Latest news with #Merus
Yahoo
2 days ago
- Business
- Yahoo
Merus N.V. Announces Pricing of Public Offering of Common Shares
UTRECHT, The Netherlands and CAMBRIDGE, Mass., June 04, 2025 (GLOBE NEWSWIRE) -- Merus N.V. (Nasdaq: MRUS) ('Merus', the 'Company,' 'we' and 'our'), an oncology company developing innovative, full-length multispecific antibodies and antibody drug conjugates (Biclonics®, Triclonics® and ADClonics®), today announced the pricing of an underwritten public offering of 5,263,158 common shares, at a public offering price of $57.00 per share (the 'Offer Shares'). Merus also granted the underwriters a 30-day option to purchase up to an additional 789,473 common shares (the 'Option Shares' and together with the Offer Shares, the 'Shares'). The gross proceeds from the offering, before deducting underwriting discounts and commissions and estimated offering expenses and excluding the underwriters' option to purchase the Option Shares, are expected to be approximately $300.0 million. All of the shares in the offering are to be sold by Merus. The offering is expected to close on or about June 5, 2025, subject to customary closing conditions. Merus currently intends to use the net proceeds from the offering, together with its existing cash, cash equivalents and marketable securities, to advance the clinical development of its product candidates, for preclinical research and technology development, and for working capital and general corporate purposes. Jefferies, BofA Securities, Leerink Partners, Guggenheim Securities, Truist Securities, and LifeSci Capital are acting as joint book-running managers for the offering. Van Lanschot Kempen is acting as lead manager for the offering. The offering is being made pursuant to a shelf registration statement on Form S-3 that was filed with the Securities and Exchange Commission ('SEC') on February 28, 2024 and was effective upon filing. The offering will be made only by means of a written prospectus and prospectus supplement that form a part of the registration statement, which, for the avoidance of doubt, will not constitute a 'prospectus' for the purposes of (i) Regulation (EU) 2017/1129 (the 'Prospectus Regulation') and has not been reviewed by any competent authority in any member state in the European Economic Area (the 'EEA') and (ii) the Prospectus Regulation as it forms part of domestic law in the United Kingdom by virtue of the European Union (Withdrawal) Act 2018 (the 'UK Prospectus Regulation') and has not been reviewed by the Financial Conduct Authority in the United Kingdom. A preliminary prospectus supplement and accompanying prospectus relating to the offering was filed with the SEC on June 3, 2025, and a final prospectus supplement will be filed with the SEC and will be available on the SEC's website at Copies of the final prospectus supplement and the accompanying prospectus relating to the offering may be obtained, when available, from Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, by telephone at (877) 821-7388, or by email at Prospectus_Department@ BofA Securities NC1-0220-02-25, Attention: Prospectus Department, 201 North Tryon Street, Charlotte, NC 28255‐0001, or by email at Leerink Partners LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, by telephone at (800) 808-7525 ext. 6105, or by email at syndicate@ Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, 8th Floor, New York, NY 10017, by telephone at (212) 518-9544, or by email at GSEquityProspectusDelivery@ or Truist Securities, Inc., Attention: Equity Capital Markets, 3333 Peachtree Road NE, 9th Floor, Atlanta, GA 30326 at (800) 685-4786 or by email to This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. This press release is an advertisement and not a prospectus within the meaning of either the Prospectus Regulation or the UK Prospectus Regulation. EEA: In relation to each member state of the EEA (each, a 'Relevant State'), no Shares have been offered or will be offered pursuant to the offering to the public in that Relevant State prior to the publication of a prospectus in relation to the Shares which has been approved by the competent authority in that Relevant State or, where appropriate, approved in another Relevant State and notified to the competent authority in that Relevant State, all in accordance with the Prospectus Regulation, except that Shares may be offered to the public in that Relevant State at any time: to any legal entity which is a 'qualified investor' as defined under Article 2 of the Prospectus Regulation; to fewer than 150 natural or legal persons (other than qualified investors as defined under Article 2 of the Prospectus Regulation), subject to obtaining the prior consent of the representatives for