Associated tags: Pharmaceutical industry, AMD, Patient, Cystic fibrosis, Safety, Ophthalmology, Vaccine, Clinical trial, Fabry disease, Choroideremia, Tissue, Cardiology
Locations: EMERYVILLE, CA, US, FLORIDA, TAIWAN, AUSTRALIA
FDA,
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Research,
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Biopsy,
European Medicines Agency,
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Food,
Alpha-1 antitrypsin,
Cystic fibrosis,
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Retina,
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DME,
Angiogenesis,
PRISM,
AMD,
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PRIME,
EMA,
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Clinical trial,
A1AT,
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Pharmaceutical industry “The first quarter of 2024 kicks off another transformative year for 4DMT with exceptional progress across our product pipeline and platform in multiple therapeutic areas, particularly our lead program 4D-150 in large market VEGF-driven retinal diseases,” said David Kirn, M.D., Co-founder and Chief Executive Officer of 4DMT.
Key Points:
- “The first quarter of 2024 kicks off another transformative year for 4DMT with exceptional progress across our product pipeline and platform in multiple therapeutic areas, particularly our lead program 4D-150 in large market VEGF-driven retinal diseases,” said David Kirn, M.D., Co-founder and Chief Executive Officer of 4DMT.
- R&D Expenses: Research and development expenses were $27.9 million for the first quarter of 2024, as compared to $22.4 million for the first quarter of 2023.
- G&A Expenses: General and administrative expenses were $10.3 million for the first quarter of 2024, as compared to $8.0 million for the first quarter of 2023.
- Net Loss: Net loss was $32.4 million for the first quarter of 2024, as compared to net loss of $28.7 million for the first quarter of 2023.
EMERYVILLE, Calif., May 07, 2024 (GLOBE NEWSWIRE) -- 4D Molecular Therapeutics (Nasdaq: FDMT, 4DMT or the Company), a leading clinical-stage genetic medicines company focused on unlocking the full potential of genetic medicines to treat large market diseases, today announced that management will participate in a fireside chat at an upcoming investor conference in May.
Key Points:
- EMERYVILLE, Calif., May 07, 2024 (GLOBE NEWSWIRE) -- 4D Molecular Therapeutics (Nasdaq: FDMT, 4DMT or the Company), a leading clinical-stage genetic medicines company focused on unlocking the full potential of genetic medicines to treat large market diseases, today announced that management will participate in a fireside chat at an upcoming investor conference in May.
- Members of the management team will also be available for one-on-one meetings.
CDMO,
Conference,
TDN,
Patient,
Lung,
Cohort,
RNA,
EMA,
Technology transfer,
Cystic fibrosis,
European Medicines Agency,
GMP,
Clinical trial,
ECFS,
Safety,
CFTR,
AMD,
Food,
FDA,
VG,
Pharmaceutical industry Phase 3 clinical endpoints include changes after 4D-710 treatment in ppFEV1, quality-of-life (Cystic Fibrosis Questionnaire Revised Respiratory Domain, CFQ-R-RD) and frequency of pulmonary exacerbations.
Key Points:
- Phase 3 clinical endpoints include changes after 4D-710 treatment in ppFEV1, quality-of-life (Cystic Fibrosis Questionnaire Revised Respiratory Domain, CFQ-R-RD) and frequency of pulmonary exacerbations.
- The Company anticipates initiation of technology transfer to a commercial contract development and manufacturing organization (CDMO) in H1 2025.
- Our goal is to initiate Phase 3 development in H2 2025 with 4D-710 suspension GMP process clinical trial material.
- We look forward to sharing interim clinical data from the AEROW Phase 1/2 clinical trial at the ECFS conference in June 2024.”
EMERYVILLE, Calif., March 04, 2024 (GLOBE NEWSWIRE) -- 4D Molecular Therapeutics (Nasdaq: FDMT, 4DMT or the Company), a leading clinical-stage genetic medicines company focused on unlocking the full potential of genetic medicines to treat large market diseases, today announced that management will participate in fireside chats at upcoming investor conferences in March.
