Arvinas downgraded to Market Perform from Outperform at Leerink
Leerink analyst Andrew Berens downgraded Arvinas (ARVN) to Market Perform from Outperform with a price target of $9, down from $10, after the company presented full results from the Phase 3 VERITAC-2 trial evaluating vepdegestrant in second-line HR+/HER2- metastatic breast cancer patients. The firm says that while the full presentation demonstrates the drug is active in patients with ESR1 mutations and likely approvable, it is not convinced vepdeg is best-in-class. Further, a number of key uncertainties in the rapidly evolving treatment paradigm for ESR1m breast cancer landscape have emerged, the analyst tells investors in a research note. Leerink 'gradually tempered the ESR1m rate in second-line from 30% to 15% to reflect potential impact from the SERENA-6 data, as well as ongoing first-line oral SERD trials, lowering its assumed worldwide peak vepdeg sales to $416M from $576M.
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USA Today
an hour ago
- USA Today
A new Lululemon dress is stirring up the internet. Here's why
A new Lululemon dress is stirring up the internet. Here's why "Is this just for the label? Who walks into Lululemon and they're like, 'Oh my gosh, that's the cutest summer dress I've ever seen?'" TikTok creator Dasie said. Show Caption Hide Caption Steven Madden to buy UK-based luxury shoe brand Kurt Geiger The world of fashion footwear has a new pair, as shoe designer Steven Madden said it would buy UK-based luxury brand Kurt Geiger. The all-cash deal, valued at $360 million, expands Steve Madden's presence in international markets. The internet is going crazy over a new dress, and no, it is not "the dress" from 2015. Behind the hysteria is a multi-functional athleisure maxi skirt-dress duo from trendy sportswear brand Lululemon. Lululemon's new 2-in-1 Maxi Dress, a basic one-color dress that can be worn as an ankle-length maxi skirt or strapless dress, has garnered mixed emotions from social media users. Some believe the nearly $150 dress is worth every penny because of its versatility, enough that the dress is sold out in every size except extra large, and others think it's undeserving of the hype. Interested to hear what people think? Here's what the internet is saying about the viral Lululemon 2-in-1 Maxi Dress. Viral trends: 10 years later, 'the dress' still divides us. But we understand a lot more about why. How much does Lululemon's 2-in-1 Maxi Dress cost? The 2-in-1 Maxi Dress costs $148 on the Lululemon website, before shipping. As of June 3, the dress was sold out in every size and color but Light Ivory in extra large. However, shoppers can sign up to be notified if and when the dress will be restocked on the Lululemon website. What are people saying about the dress? In a TikTok video with 83,000 views as of June 3, content creator Chantalissa models the dress, which she encourages her followers to buy. "It takes a lot for me to buy something that I see on TikTok, but the second I saw this 2-in-1 dress from Lululemon, I literally went to the store instantly and tried it on," Chantalissa said in her video. "I actually feel like a princess in it. It's so beautiful, so flowy. I'm obsessed." On the flip side, content creator Dasie expressed her confusion about the dress's popularity, specifically because of the price and simple design. "Is this just for the label? Who walks into Lululemon and they're like, 'Oh my gosh, that's the cutest summer dress I've ever seen?'" Dasie said in a TikTok video with about 4,800 views as of June 3. "I'm not trying to be mean. No hate. You could walk into Walmart and get a cuter dress than that." To 'thneed' or not to 'thneed' Lululemon's 2-in-1 Maxi Dress quickly became deemed a "thneed" on social media. A "thneed" is a garment that can be worn multiple ways, and its name comes from the highly versatile object knitted by the Once-ler in Dr. Seuss' "The Lorax." As depicted in the original Lorax book and movie, a "thneed" can be used as a shirt, sock, glove, hat, carpet or pillow − "a fine thing that all people need." In addition to being multifunctional, a "thneed" is cheap ($3.98, as outlined in "The Lorax") and ethically sourced, as "thneeds" are made entirely from foliage of Truffula Trees, the circular and wispy trees in the story. While some may believe the 2-in-1 Maxi Dress is a "thneed," TikTok user Rachael, commonly known as "the Thneed Girl," disagrees. "The garment really isn't transforming at all. It's just going from being worn down at the hip to up at like the chest. It's really not transforming like a thneed really needs to do," Rachael said in a TikTok video. "You can love this dress. You can hate this dress. You can make whatever arguments you want about the ethics of this dress, Lululemon as a company, I really don't care, but it's not a thneed." Greta Cross is a national trending reporter at USA TODAY. Story idea? Email her at gcross@
Yahoo
an hour ago
- Yahoo
Bluejay Diagnostics Provides Mid-Year Business and Corporate Update
