GSK, SCYNEXIS Ink Exclusive Licence Agreement For Brexafemme

RTTNews | 578 days ago
GSK, SCYNEXIS Ink Exclusive Licence Agreement For Brexafemme

(RTTNews) - GSK plc (GSK, GSK.L) and SCYNEXIS, Inc. (SCYX) announced Thursday they have entered into an exclusive licence agreement for Brexafemme (ibrexafungerp tablets), a US FDA approved, first-in-class antifungal for the treatment of vulvovaginal candidiasis (VVC) and for reduction in the incidence of recurrent VVC (RVVC).

This exclusive licence agreement gives GSK rights to commercialise Brexafemme for VVC and RVVC while continuing to develop ibrexafungerp, which is in phase III clinical trials for the potential treatment of invasive candidiasis (IC), a life-threatening fungal infection.

Brexafemme complements GSK's first or best-in-class portfolio alongside late-stage antibiotics gepotidacin, potentially the first novel antibiotic for uncomplicated urinary tract infections (uUTI) in over 20 years, and tebipenem, a potential new treatment of complicated urinary tract infections (cUTI).

Under the terms of the agreement, GSK will make an upfront payment to SCYNEXIS of $90 million, plus additional potential milestone-based payments totalling $503 million.

GSK will also receive an exclusive licence to develop ibrexafungerp and commercialise Brexafemme in all countries except the greater China region and certain other countries already out-licensed by SCYNEXIS to third parties. Under the licence agreement, SCYNEXIS will continue executing the phase III programme for IC and other ongoing trials.

SCYNEXIS retains rights to all other assets derived from enfumafungin. As part of this exclusive licence agreement, GSK has been granted a right of first negotiation to these compounds.

This agreement is conditional upon customary conditions including review by the appropriate regulatory agencies under the Hart-Scott-Rodino Act.

read more
GSK Lifts FY23 Outlook As Q3 Profit From Cont. Opns Surges

GSK Lifts FY23 Outlook As Q3 Profit From Cont. Opns Surges

British drug major GSK Plc on Wednesday lifted its fiscal 2023 forecast for earnings and sales after reporting higher third-quarter profit on continuing operations basis. The results were benefited by vaccines' performance, mainly the US launch of Arexvy, the world's first RSV vaccine. Total profit for the quarter, meanwhile, plunged from last year on the absence of prior year's hefty gain.
RTTNews | 362 days ago
IDEAYA Biosciences Says FDA Clears IND For Pol Theta Helicase Development Candidate GSK101

IDEAYA Biosciences Says FDA Clears IND For Pol Theta Helicase Development Candidate GSK101

Oncology company IDEAYA Biosciences, Inc. (IDYA) announced Monday the clearance of an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for initiation of a GSK-sponsored Phase 1/2 clinical trial to evaluate GSK101 (IDE705) for the treatment of patients having tumors with BRCA or other homologous recombination (HR) mutations or homologous recombination deficiency (HRD).
RTTNews | 433 days ago
FDA Approves GSK's Drug For Anemia Caused By CKD For Adults On Dialysis

FDA Approves GSK's Drug For Anemia Caused By CKD For Adults On Dialysis

The U.S. Food and Drug Administration approved GlaxoSmithKline LLC's Jesduvroq tablets (daprodustat) for anemia caused by chronic kidney disease or CKD for adults who have been receiving dialysis for at least four months. It is the first oral treatment for anemia, i.e., decreased number of red blood cells, in the given indication that has received FDA approval.
RTTNews | 634 days ago
FDA Approves GSK's Vaccine For Use In Pregnancy To Prevent Whooping Cough In Infants

FDA Approves GSK's Vaccine For Use In Pregnancy To Prevent Whooping Cough In Infants

The FDA has approved GSK plc's Boostrix vaccine for immunization during the third trimester of pregnancy to prevent pertussis, commonly known as whooping cough, in infants younger than two months of age. The agency noted that Boostrix (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed [Tdap]), when given during pregnancy, boosts antibodies in the mother.
RTTNews | 749 days ago
FTSE 100 Marginally Higher Ahead Of Budget

FTSE 100 Marginally Higher Ahead Of Budget

U.K. stocks were slightly higher on Monday ahead of Prime Minister Sir Keir Starmer's new government's first budget to be unveiled on Wednesday and the release of the widely watched monthly U.S. jobs report due on Friday.
RTTNews | 4h 3min ago