any such offer; and in any other circumstances falling within Article 1(4) of the Prospectus Regulation, provided that no such offer of the Shares shall require us or any of the underwriters to publish a prospectus pursuant to Article 3 of the Prospectus Regulation or supplement a prospectus pursuant to Article 23 of the Prospectus Regulation. Each person who initially acquires any Shares or to whom any offer is made will be deemed to have represented, warranted, acknowledged and agreed to and with us and each of the underwriters that it is a 'qualified investor' within the meaning of Article 2 of the Prospectus Regulation. For the purposes of the above, the expression 'offer to the public' in relation to the Shares in any Relevant State means the communication in any form and by any means of sufficient information on the terms of the offer and any Shares to be offered so as to enable an investor to decide to purchase or subscribe for any Shares, and the expression 'Prospectus Regulation' means Regulation (EU) 2017/1129. United Kingdom: No Shares have been offered or will be offered pursuant to this offering to the public in the United Kingdom prior to the publication of a prospectus in relation to the Shares which has been approved by the Financial Conduct Authority in the United Kingdom, except that the Shares may be offered to the public in the United Kingdom at any time: a) to any legal entity which is a qualified investor as defined under Article 2 of the UK Prospectus Regulation; b) to fewer than 150 natural or legal persons (other than qualified investors as defined under Article 2 of the UK Prospectus Regulation), subject to obtaining the prior consent of the representatives for any such offer; or c) in any other circumstances falling within Section 86 of the Financial Services and Markets Act 2000 (the 'FSMA'), provided that no such offer of the Shares shall require us or any of the underwriters to publish a prospectus pursuant to Section 85 of the FSMA or Article 3 of the UK Prospectus Regulation or supplement a prospectus pursuant to Article 23 of the UK Prospectus Regulation. Each person in the United Kingdom who initially acquires any Shares or to whom any offer is made will be deemed to have represented, warranted, acknowledged and agreed to and with us and each of the underwriters that it is a 'qualified investor' within the meaning of the UK Prospectus Regulation. For the purposes of this provision, the expression an 'offer to the public' in relation to the Shares in the United Kingdom means the communication in any form and by any means of sufficient information on the terms of the offer and any Shares to be offered so as to enable an investor to decide to purchase or subscribe for any Shares. In addition, in the United Kingdom, the transaction to which this press release relates will only be available to, and will be engaged in only with persons who are 'qualified investors' (as defined in the UK Prospectus Regulation) (i) who have professional experience in matters relating to investments falling within Article 19(5) of the FSMA (Financial Promotion) Order 2005, as amended (the Order), and/or (ii) who are high net worth entities (or persons to whom it may otherwise be lawfully communicated) falling within Article 49(2)(a) to (d) of the Order (all such persons together being referred to as 'relevant persons'). In the United Kingdom, the securities referred to herein are only available to, and any invitation, offer or agreement to subscribe, purchase or otherwise acquire such securities will be engaged in only with relevant persons. Any person in the United Kingdom who is not a relevant person should not act or rely on this communication or any of its contents. About Merus N.V. Merus is an oncology company developing innovative full-length human bispecific and trispecific antibody therapeutics, referred to as Multiclonics®. Multiclonics® are manufactured using industry standard processes and have been observed in preclinical and clinical studies to have several of the same features of conventional human monoclonal antibodies, such as long half-life and low immunogenicity. