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Biotech Stock Roundup: BLUE Down on Share Issuance, CPRX Falls on Generic Filing & More
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The biotech sector was in focus with key pipeline and regulatory updates. Among these, bluebird (BLUE - Free Report) was significantly down on the issuance of additional shares.
Recap of the Week’s Most Important Stories:
bluebird Down on Secondary Issue: Shares of bluebird bio were down after it announced a secondary issue of 20 million shares of its common stock to the public at an issue price of $6.00 per share (excluding underwriting discounts), approximately amounting to $120 million. bluebird also granted an option to underwriters of the issue to purchase an additional 3 million shares at the same price.
Investors were most likely disappointed with such a large issuance, which will significantly dilute the existing shareholder base. The company plans to use the net proceeds from this new issue and its existing cash balance to support the commercialization and manufacturing activities for its recently approved gene therapy treatments. It also plans to use the proceeds to accelerate the future commercialization activities of its new gene therapy candidate, lovotibeglogene autotemcel (lovo-cel), for sickle cell disease. Management will also use the proceeds for general corporate purposes, including working capital requirements.
Catalyst Down on Generic Filing: Catalyst Pharmaceuticals (CPRX - Free Report) received a Paragraph IV Certification Notice Letter stating that generic company Teva Pharmaceuticals filed an abbreviated new drug application (ANDA) to the FDA for a generic version of Firdapse. The drug is Catalyst’s only marketed drug, and shares were down on the news. The FDA approved Firdapse in November 2018 as a treatment for Lambert-Eaton Myasthenic Syndrome (LEMS) in adults. Last September, the drug received label expansion from the regulatory agency for treating LEMS in children aged six through 17 years.
The notice letter, issued by Teva to CPRX, states that the former intends to market a generic version of Firdapse before the latter’s patents covering Firdapse expire. Teva alleges that Catalyst’s patents are neither valid nor enforceable. In the notice, Teva also states that the commercial manufacturing, use or sale of its own generic formulation of Firdapse will not infringe any of Catalyst’s patents. CPRX is currently assessing the notice letter and has 45 days from the date of receipt of the notice to decide whether to commence a patent infringement lawsuit against Teva for approving the ANDA.
Catalyst currently carries a Zacks Rank #1 (Strong Buy).
Axcella Gains on Regulatory Update: Shares of clinical-stage biotechnology company Axcella Therapeutics surged after the company announced a regulatory path to the registration of AXA1125 in the treatment of long COVID Fatigue. Axcella received regulatory guidance from the U.K.’s regulatory agency, The Medicines and Healthcare products Regulatory Agency (“MHRA”), supporting a single trial that could serve as the registration trial for patients with long COVID fatigue. The company and MHRA also aligned on key measurements, including primary endpoint and trial design. Axcella will meet the MHRA shortly to discuss the Innovative Licensing and Access Pathway (ILAP) application. In addition, Axcella submitted an investigational new drug (IND) application to the FDA for a phase IIb/III trial.
Pliant Surges on Study Data: Shares of Pliant Therapeutics, Inc. (PLRX - Free Report) surged after the company announced positive 12-week interim data from the 320 mg dose group of phase II INTEGRIS-IPF study evaluating bexotegrast (PLN-74809) in patients with idiopathic pulmonary fibrosis (IPF). The study is evaluating bexotegrast at once-daily doses of 40 mg, 80 mg, 160 mg, 320 mg or placebo for 12 weeks in 119 patients with IPF. The 320 mg group achieved its primary and secondary endpoints demonstrating that bexotegrast was well-tolerated over a 12-week treatment period and displayed a favorable pharmacokinetic profile.
Bexotegrast at 320 mg demonstrated a statistically significant mean increase in forced vital capacity (FVC) from baseline at all timepoints, surpassing all lower dose cohorts, and showed a strong treatment effect on FVC percent predicted (FVCpp), QLF and profibrotic biomarkers versus placebo at 12 weeks. The study will continue at this dose level until all patients have been treated for at least 24 weeks, with final data expected in the second quarter of 2023.
Performance
The Nasdaq Biotechnology Index has gained 0.17% in the past five trading sessions. Among the biotech giants, Moderna has jumped 3.18% during the period. Over the past six months, shares of Biogen have soared 41.52%. (See the last biotech stock roundup here: Biotech Stock Roundup: REGN Down on Eylea Data, CINC Surges on AZN Offer & More)
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What's Next in Biotech?
Stay tuned for other updates.
