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Biotech Stock Roundup: AMGN's Acquisition, ACAD's Regulatory Update & More
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The biotech sector continues to be in focus with acquisition deals and drug approvals. Other pipeline and regulatory updates also grabbed the spotlight.
Recap of the Week’s Most Important Stories:
Amgen Acquires Five Prime Therapeutics:Amgen (AMGN - Free Report) announced that it will acquire a clinical-stage biotechnology company, Five Prime Therapeutics , for $38.00 per share in cash to strengthen its oncology portfolio. The offer price represents an equity value of approximately $1.9 billion. The acquisition will add the latter’s lead asset, bemarituzumab, a first-in-class, phase III ready, anti-FGFR2b antibody, to its portfolio. The transaction is expected to close by the end of the second quarter.
Five Prime has successfully completed a phase II study evaluating bemarituzumab in frontline advanced gastric or gastroesophageal junction (GEJ) cancer. Bemarituzumab targets FGFR2b, which has been found to be overexpressed in approximately 30% of patients with non-HER2 positive gastric cancer, as well as other solid tumors. Amgen plans to leverage its presence in Japan and other Asia-Pacific markets to maximize bemarituzumab's potential.
Gilead’s CAR T Cell Therapy Gets Approval for Another Indication: Gilead Sciences, Inc.’s (GILD - Free Report) Kite announced that the FDA has granted accelerated approval to its chimeric antigen receptor (CAR) T-cell therapy, Yescarta (axicabtagene ciloleucel), for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. Yescarta is already approved for adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high-grade B-cell lymphoma and DLBCL arising from FL.
The approval was based on results from ZUMA-5, a single-arm, open-label study, in which 91% of patients with relapsed or refractory FL (n=81) responded to Yescarta, including an estimated 74% of patients in a continued remission at 18 months (Kaplan-Meier estimate). Among all FL patients, the median duration of response was not reached at a median follow-up of 14.5 months.
The approval will strengthen Gilead’s CAR T cell therapy franchise, which includes another CAR T cell therapy — Tecartus.
Immunovant Up on a Possible Buyout: Shares of clinical-stage biopharmaceutical company Immunovant, Inc. (IMVT - Free Report) surged after its major stakeholder, Roivant Sciences Ltd., announced intentions to acquire all of the outstanding shares of the former. Roivant already has a 57.5% stake in the company and is considering to acquire the remaining. It expects any potential transaction to be at a per-share price representing a premium to current trading levels.
Roivant is evaluating a potential public listing that would take effect prior to the consummation of any transaction with Immunovant. Last month, Immunovant suffered a setback when it voluntarily paused dosing in studies on IMVT-1401 due to elevated total cholesterol and LDL levels observed in patients treated with the candidate.
The company has informed its regulators and investigators of this voluntary pause on dosing in ASCEND GO-2, a phase IIb trial in Thyroid Eye Disease (TED), and ASCEND-WAIHA, a phase II study in Warm Autoimmune Hemolytic Anemia (WAIHA).
Acadia Plunges on Regulatory Update: Shares of Acadia Pharmaceuticals Inc. (ACAD - Free Report) plunged significantly after it announced a notification from the FDA about the identification of some deficiencies in its review of the supplemental New Drug Application (sNDA) for pimavanserin. The notification was sent on Mar 3 as part of the agency’s ongoing review of the sNDA.
The FDA has identified deficiencies that preclude discussions of labeling and post-marketing requirements/commitments at this time. The FDA stated that the notification does not reflect a final decision on the information under review. However, the notification does not specify the deficiencies identified by the FDA and no clarification has been received from the agency until now. The candidate is approved under the brand name, Nuplazid, for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis.
Performance
Medical - Biomedical and Genetics Industry 5YR % Return
The Nasdaq Biotechnology Index lost 3.18% in the last five trading sessions. Among the biotech giants, Regeneron gained 3.51% during the period. Over the past six months, shares of Alexion have surged 40.9%. (See the last biotech stock roundup here : Biotech Stock Roundup: REGN, VIR's COVID-19 Updates, KMPH's Drug Approval & More)
What's Next in Biotech?
Stay tuned for more pipeline and regulatory updates.
5 Stocks Set to Double
Each was hand-picked by a Zacks expert as the #1 favorite stock to gain +100% or more in 2020. Each comes from a different sector and has unique qualities and catalysts that could fuel exceptional growth.
Most of the stocks in this report are flying under Wall Street radar, which provides a great opportunity to get in on the ground floor.
