X-linked ichthyosis

Timber Pharmaceuticals Provides Business Update and Announces First Quarter 2023 Financial Results

Retrieved on: 
Monday, May 15, 2023
Maintenance, Clinical and Experimental Dermatology, Civil service commission, Bank statement, CI, Clinical trial, XLRI, Dermatology, Fast Track, Breakthrough therapy, Ichthyosis, Publication, CONTROL, ASCEND, Patient, X-linked ichthyosis, Security (finance), Isotretinoin, FDA, EC, NYSE, Skin, European Commission, ARCI, Pharmaceutical industry, Lumber

WARREN, NJ, May 15, 2023 (GLOBE NEWSWIRE) -- via NewMediaWire – Timber Pharmaceuticals, Inc. ("Timber" or the “Company”) (NYSE American: TMBR), a clinical-stage biopharmaceutical company focused on the development and commercialization of treatments for rare and orphan dermatologic diseases, today provided a business update and announced financial results for the first quarter ended March 31, 2023.

Key Points: 
  • WARREN, NJ, May 15, 2023 (GLOBE NEWSWIRE) -- via NewMediaWire – Timber Pharmaceuticals, Inc. ("Timber" or the “Company”) (NYSE American: TMBR), a clinical-stage biopharmaceutical company focused on the development and commercialization of treatments for rare and orphan dermatologic diseases, today provided a business update and announced financial results for the first quarter ended March 31, 2023.
  • John Koconis, Chairman and Chief Executive Officer of Timber, commented, “The development of our lead asset, TMB-001, continued to progress on several fronts during the first quarter of 2023.
  • For the first quarter ended March 31, 2023, Timber recorded no revenue compared to revenue of $83,177 in the first quarter of 2022.
  • For Timber’s complete financial results for the first quarter ended March 31, 2023, see the Company’s Quarterly Form 10-Q filed with the Securities and Exchange Commission on May 15, 2023.

Timber Pharmaceuticals Provides Business Update and Announces Fourth Quarter and Year End 2022 Financial Results

Retrieved on: 
Friday, March 31, 2023
Clinical and Experimental Dermatology, Civil service commission, Intellectual property, Commission, CI, Clinical trial, XLRI, Skin, American Academy, Fast Track, Sale, Breakthrough therapy, Journal of the American Academy of Dermatology, Ichthyosis, ASCEND, CONTROL, Patient, X-linked ichthyosis, Security (finance), Isotretinoin, FDA, EC, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, NYSE, Food, European Commission, ARCI, Pharmaceutical industry, Cryptocurrency, Dermatology, Lumber

WARREN, NJ, March 31, 2023 (GLOBE NEWSWIRE) -- via NewMediaWire – Timber Pharmaceuticals, Inc. ("Timber" or the “Company”) (NYSE American: TMBR), a clinical-stage biopharmaceutical company focused on the development and commercialization of treatments for rare and orphan dermatologic diseases, today provided a business update and announced financial results for the fourth quarter and year ended December 31, 2022.

Key Points: 
  • John Koconis, Chairman and Chief Executive Officer of Timber, commented, “Timber had an exciting year in 2022 and achieved several significant milestones.
  • These designations, combined with the positive Phase 2b results, are assisting in our Phase 3 ASCEND clinical trial recruitment, which has now reached 50%.
  • In Spring 2022, Timber received Breakthrough Therapy designation and Fast Track designation from the FDA for TMB-001.
  • For Timber’s complete financial results for the fourth quarter and year ended December 31, 2022, see the Company’s Annual Form 10-K filed with the Securities and Exchange Commission on March 31, 2023.

