Summary
8.24 0.99(13.66%)07/01/2024
Larimar Therapeutics Inc (LRMR)
Larimar Therapeutics Inc (LRMR)
Key Facts
| 1 Day | 1 Week | 1 Month | 3 Months | 6 Months | 1 Year | 5 Years | All Time |
| 13.72 | 13.03 | -10.04 | 10.46 | 61.25 | 167.53 | 604.27 | -58.28 |
Last 730 data points are shown. To view all data, Upgrade to PRO plan with only $1
| Trading Data | ||
| Close | 8.24 | |
| Open | 7.25 | |
| High | 8.40 | |
| Low | 7.13 | |
| Volume | 428,471 | |
| Change | 0.99 | |
| Change % | 13.72 | |
| Avg Volume (20 Days) | 422,524 | |
| Volume/Avg Volume (20 Days) Ratio | 1.01 | |
| 52 Week Range | 2.18 - 13.68 | |
| Price vs 52 Week High | -39.77% | |
| Price vs 52 Week Low | 277.98% | |
| Range | 13.66 | |
| Gap Up/Down | -0.49 | |
Fundamentals | ||
| Market Capitalization (Mln) | 526 | |
| EBIDTA | 0 | |
| PE Ratio | 0.0000 | |
| PEG Ratio | 0.0000 | |
| WallStreet Target Price | 24.50 | |
| Book Value | 4.0690 | |
| Earnings Per Share | -3.3660 | |
| EPS Estimate Current Quarter | -0.6400 | |
| EPS Estimate Next Quarter | -0.5800 | |
| EPS Estimate Current Year | -3.3400 | |
| EPS Estimate Next Year | -3.0100 | |
| Diluted EPS (TTM) | -3.3660 | |
| Revenues | ||
| Profit Marging | 0.0000 | |
| Operating Marging (TTM) | 0.0000 | |
| Return on asset (TTM) | -0.3453 | |
| Return on equity (TTM) | -0.6377 | |
| Revenue TTM | 0 | |
| Revenue per share TTM | 0.0000 | |
| Quarterly Revenue Growth (YOY) | 0.0000 | |
| Quarterly Earnings Growth (YOY) | 0.0000 | |
| Gross Profit (TTM) | 0 | |
| Dividends | ||
| Dividend Share | 0.0000 | |
| Dividend Yield | ||
| Valuations | ||
| Trailing PE | 0.0000 | |
| Forward PE | 0.0000 | |
| Price Sales (TTM) | 0.0000 | |
| Price Book (MRQ) | 2.3174 | |
| Revenue Enterprise Value | 0.0000 | |
| EBITDA Enterprise Value | 0.0000 | |
| Shares | ||
| Shares Outstanding | 17,710,400 | |
| Shares Float | 8,632,073 | |
| Shares Short | 0 | |
| Shares Short (Prior Month) | 0 | |
| Shares Ratio | 0.00 | |
| Short Outstanding (%) | 0.00 | |
| Short Float (%) | 0.00 | |
| Insider (%) | 2.13 | |
| Institutions (%) | 85.80 | |
05/30 16:05 EST - globenewswire.com
Larimar Therapeutics Selected by FDA to Participate in START Pilot Program for Nomlabofusp in Friedreich's Ataxia
BALA CYNWYD, Pa., May 30, 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 the United States Food and Drug Administration (FDA) has selected nomlabofusp to participate in the Support for Clinical Trials Advancing Rare Disease Therapeutics (START) pilot program. Nomlabofusp is a novel protein replacement therapy designed to address the root cause of Friedreich's ataxia (FA) by delivering frataxin to mitochondria. START selection was based on demonstrated development program readiness, including the potential of nomlabofusp to address the serious and unmet medical needs in a rare neurodegenerative condition, alignment of chemistry, manufacturing, and controls (CMC) development timelines with clinical development plans, and a proposed communications plan where enhanced communication could accelerate pivotal study initiation and path to potential Biologics License Application (BLA) submission.
