The biotech sector was in the spotlight with fourth-quarter results. Other pipeline and regulatory updates were also in focus.
Recap of the Week’s Most Important Stories:
Biogen’s Q4 Earnings: Biogen (BIIB - Free Report) reported better-than-expected results as it topped both earnings and revenue estimates. Adjusted earnings per share (EPS) of $4.05 beat the Zacks Consensus Estimate of $3.51. Earnings rose 19% year over year, driven by lower costs. Sales came in at $2.54 billion, down 7% on a reported basis (4% on a constant-currency basis) from the year-ago quarter due to lower sales of multiple sclerosis (MS) drugs like Tecfidera. However, sales of the spinal muscular atrophy (SMA) drug, Spinraza, improved in the quarter. Sales beat the Zacks Consensus Estimate and our estimate of $2.44 billion and $2.43 billion, respectively. For 2023, Biogen expects adjusted EPS in the range of $15.00 to $16.00 and the Zacks Consensus Estimate is pegged at $15.77.
Blueprint's Study on Hold: Blueprint Medicines (BPMC ) announced that the FDA placed a partial clinical hold on phase I/II study of pipeline candidate BLU-222. The company is developing investigational inhibitor, BLU-222, targeting CDK2 for the treatment of patients with CDK2-vulnerable cancers. The company initiated the phase I/II study, VELA, of BLU-222 in the first quarter of 2022. BLU-222 is being evaluated in the phase I dose escalation portion of the VELA trial.
The regulatory body informed the company about the hold in verbal communication. The partial clinical hold was placed due to visual adverse events (AEs) observed in a limited number of patients. Patients currently enrolled in the trial are continuing to take the study drug at this time, but additional patients will not be enrolled until the partial clinical hold is resolved.
The reported visual AEs consisted of transient, reversible episodes of light sensitivity and blurred vision. All events were Grade 1, except one Grade 3 event involving light sensitivity and blurred vision in a patient treated at 600 mg BID. The company claims to have resolved all events involving dose interruption or reduction.
The company has stated that patients have been treated with BLU-222 at doses ranging from 50 mg BID to 800 mg BID to date, with evidence of clinical benefit observed and no discontinuations due to AEs.
Blueprint Medicines will look to amend the VELA trial protocol to provide specific guidance to investigators on how to monitor and manage these events, should they occur. The company targets to present its initial dose escalation data from the VELA trial of BLU-222 in the first half of 2023.
Blueprint Medicines currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Updates From Emergent BioSolutions: Emergent (EBS - Free Report) announced that the FDA’s Nonprescription Drugs Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee have unanimously voted in favor (a total of 19 votes) of Narcan (naloxone HCI) nasal spray for over-the-counter use. The FDA Advisory Committees were of the opinion that the benefit-risk profile of NARCAN (naloxone HCl) Nasal Spray is supportive of its use as a nonprescription opioid overdose reversal agent. Emergent presented an overview of its over-the-counter (OTC) development program, the medical need, Human Factors study data and seven years of post-marketing safety data. The FDA is not bound by the committees’ guidance but will take its advice into consideration. Shares gained on the same.
Emergent also entered into an agreement to sell its travel health business to Bavarian Nordic for 380 million, including potential future milestone payments. Per the terms, Bavarian Nordic will acquire the rights to Vivotif, indicated for the active immunization to prevent typhoid fever, and Vaxchora, indicated for the active immunization to prevent cholera, as well as the development-stage chikungunya vaccine candidate CHIKV VLP. Bavarian Nordic will also acquire Emergent’s manufacturing site in Bern, Switzerland, and development facilities in San Diego, CA.
Performance
The Nasdaq Biotechnology Index has lost 0.75% in the past five trading sessions. Among the biotech giants, Moderna has gained 7.90% during the period. Over the past six months, shares of Gilead have soared 30.99%. (See the last biotech stock roundup here: Biotech Stock Roundup: AMGN, GILD, BMY, REGN’s Q4 Results, KPRX Up on Study Update)
What's Next in Biotech?
Stay tuned for other updates.
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The biotech sector was in the spotlight with fourth-quarter results. Other pipeline and regulatory updates were also in focus.