Timber Pharmaceuticals Announces Publication of Sub-Analysis of Phase 2b CONTROL study in Clinical and Experimental Dermatology

Retrieved on: 
Monday, March 20, 2023
Clinical and Experimental Dermatology, Civil service commission, Ichthyosis, CI, Aes, XLRI, Quality of life, Associate, British Association of Dermatologists, Yale School of Medicine, IGA, CONTROL, Patient, CED, PP, X-linked ichthyosis, Isotretinoin, ITT, NYSE, European Commission, Safety, ARCI, Disease, Pharmaceutical industry, Dermatology

BASKING RIDGE, NJ, March 20, 2023 (GLOBE NEWSWIRE) -- via NewMediaWire -- Timber Pharmaceuticals, Inc. ("Timber" or the “Company”) (NYSE American: TMBR), a clinical-stage biopharmaceutical company focused on the development and commercialization of treatments for rare and orphan dermatologic diseases, today announced the online publication of a sub-analysis of the Phase 2b CONTROL study in Clinical and Experimental Dermatology (CED), the educational journal of the British Association of Dermatologists. The CONTROL study evaluated TMB-001, a topical isotretinoin formulated using the Company’s patented IPEG™ delivery system, in subjects nine years of age and older with moderate to severe congenital ichthyosis (CI).

Key Points: 
  • The CONTROL study evaluated TMB-001, a topical isotretinoin formulated using the Company’s patented IPEG™ delivery system, in subjects nine years of age and older with moderate to severe congenital ichthyosis (CI).
  • CI is a group of rare genetic keratinization disorders that lead to dry, thickened, and scaling skin.
  • “In this sub-analysis, participants in the CONTROL study with ARCI and XLRI mostly showed comparable percentage differences in responses to treatment with a novel topical isotretinoin formulation versus vehicle.
  • The intent-to-treat (ITT) population consisted of all randomized participants who received one or more doses of the study medication.

Timber Pharmaceuticals Receives European Orphan Drug Designation for TMB-001 in X-Linked Recessive Ichthyosis

Retrieved on: 
Friday, February 24, 2023
Epidermis, Clinical trial, Marketing, Safety, Hearing, CI, Civil service commission, Quality of life, Perspiration, EC, European, Rare, ASCEND, NYSE, Disease, Ichthyosis, Pharmacokinetics, Patient, X-linked ichthyosis, XLRI, Isotretinoin, Pivotal, Lumber, European Commission, Motion, Dermis, ARCI, Pharmaceutical industry, EU

BASKING RIDGE, NJ, Feb. 24, 2023 (GLOBE NEWSWIRE) -- via NewMediaWire – Timber Pharmaceuticals, Inc. ("Timber" or the “Company”) (NYSE American: TMBR), a clinical-stage biopharmaceutical company focused on the development and commercialization of treatments for rare and orphan dermatologic diseases, today announced the European Commission (EC) granted orphan drug designation for TMB-001 for the treatment of X-linked recessive ichthyosis (XLRI) on February 15, 2023. The EC previously granted orphan drug designation for TMB-001 for the treatment of autosomal recessive congenital ichthyosis (ARCI).

Key Points: 
  • The EC previously granted orphan drug designation for TMB-001 for the treatment of autosomal recessive congenital ichthyosis (ARCI).
  • “We are pleased to receive an additional orphan drug designation in Europe for the treatment of XLRI as we continue to make steady progress with our global Phase 3 clinical trial,” said John Koconis, Chairman and Chief Executive Officer of Timber.
  • “These orphan drug designations underscore the significant unmet needs in congenital ichthyosis (CI), which can lead to a limited range of motion, chronic itching, an inability to sweat normally, high risk of secondary infections, and impaired eyesight or hearing.
  • Orphan drug designation is available for treatments for rare diseases that are life-threatening or chronically debilitating that affect fewer than five in 10,000 people across the European Union (EU).

