Group 1 - Roivant Sciences Ltd. (NASDAQ:ROIV) is considered a promising low-cost stock, with multiple firms raising their price targets following positive Phase 2 data for brepocitinib in cutaneous sarcoidosis [1][2][3] - Citi raised its price target for Roivant Sciences to $35 from $26 while maintaining a Buy rating, citing the drug's growth potential and integrating revenue projections into its financial model [1][4] - H.C. Wainwright also increased its price target to $33 from $26, characterizing the Phase 2 data as impressive and adding this indication to its valuation model [2] - Bank of America raised its price target to $26 from $22 with a Neutral rating, noting that the FQ3 2026 results were in line and highlighting the positive Phase 2 topline results of brepocitinib [3]

Market Overview - Richard Bernstein, CEO of Richard Bernstein Advisors, discussed the equity markets on CNBC, noting a significant broadening of the market since late October 2025 [1] - The unexpected strength of the overall economy has contributed to this shift, with nominal GDP exceeding 8% last quarter, a level not seen since 2006, excluding the post-pandemic period [2] Investment Strategy - Bernstein emphasized a macro-focused investment strategy, avoiding individual stock picks, and questioned the rationale behind paying high valuations for well-known tech stocks when similar growth can be found at lower valuations globally [3] Promising Low-Cost Stocks - A list of 11 promising low-cost stocks was compiled, focusing on those priced between $10 and $30 and favored by elite hedge funds [6] - The strategy of imitating top hedge fund stock picks has historically outperformed the market, with a reported return of 427.7% since May 2014 [7] Company Highlights Roivant Sciences Ltd. (NASDAQ:ROIV) - Roivant Sciences is highlighted as a promising low-cost stock, with a price target raised by Citi to $35 from $26 due to positive Phase 2 data for brepocitinib [8][9] - H.C. Wainwright also increased its price target for Roivant to $33, citing impressive Phase 2 data [9] - Bank of America raised its price target to $26 from $22, noting that FQ3 2026 results were in line with expectations [10] News Corporation (NASDAQ:NWSA) - News Corporation is also listed as a promising low-cost stock, with a recent price target adjustment by Citi to $39 from $40 while maintaining a Buy rating [12] - The company reported a 6% revenue increase to $2.4 billion and a 9% expansion in total segment EBITDA to $521 million for FQ2 2026 [13] - Despite a 21% decline in net income from continuing operations, adjusted EPS rose to $0.40, and profitability margins improved to 22.1% [13] - Performance was driven by the Dow Jones and Digital Real Estate segments, while the News Media segment faced challenges [14]

Core Insights - Roivant Sciences Ltd. (NASDAQ:ROIV) is recognized as a promising healthcare stock under $50, with a revised price target of $38 from TD Cowen, maintaining a Buy rating following positive Phase 2 results for brepocitinib in cutaneous sarcoidosis [1][2] Financial Performance - The company reported $4.5 billion in consolidated cash, cash equivalents, restricted cash, and marketable securities as of December 31, 2025, indicating a strong cash runway towards profitability [3] Product Development - Brepocitinib 45 mg showed significant improvement in cutaneous sarcoidosis disease activity, with rapid and sustained efficacy across all measured endpoints and a consistent safety profile [2] - An NDA has been submitted to the FDA for brepocitinib in dermatomyositis, with topline data from Phase 3 studies in non-infectious uveitis expected in the second half of 2026 [2] - The company is actively exploring additional indications for brepocitinib [2] Product Portfolio - Roivant Sciences Ltd. develops transformative medicines, with a product portfolio that includes Vtama, Batoclimab, Brepocitinib, Namilumab, and RVT-2001, targeting various therapeutic areas such as oncology, immunology, dermatology, and hematology [4]