Recap of the Week’s Most Important Stories:
Biogen’s Q4 Earnings: Biogen (BIIB - Free Report) reported better-than-expected results as it topped both earnings and revenue estimates. Adjusted earnings per share (EPS) of $4.05 beat the Zacks Consensus Estimate of $3.51. Earnings rose 19% year over year, driven by lower costs. Sales came in at $2.54 billion, down 7% on a reported basis (4% on a constant-currency basis) from the year-ago quarter due to lower sales of multiple sclerosis (MS) drugs like Tecfidera. However, sales of the spinal muscular atrophy (SMA) drug, Spinraza, improved in the quarter. Sales beat the Zacks Consensus Estimate and our estimate of $2.44 billion and $2.43 billion, respectively. For 2023, Biogen expects adjusted EPS in the range of $15.00 to $16.00 and the Zacks Consensus Estimate is pegged at $15.77.
Blueprint's Study on Hold: Blueprint Medicines (BPMC ) announced that the FDA placed a partial clinical hold on phase I/II study of pipeline candidate BLU-222. The company is developing investigational inhibitor, BLU-222, targeting CDK2 for the treatment of patients with CDK2-vulnerable cancers. The company initiated the phase I/II study, VELA, of BLU-222 in the first quarter of 2022. BLU-222 is being evaluated in the phase I dose escalation portion of the VELA trial.
The regulatory body informed the company about the hold in verbal communication. The partial clinical hold was placed due to visual adverse events (AEs) observed in a limited number of patients. Patients currently enrolled in the trial are continuing to take the study drug at this time, but additional patients will not be enrolled until the partial clinical hold is resolved.
The reported visual AEs consisted of transient, reversible episodes of light sensitivity and blurred vision. All events were Grade 1, except one Grade 3 event involving light sensitivity and blurred vision in a patient treated at 600 mg BID. The company claims to have resolved all events involving dose interruption or reduction.
The company has stated that patients have been treated with BLU-222 at doses ranging from 50 mg BID to 800 mg BID to date, with evidence of clinical benefit observed and no discontinuations due to AEs.
Blueprint Medicines will look to amend the VELA trial protocol to provide specific guidance to investigators on how to monitor and manage these events, should they occur. The company targets to present its initial dose escalation data from the VELA trial of BLU-222 in the first half of 2023.
Blueprint Medicines currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Updates From Emergent BioSolutions: Emergent (EBS - Free Report) announced that the FDA’s Nonprescription Drugs Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee have unanimously voted in favor (a total of 19 votes) of Narcan (naloxone HCI) nasal spray for over-the-counter use. The FDA Advisory Committees were of the opinion that the benefit-risk profile of NARCAN (naloxone HCl) Nasal Spray is supportive of its use as a nonprescription opioid overdose reversal agent. Emergent presented an overview of its over-the-counter (OTC) development program, the medical need, Human Factors study data and seven years of post-marketing safety data. The FDA is not bound by the committees’ guidance but will take its advice into consideration. Shares gained on the same.
Emergent also entered into an agreement to sell its travel health business to Bavarian Nordic for 380 million, including potential future milestone payments. Per the terms, Bavarian Nordic will acquire the rights to Vivotif, indicated for the active immunization to prevent typhoid fever, and Vaxchora, indicated for the active immunization to prevent cholera, as well as the development-stage chikungunya vaccine candidate CHIKV VLP. Bavarian Nordic will also acquire Emergent’s manufacturing site in Bern, Switzerland, and development facilities in San Diego, CA.
Performance
The Nasdaq Biotechnology Index has lost 0.75% in the past five trading sessions. Among the biotech giants, Moderna has gained 7.90% during the period. Over the past six months, shares of Gilead have soared 30.99%. (See the last biotech stock roundup here: Biotech Stock Roundup: AMGN, GILD, BMY, REGN’s Q4 Results, KPRX Up on Study Update)
What's Next in Biotech?
Stay tuned for other updates.
Infrastructure Stock Boom to Sweep America
A massive push to rebuild the crumbling U.S. infrastructure will soon be underway. It’s bipartisan, urgent, and inevitable. Trillions will be spent. Fortunes will be made.
The only question is “Will you get into the right stocks early when their growth potential is greatest?”
Zacks has released a Special Report to help you do just that, and today it’s free. Discover 5 special companies that look to gain the most from construction and repair to roads, bridges, and buildings, plus cargo hauling and energy transformation on an almost unimaginable scale.
Download FREE: How To Profit From Trillions On Spending For Infrastructure >>
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