Lantheus Holdings LNTH

Unicycive Therapeutics, Inc. (Nasdaq: $UNCY ) has a Prescription Drug User Fee Act (PDUFA) target action date of March 25, 2027 for oxylanthanum carbonate (OLC), its investigational oral phosphate binder for the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis, now that the U.S. Food and Drug Administration (FDA) has accepted the company's New Drug Application (NDA) resubmission. The FDA has deemed the resubmission a Class II with a six-month review period from the resubmission date. Unicycive Therapeutics, Inc. is a B2i Digital Featured Company. See the company's in-depth profile at: https://b2idigital.com/unicycive-therapeutics Under the 505(b)(2) regulatory pathway, the NDA for OLC is supported by clinical, preclinical and Chemistry, Manufacturing, and Controls (CMC) data: • Three clinical studies: a Phase 1 study in healthy volunteers, a bioequivalence study in healthy volunteers, and a tolerability study of OLC in CKD patients on dialysis • Multiple preclinical studies • The resubmission includes CMC data from a new third-party drug product manufacturing vendor Regarding the review, Shalabh Gupta, M.D., Chief Executive Officer of Unicycive, stated: "We hope to continue working with the FDA toward potential approval of this important medication to patients with CKD on dialysis who need additional treatment options for managing hyperphosphatemia." Read the full release: https://ir.unicycive.com/news/detail/128/unicycive-therapeutics-announces-fda-acceptance-of Unicycive Therapeutics is a biotechnology company developing novel treatments for kidney diseases. Unicycive’s lead investigational treatment is oxylanthanum carbonate, a novel phosphate binding agent for the treatment of hyperphosphatemia in patients with chronic kidney disease who are on dialysis. Unicycive’s second investigational treatment UNI-494 is intended for the treatment of conditions related to acute kidney injury. It has been granted orphan drug designation (ODD) by the FDA for the prevention of Delayed Graft Function (DGF) in kidney transplant patients and has completed a Phase 1 dose-ranging safety study in healthy volunteers. For more information, please visit Unicycive.com and follow us on LinkedIn and X. Discover more Featured Companies, Featured Experts, and upcoming Featured Conferences at b2idigital.com. David Shapiro, Chief Executive Officer of B2i Digital, personally purchased in the open market and currently owns shares of unrestricted UNCY stock, in line with B2i Digital’s practice of investing alongside its Featured Companies. B2i Digital is not a broker-dealer or investment adviser. This post is informational and not an offer or solicitation regarding any security. See the complete Disclosure at https://b2idigital.com/disclaimer. $XOMA, $RMTI, $LNTH, $XBI

$LNTH Lantheus filed supplemental proxy disclosures ahead of the Oct 14 shareholder vote on the Curium buyout, and the numbers inside Morgan Stanley's fairness opinion are worth a look. Terms: 102.50 in cash per share, plus a contingent value right worth up to 12.00 more across eight sales milestones. Morgan Stanley's DCF put standalone value at 88.10 to 118.60 per share. Its public-company comps analysis came in lower: 63.85 to 84.20. So the 102.50 deal price sits mid-range of the DCF but above the entire comps range. The Street's own targets (98 to 129, twelve analysts) put the bid in the lower half of their band. One structural note: the merger needs a majority of all outstanding shares, and abstentions count as no votes. Watching the vote count, not just the price.

