Hillrom previously announced its intent to acquire Bardy Diagnostics. On April 10, the Medicare Administrative Contractor, or MAC, Novitas Solutions, published updated reimbursement rates applicable to the Current Procedural Terminology, or CPT, codes 93241, 93243, 93245 and 93247 for the extended Holter cardiac monitoring category applicable to all of BardyDx's products and services. The original Novitas rate decision was published on January 29, 2021. Following the updated Novitas rate decision, Hillrom reconfirms its position that a "Company Material Adverse Effect" has occurred under the acquisition agreement with BardyDx, and therefore closing conditions have not been satisfied. "Hillrom will not comment further due to current litigation with BardyDx, which is pending in the Delaware Court of Chancery with trial scheduled to begin May 5, 2021. Hillrom remains committed to creating long-term shareholder value, and as previously disclosed will host its fiscal second quarter 2021 earnings conference call and webcast on Friday, April 30," the company stated.

DiaSorin SpA (DSRLF) announced that its Board of Directors has unanimously approved and signed a definitive merger agreement for DiaSorin to acquire Luminex (LMNX) for a price of $37 per share in an all-cash transaction. This corresponds to a total equity value of approximately $1.8B on a fully diluted basis and an enterprise value of approximately $1.8B. Following the acquisition, the combined entity will have combined 2020 revenues of approximately EUR 1.25B, adjusted EBITDA of approximately EUR 472M, and positive Net Financial Position of approximately EUR 335M. The transaction is expected to close within the third quarter of 2021 and is subject to Luminex shareholder approval and to other customary closing conditions, including the satisfaction of antitrust and CFIUS regulatory requirements. The transaction will be immediately accretive to DiaSorin's earnings per share following closing of the transaction and will generate an attractive return on invested capital profile. The combination is also anticipated to result in cost synergies of approximately $55M within 3 years after closing.

Checkmate Pharmaceuticals announced the presentation of new translational data from Checkmate's Phase 1b trial of vidutolimod in combination with pembrolizumab in patients with advanced anti-PD-1 refractory melanoma. Key highlights from these clinical data include: 93% of patients had progressive disease as their last response assessment on prior PD-1 blockade therapy, 42% had an elevated LDH, and the median sum of the target lesions longest diameter was 6.7 cm, indicating advanced disease; Response rates to vidutolimod in combination with pembrolizumab were similar across baseline patient characteristics including BRAF mutation, LDH level, number of prior systemic cancer treatments, best response to prior PD-1 blockade therapy, and prior ipilimumab; Responders and non-responders were not distinguished by baseline tumor characteristics including PD-L1 CPS, IFNg transcriptional signature, CD8+ T cells, or nonsynonymous mutations; All patients showed the expected rapid induction of anti-Qb antibodies to the virus-like particle, which facilitate the pharmacodynamic response to vidutolimod, and the antibody titers were not associated with clinical response; Clinical activity of vidutolimod in combination with pembrolizumab was associated with serum CXCL10 induction magnitude, induction of an inflammatory gene expression profile, and CD8+ T cells in injected and noninjected tumors.