Timber Pharmaceuticals Receives European Orphan Designation for Autosomal Recessive Congenital Ichthyosis & Positive Comments on Pediatric Investigation Plan for TMB-001 in Autosomal Recessive CI & X-Linked Recessive Ichthyosis

Retrieved on: 
Tuesday, October 25, 2022
European Medicines Agency, U.S. Securities and Exchange Commission, EC, Union, PIP, Pharmacokinetics, Securities Act of 1933, Lumber, NYSE, GLOBE, Birth defect, Skin, European Commission, Nature, Marketing, ARCI, Annual report, Private Securities Litigation Reform Act, Isotretinoin, Industry, XLRI, X-linked ichthyosis, Clinical trial, Chemistry, ASCEND, Patient, Securities Exchange Act of 1934, MAA, Company, Genta (company), Ichthyosis, EMA, Program, CMC, Royal commission, Intellectual property, Security (finance), Degenerative disease, Safety, Pharmaceutical industry, EU

BASKING RIDGE, NJ, Oct. 25, 2022 (GLOBE NEWSWIRE) -- via NewMediaWire – Timber Pharmaceuticals, Inc. ("Timber" or the “Company”) (NYSE American: TMBR), a clinical-stage biopharmaceutical company focused on the development and commercialization of treatments for rare and orphan dermatologic diseases, today announced the European Commission (EC) has granted orphan designation for TMB-001 for the treatment of autosomal recessive congenital ichthyosis (ARCI). The European Medicines Agency (EMA) Pediatric Committee (PDCO) also provided positive comments on the Pediatric Investigation Plan (PIP) for the treatment of ARCI and X-linked recessive ichthyosis (XLRI), setting the basis for a final discussion in mid-November, which is a prerequisite for filing a Marketing Authorization Application (MAA) with the EMA.

Key Points: 
  • We are executing on a well-defined plan to address these unmet needs, not just in the U.S., but around the world, including Europe and other regions.
  • Congenital ichthyosis is a group of rare genetic keratinization disorders that lead to dry, thickened, and scaling skin.
  • Timber Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on the development and commercialization of treatments for rare and orphan dermatologic diseases.
  • The Company is initially focused on developing non-systemic treatments for rare dermatologic diseases including congenital ichthyosis (CI) and sclerotic skin diseases.

Timber Pharmaceuticals Receives Positive Opinion on Orphan Designation from European Medicines Agency for TMB-001 for Treatment of Autosomal Recessive Congenital Ichthyosis

Retrieved on: 
Wednesday, September 14, 2022
Securities Exchange Act of 1934, CMC, Safety, NYSE, FDA, COMP, CI, Food, Drug Quality and Security Act, European Medicines Agency, Lumber, Isotretinoin, Nature, Company, European Commission, Genta (company), Sex linkage, Intellectual property, Degenerative disease, Securities Act of 1933, Industry, U.S. Securities and Exchange Commission, Patient, Clinical trial, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, ASCEND, X-linked ichthyosis, Annual report, Private Securities Litigation Reform Act, XLRI, Committee, Pharmacokinetics, Ichthyosis, GLOBE, Royal commission, Union, Marketing, Security (finance), EMA, Chemistry, Pharmaceutical industry, EU, ARCI

BASKING RIDGE, NJ, Sept. 14, 2022 (GLOBE NEWSWIRE) -- via NewMediaWire -- Timber Pharmaceuticals, Inc. ("Timber" or the “Company”) (NYSE American: TMBR), a clinical-stage biopharmaceutical company focused on the development and commercialization of treatments for rare and orphan dermatologic diseases, today announced that the Committee for Orphan Medicinal Products (COMP) at the European Medicines Agency (EMA) issued a positive opinion on the Company’s application for orphan designation for TMB-001 for the treatment of autosomal recessive congenital ichthyosis (ARCI). Based on the COMP’s opinion, the European Commission is expected to issue its decision on the orphan designation in approximately 30 days.

Key Points: 
  • Based on the COMPs opinion, the European Commission is expected to issue its decision on the orphan designation in approximately 30 days.
  • I want to thank our team at Timber and all trial investigators and patients who have helped us reach this stage in development.
  • As we wait for the European Commission to issue its decision to hopefully grant orphan designation for TMB-001 in ARCI, Timber now plans to also submit an application for EMA orphan designation for TMB-001 for the treatment of X-linked ichthyosis.
  • Timber Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on the development and commercialization of treatments for rare and orphan dermatologic diseases.