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation, statements regarding the completion of the proposed offering, the anticipated gross proceeds from the offering and our intended use of any net proceeds from the offering. These forward-looking statements are based on management's current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: our need for additional funding, which may not be available and which may require us to restrict our operations or require us to relinquish rights to our technologies or Biclonics®, Triclonics® and multispecific antibody candidates; potential delays in regulatory approval, which would impact our ability to commercialize our product candidates and affect our ability to generate revenue; the lengthy and expensive process of clinical drug development, which has an uncertain outcome; the unpredictable nature of our early stage development efforts for marketable drugs; potential delays in enrollment of patients, which could affect the receipt of necessary regulatory approvals; our reliance on third parties to conduct our clinical trials and the potential for those third parties to not perform satisfactorily; impacts of the global instability caused by the Russia Ukraine conflict and conflict in the Middle East; we may not identify suitable Biclonics® or bispecific antibody candidates under our collaborations or our collaborators may fail to perform adequately under our collaborations; our reliance on third parties to manufacture our product candidates, which may delay, prevent or impair our development and commercialization efforts; protection of our proprietary technology; our patents may be found invalid, unenforceable, circumvented by competitors and our patent applications may be found not to comply with the rules and regulations of patentability; we may fail to prevail in potential lawsuits for infringement of third-party intellectual property; and our registered or unregistered trademarks or trade names may be challenged, infringed, circumvented or declared generic or determined to be infringing on other marks. These and other important factors discussed under the caption 'Risk Factors' in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2025 filed with the Securities and Exchange Commission, or SEC, on May 7, 2025, and our other reports filed with the SEC, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change, except as required under applicable law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release. Multiclonics®, ADClonics®, Biclonics® and Triclonics® are registered trademarks of Merus N.V. CONTACT: Investor and Media Inquiries: Sherri Spear Merus N.V. SVP Investor Relations and Strategic Communications 617-821-3246 Kathleen Farren Merus N.V. Director Investor Relations and Corporate Communications 617-230-4165
Yahoo
2 days ago
- Business
- Yahoo
Merus N.V. Announces Pricing of Public Offering of Common Shares
UTRECHT, The Netherlands and CAMBRIDGE, Mass., June 04, 2025 (GLOBE NEWSWIRE) -- Merus N.V. (Nasdaq: MRUS) ('Merus', the 'Company,' 'we' and 'our'), an oncology company developing innovative, full-length multispecific antibodies and antibody drug conjugates (Biclonics®, Triclonics® and ADClonics®), today announced the pricing of an underwritten public offering of 5,263,158 common shares, at a public offering price of $57.00 per share (the 'Offer Shares'). Merus also granted the underwriters a 30-day option to purchase up to an additional 789,473 common shares (the 'Option Shares' and together with the Offer Shares, the 'Shares'). The gross proceeds from the offering, before deducting underwriting discounts and commissions and estimated offering expenses and excluding the underwriters' option to purchase the Option Shares, are expected to be approximately $300.0 million. All of the shares in the offering are to be sold by Merus. The offering is expected to close on or about June 5, 2025, subject to customary closing conditions. Merus currently intends to use the net proceeds from the offering, together with its existing cash, cash equivalents and marketable securities, to advance the clinical development of its product candidates, for preclinical research and technology development, and for working capital and general corporate purposes. Jefferies, BofA Securities, Leerink Partners, Guggenheim Securities, Truist Securities, and LifeSci Capital are acting as joint book-running managers for the offering. Van Lanschot Kempen is acting as lead manager for the offering. The offering is being made pursuant to a shelf registration statement on Form S-3 that was filed with the Securities and Exchange Commission ('SEC') on February 28, 2024 and was effective upon filing. The offering will be made only by means of a written prospectus and prospectus supplement that form a part of the registration statement, which, for the avoidance of doubt, will not constitute a 'prospectus' for the purposes of (i) Regulation (EU) 2017/1129 (the 'Prospectus Regulation') and has not been reviewed by any competent authority in any member state in the European Economic Area (the 'EEA') and (ii) the Prospectus Regulation as it forms part of domestic law in the United Kingdom by virtue of the European Union (Withdrawal) Act 2018 (the 'UK Prospectus Regulation') and has not been reviewed by the Financial Conduct