Larimar Therapeutics Selected by FDA to Participate in START Pilot Program for Nomlabofusp in Friedreich's Ataxia
BALA CYNWYD, Pa., May 30, 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 the United States Food and Drug Administration (FDA) has selected nomlabofusp to participate in the Support for Clinical Trials Advancing Rare Disease Therapeutics (START) pilot program. Nomlabofusp is a novel protein replacement therapy designed to address the root cause of Friedreich's ataxia (FA) by delivering frataxin to mitochondria. START selection was based on demonstrated development program readiness, including the potential of nomlabofusp to address the serious and unmet medical needs in a rare neurodegenerative condition, alignment of chemistry, manufacturing, and controls (CMC) development timelines with clinical development plans, and a proposed communications plan where enhanced communication could accelerate pivotal study initiation and path to potential Biologics License Application (BLA) submission.
05/29 08:45 EST - fool.com
2 Potentially High-Reward Growth Stocks to Buy Right Now
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2 Potentially High-Reward Growth Stocks to Buy Right Now
Growth stocks have been the U.S. market's primary value driver since 2008. Biotechnology equities, however, have been in a wilderness period since the central bank ramped up interest rates.
05/22 12:25 EST - zacks.com
Larimar (LRMR) Up on Lifting of Partial Clinical Hold on FA Study
The FDA removes the partial clinical hold on Larimar's (LRMR) nomlabofusp clinical program for the treatment of patients with Friedreich's Ataxia.
Larimar (LRMR) Up on Lifting of Partial Clinical Hold on FA Study
The FDA removes the partial clinical hold on Larimar's (LRMR) nomlabofusp clinical program for the treatment of patients with Friedreich's Ataxia.
05/20 16:05 EST - globenewswire.com
Larimar Therapeutics Announces FDA has Removed Partial Clinical Hold for Nomlabofusp Program in Friedreich's Ataxia
BALA CYNWYD, Pa., May 20, 2024 (GLOBE NEWSWIRE) -- Larimar Therapeutics, Inc. (Larimar) (Nasdaq: LRMR), a clinical-stage biotechnology company focused on developing treatments for complex rare diseases, today announced the U.S. FDA has removed the partial clinical hold previously placed on the company's nomlabofusp (CTI-1601) clinical program. Nomlabofusp is currently in development for the treatment of patients with Friedreich's Ataxia (FA). Nomlabofusp is a novel protein replacement therapy designed to address the root cause of FA by delivering frataxin to mitochondria. The FDA removed the partial clinical hold after a review of data from the Company's recently completed four-week, placebo-controlled Phase 2 dose exploration study. The review included data from both the 25 mg and 50 mg cohorts in patients who received daily dosing of nomlabofusp for 14 days followed by every other day dosing until day 28.
Larimar Therapeutics Announces FDA has Removed Partial Clinical Hold for Nomlabofusp Program in Friedreich's Ataxia
BALA CYNWYD, Pa., May 20, 2024 (GLOBE NEWSWIRE) -- Larimar Therapeutics, Inc. (Larimar) (Nasdaq: LRMR), a clinical-stage biotechnology company focused on developing treatments for complex rare diseases, today announced the U.S. FDA has removed the partial clinical hold previously placed on the company's nomlabofusp (CTI-1601) clinical program. Nomlabofusp is currently in development for the treatment of patients with Friedreich's Ataxia (FA). Nomlabofusp is a novel protein replacement therapy designed to address the root cause of FA by delivering frataxin to mitochondria. The FDA removed the partial clinical hold after a review of data from the Company's recently completed four-week, placebo-controlled Phase 2 dose exploration study. The review included data from both the 25 mg and 50 mg cohorts in patients who received daily dosing of nomlabofusp for 14 days followed by every other day dosing until day 28.
