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CHMP recommends five new drugs, gives advice on Celltrion COVID antibody
... European Medicines Agency?s (EMA) Committee for Medicinal Products for Human Use (CHMP) on Friday issued positive opinions for five new medicines and six extensions of therapeutic indications following its meeting earlier this week.
The newly recommended medicines include Verastem?s Copiktra (duvelisib) to treat relapsed or refractory chronic lymphocytic leukemia and refractory follicular lymphoma and Janssen-Cilag?s multiple sclerosis treatment Ponvory (ponesimod). The committee also recommended two oral contraceptives with the same active substances, Gedeon Richter?s Drovelis (estetrol/drospirenone), Estetra SPRL?s Lydisilka (estetrol/drospirenone), and Diurnal Europe BV?s hybrid medicine Efmody (hydrocortisone) for patients 12 and older with congenital adrenal hyperplasia (CAH)....
H.C. Wainwright analyst Sean Lee CFA maintained a Buy rating on Verastem (VSTM) today and set a price target of $4.00. The company?s shares closed last Wednesday at $2.80.
Verastem Oncology Receives Breakthrough Therapy Designation for VS-6766 with Defactinib in Recurrent Low-Grade Serous Ovarian Cancer
Results of Early Trial Demonstrate 70% Overall Response Rate (ORR) in Patients with KRAS Mutant Tumors, 44% ORR in KRAS Wild-Type Tumors and 52% ORR in All Evaluable Patients with a Favorable Safety Profile
Verastem Oncology and Amgen Partner to Evaluate VS-6766 in Combination with LUMAKRASTM (Sotorasib) in Patients with KRAS G12C-Mutant Non-Small Cell Lung Cancer
Verastem Oncology Announces Updated Investigator-Sponsored Phase 1/2 FRAME Study Data of VS-6766 with Defactinib in Low-Grade Serous Ovarian Cancer Showing Encouraging Response Rates and Progression-Free Survival Presented at ESMO 2021
?Median progression-free survival (mPFS) across all patients treated with VS-6766 in combination with defactinib in the study is 23.0 months.
?11 of 24 (46%) patients treated with the combination achieved a confirmed partial response (PR). Of the 11 patients with KRAS mutant LGSOC, 7 (64%) achieved a confirmed PR.
?Combination continues to exhibit a favorable tolerability profile.
?Top-line results from the selection portion of Verastem?s registration-directed Phase 2 RAMP 201 LGSOC study expected during the first half of 2022.
- Company Secures up to $150 Million in Non-Dilutive Funding from Oxford Finance LLC;
- Expected Cash Runway Through 2025 to Support Continued Development and Potential Commercial Launches of VS-6766 and Defactinib
- Enrollment Complete in Selection Phase (Part A) of RAMP 201 Evaluating VS-6766 +/- Defactinib for the Treatment of Low-Grade Serous Ovarian Cancer; Expect to Report Results from Part A in 2Q 2022
- Enrollment Complete in Selection Phase (Part A) of RAMP 202 Evaluating VS-6766 +/- Defactinib for the Treatment of KRAS G12V Mutant Non-Small Cell Lung Cancer; Expect to Report Results from Part A in 2H 2022