Authority in the United Kingdom. A preliminary prospectus supplement and accompanying prospectus relating to the offering was filed with the SEC on June 3, 2025, and a final prospectus supplement will be filed with the SEC and will be available on the SEC's website at Copies of the final prospectus supplement and the accompanying prospectus relating to the offering may be obtained, when available, from Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, by telephone at (877) 821-7388, or by email at Prospectus_Department@ BofA Securities NC1-0220-02-25, Attention: Prospectus Department, 201 North Tryon Street, Charlotte, NC 28255‐0001, or by email at Leerink Partners LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, by telephone at (800) 808-7525 ext. 6105, or by email at syndicate@ Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, 8th Floor, New York, NY 10017, by telephone at (212) 518-9544, or by email at GSEquityProspectusDelivery@ or Truist Securities, Inc., Attention: Equity Capital Markets, 3333 Peachtree Road NE, 9th Floor, Atlanta, GA 30326 at (800) 685-4786 or by email to This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. This press release is an advertisement and not a prospectus within the meaning of either the Prospectus Regulation or the UK Prospectus Regulation. EEA: In relation to each member state of the EEA (each, a 'Relevant State'), no Shares have been offered or will be offered pursuant to the offering to the public in that Relevant State prior to the publication of a prospectus in relation to the Shares which has been approved by the competent authority in that Relevant State or, where appropriate, approved in another Relevant State and notified to the competent authority in that Relevant State, all in accordance with the Prospectus Regulation, except that Shares may be offered to the public in that Relevant State at any time: to any legal entity which is a 'qualified investor' as defined under Article 2 of the Prospectus Regulation; to fewer than 150 natural or legal persons (other than qualified investors as defined under Article 2 of the Prospectus Regulation), subject to obtaining the prior consent of the representatives for any such offer; and in any other circumstances falling within Article 1(4) of the Prospectus Regulation, provided that no such offer of the Shares shall require us or any of the underwriters to publish a prospectus pursuant to Article 3 of the Prospectus Regulation or supplement a prospectus pursuant to Article 23 of the Prospectus Regulation. Each person who initially acquires any Shares or to whom any offer is made will be deemed to have represented, warranted, acknowledged and agreed to and with us and each of the underwriters that it is a 'qualified investor' within the meaning of Article 2 of the Prospectus Regulation. For the purposes of the above, the expression 'offer to the public' in relation to the Shares in any Relevant State means the communication in any form and by any means of sufficient information on the terms of the offer and any Shares to be offered so as to enable an investor to decide to purchase or subscribe for any Shares, and the expression 'Prospectus Regulation' means Regulation (EU) 2017/1129. United Kingdom: No Shares have been offered or will be offered pursuant to this offering to the public in the United Kingdom prior to the publication of a prospectus in relation to the Shares which has been approved by the Financial Conduct Authority in the United Kingdom, except that the Shares may be offered to the public in the United Kingdom at any time: a) to any legal entity which is a qualified investor as defined under Article 2 of the UK Prospectus Regulation; b) to fewer than 150 natural or legal persons (other than qualified investors as defined under Article 2 of the UK Prospectus Regulation), subject to obtaining the prior consent of the representatives for any such offer; or c) in any other circumstances falling within Section 86 of the Financial Services and Markets Act 2000 (the 'FSMA'), provided that no such offer of the Shares shall require us or any of the underwriters to publish a prospectus pursuant to Section 85 of the FSMA or Article 3 of the UK Prospectus Regulation or supplement a prospectus pursuant to Article 23 of the UK Prospectus Regulation. Each person in the United Kingdom who initially acquires any Shares or to whom any offer is made will be deemed to have represented, warranted, acknowledged and agreed to and with us and each of the underwriters that it is a 'qualified investor' within the meaning of the UK Prospectus Regulation. For the purposes of this provision, the expression an 'offer to the public' in relation to the Shares in the United Kingdom