Checkpoint Therapeutics

Sun Pharma Invests $25 Million in Pharmazz, Expanding Stake to 22.7% and Securing Key Drug Rights

a day ago

• Sun Pharmaceutical Industries Ltd has announced a strategic $25 million investment in US-based Pharmazz Inc, increasing its ownership stake to 22.7% in the biopharmaceutical company. • The investment will be completed in stages, with an initial $10 million tranche plus $7.5 million from a previous agreement by May 2025, and an additional $15 million expected by November 2025. • Through this investment, Sun Pharma secures exclusive rights to market Sovateltide in select emerging markets and gains options to negotiate licensing rights in certain developed countries.

Novo Nordisk Launches NovoCare® Pharmacy, Offering Authentic Wegovy® at $499 Monthly

2 months ago

• Novo Nordisk has introduced NovoCare® Pharmacy, providing FDA-approved Wegovy® (semaglutide) at $499 per month for cash-paying patients, with convenient home delivery service. • The new service aims to combat the rising problem of counterfeit semaglutide products by offering reliable access to authentic medication in a once-weekly, single-dose pen format. • This initiative addresses affordability concerns for weight management medication while ensuring patients receive legitimate FDA-approved treatment amid growing demand for GLP-1 receptor agonists.

Fortress Biotech Reports Strong 2024 Results with Two FDA Approvals and Strategic Acquisition Deal

2 months ago

• Fortress Biotech secured FDA approvals for two key products in Q4 2024: Emrosi for inflammatory lesions of rosacea and UNLOXCYT for advanced cutaneous squamous cell carcinoma, with commercial launch of Emrosi already underway. • Subsidiary Checkpoint Therapeutics is being acquired by Sun Pharma in a deal valued at $4.10 per share plus potential CVR of $0.70, expected to generate approximately $28 million for Fortress plus a 2.5% royalty on UNLOXCYT sales. • FDA accepted New Drug Application for CUTX-101 for priority review with PDUFA date of September 30, 2025, potentially qualifying for a valuable Priority Review Voucher upon approval.

Sun Pharma to Acquire Checkpoint Therapeutics in $355 Million Deal for Novel Skin Cancer Treatment

3 months ago

• Sun Pharmaceutical Industries will acquire Checkpoint Therapeutics for $355 million upfront, with stockholders receiving $4.10 per share plus a contingent value right worth up to $0.70 per share based on European approval milestones. • The acquisition adds UNLOXCYT (cosibelimab-ipdl), the first and only FDA-approved anti-PD-L1 treatment for advanced cutaneous squamous cell carcinoma (cSCC), to Sun Pharma's global onco-dermatology portfolio. • Sun Pharma plans to leverage its global presence to accelerate patient access to UNLOXCYT in the United States, Europe, and other markets worldwide, addressing a significant unmet need in the second most common skin cancer.

Biotech Deal Landscape: February-March 2025 Sees Surge in Partnerships Across Multiple Therapeutic Areas

3 months ago

• The first quarter of 2025 witnessed significant biotech partnership activity, with Eli Lilly, AstraZeneca, and Novo Nordisk emerging as top collaborators in deals worth billions across small molecules, antibodies, and RNA therapeutics. • February 2025 featured notable acquisitions including Novartis's $2.15 billion buyout of Anthos Therapeutics, while March saw AstraZeneca acquire Belgian biotech EsoBiotec and Bristol Myers Squibb purchase 2seventy bio for $286 million. • Obesity therapeutics gained significant traction in March 2025, with AbbVie entering the field through a $350 million upfront deal with Gubra for an amylin analog, while Roche partnered with Zealand Pharma on petrelintide in a deal worth up to $5.25 billion.

Cingulate's Once-Daily ADHD Drug CTx-1301 Shows Promising Safety Profile in Phase 3 Trials

3 months ago

• Cingulate's CTx-1301, a novel once-daily dexmethylphenidate formulation for ADHD, demonstrated consistent safety results across three Phase 3 trials with no serious adverse events reported. • The drug utilizes Precision Timed Release technology to deliver three precisely timed doses throughout the day, potentially eliminating the need for multiple daily medications. • With FDA meeting scheduled for April 2025 and NDA submission planned for mid-2025, CTx-1301 could address a significant unmet need in ADHD treatment affecting over 17 million Americans.

FDA Issues Complete Response Letter for Checkpoint's Cosibelimab in Advanced Skin Cancer

4 months ago

• The FDA has rejected Checkpoint Therapeutics' application for cosibelimab in advanced cutaneous squamous cell carcinoma, citing manufacturing facility issues rather than safety or efficacy concerns. • Clinical trials demonstrated promising results with a 55% overall response rate in locally advanced cSCC and 50% in metastatic disease, positioning cosibelimab as a potential low-cost alternative to existing treatments. • Checkpoint Therapeutics plans to address the manufacturing concerns and resubmit their application, aiming for potential approval in 2024, though the news triggered a 45% drop in company stock.