Financial Data and Key Metrics Changes - The company reported a non-GAAP net loss of $167 million for the quarter, with R&D expenses at $165 million and G&A expenses at $175 million [30] - The company maintains a strong cash position with $4.5 billion in consolidated cash, providing ample capital to reach profitability [30] Business Line Data and Key Metrics Changes - The NDA for brepocitinib in dermatomyositis has been submitted, and the phase 2b study for 1402 in D2T-RA has fully enrolled [6][7] - The phase 2 study for mosliciguat in PH-ILD has also fully enrolled, with top-line data expected in the second half of the year [7][8] Market Data and Key Metrics Changes - The company is targeting a large addressable patient population for brepocitinib, particularly in orphan inflammatory diseases with high unmet needs [25][36] - The potential market for cutaneous sarcoidosis is estimated to be slightly smaller than dermatomyositis, with around 40,000 eligible patients [79] Company Strategy and Development Direction - The company is focused on expanding the development of brepocitinib into additional indications, emphasizing its potential as a first-in-class therapy for sarcoidosis [35][36] - The company plans to leverage insights from the phase 2 study to inform the design of the phase 3 trial, aiming for a similar size and endpoint duration [79] Management's Comments on Operating Environment and Future Outlook - Management expressed enthusiasm about the strong phase 2 data for brepocitinib, highlighting its potential to address significant patient needs [25][36] - The company anticipates a busy year ahead with multiple pivotal study readouts and potential commercial launches [30][31] Other Important Information - The jury trial against Moderna is scheduled for March 9, with recent favorable decisions regarding summary judgment [29] - The company is exploring further development opportunities for brepocitinib, including other forms of sarcoidosis and related conditions [35][36] Q&A Session Summary Question: What are the further development opportunities for brepocitinib? - Management is enthusiastic about expanding brepocitinib's development, particularly in large orphan markets with high unmet needs [35][36] Question: Can you provide more details on the baseline characteristics of the CSAMI numbers? - There were significant differences in baseline characteristics, including disease duration and morphology, which may have influenced the results [42][43] Question: What is the pricing strategy for brepocitinib? - Pricing has not been finalized, but it is expected to be positioned within the orphan drug pricing envelope [48][50] Question: What are the expectations for the phase 3 trial design? - The phase 3 trial is expected to be similar in size to the phase 2 trial, with final details to be discussed with the FDA [58][79] Question: What percentage of patients in the Beacon study had organ involvement? - Approximately 60% of patients had pulmonary involvement, and exploratory endpoints related to organ involvement were collected but not analyzed yet [83][84]

Financial Data and Key Metrics Changes - The company reported a non-GAAP net loss of $167 million for the quarter, with R&D expenses at $165 million and G&A expenses at $175 million [30] - The company maintains a strong cash position with $4.5 billion in consolidated cash, providing ample capital to reach profitability and pursue additional opportunities [30] Business Line Data and Key Metrics Changes - The NDA for brepocitinib in dermatomyositis has been submitted, and the phase IIb study for 1402 in D2T-RA has fully enrolled [6][7] - The phase II study for mosliciguat in PH-ILD has also fully enrolled, with top-line data expected in the second half of the year [7][28] Market Data and Key Metrics Changes - The company is targeting a large addressable patient population for brepocitinib, particularly in orphan inflammatory diseases with high unmet needs [25][36] - The company estimates around 40,000 eligible patients for cutaneous sarcoidosis, indicating a significant market opportunity [77] Company Strategy and Development Direction - The company is focused on expanding the development of brepocitinib into additional indications, emphasizing its potential as a first-in-class therapy for sarcoidosis [35][36] - The company plans to leverage insights from the phase II study to inform the design of the phase III trial, aiming for a similar size and endpoint duration [79] Management's Comments on Operating Environment and Future Outlook - Management expressed enthusiasm about the strong phase II data for brepocitinib, highlighting its potential to address significant patient needs in various indications [25][36] - The company anticipates a catalyst-rich period ahead, with multiple NDA and BLA filings expected in the coming years [31] Other Important Information - The jury trial against Moderna is scheduled for March 9, with recent favorable decisions regarding summary judgment [29] - The company is exploring further development opportunities for brepocitinib, including potential expansion into other forms of sarcoidosis [36][84] Q&A Session Summary Question: What are the further development opportunities for brepocitinib? - Management is enthusiastic about further development and is considering additional indications, emphasizing the strong data supporting brepocitinib's efficacy [35] Question: Can you provide more details on the baseline characteristics of the CSAMI numbers? - Management noted that there were some significant differences in baseline characteristics, including disease duration and morphology, which may have influenced the results [42][43] Question: What is the pricing strategy for brepocitinib? - Management has not finalized pricing but indicated it will be positioned as an orphan-priced drug, with considerations based on existing therapies [48][50] Question: What is the expected size and design of the phase III study? - Management indicated that the phase III study would likely be similar in size to the DM trial, with final details to be determined after discussions with the FDA [59][79] Question: What percentage of patients in the Brepo study had organ involvement? - Approximately 60% of patients had pulmonary involvement, and around 30% had other organ involvement, primarily ocular [84]

