Jun 30, 2:05 PM EDT
Unicycive plummets following second CRL for OLC for hyperphosphatemia
UNCY
Unicycive Therapeutics is down ~37% in Tuesday afternoon trading after announcing it has received a Complete Response Letter from the FDA for its resubmitted NDA for oxylanthanum carbonate (OLC) to treat hyperphosphatemia in patients with chronic kidney diseas…
Jun 30, 8:49 AM EDT
HCW Biologics regains Nasdaq compliance
HCWB
HCW Biologics ( HCWB ) regained compliance with Nasdaq's minimum bid price requirement. The company will remain under a mandatory Nasdaq monitoring period through June 17, 2027. To support long-term compliance, HCW Biologics will implement a 1-for-6 reverse st…
Jun 30, 3:49 AM EDT
Abivax stock jumps on positive Phase 3 ulcerative colitis data
ABVX
Tashi-Delek Abivax SA ( ABVX ) shares surged Tuesday premarket after the biotech reported positive topline supplemental data from its Phase 3 ulcerative colitis maintenance program, delivering strong efficacy while easing long-term safety and cancer concerns a…
Jun 30, 2:03 AM EDT
Innovent, Eli Lilly partner to commercialize Verzenios in China
LLYIVBIY
Innovent Biologics ( IVBIY ) and Eli Lilly and Company ( LLY ) Tuesday jointly announced that they have entered into a distribution and promotion agreement regarding Lilly's CDK4 & 6 inhibitor Verzenios® (abemaciclib) in mainland China . Innovent will be r…
Jun 30, 12:09 AM EDT
Nuvectis Pharma shares slide 19% on pricing of $100M stock offering
NVCT
Nuvectis Pharma ( NVCT ) had priced its underwritten public offering of 5M shares of its common stock at $20 per share, with expected gross proceeds of $100M, the company said Monday, sending shares down 19% in after-market trading. Nuvectis has also granted
Jun 29, 6:28 PM EDT
AbbVie touts phase 3 results for Epkinly in 2L large B-cell lymphoma
ABBVGMAB
Nemes Laszlo/iStock via Getty Images AbbVie ( ABBV ) said that its experimental T-cell engaging bispecific antibody Epkinly (epcoritamab) in combination with Revlimid (lenalidomide) led to better progression-free survival in large B-cell lymphoma patients who…
Jun 29, 6:14 PM EDT
Praxis sees encephalopathies asset relutrigine action date extended
PRAX
Tashatuvango/iStock via Getty Images The US FDA has extended the review period for Praxis Precision Medicines' ( PRAX ) application for relutrigine for SCN2A and SCN8A developmental and epileptic encephalopathies by three months to Dec. 27. The reason is that…
Jun 29, 5:50 PM EDT
Eli Lilly, Regeneron named to FDA pilot program to boost US drug manufacturing
LLYREGNAMRXKYKOF
Thibault Renard/iStock via Getty Images Eli Lilly ( LLY ) and Regeneron Pharmaceuticals ( REGN ) are among seven drug companies selected by the US FDA to become a part of the FDA PreCheck Pilot Program, which is designed to improve US drug manufacturing capabi…
Jun 29, 5:18 PM EDT
Z Squared raises $15.3M via equity sale to accelerate 100 MW AI capacity buildout
ZSQR
Z Squared ( ZSQR ) announced on Monday that it raised ~$15.3M via equity sales under its standby equity purchase agreement, without taking on any new debt. The company said it continues to maintain virtually no corporate debt, with the all-equity financing str…
Jun 29, 4:10 PM EDT
Nuvectis Pharma announces public share offering to support drug programs
NVCT
Nuvectis Pharma ( NVCT ) announced on Monday that it has launched an underwritten public offering of its common stock. The underwriters will have a 30-day option to purchase up to an additional 15% of the shares offered by the company. The
Jun 29, 9:56 AM EDT
Evommune drops on phase 2 data for EVO756 in urticaria
EVMN
Evommune ( EVMN ) is down ~31% in early Monday trading after reporting phase 2b data on chronic spontaneous urticaria candidate EVO756 that missed its primary goal. In the trial, patients received one of three doses or placebo. None of the active dose cohorts
Jun 29, 9:09 AM EDT
Decoy Therapeutics secures $3.5M PIPE financing; shares surge
DCOY
Decoy Therapeutics ( DCOY ) entered into a $3.5M PIPE financing with a single healthcare-focused institutional investor. The company will use the net proceeds to advance its lead antiviral candidate into clinical trials. The PIPE is priced at $5.91/share, with…
Jun 29, 7:23 AM EDT
NovaBridge Biosciences appoints Srishti Gupta as CEO
NBP
NovaBridge Biosciences ( NBP ) appointed Srishti Gupta as CEO and a member of its board, effective July 1, succeeding Xi-Yong (Sean) Fu, who is stepping down. Fu will remain with the company in an advisory role during the leadership transition. Gupta, an