BeiGene (BGNE) announced that clinical data on its anti-PD-1 antibody tislelizumab, in combination with the investigational spectrum-selective kinase inhibitor sitravatinib being jointly developed with Mirati Therapeutics (MRTX), were presented in two oral presentations at the American Association for Cancer Research Annual Meeting 2021. Data presented at the meeting were from two cohorts of a Phase 1b trial, in patients with unresectable or metastatic melanoma who were refractory or resistant to PD-1/L1 inhibitors and in patients with advanced platinum-resistant ovarian cancer. BeiGene has an exclusive collaboration and license agreement with Mirati for the development, manufacturing and commercialization of sitravatinib in Asia - excluding Japan, Australia, and New Zealand. This open-label, multicohort, Phase 1b trial was designed to evaluate safety/tolerability and preliminary antitumor activity of sitravatinib in combination with tislelizumab in advanced solid tumors. The primary endpoint of the trial was safety/tolerability of the combination; key secondary endpoints include investigator-assessed objective response rate, disease control rate, and progression-free survival per RECIST v1.1; overall survival was also assessed. At the time of data cutoff on October 13, 2020, a total of 25 patients with unresectable or metastatic melanoma who were refractory or resistant to anti-PD-1/L1 antibodies and had not received other prior immunotherapy had been enrolled in cohort G of the Phase 1b trial, including 12 with cutaneous subtype, seven with acral subtype, and four with mucosal subtype. At the time of data cutoff, 16 patients remained on study treatment. With a median follow-up time of 5.5 months, results included: All 25 patients experienced at least one treatment-emergent adverse event of any grade; Twelve patients experienced at least one Grade greater than or equal to 3 TEAE; One patient experienced a serious TEAE of anal abscess, associated with sitravatinib; Treatment discontinuation due to TEAEs occurred in two patients, with one discontinuing tislelizumab due to vaginal hemorrhage and the other sitravatinib due to increased BCK; Dose interruptions and reductions of sitravatinib occurred in 18 patients and 13 patients, respectively; All 25 patients were evaluable for efficacy and the confirmed ORR was 24%, including six partial responses, and the disease control rate was 88%; and the media duration of response was not reached, and the investigator-assessed median PFS was 6.7 months. Results in Patients with Advanced PROC include: At the time of data cutoff on October 13, 2020, a total of 60 patients with recurrent PROC who had no prior exposure to anti-PD-1/L1 antibodies had been enrolled in cohort E of the Phase 1b trial and 13 of them remained on study treatment. These patients received a median of four prior regimens. With a median follow-up time of six months, results included: Fifty-eight patients experienced at least one TEAE of any grade; Forty-one patients experienced at least one Grade greater than or equal to 3 TEAE; Forty-two patients experienced at least one serious TEAE; Treatment discontinuation due to TEAEs occurred in 23 patients, with nine patients discontinuing tislelizumab and 14 sitravatinib; Dose interruptions and reductions of sitravatinib occurred in 50 patients and 30 patients, respectively, and dose interruption of tislelizumab occurred in one patient; Four fatal TEAEs were reported, with none considered related to study treatment; Among the 53 patients who were evaluable for efficacy, the confirmed ORR was 26%; The median DoR was 4.7 months; and The median PFS and OS was 4.1 months and 12.9 months, respectively.

Lyra Therapeutics presented data from its Phase 2 LANTERN study of LYR-210, the company's lead long-acting product candidate for chronic rhinosinusitis, at the Combined Otolaryngology Spring Meetings 2021. LYR-210 is an investigational product candidate designed to be administered in-office and to deliver a sustained release therapeutic for up to six months at difficult-to-access nasal inflammation sites, as a non-invasive alternative to surgery for patients who have failed medical management. Lyra reported positive topline data from the LANTERN study in December 2020. The COSM oral presentation, titled Long-acting implantable corticosteroid matrix for chronic rhinosinusitis: Results of LANTERN Phase 2 randomized controlled study, contains the full 24-week data set from the company's Phase 2 clinical trial of LYR-210. Previously unpublished data included: improvement from baseline in bilateral ethmoid Zinreich scores by magnetic resonance imaging; symptom improvement in both polyp and non-polyp patients; and the need for and use of rescue medication during the trial. In Polyp vs Non-Polyp patients, symptom improvement was observed in both polyp and non-polyp patients, with 100% of patients at the 7500microgram dose in each group achieving the minimal clinically important difference of 8.9 points for SNOT-22 total score by week 24, with a single administration of LYR-210. In the LANTERN study, subjects underwent paranasal sinus MRI at baseline as well as at the end of treatment. LYR-210 achieved improvement in bilateral ethmoid Zinreich scores at week 24 in a dose-dependent manner, providing evidence of disease modification, with the 7500microgram dose achieving significant improvement compared to control between the two timepoints. Only 1 patient in the 7500microgram group and 2 patients in the 2500microgram group required a rescue treatment compared to 7 patients in the control group over the 24-week treatment period. The first incidence of rescue treatment in the control group occurred at week 2, while the only patient to require rescue treatment in the 7500microgram group did not require rescue treatment until after week 18. As such, LYR-210 reduced the need for rescue treatment. The need for rescue treatment in the LANTERN study was determined by the treating physician. Separately, Lyra has shared an analysis of the LANTERN study focused on a composite of three of the cardinal symptoms of CRS. Lyra announced an analysis of a composite score of three cardinal symptoms of CRS, which includes nasal blockage, nasal discharge and facial pain, which are the most prevalent symptoms for surgically naive CRS patients both with and without nasal polyps. With a single administration, LYR-210 achieved statistically significant improvement in the 3CS composite score compared to control at week 24 and at earlier timepoints.

