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Biotech Stock Roundup: ACAD's Drug Approval, SGEN to be Acquired by PFE & More
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The biotech sector was in focus with key pipeline and regulatory updates. Among these, Seagen was up on news of its acquisition by Pfizer. New drug approvals were also in the spotlight.
Recap of the Week’s Most Important Stories:
Acadia’s Drug Approval: Acadia Pharmaceuticals Inc. (ACAD - Free Report) announced that the FDA has approved trofinetide, under the brand name Daybue, for treating Rett syndrome in adult and pediatric patients two years of age and older. The FDA approval was supported by results from the phase III LAVENDER study which evaluated the efficacy and safety of trofinetide versus placebo in 187 female patients with Rett syndrome five to 20 years of age. Data showed treatment with Daybue demonstrated statistically significant improvement compared to placebo on both co-primary efficacy endpoints, as measured by the change from baseline in Rett Syndrome Behaviour Questionnaire (RSBQ) total score (p=0.018) and the Clinical Global Impression-Improvement (CGI-I) scale score (p=0.003) at week 12. Along with the FDA approval, Acadia has received a Rare Pediatric Disease Priority Review Voucher, which can be used to obtain priority review for a subsequent application.
GSK’s Vaccine Data: GSK plc (GSK - Free Report) announced positive data from a phase III study for its MenABCWY combination vaccine candidate, administered as two doses six months apart in healthy individuals aged 10-25 years. The phase III randomized, controlled, observer-blind, multi-country study is evaluating the safety, tolerability and immunogenicity of GSK’s MenABCWY vaccine candidate. MenABCWY vaccine candidate combines the antigenic components of its licensed meningococcal vaccines, Bexsero (MenB) and Menveo (MenACWY).
The study met all its primary endpoints, including the non-inferiority of the vaccine candidate for all five Neisseria meningitides serogroups (A, B, C, W, and Y) compared to licensed meningococcal vaccines Bexsero and Menveo in terms of an immune response. Per GSK, a potential approval of this 5-in-1 vaccine candidate could provide the broadest meningococcal serogroup coverage and lead to a simplified immunization schedule.
Setback for Mersana: Clinical-stage biopharmaceutical Mersana Therapeutics, Inc. (MRSN - Free Report) announced that the phase I study of XMT-2056 has been placed on clinical hold by the FDA. Mersana voluntarily suspended the trial due to a recent Grade 5 (fatal) serious adverse event (SAE) that was deemed related to XMT-2056 and informed the FDA about the same. XMT-2056 is Mersana’s first Immunosynthen STING-agonist ADC product candidate to enter the clinic. The SAE was observed in the second patient enrolled at the initial dose level in the dose escalation portion of the phase I study in previously treated patients with HER2+ recurrent or metastatic solid tumors.
Aridis Meets Study Goals: Aridis Pharmaceuticals, Inc. (ARDS - Free Report) announced positive preliminary top-line results from the randomized, double-blinded, placebo-controlled phase IIa study of AR-501. The study evaluated the safety and pharmacokinetics (PK) of three ascending doses of AR-501 administered as an inhaled aerosol in cystic fibrosis (CF) patients with confirmed pseudomonas aeruginosa bacterial and other potential infections. AR-501 is being developed as a once-per-week inhaled dosing regimen that is self-administered using a commercially available nebulizer device. The study’s primary and secondary endpoints of safety and PK were met.
The study achieved high uptake of AR-501 in the respiratory tract at levels that were more than 50-fold higher than required for inhibition of the target bacteria P. aeruginosa.
Seagen to be Acquired by Pfizer: Shares of Seagen, Inc. surged after pharma giant Pfizer announced that it will acquire the former for $229 in cash per share for a total enterprise value of $43 billion. The news was mostly expected as last month there were reports of the same. Seagen’s portfolio includes four approved drugs, including three ADCs: Adcetris (brentuximab vedotin), Padcev (enfortumab vedotin), and Tivdak (tisotumab vedotin). The company also commercializes Tuksya (tucatinib).
Seagen expects to generate approximately $2.2 billion of revenues in 2023, up 12% year over year, with growth from its four in-line medicines, royalties and collaboration and license agreements. Pfizer believes Seagen could contribute more than $10 billion in risk-adjusted revenues in 2030, with significant potential for growth beyond 2030.
Performance
The Nasdaq Biotechnology Index has lost 0.10% in the past five trading sessions. Among the biotech giants, Moderna has gained 5.29% during the period. Over the past six months, shares of Biogen have soared 26.92%. (See the last biotech stock roundup here: Biotech Stock Roundup: PTGX Gains on Study Data, BMRN Faces Setback & More)
What's Next in Biotech?
Stay tuned for other updates.
