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Latest FDA New Drug Application News

Verastem Oncology Completes Rolling NDA Submission to the FDA for Avutometinib Plus Defactinib as a Treatment for Recurrent KRAS Mutant Low-Grade Serous Ovarian Cancer

October 31
Last Trade: 3.76 0.02 0.53

Recurrent low-grade serous ovarian cancer is a rare cancer with no FDA-approved treatments Company seeking accelerated approval and priority review of its NDA submission in patients with KRAS mutant low-grade serous ovarian cancer; FDA filing decision expected before the end of 2024 with potential for FDA approval decision by mid-2025 BOSTON / Oct 31, 2024 / Business Wire / Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company...Read more


PTC Therapeutics Announces FDA Acceptance of Translarna™ NDA Resubmission

October 30
Last Trade: 39.92 -0.74 -1.82

WARREN, N.J., Oct. 30, 2024 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) announced today the U.S. Food and Drug Administration (FDA) has accepted for review the resubmission of the New Drug Application (NDA) for Translarna™ (ataluren) for the treatment of nonsense mutation Duchenne muscular dystrophy (nmDMD). "The NDA acceptance for review is a significant milestone that brings us one step closer to providing this important...Read more


Kiora Pharmaceuticals Receives Investigational New Drug Approval to Initiate ABACUS-2, a Phase 2 Clinical Trial of KIO-301 for the Treatment of Retinitis Pigmentosa

October 29
Last Trade: 3.62 -0.08 -2.16

Encinitas, California--(Newsfile Corp. - October 29, 2024) - Kiora Pharmaceuticals, Inc. (NASDAQ: KPRX) ("Kiora" or the "Company") today announced it received regulatory approval to initiate a Phase 2 clinical trial to investigate KIO-301 for vision restoration in patients with retinitis pigmentosa. The ABACUS-2 trial will be a 36 patient, multi-center, double-masked, randomized, controlled, multiple dose study enrolling patients with...Read more


Tyra Biosciences Receives IND Clearance from FDA to Proceed with Phase 2 Study of TYRA-300 in Pediatric Achondroplasia (BEACH301)

October 28
Last Trade: 16.68 0.71 4.45

TYRA-300 is the first oral FGFR-3 selective inhibitor to be well-tolerated in clinical studies  First child with achondroplasia expected to be dosed in Q1 2025  CARLSBAD, Calif., Oct. 28, 2024 /PRNewswire/ -- Tyra Biosciences, Inc. (Nasdaq: TYRA), a clinical-stage biotechnology company focused on developing next-generation precision medicines that target large opportunities in Fibroblast Growth Factor Receptor (FGFR)...Read more


IDEAYA Biosciences Announces IND-Clearance for Werner Helicase Development Candidate IDE275 (GSK959) for a Phase 1 Study in MSI-High Solid Tumors

October 28
Last Trade: 28.15 -1.31 -4.45

IDE275 (GSK959) development is progressing into First-in-Human Phase 1 clinical trial(s) for the treatment of MSI-High solid tumors, representing IDEAYA's 5th potential first-in-class clinical program MSI-High prevalence in endometrial, colorectal, and gastric cancers is ~31%, 20%, and 19%, respectively, highlighting the market potential of IDE275 (GSK959) IDEAYA to receive a $7 million payment for IND acceptance, and potential future...Read more


Aligos Therapeutics Announces U.S. FDA Clearance of IND Application for ALG-000184

October 22
Last Trade: 9.78 0.01 0.10

Company to conduct a Phase 1 Drug-Drug Interaction Study Phase 2 filing on track for Q1 2025 SOUTH SAN FRANCISCO, Calif., Oct. 22, 2024 (GLOBE NEWSWIRE) -- Aligos Therapeutics, Inc. (Nasdaq: ALGS, “Aligos”), a clinical stage biopharmaceutical company focused on improving patient outcomes through best-in-class therapies for liver and viral diseases, today announced that the U.S. Food and Drug Administration (FDA) has cleared the...Read more


Amneal Pharmaceuticals Receives U.S. FDA Approval of New Drug Application for Pyridostigmine Bromide Extended-Release Tablets

October 21
Last Trade: 8.47 -0.10 -1.17

Pyridostigmine Bromide Extended Release is a once-daily soman nerve agent pretreatment pyridostigmine product for the U.S. Armed Services and U.S. allies developed utilizing Amneal’s GRANDE® drug delivery technology Developed with the support of Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) BRIDGEWATER, N.J. / Oct 21, 2024 / Business Wire / Amneal Pharmaceuticals, Inc. (Nasdaq:...Read more


LENZ Therapeutics Announces FDA Acceptance of New Drug Application for LNZ100 for the Treatment of Presbyopia

October 21
Last Trade: 26.96 0.00 0.00

SAN DIEGO, Oct. 21, 2024 (GLOBE NEWSWIRE) -- LENZ Therapeutics, Inc. (Nasdaq: LENZ or “LENZ” or the “Company”), a pre-commercial biopharmaceutical company focused on the development and commercialization of the first and only aceclidine-based eye drop to improve near vision in people with presbyopia, today announced that the U.S. Food and Drug Administration (FDA) has accepted the Company’s New Drug Application (NDA) for LNZ100 for the...Read more


Tonix Pharmaceuticals Announces Submission of the TNX-102 SL New Drug Application (NDA) for Fibromyalgia to the U.S. Food and Drug Administration (FDA)

October 16
Last Trade: 0.15 -0.0091 -5.89

NDA based on two Phase 3 studies of TNX-102 SL in fibromyalgia with statistically significant results on the primary endpoint of reducing widespread pain; generally well tolerated TNX-102 SL is a non-opioid, centrally acting analgesic, granted Fast Track designation by FDA Fibromyalgia affects more than 10 million adults in the U.S. who are mostly women If approved by FDA, TNX-102 SL would be the first member of a new class of...Read more


Adicet Bio Announces FDA Clearance of IND Amendment to Evaluate ADI-001 in Idiopathic Inflammatory Myopathy and Stiff Person Syndrome

October 16
Last Trade: 1.28 -0.08 -5.88

ADI-001 clinical development program now addresses six autoimmune diseases Patient enrollment for idiopathic inflammatory myopathy and stiff person syndrome cohort expected to be initiated in the first quarter of 2025 Company plans to report initial clinical data from Phase 1 study in multiple autoimmune diseases in the first half of 2025 REDWOOD CITY, Calif. & BOSTON / Oct 16, 2024 / Business Wire / Adicet Bio, Inc. (Nasdaq:...Read more


Cullinan Therapeutics Receives U.S. FDA Clearance of Investigational New Drug Application for CLN-978 Administered Subcutaneously in Patients with Moderate to Severe Systemic Lupus Erythematosus

