Summary of Key Points from Biotechnology Equity Research Conference Call Industry Overview - The report focuses on the biotechnology sector, specifically highlighting companies with significant potential for growth and upcoming catalysts in 2026. Key Companies and Their Outlook 1. **Dianthus Therapeutics, Inc. (DNTH)** - Market Cap: $1.82 billion - Price Target: $66 - Key catalysts include: - CIDP Phase III interim analysis in Q2 2026 - Initiation of gMG Phase III study in mid-2026 - Phase II MMN topline data in 2H26 - Potential for significant upside based on peak revenue estimates of ~$2 billion across neuromuscular diseases [19][20][24] 2. **Taysha Gene Therapies, Inc. (TSHA)** - Market Cap: $1.50 billion - Price Target: $11 - Focus on pivotal study for TSHA-102 in Rett syndrome with potential for a 6-month interim readout by YE26/1Q27 [26][27] 3. **Tyra Biosciences (TYRA)** - Market Cap: $1.36 billion - Price Target: $32 - Major catalysts include: - Phase III data for achondroplasia in early 2026 - Initial data for IR-NMIBC in 1H26 - Potential to disrupt the market with oral FGFR3 inhibitors [31][35] 4. **Tango Therapeutics, Inc. (TNGX)** - Market Cap: $1.15 billion - Price Target: $14 - Expected to show de-risking data for vopimetostat in combination with RVMD's RAS inhibitors in 2026 [37][40] 5. **ORIC Pharmaceuticals (ORIC)** - Market Cap: $783 million - Price Target: $23 - Key catalysts include dose-optimization data for prostate cancer and validating data from PFE's MEVPRO-1 trial [42][48] 6. **Solid Biosciences (SLDB)** - Market Cap: $463 million - Price Target: $15 - Focus on DMD program with key regulatory feedback expected in 1H26 [49][53] Major Catalysts and Events - **Upcoming Catalysts:** - RARE and MREO Phase III ORBIT final analysis expected in Dec'25/Jan'26 with potential stock movements of +100%/-30% [2] - ALNY, CRSP, and others expected to provide revenue guidance and business plans early in 2026 [1] - Regulatory events including FDA's Rare Disease Day on 2/23/26 [12] - **Drug Launches:** - Expected launches in 2026 include drugs from ALNY, ARWR, KALV, and others targeting various conditions [3] Financial Updates - **Price Target Changes:** - ARWR raised from $67 to $90 - KOD raised from $24 to $39 [6][10] Market Dynamics - **Pricing Stability:** - 2026 net pricing expected to remain stable with current Medicare contracts influencing high gross-to-net (GTN) guidance [12] - **Strategic Interest:** - Potential for M&A activity as companies like ORIC attract interest due to their prostate cancer programs [43] Conclusion - The biotechnology sector is poised for significant developments in 2026, with multiple companies presenting strong investment opportunities based on upcoming catalysts, drug launches, and strategic positioning in the market.

