Target $350
Wednesday, April 5, 2023
Why Shares of MorphoSys Are Up
Shares of MorphoSys (MOR 16.20%) were up more than 16% Wednesday afternoon after the biopharmaceutical company updated the trials status of the company's lead therapy. The stock is up more than 28% so far this year. The company specializes in therapies to treat cancer and autoimmune diseases.
NASDAQ: MOR
MorphoSys Ag
Today's Change
(16.20%) $0.64
Current Price
$4.59
MorphoSys announced that its phase 3 combination study of pelabresib with ruxolitinib to treat myelofibrosis had completed its enrollment earlier than expected. That meant that the top-line data from the study should come by the end of this year instead of in early 2024 as it had said previously. In the study, the combination of pelabresib and ruxolitinb is being tested for efficacy and safety versus ruxolitinib alone. Pelabresib is designed as an anti-tumor agent that inhibits bromodomain and extra-terminal domain (BET) proteins to disrupt the forming of abnormal genes in cancer. Myelofibrosis is a blood cancer where there's a buildup of scar tissue in the bone marrow and can cause anemia and spleen enlargement.
The biotech company also has one other therapy in late-stage trials, large B-cell lymphoma therapy tafasitamab, which is in a phase 2 trial as a combination therapy with Revlimid to treat relapsed or refractory diffuse large B-cell lymphoma (DLBCL),
The company reported fourth-quarter revenue of 81.6 million euros ($89.08 million), up 54% year over year. MorphoSys reported yearly revenue of 278.3 euros ($303.81 million), up 55%. Most of the company's revenue, though, came from royalties and from DLBCL therapy Monjuvi, with $25.3 million in Q4 sales as well as 2022 sales of $89.4 million. However, the company lost 151.9 million euros last year ($161.39 million). The potential to add another therapy is what got investors excited. The company had predicted falling Monjuvi sales and in anticipation of that, the company had said in February that it planned to halt its preclinical programs and trim 17% of its workforce.
https://www.fool.com/investing/2023/04/05/why-shares-of-morphosys-are-up-wednesday/
Eagle, Dr. Reddy's Settle on BENDEKA® (bendamustine hydrochloride)
Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) (“Eagle” or the “Company”) today announced that it has reached a settlement agreement with Dr. Reddy’s Laboratories, Ltd. and Dr. Reddy’s Laboratories, Inc. (collectively, “Dr. Reddy’s”). Eagle had asserted its Orange Book-listed patents against Dr. Reddy’s related to its new drug application referencing BENDEKA®. Under the settlement agreement, Dr. Reddy’s has the right to market its product beginning November 17, 2027, or earlier based on certain circumstances. The settlement agreement is confidential and subject to review by the U.S. Federal Trade Commission and the U.S. Department of Justice. The settlement with Dr. Reddy’s follows Eagle’s previously announced settlements with Hospira, Inc. (“Hospira”) and Accord Healthcare, Inc. (“Accord”) related to their new drug applications referencing BENDEKA®.
https://finance.yahoo.com/news/eagle-pharmaceuticals-reaches-settlement-agreement-105000522.html
Abbvie lowers guidance after $150 million charge
Abbvie Inc. (ABBV) late Wednesday lowered its guidance for the year to include a charge of about $150 million. The pharma company said GAAP as well as adjusted earnings for its first quarter are expected to include expenses around in-progress research and development and milestones expenses resulting in the charge, which translates to "an unfavorable impact" of 8 cents a share on both GAAP and adjusted EPS. First-quarter results are not yet completed, AbbVie said. The company tweaked its first-quarter adjusted earnings guidance to a range between $2.31 a share and $2.41 a share. It lowered its 2023 adjusted EPS guidance to between $10.62 and $11.02. Abbvie in February guided for full-year adjusted EPS between $10.70 and $11.10. Analysts polled by FactSet expect adjusted EPS of $2.56 for Abbvie in the first quarter, and of $11.01 for the year. The stock dropped 1% in the extended session Wednesday after ending the regular trading session up 0.6%.
