Top Biotech Gainers: BOLD Begins Anew, MNPR NDA Filing On Track, GALT Soars On FDA Alignment
I'm LongbridgeAI, I can summarize articles.Top biotech gainers include Boundless Bio (BOLD), which agreed to merge with Serapha Bio, and Galectin Therapeutics (GALT), which reached an FDA agreement on its Phase 3 MASH program. Monopar Therapeutics (MNPR) is on track for an NDA submission for Wilson disease treatment in mid-2026. Jade Biosciences (JBIO) advanced its autoimmune pipeline with positive Phase 1 results, while Edesa Biotech (EDSA) and Treace Medical Concepts (TMCI) also saw significant stock increases due to clinical progress and product commercialization updates.
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Today's top gainers include Boundless Bio, which is combining with privately held Serapha; Monopar, on track for an NDA submission of ALXN1840 for Wilson disease; Jade Biosciences, advancing its autoimmune disease pipeline; and Galectin Therapeutics, which has reached an agreement with the FDA on key elements of its planned Phase 3 MASH program, among others.
Read on…
Boundless Bio Makes a Bold Move with Serapha Merger
Boundless Bio Inc. (BOLD) has agreed to combine with privately held Serapha Bio, Inc in an all-stock merger. Before the closing, Boundless Bio expects to declare a cash dividend to pre-merger Boundless stockholders.
The transaction is expected to close in the fourth quarter of 2026.
Following completion of the transaction, the combined company plans to operate under the name Serapha Bio, Inc. and is expected to trade on Nasdaq under the ticker symbol "AATD".
Serapha's lead clinical-stage candidate is SERP-01, being developed for the treatment of severe Alpha-1 Antitrypsin Deficiency (AATD). Serapha licensed SERP-01, developed as YOLT-202 in Greater China, from YolTech Therapeutics in June 2026, in exchange for an upfront cash payment and a minority equity stake in Serapha.
BOLD closed Tuesday's trading at $2.60, up 85.71%.
Monopar's NDA Submission On Track
Shares of Monopar Therapeutics Inc. (MNPR) were up over 19% on Tuesday on no specific news.
This clinical-stage biopharmaceutical company has late-stage ALXN1840 for Wilson disease, and radiopharmaceutical programs including MNPR-101-Zr (Phase 1) for imaging advanced cancers along with MNPR-101-Lu (Phase 1a) and MNPR-101-Ac (late preclinical) for the treatment of advanced cancers.
The company plans to submit its New Drug Application for ALXN1840 for the treatment of Wilson disease to the FDA in mid-2026.
MNPR closed Tuesday's trading at $81.77, up 19.09%.
Jade Moves Ahead with Clinical Progress
Jade Biosciences Inc. (JBIO), a biotechnology company developing therapies for autoimmune diseases, has several clinical trial events to watch in the coming months.
Earlier this month, the company reported positive interim results from its Phase 1 trial evaluating JADE101 in development for the treatment of immunoglobulin A nephropathy (IgAN). A Phase 2 clinical trial in patients with IgA nephropathy, dubbed JUNIPER, is underway, with interim clinical data expected in 2027.
A Phase 3 registrational trial of JADE101 in IgAN is expected to be initiated in the first half of 2027.
Last month, the company dosed the first participant in a Phase 1 clinical trial evaluating single ascending doses of JADE201 in participants with rheumatoid arthritis, with interim data expected in 2027.
JBIO closed Tuesday's trading at $21.97, up 12.96%.
What's the Buzz at Edesa?
Edesa Biotech Inc. (EDSA) was also one of the top gainers on Tuesday, with shares jumping over 12%.
This clinical-stage biopharmaceutical company is developing host-directed therapeutics for immuno-inflammatory diseases.
The company plans to begin patient recruitment in its Phase 2 clinical study of EB06 in moderate-to-severe nonsegmental vitiligo in mid-2026. Its lead drug candidate Paridiprubart is under a Phase 3 study in subjects with Acute Respiratory Distress Syndrome. Also in the pipeline is Daniluromer, a Phase 3-ready asset developed for use as a potential therapy for Allergic Contact Dermatitis, a common occupational skin condition.
EDSA closed Tuesday's trading at $7.64, up 12.19%.
Treace Medical on the Move
Shares of Treace Medical Concepts, Inc. (TMCI) were up nearly 12% on Tuesday on no specific news.
Last week, the company announced the successful completion of the first case utilizing its HyperPlate XM Dynamic Compression Locking Implant. It is a foot and ankle implant that can be used in a variety of midfoot and hindfoot surgeries, including bone fusion procedures and Evans calcaneal osteotomies.
Full commercialization of the HyperPlate XM Dynamic Compression Locking Implant, along with a suite of complementary sterile instruments, is anticipated in the third quarter of 2026.
For the first quarter ended March 31, 2026, the results of which were reported last month, revenue was $47.2 million compared to $52.6 million in the same period in 2025.
TMCI closed Tuesday's trading at $4.49, up 11.97%.
Galectin's Phase 3 MASH Trial Gains Momentum
Galectin Therapeutics Inc. (GALT) has reached an agreement with the FDA on the key elements of its planned Phase 3 program for Belapectin in the treatment of patients with metabolic dysfunction-associated steatohepatitis (MASH) cirrhosis and portal hypertension.
The company is expected to submit the final Phase 3 protocol in the third quarter of 2026.
The trial's primary endpoint will be a composite measure of liver health, including preventing the development of large esophageal varices (more than 5 mm), which indicate worsening disease in patients with compensated MASH cirrhosis.
The company is also actively pursuing potential strategic and financial partners.
GALT closed Tuesday's trading at $3.12, up 11.43%.
Did you Know?
In humans, each cell has 23 pairs of chromosomes. In individuals with Down syndrome, instead of two copies of Chromosome 21, there are three copies in all cells - a reason why the condition is also known as Trisomy 21.
A research team led by Dr.Ryotaro Hashizume from the Mie University Graduate School of Medicine, Japan, has developed a pioneering technique for eliminating the extra copy of Chromosome 21 in cells derived from individuals with Down syndrome by using the CRISPR-Cas9 genome editing technology. According to the authors, a similar approach will lay the groundwork for more sophisticated medical interventions targeting Trisomy 21. (Source: PNAS Nexus Journal).
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