October 16
Last Trade: 15.55 -0.67 -4.13

CLN-978 is the first development stage CD19 T cell engager to receive U.S. FDA IND clearance in autoimmune diseases CAMBRIDGE, Mass., Oct. 16, 2024 (GLOBE NEWSWIRE) -- Cullinan Therapeutics, Inc. (Nasdaq: CGEM), a biopharmaceutical company focused on developing modality-agnostic targeted therapies, today announced that the U.S. Food and Drug Administration (FDA) cleared the Company’s Investigational New Drug (IND) Application...Read more


UroGen Pharma Announces FDA Acceptance of its New Drug Application for UGN-102

October 15
Last Trade: 12.26 -0.76 -5.84

PDUFA goal date set for June 13, 2025 UGN-102 would be the first FDA-approved medicine for LG-IR-NMIBC, if approved PRINCETON, N.J. / Oct 15, 2024 / Business Wire / UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced U.S. Food and Drug Administration (FDA) acceptance of the New Drug Application (NDA) for...Read more


Alnylam Pharmaceuticals Submits Supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration for Vutrisiran for the Treatment of Transthyretin Amyloidosis with Cardiomyopathy

October 9
Last Trade: 266.59 -14.90 -5.29

sNDA is Based on Full Findings from the Positive HELIOS-B Phase 3 Study  Priority Review Voucher Utilized to Accelerate Review Period  Alnylam to Host and Webcast TTR Investor Day Event Today in New York City  CAMBRIDGE, Mass. / Oct 09, 2024 / Business Wire / Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today announced the submission of its supplemental New Drug Application...Read more


Kymera Therapeutics Announces FDA Clearance of Investigational New Drug Application for KT-621, a First-in-Class, Oral STAT6 Degrader

October 9
Last Trade: 46.17 -1.50 -3.15

KT-621 has demonstrated dupilumab-like activity and was well tolerated in a wide variety of preclinical models of TH2 diseases KT-621 is expected to start Phase 1 in October, with Phase 1 data in the first half of 2025 WATERTOWN, Mass., Oct. 09, 2024 (GLOBE NEWSWIRE) --  Kymera Therapeutics, Inc. (NASDAQ: KYMR), a clinical-stage biopharmaceutical company advancing a new class of small molecule medicines using targeted protein...Read more


FDA Approves Use of Up To Three Tubes of Biofrontera’s Ameluz (aminolevulinic acid HCI) Topical Gel, 10% In One Treatment

October 7
Last Trade: 1.23 0.30 31.71

Approval allows for larger field treatment of actinic keratosis (AK) on face and scalp with Ameluz®-PDT using the BF-RhodoLED or the RhodoLED XL lamp Supplemental New Drug Application (sNDA) supported by two Phase 1 safety studies AK is the second most common diagnosis made by dermatologists in the United States1 An estimated 13 million treatments given each year for AK in the US2 WOBURN, Mass., Oct. 07, 2024 (GLOBE NEWSWIRE) --...Read more


AstraZeneca: CALQUENCE® (acalabrutinib) granted Priority Review in the US for patients with untreated mantle cell lymphoma

October 3
Last Trade: 71.15 -1.68 -2.31

Based on ECHO Phase III trial which demonstrated CALQUENCE combination reduced risk of disease progression or death by 27% compared to standard-of-care chemoimmunotherapy Submission to be reviewed under Project Orbis WILMINGTON, Del. / Oct 03, 2024 / Business Wire / AstraZeneca’s supplemental New Drug Application (sNDA) for CALQUENCE® (acalabrutinib) has been accepted and granted Priority Review in the US for the treatment of adult...Read more


Aldeyra Therapeutics Resubmits Reproxalap New Drug Application for the Treatment of Dry Eye Disease

October 3
Last Trade: 5.26 -0.08 -1.50

LEXINGTON, Mass. / Oct 03, 2024 / Business Wire / Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a biotechnology company devoted to discovering and developing innovative therapies designed to treat immune-mediated and metabolic diseases, today announced the resubmission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for topical ocular reproxalap, an investigational new drug candidate, for the treatment...Read more


Recursion Announces FDA Clearance of Investigational New Drug Application for REC-1245, a Potential First-In-Class RBM39 Degrader for Biomarker-Enriched Solid Tumors and Lymphoma

October 2
Last Trade: 6.32 -0.36 -5.39

First program to combine Recursion’s end-to-end suite of AI-enabled active learning modules, resulting in target identification to IND enabling studies in under 18 months Plan to initiate dosing of Phase 1/2 in Q4 2024 to evaluate REC-1245 in a biomarker enriched patient population, including patients with solid tumors and lymphoma SALT LAKE CITY, Oct. 02, 2024 (GLOBE NEWSWIRE) -- Recursion (NASDAQ: RXRX), a leading clinical stage...Read more


PTC Therapeutics Announces FDA Acceptance for Filing of NDA for Sepiapterin for the Treatment of Pediatric and Adult Phenylketonuria Patients

October 1
Last Trade: 39.92 -0.74 -1.82

WARREN, N.J., Oct. 1, 2024 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) announced today the FDA has accepted for filing the New Drug Application (NDA) of sepiapterin for the treatment of pediatric and adult patients living with phenylketonuria (PKU). A Prescription Drug User Fee Act (PDUFA) target action date is expected to be provided in the Day 74 Letter. "The FDA filing acceptance for sepiapterin is a critical milestone...Read more


Calidi Biotherapeutics Announces FDA Clearance of the Northwestern University IND Application for CLD-101 Clinical Trial in High-Grade Glioma

September 30
Last Trade: 1.18 0.07 6.30

Trial will evaluate multiple doses of CLD-101 for the treatment of newly diagnosed high-grade glioma CLD-101 is Calidi’s novel allogeneic immunotherapy utilizing neural stem cells to deliver engineered oncolytic adenoviruses Phase 1b/2 trial expected to initiate in the first quarter of 2025 SAN DIEGO, Sept. 30, 2024 (GLOBE NEWSWIRE) -- Calidi Biotherapeutics, Inc. (NYSE American: CLDI) (“Calidi”), a clinical-stage biotechnology...Read more


Crinetics Pharmaceuticals Submits New Drug Application for Paltusotine for the Treatment of Acromegaly

September 26
Last Trade: 55.96 0.20 0.36

SAN DIEGO, Sept. 26, 2024 (GLOBE NEWSWIRE) -- Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX) today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for paltusotine, the first once-daily, oral, selectively-targeted somatostatin receptor type 2 nonpeptide agonist in development for the proposed treatment and long-term maintenance therapy of acromegaly. “This NDA submission brings us...Read more


ANI Pharmaceuticals Announces the FDA Approval and Launch of Ketoconazole Shampoo, 2%

September 26
Last Trade: 57.25 -1.27 -2.17

PRINCETON, N.J., Sept. 26, 2024 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced that following final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA), the Company launched Ketoconazole Shampoo, 2%. ANI’s Ketoconazole Shampoo, 2% is the generic version of the reference listed drug (RLD) Nizoral®. "We are proud to announce the FDA...Read more


