Larimar Therapeutics Selected By FDA To Participate In Support For Clinical Trials Advancing Rare Disease Therapeutics Pilot Program For Nomlabofusp In Friedreich's Ataxia

5/30/24 4:35:28 PM ET

$LRMR

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START is a new milestone-driven program designed to accelerate development of novel therapies intended to address an unmet medical need for rare diseases
Nomlabofusp was selected based on potential for clinical benefit in a rare neurodegenerative disease and demonstrated development program readiness
START pilot program is intended to improve development efficiency through enhanced communication with the FDA
Nomlabofusp is expected to be one of three CDER programs and one of six total programs selected by the FDA
- BLA submission continues to be targeted for 2H 2025

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Recent Analyst Ratings for
$LRMR

Date	Price Target	Rating	Analyst
10/16/2024	$26.00	Outperform	Oppenheimer
10/3/2024	$22.00	Outperform	Wedbush
10/2/2024	$15.00	Buy	H.C. Wainwright
9/4/2024	$16.00	Outperform	Robert W. Baird
4/3/2024	$25.00	Outperform	Leerink Partners
11/17/2023	$4.50	Neutral → Buy	Citigroup
10/19/2022	$12.00	Buy	Guggenheim
2/15/2022		Outperform → Market Perform	William Blair

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$LRMR
Leadership Updates

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Larimar Therapeutics Appoints Dr. Jeffery W. Sherman to its Board of Directors
BALA CYNWYD, Pa., Oct. 03, 2023 (GLOBE NEWSWIRE) -- Larimar Therapeutics, Inc. ("Larimar") (NASDAQ:LRMR), a clinical-stage biotechnology company focused on developing treatments for complex rare diseases, today announced the appointment of Jeffrey W. Sherman, M.D., F.A.C.P. to the Company's Board of Directors, effective today. Dr. Sherman, currently Executive Vice President, Chief Medical Officer (CMO) at Horizon Therapeutics Public Limited Company, has over 20 years of executive experience in regulatory and clinical strategy. "Dr. Sherman is a pharmaceutical industry veteran who brings decades of leadership experience in global regulatory and clinical strategy to our Board of Directors.
10/3/23 4:05:00 PM ET
$LRMR
Biotechnology: Pharmaceutical Preparations
Health Care
Larimar Therapeutics Reports Second Quarter 2023 Operating and Financial Results
Initiation cleared for 50 mg cohort in Phase 2 Friedreich's ataxia (FA) dose exploration trial following FDA review of unblinded 25 mg cohort Phase 2 dataInitiation cleared for open-label extension (OLE) trial following FDA review of unblinded 25 mg cohort Phase 2 dataTop-line safety, pharmacokinetic, and frataxin data from the Phase 2 trial's 50 mg cohort expected in 1H 2024Initiation of OLE trial with 25 mg daily dosing expected in Q1 2024; interim data expected in Q4 2024 Cash, cash equivalents and marketable securities of $104.2 million as of June 30, 2023, provides projected cash runway into Q4 2024 BALA CYNWYD, Pa., Aug. 10, 2023 (GLOBE NEWSWIRE) -- Larimar Therapeutics, Inc. ("Lari
8/10/23 7:00:00 AM ET
$LRMR
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Larimar Therapeutics Appoints Dr. Rusty Clayton as Chief Medical Officer
BALA CYNWYD, Pa., July 17, 2023 (GLOBE NEWSWIRE) -- Larimar Therapeutics, Inc. ("Larimar") (NASDAQ:LRMR), a clinical-stage biotechnology company focused on developing treatments for complex rare diseases, today announced the appointment of Russell "Rusty" Clayton, DO, as Chief Medical Officer ("CMO"), effective today. Dr. Clayton succeeds former CMO Nancy M. Ruiz, MD, who is retiring and will provide consulting support to the Company as needed. "We are delighted to welcome Dr. Clayton in his new role as CMO as we further expand our clinical development of CTI-1601. Rusty has been one of our closest advisors for the last 5 years, has attended every meeting between Larimar and the FDA, in
7/17/23 4:05:00 PM ET
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Larimar Therapeutics Reports Positive Top-line Data from Phase 2 Dose Exploration Study from 25 mg and 50 mg Cohorts of Nomlabofusp in Patients with Friedreich's Ataxia
Nomlabofusp was generally well tolerated following repeated subcutaneous injections in patients in the 25 and 50 mg cohorts with no serious adverse eventsDose dependent increases in frataxin levels were observed in skin and buccal cells Open Label Extension (OLE) study initiated in January 2024 to dose 25 mg daily of nomlabofusp with dosing anticipated to be starting later this quarter; Initial data expected in Q4 2024Initiated discussions with the FDA on use of tissue frataxin levels as a novel surrogate endpoint to support a potential Biologics License Application ("BLA") submission for accelerated approval targeted for 2H 2025 Company management to host webcast and conference call today a
2/12/24 7:00:00 AM ET
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Larimar Therapeutics Receives FDA Clearance to Proceed to 50 mg Cohort in CTI-1601's Phase 2 Friedreich's Ataxia Trial and to Initiate Open Label Extension Trial
Top-line safety, pharmacokinetic, and pharmacodynamic (frataxin level) data from Phase 2 trial's 50 mg cohort expected in 1H 2024Initiation of open label extension trial with 25 mg daily dosing expected in Q1 2024; interim data expected in Q4 2024Company management hosting a webcast and conference call today at 8:00 a.m. ET BALA CYNWYD, Pa., July 25, 2023 (GLOBE NEWSWIRE) -- Larimar Therapeutics, Inc. ("Larimar") (NASDAQ:LRMR), a clinical-stage biotechnology company focused on developing treatments for complex rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company's four-week, placebo-controlled, Phase 2 dose exploration trial of CTI-1601 i
7/25/23 7:00:00 AM ET
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Biotechnology: Pharmaceutical Preparations
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Larimar Therapeutics Reports Preliminary Top-line Data from Phase 2 Trial's 25 mg Cohort Showing Increases in Frataxin Levels in Patients with Friedreich's Ataxia and First Quarter 2023 Financial Results
