Krystal Biotech Shares Rise Following FDA Approval for Vyjuvek Label Revision
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Sep 16 2025
0mins
Should l Buy ALLO?
Source: NASDAQ.COM
FDA Approval Update: Krystal Biotech's Vyjuvek has received FDA approval to include dystrophic epidermolysis bullosa (DEB) patients from birth, allowing for greater flexibility in home administration and wound management.
Market Performance and Future Prospects: Following the announcement, Krystal Biotech's shares rose 8.4%, and the company has secured over 575 reimbursement approvals in the U.S. Vyjuvek is also set for launches in Europe and Japan, with sales reaching $184.2 million in the first half of 2025, indicating strong future growth potential.
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Analyst Views on ALLO
Wall Street analysts forecast ALLO stock price to rise
11 Analyst Rating
10 Buy
0 Hold
1 Sell
Strong Buy
Current: 1.620
Low
5.00
Averages
8.50
High
14.00
Current: 1.620
Low
5.00
Averages
8.50
High
14.00
About ALLO
Allogene Therapeutics, Inc. is a clinical-stage immuno-oncology company. The Company is focused on development of genetically engineered allogeneic T cell product candidates for the treatment of cancer and autoimmune diseases. It is focused on three core programs: Large B-Cell Lymphoma (LBCL), Autoimmune Disease (AID), and Renal Cell Carcinoma (RCC). It is developing a pipeline of multiple allogeneic chimeric antigen receptor (CAR) T cell product candidates utilizing protein engineering, gene editing, gene insertion and advanced proprietary T cell manufacturing technologies. Its product candidate, cemacabtagene ansegedleucel, referred to as cema-cel, is an engineered allogeneic CAR T cell product candidate that targets CD19, a protein expressed on the cell surface of B cells and a validated target for B cell driven hematological malignancies. It is focused on developing cema-cel for LBCL. Its pipeline also includes ALLO-316 and ALLO-329.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Allogene Therapeutics to Participate in Investor Conferences
- Investor Conference Schedule: Allogene Therapeutics will participate in Citi's 2026 Virtual Oncology Leadership Summit on February 18 and TD Cowen's 46th Annual Health Care Conference on March 3, showcasing its innovations in cancer and autoimmune disease treatment.
- Webcast Availability: Live webcasts will be available during the conferences, with replays accessible on the company's website for approximately 30 days post-event, ensuring investors can stay informed and engaged with the latest developments.
- Technological Innovation Focus: Allogene Therapeutics is dedicated to developing 'off-the-shelf' CAR T cell products aimed at providing more reliable and scalable cell therapies for cancer and autoimmune diseases, highlighting its leading position in the biotechnology sector.
- Cautionary Note on Forward-Looking Statements: The company emphasizes potential risks and uncertainties in its press release regarding product development timelines and costs, urging investors to consider these factors when evaluating future prospects.
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- Volume Spike: Trading volume reached 93.5 million shares on Wednesday, about 357% above the three-month average of 20.5 million shares, signaling a significant rise in investor attention that could lead to further price volatility.
- Short-Seller Losses: With 35% of the public float held short, short-sellers now face nearly $500 million in paper losses, reflecting optimistic market sentiment towards ImmunityBio's future developments, which may prompt short-covering to mitigate losses.
- Market Reaction: Although there was no specific news driving the price increase, the actions of short-sellers covering their positions combined with recent positive developments have contributed to the stock's rise, showcasing ongoing interest in the biotechnology sector.
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Arbitration Outcome Details: The tribunal dismissed Cellectis's claims against Servier, including financial claims related to milestone payments, and mandated a partial termination of the license concerning the discontinued UCART19 V1 product.
Allogene's Future Prospects: With the legal dispute resolved, Allogene is positioned for a significant catalyst period in 2026, including an interim analysis of cema-cel's efficacy in treating large B-cell lymphoma.
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- Clinical Progress: Allogene is set to conduct an interim futility analysis of cema-cel in the pivotal Phase 2 ALPHA3 trial in 1H 2026, aimed at evaluating its efficacy in large B-cell lymphoma patients, potentially yielding significant clinical data for the company.
- Market Outlook: With the arbitration results, Allogene strengthens its market position in the CAR T cell therapy sector, likely attracting more investments and enhancing its competitiveness in the global biotechnology market.
See More
Allogene Therapeutics to Participate in Investor Conferences
- Investor Conference Schedule: Allogene Therapeutics will participate in Citi's 2026 Virtual Oncology Leadership Summit on February 18 and TD Cowen's 46th Annual Health Care Conference on March 3, showcasing its innovations in cancer and autoimmune disease treatment.
- Webcast Availability: Live webcasts will be available during the conferences, with replays accessible on the company's website for approximately 30 days post-event, ensuring investors can stay informed and engaged with the latest developments.
- Technological Innovation Focus: Allogene Therapeutics is dedicated to developing 'off-the-shelf' CAR T cell products aimed at providing more reliable and scalable cell therapies for cancer and autoimmune diseases, highlighting its leading position in the biotechnology sector.
