Recent Funding:
Light Horse Therapeutics (SD) Launches with $62M Series A and Novartis Partnership
Raised $62M in Series A funding from Bristol Myers Squibb, AbbVie, Mubadala Capital, and Taiho Ventures to advance its precision genetic editing platform for small molecule drug discovery. Announced a $25M upfront collaboration with Novartis, with potential milestones reaching $1 billion, to advance its oncology pipeline. Led by former Cyteir CEO Markus Renschler, with a scientific team featuring experts from Harvard, Stanford, and Scripps Research.
M&A, Deals, Partnerships:
Among Intra-Cellular’s neuropsychiatric assets is Caplyta, a pill approved for schizophrenia and bipolar depression and proposed for major depressive disorder. “This is the 4th multi-billion dollar neuroscience deal after Karuna, Cerevel, and Longboard,” the Stifel analysts stated. “In our view, this continues to validate the size of major CNS end-markets (schizophrenia, depression, epilepsy) even in the presence of many old generics.” The centerpiece of Monday’s acquisition agreement is Intra-Cellular’s Caplyta (lumateperone) a once-daily antipsychotic pill indicated for schizophrenia and depressive episodes in bipolar I or bipolar II disorder. Caplyta is also poised for a label expansion, with a supplemental New Drug Application filed in December 2024 proposing the drug’s use in major depressive disorder as an adjunct to antidepressants.
Strategist GSK acquires IDRx for $1B in hopes of bringing GIST patients new standard of care
In a deal worth up to $1.15 billion, GSK is acquiring precision medicine biotech IDRx and its phase 3-ready gastrointestinal cancer asset. The Big Pharma will also assume responsibility for milestone payments and potential royalties for the cancer candidate—dubbed IDRX-42—that are owed to Merck KGaA, from which IDRx licensed it in 2022. The tyrosine kinase inhibitor (TKI) is designed to be a first- and second-line therapy for gastrointestinal stromal tumors (GIST) by hitting all key KIT mutations, something that gives the asset best-in-class potential.
Eli Lilly strikes $2.5B Scorpion Therapeutics buyout in twist to breast cancer tale
Eli Lilly is reenergizing its attempt to challenge Novartis and Roche for a breast cancer market, kicking off the J.P. Morgan Healthcare Conference with a deal to buy Scorpion Therapeutics’ PI3Kα pipeline for up to $2.5 billion. Novartis won FDA approval for its PI3Kα inhibitor Piqray in 2019. Roche’s Itovebi joined the party late last year. Lilly’s attempt to follow its peers took a hit last year when it axed LOXO-783 after comparing clinical data on the molecule to its next-generation candidates. At the time, Lilly’s chief scientific officer Daniel Skovronsky, M.D., Ph.D., said a next-generation prospect would enter the clinic in 2025. The Scorpion deal secures Lilly a clinical-phase candidate ahead of schedule. Scorpion published phase 1 data on its candidate STX-478 last year, generating early evidence that the molecule may have an edge over Piqray and Itovebi and hold its own against Relay Therapeutics’ rival next-generation prospect.
Roche completes acquisition of Poseida Therapeutics (SD)
Roche has accepted nearly 65 million shares in Poseida Therapeutics for a cash payment of $9 per share, with an additional contingent payment of up to $4 per share, the Big Pharma announced Wednesday. The purchase represents about 66% of Poseida, which will give Roche access to the biotech’s off-the-shelf CAR T candidates. The total deal is worth up to $1.5 billion and is expected to close in the first quarter of this year, Seeking Alpha reported.
Scribe Therapeutics Inc. (Alameda), a genetic medicines company unlocking the potential of CRISPR to transform human health, today announced the achievement of a success milestone for one of the targets in its research collaboration with Sanofi to develop in vivo CRISPR-based therapeutics. Scribe is eligible to receive over $1.2 billion across all programs in milestone payments for the achievement of certain research, development, regulatory and commercial milestones, as well as high-single-digit to mid-teen royalties.
Viking Therapeutics (SD), a developer of drugs for obesity, aims to compete in a market now dominated by big pharma. As such, analysts have thought it likely the company may look to license its drug or sell entirely. Company CEO Brian Lian isn’t about to say who he’s talking with, but in a presentation Monday he did outline what characteristics would make for an ideal partner. On-market competitors like Eli Lilly and Novo Nordisk have struggled to deliver enough of their obesity drugs to meet demand. On Monday, Lian sought to assure investors Viking is planning ahead on manufacturing. He said the company has enough supply of the subcutaneous formulation of its lead product, VK2735, to complete Phase 3 testing, and enough of the oral formulation to get through Phase 2.