Basal Cell Carcinoma Market Set to Reach $9.7 Billion by 2035, Driven by Early Detection and Novel Therapies

4 months ago

• The global basal cell carcinoma market is projected to grow from $5.48 billion in 2024 to $9.7 billion by 2035, exhibiting a CAGR of 5.34% according to IMARC Group research. • Increased public awareness, improved diagnostic technologies, and a growing preference for non-invasive treatment options are key factors driving market expansion. • Novel therapies including hedgehog pathway inhibitors and immunotherapies are transforming treatment approaches, with companies like Verrica Pharmaceuticals and AiViva BioPharma advancing promising pipeline candidates.

FDA Grants Priority Review to CUTX-101 for Menkes Disease, Offering Hope for Rare Pediatric Condition

5 months ago

• The FDA has accepted Sentynl Therapeutics' NDA for CUTX-101, granting priority review for the treatment of Menkes disease, a rare genetic disorder. • Clinical trials of CUTX-101 demonstrated an almost 80% reduction in mortality risk compared to untreated patients, significantly improving overall survival. • CUTX-101 has been granted multiple designations, including Breakthrough Therapy and Orphan Drug, highlighting its potential to address a critical unmet need. • Cyprium Therapeutics is eligible to receive up to $129 million in milestone payments and royalties, retaining ownership of a potential Priority Review Voucher.

FDA Approves Multiple Breakthrough Therapies: Crenessity for CAH, Unloxcyt for Skin Cancer

5 months ago

• The FDA has approved Neurocrine's Crenessity as an adjunct therapy for classic congenital adrenal hyperplasia, offering patients a way to reduce steroid treatment burden. • Checkpoint Therapeutics received FDA approval for Unloxcyt to treat advanced cutaneous squamous cell carcinoma, targeting a $1 billion market opportunity. • Galderma's Nemluvio gains FDA approval for moderate-to-severe atopic dermatitis in patients 12 and older, with projected peak annual sales exceeding $2 billion.

FDA Approves Checkpoint Therapeutics' Unloxcyt for Advanced Cutaneous Squamous Cell Carcinoma

5 months ago

• The FDA has approved Unloxcyt (cosibelimab-ipdl) for metastatic or locally advanced cutaneous squamous cell carcinoma (cSCC) in adults who cannot undergo surgery or radiation. • Approval was based on Study CK-301-101, showing a 47% objective response rate in metastatic cSCC and 48% in locally advanced cSCC patients. • Unloxcyt is administered intravenously every three weeks and is the first PD-L1 blocking antibody approved for this specific indication. • Common adverse reactions include fatigue, musculoskeletal pain, rash, diarrhea and hypothyroidism, with serious immune-mediated reactions possible.

FDA Approves Checkpoint Therapeutics' Unloxcyt (cosibelimab-ipdl) for Advanced Cutaneous Squamous Cell Carcinoma

5 months ago

• The FDA has granted approval to Checkpoint Therapeutics' Unloxcyt (cosibelimab-ipdl) for the treatment of advanced cutaneous squamous cell carcinoma (cSCC). • Unloxcyt, a PD-L1 antibody, represents Checkpoint Therapeutics' first FDA-approved drug, marking a significant milestone for the company. • The approval allows Unloxcyt to compete in the U.S. market for cSCC, estimated to exceed $1 billion annually, offering a new treatment option. • Checkpoint Therapeutics is now developing a commercial launch plan for Unloxcyt, aiming to provide a differentiated treatment by targeting PD-L1.

FDA Wraps Up 2024 with Key Approvals for Drugs Targeting Various Conditions

6 months ago

• The FDA approved Vertex's Alyftrek for cystic fibrosis, offering improved dosing and potential market exclusivity. • Novo Nordisk's Alhemo was approved for hemophilia A and B, providing a new option for patients with inhibitors. • Bristol Myers Squibb's Opdivo Qvantig gained approval as a subcutaneous formulation, offering faster administration for various solid tumors. • Eli Lilly's Zepbound secured approval for obstructive sleep apnea in obese adults, marking the first prescription medicine for this condition.

FDA Approves Bizengri for NRG1 Fusion-Positive Lung and Pancreatic Cancers

7 months ago

• The FDA has granted accelerated approval to Bizengri (zenocutuzumab-zbco) for advanced pancreatic adenocarcinoma and non-small cell lung cancer with NRG1 gene fusions. • Bizengri is the first systemic therapy approved by the FDA specifically targeting NRG1 gene fusions in these cancers after prior systemic therapy. • Clinical trial data showed overall response rates of 40% in pancreatic cancer and 33% in NSCLC, with manageable side effects, supporting the approval. • This approval highlights the importance of biomarker testing to identify NRG1 fusions, enabling personalized treatment for these difficult-to-treat cancers.