Safety data indicate that repeated subcutaneous injections of 25 mg CTI-1601 were generally well tolerated when administered daily for 14 days and then every-other-day thereafter until day 28Daily subcutaneous injections of 25 mg CTI-1601 for 14 days led to increases in frataxin levels from baseline compared to placebo in all evaluated tissues (skin and buccal cells)Median placebo-adjusted increases from baseline of 3.5 pg/µg and 0.9 pg/µg in frataxin levels observed in skin and buccal cells, respectively, with 14 days of daily dosing of CTI-1601Larimar has submitted data to FDA and will meet with the Agency to discuss next steps; update expected in Q3 2023 Company management to host webcast
5/15/23 7:00:00 AM ET
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Why Helen of Troy Shares Are Trading Lower By Around 30%? Here Are Other Stocks Moving In Tuesday's Mid-Day Session
Shares of Helen of Troy Limited (NASDAQ:HELE) fell sharply during Tuesday's session after the company reported soft first-quarter earnings and lowered its FY25 guidance. Helen of Troy reported quarterly earnings of 99 cents per share which missed the analyst consensus estimate of $1.59. The company reported quarterly sales of $416.85 million which missed the analyst consensus estimate of $446.22 million, according to data from Benzinga Pro. Helen of Troy shares dipped 30.3% to $62.06 on Tuesday. Here are some other stocks moving in today’s mid-day session. Gainers Soligenix, Inc. (NASDAQ:SNGX) shares jumped 195% to $5.90 after the company announced interim results for extende
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U.S. stocks were mixed, with the Dow Jones index falling around 100 points on Tuesday. Shares of NVIDIA Corporation (NASDAQ:NVDA) rose during Tuesday's session. Keybanc analyst John Vinh maintained NVIDIA with an Overweight and raised the price target from $130 to $180. NVIDIA shares gained 3.5% to $132.65 on Tuesday. Here are some other big stocks recording gains in today’s session. Kymera Therapeutics, Inc. (NASDAQ:KYMR) shares rose 21.7% to $38.91. Jumia Technologies AG (NYSE:JMIA) shares surged 20.7% to $10.22 after Benchmark initiated coverage on the stock with a Buy rating and $14 price target. Arlo Technologies, Inc. (NYSE:ARLO) shares gained 14.5% to $15.80 afte
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Worthington Enterprises Posts Downbeat Results, Joins Taysha Gene Therapies, General Mills And Other Big Stocks Moving Lower In Wednesday's Pre-Market Session
U.S. stock futures were mixed this morning, with the Nasdaq futures gaining around 0.2% on Wednesday. Shares of Worthington Enterprises, Inc. (NYSE:WOR) fell sharply in today's pre-market trading after the company posted downbeat quarterly results. Worthington Industries posted adjusted earnings of 74 cents per share, missing analysts' estimates of 94 cents per share. The company posted quarterly sales of $318.801 million versus estimates of $359.390 million, according to data from Benzinga Pro. Worthington shares dipped 7.5% to $46.38 in pre-market trading. Here are some big stocks recording losses in today's pre-market trading session. Taysha Gene Therapies, Inc. (NASDAQ:TS
6/26/24 7:36:28 AM ET
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Larimar Therapeutics Presents Additional Data from Phase 1 Studies and Phase 2 Dose Exploration Study Supporting the Nomlabofusp Clinical Program at ICAR 2024
Treatment with nomlabofusp modified gene expression and lipid profiles in addition to increasing frataxin (FXN) levels in study participants with Friedreich's ataxia (FA)Modeling and simulation predict that, in most patients with FA, 50 mg of nomlabofusp administered daily is likely to achieve FXN levels that are ≥50% of levels observed in healthy controls and similar to mean FXN levels reported in asymptomatic heterozygous carriers Disease characteristics of adult participants in the nomlabofusp studies were representative of the broad population of adults with FARelationships between tissue FXN levels and onset of disease and GAA repeat length observed at baseline in nomlabofusp clinica
11/18/24 7:00:00 AM ET
$LRMR
Biotechnology: Pharmaceutical Preparations
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Larimar Therapeutics Reports Third Quarter 2024 Operating and Financial Results
Nomlabofusp program update expected mid-December to include available safety, pharmacokinetic (PK) and frataxin data, as well as available clinical outcomes observations from patients with Friedreich's ataxia (FA) receiving 25 mg of nomlabofusp daily for 30-180 days in ongoing open label extension (OLE) studyInitiation of PK run-in study in adolescents on track by year-end 2024Initiation of global confirmatory/registration study planned mid-2025Biologics License Application (BLA) submission for nomlabofusp targeted for 2H 2025 to support potential accelerated approvalStrong balance sheet of $203.7 million cash, cash equivalents and marketable securities as of September 30, 2024, with project
10/30/24 7:00:00 AM ET
$LRMR
Biotechnology: Pharmaceutical Preparations
Health Care
Larimar Therapeutics Announces Three Poster Presentations at the Upcoming International Congress for Ataxia Research
BALA CYNWYD, Pa., Sept. 19, 2024 (GLOBE NEWSWIRE) -- Larimar Therapeutics, Inc. (Larimar) (NASDAQ:LRMR), a clinical-stage biotechnology company focused on developing treatments for complex rare diseases, today announced that data from the Company's nomlabofusp Phase 1 studies and Phase 2 dose exploration study, some of which has been previously disclosed, will be presented at the annual International Congress for Ataxia Research (ICAR) being held November 12-15, 2024 in London, U.K. Nomlabofusp is a novel protein replacement therapy designed to address the root cause of Friedreich's ataxia by delivering frataxin to mitochondria. Larimar will present three posters during the conference, on
9/19/24 7:00:00 AM ET
$LRMR
Biotechnology: Pharmaceutical Preparations
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Larimar Therapeutics Selected By FDA To Participate In Support For Clinical Trials Advancing Rare Disease Therapeutics Pilot Program For Nomlabofusp In Friedreich's Ataxia

