Lilly Seeks To Expand Into Cancer Radiopharma And Fatty Liver, With Two Global Deals

 On Monday, Eli Lilly And Co (NYSE:LLY) inked two strategic collaborations to expand radiopharmaceuticals and metabolic-associated steatohepatitis (MASH), respectively.

AdvanCell announced that it is expanding the scope and breadth of its strategic collaboration with Eli Lilly to research and develop cancer treatments.

Under this new agreement, the parties will leverage AdvanCell's proprietary Pb-212 production technology, radionuclide development infrastructure, and Lilly's drug candidate programs to facilitate the development and accelerate the clinical advancement of an expanded portfolio of targeted alpha therapies.

In 2023, Eli Lilly acquired POINT Biopharma Global at $12.50 per share in cash, an aggregate of approximately $1.4 billion.

In June 2023, POINT Biopharma and AdvanCell collaborated on developing a global 212Pb radioisotope and radioligand supply chain and drug manufacturing network for 212Pb-labeled radioligands by each company.

Financial terms of the agreement were not disclosed.

Concurrently, Korea-based OliX Pharmaceuticals Inc. announced a global licensing agreement with Eli Lilly for the development and commercialization of OliX's OLX75016, a Phase 1 candidate primarily targeting metabolic-associated steatohepatitis (MASH) and other cardiometabolic indications.

OliX will receive an initial payment from Lilly to complete the Phase 1 clinical trial underway in Australia.

In preclinical studies, OliX has demonstrated the efficacy of OLX75016 in addressing MASH, liver fibrosis, and other cardiometabolic indications.

Recently, Eli Lilly reported fourth-quarter revenue of $13.53 billion, up 45% year over year, almost in line with the consensus of $13.57 billion.

The increase was driven by a 48% increase in volume, partially offset by a 4% decrease due to lower realized prices.

https://finance.yahoo.com/news/eli-lilly-seeks-expand-cancer-165521266.html

Bristol Positive Topline Results for Breyanzi in Relapsed or Refractory Marginal Zone Lymphoma

Trial met primary endpoint of overall response rate and key secondary endpoint of complete response rate

With these data, Breyanzi demonstrates efficacy and manageable safety in a fifth cancer type, the most of any CD19-directed CAR T cell therapy

Bristol Myers Squibb (NYSE: BMY) today announced the Phase 2 TRANSCEND FL trial evaluating Breyanzi® (lisocabtagene maraleucel) in adult patients with relapsed or refractory indolent B-cell non-Hodgkin lymphoma met its primary endpoint in the marginal zone lymphoma (MZL) cohort. Results showed Breyanzi demonstrated a statistically significant and clinically meaningful overall response rate (ORR) in these patients.

The study also met the key secondary endpoint of complete response rate (CRR). In the topline analysis, Breyanzi continued to demonstrate durable responses and a consistent safety profile with no new safety signals observed. This study marks the fifth cancer type in which Breyanzi has demonstrated clinically meaningful benefit, representing the broadest array of B-cell malignancies of any CD19-directed CAR T cell therapy and furthering evidence of Breyanzi’s best-in-class and best-in-disease profile.

https://www.businesswire.com/news/home/20250207490270/en/

Grace Therapeutics Touts Positive Data From Brain Hemorrhage Study

 On Monday, Grace Therapeutics, Inc. (NASDAQ:GRCE), formerly b, announced topline data from its Phase 3 STRIVE-ON safety trial of GTx-104 compared with oral nimodipine in patients hospitalized with aneurysmal Subarachnoid Hemorrhage (aSAH).

aSAH is bleeding over the brain’s surface in the subarachnoid space between the brain and the skull, which contains blood vessels that supply the brain.

The study met its primary endpoint and provides evidence of clinical benefit compared to orally administered nimodipine.

The trial met its primary endpoint, with patients receiving GTx-104 observed to have a 19% reduction in at least one incidence of clinically significant hypotension compared to oral nimodipine (28% versus 35%). Other measures also favored or were comparable to GTx-104, including:

Adverse events were comparable between the two arms and no new safety issues were identified with patients receiving GTx-104. All deaths in both arms of the trial were due to the severity of the patient’s underlying disease.

US new drug application submission is expected in the first half of 2025.