BioNTech and Takeda add new ADCs to their pipelines
A pair of licensing deals today for BioNTech and Takeda provide further examples that antibody-drug conjugates (ADCs) are cementing their place as in the biopharma armamentarium.
ADCs are antibodies linked to cancer-killing molecules that are designed to target tumour cells more effectively, so they have fewer harmful effects on healthy tissues.
The agreement between Germany’s BioNTech and China-based DualityBio is the larger of the two, with an upfront fee of $170 million giving it rights to a pair of ADCs for oncology indications outside of Chinese, Hong Kong, and Macau.
The value of the deal could rise to more than $1.5 billion if the ADCs – both destined for development as therapies for solid tumours – meet development, regulatory, and commercial objectives.
The first of the duo is DB-1303, which includes an antibody component targeting HER2, making it a potential competitor to AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) and Roche’s Kadcyla (trastuzumab emtansine). It carries a topoisomerase inhibitor payload and has already advanced to phase 2 testing for HER2-positive cancers, and has picked up a fast-track designation from the FDA in the US.
Next up is DB-1311 – mechanism as yet not divulged, but also carrying a topoisomerase inhibitor – which is in preclinical development.
“Over the last years, the ADC field has made significant progress, overcoming several limitations and demonstrating its potential as a broadly applicable precision medicine drug class that might be an alternative to standard chemotherapy,” commented Uğur Şahin, BioNTech’s chief executive and co-founder.
The DualityBio agreement is BioNTech’s second in the oncology category in quick succession, coming after it teamed up with OncoC4 to develop CTLA4 antibody ONC-392 last month for $200 million upfront.
Japanese drugmaker Takeda, meanwhile, is paying $5 million upfront to Innate Pharma of the US in a deal that is seeking to extend the use of ADCs beyond their main use in oncology.
The agreement – with a value of up to $410 million if objectives are met – covers a number of ADCs based on Innate antibodies against an undisclosed target that are destined for development as therapies for coeliac disease, an autoimmune condition caused by an intolerance to dietary gluten with no approved therapies.
Last October, Takeda licensed rights to Dr Falk Pharma’s small-molecule coeliac therapy ZED1227, now renamed TAK-227, which is in phase 2 testing.
The two ADC licensing deals comes shortly after Pfizer agreed a $43 billion for ADC pioneer Seagen, whose technology has underpinned four of the 12 ADCs that have made it onto the US market to date.
https://pharmaphorum.com/news/biontech-and-takeda-add-new-adcs-their-pipelines
Palisade starts Phase 3 gastrointestinal trial
Palisade Bio, Inc. (Nasdaq: PALI) (“Palisade” or the “Company”), a biopharmaceutical company advancing therapies for acute and chronic gastrointestinal (GI) complications, announced today that its development partner Newsoara Biopharma Co. Ltd, has enrolled the first patient in its ongoing Phase 3 clinical trial in China. The trial is being fully conducted and funded by Newsoara.
“The start of patient enrollment marks an important milestone for our partner Newsoara’s advancement of its Phase 3 LB1148 study in China. We continue to be encouraged by the potential of LB1148 to protect gastrointestinal integrity in surgery patients and look forward to the forthcoming data readout from Newsoara’s study,” commented J.D. Finley, CEO of Palisade Bio.
LB1148 is a broad-spectrum serine protease inhibitor which acts to neutralize digestive enzymes, potentially reducing intestinal damage. The Phase 3 trial being conducted in China is designed as a multi-centered, randomized, double-blinded, parallel-group, placebo-controlled clinical trial, and will assess the safety and efficacy of LB1148 to accelerate the return of bowel function following abdominal surgery. All patients enrolled in the trial will undergo a scheduled bowel resection surgery that will include either laparotomy or laparoscopic surgical approaches.
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