ACTON, Mass., June 03, 2025 (GLOBE NEWSWIRE) -- Bluejay Diagnostics, Inc. (NASDAQ: BJDX) ('Bluejay' or the 'Company'), a medical diagnostics company developing rapid near-patient testing solutions for critical care, today provided a 2025 mid-year business and corporate update. Recent Business Highlights and Developments: SYMON Clinical Program Update: The Company has initiated its pivotal SYMON-II clinical study, following the successful completion of the SYMON-I pilot study, for which a primary analysis highlighted that IL-6 levels within 24 hours of ICU admission may predict sepsis patient mortality out to 28 days. Currently, the Company is collecting, freezing and biobanking samples, with plans to subsequently measure IL-6 concentrations in the bio banked samples near the end of patient enrollment or after the patient enrollment has completed, and later analyze the IL-6 data with the patient outcomes to see if the established IL-6 cutoff value has been validated for 28-day all-cause mortality. Patient enrollment started during the fourth quarter of 2024 and is continuing. The Company's goal is to use the Symphony IL-6 test to complete the testing in the SYMON-II clinical trial, following completion of the Company's redevelopment of the cartridges used in the Symphony system. Regulatory Pathway: Based on previous interactions with the U.S. Food and Drug Administration (FDA), the Company continues to plan for a 510(k) submission for its Symphony IL-6 test, with a goal of submitting a 510(k) regulatory application to the FDA in the fourth quarter of 2027 and an objective of achieving FDA approval as early as the third quarter of 2028. Manufacturing Progress: Bluejay continues its collaboration with SanyoSeiko for manufacturing of the Symphony analyzer. The Company is also beginning the process of redeveloping aspects of the Symphony cartridges to address several technical challenges to bring Symphony to a level consistent with necessary performance and quality requirements. While the Company continues to explore the potential for conducting cartridge redevelopment at an in-house facility, it is now actively exploring other alternative pathways for how to pursue such redevelopment, including by outsourcing this work to a third-party contract manufacturing organization that would oversee this process and provide cartridge supply to the Company. Recent Financial Results: As of April 30, 2025, the Company possessed cash and cash equivalents of approximately $ 5.7 million, while having current liabilities of approximately $1.0 million. The Company incurred losses of approximately $7.7 million for the fiscal year ended December 31, 2024, and $1.9 million for the fiscal quarter ended March 31, 2025. April 2025 Private Placement: In April 2025, the Company raised gross proceeds of approximately $3.8 million via inducement agreements related to Class C warrant exercises and the issuance of new Class E warrants, strengthening the near-term balance sheet. The Company continues to seek further financing, with a goal of raising at least $30 million in the aggregate through the end of the 2027 fiscal year. Downsizing of Organization: To preserve cash resources and seek to extend its cash runway, the Company has recently implemented a series of recent cost savings measures in its product development operations and has reduced its overall Company-wide full-time employee headcount to 5 persons following the recent departure of its Chief Technology Officer. Upcoming 2025 Annual Meeting of Stockholders: The Company's 2025 annual meeting of stockholders (the '2025 Annual Meeting') is scheduled to be held at 1:00 p.m. Eastern Time on June 18, 2025. The Company's Board of Directors will be reduced from six to five seats as of the 2025 Annual Meeting, and the Board has nominated five currently serving directors to stand for re-election, three of whom are independent, non-employee directors. The Company has proposed the consideration of two reverse stock split proposals at the 2025 Annual Meeting, which are intended, if ultimately approved and implemented, to increase the price of the Company's common stock to assist the Company in continuing to meet the Nasdaq Stock Market's minimum price per share criteria for continued listing on that exchange. 'We continue to make focused progress despite a constrained capital environment,' said Neil Dey, Bluejay's President and Chief Executive Officer. 