Blueprint Medicines announced that multiple presentations across the company's leading systemic mastocytosis program were reported at the virtual American Association for Cancer Research Annual Meeting 2021. The presentations focused on registrational PATHFINDER trial data of AYVAKIT in advanced SM, PIONEER Part 1 data highlighting the impact of AYVAKIT on skin manifestations of SM, and Phase 1 trial data for BLU-263, a next-generation KIT D816V inhibitor. Blueprint Medicines is developing AYVAKIT for advanced and non-advanced SM, and BLU-263 to further address the range of patient needs in non-advanced SM and other mast cell disorders. In a pre-specified interim analysis from the PATHFINDER trial, 32 patients who primarily received a starting dose of 200 mg once daily were evaluable for response, as of a data cutoff date of June 23, 2020. Combined with Phase 1 EXPLORER trial results, these data support Blueprint Medicines' marketing applications in advanced SM under review in the U.S. and Europe. Overall, 75 percent of patients had a confirmed response, which was defined as complete remission with full or partial recovery of peripheral blood counts, partial remission or clinical improvement. The median time to response was two months, and all responses were ongoing at a median follow-up of 10.4 months. The CRh rate was 19 percent, with a median time to CRh of 5.6 months. These results show that responses deepened over time at a rate consistent with the EXPLORER trial. The company said that AYVAKIT led to robust and durable benefits across a number of additional clinical activity measures. In new patient-reported outcomes data, AYVAKIT showed a statistically significant reduction in total symptom score after 40 weeks, as measured by the Advanced Systemic Mastocytosis Symptom Assessment Form. Treatment with AYVAKIT resulted in robust improvements in patient-reported quality of life, based on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire. Across multiple measures of mast cell burden, AYVAKIT showed profound reductions in serum tryptase, bone marrow mast cells, KIT D816V allele burden and spleen volume. Consistent with previously disclosed data, AYVAKIT was generally well-tolerated in 62 patients enrolled in the PATHFINDER trial, and most adverse events were reported as Grade 1 or 2. The most common AEs were peripheral edema, periorbital edema, thrombocytopenia, anemia, neutropenia, diarrhea, nausea, vomiting and fatigue. Three patients discontinued AYVAKIT due to treatment-related AEs, and most patients have remained on treatment as of the data cutoff date. In non-advanced SM, skin symptoms frequently persist and can severely impact quality of life. To assess the effects of AYVAKIT on mast cell burden in skin lesions, skin biopsies were obtained at baseline and week 12 in Part 1 of the PIONEER trial. Immunohistochemistry tests were performed to determine the proportion of aberrant mast cells in skin tissue, based on expression of CD25, CD30 and other transmembrane receptors observed in SM. Skin lesional tissue at baseline had more CD30-positive than CD25-positive mast cells. Following 12 weeks of treatment, AYVAKIT significantly reduced the proportion of aberrant CD30-positive mast cells in skin lesions compared to placebo, as of a data cutoff date of December 4, 2020. These data expand on previously reported results showing the impact of AYVAKIT on skin manifestations of SM, and suggest that CD30 may be an important biomarker of aberrant mast cells in SM-related skin lesions. A placebo-controlled, Phase 1 trial evaluated the safety, tolerability and pharmacokinetics of BLU-263 in healthy volunteers. This AACR presentation reported on single ascending dose cohorts and multiple ascending dose cohorts, as of a data cutoff date of November 9, 2020. BLU-263 was well-tolerated across all doses studied, and all AEs were reported as Grade 1. Pharmacokinetic data showed dose-dependent increases in systemic exposure of BLU-263, with the half-life of BLU-263 supporting once-daily dosing. Based on these results, the company plans to evaluate BLU-263 at doses ranging from 25 to 100 mg once daily in Part 1 of the Phase 2/3 HARBOR trial in patients with non-advanced SM, which the company plans to initiate in mid-2021.