- Cautionary Note on Forward-Looking Statements: The company emphasizes potential risks and uncertainties in its press release regarding product development timelines and costs, urging investors to consider these factors when evaluating future prospects.
See More
ImmunityBio Shares Triple in Three Weeks, Short-Sellers Face $500 Million Loss
- Price Surge: ImmunityBio's stock price has tripled over three weeks, closing at $6.92 on Wednesday with a 6.79% increase, indicating strong market interest in its immunotherapy developments, potentially attracting more investors.
- Volume Spike: Trading volume reached 93.5 million shares on Wednesday, about 357% above the three-month average of 20.5 million shares, signaling a significant rise in investor attention that could lead to further price volatility.
- Short-Seller Losses: With 35% of the public float held short, short-sellers now face nearly $500 million in paper losses, reflecting optimistic market sentiment towards ImmunityBio's future developments, which may prompt short-covering to mitigate losses.
- Market Reaction: Although there was no specific news driving the price increase, the actions of short-sellers covering their positions combined with recent positive developments have contributed to the stock's rise, showcasing ongoing interest in the biotechnology sector.
See More
Oncolytics Biotech Advances Immunotherapy for Accelerated Approval in Oncology
- Clinical Data Breakthrough: Oncolytics Biotech's pelareorep demonstrated a 29% objective response rate in GOBLET Cohort 4, significantly surpassing the historical benchmark of 10%, indicating substantial clinical value in third-line anal cancer patients with no FDA-approved treatment options.
- Duration of Response: The median duration of response reached approximately 17 months, far exceeding the standard treatment's 9.5 months, showcasing pelareorep's durable efficacy in heavily pretreated patients and addressing a critical unmet medical need.
- FDA Interaction Plan: Oncolytics plans to hold a Type C meeting with the FDA in Q1 2026 to discuss its registration-directed clinical study plan for second-line and later SCAC, with the potential for accelerated approval if data meets expectations.
- Strategic Investment and Expansion: The company is enhancing its expertise in gastrointestinal oncology through the expansion of its Scientific Advisory Board, further validating its Phase 3 study design for first-line metastatic pancreatic cancer, demonstrating its strategic positioning in the oncology immunotherapy landscape.
See More
CG Oncology Accelerates Phase 3 Data Readout to First Half of 2026
- Significant Stock Surge: Shares of CG Oncology Inc soared 21.8% to $51.05 after the announcement of an expedited topline data readout for the PIVOT-006 clinical trial, reflecting strong market confidence in the company's future prospects.
- Clinical Trial Advancement: The trial compares adjuvant intravesical treatment versus surveillance in patients with intermediate-risk non-muscle invasive bladder cancer, and the earlier data release is expected to attract more investor interest, further propelling the company's growth.
- Positive Market Reaction: This stock price increase not only indicates investor optimism about CG Oncology's potential but may also enhance the company's financing capabilities in the biopharmaceutical sector, strengthening its competitive position.
- Significant Industry Impact: CG Oncology's progress could influence treatment standards for non-muscle invasive bladder cancer, prompting other companies in the industry to accelerate their R&D efforts, thereby boosting overall market vitality.
See More
Cellectis Shares Under Pressure Following Allogene Arbitration Win on Tuesday
Cellectis Stock Decline: Shares of Cellectis S.A. fell 17.35% following a favorable arbitration outcome for Allogene Therapeutics, which confirmed Allogene's control over the CAR-T therapy cema-cel.
Arbitration Outcome Details: The tribunal dismissed Cellectis's claims against Servier, including financial claims related to milestone payments, and mandated a partial termination of the license concerning the discontinued UCART19 V1 product.
Allogene's Future Prospects: With the legal dispute resolved, Allogene is positioned for a significant catalyst period in 2026, including an interim analysis of cema-cel's efficacy in treating large B-cell lymphoma.
Current Stock Prices: As of the latest update, Cellectis stock is priced at $3.96, while Allogene stock is at $1.49, reflecting a 1.37% increase for Allogene.
See More
Allogene Secures Global Control of Cema-Cel, Interim Analysis Set for 1H 2026
- Legal Victory: Allogene's favorable arbitration outcome against Cellectis reaffirms its full control over cema-cel, securing development and commercialization rights in the U.S., EU, and UK, thereby paving the way for global market expansion.
- Financial Impact: The ruling dismissed Cellectis's financial claims, clarifying that milestone payments are contingent upon FDA acceptance of a Biologics License Application, which alleviates short-term financial pressures for Allogene.
- Clinical Progress: Allogene is set to conduct an interim futility analysis of cema-cel in the pivotal Phase 2 ALPHA3 trial in 1H 2026, aimed at evaluating its efficacy in large B-cell lymphoma patients, potentially yielding significant clinical data for the company.
- Market Outlook: With the arbitration results, Allogene strengthens its market position in the CAR T cell therapy sector, likely attracting more investments and enhancing its competitiveness in the global biotechnology market.
See More