'Our SYMON-I clinical data underscored IL-6's potential to transform sepsis risk stratification and we look forward to the future completion of our SYMON-II clinical trial. We are actively engaged in identifying funding and strategic opportunities to advance Symphony's regulatory and commercial roadmap.' For additional information, please refer to Bluejay's filings with the Securities and Exchange Commission (the 'SEC'), including its quarterly report on Form 10-Q for the period ended March 31, 2025, filed with the SEC on May 13, 2025 and available here. About the Symphony IL-6 Test: The Symphony Test platform is designed to determine patient acuity for triage and monitoring based on the measurement of a specific biomarker. The Symphony IL-6 Test to determine patient acuity for sepsis triage and monitoring ('Symphony IL-6 Test') is currently Bluejay's lead product candidate. About the SYMON Clinical Study Program: The SYMON Clinical Study Program includes SYMON-I I ( ID NCT06181604) and SYMON-II (NCT06654895). SYMON-I is a pilot study to determine IL-6 levels associated with various endpoints, including, but not limited to 28-day all-cause mortality and in-hospital mortality. The SYMON-II study is the pivotal study to validate the outcomes of the SYMON-I study, which the Company plans to use to support a 510(k) application to the FDA. About Bluejay Diagnostics: Bluejay Diagnostics, Inc. is a medical diagnostics company focused on improving patient outcomes using its Symphony System, a cost-effective, rapid, near-patient testing system for sepsis triage and monitoring of disease progression. Bluejay's first product candidate, an IL-6 Test for sepsis, is designed to provide accurate, reliable results in approximately 20 minutes from 'sample-to-result' to help medical professionals make earlier and better triage/treatment decisions. More information is available at . Forward Looking Statements: This press release contains statements that the Company believes are 'forward-looking statements' within the meaning of the Private Litigation Reform Act. Forward-looking statements in this press release include, without limitation, statements about the ongoing SYMON-II clinical trial, plans to redevelop the cartridges used in the Company's Symphony system, including the potential for working with a third-party contract manufacturing organization in connection with such redevelopment, the expected nature and timing of the Company's planned FDA submission and related plans for clinical study completion, whether the Company's cash position will be sufficient to fund operations needed to achieve regulatory approval and initial commercialization of the Symphony IL-6 Test, whether such regulatory approval will actually occur, the Company's plans for future fundraising, the continuation of the Company as a going concern, the Company's plans to hold its 2025 Annual Meeting on June 18, 2025 and request stockholder approval of two reverse stock split proposals and the re-election of five continuing directors, and the Company's ability to continue to have its common stock listed on the Nasdaq Capital Market in the future. Forward-looking statements may be identified by words such as 'anticipates,' 'believes,' 'estimates,' 'expects,' 'intends,' 'may,' 'plans,' 'projects,' 'seeks,' 'should,' 'suggest,' 'will,' and similar expressions. The Company has based these forward-looking statements on its current expectations and projections about future events, nevertheless, actual results or events could differ materially from the plans, intentions and expectations disclosed in, or implied by, the forward-looking statements the Company makes. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including market and other conditions and those discussed under Part I, Item 1A, 'Risk Factors' in its Annual Report on Form 10-K for the fiscal year ended December 31, 2024, filed with the SEC on March 31, 2025, and in Part II, Item 1A, 'Risk Factors' in its Quarterly Report on Form 10-Q for the fiscal quarter ended March 31, 2025, filed with the SEC on May 13, 2025. You should not place undue reliance on these forward-looking statements, as they are subject to risks and uncertainties, and actual results and performance in future periods may not occur or may be materially different from any future results or performance suggested by the forward-looking statements in this release. This press release speaks as of the date indicated above. The Company undertakes no obligation to update any forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by law. The Company expressly disclaims any obligation to update or revise any forward-looking statements found herein to reflect any future changes in the Company's expectations of results or any future change in events, except as required by law. Additional Information about the 2025 Annual Meeting and Where to Find It: In connection with the 2025 Annual Meeting, Bluejay filed a Definitive Proxy Statement with the SEC on May 16, 2025. Only Bluejay stockholders of record at the close of business on May 15, 2025 are entitled to vote at the 2025 Annual Meeting or any adjournment or postponement thereof. The Definitive Proxy Statement and proxy card were mailed to Bluejay stockholders on or about May 22, 2025. BEFORE MAKING ANY VOTING DECISION, BLUEJAY STOCKHOLDERS ARE URGED TO READ IN THEIR ENTIRETY THE DEFINITIVE PROXY STATEMENT (INCLUDING ANY FUTURE AMENDMENTS OR SUPPLEMENTS THERETO) AND ANY OTHER DOCUMENTS FILED WITH THE SEC IN CONNECTION WITH THE 2025 ANNUAL MEETING OR INCORPORATED BY REFERENCE IN THE PROXY STATEMENT BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSALS BEING VOTED ON AT THE 2025 ANNUAL MEETING. Investors and security holders may