Key Points:
- EMERYVILLE, Calif., March 04, 2024 (GLOBE NEWSWIRE) -- 4D Molecular Therapeutics (Nasdaq: FDMT, 4DMT or the Company), a leading clinical-stage genetic medicines company focused on unlocking the full potential of genetic medicines to treat large market diseases, today announced that management will participate in fireside chats at upcoming investor conferences in March.
- Members of the management team will also be available for one-on-one meetings.
Retrieved on:
Thursday, February 29, 2024
Therapy,
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Chelsea Handler,
Fabry disease,
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EMA,
Injection,
Research,
CRISPR,
Cystic fibrosis,
FDA,
Partnership,
Inflammation,
Retinitis pigmentosa,
Security (finance),
Overalls,
Biopsy,
Șaeș,
PRISM,
Conference,
Cash,
Diabetic retinopathy,
Geographic atrophy,
Astellas Pharma,
CFTR,
CNS,
PRIME,
AMD,
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Patient,
Safety,
Clinical trial,
Angiogenesis,
VG,
DME,
AAV,
Vaccine We currently expect cash and cash equivalents to be sufficient to fund operations into the first half of 2027.
Key Points:
- We currently expect cash and cash equivalents to be sufficient to fund operations into the first half of 2027.
- R&D Expenses: Research and development expenses were $97.1 million for 2023, as compared to $80.3 million for 2022.
- G&A Expenses: General and administrative expenses were $36.5 million for 2023, as compared to $32.9 million for 2022.
- Net Loss: Net loss was $100.8 million for 2023, as compared to net loss of $107.5 million for 2022.
Retrieved on:
Monday, February 12, 2024
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Atypical hemolytic uremic syndrome,
Fabry disease,
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FDA,
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Chelsea Handler,
Pharmaceutical industry The data was presented in a late-breaking session at WORLDSymposium™ 2024 in San Diego, California on Friday, February 9, 2024.
Key Points:
- The data was presented in a late-breaking session at WORLDSymposium™ 2024 in San Diego, California on Friday, February 9, 2024.
- “We are pleased to see 4D-310 continue to consistently demonstrate clinical activity across multiple important cardiac endpoints including cardiac function, exercise capacity and quality of life,” said Robert Kim, M.D., Chief Medical Officer of 4DMT.
- “Current therapies do not adequately address Fabry-related cardiovascular manifestations, and cardiovascular disease is the most common cause of death in these patients.
- “No approved therapy has been shown to definitively clear accumulated Gb3 from cardiomyocytes in patients with Fabry disease, which speaks to 4D-310’s highly differentiated profile.
Retrieved on:
Wednesday, February 7, 2024
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Security (finance) EMERYVILLE, Calif., Feb. 06, 2024 (GLOBE NEWSWIRE) -- 4D Molecular Therapeutics, Inc. (Nasdaq: FDMT), a leading clinical-stage genetic medicines company focused on unlocking the full potential of genetic medicines to treat large market diseases, announced today that it priced an upsized underwritten public offering of 6,586,015 shares of its common stock at a public offering price of $29.50 per share and, in lieu of shares of common stock, to certain investors, pre-funded warrants to purchase 3,583,476 shares of common stock at a public offering price of $29.4999, which represents the per share public offering price for the common stock less the $0.0001 per share exercise price for each pre-funded warrant.
Key Points:
- EMERYVILLE, Calif., Feb. 06, 2024 (GLOBE NEWSWIRE) -- 4D Molecular Therapeutics, Inc. (Nasdaq: FDMT), a leading clinical-stage genetic medicines company focused on unlocking the full potential of genetic medicines to treat large market diseases, announced today that it priced an upsized underwritten public offering of 6,586,015 shares of its common stock at a public offering price of $29.50 per share and, in lieu of shares of common stock, to certain investors, pre-funded warrants to purchase 3,583,476 shares of common stock at a public offering price of $29.4999, which represents the per share public offering price for the common stock less the $0.0001 per share exercise price for each pre-funded warrant.
- In addition, 4D Molecular Therapeutics has granted the underwriters a 30-day option to purchase up to an additional 1,525,423 shares of common stock at the public offering price, less underwriting discounts and commissions.
