defensive linemen. He also had two tackles for loss with a sack.

Hes such a gritty guy, Kiser said. Hes a leader for us, a captain and that energy. He had a great game today. Every play he was a force to be reckoned with. I cant speak highly enough about him.

We have him fortunately. I dont want to play against him, let me tell you that.

The Irish almost didnt have its triple-option ace fromNDs last two games against Navy lopsided wins in 2018 and 2019 before the COVID-19 pandemic coaxed a break in the series that hadbeen played every year since 1927.

Linebacker Drew White, Kelly said, tore his posterior cruciate ligament (PCL) in his knee during the week leading up to the game, in practice, and played with the injury Saturday and recorded a pair of tackles..

He's a warrior, Kelly said. Drew just had the mental toughness to play through it.

Fellow linebacker JD Bertrand had nine tackles, and leads the team with 80 for the season.

Converted wide receiver Xavier Watts got his first high-leverage snaps on defense and finished with three tackles while lining up on the edge and at safety. Freshman defensive end Kahanu Kia (four tackles) and freshman linebacker Prince Kollie (three tackles) were impressive late as the Irish pulled away.

Sophomore Jordan Botelho, who lined up at end and at linebacker Saturday, got a sack for the second straight weekagainst a team that officially attempted only three passes and completed one for 18 yards.

Thats the third-lowest passing total an ND defense has given up in a game since at least 1996.

I mean, we needed to make some progress, Kelly said, referring specifically to a plethora of missed tackles and missed assignments in a 44-34 survival of North Carolina on Oct. 30.

We weren't happy with some of the things last week, and so we needed to see the incremental progress. And so this week was much better, but it's a snapshot, right? Next week we got a team that's one of the more prolific passing offenses in the country.

"Job well done. Checkmark on the old option. Let's go see how we handle now (quarterback) Brennan Armstrong and the Cavaliers. So this is work in progress for us. We like the step we took today, because the communication was really good and the tackling was much better.

Weve got to go cover some people next week.

And get the offense operating at maximum efficiency.

Against Navy, it sputtered and surged, with the Irish scoring a couple of touchdowns in the final 2:46 of the second quarter for a 17-3 halftime lead and outscoring the Mids 17-0 in the fourth quarter.

Quarterback Jack Coan recorded his highest completion percentage of the season (.793, 23-of-29 for 269 yards, 1 TD) and had his longest pass play in a Notre Dame uniform, a 70-yard strike to Kevin Austin Jr. with 50 seconds left in the first half.

It also tied the career long of the 297 completions he had during the Wisconsin portion of his career. And it capped a 95-yard, five play drive that took all of 60 seconds.

Coach Kelly was screaming at me, because it was open the play before, Coan said of the pass to Austin. He basically told me to throw it there, so thats what I did.

I followed the plan and got the ball to a guy like Kevin Austin, who can take it the distance every time. Great by coach Kelly. Great by Kevin.

Austin tied a career-high with six catches and exceeded his career high with 139 receiving yards.

Running back Kyren Williams amassed 176 all-purpose yards, including 95 rushing yards on 17 carries and two TDs. The junior has seven scores in the past five games and at least one TD in five consecutive games.

He also had a team high in receptions Saturday with seven.

Kelly admitted, though, he may need to move a player from another position group after slot receiver Avery Davis appeared to suffer a serious left knee injury. Kelly declined to speculate about the specifics until the grad senior has an MRI.

The Irish are down to five healthy scholarship receivers, three of whom are freshmen and one of whom Jayden Thomas hasn't played a down this season.

With the emergence of freshman running back Logan Diggs (8 carries, 59 yards and a TD) as a sidekick to Williams, running back Chris Tyree may be a strong candidate to slip into the slot as he plays his way back into form from a turf toe injury.

In the meantime, Kelly is happy to have his schematic curveball in the rearview mirror, though the two teams this week announced the signing of a 10-year extension that will take them through 2032.

I'll be able to watch that on TV, in the back end of that rivalry, Kelly said with a chuckle. (Athletic director) Jack (Swarbrick) will still be here, I'm sure.

The Irish turn their attention to transitioning out of the Xs and Os part of Navy to face traditional offense, but hoping to retain the defensive lessons learned in digging in for the Mids.

Navy is a difficult opponent to play. Very difficult, Kelly said. Look, we didn't run 7-on-7 this week. Didn't get our two-minute drill in this week. We didn't work on the basic parameters of football that prepare you each week. Things that you do naturally each and every week, we didn't do them.

Now we've got to go switch ... and play Virginia. So those are real. Those are hard things. But it's all worth it when you get a chance to go hand in hand with the Naval Academy as they sing their alma mater.

There is nothing like that. Where else in sport does that happen where you play on the field in intense competition, and then our players are arm in arm with their players as their alma mater is being sung.

Follow ND Insider Eric Hansen on Twitter: @EHansenNDI

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Hansen: Irish look to carry defensive strides beyond their taming of Navy's triple option - Notre Dame Insider