Core Viewpoint - Jefferies recently released a report on the outlook for the U.S. biotech industry in 2026, focusing on preferred investment targets, undervalued potential companies, and potential acquisition opportunities. The report highlights that the biotech sector will see multiple key clinical trial data disclosures, new drug approvals, and policy dynamics, with companies in niche segments expected to achieve value re-evaluation through technological breakthroughs and commercialization progress [1]. Six Preferred Targets - Jefferies identified six companies as core recommendations for 2026 based on market catalysts and valuation potential: - **Dianthus Therapeutics (DNTH.US)**, target price $66: Focused on the drug claseprubart, showing potential in various neuromuscular diseases with an estimated peak revenue of $2 billion. Key milestones include mid-analysis of Phase III trials for CIDP and initiation of trials for gMG in 2026 [3]. - **Taysha Gene Therapies (TSHA.US)**, target price $11: The gene therapy TSHA-102 for Rett syndrome has a market potential of $2 billion. The three-phase clinical trial is expected to disclose mid-term data by the end of 2026 [3]. - **Tyra Biosciences (TYRA.US)**, target price $32: The oral FGFR3 inhibitor dabogratinib has disruptive potential in two areas, with key data expected next year [4]. - **Tango Therapeutics (TNGX.US)**, target price $14: Collaborating with Revolution Medicines to explore a combination therapy for pancreatic cancer, with data expected in the first half of 2026 [4]. - **ORIC Pharmaceuticals (ORIC.US)**, target price $23: Focused on two potential assets for prostate cancer and lung cancer, with key catalysts expected next year [5]. - **Solid Biosciences (SLDB.US)**, target price $15: Concentrating on gene therapy for Duchenne muscular dystrophy, with critical meetings with the FDA planned for 2026 [5]. Seven Undervalued Companies - The report highlights seven companies with significant catalysts and potential for value re-evaluation: - **Ultragenyx Pharmaceutical (RARE.US)**, target price $114: Current stock price undervalued, with key catalysts expected in 2026, including data for treatments of osteogenesis imperfecta and Angelman syndrome [6]. - **Beam Therapeutics (BEAM.US)**, target price $41: Focused on gene editing, with promising data updates expected in early 2026 [6]. - **Aurinia Pharmaceuticals (AUPH.US)**, target price $21: Core product Lupkynis shows steady growth, with new drug development paths expected to be announced in early 2026 [7]. - **Kodiak Sciences (KOD.US)**, target price $39: Potential in retinal disease therapies, with three Phase III trial data readouts expected in 2026 [7]. - **Intellia Therapeutics (NTLA.US)**, target price $45: A leader in gene editing, with key data expected in mid-2026 [8]. - **Compass Therapeutics (CMPX.US)**, target price $8: Focused on tumor bispecific antibodies, with data expected in early 2026 [8]. - **KalVista Pharmaceuticals (KALV.US)**, target price $38: Known for the first oral treatment for hereditary angioedema, with significant revenue growth expected in 2026 [9]. Five Potential Acquisition Targets - Jefferies identified five companies that may become acquisition targets in 2026 due to their unique assets or market positions: - **Arrowhead Pharmaceuticals (ARWR.US)**: Strong RNAi product line for cardiovascular metabolism and new obesity targets [10]. - **Celcuity (CELC.US)**: Drug gedatolisib shows unique efficacy in PIK3CA wild-type breast cancer [11]. - **ORIC Pharmaceuticals**: High-value prostate and lung cancer projects [12]. - **Travere Therapeutics (TVTX.US)**: Potential market opening in rare kidney diseases if FSGS indication is approved [13]. - **KalVista Pharmaceuticals**: First-mover advantage and strong growth in oral HAE drugs [14].

Core Insights - Jefferies recently released a report on the outlook for the U.S. biotech industry in 2026, focusing on preferred investment targets, undervalued potential companies, and potential acquisition opportunities. The report highlights that the biotech sector will see multiple key clinical trial data disclosures, new drug approvals, and policy developments in 2026, with companies in niche segments likely to achieve value re-evaluation through technological breakthroughs and commercialization progress [1]. Preferred Investment Targets - Jefferies identified six core recommended companies for 2026 based on market catalysts and valuation potential: - **Dianthus Therapeutics**: Target price of $66, focusing on the drug claseprubart for various neuromuscular diseases, with peak revenue estimated at $2 billion. Key milestones include mid-analysis of Phase III trials for CIDP and initiation of trials for gMG in 2026 [1]. - **Taysha Gene Therapies**: Target price of $11, with TSHA-102 for Rett syndrome showing significant market potential (peak revenue of $2 billion). Phase III trial data is expected by the end of 2026 [2]. - **Tyra Biosciences**: Target price of $32, with the drug dabogratinib showing disruptive potential in bladder cancer and achondroplasia. Key data is expected next year [2]. - **Tango Therapeutics**: Target price of $14, exploring a combination therapy for pancreatic cancer with expected data release in mid-2026 [2]. - **ORIC Pharmaceuticals**: Target price of $23, with two key assets targeting prostate cancer and lung cancer. Key data updates are anticipated next year [3]. - **Solid Biosciences**: Target price of $15, focusing on gene therapy for Duchenne muscular dystrophy, with critical meetings with the FDA planned for 2026 [3]. Undervalued Companies - The report highlights seven undervalued companies with significant catalysts and potential for value re-evaluation: - **Ultragenyx Pharmaceutical**: Target price of $114, with a current undervalued stock price. Key catalysts include Phase III data for setrusumab expected in late 2025 to early 2026, potentially driving a 100% stock price increase [4]. - **Beam Therapeutics**: Target price of $41, focusing on gene editing with promising data updates expected in early 2026 [5]. - **Aurinia Pharmaceuticals**: Target price of $21, with steady growth in lupus nephritis treatment and new drug development expected to drive growth [5]. - **Kodiak Sciences**: Target price of $39, with three Phase III trial data readouts expected in 2026 [6]. - **Intellia Therapeutics**: Target price of $45, with key data for hereditary angioedema therapy expected in mid-2026 [6]. - **Compass Therapeutics**: Target price of $8, with upcoming data for cholangiocarcinoma therapy expected in early 2026 [6]. - **KalVista Pharmaceuticals**: Target price of $38, with a first-in-class oral treatment for hereditary angioedema expected to drive rapid growth [7]. Potential Acquisition Targets - Jefferies identified five companies that may become acquisition targets in 2026 due to their unique assets or market positions: - **Arrowhead Pharmaceuticals**: Strong RNAi product line in cardiovascular metabolism and new obesity targets [8]. - **Celcuity**: Unique efficacy of gedatolisib in PIK3CA wild-type breast cancer [8]. - **ORIC Pharmaceuticals**: High-value prostate and lung cancer projects [8]. - **Travere Therapeutics**: Potential market expansion in rare kidney diseases if FSGS indication is approved [8]. - **KalVista Pharmaceuticals**: First-mover advantage and strong growth in oral HAE treatment [8].