05/09 07:00 EST - globenewswire.com
Larimar Therapeutics Reports First Quarter 2024 Operating and Financial Results
BALA CYNWYD, Pa., May 09, 2024 (GLOBE NEWSWIRE) -- Larimar Therapeutics, Inc. (“Larimar”) (Nasdaq: LRMR), a clinical-stage biotechnology company focused on developing treatments for complex rare diseases, today reported its first quarter 2024 operating and financial results.
Larimar Therapeutics Reports First Quarter 2024 Operating and Financial Results
BALA CYNWYD, Pa., May 09, 2024 (GLOBE NEWSWIRE) -- Larimar Therapeutics, Inc. (“Larimar”) (Nasdaq: LRMR), a clinical-stage biotechnology company focused on developing treatments for complex rare diseases, today reported its first quarter 2024 operating and financial results.
03/14 16:05 EST - globenewswire.com
Larimar Therapeutics Reports Fourth Quarter and Full Year 2023 Operating and Financial Results and Provides Update on Nomlabofusp Development
BALA CYNWYD, Pa., March 14, 2024 (GLOBE NEWSWIRE) -- Larimar Therapeutics, Inc. (“Larimar”) (Nasdaq: LRMR), a clinical-stage biotechnology company focused on developing treatments for complex rare diseases, today reported its fourth quarter and full year 2023 operating and financial results.
Larimar Therapeutics Reports Fourth Quarter and Full Year 2023 Operating and Financial Results and Provides Update on Nomlabofusp Development
BALA CYNWYD, Pa., March 14, 2024 (GLOBE NEWSWIRE) -- Larimar Therapeutics, Inc. (“Larimar”) (Nasdaq: LRMR), a clinical-stage biotechnology company focused on developing treatments for complex rare diseases, today reported its fourth quarter and full year 2023 operating and financial results.
03/11 16:05 EST - globenewswire.com
Larimar Therapeutics Announces the Dosing of the First Patient in Long-term Open Label Extension Study for Nomlabofusp in Patients with Friedreich's Ataxia
BALA CYNWYD, Pa., March 11, 2024 (GLOBE NEWSWIRE) -- Larimar Therapeutics, Inc. (“Larimar”) (Nasdaq: LRMR), a clinical-stage biotechnology company focused on developing treatments for complex rare diseases, today announced dosing of the first patient in an open label extension (OLE) study evaluating 25 mg daily subcutaneous injections of nomlabofusp in participants with Friedreich's ataxia (FA). Nomlabofusp (CTI-1601) is a novel protein replacement therapy designed to address the root cause of Friedreich's ataxia (FA) by delivering frataxin to mitochondria.
Larimar Therapeutics Announces the Dosing of the First Patient in Long-term Open Label Extension Study for Nomlabofusp in Patients with Friedreich's Ataxia
BALA CYNWYD, Pa., March 11, 2024 (GLOBE NEWSWIRE) -- Larimar Therapeutics, Inc. (“Larimar”) (Nasdaq: LRMR), a clinical-stage biotechnology company focused on developing treatments for complex rare diseases, today announced dosing of the first patient in an open label extension (OLE) study evaluating 25 mg daily subcutaneous injections of nomlabofusp in participants with Friedreich's ataxia (FA). Nomlabofusp (CTI-1601) is a novel protein replacement therapy designed to address the root cause of Friedreich's ataxia (FA) by delivering frataxin to mitochondria.
03/06 16:05 EST - globenewswire.com
Larimar Therapeutics to Present at the Leerink Partners Global Biopharma Conference
BALA CYNWYD, Pa., March 06, 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 members of the company's management team will present and participate in 1x1 investor meetings at the Leerink Partners Global Biopharma Conference, taking place in Miami Beach, FL from March 11 – 13, 2024.
Larimar Therapeutics to Present at the Leerink Partners Global Biopharma Conference
BALA CYNWYD, Pa., March 06, 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 members of the company's management team will present and participate in 1x1 investor meetings at the Leerink Partners Global Biopharma Conference, taking place in Miami Beach, FL from March 11 – 13, 2024.