Financial Data and Key Metrics Changes - The company reported a non-GAAP net loss of $167 million for the quarter, with R&D expenses at $165 million and G&A expenses at $175 million [27][28] - The company maintains a strong cash position with $4.5 billion in consolidated cash, providing ample capital to reach profitability [28] Business Line Data and Key Metrics Changes - The NDA for brepocitinib in dermatomyositis has been submitted, and the phase 2b study for 1402 in D2T-RA has fully enrolled [5][6] - The phase 2 study for mosliciguat in PH-ILD has also fully enrolled, with top-line data expected in the second half of the year [6][25] Market Data and Key Metrics Changes - The company is targeting a large addressable patient population for brepocitinib, particularly in orphan inflammatory diseases with high unmet needs [23][34] - The market opportunity for cutaneous sarcoidosis is estimated at around 40,000 eligible patients, which is slightly smaller than the dermatomyositis opportunity [75] Company Strategy and Development Direction - The company is focused on expanding the development of brepocitinib into additional indications, including other forms of sarcoidosis [33][94] - The company aims to leverage its unique TYK2 and JAK1 inhibition mechanism to explore new therapeutic areas with high unmet needs [93] Management's Comments on Operating Environment and Future Outlook - Management expressed enthusiasm about the strong phase 2 data for brepocitinib, indicating it could be a significant treatment option for patients with cutaneous sarcoidosis [9][23] - The company anticipates a busy year ahead with multiple pivotal study readouts and potential commercial launches [30][31] Other Important Information - The jury trial against Moderna is scheduled for March 9, with recent favorable decisions regarding summary judgment [26][27] - The company is preparing for pivotal data readouts in 2027 for its FcRn product, IMVT-1402, which is expected to have best-in-class efficacy [24] Q&A Session Summary Question: What are the further development opportunities for brepocitinib? - Management is enthusiastic about further development and sees brepocitinib as a strong agent for patient populations in need, with ongoing considerations for other forms of sarcoidosis [33] Question: Can you provide more details on the baseline characteristics of the CSAMI numbers? - Management noted that there were significant differences in baseline characteristics, including disease duration and morphology, which may have influenced the results [42] Question: What are the pricing considerations for brepocitinib? - Pricing has not been finalized, but management indicated it would be positioned as an orphan-priced drug, with considerations based on existing therapies [48] Question: What is the expected size and design of the phase 3 study? - Management indicated that the phase 3 study would likely be similar in size to the dermatomyositis trial, but final details will depend on discussions with the FDA [56][75] Question: What percentage of patients in the Beacon study had organ involvement? - Approximately 60% of patients had pulmonary involvement, and exploratory endpoints related to organ involvement were collected but not analyzed yet [82]

Core Insights - Roivant announced positive Phase 2 results for brepocitinib in cutaneous sarcoidosis, marking a significant breakthrough in treatment options for this condition [1][2][10] - The company reported a consolidated cash position of approximately $4.5 billion as of December 31, 2025, supporting its financial stability and ongoing development efforts [12][17] Clinical Development - The BEACON study involved 31 patients and demonstrated that brepocitinib 45 mg resulted in a 22.3-point improvement in mean CSAMI-A at Week 16 compared to a 0.7-point improvement in placebo, with statistical significance (Δ21.6, P<0.0001) [3][4][10] - Brepocitinib 45 mg achieved a 100% response rate on multiple endpoints, with 62% of patients reaching functional remission (CSAMI-A <5) compared to 0% in the placebo group [5][6] - The company plans to initiate a Phase 3 study for cutaneous sarcoidosis in 2026, following engagement with the FDA, representing the third pivotal program for brepocitinib [4][8][10] Financial Performance - Research and development expenses increased by $23.8 million to $165.4 million for Q3 2025, driven by program-specific costs and share-based compensation [13][15] - General and administrative expenses rose by $33.5 million to $175.1 million for the same period, primarily due to an impairment loss related to the relocation of the corporate headquarters and increased share-based compensation [16][18] - The company reported a loss from continuing operations of $313.7 million for Q3 2025, compared to a loss of $208.9 million for the same period in 2024 [20][21] Upcoming Milestones - Topline data from Phase 3 studies in non-infectious uveitis are expected in the second half of 2026, along with data from trials for other indications of brepocitinib and IMVT-1402 [4][10][17] - A jury trial in the U.S. Moderna case is scheduled for March 2026, with significant developments anticipated in ongoing litigation [17][10]