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Recent Analyst Ratings for $LRMR

$LRMR Leadership Updates

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Larimar Therapeutics Appoints Dr. Jeffery W. Sherman to its Board of Directors

Larimar Therapeutics Reports Second Quarter 2023 Operating and Financial Results

Larimar Therapeutics Appoints Dr. Rusty Clayton as Chief Medical Officer

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Oppenheimer initiated coverage on Larimar Therapeutics with a new price target

Wedbush initiated coverage on Larimar Therapeutics with a new price target

H.C. Wainwright initiated coverage on Larimar Therapeutics with a new price target

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Larimar Therapeutics Reports Positive Top-line Data from Phase 2 Dose Exploration Study from 25 mg and 50 mg Cohorts of Nomlabofusp in Patients with Friedreich's Ataxia

Larimar Therapeutics Receives FDA Clearance to Proceed to 50 mg Cohort in CTI-1601's Phase 2 Friedreich's Ataxia Trial and to Initiate Open Label Extension Trial

Larimar Therapeutics Reports Preliminary Top-line Data from Phase 2 Trial's 25 mg Cohort Showing Increases in Frataxin Levels in Patients with Friedreich's Ataxia and First Quarter 2023 Financial Results

SEC Form 4 filed by Flynn James E

SEC Form 4 filed by Thomas Frank E

SEC Form 4 filed by Leff Jonathan S

$LRMR SEC Filings

Larimar Therapeutics Inc. filed SEC Form 8-K: Other Events, Financial Statements and Exhibits

SEC Form 10-Q filed by Larimar Therapeutics Inc.

Larimar Therapeutics Inc. filed SEC Form 8-K: Results of Operations and Financial Condition, Other Events, Financial Statements and Exhibits

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Why Helen of Troy Shares Are Trading Lower By Around 30%? Here Are Other Stocks Moving In Tuesday's Mid-Day Session

Nvidia, Micron, Arlo Technologies And Other Big Stocks Moving Higher On Tuesday

Worthington Enterprises Posts Downbeat Results, Joins Taysha Gene Therapies, General Mills And Other Big Stocks Moving Lower In Wednesday's Pre-Market Session

Amendment: SEC Form SC 13G/A filed by Larimar Therapeutics Inc.

Amendment: SEC Form SC 13G/A filed by Larimar Therapeutics Inc.

Amendment: SEC Form SC 13G/A filed by Larimar Therapeutics Inc.

Hamilton Thomas Edward bought $499,998 worth of shares (57,208 units at $8.74), increasing direct ownership by 11% to 564,798 units (SEC Form 4)

Flynn James E bought $37,499,993 worth of shares (4,290,617 units at $8.74) (SEC Form 4)

Thomas Frank E bought $22,000 worth of shares (2,000 units at $11.00) (SEC Form 4)

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Larimar Therapeutics Presents Additional Data from Phase 1 Studies and Phase 2 Dose Exploration Study Supporting the Nomlabofusp Clinical Program at ICAR 2024

Larimar Therapeutics Reports Third Quarter 2024 Operating and Financial Results

Larimar Therapeutics Announces Three Poster Presentations at the Upcoming International Congress for Ataxia Research

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