02/16 16:20 EST - globenewswire.com
Larimar Therapeutics Announces Closing of Underwritten Public Offering of Common Stock and Exercise in Full of the Underwriters' Option to Purchase Additional Shares
BALA CYNWYD, Pa., Feb. 16, 2024 (GLOBE NEWSWIRE) -- Larimar Therapeutics, Inc. (“Larimar”) (Nasdaq: LRMR), a clinical-stage biotechnology company focused on developing treatments for complex rare diseases, today announced the closing of its previously announced underwritten public offering of 19,736,842 shares of its common stock, which includes the exercise in full of the underwriters' option to purchase 2,574,370 additional shares, at the public offering price of $8.74 per share, the closing price of its common stock on February 13, 2024. The aggregate gross proceeds to Larimar from this offering, before deducting underwriting discounts and commissions and estimated offering expenses, were approximately $172.5 million.
Larimar Therapeutics Announces Closing of Underwritten Public Offering of Common Stock and Exercise in Full of the Underwriters' Option to Purchase Additional Shares
BALA CYNWYD, Pa., Feb. 16, 2024 (GLOBE NEWSWIRE) -- Larimar Therapeutics, Inc. (“Larimar”) (Nasdaq: LRMR), a clinical-stage biotechnology company focused on developing treatments for complex rare diseases, today announced the closing of its previously announced underwritten public offering of 19,736,842 shares of its common stock, which includes the exercise in full of the underwriters' option to purchase 2,574,370 additional shares, at the public offering price of $8.74 per share, the closing price of its common stock on February 13, 2024. The aggregate gross proceeds to Larimar from this offering, before deducting underwriting discounts and commissions and estimated offering expenses, were approximately $172.5 million.
02/14 06:15 EST - globenewswire.com
Larimar Therapeutics Announces Pricing of Underwritten Public Offering of Common Stock
BALA CYNWYD, Pa., Feb. 14, 2024 (GLOBE NEWSWIRE) -- Larimar Therapeutics, Inc. (“Larimar”) (Nasdaq: LRMR), a clinical-stage biotechnology company focused on developing treatments for complex rare diseases, today announced the pricing of its previously announced underwritten public offering of 17,162,472 shares of its common stock at a price to the public of $8.74 per share, the closing price of its common stock on February 13, 2024, for gross proceeds of approximately $150.0 million, before deducting underwriting discounts and commissions and other offering expenses. In addition, Larimar has granted the underwriters a 30-day option to purchase up to an additional 2,574,370 shares of its common stock at the public offering price, less underwriting discounts and commissions. All shares of common stock are being offered by Larimar. The offering is expected to close on or about February 16, 2024, subject to the satisfaction of customary closing conditions.
Larimar Therapeutics Announces Pricing of Underwritten Public Offering of Common Stock
BALA CYNWYD, Pa., Feb. 14, 2024 (GLOBE NEWSWIRE) -- Larimar Therapeutics, Inc. (“Larimar”) (Nasdaq: LRMR), a clinical-stage biotechnology company focused on developing treatments for complex rare diseases, today announced the pricing of its previously announced underwritten public offering of 17,162,472 shares of its common stock at a price to the public of $8.74 per share, the closing price of its common stock on February 13, 2024, for gross proceeds of approximately $150.0 million, before deducting underwriting discounts and commissions and other offering expenses. In addition, Larimar has granted the underwriters a 30-day option to purchase up to an additional 2,574,370 shares of its common stock at the public offering price, less underwriting discounts and commissions. All shares of common stock are being offered by Larimar. The offering is expected to close on or about February 16, 2024, subject to the satisfaction of customary closing conditions.