means the communication in any form and by any means of sufficient information on the terms of the offer and any Shares to be offered so as to enable an investor to decide to purchase or subscribe for any Shares. In addition, in the United Kingdom, the transaction to which this press release relates will only be available to, and will be engaged in only with persons who are 'qualified investors' (as defined in the UK Prospectus Regulation) (i) who have professional experience in matters relating to investments falling within Article 19(5) of the FSMA (Financial Promotion) Order 2005, as amended (the Order), and/or (ii) who are high net worth entities (or persons to whom it may otherwise be lawfully communicated) falling within Article 49(2)(a) to (d) of the Order (all such persons together being referred to as 'relevant persons'). In the United Kingdom, the securities referred to herein are only available to, and any invitation, offer or agreement to subscribe, purchase or otherwise acquire such securities will be engaged in only with relevant persons. Any person in the United Kingdom who is not a relevant person should not act or rely on this communication or any of its contents. About Merus N.V. Merus is an oncology company developing innovative full-length human bispecific and trispecific antibody therapeutics, referred to as Multiclonics®. Multiclonics® are manufactured using industry standard processes and have been observed in preclinical and clinical studies to have several of the same features of conventional human monoclonal antibodies, such as long half-life and low immunogenicity. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation, statements regarding the completion of the proposed offering, the anticipated gross proceeds from the offering and our intended use of any net proceeds from the offering. These forward-looking statements are based on management's current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: our need for additional funding, which may not be available and which may require us to restrict our operations or require us to relinquish rights to our technologies or Biclonics®, Triclonics® and multispecific antibody candidates; potential delays in regulatory approval, which would impact our ability to commercialize our product candidates and affect our ability to generate revenue; the lengthy and expensive process of clinical drug development, which has an uncertain outcome; the unpredictable nature of our early stage development efforts for marketable drugs; potential delays in enrollment of patients, which could affect the receipt of necessary regulatory approvals; our reliance on third parties to conduct our clinical trials and the potential for those third parties to not perform satisfactorily; impacts of the global instability caused by the Russia Ukraine conflict and conflict in the Middle East; we may not identify suitable Biclonics® or bispecific antibody candidates under our collaborations or our collaborators may fail to perform adequately under our collaborations; our reliance on third parties to manufacture our product candidates, which may delay, prevent or impair our development and commercialization efforts; protection of our proprietary technology; our patents may be found invalid, unenforceable, circumvented by competitors and our patent applications may be found not to comply with the rules and regulations of patentability; we may fail to prevail in potential lawsuits for infringement of third-party intellectual property; and our registered or unregistered trademarks or trade names may be challenged, infringed, circumvented or declared generic or determined to be infringing on other marks. These and other important factors discussed under the caption 'Risk Factors' in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2025 filed with the Securities and Exchange Commission, or SEC, on May 7, 2025, and our other reports filed with the SEC, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change, except as required under applicable law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release. Multiclonics®, ADClonics®, Biclonics® and Triclonics® are registered trademarks of Merus N.V. CONTACT: Investor and Media Inquiries: Sherri Spear Merus N.V. SVP Investor Relations and Strategic Communications 617-821-3246 Kathleen Farren Merus N.V. Director Investor Relations and Corporate Communications 617-230-4165
CNBC
2 days ago
- Business
- CNBC
This biotech stock rallying on cancer treatment data has more room to run, analysts say