Concurrently, Grace Therapeutics announced a private placement of approximately $30 million consisting of initial upfront funding of approximately $15.0 million and the potential to receive up to an additional approximately $15.0 million upon cash exercise of accompanying warrants at the election of the investors.

Grace Therapeutics will issue an aggregate of 4.42 million common shares and accompanying common warrants to purchase up to 4.42 million at a combined purchase price of $3.395.

Grace Therapeutics will use the net proceeds to fund the development of GTx-104.

https://finance.yahoo.com/news/small-cap-grace-therapeutics-touts-170559950.html

Repligen started at Buy by TD Cowen

 Target $200

https://finviz.com/quote.ashx?t=RGEN&ty=c&ta=1&p=d

Merck cut to Hold from Buy by TD Cowen

 Target to $100 from $121

https://finviz.com/quote.ashx?t=MRK&ty=c&ta=1&p=d

Incyte Q4: EPS Miss, Strong Jakafi And Opzelura Sales, 2025 To Be Catalyst Rich, 4 Launches

 On Monday, Incyte Corporation (NASDAQ:INCY) reported fourth-quarter revenue of $1.18 billion, up 16% year over year and beating the consensus of $1.14 billion.

The company reported an adjusted EPS of $1.43, which was up from $1.06 a year ago and missing the consensus estimate of $1.56.

Jakafi’s net product revenue increased 11% to $773.1 million, primarily due to a 14% increase in paid demand.

Opzelura net product revenue increased 48% to $161.6 million, driven by continued growth in new patient starts and refills in the U.S. and increased contribution from Europe.

Minjuvi/Monjuvi net product revenue increased 265% to $32.81 million, as the company recognized all revenue from sales of Monjuvi in the United States following the acquisition of exclusive global rights for tafasitamab in February 2024.

“2024 was an important year for Incyte, with a 15% increase in total revenues, driven by strong growth from both Jakafi and Opzelura, as well as significant progress across our R&D pipeline,” said Hervé Hoppenot, Chief Executive Officer, Incyte.

Guidance: Incyte forecasts 2025 Jakafi revenue of $2.925 billion-$2.975 billion, up 4.76%-6.55% from 2024.

Opzelura sales are expected to increase between 23.9%-31.81% to $630 million-$670 million.

“Looking ahead to 2025, we anticipate a year of continued strong revenue growth and diversification, as well as several defining milestones that will serve as an inflection point for Incyte. A year ago, we set the goal to achieve more than 10 impactful product launches by 2030. In 2025, a number of key catalysts across the entire portfolio will bring that goal closer to reality,” Hoppenot added.

Incyte says 2025 is expected to be a year of defining catalysts with four launches, four pivotal study readouts, at least three Phase 3 study initiations, and seven proof-of-concept study readouts.

William Blair writes, “We continue to see steady growth of Jakafi in approved indications and believe that ongoing studies for lifecycle management could provide upside to current peak sales and offer the potential to extend Jakafi franchise exclusivity. We believe that Opzelura should provide Incyte with an additional meaningful commercial opportunity in large immune dermatological indications. Povorcitinib remains underappreciated by investors and has 

The analyst Matt Phipps reiterates the Outperform rating.

In November, Incyte announced that it would pause enrollment in the ongoing Phase 2 study of MRGPRX2 (INCB000262) in chronic spontaneous urticaria (CSU).

The decision was made following the observation of certain in vivo preclinical toxicology findings.

https://finance.yahoo.com/news/incyte-q4-earnings-eps-miss-153828776.html

Skye Bioscience At Conference Today

 Skye Bioscience (Nasdaq: SKYE), a clinical-stage biopharmaceutical company focused on obesity and metabolic health disorders, has announced its participation in two upcoming investor conferences in February 2025.

The company will participate in the BIO CEO & Investor Conference in New York on February 10, where they will join a panel discussion on 'Obesity: Next Medicines with Impact' at 11:00 AM ET. Additionally, Skye will present a corporate overview at the virtual Oppenheimer 35th Healthcare Life Sciences Conference on February 12 at 12:00 PM ET. A webcast of the presentation will be available on Skye's website

https://www.stocktitan.net/news/SKYE/skye-bioscience-announces-participation-in-february-o0r1ba7g06aw.html