New Drug Application

EQS-News: Abivax reports 2023 financial results and operational update

Retrieved on: 
Mittwoch, April 10, 2024
Q&A, Nomination, New Drug Application, Patient, Shanda, MRO, G&A, IND, EQT, Marketing, Research, EST, McKinsey & Company, Carcinoma, Schering-Plough, Partnership, Webcast, SVP, IBD, Inflammatory Bowel Diseases, American College, Safety, Phase 10, Compensated emancipation, BB Biotech, URD, IPO, F2G, Sofinnova, FDA, AbbVie, EUR, Abstract, Takeda, Pharmaceutical industry

Total number of employees at the end of December 2023 was 61 and significantly increased compared to 2022, due to the implementation of the U.S. and European operational infrastructure.

Key Points: 
  • Total number of employees at the end of December 2023 was 61 and significantly increased compared to 2022, due to the implementation of the U.S. and European operational infrastructure.
  • Cash position (including other financial assets of EUR 9.0M) at the end of 2023 was EUR 261.0M, compared to EUR 27.0M at the end of 2022.
  • A webcast will be organized on Monday, April 8, 2024, at 2:30 p.m. CEST (8:30 a.m. EST) following the announcement of the 2023 yearly results.
  • The Abivax management will give an overview of the Company’s 2023 highlights and projects going forward, followed by a live Q&A session.

Basilea announces US FDA approval of antibiotic ZEVTERA® (ceftobiprole medocaril) for three indications

Retrieved on: 
Donnerstag, April 4, 2024
Disease, MSSA, MRSA, Development, TARGET, Associate, Partnership, CABP, New Drug Application, Patient, HHS, Mortality, NDA, Fungal infection, Staphylococcus aureus, Bronchopneumonia, Infection, Safety, SAB, ASPR, Staphylococcus, Ceftobiprole, Administration, FDA, ABSSSI, Pharmaceutical industry

David Veitch, Chief Executive Officer of Basilea, said: “We are excited with the US approval of ZEVTERA.

Key Points: 
  • David Veitch, Chief Executive Officer of Basilea, said: “We are excited with the US approval of ZEVTERA.
  • The positive decision by the FDA is a key milestone towards bringing ZEVTERA to patients in the US.
  • This approval is a landmark for ceftobiprole and reflects its broad clinical utility.
  • Through this partnership, Basilea has been awarded approximately USD 112 million, or approximately 75 percent of the costs related to the SAB and ABSSSI phase 3 studies, regulatory activities and non-clinical work.

ARS Pharmaceuticals Submits Response to FDA Complete Response Letter for neffy® (Epinephrine Nasal Spray)

Retrieved on: 
Mittwoch, April 3, 2024
Nitrosamine, Anaphylaxis, Symantec Endpoint Protection, Entrepreneurship, ARS, Caregiver, NAC, PD, New Drug Application, Patient, Adrenaline, CRL, Allergy, NDA, Food, FDA, PDUFA, Pharmaceutical industry

In February 2024, ARS Pharma announced the successful completion of the repeat dosing study of neffy in seasonal allergic rhinitis under NAC conditions.

Key Points: 
  • In February 2024, ARS Pharma announced the successful completion of the repeat dosing study of neffy in seasonal allergic rhinitis under NAC conditions.
  • ARS Pharma also completed the nitrosamine testing requested with no measurable levels of nitrosamines detected.
  • In May 2023, the FDA Advisory Committee (PADAC) determined a favorable benefit-risk profile for neffy (16:6 for adults and 17:5 for children).
  • ARS Pharma anticipates an FDA review period of up to six months, and the PDUFA date is anticipated to be October 2, 2024, based on the submission receipt date of April 2, 2024.

HUTCHMED and Innovent Jointly Announce NDA Acceptance in China for Fruquintinib Combination with Sintilimab for the Treatment of Advanced Endometrial Cancer with Priority Review Status

Retrieved on: 
Dienstag, April 2, 2024
Toxicity, Radiation, Sintilimab, NMPA, Endometrial cancer, Disease, DCR, New Drug Application, Patient, NDA, Breakthrough therapy, Senior, Priority review, HKEX, Dor, IRC, Prognosis, PFS, Pharmaceutical industry

HONG KONG, SHANGHAI, China & FLORHAM PARK, N.J., April 02, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:​HCM; HKEX:​13) and Innovent Biologics, Inc. (“Innovent”) (HKEX:1801) today jointly announce that the New Drug Application (“NDA”) for the combination of fruquintinib and sintilimab for the treatment of patients with advanced endometrial cancer with pMMR1 or non-MSI-H2 tumors that have failed prior systemic therapy but are not candidates for curative surgery or radiation has been accepted and granted priority review by the China National Medical Products Administration (“NMPA”).