02/13 16:18 EST - globenewswire.com
Larimar Therapeutics Announces Proposed Underwritten Public Offering
BALA CYNWYD, Pa., Feb. 13, 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 it has commenced an underwritten public offering of shares of its common stock and, in lieu of shares of common stock to certain investors that so choose, pre-funded warrants to purchase shares of common stock. In addition, Larimar expects to grant the underwriters a 30-day option to purchase up to an additional 15% of the securities to be sold in the proposed offering at the public offering price, less underwriting discounts and commissions. All shares of common stock and pre-funded warrants in the proposed offering are to be sold by Larimar. The proposed offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or the actual size or terms of the proposed offering.
Larimar Therapeutics Announces Proposed Underwritten Public Offering
BALA CYNWYD, Pa., Feb. 13, 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 it has commenced an underwritten public offering of shares of its common stock and, in lieu of shares of common stock to certain investors that so choose, pre-funded warrants to purchase shares of common stock. In addition, Larimar expects to grant the underwriters a 30-day option to purchase up to an additional 15% of the securities to be sold in the proposed offering at the public offering price, less underwriting discounts and commissions. All shares of common stock and pre-funded warrants in the proposed offering are to be sold by Larimar. The proposed offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or the actual size or terms of the proposed offering.
02/12 07:00 EST - globenewswire.com
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
BALA CYNWYD, Pa., Feb. 12, 2024 (GLOBE NEWSWIRE) -- Larimar Therapeutics, Inc. (“Larimar”) (Nasdaq: LRMR), a clinical-stage biotechnology company focused on developing treatments for complex rare diseases, today announced positive top-line data and successful completion of its four-week, placebo-controlled Phase 2 dose exploration study of nomlabofusp (CTI-1601) in participants with Friedreich's ataxia (FA). Nomlabofusp was generally well tolerated and demonstrated dose dependent increases in frataxin (FXN) levels in all evaluated tissues (skin and buccal cells) after daily dosing of 14 days followed by every other day dosing until day 28 in the 25 mg and 50 mg cohorts. Participants in the 25 mg (n=13) and 50 mg (n=15) cohorts were randomized 2:1 to receive subcutaneous injections of nomlabofusp or placebo.
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
BALA CYNWYD, Pa., Feb. 12, 2024 (GLOBE NEWSWIRE) -- Larimar Therapeutics, Inc. (“Larimar”) (Nasdaq: LRMR), a clinical-stage biotechnology company focused on developing treatments for complex rare diseases, today announced positive top-line data and successful completion of its four-week, placebo-controlled Phase 2 dose exploration study of nomlabofusp (CTI-1601) in participants with Friedreich's ataxia (FA). Nomlabofusp was generally well tolerated and demonstrated dose dependent increases in frataxin (FXN) levels in all evaluated tissues (skin and buccal cells) after daily dosing of 14 days followed by every other day dosing until day 28 in the 25 mg and 50 mg cohorts. Participants in the 25 mg (n=13) and 50 mg (n=15) cohorts were randomized 2:1 to receive subcutaneous injections of nomlabofusp or placebo.
01/03 13:15 EST - fool.com
Wall Street Thinks These 2 Biotech Stocks Could Soar in 2024
Biotech could be poised to rebound in 2024. Wall Street thinks clinical and early commercial-stage drugmakers may be among the group's best performers this year.
Wall Street Thinks These 2 Biotech Stocks Could Soar in 2024
Biotech could be poised to rebound in 2024. Wall Street thinks clinical and early commercial-stage drugmakers may be among the group's best performers this year.
11/14 07:00 EST - globenewswire.com
Larimar Therapeutics Reports Third Quarter 2023 Operating and Financial Results
BALA CYNWYD, Pa., Nov. 14, 2023 (GLOBE NEWSWIRE) -- Larimar Therapeutics, Inc. (“Larimar”) (Nasdaq: LRMR), a clinical-stage biotechnology company focused on developing treatments for complex rare diseases, today reported its third quarter operating and financial results.
Larimar Therapeutics Reports Third Quarter 2023 Operating and Financial Results
BALA CYNWYD, Pa., Nov. 14, 2023 (GLOBE NEWSWIRE) -- Larimar Therapeutics, Inc. (“Larimar”) (Nasdaq: LRMR), a clinical-stage biotechnology company focused on developing treatments for complex rare diseases, today reported its third quarter operating and financial results.