obtain free copies of the Definitive Proxy Statement, definitive additional materials and such other documents containing important information about the 2025 Annual Meeting at the SEC's web site at and on Bluejay's website at by clicking on the 'Investors' link and then reviewing the "SEC Filings" feed. Electronic Copies of the Definitive Proxy Statement and the Company's 2024 Annual Report on Form 10-K are also available at The contents of the websites referenced above are not deemed to be incorporated by reference into the Definitive Proxy Statement. Participants in the 2025 Annual Meeting Solicitation: Bluejay and its directors and executive officers may be deemed participants in the solicitation of proxies from Bluejay stockholders in connection with the 2025 Annual Meeting. Security holders may obtain information regarding Bluejay's directors and executive officers in the Definitive Proxy Statement referred to above (filed with the SEC on May 16, 2025), and in subsequent filings on Form 8-K. Investor Contact:Investor RelationsBluejay Diagnostics,
Yahoo
2 hours ago
- Yahoo
Immix Biopharma Announces Primary Endpoint Met in positive NXC-201 Interim Results Presented at ASCO, Enabling Path to Best-in-Class Therapy for relapsed/refractory AL Amyloidosis
Immix Biopharma today presented results at ASCO from its U.S. multi-center NEXICART-2 Phase 1/2 clinical trial of NXC-201, meeting its primary endpoint. – NXC-201 met primary endpoint with a complete response (CR) rate of 70% (7/10 patients) – – No relapses recorded to-date; no safety signals identified – – Immix plans Biologics License Application (BLA) for FDA approval – – Results were presented by Heather Landau, MD, of Memorial Sloan Kettering Cancer Center – – KOL event to discuss significance Tuesday, June 3, 2025 3:00pm ET after ASCO presentation: – LOS ANGELES, CA, June 03, 2025 (GLOBE NEWSWIRE) -- Immix Biopharma, Inc. ('ImmixBio', 'Company', 'We' or 'Us' or 'IMMX'), a clinical-stage biopharmaceutical company developing cell therapies for AL Amyloidosis and other serious diseases, today announced meeting its primary endpoint of complete response (CR) rate for cell therapy NXC-201 at an oral presentation of interim results at the 2025 American Society of Clinical Oncology Annual Meeting (ASCO 2025) in Chicago, Illinois. The oral presentation summarized meeting its interim results endpoint in from the U.S. multi-site NEXICART-2 clinical trial evaluating NXC-201 in relapsed/refractory AL Amyloidosis with a data cutoff of April 11, 2025. A Key Opinion Leader (KOL) event to discuss the significance will be held Tuesday, June 3, 2025 3:00pm ET with live Q&A (register here to participate). 'Meeting primary endpoint at this interim data readout is a testament to the groundbreaking efficacy of NXC-201, as we work toward the first approval in the challenging indication of relapsed/refractory AL Amyloidosis,' said Ilya Rachman, MD, PhD, Chief Executive Officer of Immix Biopharma. Gabriel Morris, Chief Financial Officer of Immix Biopharma, added, 'This inflection point further accelerates our progress toward BLA submission for FDA approval.' Immix's Phase 1/2 NEXICART-2 clinical trial is a U.S. multi-site, single-arm study to evaluate the efficacy and safety of NXC-201 in patients who are refractory to, or relapse on treatment for relapsed/refractory AL Amyloidosis. ASCO Presentation ResultsPrior to NXC-201 treatment, the median lines of therapy was 4 (range: 2-12). All patients had baseline relapsed/refractory AL Amyloidosis organ involvement. After NXC-201 treatment, all patients normalized pathological disease markers. Complete responses (CRs) were observed in 70% (7 out of 10) of patients treated with NXC-201. The remaining 3 patients are bone marrow minimum residual disease (MRD) negative (10-6), predicting future CR (Immix believes remaining three MRD negative (10-6) patients could be confirmed as CRs in the coming weeks and months). Downstream clinical improvement, including cardiac and renal organ responses, were recorded after CRs. There have been no relapses recorded to-date and no safety signals identified. No neurotoxicity has been observed. Only low-grade cytokine release syndrome has been observed. The ASCO presentation contains clinical data as of April 11, 2025. Current treatments typically result in a lower than 10% complete response (CR) rate in relapsed/refractory AL Amyloidosis according to Zanwar, et al 2024, indicating a high unmet medical need. KOL Event to Discuss NXC-201 ASCO Clinical Data PresentationA Key Opinion Leader (KOL) event with lead investigator Heather Landau, MD, of Memorial Sloan Kettering Cancer Center, Shahzad Raza, MD of Cleveland Clinic and Jeffrey Zonder, MD of Karmanos Cancer Center will be held Tuesday, June 3, 2025 at 3:00 pm ET to discuss these results. Register here: About NEXICART-2NEXICART-2 (NCT06097832) is an ongoing single-arm multi-site U.S. Phase 1/2 clinical trial of sterically-optimized CAR-T NXC-201 in relapsed/refractory AL Amyloidosis. NEXICART-2 is expected to enroll 40 patients with preserved