FDA Accepts Arcutis Biotherapeutics’ Supplemental New Drug Application for ZORYVE® (roflumilast) Foam for the Treatment of Scalp and Body Psoriasis in Adults and Adolescents Ages 12 and Over

September 24
Last Trade: 8.31 -0.21 -2.46

U.S. Food and Drug Administration (FDA) has set a Prescription Drug User Fee Act (PDUFA) target action date of May 22, 2025 Almost half of the 9 million individuals in the United States with plaque psoriasis experience involvement of the scalp Supplemental New Drug Application (sNDA) supported by positive efficacy and safety data from Phase 2b and pivotal Phase 3 trials, and long-term ZORYVE cream plaque psoriasis program WESTLAKE...Read more


Innate Pharma Announces FDA Clearance of the IND for IPH4502, a Nectin-4 ADC to Be Developed in Solid Tumors

September 23
Last Trade: 1.89 0.06 3.33

IPH4502 is Innate’s novel and differentiated topoisomerase I inhibitor antibody drug conjugate (ADC) targeting Nectin-4 MARSEILLE, France / Sep 23, 2024 / Business Wire / Regulatory News: Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) (“Innate” or the “Company”) today announced that the U.S Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application to initiate a Phase 1 clinical study of...Read more


SciSparc Takes Major Step Forward with IND Application submitted to the FDA for Phase IIb Clinical Trial for Tourette Syndrome Treatment

September 18
Last Trade: 0.25 0.01 5.09

Yale Child Study Center at the Yale School of Medicine in the USA, Hannover Medical School in Germany and Tel Aviv Sourasky Medical Center in Israel will take part in the trial TEL AVIV, Israel, Sept. 18, 2024 (GLOBE NEWSWIRE) -- SciSparc Ltd. (Nasdaq: SPRC) ("Company" or "SciSparc"), a specialty clinical-stage pharmaceutical company focusing on the development of therapies to treat disorders and rare diseases of the central nervous...Read more


Cullinan Therapeutics Announces Submission of Investigational New Drug Application to U.S. Food and Drug Administration for CLN-978 to Treat Systemic Lupus Erythematosus

September 16
Last Trade: 15.55 -0.67 -4.13

CAMBRIDGE, Mass., Sept. 16, 2024 (GLOBE NEWSWIRE) -- Cullinan Therapeutics, Inc. (Nasdaq: CGEM), a biopharmaceutical company focused on developing modality-agnostic targeted therapies, today shared that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) to evaluate its CD19xCD3 bispecific T cell engager, CLN-978, for the treatment of systemic lupus erythematosus (SLE). “We are...Read more


ARS Pharmaceuticals Submits sNDA to FDA for neffy® 1 mg Dose for Pediatric Patients with Type I Allergic Reactions Who Weigh 15 to 30 kg (33-66 lbs.)

September 9
Last Trade: 14.72 0.45 3.15

If approved, neffy 1 mg will be the first and only needle-free epinephrine treatment available for younger school-aged children The submission of neffy 1 mg sNDA follows FDA approval on August 9, 2024, of neffy (2 mg) for the treatment of Type I Allergic Reactions, including anaphylaxis, in adults and children who weigh 30 kg (66 lbs.) or greater SAN DIEGO, Sept. 09, 2024 (GLOBE NEWSWIRE) --  ARS Pharmaceuticals,...Read more


Axsome Therapeutics Announces FDA Acceptance of NDA Resubmission for AXS-07 for the Acute Treatment of Migraine

September 4
Last Trade: 89.03 -0.43 -0.48

NEW YORK, Sept. 04, 2024 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, today announced that the U.S. Food and Drug Administration (FDA) has acknowledged the resubmission of the Company’s New Drug Application (NDA) for AXS-07 for the acute treatment of migraine. The FDA designated the...Read more


Arcturus Therapeutics Receives Clearance of an Investigational New Drug Application to U.S. Food and Drug Administration for ARCT-032, an Investigational Inhaled mRNA Therapeutic to Treat Cystic Fibrosis

September 3
Last Trade: 17.73 -0.66 -3.59

SAN DIEGO / Sep 03, 2024 / Business Wire / Arcturus Therapeutics Holdings Inc. (the “Company”, “Arcturus”, Nasdaq: ARCT), a global messenger RNA medicines company focused on the development of infectious disease vaccines and addressing unmet medical needs within liver and respiratory rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has issued a “Study May Proceed” notification for the Company’s Investigational...Read more


BioVie Announces FDA Authorization of Investigational New Drug Application for Phase 2 Trial to Evaluate Bezisterim in Long COVID

September 3
Last Trade: 2.74 -0.10 -3.52

Authorization expands use of bezisterim in a Phase 2, placebo-controlled, multicenter trial assessing bezisterim’s impact on neurological symptoms associated with long COVID Key milestone reached ahead of schedule, with BioVie on track to receive additional $12.6 million of award from the U.S. Department of Defense and initiate the Phase 2 trial Recent Centers for Disease Control and Prevention survey estimated over 5% of U.S. adults...Read more


Unicycive Therapeutics Announces Submission of the New Drug Application (NDA) to the U.S. FDA for Oxylanthanum Carbonate (OLC) for the Treatment of Hyperphosphatemia in Patients with Chronic Kidney Disease on Dialysis

September 3
Last Trade: 0.54 0.03 4.90

LOS ALTOS, Calif., Sept. 03, 2024 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease (the “Company” or “Unicycive”), today announced that the Company has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Oxylanthanum Carbonate (OLC) for the treatment of hyperphosphatemia in patients...Read more


KalVista Announces FDA Acceptance of New Drug Application for Sebetralstat for Oral On-Demand Treatment of Hereditary Angioedema

September 3
Last Trade: 10.27 -0.93 -8.30

If approved, sebetralstat will be the first, oral on-demand treatment for HAE  FDA PDUFA goal date of June 17, 2025  CAMBRIDGE, Mass. & SALISBURY, England / Sep 03, 2024 / Business Wire / KalVista Pharmaceuticals, Inc. (NASDAQ: KALV), today announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for sebetralstat, a novel, investigational oral plasma kallikrein inhibitor for...Read more


Scilex Announces FDA Final Approval to Precision Dosing for GLOPERBA® Label

August 29
Last Trade: 0.96 0.02 1.96

FDA Final Approval to Precision Dosing for GLOPERBA® Label. We believe GLOPERBA® is the first and only liquid oral version of the anti-gout medicine colchicine indicated for the prophylaxis of painful gout flares in adults. Gout is a painful arthritic disorder affecting an estimated 9.2 million people in the United States1. As gout cases increase every year, treatment requirements increase. According to data gathered by Evaluate...Read more