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Biotech Stock Roundup: AMGN's Acquisition, ACAD's Regulatory Update & More
The biotech sector continues to be in focus with acquisition deals and drug approvals. Other pipeline and regulatory updates also grabbed the spotlight.
Recap of the Week’s Most Important Stories:
Amgen Acquires Five Prime Therapeutics: Amgen (AMGN - Free Report) announced that it will acquire a clinical-stage biotechnology company, Five Prime Therapeutics , for $38.00 per share in cash to strengthen its oncology portfolio. The offer price represents an equity value of approximately $1.9 billion. The acquisition will add the latter’s lead asset, bemarituzumab, a first-in-class, phase III ready, anti-FGFR2b antibody, to its portfolio. The transaction is expected to close by the end of the second quarter.
Five Prime has successfully completed a phase II study evaluating bemarituzumab in frontline advanced gastric or gastroesophageal junction (GEJ) cancer. Bemarituzumab targets FGFR2b, which has been found to be overexpressed in approximately 30% of patients with non-HER2 positive gastric cancer, as well as other solid tumors. Amgen plans to leverage its presence in Japan and other Asia-Pacific markets to maximize bemarituzumab's potential.
Amgen currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Gilead’s CAR T Cell Therapy Gets Approval for Another Indication: Gilead Sciences, Inc.’s (GILD - Free Report) Kite announced that the FDA has granted accelerated approval to its chimeric antigen receptor (CAR) T-cell therapy, Yescarta (axicabtagene ciloleucel), for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. Yescarta is already approved for adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high-grade B-cell lymphoma and DLBCL arising from FL.
The approval was based on results from ZUMA-5, a single-arm, open-label study, in which 91% of patients with relapsed or refractory FL (n=81) responded to Yescarta, including an estimated 74% of patients in a continued remission at 18 months (Kaplan-Meier estimate). Among all FL patients, the median duration of response was not reached at a median follow-up of 14.5 months.
The approval will strengthen Gilead’s CAR T cell therapy franchise, which includes another CAR T cell therapy — Tecartus.
Immunovant Up on a Possible Buyout: Shares of clinical-stage biopharmaceutical company Immunovant, Inc. (IMVT - Free Report) surged after its major stakeholder, Roivant Sciences Ltd., announced intentions to acquire all of the outstanding shares of the former. Roivant already has a 57.5% stake in the company and is considering to acquire the remaining. It expects any potential transaction to be at a per-share price representing a premium to current trading levels.
Roivant is evaluating a potential public listing that would take effect prior to the consummation of any transaction with Immunovant. Last month, Immunovant suffered a setback when it voluntarily paused dosing in studies on IMVT-1401 due to elevated total cholesterol and LDL levels observed in patients treated with the candidate.
The company has informed its regulators and investigators of this voluntary pause on dosing in ASCEND GO-2, a phase IIb trial in Thyroid Eye Disease (TED), and ASCEND-WAIHA, a phase II study in Warm Autoimmune Hemolytic Anemia (WAIHA).
Acadia Plunges on Regulatory Update: Shares of Acadia Pharmaceuticals Inc. (ACAD - Free Report) plunged significantly after it announced a notification from the FDA about the identification of some deficiencies in its review of the supplemental New Drug Application (sNDA) for pimavanserin. The notification was sent on Mar 3 as part of the agency’s ongoing review of the sNDA.
The FDA has identified deficiencies that preclude discussions of labeling and post-marketing requirements/commitments at this time. The FDA stated that the notification does not reflect a final decision on the information under review. However, the notification does not specify the deficiencies identified by the FDA and no clarification has been received from the agency until now. The candidate is approved under the brand name, Nuplazid, for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis.
Performance
Medical - Biomedical and Genetics Industry 5YR % Return
Medical - Biomedical and Genetics Industry 5YR % Return
The Nasdaq Biotechnology Index lost 3.18% in the last five trading sessions. Among the biotech giants, Regeneron gained 3.51% during the period. Over the past six months, shares of Alexion have surged 40.9%. (See the last biotech stock roundup here : Biotech Stock Roundup: REGN, VIR's COVID-19 Updates, KMPH's Drug Approval & More)
Stay tuned for more pipeline and regulatory updates.
5 Stocks Set to Double
Each was hand-picked by a Zacks expert as the #1 favorite stock to gain +100% or more in 2020. Each comes from a different sector and has unique qualities and catalysts that could fuel exceptional growth.
Most of the stocks in this report are flying under Wall Street radar, which provides a great opportunity to get in on the ground floor.
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