Analysts are closely watching Merus and see more upside ahead coming out of one of the biggest biotechnology conferences in the U.S. Merus shares shot up late last month following the release of promising Phase 2 data for a treatment for head and neck cancer. This has made the Netherlands-based company the talk of the investing set that flocked to Chicago for the American Society of Clinical Oncology's annual meeting , which concludes Tuesday. "They're first in class. We think they're best in class," said Matt Phipps, group head of the biotech equity research team at William Blair. "That's just kind of a combination that a lot of investors really want to be a part of." The stock has popped about 40% in the past month and rallied to a new all-time high on Tuesday. Still, multiple analysts interviewed by CNBC Pro said Merus can surge even higher — with one even suggesting shares can more than double from current levels given there are more catalysts on the horizon. MRUS 1M mountain Merus, 1-month Phipps said Merus' data overshadowed a similar report from Bicara Therapeutics , whose shares have tumbled 24% over the past month. He said Merus' release cemented itself as the best drug in combination with Merck 's Keytruda for head and neck cancer. Guggenheim analyst Michael Schmidt said similar success in Phase 3 data could more than double the value of Merus' shares. To be sure, he noted that investors should be prepared to wait between 12 and 18 months to see this upside given the schedule for data releases that can boost the stock. Beyond that, he said the same drug combination has potential for treating colorectal cancer. While Schmidt acknowledged that its not a major focus of investors yet, he said data from ongoing Phase 2 studies expected in the second half of 2025 is something to keep an eye on. Expectations for this, he said, are "very modest." "It's a stock that we have a lot of conviction on," Schmidt said. "We like this story a lot." Multiple analysts interviewed by CNBC said the name could also be an acquisition target from bigger-name biopharmaceutical companies, which could further drive upside. That can also help explain why Wall Street is so bullish. Every analyst polled by LSEG has a buy or strong buy rating, with an average price target suggesting 45% in upside ahead. "You want to buy it now," said BMO analyst Evan Seigerman, who called the company's data "really compelling." "This is the type of company that a large pharma company would want to acquire." Seigerman said the company has both "great" clinical data and is in an area with "unmet need," which is a combination that can make the stock a winner in what he described as a competitive sector. A boost to Merck? The treatment's success can also have knock-on benefits for Merck shares given the potential sales bump for Keytruda, according to Leerink analyst Andrew Berens. Berens said Keytruda is approved as a monotherapy, but only about 20% of patients respond to it, making the average time spent on the drug about few months. But used in conjunction with Merus' product, he noted that data shows that rate shoots up to the high 60% level and increases duration to nearly a year. "It's a win-win for Merck," Berens said. "This drug has its own activity," he said, "but it also means they can sell more of their flagship drug."
Yahoo
28-05-2025
- Business
- Yahoo
Biohaven Presents Oncology Program Updates and Preliminary Clinical Data Showcasing Innovative Trop2 and FGFR3 Antibody Drug Conjugates (ADCs) Incorporating Novel TopoIx Payload with Potential to Treat a Wide Variety of Tumors
BHV-1510, a highly differentiated Trop2 ADC incorporating the proprietary TopoIx payload, demonstrates early clinical activity and favorable safety profile in Phase 1 study as a monotherapy and in combination with Regeneron's anti-PD-1 cemiplimab. Tumor reduction was observed in the first 6 out of 6 patients treated with BHV-1510 plus cemiplimab including confirmed partial responses First patient dosed with Biohaven's novel, first-in-class FGFR3 directed TopoIx ADC, BHV-1530 Promising progress in the clinic demonstrates potential of Biohaven's innovative, next-generation ADC platform and TopoIx payload, with additional collaboration programs with Merus and GeneQuantum advancing preclinically. NEW HAVEN, Conn., May 28, 2025 /PRNewswire/ -- Biohaven Ltd. (NYSE: BHVN) (Biohaven), a global clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of life-changing therapies to treat a broad range of rare and common diseases, today provided an update and preliminary clinical data from its oncology development programs at Biohaven's 2025 R&D Day, held concurrently with the Yale Innovation Summit in New Haven, Connecticut. The presentation slides from Biohaven's R&D day for Oncology and its other platforms will be available on the Events and Presentations page of the Biohaven website just prior to their presentations. Biohaven