- All of the shares and pre-funded warrants in the offering are to be sold by 4D Molecular Therapeutics.
- Goldman Sachs & Co. LLC, BofA Securities, Jefferies and Barclays are acting as joint book-running managers for the offering.
EMERYVILLE, Calif., Feb. 05, 2024 (GLOBE NEWSWIRE) -- 4D Molecular Therapeutics, Inc. (Nasdaq: FDMT), a leading clinical-stage genetic medicines company focused on unlocking the full potential of genetic medicines to treat large market diseases, announced today that it has commenced an underwritten public offering of $250.0 million of shares of its common stock.
Key Points:
- EMERYVILLE, Calif., Feb. 05, 2024 (GLOBE NEWSWIRE) -- 4D Molecular Therapeutics, Inc. (Nasdaq: FDMT), a leading clinical-stage genetic medicines company focused on unlocking the full potential of genetic medicines to treat large market diseases, announced today that it has commenced an underwritten public offering of $250.0 million of shares of its common stock.
- 4D Molecular Therapeutics also intends to grant the underwriters a 30-day option to purchase up to an additional $37.5 million of shares of common stock offered in the proposed offering.
- All of the shares in the proposed offering are to be sold by 4D Molecular Therapeutics.
- Goldman Sachs & Co. LLC, BofA Securities, Jefferies and Barclays are acting as joint book-running managers for the proposed offering.
Retrieved on:
Saturday, February 3, 2024
Injection,
Paratriathlon,
Conference,
Inflammation,
Aflibercept,
Data,
Clinical trial,
AMD,
Patient,
Conditional sentence,
OCT,
PRISM,
FDA,
EMA,
Retina,
Visual acuity,
Arm,
DME,
Angiogenesis,
M.A,
Webcast,
CST,
Pharmaceutical industry Data presented at the Angiogenesis, Exudation, and Degeneration 2024 Conference by Arshad M. Khanani, M.D., M.A., FASRS, consisted of 24-week landmark results from the randomized Phase 2 Dose Expansion cohort of the PRISM clinical trial.
Key Points:
- Data presented at the Angiogenesis, Exudation, and Degeneration 2024 Conference by Arshad M. Khanani, M.D., M.A., FASRS, consisted of 24-week landmark results from the randomized Phase 2 Dose Expansion cohort of the PRISM clinical trial.
- "I am encouraged by the potential of a one-time intravitreal injection of 4D-150 for treating wet AMD.
- Results from the Phase 1 and interim results from Phase 2 cohorts of the PRISM study confirm that 4D-150 is well tolerated and maintains stable visual acuity in previously treated high-need patients.
- I believe 4D-150 has the potential to revolutionize the treatment approach for our patients with wet AMD, and I am looking forward to participating in the Phase 3 trials."
PRISM,
Angiogenesis,
Patient,
Science,
Clinical research,
University,
Medicine,
M.A,
Conference,
AMD,
Webcast,
University of Nevada, Reno,
Clinical trial,
Pharmaceutical industry Initial interim landmark data analysis (N=50 at 24 Weeks) will be presented by Arshad M. Khanani, M.D., M.A., FASRS, Principal Investigator of the PRISM clinical trial at Angiogenesis, Exudation, and Degeneration 2024 Conference on Saturday, February 3, 2024 during Session VI (3:30 to 5:00 p.m.
Key Points:
- Initial interim landmark data analysis (N=50 at 24 Weeks) will be presented by Arshad M. Khanani, M.D., M.A., FASRS, Principal Investigator of the PRISM clinical trial at Angiogenesis, Exudation, and Degeneration 2024 Conference on Saturday, February 3, 2024 during Session VI (3:30 to 5:00 p.m.
- ET)
Company to host webcast on Monday, February 5, 2024 at 8:00 a.m.
- Arshad M. Khanani, M.D., M.A., FASRS, Principal Investigator of the PRISM clinical trial, will also present in the webcast and be available for Q&A.
- An archived copy of the webcast will be available for up to one year by visiting the “Investors & Media” section of the 4DMT website at the following link: https://ir.4dmoleculartherapeutics.com/events .