Timber Pharmaceuticals Provides Business Update and Announces Second Quarter 2022 Financial Results

Retrieved on: 
Thursday, August 11, 2022
FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Intellectual property, U.S. Securities and Exchange Commission, Drug Quality and Security Act, Ichthyosis, Industry, NYSE, GLOBE, American Academy, Securities Exchange Act of 1934, Clinical trial, Isotretinoin, Toxicity, Breakthrough therapy, XRI, Security (finance), X-linked ichthyosis, Annual report, Patient, Review, Company, Journal of the American Academy of Dermatology, Skin, ASCEND, Nature, CONTROL, Â, Genta (company), Chemistry, Securities Act of 1933, Private Securities Litigation Reform Act, Fast Track, CMC, Food, Program, Pharmaceutical industry, Lumber

BASKING RIDGE, NJ, Aug. 11, 2022 (GLOBE NEWSWIRE) -- via NewMediaWire – Timber Pharmaceuticals, Inc. ("Timber" or the “Company”) (NYSE American: TMBR), a biopharmaceutical company focused on the development and commercialization of treatments for rare and orphan dermatologic diseases, today provided a business update and announced financial results for the second quarter of 2022, ended June 30, 2022.

Key Points: 
  • BASKING RIDGE, NJ, Aug. 11, 2022 (GLOBE NEWSWIRE) -- via NewMediaWire Timber Pharmaceuticals, Inc. ("Timber" or the Company) (NYSE American: TMBR), a biopharmaceutical company focused on the development and commercialization of treatments for rare and orphan dermatologic diseases, today provided a business update and announced financial results for the second quarter of 2022, ended June 30, 2022.
  • John Koconis, Chairman and Chief Executive Officer of Timber, commented, During the second quarter, Timber achieved several significant milestones for our lead asset, TMB-001.
  • Timber recognized no revenue in the second quarter of 2022 compared to revenue of $388,819 for the second quarter of 2021.
  • First the first six months of 2022, Timber recognized revenue of $83,177 in the 2022 period and $429,553 in the 2021 period.

Timber Pharmaceuticals Receives FDA Breakthrough Therapy Designation for TMB-001 for the Treatment of Congenital Ichthyosis

Retrieved on: 
Tuesday, May 31, 2022
Chemistry, Genta (company), American Academy of Dermatology, American Academy, Company, Annual general meeting, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, U.S. Securities and Exchange Commission, CONTROL, Ichthyosis, CI, Patient, AAD, Review, Nature, Clinical trial, Pharmacokinetics, ASCEND, XRI, Caregiver, X-linked ichthyosis, FDA, CMC, Breakthrough therapy, Securities Act of 1933, Securities Exchange Act of 1934, Industry, Intellectual property, Fas, Safety, Lumber, Drug Quality and Security Act, Isotretinoin, Private Securities Litigation Reform Act, Security (finance), NYSE, TSC, Annual report, GLOBE, Pharmaceutical industry

BASKING RIDGE, NJ, May 31, 2022 (GLOBE NEWSWIRE) -- via NewMediaWire – Timber Pharmaceuticals, Inc. ("Timber" or the “Company”) (NYSE American: TMBR), a clinical-stage biopharmaceutical company focused on the development and commercialization of treatments for rare and orphan dermatologic diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to TMB-001, a topical isotretinoin formulated using the Company’s patented IPEG™ delivery system, for the treatment of congenital ichthyosis (CI). 

Key Points: 
  • Through half of FDAs 2022 fiscal year, more breakthrough applications have been rejected by FDA or withdrawn (16), than have been granted (9).
  • Breakthrough Therapy designation is a process designed to expedite the development and review of drugs that are intended to treat serious or life-threatening conditions.
  • Preliminary clinical evidence must indicate that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint.
  • Timber is developing TMB-001 for the treatment of moderate to severe forms of CI, including X-linked recessive ichthyosis (XRI) and autosomal recessive congenital ichthyosis lamellar ichthyosis (ARCI-LI).