Unicycive Therapeutics, Inc. (Nasdaq: $UNCY ) has appointed Meredith Manning, M.B.A., to its Board of Directors, where she will serve on the Audit, Compensation, and Nominating and Corporate Governance Committees and will chair the Nominating and Corporate Governance Committee. Unicycive Therapeutics, Inc. is a B2i Digital Featured Company. See the company's in-depth profile at: https://b2idigital.com/unicycive-therapeutics Ms. Manning has more than 25 years of global biopharmaceutical experience, including commercial leadership roles at three companies: • As Chief Commercial Officer of Soleno Therapeutics, Inc., she built the commercial organization from inception and led the U.S. launch of VYKAT™ XR, the first FDA-approved treatment for hyperphagia in Prader-Willi syndrome • As General Manager, and later, President, The Americas, of PharmaEssentia Corporation, she built the U.S. organization and led the U.S. commercial launch of BESREMi® • At Shire (formerly Baxter/Baxalta), she led a seven-brand portfolio across more than 65 countries Regarding Ms. Manning's role as Unicycive advances oxylanthanum carbonate (OLC), Shalabh Gupta, M.D., Chief Executive Officer of Unicycive Therapeutics, said: "We look forward to benefiting from Meredith’s strategic insight and first-hand experience as we advance OLC towards potential approval and prepare for the next stage of the Company’s growth." Read the full release: https://ir.unicycive.com/news/detail/127/unicycive-therapeutics-appoints-meredith-manning-to-board Unicycive Therapeutics is a biotechnology company developing novel treatments for kidney diseases. Unicycive’s lead investigational treatment is oxylanthanum carbonate, a novel phosphate binding agent for the treatment of hyperphosphatemia in patients with chronic kidney disease who are on dialysis. Unicycive’s second investigational treatment UNI-494 is intended for the treatment of conditions related to acute kidney injury. It has been granted orphan drug designation (ODD) by the FDA for the prevention of Delayed Graft Function (DGF) in kidney transplant patients and has completed a Phase 1 dose-ranging safety study in healthy volunteers. For more information, please visit Unicycive.com and follow us on LinkedIn and X. Discover more Featured Companies, Featured Experts, and upcoming Featured Conferences at b2idigital.com. David Shapiro, Chief Executive Officer of B2i Digital, personally purchased in the open market and currently owns shares of unrestricted UNCY stock, in line with B2i Digital’s practice of investing alongside its Featured Companies. B2i Digital is not a broker-dealer or investment adviser. This post is informational and not an offer or solicitation regarding any security. See the complete Disclosure at https://b2idigital.com/disclaimer. $XOMA, $RMTI, $LNTH, $XBI

H.C. Wainwright on $TLX (Buy; PT $20) said: We view the FDA's decision to grant Fast Track designation to BiPASS as incrementally positive. $LNTH $NVS GEHC MYGN OPK MDXH Here's what H.C. Wainwright went on to say in its note to investors: https://x.com/Quantumup1/status/2105371184313336167?s=20

Unicycive Therapeutics, Inc. (Nasdaq: $UNCY ) announced on September 29, 2026 that it has resubmitted its New Drug Application (NDA) for oxylanthanum carbonate (OLC), its investigational oral phosphate binder for hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis. The company anticipates FDA acceptance of the NDA within 30 days, with a new assigned PDUFA date expected to be six months from resubmission. Unicycive Therapeutics, Inc. is a B2i Digital Featured Company. See the company's in-depth profile at: https://b2idigital.com/unicycive-therapeutics The resubmission carries CMC data from a new third-party drug product manufacturing vendor, and the company's expected cash runway extends into the second half of 2027: • The new vendor has already produced OLC drug product and completed 12-month stability studies • Unaudited cash, cash equivalents and marketable securities totaled $61.4 million as of June 30, 2026, supporting continued OLC commercial launch preparation • The company also provided additional in-vitro bridging data between the two vendors, as recommended by the FDA in previous discussions Regarding the resubmission, "We believe this resubmission reflects an efficient path to potential approval and, if approved, a potentially faster path to bringing OLC to patients who need additional treatment options," said Shalabh Gupta, M.D., Chief Executive Officer of Unicycive. Read the full release: https://ir.unicycive.com/news/detail/126/unicycive-therapeutics-announces-resubmission-of-new-drug Unicycive Therapeutics is a biotechnology company developing novel treatments for kidney diseases. Unicycive’s lead investigational treatment is oxylanthanum carbonate, a novel phosphate binding agent for the treatment of hyperphosphatemia in patients with chronic kidney disease who are on dialysis. Unicycive’s second investigational treatment UNI-494 is intended for the treatment of conditions related to acute kidney injury. It has been granted orphan drug designation (ODD) by the FDA for the prevention of Delayed Graft Function (DGF) in kidney transplant patients and has completed a Phase 1 dose-ranging safety study in healthy volunteers. For more information, please visit Unicycive.com and follow us on LinkedIn and X. Discover more Featured Companies, Featured Experts, and upcoming Featured Conferences at b2idigital.com. David Shapiro, Chief Executive Officer of B2i Digital, personally purchased in the open market and currently owns shares of unrestricted UNCY stock, in line with B2i Digital’s practice of investing alongside its Featured Companies. B2i Digital is not a broker-dealer or investment adviser. This post is informational and not an offer or solicitation regarding any security. See the complete Disclosure at https://b2idigital.com/disclaimer. $XOMA, $RMTI, $LNTH, $XBI

$LNTH another approval. Scam ass management gave this CO away for free. And golden parachute.

$RADX $CATX $LNTH $TLX $AUPH + 12,5% since my post. You guys missed on that. Not too late to join I guess. The run is starting.

$LNTH / Curium have to file HSR by today. Not a clearance deadline. A filing deadline — written into the merger agreement so one side can't stall the clock by sitting on the paperwork. Boring covenant. It's also why deals with motivated buyers close faster than deals without.