Key Points: 
  • The NDA is supported by data from FRUSICA-1, the endometrial cancer registration cohort of a multi-center, open-label Phase II study investigating fruquintinib in combination with sintilimab in endometrial cancer patients who experienced disease recurrence, disease progression or intolerable toxicity with treatment on platinum-based doublet chemotherapy.
  • Data from FRUSICA-1 will be submitted for presentation at an upcoming medical conference.
  • “This is the first regulatory filing for the combination of fruquintinib and the immune checkpoint inhibitor sintilimab.
  • “Endometrial cancer remains one of the most common gynecological malignancies.

Abivax reports 2023 financial results and operational update

Retrieved on: 
Dienstag, April 2, 2024
Q&A, Nomination, New Drug Application, Patient, Shanda, MRO, G&A, IND, EQT, Marketing, Research, EST, McKinsey & Company, Carcinoma, Schering-Plough, Partnership, Webcast, SVP, IBD, Inflammatory Bowel Diseases, American College, Safety, Phase 10, Compensated emancipation, BB Biotech, URD, IPO, F2G, Sofinnova, FDA, AbbVie, EUR, Abstract, Takeda, Pharmaceutical industry

Total number of employees at the end of December 2023 was 61 and significantly increased compared to 2022, due to the implementation of the U.S. and European operational infrastructure.

Key Points: 
  • Total number of employees at the end of December 2023 was 61 and significantly increased compared to 2022, due to the implementation of the U.S. and European operational infrastructure.
  • Cash position (including other financial assets of EUR 9.0M) at the end of 2023 was EUR 261.0M, compared to EUR 27.0M at the end of 2022.
  • A webcast will be organized on Monday, April 8, 2024, at 2:30 p.m. CEST (8:30 a.m. EST) following the announcement of the 2023 yearly results.
  • The Abivax management will give an overview of the Company’s 2023 highlights and projects going forward, followed by a live Q&A session.

SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims on Behalf of Investors of Vanda Pharmaceutical Inc. - VNDA

Retrieved on: 
Sonntag, März 31, 2024
Symantec Endpoint Protection, New Drug Application, Insomnia, Shanda, CRL, Sleep, News, LLP, Pomerantz, FDA, Food

NEW YORK, March 31, 2024 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Vanda Pharmaceutical Inc. (“Vanda” or the “Company”) (NASDAQ: VNDA).

Key Points: 
  • NEW YORK, March 31, 2024 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Vanda Pharmaceutical Inc. (“Vanda” or the “Company”) (NASDAQ: VNDA).
  • The investigation concerns whether Vanda and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices.
  • Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, Pomerantz pioneered the field of securities class actions.
  • The Firm has recovered billions of dollars in damages awards on behalf of class members.

Zevra Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Corporate Updates

Retrieved on: 
Donnerstag, März 28, 2024
Narcolepsy, Exercise, Somnolence, New Drug Application, Patient, Visual analogue scale, Sale, NDA, G&A, Arimoclomol, Nature, IND, Bank statement, Microsoft Access, Investment, Therapy, Priority review, Corporation, Audit committee, Research, Niemann–Pick disease, Medical science liaison, Sleep disorder, Brain, Trial of the century, Safety, Interim, Food, Sleep, QuickStart, Disease, FY, Acquisition, Emetine, UCD, COL3A1, Celiprolol, Syndrome, FDA, Marketing, Conference call, Conference, EAP, SDX, NPC, Epworth Sleepiness Scale, Idiopathic hypersomnia, Physician, PDUFA, Pharmaceutical industry

CELEBRATION, Fla., March 28, 2024 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra, or the Company), a rare disease therapeutics company, today provided corporate updates and reported its financial results for the fourth quarter and year ended December 31, 2023. 