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Biotech Stock Roundup: ACAD's Drug Approval, SGEN to be Acquired by PFE & More
The biotech sector was in focus with key pipeline and regulatory updates. Among these, Seagen was up on news of its acquisition by Pfizer. New drug approvals were also in the spotlight.
Recap of the Week’s Most Important Stories:
Acadia’s Drug Approval: Acadia Pharmaceuticals Inc. (ACAD - Free Report) announced that the FDA has approved trofinetide, under the brand name Daybue, for treating Rett syndrome in adult and pediatric patients two years of age and older. The FDA approval was supported by results from the phase III LAVENDER study which evaluated the efficacy and safety of trofinetide versus placebo in 187 female patients with Rett syndrome five to 20 years of age. Data showed treatment with Daybue demonstrated statistically significant improvement compared to placebo on both co-primary efficacy endpoints, as measured by the change from baseline in Rett Syndrome Behaviour Questionnaire (RSBQ) total score (p=0.018) and the Clinical Global Impression-Improvement (CGI-I) scale score (p=0.003) at week 12. Along with the FDA approval, Acadia has received a Rare Pediatric Disease Priority Review Voucher, which can be used to obtain priority review for a subsequent application.
Acadia currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
GSK’s Vaccine Data: GSK plc (GSK - Free Report) announced positive data from a phase III study for its MenABCWY combination vaccine candidate, administered as two doses six months apart in healthy individuals aged 10-25 years. The phase III randomized, controlled, observer-blind, multi-country study is evaluating the safety, tolerability and immunogenicity of GSK’s MenABCWY vaccine candidate. MenABCWY vaccine candidate combines the antigenic components of its licensed meningococcal vaccines, Bexsero (MenB) and Menveo (MenACWY).
The study met all its primary endpoints, including the non-inferiority of the vaccine candidate for all five Neisseria meningitides serogroups (A, B, C, W, and Y) compared to licensed meningococcal vaccines Bexsero and Menveo in terms of an immune response. Per GSK, a potential approval of this 5-in-1 vaccine candidate could provide the broadest meningococcal serogroup coverage and lead to a simplified immunization schedule.
Setback for Mersana: Clinical-stage biopharmaceutical Mersana Therapeutics, Inc. (MRSN - Free Report) announced that the phase I study of XMT-2056 has been placed on clinical hold by the FDA. Mersana voluntarily suspended the trial due to a recent Grade 5 (fatal) serious adverse event (SAE) that was deemed related to XMT-2056 and informed the FDA about the same. XMT-2056 is Mersana’s first Immunosynthen STING-agonist ADC product candidate to enter the clinic. The SAE was observed in the second patient enrolled at the initial dose level in the dose escalation portion of the phase I study in previously treated patients with HER2+ recurrent or metastatic solid tumors.
Aridis Meets Study Goals: Aridis Pharmaceuticals, Inc. (ARDS - Free Report) announced positive preliminary top-line results from the randomized, double-blinded, placebo-controlled phase IIa study of AR-501. The study evaluated the safety and pharmacokinetics (PK) of three ascending doses of AR-501 administered as an inhaled aerosol in cystic fibrosis (CF) patients with confirmed pseudomonas aeruginosa bacterial and other potential infections. AR-501 is being developed as a once-per-week inhaled dosing regimen that is self-administered using a commercially available nebulizer device.
The study’s primary and secondary endpoints of safety and PK were met.
The study achieved high uptake of AR-501 in the respiratory tract at levels that were more than 50-fold higher than required for inhibition of the target bacteria P. aeruginosa.
Seagen to be Acquired by Pfizer: Shares of Seagen, Inc. surged after pharma giant Pfizer announced that it will acquire the former for $229 in cash per share for a total enterprise value of $43 billion. The news was mostly expected as last month there were reports of the same. Seagen’s portfolio includes four approved drugs, including three ADCs: Adcetris (brentuximab vedotin), Padcev (enfortumab vedotin), and Tivdak (tisotumab vedotin). The company also commercializes Tuksya (tucatinib).
Seagen expects to generate approximately $2.2 billion of revenues in 2023, up 12% year over year, with growth from its four in-line medicines, royalties and collaboration and license agreements. Pfizer believes Seagen could contribute more than $10 billion in risk-adjusted revenues in 2030, with significant potential for growth beyond 2030.
Performance
The Nasdaq Biotechnology Index has lost 0.10% in the past five trading sessions. Among the biotech giants, Moderna has gained 5.29% during the period. Over the past six months, shares of Biogen have soared 26.92%. (See the last biotech stock roundup here: Biotech Stock Roundup: PTGX Gains on Study Data, BMRN Faces Setback & More)
What's Next in Biotech?
Stay tuned for other updates.