Biotech

The U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet on Thursday, June 18, to discuss approval of Moderna Inc.’s (NASDAQ:MRNA) experimental mRNA-based flu vaccine. FDA Advisory Committee To Review Moderna Flu...

Scilex Holding Company (NASDAQ:SCLX) shares surged 18.79% in Tuesday's regular session after the company announced that its Dream Bowl I Meme Coin tokens could begin trading on Biconomy Exchange as early as June 23. Scilex is a revenue-generating biotech company focused on non-opioid pain...

Lunai Bioworks Inc. (NASDAQ:LNAI) shares are trending on Wednesday. LNAI shares soared 80.88% to $5.15 after the bell on Tuesday, after the AI-powered biotechnology and biodefense company disclosed via a Securities and Exchange Commission filing that Nasdaq confirmed it had regained compliance with...

Edgewise Therapeutics Inc. (NASDAQ:EWTX) on Tuesday released topline results from the 12-week Part D cohort of its Phase 2 CIRRUS-HCM trial. Patients received doses ranging from 25 mg to 150 mg. EDG-7500 demonstrated clinically meaningful improvements in patients with both obstructive and...

Moderna Inc. (NASDAQ:MRNA) announced changes to its operating model and leadership structure. The biotechnology company is preparing for potential new product launches and advancing a broad pipeline. The company said the changes will support both its near-term and long-term objectives. On May 1,...

Adaptive Biotechnologies Corporation (NASDAQ:ADPT) shares are trading higher during Tuesday’s session as the company has announced plans to separate its Minimal Residual Disease (MRD) and Immune Medicine businesses. The decision announced on Monday comes after both segments have shown...

HCW Biologics Inc. (NASDAQ:HCWB) stock fell during Tuesday’s session. The company announced preliminary results from its Phase 1 trial for HCW9302, an IL-2-based treatment for alopecia areata. All participants in the second-dose cohort showed clinical responses after a single dose of the...

Cuprina Holdings (Cayman) Limited (NASDAQ:CUPR) shares are trending on Monday. CUPR shares fell 22.47% to $6.52 in after-hours trading on Monday. The stock of the Singapore-based biomedical company developing wound care and biotechnology products surged 111.84% intraday to $8.41, according to...

Regentis Biomaterials Ltd. (NYSE: RGNT) shares are trending on Monday. RGNT shares fell 9.15% to $8.54 in after-hours trading on Monday. The stock of the regenerative medicine company surged 506.45% intraday to $9.40, according to market data. Public Offering Withdrawal Draws Attention The move...

Eli Lilly and Co. (NYSE:LLY) said Sunday that its Phase 3 BRUIN CLL-322 trial met its primary endpoint, with the addition of Jaypirca (pirtobrutinib) to venetoclax and rituximab significantly improving progression-free survival in patients with relapsed or refractory chronic lymphocytic leukemia or...

The U.S. Food and Drug Administration has granted accelerated approval to Sanofi SA’s (NASDAQ:SNY) Tzield (teplizumab-mzwv) to delay the decline of endogenous insulin production in children ages 8 to 17 who have been recently diagnosed with stage 3 type 1 diabetes (T1D). The decision expands...

Rhythm Pharmaceuticals Inc. (NASDAQ:RYTM) stock is trading higher on Monday after the company reported preliminary results from an ongoing Phase 2 study evaluating setmelanotide in patients with Prader-Willi syndrome (PWS). The six-month data shared on Saturday showed improvements in body mass...

AstraZeneca Plc (NYSE:AZN) received two significant regulatory updates from the U.S. Food and Drug Administration, with its cancer therapy Truqap gaining approval for a subset of prostate cancer patients and its kidney disease treatment Ultomiris receiving Priority Review for a new indication....

Neumora Therapeutics Inc. (NASDAQ:NMRA) on Monday said it is discontinuing development of its lead depression candidate, navacaprant, after two Phase 3 studies failed to achieve statistical significance on both primary and key secondary endpoints in patients with major depressive disorder (MDD)....

Elicio Therapeutics Inc. (NASDAQ:ELTX) stock is trading lower on Monday after disappointing results from its Phase 2 AMPLIFY-7P study of ELI-002 7P in patients with mutant KRAS-driven pancreatic ductal adenocarcinoma (PDAC) following standard locoregional treatment. Elicio Therapeutics Misses...