FDA Grants Priority Review to SpringWorks Therapeutics’ New Drug Application for Mirdametinib for the Treatment of Adults and Children with NF1-PN

August 28
Last Trade: 30.13 -0.35 -1.15

PDUFA target action date of February 28, 2025  EU Marketing Authorization Application also validated by European Medicines Agency  STAMFORD, Conn., Aug. 28, 2024 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a commercial-stage biopharmaceutical company focused on severe rare diseases and cancer, announced today that the U.S. Food and Drug Administration (FDA) has accepted the Company’s New Drug...Read more


Soleno Therapeutics Announces U.S. FDA Acceptance for Filing and Priority Review of NDA for DCCR (Diazoxide Choline) Extended-Release Tablets in Prader-Willi Syndrome

August 27
Last Trade: 55.06 -0.66 -1.18

PDUFA target action date set for December 27, 2024 FDA currently plans to hold an Advisory Committee meeting REDWOOD CITY, Calif., Aug. 27, 2024 (GLOBE NEWSWIRE) -- Soleno Therapeutics, Inc. (“Soleno”) (NASDAQ: SLNO), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing its New Drug...Read more


Rhythm Pharmaceuticals Announces FDA Acceptance for Priority Review of Supplemental New Drug Application for IMCIVREE® (setmelanotide) in Patients as Young as 2 years old

August 26
Last Trade: 47.73 -1.81 -3.65

Label expansion sought to treat younger children with Bardet-Biedl syndrome or POMC/LEPR deficiency  FDA sets PDUFA goal date of December 26, 2024  BOSTON, Aug. 26, 2024 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a global commercial-stage biopharmaceutical company focused on transforming the lives of patients living with rare neuroendocrine diseases, today announced that the U.S. Food and Drug...Read more


SciSparc Submitted IND Application to the FDA for SCI-110 Phase IIb Clinical Trial for Patients with Tourette Syndrome

August 23
Last Trade: 0.25 0.01 5.09

SciSparc to conduct the trial at the Yale Child Study Center at the Yale School of Medicine in the USA, Hannover Medical School in Germany and Tel Aviv Sourasky Medical Center in Israel TEL AVIV, Israel, Aug. 23, 2024 (GLOBE NEWSWIRE) --  SciSparc Ltd. (Nasdaq: SPRC) ("Company" or "SciSparc"), a specialty clinical-stage pharmaceutical company focusing on the development of therapies to treat disorders and rare diseases of the...Read more


Azitra Receives Study May Proceed letter from the FDA for IND to Treat Skin Rash from EGFR Inhibitors

August 22
Last Trade: 0.50 -0.01 -2.41

New investigational new drug (IND) application cleared to proceed by the US FDA for a Phase 1/2 clinical study of ATR-04 for moderate to severe EGFR inhibitor (“EGFRi”) associated dermal toxicity. There are an estimated 150,000 patients with EGFRi-associated skin rash in the US, representing a >$1 billion global market size. Preclinical data show ATR-04 reduces IL-36γ and Staphylococcus aureus, key drivers of EGFRi-associated skin...Read more


Amneal Pharmaceuticals Receives U.S. FDA Approval for Propofol Injectable Emulsion Single Dose Vials

August 20
Last Trade: 8.47 -0.10 -1.17

Propofol is an essential surgical anesthetic in hospitals that is in chronic shortage Complex emulsion injectable expands Amneal’s injectables portfolio BRIDGEWATER, N.J. / Aug 20, 2024 / Business Wire / Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”) today announced that it has received Abbreviated New Drug Application (“ANDA”) approval from the U.S. Food and Drug Administration (FDA) for Propofol Injectable...Read more


Supernus Pharmaceuticals Announces SPN-830 Apomorphine Infusion Device NDA Accepted for Review by FDA

August 19
Last Trade: 34.07 -0.80 -2.29

PDUFA Target Action Date of February 1, 2025 ROCKVILLE, Md., Aug. 19, 2024 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, today announced that the U.S. Food and Drug Administration (FDA) has acknowledged the resubmission of the new drug application (NDA) for its...Read more


Liquidia: U.S. FDA Grants Tentative Approval of YUTREPIA™ (treprostinil) Inhalation Powder for Patients with Pulmonary Arterial Hypertension (PAH) and Pulmonary Hypertension Associated with Interstitial Lung Disease (PH-ILD)

August 19
Last Trade: 10.85 -0.16 -1.45

FDA confirmed that the amendment to add PH-ILD to the YUTREPIA NDA was proper and that application otherwise meets the requirements for approval under the Federal Food, Drug, and Cosmetic Act Final Approval of YUTREPIA for PAH and PH-ILD may occur after expiration of 3-year regulatory exclusivity for Tyvaso DPI on May 23, 2025 FDA’s tentative approval is based upon all information submitted in the NDA, including the status of good...Read more


UroGen Pharma Submits Completed UGN-102 NDA Seeking Approval as the First FDA-Approved Treatment for Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer

August 14
Last Trade: 12.26 -0.76 -5.84

PRINCETON, N.J. / Aug 14, 2024 / Business Wire / UroGen Pharma Ltd. (Nasdaq: URGN), a leading biotech company specializing in novel therapies for urothelial and specialty cancers, today announced the successful completion of its New Drug Application (NDA) submission for investigational drug UGN-102, (mitomycin) for intravesical solution, a significant step forward in potentially addressing the urgent need for innovative treatments for...Read more


LENZ Therapeutics Announces Submission of New Drug Application to U.S. Food and Drug Administration for LNZ100 for the Treatment of Presbyopia

August 12
Last Trade: 26.96 0.00 0.00

SAN DIEGO, Aug. 12, 2024 (GLOBE NEWSWIRE) -- LENZ Therapeutics, Inc. (Nasdaq: LENZ or “LENZ” or the “Company”), a late clinical-stage biopharmaceutical company focused on developing the first and only aceclidine-based eye drop to improve near vision in people with presbyopia, today announced that the Company has submitted a New Drug Application (NDA) to U.S. Food and Drug Administration (FDA) for LNZ100 (an aceclidine-based ophthalmic...Read more


scPharmaceuticals Announces FDA Approval of Supplemental New Drug Application Expanding the FUROSCIX Indication in Heart Failure

August 12
Last Trade: 4.15 -0.31 -6.95

FUROSCIX is now indicated for the treatment of congestion due to fluid overload in adult patients with chronic heart failure, regardless of New York Heart Association (NYHA) functional class Indication expansion allows for the use of FUROSCIX in NYHA Class IV chronic heart failure patients BURLINGTON, Mass., Aug. 12, 2024 (GLOBE NEWSWIRE) -- scPharmaceuticals Inc. (Nasdaq: SCPH) (the “Company”), a pharmaceutical company focused on...Read more