Key Points: 
  • ET
    CELEBRATION, Fla., March 28, 2024 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra, or the Company), a rare disease therapeutics company, today provided corporate updates and reported its financial results for the fourth quarter and year ended December 31, 2023.
  • “We made solid progress on our key priorities in 2023,” said Neil F. McFarlane, President and Chief Executive Officer of Zevra.
  • Overview of Q4 2023 and FY 2023 Financial Results:
    Net revenue for Q4 2023 was $13.2 million, compared to prior year Q4 net revenue of $2.2 million.
  • ET, to discuss its corporate and financial results for Q4 and FY 2023.

Fortress Biotech Reports 2023 Financial Results and Recent Corporate Highlights

Retrieved on: 
Donnerstag, März 28, 2024
AstraZeneca, Exercise, Fortification, New Drug Application, Patient, GBM, CRL, NDA, Menkes, Minocycline, Therapy, Marketing, Radiation, CKPT, Rosacea, Investigational New Drug, Erythema, Safety, BLA, Fortress Biotech, Food, Red, Amyloidosis, Dermatology, Carcinoma, FDA, Hyperhidrosis, Mustang Bio, Menkes disease, PDUFA, Pharmaceutical industry

MIAMI, March 28, 2024 (GLOBE NEWSWIRE) -- Fortress Biotech, Inc. (Nasdaq: FBIO) (“Fortress”), an innovative biopharmaceutical company focused on acquiring and advancing assets to enhance long-term value for shareholders through product revenue, equity holdings and dividend and royalty revenue, today announced financial results and recent corporate highlights for the full-year ended December 31, 2023.

Key Points: 
  • Lindsay A. Rosenwald, M.D., Fortress’ Chairman, President and Chief Executive Officer, said, “In 2023, we built a significant amount of momentum to position our Company to achieve multiple milestones in 2024.
  • In March 2024, the FDA accepted the NDA and has set a PDUFA goal date of November 4, 2024.
  • In December 2023, the FDA issued a complete response letter (“CRL”) for the cosibelimab BLA.
  • Fortress’ consolidated net revenue totaled $84.5 million for the full year ended December 31, 2023, which included $59.7 million in net revenue generated from our marketed dermatology products.

Applied Therapeutics Provides FDA Update on PDUFA Target Action Date for Govorestat for the Treatment of Classic Galactosemia

Retrieved on: 
Donnerstag, März 28, 2024
Galactitol, MAA, New Drug Application, Patient, Ageing, NDA, PRV, EMA, Doctor of Philosophy, Marketing, Priority review, Therapy, ARI, Food, FDA, CHMP, PDUFA, Pharmaceutical industry

The FDA has set a new Prescription Drug User Fee Act (PDUFA) target action date of November 28, 2024.

Key Points: 
  • The FDA has set a new Prescription Drug User Fee Act (PDUFA) target action date of November 28, 2024.
  • In February 2024, the Company announced that the FDA accepted and granted Priority Review to the NDA.
  • “While the PDUFA action date extension represents a delay, we remain confident in the potential for govorestat approval for Galactosemia and we will continue to work closely with the FDA throughout the review process,” said Shoshana Shendelman, PhD, Founder and CEO of Applied Therapeutics.
  • If approved, govorestat would be the first medication indicated for the treatment of Galactosemia and would be Applied Therapeutics’ first commercial product.

Apollomics Highlights Clinical Progress and Reports Full Year 2023 Financial Results

Retrieved on: 
Donnerstag, März 28, 2024
APLM, NSCLC, New Drug Application, Patient, NDA, Lung cancer, MET, GCN, FDA, Met, Food, Pharmaceutical industry

ET

Key Points: 
  • ET
    FOSTER CITY, Calif., March 28, 2024 (GLOBE NEWSWIRE) --  Apollomics Inc. (Nasdaq: APLM) (“Apollomics” or the “Company”), a late- stage clinical biopharmaceutical company developing multiple oncology drug candidates to address difficult-to-treat and treatment-resistant cancers, today announced financial results for the full year ended December 31, 2023, and highlighted progress of its pipeline.
  • As a result, Apollomics believes that its current capital resources will fund planned operations through the first quarter of 2025.
  • Dr. Plunkett brings to Apollomics over 25 years of strategic and financial experience within the biopharmaceutical sector, including extensive fundraising and corporate development expertise.
  • In March 2023, the Company raised $23.7 million in a private placement in public equity (PIPE) financing, before transaction expenses.