Core Insights - Jefferies has released a report on the outlook for the U.S. biotech industry in 2026, highlighting key clinical trial data disclosures, new drug approvals, and policy dynamics that could lead to value re-evaluation for companies in the sector [1] Six Preferred Stocks - Jefferies identified six companies as core recommendations for 2026 based on market catalysts and valuation potential: - Dianthus Therapeutics (DNTH.US), target price $66: Focused on claseprubart for various neuromuscular diseases, with peak revenue estimated at $2 billion [2] - Taysha Gene Therapies (TSHA.US), target price $11: TSHA-102 for Rett syndrome, with peak revenue potential of $2 billion and a key trial data disclosure expected by the end of 2026 [2] - Tyra Biosciences (TYRA.US), target price $32: Dabogratinib for bladder cancer and achondroplasia, with critical data expected next year [3] - Tango Therapeutics (TNGX.US), target price $14: Collaboration with Revolution Medicines for a pancreatic cancer treatment, with data expected in mid-2026 [3] - ORIC Pharmaceuticals (ORIC.US), target price $23: Two potential assets targeting prostate cancer and lung cancer, with key data expected next year [4] - Solid Biosciences (SLDB.US), target price $15: Focused on gene therapy for Duchenne muscular dystrophy, with critical meetings with the FDA planned for 2026 [4] Seven Undervalued Companies - The report also highlighted seven undervalued companies with significant catalysts: - Ultragenyx Pharmaceutical (RARE.US), target price $114: Expected key catalysts in 2026, including data for treatments for osteogenesis imperfecta and Angelman syndrome [5] - Beam Therapeutics (BEAM.US), target price $41: Updates on AATD therapy and SCD therapy expected in 2026, showcasing strong potential [5] - Aurinia Pharmaceuticals (AUPH.US), target price $21: Steady growth in lupus nephritis treatment, with new drug development paths expected to expand growth [6] - Kodiak Sciences (KOD.US), target price $39: Anticipated data from three pivotal trials in 2026, with significant potential for stock volatility [7] - Intellia Therapeutics (NTLA.US), target price $45: Key data for hereditary angioedema therapy expected in mid-2026, with sufficient cash reserves to support operations [7] - Compass Therapeutics (CMPX.US), target price $8: Data for cholangiocarcinoma therapy expected in early 2026, with a significant market opportunity [8] - KalVista Pharmaceuticals (KALV.US), target price $38: First oral treatment for hereditary angioedema expected to see rapid growth in 2026 [8] Five Potential Acquisition Targets - Jefferies identified five companies that may become acquisition targets in 2026 due to their unique assets or market positions: - Arrowhead Pharmaceuticals (ARWR.US): Strong RNAi product line for cardiovascular and metabolic diseases [9] - Celcuity (CELC.US): Unique efficacy of gedatolisib in breast cancer [9] - ORIC Pharmaceuticals: High-value prostate and lung cancer projects [9] - Travere Therapeutics (TVTX.US): Potential for significant market expansion in rare kidney diseases [9] - KalVista Pharmaceuticals: First-mover advantage in oral HAE treatment [9]