10/03 16:05 EST - globenewswire.com
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.
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.
08/31 16:05 EST - globenewswire.com
Larimar Therapeutics to Present at the Citi 18th Annual BioPharma Conference
BALA CYNWYD, Pa., Aug. 31, 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 company management will participate in a panel discussion and 1x1 investor meetings at the Citi 18th Annual BioPharma Conference, taking place in Boston, MA from September 5 - 7, 2023.
Larimar Therapeutics to Present at the Citi 18th Annual BioPharma Conference
BALA CYNWYD, Pa., Aug. 31, 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 company management will participate in a panel discussion and 1x1 investor meetings at the Citi 18th Annual BioPharma Conference, taking place in Boston, MA from September 5 - 7, 2023.
08/10 07:00 EST - globenewswire.com
Larimar Therapeutics Reports Second Quarter 2023 Operating and Financial Results
BALA CYNWYD, Pa., Aug. 10, 2023 (GLOBE NEWSWIRE) -- Larimar Therapeutics, Inc. (“Larimar”) (Nasdaq: LRMR), a clinical-stage biotechnology company focused on developing treatments for complex rare diseases, today reported its second quarter operating and financial results.
Larimar Therapeutics Reports Second Quarter 2023 Operating and Financial Results
BALA CYNWYD, Pa., Aug. 10, 2023 (GLOBE NEWSWIRE) -- Larimar Therapeutics, Inc. (“Larimar”) (Nasdaq: LRMR), a clinical-stage biotechnology company focused on developing treatments for complex rare diseases, today reported its second quarter operating and financial results.
08/02 06:02 EST - seekingalpha.com
Larimar: Friedreich's Ataxia Drug With Significant Potential
Clearance given by FDA to initiate higher 50 mg dosing of CTI-1601 for patients with Friedreich's Ataxia for phase 2 study; results from this cohort expected 1st half of 2024. Clearance given to initiate open-label extension study of CTI-1601 for Friedreich's Ataxia; study initiation Q1 of 2024 and then interim results Q4 of 2024. Prior phase 1 study, using CTI-1601 for the treatment of patients with Friedreich's Ataxia, showed that the drug was able to increase frataxin levels in a dose-dependent manner.
Larimar: Friedreich's Ataxia Drug With Significant Potential
Clearance given by FDA to initiate higher 50 mg dosing of CTI-1601 for patients with Friedreich's Ataxia for phase 2 study; results from this cohort expected 1st half of 2024. Clearance given to initiate open-label extension study of CTI-1601 for Friedreich's Ataxia; study initiation Q1 of 2024 and then interim results Q4 of 2024. Prior phase 1 study, using CTI-1601 for the treatment of patients with Friedreich's Ataxia, showed that the drug was able to increase frataxin levels in a dose-dependent manner.
07/25 07:00 EST - globenewswire.com
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
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 in patients with Friedreich's ataxia (FA) to proceed to a 50 mg cohort in which participants will be dosed daily for the first 14 days, and then every other day until day 28. In addition, Larimar's open label extension (OLE) trial was also cleared for initiation by the FDA. Participants in the OLE will receive 25 mg of CTI-1601 daily. CTI-1601 is a novel protein replacement therapy designed to deliver frataxin to the mitochondria of patients with FA who have low levels of frataxin.
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
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 in patients with Friedreich's ataxia (FA) to proceed to a 50 mg cohort in which participants will be dosed daily for the first 14 days, and then every other day until day 28. In addition, Larimar's open label extension (OLE) trial was also cleared for initiation by the FDA. Participants in the OLE will receive 25 mg of CTI-1601 daily. CTI-1601 is a novel protein replacement therapy designed to deliver frataxin to the mitochondria of patients with FA who have low levels of frataxin.
07/17 16:05 EST - globenewswire.com
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.
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.