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The biotech sector witnessed a series of events over the past week. The FDA accepted Alkermes’ new drug application (“NDA”) for ALKS 5461. This provided a major a boost to the company’s stock. However, Celldex’s breast cancer study failed to meet the primary endpoint owing to which the stock plummeted significantly. In another news, Alexion announced plans to acquire Wilson Therapeutics for $855 million. Thus, the space remained one of the key areas of investors focus.
Recap of Important Stories:
Alkermes Jumps on FDA Decision: Following the FDA’s decision to review the NDA for ALKS 5461 for the treatment of major depressive disorder (“MDD”), shares of Alkermes ALKS moved up. The FDA had initially issued a Refusal to File letter on Mar 30 for the candidate stating that the NDA did not have enough evidence for the oral medication to work. The FDA suggested that additional studies might be required to demonstrate the drug’s overall effectiveness for the proposed indication. ALKS 5461, a once-daily oral medication has been developed for the adjunctive treatment of MDD in patients who have not responded well to standard antidepressant therapies. The FDA's acceptance of the ALKS 5461 NDA and rescission of the Refusal to File letter followed productive interactions with the Agency in which Alkermes clarified certain aspects of the NDA submission. No additional data or analyses were submitted by Alkermes to FDA. The FDA has set an action date of Jan 31, 2019. (Read more: Alkermes Rallies as FDA Accepts NDA for Depression Drug )
Alkermes currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here..
FDA Lifts Hold on Bellicum’s BPX-501: Bellicum BLCM announced that FDA has lifted clinical hold on studies conducted in the United States evaluating its T cell therapy, BPX-501. The company consulted with the regulatory body and agreed to make amendments to the study protocols, which include guidance on monitoring and management of neurologic adverse events.Bellicum will resume patient enrolment in the studies after implementing the amended protocols in the clinical study sites. BPX-501 is being developed as an adjunct T cell therapy for the treatment of patients with hematologic cancers and inherited blood diseases, who have undergone haploidentical (partial match) hematopoietic stem cell transplant.However, Bellicum claims the clinical hold did not have any impact on the ongoing registrational study, BP-004, in Europe, which was evaluating BPX-501 in pediatric patients with acute myeloid leukemia and primary immunodeficiencies. Per interim data announced in March, BPX-501 has demonstrated anti-leukemic effect in patients with AML in the study. (Read more: FDA Lifts Clinical Hold on Bellicum's T Cell Therapy)
Alexion to Acquire Wilson Therapeutics: Alexion ALXN recently announced that it will acquire Sweden-based Wilson Therapeutics. Alexion has offered SEK 232 in cash for each outstanding share of Wilson Therapeutics which translates into a total transaction value of $855 million.
Alexion has already obtained shareholder support agreements from the four largest shareholders accounting for 57.4% of Wilson Therapeutics’ outstanding shares and two additional shareholders accounting for 8.7% for a total of 66.1% of the company’s outstanding shares. The transaction is expected to close in the second quarter.The acquisition will add a late-stage candidate, WTX101 to Alexion’s pipeline. The candidate is currently in phase III for the treatment of Wilson disease, a rare genetic disorder. The candidate is a first-in-class oral copper-binding agent with a unique mechanism of action and ability to access and bind copper from serum and promote its removal from the liver.The candidate has also obtained Fast Track Designation in the United States and enjoys Orphan Drug Designation for the treatment of Wilson disease in the United States and EU. (Read more: Alexion to Acquire Wilson Therapeutics for $855M)
Celldex’s Breast Cancer Study Fails: Celldex CLDX plummeted as the phase IIb study, glembatumumab vedotin failed. The candidate failed to meet the primary endpoint of progression-free survival (“PFS”) benefit over Roche’s chemotherapy, Xeloda, in the treatment of metastatic triple-negative breast cancers that overexpress gpNMB. An assessment of the data from the mid-stage study showed that glembatumumab vedotin achieved a PFS of 2.9 months versus 2.8 months for Xeloda.The candidate was also not able to demonstrate significant advantage in key secondary endpoints, including overall response rate, duration of response and overall survival. Following the failure, Celldex has decided to discontinue studies evaluating glembatumumab vedotin across all indications. The company is currently restructuring its pipeline to focus on five candidates in ongoing clinical studies, which includes varlilumab. It may also reduce its workforce. (Read more: Celldex's Phase II Breast Cancer Study Fails, Shares Plunge)
Gilead Presents Encouraging Data on NASH Therapies: Gilead GILD announced encouraging data from a proof-of-concept study of experimental combination therapies for patients with advanced fibrosis due to nonalcoholic steatohepatitis (NASH).The data were presented at The International Liver Congress 2018 in Paris. Apoptosis signal-regulating kinase 1 (ASK1) inhibitor selonsertib was combined with either the Acetyl-CoA carboxylase (ACC) inhibitor GS-0976 or the selective, non-steroidal Farnesoid X receptor agonist GS-9674 as therapies. Patients diagnosed with NASH and liver fibrosis stages F2 to F3 based on biopsy, or by magnetic resonance elastography and MRI proton density fat fraction (MRI-PDFF) enrolled in the s tudy. They were treated with either selonsertib 18 mg plus GS-0976 20 mg (n=20), selonsertib 18 mg plus GS-9674 30 mg (n=20), or each monotherapy (n=10 per group) once daily for 12 weeks.Patients treatment the most notable change that were observed was the decrease in liver fat content (measured by MRI-PDFF), which occurred in regimens containing GS-0976. The results also showed improvements in liver biochemistry and/or markers of fibrosis across both combination arms of the study compared to baseline. Moreover, patients treated with selonsertib plus GS-0976, kinetic labeling showed reduction in the fractional synthesis rate of lumican, a marker of fibrogenesis.Hence, the favorable results suggest that combination therapy with selonsertib and either GS-0976 or GS-9674 can be evaluated further in patients with NASH and F3 and F4 fibrosis. (Read more:Gilead Presents Encouraging Data on NASH Therapies)
Medical - Biomedical and Genetics Industry 5YR % Return
Medical - Biomedical and Genetics Industry 5YR % Return
The NASDAQ Biotechnology Index gained 1.82% over the last five trading sessions. Among major biotech stocks, Vertex gained 3.84%. Over the last six months, Celgene lost 34.39% while Vertex gained 6.41% (See the last biotech stock roundup here:Biotech Stock Roundup: Spectrum Up, Incyte Down, AveXis to Merge with Novartis).
What's Next in the Biotech World?
Stay tuned for more regulatory and pipeline updates.
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Alexion Pharmaceuticals, Inc. (ALXN) : Free Stock Analysis Report
Alkermes plc (ALKS) : Free Stock Analysis Report
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