Core Insights - Priovant Therapeutics announced positive results from the Phase 2 BEACON study for brepocitinib in cutaneous sarcoidosis, marking a significant milestone in the treatment of this neglected disease [1][2] Company Overview - Priovant Therapeutics is focused on developing novel therapies for autoimmune diseases with high morbidity and limited treatment options [10] - The lead asset, brepocitinib, is a dual selective inhibitor of TYK2 and JAK1, targeting key cytokines linked to autoimmunity [10] - The company plans to initiate a Phase 3 program for cutaneous sarcoidosis in 2026, following engagement with the FDA [7][10] Study Details - The BEACON study enrolled 31 patients across 15 sites in the U.S., with a randomized design comparing brepocitinib 45 mg, 15 mg, and placebo over a 16-week treatment period [2][5] - The 45 mg treatment group included patients with longstanding and difficult-to-treat disease, yet achieved significant clinical improvements compared to placebo [2][5] Efficacy Results - Brepocitinib 45 mg achieved a 22.3-point mean improvement in the Cutaneous Sarcoidosis Activity and Morphology Instrument – Activity score (CSAMI-A) at Week 16, compared to a 0.7-point improvement in placebo (Δ 21.6, P<0.0001) [3][5] - 100% of patients in the 45 mg group achieved at least a 10-point improvement on CSAMI-A, while 62% reached functional remission (CSAMI-A <5) [4][5] Patient Outcomes - On the Investigator's Global Assessment (IGA), 69% of brepocitinib 45 mg patients achieved a two-point improvement to "Clear" or "Almost Clear," compared to 0% in the placebo group (Δ 69%, P=.0047) [5][6] - Brepocitinib also showed significant improvements in key patient-reported outcomes, with 100% of 45 mg patients reporting improvement on the Patient's Global Impression of Change (PGI-C) [6] Safety Profile - Brepocitinib was well tolerated, with no serious adverse events reported and all adverse events classified as mild or moderate [7] - The safety profile aligns with that of other approved JAK1 and TYK2 inhibitors, having been evaluated in over 1,500 patients [7]

Company Overview - Roivant is a biopharmaceutical company focused on improving patient lives by accelerating the development and commercialization of important medicines [3] - The company's pipeline includes several key product candidates such as brepocitinib for autoimmune diseases, IMVT-1402 and batoclimab targeting IgG-mediated autoimmune indications, and mosliciguat for pulmonary hypertension [3] Upcoming Events - Roivant will host a live conference call and webcast on February 6, 2026, at 8:00 a.m. ET to report its financial results for the second quarter ended December 31, 2026, and provide a business update [1][2] Investor Relations - Details for accessing the conference call will be available on Roivant's website, and an archived version of the webcast will be accessible post-event [2]

Summary of Roivant Sciences FY Conference Call Company Overview - **Company**: Roivant Sciences (NasdaqGS:ROIV) - **Event**: FY Conference Call on January 12, 2026 - **Speaker**: CEO Matt Gline Key Points Company Positioning and Strategy - Roivant is entering a new era with a significantly simplified business model focused on a smaller subset of products, emphasizing clinical execution and pipeline potential [3][4] - The company aims to shape its own destiny with a high priority on delivering results from its clinical programs [3] Financial Strength - Roivant reported a cash balance of **$4.4 billion**, positioning it well for future growth without the need for additional fundraising [5][9] - The company has a strong track record with **12 positive phase III studies** and **8 FDA approvals**, indicating robust past performance and a solid pipeline [9] Clinical Development Highlights - **Brepocitinib**: Positive data for dermatomyositis (DM) with plans to file an NDA by early 2026, marking it as the first novel oral therapeutic for DM [4][5] - **IMVT-1402**: Progressing in pivotal studies for Graves' disease, with expectations for significant disease-modifying benefits [4] - Upcoming data releases include registrational programs for brepocitinib in non-infectious uveitis (NIU) and phase IIb data for mosliciguat in pulmonary hypertension associated with interstitial lung disease (PH-ILD) [6][7] Market Opportunities - The company sees a potential **$15 billion-plus portfolio** across various indications, with significant opportunities in DM, NIU, and Graves' disease [19][70] - Brepocitinib is expected to capture market share from existing therapies, particularly for patients currently on high-dose steroids or IVIG [41][42] Competitive Landscape - Roivant is positioned to be among the first non-prostacyclin novel mechanisms in PH-ILD, competing against established treatments [6][57] - The company is optimistic about the potential for brepocitinib to outperform existing treatments in DM, especially given the enthusiasm from physicians [41][46] Legal and Regulatory Environment - Ongoing litigation with Moderna regarding lipid nanoparticle technology, with a jury trial scheduled for March 2026 [5][60] - The outcome of this case may have implications for other ongoing litigations and the company's overall strategy [62] Future Outlook - Roivant anticipates a transformative next 36 months with multiple commercial launches and pivotal study readouts [11][19] - The company is focused on executing its clinical programs and expanding its pipeline to drive future value [19][29] Unique Business Model - Roivant's model combines talent from various backgrounds, emphasizing creative clinical development and a focus on delivering value to patients [10][30] - The company aims to differentiate itself by maintaining high standards for partnerships and transactions, driven by a focus on profitability [36] Conclusion - Roivant Sciences is positioned for significant growth with a strong financial foundation, a focused pipeline, and a commitment to innovative clinical development. The upcoming years are expected to be pivotal for the company as it seeks to capitalize on its opportunities in the biotech space [19][70]