MARCH 3 --> Cidara Therapeutics 11.8M share Spot Secondary priced at $1.40 03/03 CDTX Cantor Fitzgerald acted as sole book running manager for the offering. BACK IN JAN> Cidara, Melinta report FDA advisors recommend approval for rezafungin 01/25 CDTX Cidara Therapeutics and Melinta Therapeutics announced earlier that the U.S. Food and Drug Administration, FDA, Antimicrobial Drugs Advisory Committee voted favorably 14 to 1 that Cidara, as part of its New Drug Application, NDA, provided sufficient evidence supporting a favorable benefit-risk assessment for a limited use indication for rezafungin for the treatment of candidemia and invasive candidiasis in adult patients with limited or no alternative treatment options. "We are extremely pleased that the FDA's advisory committee has recommended that the FDA approve rezafungin for difficult-to-treat and often deadly candidemia and invasive candidiasis," said Jeffrey Stein, Ph.D., president and CEO of Cidara. "This positive recommendation is a significant step towards our goal of providing a once-weekly treatment option for patients with invasive Candida infections, for which no new drugs have been approved in over a decade. We believe rezafungin, if approved, could provide an effective new alternative for patients battling these potentially deadly diseases. We want to thank the many patients and healthcare teams who have participated in the clinical studies of these deadly infections, and we look forward to working with the FDA as it completes its review of our application." The Committee's positive vote was based on clinical data from the Cidara's global ReSTORE Phase 3 and supported by the STRIVE Phase 2 clinical trials and extensive non-clinical development program. Rezafungin dosed once-weekly demonstrated statistical non-inferiority versus caspofungin, the current standard of care, dosed once-daily, meeting the primary endpoints for both the FDA and the European Medicines Agency. IS THIS THE ANTI FUNGAL????
!!!!!!! MARCH 1 Guggenheim starts Scynexis with a Buy, sees 'unique opportunity' 03/01 SCYX As previously reported, Guggenheim initiated coverage of Scynexis with a Buy rating and $8 price target. The anti-infectives space "remains out of favor with investors," but the firm believes Scynexis offers a "unique opportunity." Ibrexafungerp is already approved to treat vulvovaginal candidiasis and has shown promising early data against more severe invasive infections, said the firm, which estimates peak probability-adjusted ibrexafungerp sales of $185M.
DEC 1ST 2022- Scynexis announces FDA approval of second indication for BREXAFEMME 12/01/22 SCYX SCYNEXIS announced that the U.S. Food and Drug Administration, FDA, has approved a second indication for BREXAFEMME for the reduction in the incidence of recurrent vulvovaginal candidiasis, RVVC. "We are proud to be continuous innovators in the anti-infective space, and to provide a groundbreaking antifungal treatment option proven to reduce recurrence in women suffering from repeated vaginal yeast infections," said Marco Taglietti, M.D., President and Chief Executive Officer of SCYNEXIS. "BREXAFEMME was already the only non-azole oral therapy available for VVC and is now the only therapy FDA-approved for both VVC and RVVC. This exciting second indication supports our mission to arm both patients and healthcare providers with innovative solutions in the fight against severe fungal infections." The approval is based on positive results from the pivotal Phase 3 CANDLE study that evaluated the safety and efficacy of monthly dosing of ibrexafungerp to reduce the incidence of RVVC. Results showed that 65.4% of patients receiving ibrexafungerp achieved clinical success by having no recurrence at all, either culture-proven, presumed, or suspected, through Week 24 compared to 53.1% of placebo-treated patients.
FAVORING SLIGHTLY SCYX- SCYX SCYNEXIS, Inc. $1.560.41(+35.65%)3:59 PM 03/21/23 NASDAQ |$USD |Pre-Market:$1.70+0.14(+8.97%)<---------------
Van March 7 you said Naz was going lower. Much lower ooooo scary! March 7 Naz was 250 points lower-- I think you are smart enough to know when to shut up! If we have proven one thing over these many thousands of pages it's that i am the top market forecaster in the game. Should I go find the post i told you to erase. Your timing is 100% bad. each time you flip your view I laugh... Settle down and enjoy the ride... Soon you'll be calling for a top as you always do. You get scared at bottoms and tops... got to chill out. As The Lizard King Says-- " just sit back and enjoy it "
VOYA Voya Financial, Inc.- if the Fed works out this will hit $70 today or tomorrow. 2 day meeting-? $67.87 +2.49(+3.81%)4:00 PM 03/21/23 >>>>>>>>>>>>>>>>>Lets Check Back At Lunch>>>>>>>>>>>>>>>>>>
ON FEB 3RD YOU CALLED FOR 4200---> DID YOU MISS THE 400 POINT DROP? Stoney quit acting stupid ok. That's the only reason I post this stuff. Grow the f up.