Aurinia Pharmaceuticals Inc. ( AUPH ) has had an exciting few months, with an earnings update showing continued Lupkynis growth, a competitor's drug being approved for lupus nephritis, and a request for information from the FDA. I rated AUPH aScientist and trader of biotech stock. Focus on trading around events such as trial results and NDA/BLA approvals. Also covering companies in industries regulated by the FDA. Articles present my opinion on stocks, but don't constitute investment advice.Analyst’s Disclo ...

Core Points - The resignation of George Tidmarsh from the FDA occurred shortly after being placed on administrative leave due to personal conduct concerns [1][4] - Tidmarsh was sued for defamation by Aurinia Pharmaceuticals, which accused him of having a personal vendetta against the company's chairman [2][6] - Tidmarsh's LinkedIn post, which labeled Aurinia's lupus drug as toxic, led to a significant drop in the company's stock price [2][9] Group 1: Tidmarsh's Resignation and Legal Issues - Tidmarsh was placed on administrative leave after serious concerns about his personal conduct were raised [4] - He resigned two days later, with the HHS Secretary emphasizing the expectation of high ethical standards [4] - Aurinia Pharmaceuticals filed a lawsuit against Tidmarsh, claiming he harbored a vendetta against its chairman, Kevin Tang [2][6] Group 2: Impact on Aurinia Pharmaceuticals - Following Tidmarsh's LinkedIn post, Aurinia's shares fell approximately 20% before recovering slightly [5][9] - The company’s chairman, Kevin Tang, has a history with Tidmarsh, having previously asked him to resign from multiple positions due to management concerns [6][7] - Aurinia alleged that Tidmarsh sent harassing messages to Tang and targeted companies associated with him after joining the FDA [7][8] Group 3: Tidmarsh's Claims and Concerns - Tidmarsh claimed his leave was a result of raising concerns about the legality of a drug approval program, which he believed politicized the review process [3] - He later clarified that his LinkedIn post reflected his personal views and not those of the FDA [9]

Group 1 - Aurinia Pharmaceuticals (NASDAQ: AUPH) stock is experiencing a slow month with double-digit losses, potentially indicating profit-taking after stronger double-digit gains over the past six months [1] - The anticipated market movements in the coming month suggest a focus on the stock's performance and investor sentiment [1] Group 2 - The article highlights the author's background as a seasoned financial professional with experience in analyzing financial statements, capital markets, and macro-economy [1] - The author has contributed to reputable publications and holds advanced qualifications in investments and portfolio management [1] - There is an emphasis on the author's commitment to Responsible Investment and promoting Environmental, Social, and Governance (ESG) principles in investment decision-making [1]

Group 1 - Aurinia Pharmaceuticals Inc.'s Lupkynis sales appeared to have peaked in early to mid-2024, with stock prices falling below $5 [1] - Q1 2024 earnings report indicated a resumption of sales growth for Lupkynis in May [1]

Company Overview - Aurinia Pharmaceuticals (AUPH) shares increased by 7.5% to $8.63 in the last trading session, with a notable trading volume that exceeded the average [1] - The stock has shown a modest gain of 0.6% over the past four weeks [1] Product Performance - The rise in stock price is linked to positive investor sentiment regarding Lupkynis, the company's only marketed drug for treating adults with active lupus nephritis (LN) [2] - Sales of Lupkynis grew by 25% year-over-year, reaching $60 million in the first quarter of 2025 [2] Earnings Expectations - Aurinia is projected to report quarterly earnings of $0.18 per share, reflecting an 800% increase year-over-year [3] - Expected revenues for the upcoming quarter are $64.23 million, which is a 12.3% increase from the same quarter last year [3] - The consensus EPS estimate has remained stable over the last 30 days, indicating no recent revisions in earnings estimates [4] Industry Context - Aurinia holds a Zacks Rank of 3 (Hold), indicating a neutral outlook [5] - In the same medical-drugs industry, Corcept Therapeutics (CORT) also holds a Zacks Rank of 3 (Hold) and has seen a 0.5% increase in its stock price, but has returned -4.7% over the past month [5][6]