Kura Oncology Announces FDA Clearance of IND Application for Menin Inhibitor Ziftomenib in Advanced Gastrointestinal Stromal Tumors (GIST)

August 8
Last Trade: 16.72 -0.25 -1.47

Preclinical data suggest combination of ziftomenib and imatinib has potential to resensitize patients to imatinib and induce durable responses  Proof-of-concept study evaluating ziftomenib and imatinib in patients with advanced GIST to begin in 1H 2025  SAN DIEGO, Aug. 08, 2024 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision...Read more


Exelixis Announces U.S. Food and Drug Administration (FDA) Accepted the Supplemental New Drug Application for Cabozantinib for Patients with Advanced Neuroendocrine Tumors

August 6
Last Trade: 33.20 0.76 2.34

The FDA assigned a Prescription Drug User Fee Act target action date of April 3, 2025  Application is based on results from the phase 3 CABINET pivotal trial, in which cabozantinib provided a statistically significant and clinically meaningful improvement in progression-free survival versus placebo  ALAMEDA, Calif. / Aug 06, 2024 / Business Wire / Exelixis, Inc. (Nasdaq: EXEL) today announced that its supplemental New Drug...Read more


Rezolute Announces FDA Clearance of IND Application for Phase 3 Registrational Study of RZ358 for Treatment of Hypoglycemia Due to Tumor Hyperinsulinism

August 5
Last Trade: 5.48 0.04 0.74

Second rare disease program with RZ358 in Phase 3 development Follows successful treatment of multiple patients with tumor hyperinsulinism under the Company’s Expanded Access Program REDWOOD CITY, Calif., Aug. 05, 2024 (GLOBE NEWSWIRE) -- Rezolute, Inc. (Nasdaq: RZLT) (“Rezolute” or the “Company”), a late-stage biopharmaceutical company committed to developing novel, transformative therapies for serious rare diseases, today...Read more


Supernus Pharmaceuticals Resubmits NDA for SPN-830 Apomorphine Infusion Device

August 1
Last Trade: 34.07 -0.80 -2.29

ROCKVILLE, Md., Aug. 01, 2024 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, today announced it has resubmitted its New Drug Application (NDA) for its apomorphine infusion device (SPN-830) for the continuous treatment of motor fluctuations (OFF episodes) in Parkinson’s disease...Read more


Grifols: GigaGen Receives FDA Clearance of IND Application for Phase 1 Trial of Recombinant Polyclonal for HBV Treatment, GIGA-2339

July 31
Last Trade: 8.69 -0.08 -0.91

GIGA-2339 is the first recombinant polyclonal therapeutic in development to treat and functionally cure chronic hepatitis B virus (HBV) infection; trial initiation expected in Q4 2024 Containing more than 1,000 fully human recombinant anti-HBV antibodies, GIGA-2339 reproduces the human body’s natural immune response GigaGen’s recombinant polyclonals are part of Grifols’ robust innovation strategy and commitment to delivering the next...Read more


Vertex Pharmaceuticals Announces FDA Acceptance of New Drug Application for Suzetrigine for the Treatment of Moderate-to-Severe Acute Pain

July 30
Last Trade: 475.98 0.90 0.19

FDA grants priority review and assigns a Prescription Drug User Fee Act (PDUFA) target action date of January 30, 2025 Suzetrigine, an investigational non-opioid pain signal inhibitor, has the potential to treat millions of patients who suffer from moderate-to-severe acute pain each year BOSTON / Jul 30, 2024 / Business Wire / Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the U.S. Food and Drug Administration...Read more


Processa Pharmaceuticals Announces FDA Clearance of IND Application for a Phase 2 Clinical Trial of NGC-Cap in Breast Cancer

July 30
Last Trade: 1.16 -0.18 -13.16

Open-label Phase 2 trial in breast cancer to begin this quarter Initial data expected mid-2025 HANOVER, Md., July 30, 2024 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc. (Nasdaq: PCSA) (Processa or the Company), a clinical-stage pharmaceutical company focused on developing the next generation of chemotherapeutic drugs with improved efficacy and safety, today announced that the U.S. Food and Drug Administration (FDA) has cleared...Read more


PTC Therapeutics Announces Sepiapterin NDA Submission to FDA

July 30
Last Trade: 39.92 -0.74 -1.82

WARREN, N.J., July 30, 2024 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) announced today the submission of the sepiapterin NDA to the U.S. FDA. The NDA submission is for the treatment of pediatric and adult patients with phenylketonuria (PKU), including the full spectrum of ages and disease subtypes. "This NDA submission is an important step in bringing this therapy to children and adults living with PKU in the U.S.," said...Read more


Amneal Pharmaceuticals Receives U.S. FDA Approval for Potassium Phosphates Injection IV Bags

July 29
Last Trade: 8.47 -0.10 -1.17

First presentation of preservative-free potassium phosphates in a single-dose IV infusion bag Third 505(b)(2) injectable added this year – will launch in third quarter BRIDGEWATER, N.J. / Jul 29, 2024 / Business Wire / Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”) today announced that it has received New Drug Application (“NDA”) approval from the U.S. Food and Drug Administration (FDA) for its new...Read more


Syndax Pharmaceuticals Announces PDUFA Action Date Extension for Revumenib NDA for Relapsed or Refractory KMT2Ar Acute Leukemia

July 29
Last Trade: 18.86 -0.06 -0.32

New PDUFA action date of December 26, 2024 allows FDA additional time to complete their review WALTHAM, Mass., July 29, 2024 /PRNewswire/ -- Syndax Pharmaceuticals (Nasdaq: SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) action date for the New...Read more


Actinium Pharmaceuticals Announces FDA Clearance of Iomab-ACT Targeted Conditioning IND Application for Sickle Cell Disease Patients Undergoing Bone Marrow Transplant in Collaboration with Columbia University

July 25
Last Trade: 1.80 0.02 1.12

Sickle cell disease affects approximately 100,000 patients in the U.S. annually and is a debilitating and life-threatening condition with high unmet need Current conditioning with non-targeted chemotherapies provides limited access to potentially curative bone marrow transplant and recently approved gene therapies for sickle cell disease patients Initial trial focused on conditioning for bone marrow transplant intended to...Read more


scPharmaceuticals Announces Filing Acceptance of Supplemental New Drug Application (sNDA) Seeking to Expand FUROSCIX Indication to Include Chronic Kidney Disease

July 25
Last Trade: 4.15 -0.31 -6.95

BURLINGTON, Mass., July 25, 2024 (GLOBE NEWSWIRE) -- scPharmaceuticals Inc. (Nasdaq: SCPH) (the “Company”), a pharmaceutical company focused on developing and commercializing products that have the potential to optimize the delivery of infused therapies, advance patient care, and reduce healthcare costs, today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the Company’s Supplemental New Drug Application...Read more


Anixa Biosciences Announces FDA Approval of Individual Patient IND for its Ovarian Cancer CAR-T Therapy

