Compass Corporate Update, Advancement of New Drug Candidate

 

• Top-line Phase 2/3 data readout for CTX-009, now named tovecimig (a DLL4 x VEGF-A bispecific), in patients with biliary tract cancer (BTC) is on track for end of Q1 2025.
• CTX-10726 (a novel PD-1 x VEGF-A bispecific) is advancing as a new drug candidate after a year of preclinical development, with YE 2025 IND expected.
• Two Phase 2 biomarker trials are expected to initiate in mid-2025: tovecimig (in DLL4-positive colorectal cancer) and CTX-471 (in NCAM/CD56 expressing tumors).
• Fully enrolled the third dosing cohort of the Phase 1 dose-escalation study of CTX-8371 (PD-1 x PD-L1 bispecific) with preliminary data expected in the second half of 2025.
• Estimated $127 million in cash and marketable securities at YE 2024, which is expected to provide cash runway into Q1 2027.

https://www.globenewswire.com/news-release/2025/01/08/3006206/0/en/Compass-Therapeutics-Provides-Corporate-Update-and-Announces-Advancement-of-a-New-Drug-Candidate.html

Halozyme Prelim 2024 Estimated Ranges Consistent With Guidance; Raises FY25 Guidance

 Halozyme Therapeutics (HALO) reiterated full year 2024 financial guidance and increased full year 2025 and multi-year financial guidance. For 2025, the company now expects: non-GAAP EPS in a range of $4.95 to $5.35, revised from prior guidance range of $4.45 to $4.85. Total revenue is now expected in a range of $1.15 billion to $1.225 billion, revised from prior guidance range of $1.095 billion to $1.17 billion.

Preliminary estimates of results for the twelve months ended December 31, 2024, include: Non-GAAP EPS in a range of $4.00 to $4.20; and total revenue in a range of $970 million to $1.02 billion.

The company also announced it has recently entered into a new $250 million accelerated share repurchase program under previously announced $750 million share repurchase program.

https://www.rttnews.com/3501463/halozyme-preliminary-2024-estimated-ranges-consistent-with-guidance-raises-fy25-guidance.aspx

Merck cut to Hold from Buy by Truist

 Target $110

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

GSK Nears $1 Billion Deal for Biotech Company IDRx

 GSK Plc is in talks to buy biotech company IDRx, people with knowledge of the matter said, a deal that would see the British drugmaker further boost its growing oncology portfolio.

The purchase could value privately owned IDRx at as much as $1 billion, said the people, who asked not to be identified because the information is private. The negotiations are still ongoing and there is no guarantee that a deal will be agreed. The Financial Times first reported on the potential deal.

GSK and IDRx declined to comment.

IDRx is developing an experimental drug for gastrointestinal stromal tumor, a soft tissue sarcoma that occurs in the digestive tract.

GSK has been working to expand its cancer-drug business in recent years, including deals with Hansoh Pharma and Sierra Oncology.

That push has started to pay off, with higher than expected sales of its rare bone marrow blood cancer drug Ojjaara and positive results for Blenrep, another blood cancer drug that was previously withdrawn from the market. GSK is seeking permission to start selling Blenrep again and forecast peak annual sales potential of more than £3 billion ($3.7 billion).

https://www.msn.com/en-ae/money/companies/gsk-nears-1-billion-deal-for-biotech-company-idrx/ar-AA1xbHix

GE HealthCare upped to Buy from Hold by Jefferies

 Target to $103 from $95

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

Summit started at Buy by Truist

 Target $35

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

Collegium 2025 Financial Guidance and Business Update

 – Product Revenues, Net Expected in the Range of $735 Million to $750 Million –

– Jornay PM® Net Revenue Expected to be in Excess of $135 Million –

– Adjusted EBITDA* Expected in the Range of $435 Million to $450 Million –

– Adjusted Operating Expenses* Expected in the Range of $220 Million to $230 Million –

“In 2024, we executed on our priorities of maximizing the pain portfolio and strategically deploying capital, delivering record financial results and closing the acquisition of Ironshore,” said Vikram Karnani, President and Chief Executive Officer of Collegium. “Looking ahead to 2025 and beyond, Collegium will embark upon a new phase of growth. Jornay PM, as a highly differentiated product to treat ADHD, is positioned to be our lead growth driver, and our focus will be on commercial expansion. We are committed to maximizing and delivering strong performance across our entire portfolio as we build a leading, diversified biopharmaceutical company serving people living with serious medical conditions.”

“Our 2025 financial guidance reflects expected significant top- and bottom-line growth driven by the addition of Jornay PM and continued performance from our pain portfolio. We expect Jornay PM net revenue in 2025 to be in excess of $135 million,” said Colleen Tupper, Chief Financial Officer of Collegium. “We plan to make targeted investments in Jornay PM throughout 2025, which we expect will accelerate growth in the near-term, while creating significant momentum in 2026 and beyond. In addition, we will continue to strategically deploy capital in a disciplined manner to create long-term value for our shareholders.”

Financial Guidance for 2025

• Product revenues, net are expected in the range of $735 million to $750 million.
• Adjusted EBITDA (excluding stock-based compensation) is expected in the range of $435 million to $450 million.
• Adjusted operating expenses (excluding stock-based compensation) are expected in the range of $220 million to $230 million.
  

* Non-GAAP financial measure. Please refer to the “Non-GAAP Financial Measures” section for details regarding these measures.

https://www.globenewswire.com/news-release/2025/01/08/3006178/34897/en/Collegium-Provides-2025-Financial-Guidance-and-Business-Update.html