MorphoSys AG American Depositary Shares - MOR STOCK NEWS

MorphoSys AG (FSE:MOR)(NASDAQ:MOR) announced that its licensing partner Roche received Breakthrough Therapy Designation from the FDA for gantenerumab, targeting Alzheimer's disease (AD). The designation is based on significant reductions in brain amyloid plaques from ongoing trials. Roche will conduct two pivotal Phase III trials, involving over 2,000 participants, expected to complete in late 2022. MorphoSys will earn 5.5% to 7.0% royalties on net sales and retain 40% of future royalties linked to gantenerumab.

Incyte and MorphoSys AG have received conditional marketing authorization from the European Commission for Minjuvi (tafasitamab) in combination with lenalidomide. This approval is intended for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are ineligible for autologous stem cell transplant. The decision is supported by positive data from the L-MIND study, showing an overall response rate of 56.8%. Approximately 16,000 patients are diagnosed annually with this condition in the EU.

MorphoSys AG and Incyte announced that the European Commission has granted conditional marketing authorization for Minjuvi (tafasitamab) in combination with lenalidomide for adults with relapsed or refractory Diffuse Large B-Cell Lymphoma (DLBCL) who cannot undergo autologous stem cell transplant. This approval follows a positive opinion from the European Medicines Agency. With approximately 16,000 new DLBCL cases annually in the EU, Minjuvi addresses a significant unmet need, showing an objective response rate of 56.8% in clinical trials.

MorphoSys AG (FSE:MOR; NASDAQ:MOR) announced a collaboration with Incyte for the commercialization of tafasitamab in Greater China. Under this agreement, InnoCare will hold exclusive rights to develop and market tafasitamab in mainland China, Hong Kong, Macau, and Taiwan. MorphoSys previously partnered with Incyte for tafasitamab's global development. This partnership may enhance revenues through tiered royalties from ex-U.S. net sales, as tafasitamab is already FDA approved for certain lymphoma treatments.

MorphoSys AG (FSE:MOR)(NASDAQ:MOR) reported U.S. net product sales of Monjuvi at €14.9 million (US$18 million) for Q2 2021, reflecting a 16% quarter-over-quarter growth. The company completed its acquisition of Constellation Pharmaceuticals for US$1.7 billion and secured a strategic funding partnership with Royalty Pharma worth US$2 billion. Updated guidance for 2021 projects group revenues of €155 to 180 million and operating expenses of €435 to 465 million. The operational outlook includes ongoing clinical studies for tafasitamab, with significant focus on building a presence in hematology-oncology.

MorphoSys AG has updated its financial guidance for 2021, projecting group revenues between €155 million and €180 million, down from a previous estimate of €150 million to €200 million, due to revised expectations for Monjuvi sales. Operating expenses are now anticipated to range from €435 million to €465 million, significantly increasing from the earlier guidance of €355 million to €385 million, primarily due to the acquisition of Constellation Pharmaceuticals, along with related one-time transaction costs of €36 million.

MorphoSys AG (FSE:MOR)(NASDAQ:MOR) will release its second quarter and first half 2021 results on July 28, 2021. A conference call is scheduled for July 29, 2021, at 2:00pm CEST (8:00am EDT), where the Management Board will present the financial results and provide an outlook for the year. The call will feature key executives including CEO Jean-Paul Kress and CFO Sung Lee. A live webcast will be available on MorphoSys' website, with a replay accessible post-event. The company focuses on biopharmaceutical developments for cancer and autoimmune diseases.

MorphoSys AG (FSE:MOR; NASDAQ:MOR) announced a capital increase by issuing 1,337,552 new ordinary shares, representing 3.9% of its registered share capital. This issuance, approved by the Management and Supervisory Boards, is part of a strategic finance partnership with Royalty Pharma, which purchased these shares for US$ 100 million at €63.35 per share, a 12.1% premium over the market price. The shares will be listed on the Frankfurt Stock Exchange and will be subject to a 12-month lock-up period. The transaction is linked to MorphoSys's acquisition of Constellation Pharmaceuticals.

MorphoSys AG has successfully completed its cash tender offer for Constellation Pharmaceuticals, Inc. at $34.00 per share, with approximately 89% of shares tendered. The acquisition is valued at about $1.7 billion and will position MorphoSys strongly in hematology-oncology. It also announced a strategic partnership with Royalty Pharma involving $1.425 billion in upfront funding and additional milestone payments. This partnership will enhance MorphoSys's pipeline and maintain a significant presence in both Munich and Boston.