Eli Lilly announced for the first time data from the Phase 1/2 LIBRETTO-001 trial showing treatment with Retevmo demonstrated encouraging antitumor activity and safety across RET fusion-positive advanced solid tumors beyond lung and thyroid cancers, including multiple treatment-refractory gastrointestinal malignancies. In the Phase 1/2 LIBRETTO-001 trial, 32 adult patients with 12 unique RET fusion-positive advanced cancer types were enrolled by the efficacy cutoff date of September 19, 2020. Cancer types treated included pancreatic, colon, breast, salivary, sarcoma, carcinoid, rectal neuroendocrine, small intestine, xanthogranuloma, ovarian, pulmonary carcinosarcoma, and unknown primary cancers. Among the 32 patients, 62.5 percent had gastrointestinal tumors. Across all 32 patients, the confirmed objective response rate was 47 percent. Confirmed responses were observed in nine unique RET fusion-positive advanced cancer types. The median duration of response was not reached, with median follow-up of 13 months. Responses were ongoing in 73 percent of responding patients.

Alnylam Pharmaceuticals announced interim results from the ongoing Phase 1 study of ALN-AGT, a subcutaneous investigational RNAi therapeutic targeting liver-expressed angiotensinogen for the treatment of hypertension. ALN-AGT treatment was associated with dose-dependent knockdown of AGT and reductions in blood pressure with a durability that supports the potential for a once quarterly or biannual dosing regimen, and was found to be generally safe and well tolerated. Eighty-four patients with hypertension were randomized in this double-blind, placebo-controlled, single ascending dose study evaluating the safety, tolerability and preliminary pharmacokinetic and pharmacodynamic activity of ALN-AGT. Patients, who were either treatment naive or had discontinued other anti-hypertensive medications prior to study entry, enrolled in ascending dose cohorts of 10 mg, 25 mg, 50 mg, 100 mg, 200 mg, 400 mg or 800 mg ALN-AGT. Patients treated with single doses of ALN-AGT at 100 mg or higher experienced durable reductions in serum AGT of more than 90 percent through 12 weeks. In the 800 mg dose cohort, all patients experienced reductions in serum AGT of 96 - 98 percent at Week 12. Concomitant reductions in BP were observed with AGT knockdown, with clinically meaningful mean reductions in 24-hour systolic blood pressure of greater than 10 mm Hg observed at Week 8 after single doses of 100 mg or higher. At 800 mg, mean reductions in 24-hour SBP of 17 mm Hg were observed at Week 8 and sustained through Week 12. All data are as of a February 25, 2021 cut-off date. Suboptimal BP control remains the most common attributable risk factor for cardiovascular disease and cerebrovascular disease, and a leading cause of chronic kidney disease progression. These durable pharmacologic effects of ALN-AGT may support tonic control of BP with once quarterly and potentially biannual dosing. Less frequent dosing than available with current treatment options may help achieve improved medication adherence, an important part of maintaining BP control. ALN-AGT was shown to be generally well tolerated with an acceptable safety profile that supports advancement into Phase 2 studies. Most adverse events were mild or moderate in severity and resolved without intervention, with the most common AE consisting of mild and transient injection site reactions in 5 out of 56 patients receiving ALN-AGT. There were no clinically significant elevations in serum alanine aminotransferase, serum creatinine or serum potassium, and no patient required intervention for hypotension. There were no treatment-related serious AEs, deaths or AEs leading to study withdrawal.

Greenwich LifeSciences presented a poster of the final 5 year GP2 Phase IIb clinical trial immune response data at the 2021 AACR Annual Meeting. Immune response is the primary mechanism of action for GP2 and is critical to developing dosing and booster treatment strategies that are designed to achieve and sustain peak immunity, as well as to prevent metastatic breast cancer recurrences. The company said that potent immune response data supports the previously reported clinical outcome of 0% metastatic breast cancer recurrences over 5 years of follow up, if a patient completes the Primary Immunization Series over the first 6 months of GP2 treatment. Statistically significant peak immunity was reached after 6 months of GP2 treatment as measured in both the Dimer Binding Assay and the DTH skin test. HER2 3+ population immune response was similar to the HER2 1-2+ population immune response, suggesting the potential to treat the HER2 1-2+ population with GP2 immunotherapy in combination with trastuzumab based products and other clinically active agents. Broad based immune response suggests that GP2 immunotherapy and Herceptin based products may also have the potential to treat other HER2 1-3+ expressing cancers.