July 23
Last Trade: 3.50 -0.09 -2.51

IND follows encouraging findings of necrosis, inflammation and T cell infiltration in tumor biopsy of patient in lowest dose cohort SAN JOSE, Calif., July 23, 2024 /PRNewswire/ -- Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, today announced that its collaborator, Moffitt Cancer Center (Moffitt), has received approval by the U.S. Food and...Read more


Arcutis Biotherapeutics Submits Supplemental New Drug Application for ZORYVE® (roflumilast) Foam to the FDA for the Treatment of Scalp and Body Psoriasis in Adults and Adolescents Ages 12 and Over

July 23
Last Trade: 8.31 -0.21 -2.46

Approximately 40% of the 9 million individuals in the United States with plaque psoriasis experience involvement of the scalp Once-daily ZORYVE foam significantly improved both scalp and body psoriasis in a Phase 2b and a pivotal Phase 3 trial Data also show rapid reduction in scalp itch as soon as 24 hours after first application ZORYVE foam demonstrated a favorable safety and tolerability profile WESTLAKE VILLAGE, Calif., July...Read more


Johnson & Johnson seeks U.S. FDA approval of SPRAVATO® (esketamine) as the first and only monotherapy for adults with treatment-resistant depression

July 22
Last Trade: 159.86 -0.75 -0.47

Phase 4 SPRAVATO® monotherapy data shows rapid improvement in depressive symptoms at ~24 hours, sustained through at least 4 weeks Monotherapy submission builds on more than a decade of research, 31 clinical trials and more than five years of real-world use that reinforce the safety and efficacy of SPRAVATO® TITUSVILLE, N.J., July 22, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) announced today the submission of a...Read more


Zymeworks Announces FDA Clearance of Investigational New Drug Application for ZW191, a Novel Folate Receptor-⍺ Targeted Topoisomerase I Inhibitor Antibody-Drug Conjugate

July 22
Last Trade: 13.70 -0.17 -1.23

VANCOUVER, British Columbia, July 22, 2024 (GLOBE NEWSWIRE) -- Zymeworks Inc. (Nasdaq: ZYME), a clinical-stage biotechnology company developing a diverse pipeline of novel, multifunctional biotherapeutics to improve the standard of care for difficult-to-treat diseases, today announced that the United States Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application for ZW191, the Company’s novel folate...Read more


Clearmind Medicine Obtains IND Approval from the FDA to Start the Phase I/IIa Clinical Trial with its Innovative Treatment for Alcoholism

July 16
Last Trade: 1.39 -0.07 -4.79

Vancouver, Canada, July 16, 2024 (GLOBE NEWSWIRE) -- Clearmind Medicine Inc. (Nasdaq: CMND), (FSE: CWY0) (“Clearmind” or the "Company"), a clinical-stage biotech company focused on discovery and development of novel psychedelic-derived therapeutics to solve major under-treated health problems, today announced that  the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for its...Read more


Lexicon Pharmaceuticals Receives December 20, 2024 PDUFA Goal Date for Sotagliflozin Type 1 Diabetes NDA Resubmission

July 16
Last Trade: 1.95 0.00 0.00

Launch Preparations Actively Underway; Launch Planned for Early 2025 Lexicon Seeks Approval for Zynquista™ (sotagliflozin) as an Adjunct to Insulin Therapy for Glycemic Control in Adults with Type 1 Diabetes and Chronic Kidney Disease THE WOODLANDS, Texas, July 16, 2024 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), today announced that the U.S. Food and Drug Administration (FDA) has acknowledged the resubmission...Read more


Eton Pharmaceuticals Announces FDA Acceptance of New Drug Application for ET-400 (Hydrocortisone Oral Solution)

July 15
Last Trade: 8.47 -0.23 -2.64

- Prescription Drug User Fee Act (PDUFA) target action date is February 28, 2025 - - Product has patent protection through 2043 - DEER PARK, Ill., July 15, 2024 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (“Eton” or the “Company”) (Nasdaq: ETON), an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases, today announced the Company’s New Drug Application (NDA) for ET-400, a...Read more


Artelo Biosciences Receives FDA Clearance of its IND Application for ART26.12, a Selective Fatty Acid Binding Protein 5 Inhibitor

July 15
Last Trade: 1.15 -0.03 -2.21

ART26.12 seeks to address a critical need in painful neuropathies, including chemotherapy-induced peripheral neuropathy for which there is no FDA-approved treatment Phase 1 trial results expected in the first half of 2025 SOLANA BEACH, Calif., July 15, 2024 (GLOBE NEWSWIRE) -- Artelo Biosciences, Inc. (Nasdaq: ARTL), a clinical-stage pharmaceutical company focused on modulating lipid-signaling pathways to develop treatments for...Read more


ANI Pharmaceuticals Announces the FDA Approval and Launch of L-Glutamine Oral Powder

July 15
Last Trade: 57.25 -1.27 -2.17

PRINCETON, N.J., July 15, 2024 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced that following final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA), the Company launched L-Glutamine Oral Powder. ANI’s L-Glutamine Oral Powder is the generic version of the reference listed drug (RLD) Endari®. "The approval and launch of L-Glutamine...Read more


FDA Approves Arcutis Biotherapeutics’ ZORYVE® (roflumilast) Cream 0.15% for the Treatment of Atopic Dermatitis in Adults and Children Down to 6 Years of Age

July 9
Last Trade: 8.31 -0.21 -2.46

ZORYVE cream provides rapid relief, with efficacy, safety, and tolerability demonstrated up to 56 weeks of treatment ZORYVE cream rapidly and significantly reduces itch, the most bothersome symptom of atopic dermatitis (AD) Once-daily cream is for use anywhere on the body for any duration AD is the most common type of eczema, affecting approximately 9.6 million children and 16.5 million adults in the United States Third FDA approval...Read more


Avalo Therapeutics Announces Active IND for AVTX-009, an anti-IL-1β mAb, to Treat Hidradenitis Suppurativa

July 9
Last Trade: 13.01 0.43 3.42

Following FDA review, Avalo’s IND application for AVTX-009 is active allowing Avalo to proceed with its Phase 2 trial (LOTUS) to evaluate the efficacy and safety of AVTX-009 in patients with hidradenitis suppurativa WAYNE, Pa. and ROCKVILLE, Md., July 09, 2024 (GLOBE NEWSWIRE) -- Avalo Therapeutics, Inc. (Nasdaq: AVTX) today announced that the Investigational New Drug (IND) for AVTX-009, an anti-IL-1β monoclonal antibody (mAb), for...Read more


Vertex Pharmaceuticals Announces FDA Acceptance of New Drug Application for Vanzacaftor/Tezacaftor/Deutivacaftor, a Next-In-Class Triple Combination Treatment for Cystic Fibrosis