heart function (excluding patients with pre-existing heart failure) who have not been exposed to prior BCMA-targeted therapy. The primary endpoint of the Phase 1 portion is safety. The primary endpoint of the Phase 2 portion is efficacy. About NXC-201NXC-201 is a sterically-optimized BCMA-targeted chimeric antigen receptor T (CAR-T) cell therapy with a 'digital filter' that filters out non-specific activation. Initial data from ex-U.S. study NEXICART-1 has demonstrated high complete response rates in relapsed/refractory AL Amyloidosis. U.S. Phase 1/2 study NEXICART-2 is ongoing. NXC-201 has been awarded Regenerative Medicine Advanced Therapy (RMAT) by the FDA, and Orphan Drug Designation (ODD) by the US FDA and in the EU by the EMA. About AL AmyloidosisAL amyloidosis is caused by abnormal plasma cells in the bone marrow, which produce misfolded amyloid proteins that circulate in the blood, then build-up in the heart, kidney, liver, and other organs. This build-up causes progressive and widespread organ damage, including heart and renal failure, leading to high mortality rates. The U.S. observed prevalence of relapsed/refractory AL Amyloidosis is estimated to be growing at 12% per year according to Staron, et al Blood Cancer Journal, to approximately 33,277 patients in 2024. The Amyloidosis market was $3.6 billion in 2017, and is expected to reach $6 billion in 2025, according to Grand View Research. About Immix Biopharma, Biopharma, Inc. (ImmixBio) (Nasdaq: IMMX) is a clinical-stage biopharmaceutical company developing cell therapies for AL Amyloidosis and other serious diseases. Our lead candidate is sterically-optimized BCMA-targeted chimeric antigen receptor T (CAR-T) cell therapy NXC-201. NXC-201 is being evaluated in the U.S. multi-center study NEXICART-2 (NCT06097832). NXC-201 has demonstrated no neurotoxicity in AL Amyloidosis, supporting expansion into other serious diseases. NXC-201 has been awarded Regenerative Medicine Advanced Therapy (RMAT) by the US FDA and Orphan Drug Designation (ODD) by FDA and in the EU by the EMA. Learn more at and Forward Looking StatementsThis press release contains forward-looking statements regarding Immix Biopharma, Inc., its results of operations, prospects, future business plans and operations and the matters discussed above, including, but not limited to, the potential benefits of our product candidate CAR-T NXC-201 and the timing and results related clinical trials. These statements involve risks and uncertainties, and actual results may differ materially from any future results expressed or implied by the forward-looking statements. Forward-looking statements also include, but are not limited to, our plans, objectives, expectations and intentions and other statements that contain words such as 'expects', 'contemplates', 'anticipates', 'plans', 'intends', 'believes', 'estimates', 'potential', and variations of such words or similar expressions that convey the uncertainty of future events or outcomes, or that do not relate to historical matters. Those forward-looking statements involve known and unknown risks, uncertainties and other factors that could cause actual results to differ materially. Among those factors are: (i) the risk that the further data from the ongoing Phase 1/2 clinical trials for CAR-T NXC-201 will not be favorably consistent with the data readouts to date, (ii) the risk that the Company may not be able to continue the NEXICART-2 multi-site U.S. Phase 1/2 clinical trial; (iii) the risk that the Company may not be able to advance to registration-enabling studies for CAR-T NXC-201 or other product candidates, (iv) that success in early phases of pre-clinical and clinicals trials do not ensure later clinical trials will be successful; (v) that no drug product developed by the Company has received FDA pre-market approval or otherwise been incorporated into a commercial drug product, (vi) the risk that the Company may not be able to obtain additional working capital with which to continue the clinical trials for CAR-T NXC-201, or advance to the initiation of registration-enabling studies, for such product candidates as and when needed and (vii) those other risks disclosed in the section 'Risk Factors' included in the Company's Annual Report on Form 10-K filed with the SEC on March 25, 2025 and other periodic reports subsequently filed with the Securities and Exchange Commission. These reports are available at Immix Biopharma cautions that the foregoing list of important factors is not complete. Immix Biopharma cautions readers not to place undue reliance on any forward-looking statements. Immix Biopharma does not undertake, and specifically disclaims, any obligation to update or revise such statements to reflect new circumstances or unanticipated events as they occur, except as required by law. If we update one or more forward-looking statements, no inference should be drawn that we will make additional updates with respect to those or other forward-looking statements. ContactsMike MoyerLifeSci Advisorsmmoyer@ Company Contactirteam@