reported that its novel next-generation trophoblast cell surface antigen 2 (Trop2) directed antibody drug conjugate (ADC), BHV-1510, demonstrated encouraging preliminary clinical activity both as a monotherapy and in combination with Regeneron's anti-PD-1 antibody cemiplimab. Early clinical data is consistent with BHV-1510's preclinical profile showing high ADC stability, differentiated safety and efficacy, immunogenic cell death, and anti-PD-1 synergism. Monotherapy tumor reductions including partial responses have been seen in patients failing standard of care therapies. The combination of BHV-1510 and cemiplimab in the ongoing Phase 1 study shows encouraging anti-tumor activity, with tumor shrinkage in the first 6 out of 6 patients treated, including confirmed partial responses and in patients with brain metastasis (Figure 1). The majority of patients treated with the combination had failed prior anti–PD-1/PD-L1 therapies. BHV-1510 showed a favorable pharmacokinetic (PK) profile, with very low levels of free payload. As monotherapy, the main toxicity observed thus far in the Phase 1 study has been stomatitis, an expected on-target Trop2 class toxicity that has been manageable. Importantly, there were no cases of payload-associated interstitial lung disease (ILD), and low rates of gastrointestinal (e.g., diarrhea) and hematologic toxicities observed. The combination with cemiplimab was well tolerated with no dose limiting toxicity to date in initial cohorts. Nushmia Khokhar, M.D., Chief Medical Officer of Oncology at Biohaven, commented, "The early clinical data with BHV-1510 dosed in patients who failed standard of care treatment are highly encouraging, particularly the observed potential synergy with anti-PD-1 therapy. These findings, combined with the promising efficacy and tolerability profile of our novel TopoIx payload and stable linker technology, support the potential of BHV-1510 to advance into earlier lines of therapy for challenging tumor types." Biohaven also announced the first patient has been dosed in the Phase 1 study of BHV-1530, a potential first-in-class fibroblast growth factor receptor 3 (FGFR3)-directed ADC which utilizes the proprietary Topolx payload. BHV-1530 has potential in indications of cancers driven by FGFR3 alterations and/or upregulated FGFR3 protein expression, including urothelial cancers and other solid tumors (Figure 2). FGFR3 is a clinically validated target in oncology, with one small molecule inhibitor (erdafitinib) approved. There are no FGFR3 ADCs beyond BHV-1530 advanced in clinical testing. Michael Song, M.D., Ph.D., Principal Investigator and leading medical oncologist and hematologist at NEXT Oncology with over 22 years of experience in cancer patient care and cancer research, stated, "We are excited to partner with Biohaven and dose the first patient on this important study. This is an exciting, validated target with potential to extend therapeutic benefit to several FGFR3 driven tumors." Biohaven is also advancing a portfolio of innovative technologies to modernize next-generation ADCs through strategic collaborations with Merus and GeneQuantum (Figure 3). The preclinical programs leverage Biohaven's differentiated ADC platform directed against undisclosed novel validated and emerging high-value targets, and incorporating the TopoIx payload that preclinically demonstrated immunogenic cell death and synergistic efficacy with PD-1/PD-L1 checkpoint inhibitors. Brian Lestini, M.D., Ph.D., President of Oncology at Biohaven, commented, 'We are excited to be in the clinic with two innovative ADCs and to share the early clinical experience with the first of our two programs, demonstrating the potential of our oncology portfolio to deliver a wide range of optimized, next-generation ADCs. The early clinical data from the Trop2 ADC, BHV-1510, shows the predicted profile and potential of the proprietary TopoIx payload as seen preclinically, and supports broad investigation of ADCs incorporating TopoIx and highly stable linker technologies. Similarly, initiation of the first-in-human study of BHV-1530, an FGFR3 directed ADC, demonstrates the versatility of our approach to generate novel drugs with the potential to address a wide variety of unmet needs in oncology. Together with our collaborations with Merus and GeneQuantum as well as licensed conjugation technology from Yale University, Biohaven's platform has the potential to generate multiple differentiated mono- and bispecific ADC therapies with greater potency and selectivity over currently available ADC approaches." About BiohavenBiohaven is a biopharmaceutical company focused on the discovery, development, and commercialization of life-changing treatments in key therapeutic