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Biotech Stock Roundup: BLUE Down on Share Issuance, CPRX Falls on Generic Filing & More
The biotech sector was in focus with key pipeline and regulatory updates. Among these, bluebird (BLUE - Free Report) was significantly down on the issuance of additional shares.
Recap of the Week’s Most Important Stories:
bluebird Down on Secondary Issue: Shares of bluebird bio were down after it announced a secondary issue of 20 million shares of its common stock to the public at an issue price of $6.00 per share (excluding underwriting discounts), approximately amounting to $120 million. bluebird also granted an option to underwriters of the issue to purchase an additional 3 million shares at the same price.
Investors were most likely disappointed with such a large issuance, which will significantly dilute the existing shareholder base. The company plans to use the net proceeds from this new issue and its existing cash balance to support the commercialization and manufacturing activities for its recently approved gene therapy treatments. It also plans to use the proceeds to accelerate the future commercialization activities of its new gene therapy candidate, lovotibeglogene autotemcel (lovo-cel), for sickle cell disease. Management will also use the proceeds for general corporate purposes, including working capital requirements.
Catalyst Down on Generic Filing: Catalyst Pharmaceuticals (CPRX - Free Report) received a Paragraph IV Certification Notice Letter stating that generic company Teva Pharmaceuticals filed an abbreviated new drug application (ANDA) to the FDA for a generic version of Firdapse. The drug is Catalyst’s only marketed drug, and shares were down on the news. The FDA approved Firdapse in November 2018 as a treatment for Lambert-Eaton Myasthenic Syndrome (LEMS) in adults. Last September, the drug received label expansion from the regulatory agency for treating LEMS in children aged six through 17 years.
The notice letter, issued by Teva to CPRX, states that the former intends to market a generic version of Firdapse before the latter’s patents covering Firdapse expire. Teva alleges that Catalyst’s patents are neither valid nor enforceable. In the notice, Teva also states that the commercial manufacturing, use or sale of its own generic formulation of Firdapse will not infringe any of Catalyst’s patents. CPRX is currently assessing the notice letter and has 45 days from the date of receipt of the notice to decide whether to commence a patent infringement lawsuit against Teva for approving the ANDA.
Catalyst currently carries a Zacks Rank #1 (Strong Buy).
You can see the complete list of today’s Zacks #1 Rank stocks here.
Axcella Gains on Regulatory Update: Shares of clinical-stage biotechnology company Axcella Therapeutics surged after the company announced a regulatory path to the registration of AXA1125 in the treatment of long COVID Fatigue. Axcella received regulatory guidance from the U.K.’s regulatory agency, The Medicines and Healthcare products Regulatory Agency (“MHRA”), supporting a single trial that could serve as the registration trial for patients with long COVID fatigue. The company and MHRA also aligned on key measurements, including primary endpoint and trial design. Axcella will meet the MHRA shortly to discuss the Innovative Licensing and Access Pathway (ILAP) application. In addition, Axcella submitted an investigational new drug (IND) application to the FDA for a phase IIb/III trial.
Pliant Surges on Study Data: Shares of Pliant Therapeutics, Inc. (PLRX - Free Report) surged after the company announced positive 12-week interim data from the 320 mg dose group of phase II INTEGRIS-IPF study evaluating bexotegrast (PLN-74809) in patients with idiopathic pulmonary fibrosis (IPF). The study is evaluating bexotegrast at once-daily doses of 40 mg, 80 mg, 160 mg, 320 mg or placebo for 12 weeks in 119 patients with IPF. The 320 mg group achieved its primary and secondary endpoints demonstrating that bexotegrast was well-tolerated over a 12-week treatment period and displayed a favorable pharmacokinetic profile.
Bexotegrast at 320 mg demonstrated a statistically significant mean increase in forced vital capacity (FVC) from baseline at all timepoints, surpassing all lower dose cohorts, and showed a strong treatment effect on FVC percent predicted (FVCpp), QLF and profibrotic biomarkers versus placebo at 12 weeks. The study will continue at this dose level until all patients have been treated for at least 24 weeks, with final data expected in the second quarter of 2023.
Performance
The Nasdaq Biotechnology Index has gained 0.17% in the past five trading sessions. Among the biotech giants, Moderna has jumped 3.18% during the period. Over the past six months, shares of Biogen have soared 41.52%. (See the last biotech stock roundup here: Biotech Stock Roundup: REGN Down on Eylea Data, CINC Surges on AZN Offer & More)
Image Source: Zacks Investment Research
What's Next in Biotech?
Stay tuned for other updates.