July 2
Last Trade: 475.98 0.90 0.19

Vanza triple granted priority review with Prescription Drug User Fee Act (PDUFA) target action date of January 2, 2025 EU Marketing Authorization Application (MAA) submission also validated by European Medicines Agency (EMA) BOSTON / Jul 02, 2024 / Business Wire / Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for...Read more


ANI Pharmaceuticals Announces the FDA Approval and Launch of Naproxen Delayed-Release Tablets, USP

July 2
Last Trade: 57.25 -1.27 -2.17

PRINCETON, N.J., July 02, 2024 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced that it received U.S. Food and Drug Administration (FDA) approval for the Abbreviated New Drug Application (ANDA) and launched Naproxen Delayed-Release Tablets, USP. ANI’s Naproxen Delayed-Release Tablets is the generic version of the reference listed drug (RLD) EC-Naprosyn®. "We are pleased to announce...Read more


Neurocrine Biosciences Announces U.S. FDA Accepts New Drug Applications and Grants Priority Review for Crinecerfont for Pediatric and Adult Patients with CAH

July 1
Last Trade: 120.27 -4.06 -3.27

PDUFA Target Action Dates in Late December 2024 Highly Selective CRF1 Antagonist is the Potential First New Treatment for CAH in 70 Years SAN DIEGO, July 1, 2024 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced the U.S. Food and Drug Administration (FDA) has accepted its two New Drug Applications (NDA) with Priority Review designations for crinecerfont in the treatment of children, adolescents and...Read more


SpringWorks Therapeutics Completes Submission of New Drug Application to the FDA for Mirdametinib for the Treatment of Children and Adults with NF1-PN

July 1
Last Trade: 30.13 -0.35 -1.15

STAMFORD, Conn., July 01, 2024 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a commercial-stage biopharmaceutical company focused on severe rare diseases and cancer, announced today that the Company has completed the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for mirdametinib, an investigational MEK inhibitor, for the treatment of pediatric and adult patients with...Read more


Mirum Pharmaceuticals Submits New Drug Application to FDA for Chenodiol for the Treatment of CTX

June 28
Last Trade: 38.46 -0.72 -1.84

Submission based on the positive Phase 3 RESTORE study Mirum holds orphan designation for chenodiol in CTX Potential to have first and only therapy indicated for CTX in the US FOSTER CITY, Calif. / Jun 28, 2024 / Business Wire / Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM) today announced the submission of a new drug application (NDA) for chenodiol for the treatment of patients in the U.S. with cerebrotendinous xanthomatosis...Read more


Soleno Therapeutics Announces Submission of New Drug Application to the U.S. FDA for DCCR (Diazoxide Choline) Extended-Release Tablets for the Treatment of Prader-Willi Syndrome

June 28
Last Trade: 55.06 -0.66 -1.18

REDWOOD CITY, Calif., June 28, 2024 (GLOBE NEWSWIRE) -- Soleno Therapeutics, Inc. (“Soleno”) (NASDAQ: SLNO), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for approval of DCCR (diazoxide choline) extended-release tablets for the treatment of Prader-Willi syndrome (PWS)...Read more


GT Biopharma Announces FDA Clearance of Investigational New Drug (IND) Application for GTB-3650, an NK Cell Engager for Treatment of CD33+ Leukemia

June 27
Last Trade: 2.94 -0.07 -2.33

GTB-3650 Phase 1 trial initiation expected in H2 2024; initial clinical data expected in H1 2025 GTB-5550 TriKE® IND submission for treatment of B7H3 positive solid tumors expected in Q1 2025 GTB-5550 Phase 1 dose escalation basket trial initiation expected in 2025 evaluating GTB-5550 in six solid tumor cancers, including prostate, breast, head and neck, ovarian, lung, and GI Cash runway anticipated to be sufficient to fund...Read more


Synaptogenix Announces FDA Authorization of IND Application for Clinical Trial for Bryostatin-1 in Multiple Sclerosis

June 26
Last Trade: 2.98 -0.10 -3.09

Collaborative study will evaluate drug's potential to improve synaptic health and cognitive function in MS patients NEW YORK, June 26, 2024 /PRNewswire/ -- Synaptogenix, Inc. (Nasdaq: SNPX) ("Synaptogenix" or the "Company"), an emerging biopharmaceutical company developing therapeutics for neurodegenerative disorders, today announced that the Food & Drug Administration (FDA) has authorized an Investigational New Drug (IND)...Read more


Vir Biotechnology Receives FDA IND Clearance and Fast Track Designation for Tobevibart and Elebsiran for the Treatment of Chronic Hepatitis Delta Infection

June 26
Last Trade: 7.49 -0.11 -1.45

Fast Track designation follows positive preliminary Phase 2 trial data presented at the European Association for the Study of the Liver Congress 2024 and underscores the unmet need for people living with chronic hepatitis delta SAN FRANCISCO / Jun 26, 2024 / Business Wire / Vir Biotechnology, Inc. (Nasdaq: VIR) today announced that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application...Read more


Ionis Pharmaceuticals announces olezarsen FCS New Drug Application accepted for Priority Review and enrollment in Phase 3 sHTG program completed

June 25
Last Trade: 38.39 -0.87 -2.22

Olezarsen PDUFA date set for December 19, 2024 for treatment of familial chylomicronemia syndrome Phase 3 enrollment completed in CORE, CORE2 and ESSENCE evaluating olezarsen for the treatment of severe hypertriglyceridemia, with results expected in 2H 2025 CARLSBAD, Calif., June 25, 2024 /PRNewswire/ -- Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) today announced that the U.S. Food and Drug Administration (FDA) has accepted...Read more


4DMT Announces FDA Clearance of IND Application for 4D-175 Genetic Medicine for the Treatment of Geographic Atrophy

June 24
Last Trade: 8.01 -0.26 -3.14

4D-175 comprises the proprietary low-dose intravitreal R100 AAV vector and a codon-optimized transgene encoding a highly functional shortened form of human complement factor H (sCFH) Complement factor H (CFH) variants with reduced function are a well-validated genetic risk factor for geographic atrophy (GA), with approximately 75% of age-related macular degeneration (AMD) patients carrying a high-risk variant of CFH Over 150 patients...Read more


Adicet Bio Announces FDA Clearance of IND Application for ADI-270 in Renal Cell Carcinoma

June 24
Last Trade: 1.28 -0.08 -5.88

ADI-270 is the first gamma delta 1 CAR T candidate to enter clinical development for solid tumors Phase 1 clinical study to evaluate safety and anti-tumor activity of ADI-270 in relapsed/refractory RCC patients Phase 1 clinical study to be initiated in 2H 2024; preliminary clinical data expected in 1H 2025 REDWOOD CITY, Calif. & BOSTON / Jun 24, 2024 / Business Wire / Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage...Read more