IPOs:
Sionna Therapeutics and Odyssey Therapeutics end JPM week with IPO filings
Sionna is building on the efforts of Sanofi and AbbVie in cystic fibrosis. Greg Hurlbut, Ph.D., and Mark Munson, Ph.D., set up the biotech after working together at Sanofi, and it wasn’t long before Sionna had licensed compounds designed to stabilize NBD1 from the French pharma for $1.5 million upfront. Multiple companies have studied NBD1, reflecting its key role in CFTR function, but are yet to develop a drug against the target. Sionna believes it can hit the target, positioning it to advance treatments for the 90% of cystic fibrosis patients with F508del mutations.
Odyssey is seeking funding for autoimmune and inflammatory disease programs, according to its filing. The pipeline is led by a RIPK2 inhibitor that is set to start a phase 2a monotherapy trial for ulcerative colitis this quarter. Odyssey said the IPO funding will enable it to complete the monotherapy trial and generate induction-stage data from a phase 2a trial that will test the candidate in combination with Takeda’s Entyvio
FDA Approvals:
The FDA gave full approval on Thursday for AstraZeneca’s Calquence
The FDA granted full approval to AstraZeneca’s Calquence for previously treated mantle cell lymphoma (MCL) patients and as a first-line combination treatment for those ineligible for stem cell transplantation, just before it was listed for price negotiations under the Inflation Reduction Act. Calquence is the first BTK inhibitor approved for first-line MCL treatment, showing a 27% improvement in progression-free survival in a Phase III trial, with a 36% benefit after adjusting for COVID-19-related deaths.
Datroway, previously known as datopotamab deruxtecan or dato dxd, is cleared for people whose breast tumors are HR-positive and HER2-negative, where in testing it was associated with a 37% reduction in the risk of progression or death compared to chemotherapy. Datroway will compete in that setting with Gilead Sciences’ Trodelvy, which gained a similar approval in 2023. A targeted type of cancer medicine called an antibody-drug conjugate, Datroway has struggled to show a clear benefit in lung cancer and, in breast tumors, hasn’t yet proven it can help people live longer. Nonetheless, AstraZeneca is still optimistic about Datroway’s potential, featuring Datroway among 20 drugs that can help the company achieve $80 billion in annual sales.
FDA places hold on Atara Biotherapeutics’ active INDs:
The holds affect the T cell therapy that the agency rejected last week as well as another program called ATA3219. According to Atara, FDA officials placed the hold due to the same manufacturing issues cited in the rejection letter. Both the company and regulators have agreed on actions necessary to release the clinical holds. Its stock $ATRA was down about 13% on Tuesday morning.
Other Interesting News:
- Submitting first BLA and preparing for the commercial launch of tividenofusp alfa for MPS II (Hunter syndrome).
- Enabling an accelerated approval path for DNL126 for MPS IIIA (Sanfilippo syndrome).
- Expanding their portfolio of TransportVehicle™ (TV) enabled programs for brain delivery of enzyme, oligonucleotide, and antibody therapeutics.
As leaders in the blood-brain barrier (BBB) field, they’ve pioneered a new class of barrier-crossing therapeutics. In 2025, Denali is driven to realize the potential of the TV platform and deliver on its potential to transform treatment for people living with rare and common brain-impacting diseases.
Curie.Bio (SF) Adds Biotech Investor Ben Auspitz to Lead Series A Investing
Ben Auspitz, a biotech investor and co-founder of IDRx, joins Curie.Bio to lead its Series A investments, aiming to incubate and fund new drug development startups. Curie.Bio, co-founded by Alexis Borisy, recently launched a $380M Series A fund to build on its $520M seed fund, targeting efficient early-stage deals and clinical progress from Series A investments. Auspitz brings experience from Forge Life Science Partners, which invested in IDRx (acquired by GSK for $1B) and other successful biotech ventures.
Lykos Therapeutics (SJ) Faces Leadership Shakeup Amid Financing Stalemate
Four board members, including chairman Jeff George, have stepped down, with additional departures reported last month, in light of disputes over financing the biotech’s future. MAPS and Helena, key stakeholders, remain divided on investment strategies. Following the FDA’s rejection of its MDMA drug for PTSD in August, Lykos faces pressure to finance a new Phase 3 trial, sparking layoffs, executive exits, and restructuring efforts. Antonio Gracias of Valor Equity Partners has offered $30 million in equity and $70 million in secured debt to take a controlling stake, with Paragon Biosciences as a potential commercial partner.