Timber Pharmaceuticals Provides Business Update and Announces First Quarter 2022 Financial Results

Retrieved on: 
Thursday, May 12, 2022
Chemistry, Ichthyosis, Program, Genta (company), American Academy of Dermatology, American Academy, Company, Annual general meeting, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Yale School of Medicine, U.S. Securities and Exchange Commission, CONTROL, MD, Doctor of Philosophy, CI, Patient, AAD, Review, Nature, Clinical trial, ASCEND, XRI, X-linked ichthyosis, FDA, CMC, Securities Act of 1933, Securities Exchange Act of 1934, Industry, Intellectual property, Fas, Drug Quality and Security Act, Isotretinoin, Security (finance), Private Securities Litigation Reform Act, Fast Track, NYSE, TSC, Annual report, GLOBE, Pharmaceutical industry, Online gambling, Lumber

BASKING RIDGE, NJ, May 12, 2022 (GLOBE NEWSWIRE) -- via NewMediaWire -- Timber Pharmaceuticals, Inc. ("Timber" or the “Company”) (NYSE American: TMBR), a biopharmaceutical company focused on the development and commercialization of treatments for rare and orphan dermatologic diseases, today provided a business update and announced financial results for the first quarter of 2022, ended March 31, 2022.

Key Points: 
  • Timber ended the first quarter with $13.9 million in cash and common shares outstanding of 63.7 million on March 31, 2022.
  • Timber recognized revenue of $83,177 in the first quarter of 2022 compared to $40,734 for the first quarter of 2021.
  • For Timbers complete financial results for the three-month period ended March 31, 2022, see the Companys Quarterly Form 10-Q filed with the Securities and Exchange Commission on May 12, 2022.
  • Timber Pharmaceuticals, Inc. is a biopharmaceutical company focused on the development and commercialization of treatments for rare and orphan dermatologic diseases.

Timber Pharmaceuticals Announces Fast Track Designation Granted by FDA for TMB-001 in Severe Subtypes of Congenital Ichthyosis

Retrieved on: 
Thursday, April 28, 2022
American Academy of Dermatology, CMC, ASCEND, U.S. Securities and Exchange Commission, NYSE, American Academy, Securities Exchange Act of 1934, Fas, Patient, CONTROL, FDA, GLOBE, Annual general meeting, AAD, Collection, Food, CI, Chemistry, Clinical trial, X-linked ichthyosis, XRI, Securities Act of 1933, Company, TSC, Private Securities Litigation Reform Act, Lumber, Genta (company), Intellectual property, Annual report, BLA, Security (finance), Accelerated approval (FDA), Priority review, Communication, Isotretinoin, Ichthyosis, NDA, Fast Track, Nature, Plasma protein binding, Industry, Drug Quality and Security Act, Review, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Pharmaceutical industry

BASKING RIDGE, NJ, April 28, 2022 (GLOBE NEWSWIRE) -- via NewMediaWire – Timber Pharmaceuticals, Inc. ("Timber" or the “Company”) (NYSE American: TMBR), a clinical-stage biopharmaceutical company focused on the development and commercialization of treatments for rare and orphan dermatologic diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to TMB-001, a topical isotretinoin formulated using the company’s patented IPEG™ delivery system, for the treatment of X-linked recessive ichthyosis (XRI) and autosomal recessive congenital ichthyosis lamellar ichthyosis (ARCI-LI).

Key Points: 
  • The designation of Fast Track status is a significant achievement that speaks to the unmet need in CI.
  • Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need.
  • In patients with severe subtypes of CI, including XRI and ARCI-LI, cutaneous manifestations include large, dark scaling throughout the body.
  • A drug that receives Fast Track designation may also be eligible for Accelerated Approval and Priority Review.