Lexicon Pharmaceuticals Resubmits Sotagliflozin NDA for Type 1 Diabetes

June 21
Last Trade: 1.95 0.00 0.00

Lexicon Seeks Approval for Sotagliflozin as an Adjunct to Insulin Therapy for Glycemic Control in People with Type 1 Diabetes and Chronic Kidney Disease Company Anticipates Six Month Review and Potential Launch in Early 2025 THE WOODLANDS, Texas, June 21, 2024 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), today announced that, following multiple interactions with and recent feedback from the U.S. Food and Drug...Read more


Kyverna Therapeutics' KYV-101 Receives U.S. FDA IND Clearance for Treatment of Patients With Treatment-Refractory Stiff-Person Syndrome in the KYSA-8 Phase 2 Trial

June 20
Last Trade: 4.78 -0.54 -10.15

This IND clearance expands the use of KYV-101 CAR T-cell therapy in a Phase 2, open-label KYSA-8 clinical trial targeting a devastating neuroimmunological autoimmune disease KYV-101 is a fully human anti-CD19 CAR T-cell therapy designed for use in patients with B cell-driven autoimmune diseases EMERYVILLE, Calif., June 20, 2024 /PRNewswire/ -- Kyverna Therapeutics, Inc. (Kyverna), a patient-centered, clinical-stage biopharmaceutical...Read more


KalVista Pharmaceuticals Submits New Drug Application to FDA for Sebetralstat as First Oral On-demand Treatment for Hereditary Angioedema

June 18
Last Trade: 10.27 -0.93 -8.30

CAMBRIDGE, Mass. & SALISBURY, England / Jun 18, 2024 / Business Wire / KalVista Pharmaceuticals, Inc. (NASDAQ: KALV), today announced the submission of a New Drug Application (NDA) for U.S. Food and Drug Administration (FDA) review of sebetralstat, a novel investigational oral plasma kallikrein inhibitor for the on-demand treatment of hereditary angioedema (HAE) attacks in adults and pediatric patients aged 12 years and older. “This...Read more


Zymeworks Announces FDA Clearance of Investigational New Drug Application for ZW171, a novel 2+1 T-cell Targeting Bispecific Antibody for Mesothelin-expressing Cancers

June 17
Last Trade: 13.70 -0.17 -1.23

VANCOUVER, British Columbia, June 17, 2024 (GLOBE NEWSWIRE) -- Zymeworks Inc. (Nasdaq: ZYME), a clinical-stage biotechnology company developing a diverse pipeline of novel, multifunctional biotherapeutics to improve the standard of care for difficult-to-treat diseases, today announced that the United States Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application for ZW171, a novel 2+1 T-cell targeting...Read more


Vivani Medical Announces FDA Clears Investigational New Drug Application and Lifts Clinical Hold for NPM-119, a Miniature Long-Term Subdermal GLP-1 Drug Implant

June 13
Last Trade: 1.31 -0.03 -2.24

NPM-119 is being studied to address medication non-adherence and potentially improve tolerability issues associated with oral and injectable type 2 diabetes medications, by providing long-term therapeutic delivery of exenatide for six months Study will represent first clinical application of NanoPortal™, the company’s proprietary, implant platform technology ALAMEDA, Calif. / Jun 13, 2024 / Business Wire / Vivani Medical, Inc....Read more


AstraZeneca: TAGRISSO® (osimertinib) granted Priority Review in the US for patients with unresectable, Stage III EGFR-mutated lung cancer

June 10
Last Trade: 71.15 -1.68 -2.31

Decision based on LAURA Phase III trial results which extended median progression-free survival by more than three years TAGRISSO also granted Breakthrough Therapy Designation in US in this setting WILMINGTON, Del. / Jun 10, 2024 / Business Wire / AstraZeneca’s supplemental New Drug Application (sNDA) for TAGRISSO® (osimertinib) has been accepted and granted Priority Review in the US for the treatment of adult patients with...Read more


Scilex announces the U.S. FDA has approved the sNDA for commercial manufacturing of Gloperba® which will be launched in the US in the week of June 10th 2024

June 6
Last Trade: 0.96 0.02 1.96

Gloperba® is the first and only liquid oral version of the anti-gout medicine colchicine indicated for the prophylaxis of painful gout flares in adults. Gout is a painful arthritic disorder affecting an estimated 9.2 million people in the United States1. As gout cases increase every year, treatment requirements increase. The gout treatment market is projected to be $2.0 billion in the U.S. by 2028 with a well-defined area of unmet...Read more


Medexus Pharmaceuticals: FDA Accepts for Review Treosulfan NDA Resubmission

June 6
Last Trade: 2.38 -0.17 -6.67

Toronto, Ontario and Chicago, Illinois--(Newsfile Corp. - June 6, 2024) - On Thursday, June 6, 2024, Medexus Pharmaceuticals (TSX: MDP) (OTCQX: MEDXF) was informed by medac, licensor of Medexus's commercialization rights to treosulfan, that the US Food and Drug Administration has accepted for review medac's April 2024 resubmission of the New Drug Application for treosulfan. Medexus expects that the FDA will complete its review of the...Read more


Silo Pharma Submits Pre-Investigational New Drug Application to FDA for SPC-15 as a Treatment for PTSD and Anxiety

June 4
Last Trade: 1.13 0.00 0.00

Clinical roadmap unveiled for novel and proprietary intranasal PTSD treatment SARASOTA, FL, June 04, 2024 (GLOBE NEWSWIRE) -- Silo Pharma, Inc. (Nasdaq: SILO) (“Silo” or the “Company”), a developmental stage biopharmaceutical company focused on developing novel formulations and drug delivery systems for traditional therapeutics and psychedelic treatments, today announced its submission of a pre-Investigational New Drug (pre-IND)...Read more


FibroGen Announces FDA Clearance of Investigational New Drug Application for FG-3165, a Galectin-9 Targeting Monoclonal Antibody, for the Treatment of Patients with Solid Tumors

June 3
Last Trade: 0.30 -0.02 -5.16

The safety and efficacy of FG-3165 will be evaluated in a Phase 1 trial in select solid tumors Plan to begin enrollment in 2H 2024 SAN FRANCISCO, June 03, 2024 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) of FG-3165, a galectin-9 (Gal9) targeted monoclonal antibody under development for treatment of...Read more


Iterum Therapeutics Receives FDA Acceptance of Resubmission of NDA for Oral Sulopenem for the treatment of Uncomplicated Urinary Tract Infections

May 31
Last Trade: 1.29 0.08 6.61

DUBLIN and CHICAGO, May 31, 2024 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (Nasdaq: ITRM) (the Company), a clinical-stage pharmaceutical company focused on developing next generation oral and IV antibiotics to treat infections caused by multi-drug resistant pathogens in both community and hospital settings, today announced that the U.S. Food and Drug Administration (FDA) has acknowledged receipt of the resubmission of the New Drug...Read more


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