areas, including immunology, neuroscience, and oncology. Biohaven is advancing its innovative portfolio of therapeutics, leveraging its proven drug development experience and multiple proprietary drug development platforms. Biohaven's extensive clinical and preclinical programs include Kv7 ion channel modulation for epilepsy and mood disorders; MoDE™ and TRAP™ extracellular protein degradation for immunological diseases; TRPM3 antagonism for migraine and neuropathic pain; TYK2/JAK1 inhibition for neuroinflammatory disorders; glutamate modulation for OCD and SCA; myostatin inhibition for neuromuscular and metabolic diseases, including SMA and obesity; antibody recruiting bispecific molecules; and antibody drug conjugates for cancer. For more information, visit Forward-looking StatementsThis news release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the expected timing and amounts of funding under the NPA. The use of certain words, including "continue", "plan", "will", "believe", "may", "expect", "anticipate" and similar expressions, is intended to identify forward-looking statements. Investors are cautioned that any forward-looking statements, including statements regarding the future development, timing and potential marketing approval and commercialization of development candidates, are not guarantees of future performance or results and involve substantial risks and uncertainties. Actual results, developments and events may differ materially from those in the forward-looking statements as a result of various factors including: the expected timing, commencement and outcomes of Biohaven's planned and ongoing clinical trials, including the combination of BHV-1510 and cemiplimab in the ongoing Phase 1 study; the timing of planned interactions and filings with the FDA; the timing and outcome of expected regulatory filings; complying with applicable U.S. regulatory requirements; the potential commercialization of Biohaven's product candidates and the expected timing thereof; the potential for Biohaven's product candidates to be successful therapies; and the effectiveness and safety of Biohaven's product candidates, including the safety profile of BHV-1510. Additional important factors to be considered in connection with forward-looking statements are described in Biohaven's filings with the Securities and Exchange Commission, including within the sections titled "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations". The forward-looking statements are made as of the date of this news release, and Biohaven does not undertake any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. Investor Contact:Jennifer PorcelliVice President, Investor (201) 248-0741 Media Contact:Mike BeyerSam Brown (312) 961-2502 View original content to download multimedia: SOURCE Biohaven Ltd.
Yahoo
25-05-2025
- Business
- Yahoo
BofA Maintains Buy Rating on Merus (MRUS), Lifts PT
On Friday, BofA increased its price target for Merus (NASDAQ:MRUS) to $92 from $70, while maintaining a Buy rating on the stock. The decision follows Merus' highly favorable Phase 2 trial results for the combination of petosemtamab and pembrolizumab in treating first-line head and neck squamous cell carcinoma/HNSCC. The trial achieved a 12-month objective survival rate of 79% in its full cohort. A microscope with biomedical samples, highlighting the research efforts of the company. The survival rate surpasses historical benchmarks for pembrolizumab monotherapy, which typically range from 50% to 59% in the same patient population. It also well exceeds the 50%-60% range that BofA's medical checks had indicated would constitute good data. BofA believes that the data positions the peto + pembr combination as a potentially best-in-class treatment option for patients with HNSCC. The promising interim data from the Phase 2 trial, revealed at the ASCO Annual Meeting, showed a 63% overall response rate among 43 evaluable patients, which included 6 complete responses and 21 partial responses. The median progression-free survival was 9 months, and responses were observed across various PD-L1 levels, with 14 responding patients still on treatment at the data cutoff. Merus (NASDAQ:MRUS) is a clinical-stage immuno-oncology company that primarily develops antibody therapeutics in the Netherlands. While we acknowledge the potential of MRUS to grow, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns and have limited downside risk. If you are looking for an AI stock that is more promising than MRUS and that has 100x upside potential, check out our report about the cheapest AI stock. READ NEXT: and . Disclosure: None. This article is originally published at Insider Monkey. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
